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Moving from prescribing medications by brand name to INN

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Abstract

Drug prescription is not only a routine in medical use functioning, but also plays pivotal role in improving the health status of patients seeking such services. The nature and efficacy of pharmacy services depends on the extent of professionalism, which define the methods and ethical standards with which one carries out such duties.Furthermore, pharmaceutical services vary from one place to another, and often governed by the prevailing state laws.

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This research paper therefore, presents a detailed discussion of two main aspect of pharmacy. The first section entails the shift in the drug prescription methods, from the initial brand based method to the modern based on the active ingredient making up the medicine. The second section outlines the contribution of a pharmacist in influencing the brand of medicine that can be prescribed in a clinical process.

Introduction

The efforts aimed at changing the health care provider’s prescribing behaviour to achieve consistency with the ever changing best medical practises is the chief challenge ensuring the safest dispensation and use of medicine. Due the emergence of new data about the use of drugs such as their effectiveness, dosing options, side effects, indications as well as contraindications, the existing pharmaceutical options also keep on evolving (Garcia-Gollarte et.al, 2012). As a result of the new changes in the medical practises, there are resulting gaps between the prescription options based on evidence, and the usual practises in most clinics. For example, other than the common error of under dozing and over dozing, the prescribers may occasionally give particular medicines for wrong conditions.

Biological Medicines and Biosimillar medicines

The biological medicines are also referred to as biologics, and consist of organic compounds made through biotechnological mechanisms. The biologics appeared for use in the 1980s, and have since then advanced to bring improvements in the treatment of many diseases. Their uses as alternative medicine have revolutionized the treatment of diseases, which has led to the improvement of health status across billions of people in the world. Consequently, this category of drugs has become popular since their introduction, a process whose end has seen the diminishing power of the original biological medicine. There are many manufacturing companies, who have acquired the permission to manufacture similar brands of the original biological medicine, commonly trending the medical market as biosimillar medicines.

As a result of the existing complexity in the process of manufacturing the original medicine, the biosimillar medicines do not qualify for the generic class of medicine (Dylst, Vulto & Simoens, 2013). This is mainly due to the fact that this category is not typically identical to the original medicine. There are concerns regarding the authenticity and the effectiveness of the process of differentiating between such biosimillar medicines and the original biological medicines. These concerns are based on the extents of similarities observed when such drugs are used, as compared to the original biological medicines.

For example, under same conditions of a particular patient, when a biosimillar is compared with Infliximab, the uses of biosimilars have manifested the same therapeutic efficacy, as well as the incidences of drug related events. In addition to the similar levels of therapeutic efficacy, biosimilars are equally tolerated by the body system, and also comparable in terms of their safety issues. It is the complexity in their manufacturing processes, in tandem with safety concerns that the ongoing monitoring derives its basis (Declerck & Simoens, 2012).

Concerns regarding the use of biosimilar drugs

The concerns rose over the issues relating to safety, efficacy and the cost of using the biosimilars have resulted into the urgent need for a change of prescription method from the initial brand name to the use of active ingredients. This is because of the compromise of such brands, in which certain biosimilars do not recognize the copied brands, and thus creating confusion.

The key concern that has been raised through the Pharmacovigilance involves the criteria wit which one can use to draw a line between the original biological medicine and the biosimilar medicines. There are a plethora of biosimilar medicines that after manufacturing have been approved by the European Medicines Agency. Such approvals have derived their bases on the abbreviated programs, in which the manufacturing process was purely based on copying the formula of those biological medicines already in the market. Some of these biosimilar medicines in this category exist in the market, despite lack of approval by the regulatory bodies, under the legal regulatory frameworks within Europe. Their lack of approval has therefore led to the ultimate doubt about the validity of such medicines, especially the possibility of adverse reactions occurring as side effects.

The cost of purchasing the biosimilar medicines has also raised major concerns in the pharmaceutical industries in the Europe, just like other parts of the world. The relative low cost of acquiring such medicines has led into a perception by many people, that the existence of cheaper alternatives could be derailing the development of the industry. Consequently, there is an increase of pressure to prescribe the cheaper and new alternatives among patients, who may not afford the original biological medicines. Furthermore, such pressures have led to the increased use of such alternatives without any critical attention paid to the criteria of prescription and application of brand names.

Transition from the drug brand name to the INN system of drug prescription

The recent decades have been epitomised by a major burden of chronic diseases, not only among the European member states, but also across the globe. In order to curb the ever growing menace of such diseases among populations, the concerned authorities such as the World Health Organization, through respective governments have had to act. The chief aim of such action by the WHO, through respective governments have been to facilitate, and enforce laws to ensure that all professional health workers and patients access the safest, high quality, modern and affordable medicine to improve the health status of their people.

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Biomedical studies over time have identified the biological medicines as one of the most effective categories of medicine that can meet this criterion.

However, the main challenge in the provision of such biological medicine has been manifested on the means of identification by both patients and pharmacists during prescription. Surveys have further pointed out that the method of prescription plays a pivotal role in limiting the resulting confusion during the identification of drugs from place, particularly from one country to another within Europe (CDC, 2012). For instance, over the recent decades, the method of prescription has been based on the brand name. There are a number of factors that determine the brand name for a particular medicine, such as the location or trans-border movements within Europe.

Such variation have therefore been a core ingredient in breeding the much confusion when prescribing drugs from one place, especially for patients who may be new in such places. A particular brand name for a medicine used at one point may either be unfamiliar, or used for a different medicine in another place (Rotenstein et.al, 2013). Consequently, the need for a more standardised system of naming and prescribing drugs across the globe, including the European member states becomes an indispensible discourse. The European member states, in tandem with the world, have therefore joined the movement from prescribing medications by brand name to the INN International Nonproprietary Name (INN). Currently, there is a legislation process, whose purpose is to prevent doctors from brand prescription, but rather an active ingredient in the medicine, to allow easy determination by the patient.

The International Nonproprietary Name (INN)

The International Nonproprietary Name is a special term in healthy sciences and medicines, which is given to pharmaceuticals for purposes of easy identification. Having been initiated by the World Health Organization, the INN system of identification began to operate in 1953, for the benefit of not only the health workers such as pharmacists, but also help patients identify their medication with ease. The ease of identification was based on the common aim of the system for the generation of convenient common names for the existing pharmaceutical substances. In this case, each name generated under this system becomes unique for a global recognition of the substance as a public property. Consequently, the INN given to each pharmaceutical can have wide uses for the manufacturers and users, as well as the process of generic prescription in studies regarding drug use (CDC, 2012).

The use of the International Nonproprietary Name in the drug prescription process functions to harmonise the communication regarding the medical activities among health professionals, drug consumers and patients. As a result, this system helps to prevent potential occurrence of medication errors. A medication error refers to any resulting misconception in the processes of drug prescription, dispensation, administration as well as monitoring the use of a particular drug. Medication errors are a major cause of most adverse reactions in patients, whose prevention can easily be achieved through accurate use of the relevant drugs.

The accuracy can also be achieved through a process of synchronization, in which a single drug can retain a single identification from one place to another. A prescription method, based on the active ingredient as the common component of a particular drug, such as the INN system, has been enforced through a new legislative body referred to as the European Union Pharmacovigilance Legislation. Pharmacovigilance is a process, which consists of scientific activities of detecting, conducting an assessment of the adverse risks, understanding, and the establishment of potential prevention measures for the resulting adverse reactions (CDC, 2012).

The European Medicines Agency

Responsibilities

The chief responsibility of the European Medicines Agency is to obtain and report the relevant data regarding adverse drug reactions, resulting from medical errors. Such reports are gathered and submitted to the Eudravigilance, a database that stores all the relevant data for medical errors among the European member states. Moreover, the database system is designed in such a way that it does not only receive the relevant information on adverse drug reaction, but also processes, stores and avails upon demand, the stored information after electronic submission.s

The database run by the European Medical agency also permits users to conduct a critical analysis of the data herein, and enables one t make accurate conclusions regarding the data collected in determining the prevailing medical trends in different regions of Europe (Declerck, & Simoens, 2012). In the modern system, there are legislative measures, which ensure that the data regarding medicines are stored and undergo general processing, during which drugs should maintain a standard description using the active ingredient, other than the initial brand name.

In addition to the data reception, storage, and analysis through the Eudravigilance database, the legislative body also has a role of coordination among the European member states. The coordination role between different medicine regulatory authorities across Europe also involves all the individual Pharmacovigilance centres, as well as the patient safety authorities. The main aim of this role is to ensure that there is mutual flow of relevant information among the member states, so as to enhance communication of the occurrence of adverse drug reactions.

The Pharmacovigilance Risk Assessment Committee (PRAC) is also a legislative committee charged with a duty of offering the requisite recommendations for all medicine regulatory frameworks within the EU (Allen & Ansel, 2013). The recommendations made by the Pharmacovigilance Risk Assessment Committee function to enhance further safety issues, resulting from inappropriate use of medicines in various regions across the member states
(O’Connor, Gallagher & O’Mahony, 2012). While formulating these recommendations, the committee takes into considerations, including risk management issues, to monitor the extent of effectiveness, with which various mechanisms help to eradicate the occurrence of medication errors and adverse drug reactions.

Role of a Pharmacist in Determining a Drug Prescription

Pharmacists have the most critical role in determining the type or brand of medication to prescribe. This is because they are the base of the powers for dispensing the drugs for patients, in a normal clinical routine (Gibberson et.al, 2013). When lack of professionalism occurs in the dispensation of medicines for patients, there are higher chances of adverse medical reactions resulting from medical errors. Each year, the occurrence of medical errors, emanating from inappropriate prescription and dispensation of medicines by unprofessional pharmacists has caused harm to at least 1.5 million people. Furthermore, the loss incurred in terms of the cost of treating the injuries caused in hospitals runs at higher levels of at least $3.5 Billion each year. However, these cost estimates do not take into account the additional cost in terms of the extra wages and salaries incurred while causing and correcting such messes (Spinewine, Fialova & Byrne, 2012).

Throughout history, pharmacists have played a pivotal role in ensuring an improved patient health through appropriate prescription and dispensing of the right brand of medicine. Through improved disease management techniques and therapy practises, effective spending in healthcare activities, and enhanced adherence leads to improved quality of life (Haga et.al, 2013). In order to influence the brand of medicine to prescribe for a particular patient, the pharmacist should acquire a deeper comprehension of the patients’ medical condition. Most often, the pharmacist relies entirely on the information obtained from the technician, which helps them provide additional base for the patient’s safety (O’Connor, Gallagher & O’Mahony, 2012).

In order to obtain the required accuracy, it is important for the technician to observe strict adherence to the system based procedures when obtaining the information regarding a patient’s medical condition. In cases where the technician experiences unusual or any form of abnormalities, it is their responsibility to inform the pharmacist, to enable them prescribe and dispense the right brand of medicine (Allen & Ansel, 2013).

The Scope of Practise in Pharmacy

The scope of practise for different pharmacists varies from one country to another, depending on the prevailing state laws. The governing board of pharmacy also plays a pivotal role in determining the extent to which professional pharmacists can exercise their powers, and ability to influence the type of prescription. There are sets of regulation in various countries, which permit the pharmacists to exercise their powers as professional within specific areas within the medical care system (Law et.al, 2012).

On the other hand, other countries have laws that encourage a broader approach to service delivery within the medical service delivery. The pharmacist may therefore take part in different parts of the medication, ranging from diagnosis, prescription, drug dispensation as well as monitoring. The pharmacist therefore has a wide range of options and opportunities, during which they can influence the prescription of a given medicine (Abood, 2012).

Job Satisfaction

Job satisfaction is another aspect of enabler, through which pharmacists acquire an opportunity to influence the prescription. In the modern world of health care system, the practise of pharmacy has advanced from the initial practise of dispensing medicine and offering counselling sessions to offering more detailed clinical patient care services. In cases where a pharmacist meets restraining conditions in which they are unable to offer a wider spectrum of services to their patients, they often lack satisfaction from their jobs (Allen & Ansel, 2013).

Eradication of fraudulent prescription

The main source of medical errors often emanate from fraudulent prescriptions, some of which are out of human intervention, while the rest may be unintentional. In order to take control of the process and make the relevant decision regarding the prescription, pharmacists should understand what constitutes fraudulent practises and work towards eradicating them. Fraudulent prescriptions are caused by legitimate practises, in which patients decide to make alterations to their prescriptions to suit their personal interests (Declerck & Simoens, 2012).

In such cases, the patient may show preference for a particular brand of medicine, and insist that they be treated with the same. In other experiences, patients may also alter prescriptions depending on the cost incurred, in which they either opt for cheaper brands, or prefer more expensive brands due to their perception of higher quality and efficacy. A pharmacist may use their influence in such cases to discover the fraud and alter the prescription, and dispense the right medicine depending on the patient’s conditions (Cornes, 2012).

In addition to cases of alteration, pharmacists also have the technical and professional skills to discover the validity of prescription pads. One of the most conspicuous methods of identifying the validity of such prescription pads may involve subjecting the contact information to a rigor of scrutiny, to determine if they bear the name of the bearer. Such details may include the surnames, contact phone number as well as the registration number (Campanelli, 2012). Professionally, stealing a prescription pads translates into an automatic medical error and a potential adverse reaction. In situations where the pharmacists discover such anomalies, there are a number of professional measures that can be employed to influence the brand of medication prescribed and dispensed.

Pharmacists ensure that they apply strict rules, in which only the state authorised individuals or prescribers can write prescription orders. The state authorized person is defined by the state a trained physician, dentist, veterinarian, podiatrist, as well as other state registered practitioners. For instance, there are states with strict rules in which other health professionals such as physician assistants and nurses to participate in conducting prescriptions under supervision or instruction by the pharmacist in charge. Similarly, other states also permit a sense of autonomy for the mid-level practitioners (Law, et.al, 2012).

The pharmacist therefore has a duty to understand the prevailing laws regarding the state provisions on drug prescription, before determining one. This helps them avoid cases of assumption, in which they perceive that every prescription given for the controlled substances is inappropriate. A pharmacist who obtains a prescription whose validity attracts signs of doubt or appears invalid in any way, it is professional to undertake affirmative steps aimed at establishing the authenticity of the prescription holder (Cornes, 2012). In cases where the pharmacists have doubts about the contact information, they may have to use the prescriber’s contact office, other than the patients contact information. A telephone call to the office creates an additional time in the prescription process, during the concerned parties may address the gaps in the existing prescription. This way, the pharmacist not only gets a chance to influence the types of medication prescribed, but also adheres to the legal requirements, including state laws regarding the use of drugs.

References

Abood, R. R. (2012). Pharmacy practice and the law. Jones & Bartlett Publishers.

Allen, L. V., & Ansel, H. C. (2013). Pharmaceutical dosage forms and drug delivery systems. Lippincott Williams & Wilkins.

Campanelli, C. M. (2012). American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults: The American Geriatrics Society 2012 Beers Criteria Update Expert Panel. Journal of the American Geriatrics Society, 60(4), 616.

Centers for Disease Control and Prevention (CDC. (2012). CDC grand rounds: prescription drug overdoses-a US epidemic. MMWR. Morbidity and mortality weekly report, 61(1), 10.

Cornes, P. (2012). The economic pressures for biosimilar drug use in cancer medicine. Targeted oncology, 7(1), 57-67.

Declerck, P. J., & Simoens, S. A. (2012). European perspective on the market accessibility of biosimilars. Biosimilars, 2, 33-40.

Dylst, P., Vulto, A., & Simoens, S. (2013). Demand-side policies to encourage the use of generic medicines: an overview. Expert review of pharmacoeconomics & outcomes research, 13(1), 59-72.

Garcia-Gollarte, F., Baleriola-Julvez, J., Ferrero-Lopez, I., & Cruz-Jentoft, A. J. (2012). Inappropriate drug prescription at nursing home admission. Journal of the American Medical Directors Association, 13(1), 83-e9.

Gibberson, R. A. D. M., Yoder, C. D. R., & Lee, C. D. R. (2012). Improving Patient and Health System Outcomes through Advanced Pharmacy Practice. A Report to the US Surgeon General. University of the Incarnate Word Pharmacy Review, 1(2).

Haga, S. B., Burke, W., Ginsburg, G. S., Mills, R., & Agans, R. (2012). Primary care physicians’ knowledge of and experience with pharmacogenetic testing. Clinical genetics, 82(4), 388-394.

Law, M. R., Ma, T., Fisher, J., & Sketris, I. S. (2012). Independent pharmacist prescribing in Canada

O’Connor, M. N., Gallagher, P., & O’Mahony, D. (2012). Inappropriate Prescribing. Drugs & aging, 29(6), 437-452.

Rolland, Y., Andrieu, S., Crochard, A., Goni, S., Hein, C., & Vellas, B. (2012). Psychotropic drug consumption at admission and discharge of nursing home residents. Journal of the American Medical Directors Association, 13(4), 407-e7.

Rotenstein, L. S., Ran, N., Shivers, J. P., Yarchoan, M., & Close, K. L. (2012). Opportunities and Challenges for Biosimilars: What’s on the Horizon in the Global Insulin Market?. Clinical Diabetes, 30(4), 138-150.

Spinewine, A., Fialova, D., & Byrne, S. (2012). The role of the pharmacist in optimizing pharmacotherapy in older people. Drugs & aging, 29(6), 495-510.

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