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Investigate the feasibility of Pan-European controlled drug legislation

Essay Topic:

Abstract

Background

This research project focuses on the controlled drug legislative profile of two European countries (UKandGreece). An extensive review of the current legislation systems is made and any similarities and differences are underlined. The need of setting a pan-european legislation surrounding the safe and secure handling and distribution of controlled drugs regarding their therapeutic use is identified.

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Methods

Information was gathered by using Government official websites and Government Journals.UniversityofHuddersfieldlibrary facilities were also useful in supporting the literature review. Special emphasis was given to the key characteristics of the legal systems and the current clinical use of controlled drugs. The concise research study involved ten Greek and ten British pharmacists. They were asked to answer a questionnaire and their opinions were taken under consideration for the final results. These questions aimed at leading gradually to the answer of the initial query.

Results

The majority of the Greek pharmacists interviewed, believed that the present legislation system is not sufficient. On the other hand, British pharmacists appeared to be quite satisfied by the scheme. Regarding the suggestion of establishing a common controlled drug legislation in terms of European Union, most of the pharmacists claimed that such proposal is not possible.

Conclusions

After examining all the parameters, it was concluded that the suggestion to adopt a pan-european drug legislation scheme is feasible only under certain conditions. If it is necessary, a further subdivision of the EU should be applied for better management of the local healthcare systems. Therefore factors such as the financial status of the member-states in conjunction with cultural issues should be taken under consideration.

1. Introduction

1.1 European Union

In the 1950s (Paris Treaty, 1952) the need for a collective spirit and expression was revealed in the European continent by six countries (Belgium,France,West Germany,Italy, Luxemburg andNetherlands). Nowadays, what we call European Union is the result of the combination of European Coal and Steel Community and the European Economic Community which were finally combined and finalized afterMaastricht’s Treaty in 1993. The fundamental aim of the European Union is the wider economic and political union of a total of 27 member states. The European Union acts after the acquiescence of the member states and a number of institutions are there in order to facilitate processes (Europa, 2011).

With respect to each member state’s legislation, a wider European legislation has been developed aiming not to replace the existed laws, but rather to amplify them and to give a more universal character in the union. Such legislation positively affects a series of issues including European residents’ movement between European countries, goods, justice (Court of Justice of the European Union), national economies (European Central Bank), and regional development as well as having influence in fields such as agriculture and fisheries (Foreign & Commonwealth Office, 2010).

In 1999 the establishment of the ‘Eurozone’ came to enforce the economic and monetary character of the EU by the introduction of a common currency between European countries (Barnard, 2007). Only 17 out of the 27 member states have adopted and use the euro so far but nonetheless one of the basic aims of the EU is the expanding of this flat currency into the rest of the countries as well giving and resulting to a more powerful and strong economy that could be competitive to other countries’ currency (Vale de Almeida, 2008).

Although the initial aims of the EU were practical in nature, the correct function of the union accompanied by the desirable results has led to the expansion and review of these aims. As a result a variety of other areas started to be taken under consideration for improvement and fields like foreign relations (military and humanitarian aid), energy, infrastructure, education and science, demographics and culture started to constitute increasing priorities (European Commission, 2007).

More specifically, in trying to identify any areas for improvement, a gap is observed by focusing on the health section (medicine and pharmacy). Possibly this may be due to the fact that every country sets the laws surrounding this section on its own but by a further look at the positive effects and consequences that the establishment of the European Union leads to the potential that the interference of the EU in the health could contribute to its improvement.

1.2 Controlled drugs and the need for improvement

Despite the multiple benefits that people of member states enjoy, some problems persist. An important area for consideration is the Health section which has not been highlighted much. It is quite easy for potential areas for improvement to be identified if the problem of controlled drugs come to the light. Only then it can be realized that a few member states are “well-shielding” whereas there are countries with really poor substructure around this subject.

Illegal drug use and trafficking are global phenomena who threaten people’s health and social stability. According to statistics, one out of three young Europeans has tried some illegal controlled substances and at least one European citizen’s life is ended every hour due to a drug overdose. In the meanwhile, the constantly changing patterns of offer and demand require careful observation and call for active confrontation of this problem (EMCDDA, 2011).

Independent scientific information helpsEuropeunderstand the nature of all the problems related to controlled drugs and face them in a more efficient way. In order to confront drug spreading, the European Centre of Drug Observation and Addiction was founded in 1993. This centre was inaugurated inLisbonin 1995 and is considered to be one of the European Union’s decentralized organisations.

The role of the European Centre of Drug Observation and Addiction is to provide all the members of the EU with an objective study on drugs within the EU and a reliable substantiation in order to discuss this problem-subject. It provides people in charge with documented facts so as to lay down laws and strategies against narcotic substances. In addition it helps professionals and researchers working in this specific field, improve and evolve as far as the drug problem is concerned (EMCDDA, 2011).

Controlled drugs are provided for both clinical uses and treatment plans as well as for drug addiction. Although drug addiction is in the limelight probably due to the high rate of the problems intensity, proper drug therapeutic use constitutes a really interesting area to investigation with quite opened spaces for improvement and evolution. The clinical uses of these “dangerous substances” are as important as drug addiction and the same severity is undoubtedly required.

Controlled drug legislation differs between countries as different needs require the establishment of different laws. Even though the European Union has established some general guidelines related to their use, it is still very difficult for this guidance to be applied at every single case as cultural and ethical considerations result in different approaches.

A more sophisticated study of the laws is needed in order to identify the reasons that laws are different, their different aspects, views, aims and purposes and of course what led to the establishment of these laws (e.g. Shipman incidence). It is quite logical also apart from the differences some similarities to exist as generally countries of European Union have some common characteristics. Sentences and penalties need to be identified related to the use of Controlled drugs and differences or similarities need to be considered.

Nowadays. controlled drugs are widely used in perioperative care, palliative and terminal care as well as in cancer patients. Symptoms of chronic pain can also be managed by their use and they are still useful in managing acute and emergency cases such as heart attack. Finally controlled drugs find application in patients suffering from obesity and can be used in epileptic patients too. They are usually combined with other types of medications (e.g. adjuvant drugs in cancer patients) in order to be more effective and relieve or moderate pain levels (Birks, 2006).

After all these, the introduction of a more energetic European dispensing model for Controlled drugs should be further analyzed, discussed and investigated given that apart from United Kingdom and Greece, Controlled drug reality will be briefly studied in some other European countries as well (Italy, Spain, Germany, Holland, Cyprus etc). Consistency in the approach may offer advantages like less disturbances in treatment plan in patients travelling aroundEurope.

2. Legislation – Literature review

2.1 Greek Legislation for controlled drugs

2.1.1 Law 1729/1987

According to the Hellenic Government Journal (FEK) (Law number: 1729/1987, FEK 114/A/7-8-1987 & Law number: 2161/1993, FEK 119/A/26-7-1993), Greek Legislation for Controlled Drugs (including narcotics) is expert and specific as it consists of different legal rules.

Greek Legislation states that narcotics are either natural or artificial substances that act in the Central Nervous System and their use causes addiction. Controlled Drugs are described and included especially in the four tables of the fourth article of the law above (Law 1729/1987).

The production, possession, importation, transfer, storage, commission, elaboration, trafficking and intervention by anyway in the handling of the drugs that Table A contains is an exclusive right of the state which is controlled by the National Organisation of Drugs (EOF).

The disposition of such substances can be achieved only in laboratories or hospitals for the working-out of approved programs, after the consultatory response of the narcotics’ committee of the second article of the Law 1729/1987. The raw materials and the prepared products that are imported from abroad as well as handling of substances of pharmacotechnical products and patent medicines that Table B contains, becomes only from the national monopoly of narcotic substances after the approval and licence from the drugs’ committee in collaboration with National Organisation of Drugs (Kaponis, 2005).

The production, importation etc of controlled drugs of Table D and the prepared pharmacotechnical products and patent medicines that contain such substances is operated from natural and jural persons after the response of the controlled drugs’ committee and responsibility of National Organisation of Drugs which finally releases the relative licence. Their disposition in pharmacies, wholesale drugstores and clinics is controlled again by EOF.

Import, export, transit, production, preparation, commission, storage, possession, sale, disposal and distribution of the substances above as well as conditional people or businesses experience domain’s check.

Apposite service for this purpose is the custom service in collaboration with National Organisation of Drugs (for Table A) and the General Chemistry-lab of the state (for Table B & C) when science and managerial practice are needed.

Relating to any delinquency, the specified penalties are based on the Custom Code.

The legislative texts that regulate issues relating to Controlled Drugs and medicines are:

Controlled Drugs agendas that can be found in the initial Law 5539/1932 (FEK 198/A/23-6-1932), in the Law 2430/1940 (FEK 209/A/6-7-1940), the current Law 1729/1987 (FEK 144/A/7-8-1987) and the Law 2161/1993 (FEK 119/A/26-7-1993) which modified and completed the current Law 1729/1987.
Except for the above, there are too many specific agendas in ministerial decisions that subsume by rule different drugs in Controlled Drug Schedule of the current Law.
Straight after the publicity of current legislative articles of the legislation relating to Controlled Drugs, the catalogue-Table of the drugs that come under the agendas of Law no 1729/1987 is published, as they can be seen in Y6g/oik. 2845/10-1-2003 encyclical of the Direction of Drugs and Pharmacies / Department of Controlled Drugs of the General Health Direction of the Ministry of Health and Social Solidarity.
It should also be noted that the drugs of the national monopoly are included in the catalogue.

As it was referred above, Law 1729/1987 (article 1) expresses the opposition in the propagation of controlled drugs. So for the active participation of the whole society against the proliferation and especially young people protection, by the adoption of this Law, a Council is established which consists of representatives from Local Self-administration, Higher Confederation of Parents of Secondary Education (A.S.G.M.E.), Drug – addicts Association, Recuperated Drug – addicts, representatives of teaching staff of Primary Education (D.O.E.) as well as Secondary Education (OLME – OTEE), Technological Educational Institutes (TEI) and Higher Educational Institutes (AEI), National Student Union of Greece (E.S.E.E.), Panhellenic Medical Association (P.I.S.), Panhellenic Pharmaceutical Association (P.F.S.), Law Association of Athens (D.S.A.) and the Union of Editors of Daily Journals (E.S.H.E.A.) (Boukouvalas, 2005).

With a common decision of Ministers of Health, Social Solidarity and Social Insurance, the basic needs, further details for the implementation of the above, the composition, function and appositenesses are determined in order the Council to reach its aims. The Council’s incumbency and duration is limited to three years.

According to the fifth paragraph of the same article, it is established a specialist centre called “Therapy Centre for Dependent Individuals” (KE.TH.E.A.) inThessaloniki. Aims of this centre is the treatment, the professional constitution and the social incorporation of addicted from pharmaceutical substances persons and the creation and persistent education of both staff and managers in modern therapeutic techniques (KETHEA, 2010).

For the achievement of its goals, the Therapy Centre for Dependent Individuals establishes consultive centres, centres of somatic detoxication, therapeutic communities, centres of social incorporation and others similar units. It also creates autonomic co partnership and generally supports any kind of activities or initiatives that aim to the help of drug – addicts.

The Therapy Centre for Dependent Individuals (KE.TH.E.A) is a self employed legal person that functions under the “protection” of Ministries of Health, Social Solidarity and Social Insurance. Backing from the Ministries above as well as donations, bequests, subsidies or other activities are some of the financial resources of KE.TH.E.A. centre.

It does have exactly the same tax-exemptions as the other nursing institutions that the Law 2592/1953 forecasts. It should also be noted that all the referred financial resources are completely controlled by the Ministries of Health, Social Solidarity and Social Insurance.

Doctors from Hellenic National Health Service can be extracted in KE.TH.E.A. from the hospitals in which normally provide their services (paragraph 6). The extraction can be done with the decision of Ministers of Health, Social Solidarity and Social Insurance after their application and the acquiescence of KE.TH.E.A.’s General Director. The duration of the extraction is unlimited and can stop with similar ministerial decision after either doctor’s application or KE.TH.E.A.’s proposition. Other employees of the public sector can also be extracted by KE.TH.E.A. (same procedure as in paragraph 6) (Kaponis, 2007).

The second article of the Law (F. 18/A6/B 1039/29.1-15.2.1988 – FEK B’ 87) states that in the Ministry of Health, Social Solidarity and Social Insurance is recommended committee of narcotics that consists of: a) the Director of Drugs and Pharmacies of the Ministry of Health, Social Solidarity and Social Insurance, b) a representative of the scientific council of the National Organisation of Drugs and c) four members of the teaching researching staff of Higher Educational Institutes (A.E.I). Each member should be specialized in the fields of Pharmaceutical Chemistry, Pharmacology, Toxicology and Psychiatry. It is also necessary the participation of one higher officer of the Hellenic Police with experience in issues of Controlled Drugs. For each member of the committee one replacer is determined too. The members of the committee are renewed every two years (FEK, 1987).

The members of the staff, their replacers as well as the secretary of the committee are selected and determined after proposition of the responsible bodies of management of Higher Educational Institutes. The committee then votes its president and with the council of ministers the operation rules are determined and definitized.

According to the third paragraph of the second article of the Law 1729/1987 the committee of controlled drugs has the following competences:

a)It opines for issues relative to controlled drugs that result from the ratified fromGreeceinternational conventions or from application made by responsible international organisations such as YNFDAC, P.O.Y, EU etc.

b)It opines in the National Organisation of Drugs for the issuing of production licence and import of prepared products that contain substances of the fourth article of the Law.

c)It opines for the addition or removal of substances in the Tables of the fourth article of the Law, for the transfer from table to table or for the change of terms and conditions of their disposal according to the international conventions.

d) It opines for the price of the sold controlled drugs from the government owned monopoly.

e)It opines for any relative issue that will be asked from the responsible Minister or the Central Council of the tenth article of the Law.

f) It calculates the annual needs of the country for controlled drugs and proposes in the responsible Minister respectively (FEK, 1987-1993).

The third article refers to a development and improvement services program. According to the fourth article of the Law, the planning for the confrontation of pharmaceutical addiction from narcotic substances is distinguished in three stages:

a)Prolepsis – prevention – informing

b)Therapeutic reinstatement

c)Social rehabilitation

Relating the monitoring and control of Therapeutic Centres, only the Ministry of Health, Social Solidarity and Social Insurance is responsible for the establishment and function of advisory centres, centres and health institutions of somatic and mental purgation of drug-addiction and social incorporation or any other units of not speculative character (Law 2161/1993 and second article of the Law 1894/1990 – FEK 110A`).

The Special Therapeutic “Shops” of the fourteenth article of the Law 1729/1987 depend on the Minister of Health, Social Solidarity and Social Insurance, with the reserve of provisions of the Law 1851/1989. The therapeutic programs that are applied into these shops are approved with a common decision of the Ministers of Justice and Health and Social Solidarity and Social Insurance in the knowledge of the Organisation Against Drugs of Greece (O.KA.NA).

These Special Therapeutic “Shops” which act by O.KA.NA’s support, include:

a)Municipalities and communities.

b)Charitable associations as well as institutions beneficial to the public.

c)Ecclesiastical institutions.

d) Higher Educational or Technological Institutes (AEI & TEI).

e)Natural or legal persons who seek relevant aims.

For the establishment and function of these five units above (except the units that function based on the fifth paragraph of the first article of the Law 1729/1987), an authorisation is required which can be granted by the Ministry of Public Health, Social Solidarity and Social Insurance in collaboration with O.KA.NA. These units are also fully supervised by the relative Ministry and O.KA.NA. and as they are subsidised by the state, their economic management can be checked at any time.

With presidential decree that is published after the proposal of Minister of Health, Social Solidarity and Social Insurance, the terms and conditions for the issuing of establishment permission of these units as well as the way that O.KA.NA. will supervise them are determined.

The fourth article defines “narcotics”. So narcotics according to the Law are natural or artificial substances that act to the Central Nervous System and cause addiction of the person that uses them. Four Tables are used in order to classify these substances.

With a common decision of Ministers of Health, Social Solidarity, Social Insurance and Justice that is published to the Hellenic Government Journal (FEK), after the decision of Narcotics’ Committee (article 2), different substances can be added or removed from the categories of this article or to be transferred from each category to another or the terms and conditions of their disposal to be altered according to the international conventions (Kathimerini, 1997).

The substances that come under narcotics are classified to four tables (A, B, C & D) (Appendix 1) (Fthoiotida Pharmaceutical Association, 2006).

In businessmen who come under the second paragraph of the first article of the common decision (E.2200/600/8003/1.7.1994) between Ministers of Finances and Health, Social Solidarity and Social Insurance related to the regulation of processes of production, transformation, marketing, control and preparation of controlled substances (FEK 547 A’/13.7.1994), and do not observe the necessary obligations, it is imposed fine of range between 586ˆ to 1.467ˆ (FEK, 2005).

In businessmen who proceed or participate in import, export, transportation, transformation, preparation, possession or marketing of category one substances of the Annex of Regulation (EU) 3769/1992, and have not received the approval that is provided by the third paragraph of the first article of the common ministerial decision of the previous paragraph, it is imposed fine from 1.467ˆ to 2.347ˆ.

In businessmen who proceed or participate in import, export, transportation, transformation, preparation, possession or marketing of category two substances or export of category 3 substances of the Annex of Regulation (EU) 3769/1992, and have not brought the required justifying papers for their registration (that paragraphs 4 and 5 provide), it is imposed fine from 1.173ˆ to 2.347ˆ.

In businessmen who sell or dispose category one substances of the Annex of Regulation (EU) 3769/1992 in other businessmen who do not have any approval (that paragraphs 3 and 5 of the first article provide) or do not come under in paragraph 8 of article 46 of the Law 2214/1994 (FEK Ed. 75 A’), it is imposed fine starting from 1.467ˆ to 4.400ˆ.

The fifth article was replaced by the tenth article of the Law 2161/1993 (FEK A’ 119) and is related to basic crimes and penal provisions that result from the involvement with controlled drugs. Based to the fourth article of the Law 2225/1994 (FEK A’ 121), the arsis of secrecy of communications is allowable for verification of felonies that are provided in this article as well as in the articles 6, 7 and 8 of the law.

With imprisonment of at least ten (10) years and with pecuniary sentence from 3.000ˆ to 300.000ˆ is punished everyone that (FEK, 1987) (Kaponis, 2005/07):

a)Imports, exports or transports narcotics.

b)Sells, buys, offers, disposes or distributes in thirds by anyway, stores or deposits narcotics or intervenes in any of these actions.

c)Imports controlled drugs or facilitates their import in armories, police detention rooms, workhouses, any category of juvenile shops or places of team work, nursing institutions or infirmaries.

d) Mixes by anyway narcotics in foods, drinks or other things that can be entered in human organism.

e)Prepares things of the narcotics monopoly or any narcotic substance or illegally imports, is supplied, produces, prepares, sells, disposes, transfers, possesses or distributes any of the substances that are referred to Tables I, II, III of the ninth article of this Law, or organs or vessels, knowing that are going to be used for the illegal production, growth or preparation of narcotics or for purposes different than those that these substances were imported, exported, transported or remade for.

f) Grows or harvests any plant of cannabis specie, any kind of plant of redwood specie as well as any kind of plant from which narcotic substances can be produced.

g)Possesses or transports narcotics by anyway (including land, air and water means of transport).

h)Sends or receives parcels in his/her knowledge, samples without commercial value or letters that contain any drug or commands someone else for similar dispatch or collection.

i) Disposes in others any place for drug use or directs a store in which drug use takes place repetitively or is a member of staff of this store and this happens in his knowledge.

j) Encourages the drug use by anyway.

k)Adulterates or sells adulterated narcotics’ monopoly products.

l) Organises fictitious, adulterates or uses fictitious or adulterated medical prescription in order to allow the handling and distribution of narcotic substances.

m) Organises, sponsors, directs or supervises any of the actions referred above or gives instructions or commands.

If the action has been done by more ways than the provided ones in the previous paragraph, but concerns the same quantity of drugs, only one sentence is imposed in the responsible(s) person which takes into account the total criminal action.

In distinguished cases, a fine of 15.000ˆ to 450.000ˆ is imposed in those that facilitated or encrypted the commitment of other crimes. Fines are also imposed to public officers that are mixed with controlled drugs and commit crimes.

The same penalties are distributed to those that cause or facilitate the import or distribution of drugs in schools, colleges or universities, in sport centres, camps, orphanages or even in neighbour areas of all the above.

The article that refers to the abuse of attribute of doctors and pharmacists has been changed in this Law. So by the new standards, the allowance of substances for surrogation of the addiction is not anymore allowed. However some exceptions include allowance of these substances in some government units that are able to provide the relative licence (ministerial decision in collaboration with O.KA.NA.) and of course in O.KA.NA..

The allowance of antagonistic substances that inactivate the function of opiates receptors is strictly allowed only for the indications that are referred to their licence. Terms and conditions of allowance, prescription writing and disposal of these substances from public or private carriers and doctors are being determined by O.KA.NA. and Ministry of Health and Social Solidarity (Siontis, 2007).

Persons that allow drug substances for surrogation of the addiction, something that is opposite to this Law have to deal with the penalties of the tenth article of Law 2161/1993 (which is the other basic law about controlled drugs).

The Law provides and cares about aggravating circumstances too. So, people that act respectively against articles 5, 6 and 7 and aim to cause the use of drugs by juveniles or use any types of guns in order to be able to escape during drug trafficking and generally speaking evidences prove that is a really dangerous person, then he/she has to deal with heavy penalties and sentences (30.000ˆ to 600.000ˆ).

Challenge and publicity of controlled drugs can also be a possible reason for a heavy penalty. After the assessment of the seriousness of delinquency, sentence of at least one year imprisonment and pecuniary fine from 300ˆ to 60.000ˆ can be imposed to the lawbreaker. If the lawbreaker does that repetitively, is then punished with sentence of precarious imprisonment. If challenge and publicity takes place in order for an opinion on controlled drugs to be expressed or a scientific review to be heard, considering that it becomes from justified social interest, the action then is considered absolutely legal (Kaponis, 2007).

Imprisonment of at least three years and pecuniary sentence of range 30ˆ to 30.000ˆ as well as bereavement for at least two years of the allowance licence or driving licence are some of the penalties imposed in those that drive any means of transport (terrestrial, watercraft or airy) and are under drug effect at the same time.

Performance by negligence is punished with imprisonment of at least one year and pecuniary sentence from 150ˆ to 30.000ˆ.

Relating the drug users, in everyone that only for his own use procures or possesses drug quantities that confirm and prove that are designated for his own use or uses them or grows cannabis plants in number that again reassures that these are for his own use, it is imposed imprisonment sentence. It should also be noted that the sentence duration depends on the category in which the substance belongs to.

If the responsible person (misuser) is being arrested, is then able to announce (after the penal prosecution) that desires to attend an advisory therapeutic program. If this becomes acceptable from the district attorney and the overall court, then the trial can be reprieved and the court determines the program that should be followed by the misuser. If the accused person does not properly attend the program determined from the court and this is being confirmed from the program director to the district attorney, the court recalls the reprieve and the trial is normally continued. On the other hand, if the accused attends the therapeutic program successfully (at least for six months) and this is being confirmed from the program director to the district attorney, after psychological expertise and laboratorial test (full recovery confirmation), then the court can judge the person unpunished. In case that the court considers that the justiciable action was completely coincidental, then the accused person does not have to attend any program and is judged innocent (Ta Nea, 1998).

In case that the delinquency is related to the accused person’s profession, according to articles 5, 6, 7, 8, 9 and 15, the court is able to order the prohibition of exercise of his/her profession from one (1) to five (5) years. The prohibition also implies the function pause of the store or office, if the exercise of the profession presupposes their existence and function. In this case nobody else can exercise the profession instead of him/her.

When the accused is judged for delinquencies of articles 5, 6, 7, 8 and 9, the court can order the publication of entire or summary of condemnatory decision, with expenses of the confounded, either in one or in more journals within ten (10) days since the decision is being rendered irrevocable.

Controlled drugs are always confiscated. During preliminary proceedings as well as in case of no exercise of penal prosecution or in case of abstention from it for any reason, the confiscation is ordered by the magistrates’ council. Sample of the substances found is sent to Higher Education Institutes’ (AEI) Medical jurisprudence and Toxicology laboratories or in the General Chemical laboratory of Greece or in any of its departments for further research and tests (monition) (Papageorgiou, 1995).

If there is not any doubt that these substances belong to Controlled Drugs, these are destroyed after two samples are being taken for the expertise process (the number of drug packages being destroyed is also noted).

The destruction of Controlled Drugs takes place in the presence of a committee in which the magistrates’ district attorney chairs. The means, the place where the destruction takes place as well as any other details are determined by Ministers of Justice, Citizen Protection and Finances.

Based on this Law, a policeman, customs employee, employee of Financial and Economic Crime Unit (SDOE) or a harbour employee after the command of the responsible head on the prosecution of narcotics, is able to be appeared as candidate purchaser or carrier or pretended to be interested for the distribution, safekeeping or disposal of controlled drugs. But in this case the head of service ought to inform even telephonically the magistrates’ district attorney. Research in any means of transport for the recovery of controlled drugs is allowed by the persons listed above.

2.1.2 Law 2161/1993

The second most important Law relative to Controlled Drugs (Law 2161/1993, published by the Hellenic Government Journal – FEK 119/A/26-7-1993) refers to the constitution of special official units and scientific committees, regulates the programs of prevention from organisation against narcotics – Organisation Against Drugs of Greece (O.KA.NA) and finally sets special provisions for therapeutic institutes.

More specifically, in 1993 the new law 2161/93 imposes even stricter penalties about drug trafficking as well as doctors and pharmacists who do not follow the drug prescription rules. The penalization of trafficking precursor substances is also contemplated. The amendment voted in 1995, law 2331/95, emphasized therapy, foreseeing a suspension of the prosecution in case the drug offender follows a therapeutic programme when his case (he is put on trial) is in the Public Prosecutor’s or the judge’s hands. Furthermore, according to another arrangement, the prosecution is definitively suspended after the successful ending of the therapy (FEK 117, 1993).

2.1.3 Further amendments

A new arrangement in 1996, law 2408/96 foresees a softer penalty for the drug users who are arrested for drug possession (article 4). The law 2479/97 in1997, which amends some parts of the law 2408/96, re-introduces the charge of drug dealers who are considered as “extremely dangerous”, imposing “a lifetime imprisonment if the offender is recidivist, or he uses drugs as a job or as a habit, or with the intension to initiate a minor into drug using or into any other act concerning drugs” (article 8).

In 1999 the new law 2721/99.130 lays down a small penalty for the drug users who provide others with small doses for their own use (Kaponis, et.al, 2006).

2.2 British Legislation for Controlled Drugs

By moving toUnited Kingdomreality and by having a further look at the legislation for Controlled Drugs, a more structured and detailed legislation is observed, which is characterised by an obvious hierarchy and law development. Controlled drugs are mainly governed by eight Acts and a variety of government departments and other agencies concern and surround the current legislation and guidance (NPC-NHS, 2010).

Misuse of Drugs Act 1971

First of all, the Misuse of Drugs Act 1971 designates some drugs as “Controlled Drugs”. Controlled drugs define drugs that are “dangerous or harmful drug substances”. A variety of clinical conditions can be managed by the use of these drugs. But at the same time, specific legislative controls are required as there is a hairline that dissociates therapeutic use from harm to be caused (abuse or diversion from therapeutic use). And this is exactly the reason that caused the creation of the Act (1971) and its associated regulations (inEngland,ScotlandandWales).

So, the import, export, supply, manufacture, safe custody, production, prescription, trafficking and possession of such drugs and substances is further controlled in order the misuse of Controlled drugs to be avoided which is the main aim of the Act and its associated regulations (especially the Misuse of Drugs Regulations 1985). It should also be noted that Controlled drugs are prohibited from possession and/or supply except where permitted by the Act.

The Misuse of Drugs Act 1971 divides Controlled drugs into three classes A, B and C (with A being the most dangerous) for the purposes of imposing penalties/sentences in criminal law convictions. The class of drug reflects the relative harm when misused in descending order of severity from A to C as it was mentioned above. However these classes are of no practical importance for both pharmacists and practitioners (Department of Health, 2010).

Class A includes drugs such as diamorphine, cocaine, MDMA, lysergic acid diethylamide and methadone. Penalties for possession come up to seven (7) years imprisonment or an unlimited fine or both whereas penalties for supply come up to life imprisonment or an unlimited fine or both.

Amphetamine, barbiturates and less potent opioid analgesics like codeine are some characteristic Class B controlled drugs. Penalties for possession come up to five (5) years imprisonment or an unlimited fine or both whereas penalties for supply come up to fourteen (14) years imprisonment or an unlimited fine or both.

Finally Class C involves cannabis, benzodiazepines, anabolic steroids etc. Penalties for possession come up to two (2) imprisonment or an unlimited fine or both whereas for supply they come up to fourteen (14) years imprisonment or an unlimited fine or both.

It should also be noted that any Class B drug in injectable form is treated as Class A. Some Class C drugs are legal to possess – for example, anabolic steroids are Schedule 4 Part II and may be possessed in medicinal form without a prescription.

Misuse of Drugs Regulations 2001

But because over the time different needs come up, the Misuse of Drugs Regulations are responsible for keeping up-to-date the laws. According to the Misuse of Drugs Regulations 2001, which are basically amendments that were made under the Misuse of Drugs Act 1971, the use of Controlled Drugs is allowed and permitted in medicine’s field.

The Misuse of Drug Regulations are periodically amended and reviewed in order laws being updated and correspond to the real and current needs of the society. Hence, a really decisive and of great importance amendment that is included in the 2001 Regulations was made and establishes the division of Controlled Drugs into five (5) Schedules (MEP, 2009). These are listed below (RPSGB, 2010):

Schedule 1 (CD Lic)

This Schedule includes basically Hallucinogenic drugs such as LSD, ecstasy type substances, cannabis, cannabis resin, mescaline and raw opium. These drugs have virtually no recognised therapeutic/medicinal use. In order to possess these drugs (especially for research purposes) a Home Office licence is required and lawful possession is strictly restricted. Practitioners and pharmacists can possess these drugs only to ensure their destruction or to hand them over to a police officer. Otherwise a licence from the Home Office is needed.

Schedule 2 (CD POM)

Opiates such as diamorphine and morphine and also major stimulants such as amphetamines (which have a wide range of therapeutic uses) are involved into this Schedule. The professional role of the pharmacist allows him/her to possess Schedule 2 Controlled Drug substances and supply them on the authority of a suitable prescription or requisition. Issues such as safe custody (Misuse of Drugs (Safe Custody) Regulations 1973), storage and record keeping requirements apply and also apply to patient returns for Schedule 2 drugs.

The Controlled Drug Register must:

Be a bound book or computerised system
Contain class sections
Name specified at top of each page
Entries chronological
Indelible ink for entries or computer
No cancellations, obliterations or alterations
Kept at the premises
Kept for at least 2 years from date of last entry
Not used for any other purpose
Miscellaneous: midwives and ships or installations
Records kept for all Schedule 1 and 2 Controlled drugs
Not a legal requirement for Schedule 3, 4 and 5 Controlled drugs

The Destruction of this Schedule drugs (stock) requires the presence of an appropriately authorised person. Any patient returns do not have necessarily to be witnessed but good practice recommends so.

Schedule 3 (CD No Register POM)

Minor stimulants such as benzphetamine and other more commonly used drugs such as buprenorphine, midazolam, phenobarbitone, meprobamate and temazepam can be found in Schedule 3. These are considered less likely to be misused than those in Schedule 2 and less likely to cause serious harm and danger. Records must only be kept in cases that the pharmacist manufactures or compounds these drugs. Otherwise records do not need to be kept and a Controlled Drug Register is not required. Even commonly used controlled drugs such as temazepam, diethylpropion, buprenorphine, flunitrazepam, phenobarbitone and midazolam are exempt from safe custody (that means that can be stored on the open dispensary shelf), individual pharmacists may decide to treat these as if they had with additional requirements.

is the symbol used in the British National Formulary (BNF) for Schedule 2 and 3 Controlled Drugs.

Schedule 4 (CD Benzodiazepines POM or CD Anabolic steroids POM)

Part 1 or CD Benzodiazepines includes the majority of benzodiazepines (apart from flunitrazepam and temazepam) in addition to eight other substances (e.g. zolpidem, mesocarb and fencamfamin).

Part 2 or CD Anabolic/Androgenic steroids contain testosterone together with clenbuterol and five polypeptide growth hormones.

Both Parts when are contained in medicinal products then restrictions, safe custody and record keeping requirements for Controlled Drugs do not apply. Destruction requirements only apply to importers, exporters and manufacturers.

Schedule 4 Part 1 Controlled Drugs are subject to authorization when possessed by registered practitioners and pharmacists within their professional limits.

Schedule 4 Part 2 Controlled Drugs require a Home Office license in order to be imported or exported respectively unless the active drugs are in the form of a medicinal product and are intended for personal use. The drugs of this category can also be misused by athletes or/and bodybuilders.

Finally, it should be noted that Controlled Drug Registers do not need to be used for Schedule 4 drug substances. However its use becomes necessary in cases that controlled drug substances are compounded.

Schedule 5 (CD Invoice P or CD Invoice POM)

Preparations of certain Controlled Drugs which are exempt from full control when present in medicinal products of low strength e.g. codeine, pholcodeine and morphine. No special requirements or record keeping other than to retain invoices for at least two years apply. No restrictions on import or export, no register requirements and no safe custody is needed. Schedule 5 Controlled drugs can also be manufactured or compounded by pharmacists, practitioners or any other person with an appropriate licence.

According to an amendment made by the Misuse of Drugs Regulations 2001, preparations that contain more than 0.1% cocaine are not excepted anymore from prohibitions relating to import, export and/or possession issues.

*Even morphine should always be treated as a Controlled Drug,

in lower strengths it can be a Schedule 5 Controlled Drug as well.

Sativex spray does not require a Home Office Licence.

Summary of the Legal Classification of Controlled Drugs (page 44, Policy for Controlled Drugs in Primary Care, The Law, Probity and Good Practice, NHS Brent Community Services, by Versha Varsani, NHS Brent Prescribing Adviser, May 2004)

Summary of Legal Requirements of the Possession and Supply of CDs

(page 19, Policy for Safe Management of Controlled Drugs in Primary Care, Appendix 2, Harrow PCT, NHS, 2008)

Misuse of Drugs (Safe Custody) Regulations 1973

Safe custody for Controlled drugs was first introduced by these Regulations (1973) by imposing extra controls on their storage. According to these, all Schedule 2 (except quinalbarbitone [secobarbital]) and Schedule 3 Controlled drugs (except any 5,5 disubstituted barbituric acid, cathine, ethchlorvynol, ethinamate, mazindol, meprobamate, methylphenobarbitone, methprylone, midazolam, pentazocine, phentermine or any stereoisomeric form of the above) must be stored in a cabinet or safe locker with a key, made of metal with suitable hinges and fixed to the wall or floor, with bolts not accessible from the outside of the cabinet (regulations obtainable from The Stationery Office) (EUROPA, 2011).

Controlled drugs’ Safe Custody depends on the premises in which these “dangerous or otherwise harmful drug substances” are stored, with high severity especially in retail dealers. These requirements are not applied when the actual Controlled Drug is under the personal supervision of a pharmacist (e.g. dispensing of a prescription) (Smith, 2009).

Misuse of Drugs (Safe Custody) Regulations 2007

As it was said earlier, the amendment of legislation is imperative and necessary as needs differ from generation to generation. Hence the 2007 Regulations came to amend and complete the existing Regulations (1973) relating the Safe Custody of Controlled Drugs and the Misuse of Drugs 2001. The amendments were including:

Re-schedule of Midazolam from Schedule 4 to Schedule 3. That requires all Healthcare Professionals to be informed for this legal classification change as prescription requirements change as well. Patient Group Directions (PGDs) are still recommended when this medication is supplied to patients and Safe Custody Regulations should not be applied for this Controlled drug anymore.
Requisitions for Schedule 1-3 Controlled Drugs in the community in order these drugs to be supplied to Healthcare Professionals for stock purposes.
Accountable officers have the authority to nominate a person or a class of persons to witness the destruction of Controlled Drugs.
Controlled drugs can be possessed and supplied by Operating Department Practitioners (ODPs) within a hospital operating department. This right is given only to those ODPs who are registered with the Health Profession Council (HPC).
Care homes should also be included in 1973 Safe Custody and Record keeping Regulations in order to assure safety and correct use of Controlled drugs.
Controlled Drug Register does not require a prescribed form anymore.
Electronic writing and transmission of Controlled Drug prescriptions with an advanced attached electronic signature is introduced (only within a safe and secure electronic system – environment) (Varsani, 2004).

Misuse of Drugs (supply to addicts) Regulations 1997

According to 1997 Regulations, doctors are not allowed to treat addicts or suspected addicts with diamorphine, cocaine or dipipanone except under a Home Office licence. So, this regulation prohibited doctors from prescribing, supplying or administering these three Controlled Drugs to those patients. But that happened until June 2007 where an amendment came to complete the Law. As a result an individual Home Office license is not required anymore in order doctors to prescribe and use these drugs for therapeutic purposes exclusively (disease or injury). Only a general licence is required from doctors who hold the Department’s of Health approval.

Medicines Act 1968

Medicines Act 1968 and its regulations set clearly out the specific requirements in order a Controlled Drug Prescription to be valid and lawful. The requirements of the Misuse of Drugs Act 1971 must also be satisfied. So, a prescription for a Schedule 2 or Schedule 3 controlled drug (except Temazepam) is unlawful unless it is (MEP, 2009):

Signed by the prescriber with their usual signature
Dated
Written indelibly
Gives the address of the prescriber
Specifies the dose to be taken (not “as directed” or “when required”)
Specifies the form and strength of the preparation
Gives the total quantity required in both words and figures
Specifies the name, age and address of the patient

Prescriptions should not normally be for treatment periods of more than 30 days, although this is not a legal requirement but a strong recommendation. Prescriptions for Schedule 2, 3 and 4 Controlled drugs are only valid for 28 days. Owings cannot be supplied after the 28 days after the prescription was issued. Patients or any other persons that act on their behalf must sign for Controlled drugs in order to collect them from the pharmacy. A proof of identity is asked by the pharmacist in cases of Schedule 2 Controlled drugs (Dr. Mawhinney, 2008).

In this Act of Parliament of theUnited Kingdom, some exemptions were introduced to the general restrictions relating the sale, supply and administration of Controlled Drugs. That means that drug substances such as morphine or diamorphine can be supplied or administered for example by midwives. It also allows more Healthcare Professionals other than pharmacists to deal with the supply and/or administration of controlled drugs and gives the right in some of them even to possess these drugs by using always a Patient Group Direction (PGD) (DOH, 2006).

The Health Act 2006

It would not be so beneficial to refer to all the objectives and aims of the 2006 Act as it covers a very wide range of health parameters. Relating the topic of Controlled Drugs, it can be seen that a series of amendments have been made in order to make existing Controlled Drug legislation stronger and monitor arrangements in a more efficient way. So, in order supervision of management and use of controlled drugs to be more effective and safe the following points were raised (DOH, 2008):

All healthcare organisations and independent hospitals must appoint an accountable officer for Controlled drugs – this person ensures safety, appropriate and effective management and use of Controlled drugs within organisations (The Controlled Drugs (Supervision of Management and Use) Regulations 2006).
A duty of collaboration is placed on responsible bodies, healthcare organisations, professional regulators, police forces, the Healthcare Commission and the Commission for Social Care and inspection to share intelligence on Controlled Drug issues.
Police have a power of entry and inspection to enter premises to inspect stocks and records of Controlled Drugs.
The duties and responsibilities of accountable officers are set out in safe management of Controlled Drugs.

The Drug Trafficking Act 1994

The Drug Trafficking Act 1994 which replaced the Drug Trafficking Offences Act 1986 and its associated regulations and amendments, gives the right to the court (following a conviction) to carry out a relevant research and ascertain if the offender had any benefit or took advantage from drug trafficking. In case that something like this is being proved from the court, a confiscation order can be then imposed to the accused excluding him/her from any proceeds.

According to the Act’s principles, the court that tries the affair is able to consider that all the assets of the person at the time of conviction, including any type of property that has passed through his/her hands during last six years (from the time of conviction) is the result of drug trafficking. This assessment takes place in order the amount for confiscation to be considered unless the opposite side (offender’s representatives) is presented (Medicines Management, 2010).

So, as the Act considers that all these assets and property have come from Controlled Drug Trafficking, the total value of the above is estimated and voted as liable to confiscation from the public prosecutor and the chairman of the court.

It should also be added that the Drug Trafficking Act only applies toEnglandandWales. Similar Acts such as the Proceeds of Crime Act 1995 and the Criminal Law (Consolidation) Scotland Act 1995 as well as the Proceeds of Crime Order 1996 are applied forScotlandandNorthern Irelandrespectively.

The Criminal (International Cooperation) Justice Act 1990

One of the main aims of this Act is to encourage cooperation betweenUnited Kingdomand other countries in criminal proceedings and investigations. Illegal Traffic of Narcotic Drugs and Psychotropic Substances is another topic that the Act tries to prevent by providing a better quality monitor and a more effective control of precursors (Vienna Convention).

Both Drug Trafficking Act 1994 and Criminal (International Cooperation) Justice Act 1990 work closely to Home Office in order precursor chemicals not to be diverted. Finally these two 1994 and 1990 Acts “oppose and fight” any money laundering phenomena abetted by theUnited Kingdomgovernment which enforces relevant EC regulations (Legislation.gov.uk, 2010)

The Customs and Excise Management Act 1979

Importing and exporting controlled drugs without authorization has always been punished by the Customs and Excise Management Act 1979 (CEMA) just like any trafficking offence.

The Crime and Disorder Act 1998

The Drug Treatment and Testing Order was enacted by the Crime and Disorder Act in 1998 aiming at providing with suitable treatment any drug misuser who has reached such an agreement with the court. The Act also provides drug misusers’ supervision and progress of treatment (Home Office, 2009).

The Criminal Justice and Police Act 2001

Drug traffickers have faced a new penal reality laid down by the Criminal Justice and Police Act 2001, according to which courts are authorized not to allow them to leave the country. The target of this measure is to impose a limitation or even to put an end to drug trafficking (ACPO, 2009).

The Drugs Act 2005

There have been important amendments in the Misuse of Drugs Act and the Police and Criminal Evidence Act made by the Drugs Act 2005. According to the Act, the police have the liberty to arrest drug users and lead them to treatment with their consent. Offenders who swallow drugs are likely to be kept at the police department for up to 192 hours. Any possible intention to supply drugs is not prosec

2.3 Similarities and differences in Controlled drug Legislation betweenGreeceandUnited Kingdom

2.3.1 Classification of Controlled Drugs

In a brief comparison betweenUnited Kingdomand Greek Legislation regarding Controlled Drugs some similarities or/and differences could be identified. First of all, inUnited Kingdomthere are two categories used to classify Controlled Drugs. The first one, as it was already mentioned in the legislation part, was established by the Misuse of Drugs Act 1971 and divides such dangerous substances into three classes A, B and C (in descending order of severity) for the purposes of imposing penalties in criminal law convictions. The second classification of these drugs was made by the Misuse of Drugs Regulations 2001 which determines five schedules related to how harmful a controlled drug is with Schedule I including the most dangerous substances (Department of Health, 2008).

On the other hand Greek legislation (Law 1729/1987) classifies only four lists – tables of these drugs (Tables A, B, C and D) with substances involved in Table A to be controlled by the State (cannabis, heroin, LSD, MDMA), Table B contains substances whose handling is the exclusive right of the State Drugs Monopoly (cocaine, methadone, morphine), amphetamines and codeine in Table C can be handled by authorized or licensed individuals and finally the Table D which allows pharmacists to take place in their supply (barbiturates, tranquillisers, buprenorphine).

Moreover inGreece, the penalty or sentence to the accused person is independent to drug type and the Magistrate’s court has to consider the category of the drug substance in order to serve the sentence to the user (Law 2161/1993). OppositeUKlegislation links penalties to drug type and any sentences or penalties are served with respect to the related laws (Kaponis et.al, 2005).

2.3.2 Illegal possession of Controlled drugs

Illegal possession of Controlled drugs is another issue which is treated in a different way in these two countries. According to theUKlegislation the first factor needed to be investigated in case of an offender is whether the Controlled drug is intended for personal use or for supply. In order for either the Magistrate’s or the Crown court to release its final decision, the Drugs Act 2005 introduced the idea of determining an amount, above which the possession of a Controlled drug will be constituting an indication for further supply. Penalties are again linked to the drug class and have been analytically referred to the legislation topic (different confrontation for possession and possession with intent to supply).

InGreece, the authorities first examine whether the offender is an addict or not and then the laws are applied respectively. Illegal possession of Controlled drugs by addicts compels them to follow a treatment plan (purgation of drug-addiction) according to the Article 13 of the Law 1729/1987. If they do not agree to follow this plan then they have to suffer the consequences and the sentences provided by the legislation. Article 12 of the same Law states that sentence of imprisonment is attributed to lawbreakers who are not drug addicts and this sentence depends on the controlled drug quantity. Possession of small quantities of drugs is punished with up to one year imprisonment and the payment of a fine defined from the court whereas possession of large quantities of drugs is punished with imprisonment varying from 5 to 20 years. Small and large quantities are determined in the Article 5 of the modified Law 1729/1987, Amendment – Law 3189/2003) (FEK, 1987).

2.3.3 Illegal drug trafficking

Although there is a different classification system in these two countries, generally it could be said that sentences inGreeceare more strict than in theUnited Kingdom. So inGreece, the classification of the controlled drugs for defining a sentence to the offender has to do with the quantity of the drug. In case of the sale of a small quantity for personal use the sentence comes up to 6 months imprisonment or the payment of a fine as an alternative solution. Any illegal trafficking of larger quantities is punished with at least 10 years imprisonment (small and large quantities are analytically defined in the Articles 5, 6 and 8 of the Law 2191/1993 – amendment of Law 1729/1987). Moreover when public officials are mixed into illegal drug trafficking then the sentence increases in at least 10 years and worse when recidivists, professionals or weapons users are involved they are then punished with up to life imprisonment. Once more the authorities examine if the drug trafficking becomes from addicts or non-addicts as there is again a different confrontation. Addicts can be punished from 1 to 5 years imprisonment for drug trafficking for first time (misdemeanour) or up to 10 years if they have a “heavy” background (felony). Non- addicts are punished with a sentence of imprisonment from 6 months to 5 years for supplying controlled drugs to other users (Law 2721/1999 – amendment).

Moving toUnited Kingdomit should be mentioned that the authorities do not only examine the quantity found during drug trafficking but they focus on the drug class. So different penalties and sentences are applied for Class A, B and C Controlled drugs varying from up to life imprisonment for Class A drugs and up to 14 years imprisonment for Class B and C drugs (Misuse of Drugs Act / Schedule 4). If there is any evidence that it is for the third time that the same person traffics in Class A drugs, then there is a minimum sentence of seven years imprisonment unless the court considers that this decision is unfair for the offender.

2.3.4 Legal aspects of controlled deliveries

In both countries there is no specific legislation on Controlled drug deliveries. InUnited Kingdomthere are some associations which, apart from their other activities and aims they have, they are also related to the management of deliveries of Controlled drugs aroundUKand moreover they oversee their import and export acrossUKfrontiers. These associations are listed below:

The Serious Organised Crime Agency (SOCA)
The Association of Chief Police Officers (ACPO)
Identity and Passport Service (by Home Office) (IPS)
The Border and Immigration Agency (by Home Office) (BIA)

All the above associations coordinate when required in order to avert illegal aspects (e.g. illegal commodity, quantity or other destination of Controlled drugs) and they are responsible not only for deliveries of Controlled drug substances but for any kind of goods (SOCA, 2010).

InGreecethe management of Controlled drug deliveries is an exclusive right of the Hellenic Police in coordination with the State and the apposite ministry (Ministry of Citizen Protection). When needed the Special Anti-terrorist Unit is also implicated and operates all aroundGreeceand abroad (Ministry of Public Order Press Office, 2004). Other associations such as Interpol, Europol or the Department of the SIRENE – Schengen Information System might be used in order to disarticulate illegal deliveries of Controlled drugs. In the end, Unit of Police Dogs is a special unit that uses well trained dogs and has lots of successful missions on drugs during the last few years (Hellenic Police – Ministry of Citizen Protection, 2010).

2.3.5 Threshold quantities for personal possession offences

As it was said earlier, UK legislation focuses especially on the Controlled drug class for determining the relevant sentences or penalties (that does not mean that the drug quantity is not taken into consideration) whereas Greek legislation, of course bothers about the class of the drug but besides deems the quantity found on the offender really important as well. Hence an amendment contained in the Article 15 of the Law 3727/2008 states the different amounts of Controlled drugs which separate the possession for personal use and the possession with intent to supply. Some of these substances of this classification are cannabis, heroin and cocaine. For example a quantity of 2.5g (or less) of cannabis resin (or up to 20g of herbal cannabis) is considered that it is intended for personal use. Similarly for heroin and cocaine a quantity of 1.5g of these drugs or less according to the law is intended for personal use. Any other quantities above these limits are intended to supply (as Law 3727/2008 states) and different penalties or sentences are accordingly applied (OKANA, 2010).

2.3.6 Precursor trafficking penalties

Relating to that topic both Greece and United Kingdom tend to follow similar guidelines that have been established by the European Union Instrument and have been adopted and approved by the constituted countries. So according to the Articles 2 and 4 of the Council Framework Decision 757/JHA which was taken in Brussels in 2004, the minimum amounts on the components of criminal acts and penalties were determined in order sentences to be attributed when illegal drug trafficking occurs. Sentences usually range from 1 to 5 years imprisonment and can be longer (5-10 years) when manufacture, transport or any distribution of forerunners is proved to be intended for either illegal production or manufacture of Controlled drugs and furthermore this action is proceeded by a criminal organisation. The Article 3 of the same Decision considers that the provocation and encouragement to commit as well as any aid support or help to endeavour the above (manufacture, transport or distribution of precursors that are intended for illegal actions) is deemed criminal and national laws are then responsible for determining the sentences (Home Office, 2009).

2.3.7 Substitution Treatment – Prescription Regulations

In the United Kingdom Section 7.3(a) of the Misuse of Drugs Act 1971 allocates the appropriate people in charge for prescription and administering of controlled drugs, while the section 10.2(g)-(i) Misuse Drug Act manages the control and supervision of prescriptions of narcotics. More specifically, it examines the appropriateness and effectiveness of the Pharmacist and Nurse Independent Prescribers in supplying Schedule 2 Controlled drugs to the misusers (Barnard, 2007). The Misuse of Drugs Regulations 2001 defines the legislation framework regarding the suitability of the Controlled drug supplying and dispensing. Therefore through this act the GPs are able to supply, possess, produce and administer narcotics following of course certain legal limitations (Department of Health, 2008).

InGreecethe Law 2955/2002 MD 19546/2003 states that substances used for the drug misuse scheme are only prescribed by either government public or private agencies or medics. In any other cases the prescription is forbidden (as illegal). The supply of such substances is an exclusive right of the Organisation Against Drugs of Greece (O.KA.NA) and some hospitals licensed by this organisation. In the case of naltrexone further handling is required to provide a specific prescription which is stored by the pharmacist and abides by the Ministry of Health’s regulations.

2.4 Issues and problems – need for improvement

2.4.1 Shipman Incident

English people got extremely worried after they had found out how Harold Shipman had led patients to death by the use of controlled drugs such as diamorphine. The English government was forced to take immediate action and impose new laws in order to check and limit the misuse of controlled drugs. They should be used wisely in medicine to relieve pain, which was exactly the intention of the new regulations for controlled drugs enacted on 1st January 2007. Besides, some instructions were added in order to specify and reinforce the wiser management of controlled drugs.

The intention of these arrangements was also a closer and more careful collaboration among all those who deal with controlled drugs. In the report we mean to show how all the new arrangements have worked, so as to make sure that the right and appropriate use of these drugs turn always to the patients’ profit, especially after the detailed control made by the Healthcare Commission.

It is clear that the new arrangements do not allow any interference as far as the right use of controlled drugs is concerned. Furthermore, those measures must be applied to any healthcare setting or individual practice, where controlled drugs are necessary for a specific reason. The main intentions of the new arrangements were obviously including better control methods, introduction of regulations so as to scrutinize the management of controlled drugs and a better co-operation among sectors and agencies (The Shipman Inquiry, 2005).

Substantially new laws called for creation of bigger healthcare organizations, foundation trusts and specific hospitals. Accountable officers working in these places will ensure the wise and appropriate application of the new arrangements. A combination of the strict inspection of controlled drug prescriptions and supplies with the creation of networks including all those individuals and agencies who deal with controlled drugs and any possible anxiety about them, guarantees a more secure and safe handling and management of controlled drugs in the future.

We realized that accountable officers were constituted in trusts and hospitals, although organizations did not let us know about the vacant post whenever it existed. These posts should under no circumstances be empty, as they help the new legislation be solid. The problem that had raised about the eligibility of accountable officers is now solved (Home Secretary, 2004).

According to the Healthcare commission both controlled drugs and medicines belong to the Department of Health core standard. Their use so far shows that this system works really better, although certain clarifications should be given to secure the safe management of Controlled drugs.

Both the Royal Pharmaceutical Society of Great Britain and the Commission for Social Care Inspection have been doing their best in order to reinforce the surveillance of all those who deal or have any kind of connection with controlled drugs.

The numerous deaths of Harold Shipman’s patients raised the need to inquire in depth these unfortunate and suspicious incidents. It was absolutely necessary to look at the question from all sides, checking the organizations which dealt with any previous investigation concerning those people’s deaths, in addiction to the organizations in charge of inspecting the use of controlled drugs.

Five reports came out of the inquiry. The first three concerned the police investigation of March 1998 and the coroners’ investigation of deaths.

The fourth report examined the ways Harold Shipman used in order to obtain repeatedly controlled drugs and provide his patients with them, without being revealed or raising any suspicions whereas the fifth and final report checked the arrangements under which General Practitioners are controlled and complaints are made in terms of NHS (The Times, 2004).

3. Clinical use of controlled drugs

3.1.1 Controlled drugs in palliative care

According to the World Health Organisation, palliative care is “an approach that improves the quality of life of individuals and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual” (WHO, 2010).

As in other care types (perioperative, terminal etc.), the administration of Controlled drugs is necessary in palliative care as well in order to help patients and lead them to pain relief (partial or total). It is a strong recommendation that patients should only be prescribed with the exact quantities of Controlled drugs that they really need to control their symptoms effectively. In case that patients are being prescribed with unusual higher controlled drug doses, good practice recommends the specialist palliative care team to contact with the prescriber in order to identify, find out and confirm that the prescribed controlled drug quantity is correct and is needed to be taken by the patient. Relevant recordings and information should be added in the patient’s personal notes as they could be useful for the future and generally for the medical history and profile of the patient (I. Higginson, 1997), (Controlled Drugs Policy, 2008).

As it has been mentioned so many times in both legislation and treatment topic, because drugs and especially controlled drugs are able to cause any harm or/and discomfort by their extended use, it is very important the doses and supply of such substances to be checked and inspected at frequent time intervals. As it is already known, palliative care patients can obtain Controlled Drug Prescriptions from more than one point (e.g. GPs, hospices, hospitals etc) and either unwanted or witting misuse can be achieved (K. Boyd, 2009). For exactly this reason, one from the professionals that deal with these patients within a community needs to play the role of the coordinator between the various sources of Controlled drug prescriptions in order over supply to be avoided and patient’s safety to be maintained at all times (Controlled Drugs Policy, 2009). Hence, the NHS Brent Prescribing and Medicines Management Committee (ratified in 2010) came to add (for extra protection and safety purposes) that Controlled Drug Prescriptions for palliative care should be limited to seven (7) to fourteen (14) days supply. The advantages of this limit involve that the patient’s safety is ensured, the medical condition is frequently reviewed, the doses are accurately regulated according to patient’s needs each time, medication review designates any need for new medicines, Controlled drug stock in patient’s home is checked and drug wastage is reduced (V. Varsani, 2004).

Unfortunately quite often, problems due to the lack of palliative care drugs in community pharmacies or any other collection points can be created during the out-of-hours period. For this reason Health Care Professionals are required to be provident enough and have a sufficient stock of Controlled drugs, so patients can obtain their medications (themselves or through relatives) at any time and control their symptoms wherever they are (even if they are treated in their own homes) (Controlled Drugs Policy, 2008).

Self medicating patients that are being treated in their own home must be aware of the importance of the Controlled Drugs that they have in their possession and extra education about the harm that can be caused by their use should be provided by a health care professional to ensure safety and efficacy in managing their symptoms. On the other hand, patients that are treated within a hospital, hospice or care home, they are recommended to strictly keep their Controlled drugs in a special locked receptacle attached to their bed and the key has to be under their personal supervision (Controlled Drugs Policy, 2008).

Controlled Drugs used in Palliative Care that can be prescribed by Nurse Independent Prescriber’s

Page 173, Controlled Drugs Policy, Clinical Policy CL060, Version 3,

NHSCountyDurhamand NHS Darlington, December 2009

Owner Selby & York Palliative Care Team & Pharmacy group. Version 1 January 2009 Review date January 2011. Approved by York D&T committee.

3.1.2 Controlled drugs in perioperative care

Perioperative care is divided into three phases including preoperative, intraoperative and postoperative care. These three phases exist as there are different reasons and purposes during the whole care plan (diagnostic, curative, restorative, palliative, cosmetic). Analytically, in preoperative phase various factors such as risk factors, diagnostic tests, physical exam, nursing history and medications review are assessed and tested (health status). Even in the first phase of perioperative care, pharmacology is singularly important in order to facilitate anaesthetics function, make patient to feel less anxious and minimize any secretions caused by respiratory tract. Common drug types involve opiates (Schedule 2 Controlled drugs), anticholinergics (which are administered to induce muscle spasms reduction), barbiturates (hypnotic drugs) and finally prophylactic antibiotics (J. Williams, 2010).

Intraoperative care is a term used to describe the whole process from the time that the patient is in the holding room, he/she then moves to the operating room and finally back to the recovery room. During intraoperative care both Central and Autonomic Nervous Systems (CNS & ANS) are under strict control and anaesthesia is also succeeded for analgesic mainly purposes. Depending on the operation and the patient anaesthesiologists can consider if they are going to provide general, regional or local anaesthesia. Opioids solutions are widely used for parenteral Patient Controlled Analgesia (PCA) and epidural analgesia techniques by usually combining a diluted opiate (Schedule 2 Controlled drugs) with the relevant anaesthetic/drug. It should be noted that cocaine (Schedule 2 Controlled drug) is used for topical anaesthesia (R. Birks, A. Chambers et.al, 2006). In case of any complications that is very logical to arise during an operation, there is a need for more anaesthetic agents as generally anaesthesia is something that most times can be regulated. As a result Controlled Drug use is judged necessary. Hence, opioid analgesics (Alfenta = Alfentanil, Demerol = Meperidine and Morphine) or benzodiazepines such as Valium (Diazepam which is a Sch. 4 Controlled drug) and Versed (brand name for Midazolam which is a Sch. 3 Controlled drug) are administered to patients in order to retain anaesthesia. Sedative hypnotics such as Atarax (Hydroxyzine), Seconal (Secobarbital) etc and anticholinergics (Atropine, scopolamine) are also given in combination with the above Controlled drugs (J. Williams, 2010).

In Postoperative care which is the last phase of Perioperative care, small doses of opioids are given intravenously (IV) in order to moderate pain (NUR105, Adult Health, 2010). Narcan (Naloxone) is a narcotic antagonist which is used to prevent toxic effects of opioids. On the other hand, Romazicon (Flumazenil) is a benzodiazepine antagonist which is used for reducing drowsiness and sedation (Wolters Kluwer Health, 2010).

The extended use of Controlled Drugs not only in Perioperative Care (recovery room and Intensive Care Unit) but also in acute and chronic pain services within hospitals and care homes requires, apart from registered nurses, the authorization and the undertaking of responsibility from Operating Department Practitioners (ODPs) for controlled drug issues e.g. possession, as there is an obvious wider range of preparations and the need grows bigger and bigger (Association of Anaesthetics of Great Britain and Ireland, 2008).

In an operating department, responsibilities for controlled drugs are shared between sisters or acting sisters (e.g. review of stock, recordings etc), medical staff (sign in the Controlled Drug Register, recordings of Controlled drugs administered already to patients and safe disposal of unused Controlled drugs) and of course pharmacists (supply of controlled drugs, audit etc).

Controlled Drug Register should be signed whenever Controlled Drugs are used and given to patients including their drawing up for example in Patient Controlled Analgesia (PCA) under always the responsibility of the prescriber, the registered nurse or any other designated person (Patient Controlled Analgesia, 2009).

The guidance applied to Controlled drug substances regarding their safe custody and storage in Perioperative care is in full accordance with the Misuse of Drugs (Safe Custody) Regulations 1973 which were mentioned in the Legislation topic (Legislation.gov.uk, 2010).

Regarding multiple dosing issue, although special labelled containers allow nurses and practitioners to use contents for more than one patient, it is strongly being constricted that contents of any other ampoules to be used and given to more than one patient (R. Birks, A. Chambers et.al, 2006).

Apart from the Controlled drugs that were referred to the different phases of Perioperative care, there is a list of Schedule 2 Controlled drugs that summarises the most commonly used ones implicating into this type of care. It should be finally added that Herbal Medicines are increasingly used in Perioperative care:

3.1.3 Controlled drugs in terminal care

As an attempt to define terminal care it is necessary to clarify that the terminal phase is the period of time, usually hours or days, in patient’s life before death. Since death is about to happen and cannot be avoided, terminal care concentrates on handling the symptoms and not further attempts to treat the patient’s condition are made (Stevens, 1997). Moreover, the care must aim into maintaining the level of dignity by avoiding embarrassment and any kind of discomfort. In many cases the patients realise that they are on the final stage of their life. Hence the medical staff is encouraged to interact and respond to patient’s worries about death (European Association for Palliative Care, 2007).

There are few key symptoms which allow the clinicians to decide the patients are on their terminal phase. First of all, the disease has reached a crucial stage resulting in absolute malfunction and collapse of body organs and systems (Raftery, 1997). Other psychosomatic symptoms include major depression followed by weakness and denial of talking and interacting with other people and the environment. The patient prefers to stay on his own, usually sleeping, not talking to anyone (Department of Health and Human Services, 2009).

In terminal care, opiates such as morphine are used for the management of pain or/and the shortness of breath. Regarding patients’ medications, the medical team should decide which of the patient’s drugs should be stopped and which ones should be not. For instance, drugs used for managing long term problems should be stopped as they have no use in the present situation (e.g. antihypertensives, anticoagulants etc). However, other medicines that can offer extra relief to the patient such as strong painkillers must be continued (Department of Health and Human Services, 2009).

Such medication changes are not always acceptable from patients and/or their families. Therefore the Health Care Professionals must always make sure that patients and their families understand the rationale of the changes. Also, some drugs might be given intravenously as the patient is unable to take the medicine orally (Department of Health and Human Services, 2009). However, it is really important to get written permissions for giving drugs via parenteral route.

An attempt to increase the dose of morphine or any other strong painkillers is not recommended for patients who are about to die due to their side effects causing disturbance and sensitivity to pain. If the patients experience renal failure, the associated drugs dose must be reduced or even stopped and if possible another drug must be given. Finally it is not recommended to tranquilise a patient who experiences harsh pain and dyspnoea as the anaesthetics cannot treat the causes of the condition (B. Noble, 1993).

Management of symptoms involves both pharmacological and non pharmacological support. Some of the ways to achieve the second one is to make the patient to feel as more physical comfort as possible. It sounds difficult as the patient covers the last phase of his/her life but is still a service that can be really appreciated by them. A quite environment is also another factor that can help patients to control their symptoms more effectively (I. Higginson, 1997).

Unfortunately non pharmacological support is not enough for patients to control their symptoms and hence the administration of drugs is necessary. Haloperidol is usually administered to conscious patients whose thoughts are disturbed whereas in unconscious patients, Midazolam, Clonazepam and Phenobarbitone are some of the usual first line drugs. Finally Midazolam and Diamorphine can be useful when breathlessness occurs (M. Fallon, G. Hanks, 2009).

If opiates do not have the desirable effects, then the administration of Ketorolac or Ketamine (CD Benz POM) is necessary in order to moderate severe acute pain (short-term management). The use of steroids is not recommended as they have more disadvantages than advantages (sleep disturbance, depression etc) (Department of Health and Human Services, 2009).

To summarise, health care team has to cooperate with the patient even in his/her last stage of life and always physical comfort should be tried to be attempted by the person in charge (on duty). In case of conscious patients, an attempt should be made in order to determine pain level and take any further action. When patients are not able to provide these information themselves then observations in their behaviour and movement should be made (European Association for Palliative Care, 2007).

Symptom Control in Terminal Care

Symptom

Controlled Drug

Route of administration

Period

Dose regimen

Terminal agitation

Midazolam*

Subcutaneously

Four hourly

2.5 – 5 mg

Levomepromazine

Subcutaneously

Six hourly

25mg

Nausea and vomiting

Levomepromazine

Subcutaneously

24 hours

5 – 12.5mg

Excess Bronchial Secretions

Glycopyrronium

Subcutaneously

Six hourly

200 – 400mcg as required

24 hours

1.2 – 2.4mg via a syringe driver

Hyoscine butylbromide

Subcutaneously

Six hourly

20mg as required

24 hours

90 – 120mg via a syringe driver

Breathlessness

Midazolam*

Subcutaneously (subcutaneous bolus)

Four hourly

2.5 – 5 mg

Diamorphine*

Four hourly

2.5 – 5 mg

Midazolam*

+

Diamorphine*

Continuous subcutaneous infusion

24 hours

10 mg each

Seizures

Midazolam*

Subcutaneous syringe driver

24 hours

10 – 60mg

Subcutaneous

5 – 10 mg

Buccal

5 – 10 mg

Diazepam*

Rectal

10mg

(*) The asterisk indicates the Controlled Drugs used to manage

Terminal Care symptoms (M. Fallon, G. Hanks, 2009)

Morphine (administered orally [including slow release morphine], subcutaneously, continuous subcutaneous infusion), Diamorphine, Oxycodone and Fentanyl are some of the usual drugs that are being taken from patients in Terminal care for managing basically pain and distress. These strong painkillers are available in a wide dose range for appropriate use when required (Dr L. Knott, 2009).

3.1.4 Controlled drugs in chronic pain

Generally pain is expressed as either chronic or acute. Acute pain appears suddenly and its duration is quite short compared to chronic one. It is usually the result of injury or illness and depending on the case varies from mild to severe (Dr JCD Wells, 2009). If appropriate management and treatment plan is not being received for acute pain then it is possible to be converted to chronic pain (A. Morrow, 2010). According to the Pain Association of Scotland, “chronic pain constitutes pain persisting over a long period of time (to be upwards of three months duration)” (The Scottish Parliament, 2002).

Having referred to perioperative care, controlled drugs are usually used in all the three stages and especially in intraoperative care where anaesthesia is involved and in postoperative care as well. So the same series of Controlled drugs are used to treat acute pain when surgery is needed (Dr. L. Strunin, Dr. C. Berry et.al, 1995).

Moving to chronic pain which affects an important percentage of people in the United Kingdom (approximately 8.5%), it can result to really dramatic consequences in patients health from weakness and muscle breakdown to even full paralysis as Dr. Schneider completes. As a result socio-psychological factors and general well-being are influenced (J. Brody, 2007), something that can have a serious impact in the patient and his/her pain level (The New York Times, 2007).

Even medications and other treatments aim to the reduction of pain and the improvement in the management of symptoms, the initial idea and objective is to reduce discomfort and disability and finally to improve the quality of life (WHO Treatment Guidelines on Chronic Pain in Children, 2008).

It is remarkable to say that chronic pain’s treatment is by definition palliative (The Scottish Parliament, 2002), so similar guidelines to those of palliative care are followed and applied in terms of controlled drugs use. It has been proved that opioids constitute a reliable solution in a series of medical fields including acute pain management and contribution into terminal care (The British Pain Society, 2010). However their long term use is under investigation and their safety and appropriateness cannot be guaranteed in patients suffering from chronic pain. This is because their extended use can cause drug tolerance and dependence.

Even if there are weak and strong opiods, this does not mean that the weak ones require less attention and responsibility. Both of them as controlled drugs are not excluded from prescription writing and safe custody requirements and extra caution is required while dealing with them (The British Pain Society, 2010).

Analgesia can be achieved by either opioid’s short or medium term use and certain types of pain (somatic and neuropathic) can be effectively managed and moderated. Long term use is likely to be avoided when possible, as high risk symptoms and side effects can be developed and is not as effective as short or medium term use (WHO, 2008). Constipation, nausea and vomiting are some of the common adverse effects that patients experience (hence antiemetics and antihistamines are recommended), whereas respiratory depression is associated with high doses of opioids (The British Pain Society, 2010).

Morphine is not used to be prescribed as much as Codeine, Dihydrocodeine or Dextropropoxyphene mainly because of the dangerous side effects induced by its use. However controlled use takes place when there is no any other option available. Pentazocine as well as Buprenorphine are not preferred because of the undesirable side effects and drug dependency and tolerance problems respectively (Dr. JCD Wells M.B., 2009).

The British Pain Society’s, Opioids dor persistent pain: Good practice, January 2010

3.1.5 Controlled drugs in cancer patients – cancer symptom management

Lots of researches have been conducted with aim to prove if there are finally medicines that can be effective against cancer pain. Results showed that even different medications including controlled drugs and surgery contribute to partial control of cancer pain, most of them do not completely relieve the patients from the actual pain caused by cancer symptoms. Of course this depends mainly on the progress of the cancer, the site of action in the human body (e.g. metastasis) as well as the specific type of cancer (for example liver, bowel, breast, bone cancer, brain tumours etc.). Treatment plan followed and any other conditions that the patient might have are factors to investigate (J. Raphael, S.H. Ahmedzai et.al, 2010).

Before choose the appropriate treatments for cancer patients it is important to understand their nature . So there are two treatment categories; the first one applies to the direct causes of the pain whereas the second one to the pain itself (Raber, 1995). Unfortunately, pain can be arisen from many causes in cancer patients and before administering any drug the source and pain need to be identified (Dworkin RH, Allen RR et.al, 2010). The most common causes of pain are listed below (Portenoy, 2003):

Inflammatory pain – chemicals excreted from damaged tissues make nerve fibres more susceptible.
Neuropathic pain – caused due to damaged nerves and nerve cells (because of the tumour). Antidepressants and anticonvulsants might be helpful for neuropathic pain.
Visceral pain – is caused from the internal bodily organs. This happens when metastasis occurs, where cells from primary tumour disseminate to form tumour masses at different sites – areas. Autonomic nerves may be affected too.
Somatic pain (musculo-skeletal pain) – is caused when bones are affected from cancer and nerve fibres within the bones are being damaged causing pain signals to be sent.
Cancer therapy – chemotherapy drugs such as taxols and platins are so strong and painful and nerve pain can be caused from high doses or extended use.
Surgery – pain can be caused after the attempt to remove the tumours (postoperative care).
Psychological factors, mood, fear and anxiety can also influence the pain and make it worse (J. Raphael, S.H. Ahmedzai et.al, 2010).

Regarding the options and drugs available for reducing the pain caused in cancer patients, Non-Steroidal Anti-Inflammatory Drugs (or NSAIDs alternatively) are advisable for mild and sometimes moderate pain. Acetylsalicylic acid which is well known as Aspirin is a very good option in the initial stage (M. McCaffery, 1999). But when pain becomes more intolerable then the use of strongest drugs – opiates – is necessary. Morphine and codeine are the basic drugs used in cancer treatment and most times relieve patients from pain successfully. They also become more effective when are combined with adjuvant drugs such as Prednisolone and Senna (Foley, Aulino et.al, 2006). Adjuvant analgesics can enhance analgesia even if they are not primary analgesics and according to World Health Organisation (WHO, 2007) they can be combined with both opioids and non-opioids analgesics after eradication of disease with local treatment (surgery or radiation) to treat microscopic disease and prevent local or distant recurrence (M. Raber, Schmerz et.al, 1995).

Even opioids option offers a better pain management, this does not mean that any disadvantages are not included. First of all they have too many side effects involving nausea vomiting and constipation and tolerance can also be developed by their extended use. This means that some of the side effects are not that bad but a reduced effect is observed over the time (J. Raphael, S.H. Ahmedzai et.al, 2010). As a relsult higher doses are required to produce the same effect. The same happens after surgery where a larger dose of opioids is required for tolerant cancer patients at the same time that intolerant patients are given smaller drug quantities. However patient’s safety is not affected by the use of opioids and efficacy remains (I. Higginson, 1997).

Buprenorphine is another controlled drug used to manage cancer pain and it is also available in different forms as it is usually prescribed to treat drug addiction. Different patches for either cancer pain (high strength three day version) or chronic pain (low strength seven day version) can be found on the market. Especially during the last decade an increase in buprenorphine’s use as an analgesic is observed. Hence General Practitioners have become more familiar with it and its different formulations and most of them avoid to get in contact with specialists for further information and recommendations (Dr R. Knaggs, 2008). Finally it should be added that Buprenorphine is used more and more as an alternative opiate for drug addiction after NICE recommendation (Care Quality Commission, 2009).

Even methotrexate is not a controlled drug it is remarkable to be said that is a basic drug (POM) included in consolidation/maintenance therapy in acute lymphoblasti leukaemia. It is usually used in bladder and breast cancer in combination with cisplatin and fluorouracil respectively (American Medical Association, 1998).

When medications are not enough for management of cancer pain then radiation therapy and chemotherapy may be more appropriate. Several types of chemotherapy involve induction, consolidation/intensification, adjuvant, neoadjuvant, maintenance and salvage chemotherapy. More harsh methods involve nerve blocks and even surgery (J. Raphael, S.H. Ahmedzai et.al, 2010).

Basic Drug List for Cancer Pain Relief: Analgesics and Adjuvant Drugs

Page 985, Pain Control for People with Cancer and Aids,

by Kathleen M. Foley, Hellen Gelband et.al, 2006

3.1.6 Controlled drugs used in epilepsy

Controlled Drugs might be used in severe cases of epilepsy in order to effectively manage and moderate any symptoms induced by a serious epileptic event/crisis. Very briefly in epileptic patients recurred seizures are appeared due to the episodic high-frequency discharge of impulses by a group of neurones in the brain. What starts as a local abnormal discharge may then spread to other brain areas (Dr F. Javid, 2010). As a result, an outburst is suddenly created because of the excessive electrical activity passing the brain and brain messages confusion is finally caused (Epilepsy Action, 2009). Different types of epilepsy involve partial, generalised, tonic-clonic and absence seizures.

One of the most well known Controlled drugs used to treat epilepsy is Phenobarbitone or Phenobarbital which belongs to the third Schedule of classification of such drugs (CD No register POM). It is the only Schedule 3 Controlled Drug that can be supplied in an emergency for the treatment of epilepsy by reducing both the frequency and severity of seizures. It is prescribed more than any other antiepileptic drug not only in theUnited Kingdombut universally and quite often total seizure stoppage is observed. It can be prescribed for all epilepsy forms except absence seizures (Glauzer, 1999).

Nowadays, although Phenobarbital is still useful and widely used, is not preferred as much as it used to be because of its sedative side effects. Most common side effects include behavioural changes and disturbances, nystagmus, lethargy, impaired memory and cognition as well as vitamin D deficiency which can lead to osteomalacia over the time (Schomer, 1997). Very rarely Stevens-Johnson syndrome and toxic epidermal necrolysis can occur. Skin, blood and liver may be affected by using this medicine (British National Formulary, 2010).

In women, extra protection is needed while taking Phenobarbitone with the oral contraceptive pill as co-administration of these two drugs influences the effects of the second one. So a second form of contraception such as condoms is necessary. On the other hand, epileptic pregnant women taking Phenobarbital need to be aware of the risks and complications that can be developed during pregnancy to the baby (Neurol, 1999). Therefore they are strongly recommended to start folic acid at least 8 weeks before conception and continue to take it at least until the thirteenth week of pregnancy in order to avert any danger for both baby and themselves (Dr. M. Manford,E. Chisanga, 2010).

Diazepam, Clobazam and Clonazepam are another two Controlled drugs (Schedule 4 – CD Benz POM) used in the treatment of epilepsy. First of all Diazepam preparations can be administered in both adults and children for the acute management of seizures, acute repetitive seizures, febrile convulsions, convulsions due to poisoning and status epilepticus according to William R. Garnett (2005). Diazepam is available in a variety of formulations with intravenous being shorter acting than rectal preparations (modified duration of action). Daily use of Diazepam tablets is avoided as tolerance and dependency may be developed. Finally Diazepam is very effective in its liquid form for treating acute repetitive seizures but the patient needs to be sure that the whole dose is swallowed and none of it goes to the lungs (S.C. Schachter, J.C. Cloyd et.al, 2005).

Although Clobazam and Clonazepam are not as popular as Phenobarbitone they are still quite effective and help to the management of epileptic symptoms. Clobazam can be used in the treatment plan of any form of epilepsy as well as for treating anxiety. Clobazam can contribute to intermittent treatment plan and it can usually be used in combination with other antiepileptics for faster symptom relief (Dr. M. Manford, E. Chisanga, 2010). Its immediate relief is one of its strong advantages whereas side effects are quite similar to those associated with Phenobarbital’s use (Department of Health, 2010). Moreover sedation, double or blurred vision, dizziness or/and muscle fatigue and weakness can occur (British National Formulary, 2010).

Clonazepam is also a Schedule 4 Controlled drug which as Clobazam can treat all forms of epilepsy, status epilepticus and it is quite effective for the treatment of panic disorders. However it should be avoided by epileptic patients having severe liver disease or being allergic to other benzodiazepines such as alprazolam, diazepam, lorazepam or oxazepam. Following Phenobarbital’s precaution guidelines, administration of Clonazepam during pregnancy is likely to cause harm in both unborn baby and the mother (C. Multum, 2009).

According to many epileptologists Lorazepam differs from the other medicines administered to an epileptic patient because of its great pharmacokinetics. Further studies and researches also showed that it might be more effective than diazepam in managing status epilepticus (T. Walczak, 2004). One of its strongest advantages is that acts very quickly to moderate or stop seizures and compared to Diazepam almost half doses are required (Greek National Formulary, 2010). Lorazepam’s side effects are similar to Diazepam ones involving drowsiness, confusion and ataxia, amnesia, aggression, headache, vertigo, hypotension etc. Drug dependence and tolerance can occur too (British National Formulary, 2010).

In the end, the last Controlled Drug implicated to the treatment of epilepsy is Midazolam which like most antiepileptic drugs referred above belongs to Schedule 4 (CD Benz POM). It has to do more with the emergency treatment of seizures in epilepsy and is available in different formulations (buccal, intranasal, intravenous or intramuscular). Buccal and intranasal route of administration are the most preferable and comfortable for administration in children. Buccal midazolam is more appropriate for either prolonged seizures or a series of seizures close to each other (indicated for children as well). Midazolam has a more immediate response than Diazepam but does not persist for so long (S. Jury, 2010). Midazolam has a sedative effect. Headache, nausea, vomiting, hypotension and heart rate changes are some of the most common side effects that have been observed into patients having taken Midazolam. Tolerance is developed quite quickly (British National Formulary, 2010).

3.1.7 Controlled drugs used in obesity

In an attempt to identify any Controlled Drugs that could be involved in the treatment of obesity, two centrally acting appetite suppressants were found. These are Phentermine and Diethylpropion. Regarding these two anorectic agents, Phentermine is a Schedule 3 Controlled Drug (CD No Register POM) whereas Diethylpropion and its salts are Schedule 3 Controlled drugs as well but some of its derived compounds are classified as CD Lic (Schedule 1) (British National Formulary, 2010). From November 2002, these two drugs can be prescribed again after the decision of the European Court of First Instance as previous decisions of the European Commission had judged their use inappropriate. Special knowledge around these drugs is still quite limited due to the few clinical trials have been conducted so far (GKT Holmes, JM Graham et.al, 2003).

According to the new marketing authorisations related to these anorectic agents lots of improvements have been done and additional information about safety and efficacy issues have been added. However experts have not been really persuaded by these safety and efficacy alterations as the use of these drugs has been associated with valvular heart disease and the rare but serious risk of pulmonary hypertension (Nutrition Committee, 2003). As a result these factors are still under contestation and further investigation. Generally, Phentermine and Diethylpropion are classified as short-term acting anorectic agents (for weight loss) and after the cessation of the medication, weight regain is observed. In terms of their product licences, a three months use is only allowed as any longer-term efficacy cannot be guaranteed yet (PG Kopelman, M. Elia et.al, 2003).

3.2 Emergency supply of Controlled drugs

Community Pharmacies according to the Misuse of Drugs Regulations 2001 are not able to provide the patient with any Schedule 1, 2 or 3 Controlled Drugs or any Schedule 4 substances listed in the Prescription Only Medicines (Human Use) Order 1997 as an emergency supply even if this is being demanded by a practitioner. Phenobarbitone or Phenobarbitone sodium is possibly the only exception to the rule as it can be dispensed for the treatment of epilepsy. Always in terms of emergency, when a Schedule 2 or 3 Controlled drug is requested by a practitioner who is unable to provide a signed order at the same time, he/she might be supplied with the requested controlled drug under the condition that he/she will return a written and signed requisition within 24 hours. If not, this is a criminal offence on the part of the practitioner (NHS Community Pharmacy Contractual Framework, 2008).

In an emergency it is also illegal to supply any drug that consists of or contains a substance in the following list (Royal Pharmaceutical Society of Great Britain, 2010):

Ammonium bromide
Calcium bromide
Calcium bromidolactobionate
Embutramide
Fencamfamin hydrochloride
Fluanisone
Hexobarbitone
Hexobarbitone sodium
Hydrobromic acid
Meclofenoxate hydrochloride
Methohexitone sodium
Pemoline
Piracetam
Potassium bromide
Prolintane hydrochloride
Sodium bromide
Strychnine hydrochloride
Tacrine hydrochloride
Thiopentone sodium

Supply of a Controlled Drug at request of patient should not be greater than 5 days for Phenobarbital or Schedule 4 or 5 Controlled drug or 30 days for other POMs apart from oral contraceptive, antibiotic or insulin, ointment, cream and aerosol (always the smallest pack available) (Royal Pharmaceutical Society of Great Britain, 2010).

Palliative care patients may also ask for an emergency supply from a community pharmacy in which Palliative Care Enhanced Local Services are provided and stock of substances such as Controlled Drugs is available. Any quantities supplied followed a valid prescription will be updated for Out Of Hours providers and NHS direct for patient’s safety purposes (Medicines Management, 2010).

Things are quite different in hospitals where Healthcare Professionals can make use of Controlled Drugs in emergency cases in order to improve patient’s health. In severe cases such as heart attack or a car accident, Controlled Drugs can be really useful. Morphine and Diamorphine are the commonest Controlled drugs administered in terms of heart attack in order to relieve patient from harsh pain and anxiety. They also contribute to the reduction of the workload of the heart and limit the size of heart attack effectively. These drugs are usually combined with other medications such as angiotensin-converting enzyme or alternatively ACE inhibitors for treating hypertension and heart failure, aspirin which reduces the stickiness of platelets, ?-blockers and statins as well (low raised cholesterol level) (Health Information Publications, 2010). It should also be noted that benzodiazepines can effectively manage the anxiety symptoms caused by myocardial infarction.

Morphine apart from relieving from pain and discomfort can also decrease and bring blood pressure back to normal levels by slowing down the heart rate. By its administration it is easier for blood and oxygen to reach the heart as blood vessels are opened (H.Simon, 2009). Its anti-inflammatory properties have positive effects in patients with chronic inflammation too (B. Bergeson, 2010).

4. Aims and objectives

4.1 Aims

By comparing two completely different member-states (United KingdomandGreece), to investigate if the introduction and establishment of a more energetic and common controlled drug legislation is feasible in terms of the European Union.
To provide the benefits or/and disadvantages of a possible common legislation around controlled drugs concerning especially their proper therapeutic use.
To consider if a universal legislation is going to be adopted and applied by the member-states, how quickly and in which way less developed countries within the EU (Greece) will affect the progress rate of the already developed ones (United Kingdom).
To determine if it is more useful for the GPs to prescribe according to what they think it is better for their patients rather than following a standard general guidance, always concerning the therapeutic use of controlled drugs (for example in terminal, palliative or perioperative care).
To identify how helpful and feasible is the subdivision of the European Union state members in five parts (based on the geographical position of the countries since neighbour countries have more similarities and the application of the laws could be managed better) aiming at the better control and management of this united legislation.
To consider if difficulties such as the different cost of the drugs between countries, different subsidization, substructure, plant as well as the fact that the controlled drugs are not distributed for free in some member states constitute either a roadblock which can be decisively mopped up or a new challenge for the EU.

4.2 Objectives

Compare Greek andUKlegislation on controlled drugs.
Identify any similarities or/and differences.
Comparison and comments on penalties and relevant sentences.
Issues and problems caused – need for amendments.
Controlled drug therapeutic use in both countries – flexibility on the clinical uses (palliative and terminal care, perioperative care, use in cancer patients, use in emergency cases, epilepsy and obesity).
Refer to other European Union countries as well as reflect on their controlled drug legislation in order to consider how feasible is this recommendation.

Based on Greek and British pharmacists’ opinions and points of view I combination with the research, to consider if the establishment of a common European Union controlled drug legislation could be established and applied respectively.

5. Methodology and study design

5.1 Methodology

Greek as well asUnited Kingdom’s legislation regarding the therapeutic use and distribution of controlled drugs will be obtained using Government Journals, Government official websites or any other valid sources (e.g. published articles) in order similarities and differences to be identified and further studied and discussed. Literature review will also be done either by usingUniversityofHuddersfieldlibrary facilities or any other community facilities such asHuddersfield’s library. Besides, Greek and British pharmacists will be asked to answer a questionnaire and their opinions combined with the results of the research will decisively lead and contribute to the final logical outcome and conclusion. Other member-states will be briefly referred and used as a comparison in order useful endings to arise.

5.2 Study Design

The design of this study is by providing useful aspects and information about UK and Greek reality on the clinical uses of Controlled Drugs (reference to drug addiction as well) and legislation, to lead step-by-step to the answer of the initial question regarding the establishment or not of a more universal and energetic Controlled Drug Legislation and overall model-system in terms of the member-states constituting the European Union.

6. Results

In this brief survey, ten Greek and ten British pharmacists were involved. The number ofUKpharmacists was chosen to match the number of Greek pharmacists who were difficult to access. Greek pharmacists were accessed by personal contacts and British pharmacists from within the university staff.

As the number of pharmacists involved is so small the results can only be used to prove general impression to indicate what this category of healthcare professionals thinks and recommends about the introduction of a possible European Union controlled drug legislation. The following tables and figures were constructed by asking pharmacists as individuals and anonymity was achieved by not recording any personal information and details. Either face-to-face questions and telephone interviews were used to facilitate the main conclusions and suggestions. (A copy of the questionnaire is also provided at the appendix 2).

In Table 6.1, Greek and British pharmacists were asked to answer the following questions on a scale of 1 to 5 with 5 indicating the strongly agree whereas 1 the mostly disagree opinions respectively. The aim of this set of questions was to introduce the topic to the pharmacists, make them more familiar with the subject and gradually lead them to the building up of their final aspect. This attempt was enforced by the questions included to the statistics charts below.

Greek

Pharmacists

British

Pharmacists

1. Are you satisfied with the current controlled drug legislation?2

4

2. Do you think there is an urgent need for improvement of the controlled drug legislation?4

3

3. Would it be more appropriate to include only EU counties in a possible legislative model?4

5

4. How quick the adaptation stage of this legislation would be for the EU countries?3

2

5. Do you think this legislation could finally work and function on behalf of patients?4

4

Table 6.1: Pharmacists’ thoughts regarding the current controlled drug legislation and the creation of a possible EU one

Figure 6.2 shows the possibility of the establishment of an EU controlled drug legislation. Before moving to any other questions and figures, it is very important and decisive to consider if the recommendation of a such legislation is feasible and a realistic subject to discussion and further investigation. As it can be seen from the relevant figure, Greek pharmacists are quite “confused” with this idea-suggestion whereas British ones have a more clear point of view considering that this proposal is maybe not so applicable and realistic (only 3 out of 10 support this idea).

Figure 6.2: Pharmacists’ responses regarding the introduction

of an EU controlled drug legislation

In the second figure (Fig. 6.3), the majority of Greek pharmacists believe that a possible EU controlled drug legislation would not affect the already developed countries. On the other hand, British pharmacists have a different opinion and support that a possible legislation in the field of controlled drugs could be a barrier to the progress of the existed legislation causing more regress than progress.

Figure 6.3: Pharmacists’ evaluation regarding the level of progress of the developed

countries after the establishment of this legislation

In Figure 6.4, the majority of both Greek and British Pharmacists seem to agree to the follow-up of standard general guidance and guidelines in terms of the clinical and therapeutic use of Controlled drugs.

Figure 6.4: Appropriateness in prescribing for controlled drugs

By having a further look at Figure 6.5, it encourages the subdivision of the European Union in five parts in case of a common controlled drug legislation shared between the member states. Pharmacists believe that this would contribute to the better management of legislation maintenance.

Figure 6.5: Pharmacists’ assessment of impendent subdivision of

EU state members for supervision purpose

Figure 6.6 shows the difficulties to get over some crucial barriers derived by economic, organisation or other resources in national level.

Figure 6.6: Pharmacists’ responses to the convenience of getting over some crucial

national problems for the introduction of a unified legislation

7. Discussion

7.1 Comments on the current controlled drug legislation and the background for the creation of an EU one

Table 6.1 represents the current point of view of the Greek and British pharmacists regarding the current relevant controlled drug legislation. At the moment each member state of the European Union follows national standards and although there is a general authority for inspecting suspicious actions and overseeing the distribution of controlled drugs, their clinical use is quite limited to national legislation procedures.

Through this table a first reference to the subject and the field of discussion is achieved showing a tension of Greek pharmacists for change and the need for the establishment of a new legislation in terms of the EU to seem necessary. This might derives by any gaps in the current laws referred to the therapeutic use of controlled drugs. On the contrary, the same does not happen with the British pharmacists who seem to be quite satisfied by the existed legislation for these “dangerous substances”. It could be said by analyzing the answers of British pharmacists that they would not like to put on risk their current legislation which outline functions very well or at least better than some other member states. As a result they think that a European Union controlled drug legislation could benefit both their country and the rest of the member states but it is not as imperative need as for the Greek pharmaceutical society.

The fact that both Greek and British pharmacists agree that in case of a common controlled drug legislation only the countries belonging to the EU should be included in a such legislation, implies their confidence and reliability to the union and its aims and intentions. The incorporation of non-EU countries to a probable future legislation could only cause really important problems and then this attempt on behalf of European citizens would be definitely impracticable and unthinkable. EU member states already follow and share common properties and consequently they are more “ready” to embody some changes resulting to positive effects (Mulder, 2002).

On the other hand, the time required for these changes to apply as well as to completely adopted by EU countries is a factor to investigate and is really important in order the absolute care of the patients to be maintained at all times including the transient stage. British pharmacists consider that the changes of an imminent legislation will take long in order to be completely embodied to the society’s reality whereas Greek ones seem to be a little more optimistic having a more positive opinion (3 out of5 inthe disagree-agree scale).

Always theoretically, Greek and British pharmacists agree that if this legislation was being approved and finally established having got over the possible barriers, this would be a strong achievement of the European Union in the health’s field which is the most “wronged” in the union’s priorities. However it needs to be mentioned that the most important is not to establish a legislation but create the appropriate base and conditions which will allow its fast adoption by the society and result to more advantages than the previously national used ones by decreasing any undesirable aspects (Kaponis, Loulakakis et.al, 2006).

7.2 Pharmacists’ responses regarding the feasibility of the establishment of a common EU controlled drug legislation (Fig. 6.2)

As it can be observed in this figure, Greek pharmacists seem to be quite dubious and cannot absolutely settle if the institution of a completely new legislation expressed by the European Union is realistic or not. Although it cannot be assumed that they are not neither positive nor negative in a such contingency, the “little confusion and hesitation” are encouraging elements that leave an opened space for discussion.

On the other hand, British pharmacists think this would be an unrealistic undertaking trying to get all member states to agree to one set of rules because of the differences in practice in various countries. Even if they are not fully aware of the prescribing of controlled drugs in these countries, they seem to be sure they have been developed as theUK’s has because of lessons learned following incidents such as Dr Shipman. Only three out of the ten British pharmacists implied that this legislation could be realistic and therefore a change could only occur if a greater benefit than unification of legislation and a major safety benefit was seen.

These opinions might arise due to the fact thatGreat Britainas a very well-structured and organized country realizes the responsibility and the effort needed in order to set up a legislation like this which is very crucial as it is going to have basic aspects in the human lives. In an era that the whole world, including of courseEurope, experiences a dangerous situation revealed by the economic crisis and the “economic and political paralysis” of the weaker countries, British Pharmacists consider that this recommendation is quite debatable. But at the same time the positive answers of the three pharmacists maintain some hopes as they think that a common legislation regarding a so crucial topic apart from the positive effects would have in the patients’ care, it could also save massive expenditure from the financial budget of each member state enforcing and benefiting the European one (Oldenhof, 2003).

7.3 Common controlled drug legislation in terms of the EU: progress or regress (Fig. 6.3

Although that a relatively big number of Greek pharmacists consider that a legislation around controlled drugs could stop the rate of progression of already developed countries in this area, the most of them believe that a such legislation could contribute to both developed and developing countries within the EU.

When British pharmacists were asked to answer the same question a completely different result met the public eye. Seven out of ten pharmacists supported that a possible legislation in the field of health apart from all the other consequences would dramatically decrease the possibilities for further development and evolution in developed countries as a transient stage would require long time.

Despite the fact that there are no any precedents for changes slowing progress elsewhere or any precedents for changes in law forcing positive change, pharmacists think that if best practice from all nations was adopted, there would be so many ways to implement a standard controlled drug policy. Adoption in any country would require the changes to law to be agreed by the various parliaments and this would be probably the rate limiting step. As with any change it is about the careful and planned introduction (Mitchell, 1995).

These results were quite expectable as through those the current reality into these two countries can be impressed. Very simply British pharmaceutical societies in combination with the public and the patients having passed so many incidents with the most important being this of Harold Shipman, have developed a “very well structured” system surrounded by time-tested and effective laws for controlled drugs (Joranson, 2004). So their overall response to this question proves not only that they are really satisfied with their current legislation, but a possible European one could “destroy” whatever they have built over the time.

7.4 The clinical use of controlled drugs based on General Practitioners or standard general guidance(Fig. 6.4)

A very interesting point derived from the survey plotted in Figure 6.4, shows the intention of both sets of pharmacists persist in a prescribing procedure based on a standard general guidance concerning the therapeutic distribution of controlled substances. The majority of the Greek and British pharmacists prefer the establishment of a standard and more general guidance as they believe that this could be a possible source of decreasing accidents abridge errors related to human factors. Of course, this does not mean neither proposes the replacement of GPs by any general guidance, but just their reflection and reference to a more approved general model.

Some pharmacists strongly support that a standard general guidance in the field of controlled drugs could be very helpful as this is often a difficult area for non-specialists and by this way they could get over their fear getting controlled drugs wrong. In general, General Practitioners prescribe using recommendations and advice from bodies such as the British Thoracic Society (in the case of management of asthma). There is also guidance for the use of medicines in palliative care but often the treatment is started by a specialist. Best evidence should always be followed, however a degree of autonomy should exist because every patient is different. Standard guidance should always reflect this with one or two alternatives to account for a variety of patient differences.

7.5 Subdivision of member states according to their geographical position for better control and management of the recommended legislation (Fig. 6.5)

In this brief survey, Greek and British pharmacists found to agree that in case of an EU controlled drug legislation, the subdivision of the member states in parts would be very helpful. In this way it will be easier for the legislative instruments to better manage the maintenance of the laws, to amend any incompletion as well as to assess the function of the legislative model in a more efficient way. Again even if there are no any examples most of them contemplate that this sounds like a sensible approach worthy of consideration.

On the contrary, the decriers of this recommendation assume that this subdivision will cause five different sets of legislation to be introduced instead of one. If the aim is to improve the legislation around prescribing, supply and administration of controlled drugs then they think the best way forward would be to have a model controlled drug set of rules representing best practice and allow member states to adapt to fit their own healthcare needs. The sharing of these rules and guidance on prescribing should ideally be known across the member states to allow for potential issues to be highlighted and addressed (Saitiotis, 2007). This would in the end help the free movement of both patients and practitioners across the EU and suitable training and education and well as changes to medication use be managed safely.

7.6 Crucial national problems are important barriers which need to be solved before the institution of an EU controlled drug legislation (Fig. 6.6)

“With one voice” Greek andUKpharmacists agree that necessary condition for the implementation of a legislation around the controlled drugs is some main national problems to got over. However, they substantially believe that this in nowadays is practically impossible. And this can be confirmed by observing Figure6.6 incombination with the Figure 6.2.

The majority of them support that problems such as the different cost of the drugs between countries, different subsidization, substructure, plant as well as the fact that controlled drugs are not distributed for free in some member states within the EU are very real barriers and perhaps the drivers for change are not so positive for health as for wealth.

A model / gold standard to be developed and adapted as required. The suggestion that all citizens of the EU will have the same high class treatment is probably utopia according to the asked pharmacists, however if a minimum standard is agreed then it is up to the politicians to force any member state falling short to adhere (Adams, 2011).

7.7 Historical background

Summarizing all the aspects which were analyzed in the sections above, it can be understood how difficult for any organization such as The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is to make any decisions about this “susceptible topic” which is the controlled drugs and propose any amendments or alterations in the existed legislation and applications, in order to improve and promote the correct use of these substances which were not misnamed as dangerous in the past.

Of course when this research started it was not expected more similarities than differences to be identified in the comparison between the United Kingdom and the Greek legislation as we talk about two different countries with completely different culture, civilization as well as living standard. But by the comparison of these two legislations – pyramids it was found that even if each one follows a different way in order to reach the top, the basis is exactly the same and aims absolutely at the correct use and distribution of controlled drugs. Parallel both of them blame the misuse of such substances but at any case not only do care and mind about misusers, but also try to provide with the best possible help and support for them.

Focusing on the Controlled drug clinical use in these two countries, a series of Acts and relative amendments in theUnited Kingdomshows that a more specialized and sophisticated approach has been developed and evolved regarding Controlled drugs probably due to the more incidents and offences that led to culture and education improvement around this topic. Also narcotics started to be distributed (illegally) earlier in richer countries such asUnited Kingdom, Netherlands etc and later on they appeared in countries likeGreece,LithuaniaorPortugal. That was exactly that rang a bell to the authorities in these countries in order to respond to this new challenge (EMCDDA, 2011).

Things inGreecewere completely different. Drugs took longer to engross and activate the government authorities and legislation institution as the living standard was obviously lower and as a result the controlled drug substances were inaccessible. So it was quite logical that there were no laws regulating these drugs as not many incidents had been referred in order to raise the need for the institution of new ones. The interference also ofGreecein the World War II delayed the introduction of narcotics into the Greek trade. Because of these two reasons the first law regarding controlled drugs was first introduced in 1987 (much later thanUK). This law it could be said that “copied” the key points of the laws from the developed countries (e.g.UK) and adapted them into the Greek reality. Hence enough similarities can be identified between the Law of 1987 and the Misuse of Drugs Act 1971. Afterwards other laws and amendments were added in order to offer a better control of these substances and reduce any undesirable incidents (Markatos, 2002).

7.8 Need for modification in each country

The fact that there is a difference in the classification of the Controlled drugs indicates that there is a different confrontation regarding the harmfulness levels in each country and therefore different numbers of groups – schedules have been established. In some other countries the state focuses not only on how harmful the substances are but also in their type by separating them in narcotic and psychotropic drugs. This results to an easier determination of penalties/sentences in cases of possession and facilitates the prosecution procedure in terms of any illegal activities including Controlled drugs. It is an exclusive right of each country combined with its legislation to decide and consider if the drug type is a factor to investigate or the same punishment is foreseen for any offence.Belgium,Spain,Ireland,Italy,Cyprus,Latvia,Luxembourg,Malta, theNetherlands,Portugal, and theUKare the countries in which the drug type is examined by the judicial authorities and it is taken into account in order to release the final court decision. The remaining 15 countries of the European Union including Norway generally do not officially investigate the drug type and the same penalty or sentence can be applied for the same activity e.g. drug trafficking even if the schedule of the drug is not the same. However, when the offence comes to the court the magistrates (unofficially) examine all the factors such as the type of the drug and the quantity found when sentencing. It should be mentioned that in other European countries such asBelgiumonly two lists/ schedules of drugs are used in order to classify these drugs (Oxford University Press, 2007). On the other hand there are countries like theCzechRepublicin which eleven schedules are required for determining the harm and differentiating these substances. However these are extreme cases and most European countries classify controlled drugs in four or five schedules such asGreece,United Kingdom,Denmark,Estonia, Ireland etc. The classification system ofGermanydoes not focus on the harm that can be induced by the use of these drugs but the authorities examine if the narcotic drugs are eligible or not for trade purposes or prescription.Spainis among the countries that have chosen to follow the UN Conventions. Although it would be more convenient for the authorities and legislation organs a common classification of these drugs to exist and be shared between all European countries, every country knows better what are its soft spots and needs, so harmfulness levels vary from each country to another and therefore they are different on purpose as they tailor different needs.

7.9 Need for the institution of insightful laws

A very interesting and important subject to discuss is the Shipman incident which brought on the surface any imperfections of the existed laws in theUK. Laws will never be perfect as societies evolve and change as new generations look for something new and different. Therefore laws need to be adjusted and probably to antecede of the incidents; in a few words, to be farsighted and prophetic when possible. In Shipman incident as it was mentioned earlier there was nothing wrong with the prescriptions of the patients as he prescribed what he thought was the best for his patients by spreading the death in tens of people. That means that there was a gap in the already existed legislation which could be probably filled in before the death of so many people. Probably this could have been avoided if pharmacists had a role (of course not main but supplementary at least) in the clinical diagnosis. Things look a lot easier when the problem has been identified and finally resolved and there is not any intention to make the solution seem so easy and self-explanatory. The only purpose is by studying the solution to the problem to try to avoid and avert any similar incidents.

The Fourth Report of the Shipman Inquiry revealed a series of shortcomings which did not guarantee the safety of the patients. The aim of any improvements was to reduce misuse but without influencing the appropriate clinical uses and offer a safer management of these drugs. The total freedom that doctors had in prescribing controlled drugs was discussed and collaboration and sharing information between agencies was deemed as necessary. Accountable officers with the responsible bodies came to give self-confidence to the system and the pharmacists with the extra role of detection in the large quantities of controlled substances contribute to the reduction of such possible incidents in the future. These standards sooner or later were adopted by other European countries as this was a very high-sounding and paradigmatic incident.

Although this was one of the most serious incidents that shocked the public opinion during the last decade, it does not mean that other incidents have not occurred. Hundreds of other incidents occur every single day in European countries not only relating to controlled drugs and not of such great importance which do not meet the public eye but contribute to the improvement and development of laws.

7.10 Clinical use of controlled drugs encourages the institution of an EU controlled drug legislation more than drug misuse

Although the legislation differs from one country to another this does not mean that the controlled drugs used for clinical purposes are different. The result of this research showed that same or similar drugs are used for example in palliative, perioperative care or even for succeeding in anaesthesia. In most cases regarding the clinical uses of these substances the first aim of their use is to relieve patients from disease symptoms and of course to sufficiently moderate and manage the pain. So the selection of the drugs takes place according to many factors such as the patient’s symptoms, availability, doctor’s diagnosis, stock etc. and generally speaking in most cases probably because of routine there are some standard drugs that need to be used, but this does not mean that alternative drugs cannot be administered to the patient. In some European countries concerningUnited KingdomandGreece, there are some controlled substances that are recommended in cases of e.g. chronic or acute pain or terminal care but these are only strong recommendations including doses and ranges of the drug quantities. But by having a further look at the drug recommendation tables of these two countries it can be seen that there are small differences and even if these tables are compared with the rest of the European countries it can be found out that only a few developing countries such as Romania and Albania follow a different drug scheme probably because they cannot deal with their high prices (Fig 6.4).

So in this specific section it would not be so difficult for some changes among European or at least European Union countries to occur as most of them already follow not completely the same but similar guidelines in the clinical uses of Controlled drugs. This can be a decisive criterion while coming up with the final answer to the initial question that is if a common European legislation could be established for the safer management of Controlled drugs (Blair, 2005).

Although Controlled drugs’ clinical uses constitute a really important part of any hypothetical or existed legislation, drug misuse comes to make things more difficult and complicated. This is due to different levels of misuse around European countries as well as different confrontation and substructures in each one for an attempt of avoidance and prevention of such phenomena that spot not only the misusers’ lives but also the whole society (Loulakakis, 1996).

A common legislation in this topic would not be so beneficial. It could make things really worse. This is because already developed countries such as the United Kingdom, Germany, Switzerland and others that have already tried via some specific laws to reduce and deal with this problem and have created special clinics, organizations and information centers that work normally and offer help to the misusers with aim to a gradual purgation of drug-addiction should dramatically decrease their progress and evolvement rhythms in order to follow the developing countries in the case of a common legislation. So something like that is impossible and of course unwanted by the developed European countries as every country requires the best for its societies and aspires the development in every section such as education, health, justice etc (Fig. 6.3).

7.11 Neighbour countries usually share similar laws and their study is necessary before the introduction of a unified one

A really determinant factor regarding the establishment of a European legislation specific for Controlled drugs is the study of current laws related to the illicit drug trafficking. This section is the one that causes various problems in the introduction of this common legislation as every country deals with illegal drug trafficking in a different manner and approach. As it was mentioned in the analysis above there are some organizations such as the Serious Organized Crime Agency (SOCA), Europol etc. which with the help of the police authorities of each country try to prevent illegal drug trafficking and detect any suspicious actions during the import or export of these drug substances from or to a country respectively. It has been observed that the import or export of Controlled drugs is a lot easier in neighbor countries rather than between countries that are far from each other geographically. This is more likely to happen due to the elasticity of the rules in countries likeGreeceandItaly,United KingdomandDenmarkas well asPortugalandSpain. Unlike everything including Controlled drugs things get stricter when a transfer needs to take place between geographically irrelevant countries (e.g.GreeceandUK). Of course this “tolerance” is condemnable as it services behalves with aim to make huge illegal profits which can cause even death (Maastricht Treaty, 1992).

It should also be mentioned that legislation not only referred to Controlled drugs but also to any kind is combined with the geographical position of each country. This means that there is a difference in countries’ primary needs according to their position in the map; so there are different needs for example in Greece, UK or Cyprus which are surrounded by the sea and in countries such as Austria, Slovakia or the Czech Republic which are surrounded by other countries, which means that the first ones require an extra protection which can be achieved by laws. Furthermore, similar legislation for Controlled drugs is appeared in adjacent countries which is quite logical as more or less the needs are pretty much the same. However there is a series of other factors like development and evolvement levels that cause the differentiation in laws among countries (SOCA, 2009)

7.12 Culture and civilization differences are major barriers

Another problem that could influence the implementation of the European legislation for Controlled drugs is undoubtedly the drug misuse scheme which varies in different European countries. First of all it would be at least unfair for drug misusers to be dealt and treated in a similar way designated by a common legislation. Something like that would be unfair due to the different progress that each country has made in this topic, meaning that developed countries should be adjusted in the requirements of the developing ones, the opposite or a combination of these two (Kontogiorgis, 2000). More specifically, a common legislation would have more negative than positive effects. For example in Greece, which is an obviously less organized country than UK in the area of the Controlled drugs, a similar legislation to United Kingdom could not find any application as there is not any appropriate substructure and the culture required is completely different in order for these laws to be effective. When we come to legislation we should first understand that any existed laws have been created and influenced not only by the requirements of this country but also by the culture of the people who live in a country which is equally important (Papazhshs, 2003). Also another factor to investigate before establishing a law is whether or not people can change and be adjusted in the new standards and how quickly people can adopt any change. Most times a transitional stage is required in order to lead people to the change step by step (Table 6.1).

On the other hand when the legislators come to the institution of new laws it is necessary to look at other countries’ profiles and laws that have already worked and met a desirable result over the time. In this way a time-tested law can be studied and adjusted in the real requirements of another society and country. The copy of this law, as it was said above, would not be beneficial but there are some key-points which if identified can make the difference and contribute to the success of a law in another country. Something similar happened in1987 inGreeceand a bit later inCypruswhere doctors prescribed both medications and Controlled drugs in a really high scale. When the two governments realized that something was going wrong with the abnormal national numbers of prescriptions in proportion to the population, they immediately tried to limit the unnecessary prescriptions. This was achieved by the study of the relevant German and UK laws regarding especially the specific Controlled drug prescription requirements and after the establishment of a new law for managing the prescriptions, the new data showed a remarkable improvement which prevented the possibility of the creation of a huge national debt.

7.13 Asuccessful legislation should be “well-surrounded” by accurate penalties and sentences for the correct exemplification of the offenders

But what happens when people do not obey to the laws, act independently against the existed legislation and established standards and finally what is the point of the introduction of a law if no penalties or sentences are provided for the understanding and exemplification of citizens within a society or country. Exactly for these reasons, penalties or/and sentences are provided by legislation including the illicit handling, trafficking and generally speaking any kind of illegal activities related to Controlled drugs as well as their supply and distribution. As it was referred to the similarities and differences section betweenGreeceandUKthe research shows that there is basically a different approach on behalf of both countries in case of an offence. The first one is wonderfully represented from United Kingdom where legislation focuses on drug type and is linked to it (as in Cyprus and in Belgium only for cannabis) and the second one from Greece where laws do not officially examine the drug type but they focus especially on the quantity of the Controlled drugs (like in Germany and the Czech Republic). Of course the authorities and the magistrates’ court need to examine all the aspects and elements including the Controlled drug type as well as the quantity found to be handled in an illegal way without the appropriate evidence or papers. In case of a common legislation any committee should discuss a lot about the combination of the drug type and the quantity of the drug in order to serve any court decisions (penalties and sentences) as both of them are really important and should be examined like two interlinked factors.

But before the final penalty or sentence is being served to the offender, another factor of which the authorities and the responsible persons need to be sure, is whether the quantity of the Controlled drug was intended for personal use or distribution (drug trafficking). By having a further look at the drug quantities which separate drug dealers from drug users it can be seen that the ranges vary and every European country follows different standards and ranges. My personal recommendation is that these ranges and threshold quantities could be common and shared between European countries as by this way a better control can be achieved for people-offenders who travel abroad and no discrimination will occur between them in penalties/sentences’ stage. Moreover a standard penalty or sentence could be served for a specific quantity or drug type making the juridical process easier and more clear and straight forward than now (EMCDDA, 2011).

Something else that can be observed in the analysis above is the difference in the years of imprisonment for the same offence in different countries. Some European countries are appeared to be “stricter” than some others in the penalties and sentences without any implication that is correct or not. Probably these governments consider that it is too difficult for these people to be conducted and therefore stricter laws are required (Greek Government Gazette, 2007). People are those who need to adjust to the society and laws and not the opposite. But even in this case a golden mean could be found and I do not think that the section of penalties and offences could be a brake in the establishment of a common legislation aroundEurope.

7.14Cyprusas a perfect combination-model of Greek and British legislation

If there is a perfect example of a country that could combine and explain further and better the legislation in Greece and the United Kingdom this is not other than Cyprus which is a country with mixed Greek and UK elements and characteristics almost in all its sectors.Cypruscombines both cultures as the first in habitants of the island were Greeks who step by step created their own community and country and finally theCypriotRepublicwas established in 1960. Before 1960,Cypruswas a colony ofUnited Kingdomthat finally attained independence after the agreement amongGreece,CyprusandUnited KingdominZurichandLondon(Simmons, 1999). As a result, this country could be an excellent example for this research with useful conclusions, as its legislation for Controlled drugs (and not only) is similar toUnited Kingdom’s one. But the most important is that all these laws were applied in a different country and by people who had a completely different culture proving that if the right substructure is being created for the establishment of legislation, then it can work and be efficient in another country as well.

If all the criteria that guarantee the safe management of controlled drugs in both drug use or misuse in the Cypriot legislation are studied, then it can be identified that the basic guidelines of theUKlegislation are followed. However asCyprusis a different country, it is necessary and prospective for some differences to exist for excusing some alterations in the legislation. So even if the basis of the two legislations is the same, there are still some differences in areas such as threshold quantities intended for either personal use or drug trafficking as well as in penalties and sentences. But the key point that should be highlighted again and is the final conclusion of this research is that although a legislation has been created in order to serve the interests of a specific team of people, there is still the margin of the isolation of some advantages and positive elements and introduction and application of them into another country. So as this model worked successfully inCyprus, it could also encourage its realization for a series of European countries respectively (Springer, 1999).

8. Conclusion and Recommendations

The main idea of this research was by analyzing mainly all the aspects of Controlled drugs’ clinical uses, including some crucial aspects of the misuse of the drugs, to examine whether or not the establishment and institution of a European Union legislation regulating controlled drugs could be feasible as well as beneficial for the member states. The extensive reference to the uses of controlled drugs in different types of care contributed to the compulsory need of an EU legislation covering the area of controlled drugs. Even if the research was very complicated in some sections it led to constitutive ideas and creative recommendations regarding the safer management and handling of Controlled drugs.

Hence, a generally small survey was conducted involving ten British and ten Greek pharmacists whose opinions were analyzed and were very helpful for tabulating the results and producing the relevant charts. Lots of opinions and aspects were produced and although there was not a clear answer to the initial subject and question regarding the institution of the recommended legislation, the basis for discussion was created which brought some other issues to the surface too. As a result, with a small difference in the number of pharmacists, most of them (12) persist in local control measures enforced on all in each country and the visitors. Reciprocity for other member states it would be too complex and subject to abuse and legal argument to harmonize.

On the contrary, the number of pharmacists that believes that this could be both beneficial and realistic is not that smaller as eight Greek and British pharmacists support this idea. So they believe that this controlled drug legislation within the state members of the European Union is realistic as there are many pieces of shared legislation. However, the difficulty will be in the way that the legislation is enforced and getting the full cooperation of all the regulatory bodies.

Examples such as the case ofCyprusshould show the way to establish a pan-European controlled drug legislation. European leaders should use this country as pattern in the attempt of unifying the legislation system. A very important point-recommendation that could be derived from this research is the subdivision of EU counties in five smaller parts in case of a possible legislation surrounding the field of controlled drugs. As it was observed in the survey in which Greek and UK pharmacists were asked, the majority of them considered that the subdivision of the member states (for instance in Northern, Southern, Eastern, Western and Central Europe) would be helpful offering and providing a better qualitative control and management regarding the distribution of controlled drugs in the therapeutic use of these drugs as well as in limiting their misuse (Kaponis, 2005).

The key point is the European Union to understand the needs of the problem, to be sensitized and apart from the evaluation of the difficulties for the establishment of a such legislation, to analyze if it would be more beneficial and appropriate for the member states. ThisUnionhas proved many times that is able to achieve what it considers is right for the European citizens. The most important part is to investigate if this would also have a positive effect to the economy of the union and if it would be able to gain support in the current economic climate.

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