Pharmacy Law

Introduction and a brief outline of the case/situation:
You are the ‘Responsible Pharmacist’ and manager of a community pharmacy. You employ a second pharmacist, Dave, to provide additional services such as the supply of emergency hormonal contraception (EHC) via patient group direction (PGD). Dave is accredited to supply Ella One and Levonelle One Step.
Dave is serving a patient requesting EHC in the consultation room and has come into the dispensary to select a product and support materials to supply. Dave tells you that the patient has met the criteria for supply with Ella One 30mg tablet via PGD but notes you are out of stock.
Dave tells you that as Ella One is out of stock, he has decided to supply 6 x Esmya 5mg tablets to the patient from the dispensary as an equivalent. He then begins preparing the tablets for supply to the patient.
At this point, you decide to intervene and ask Dave for further details about the supply.
Legal Issues:
There are several legal issues that are arising from the case study. The first legal issue according to the patient group direction rules is that any pharmacy must have a security system to monitor the stock control, British Pharmacopoeia commission, (2000). This means that all pharmacies registered under the (PDG) must have a system that controls their medicine stock by providing good storage conditions and monitoring their expiration date. From the case study, it seems the pharmacy has run out of the Ella One tablet, which makes it a legal issue because a pharmacy with stock control will ensure that the drug is in constant supply.

The second legal issue arising from the case is the incident where Dave decides to give the patient 6x Esmya 5mg tablet, and he is not accredited to prescribe the drug to any patient. According to the Human Medicine Regulation Act (2012), only “appropriate specialists” can prescribe medicine to a patient. The law vividly stipulates the specific specialists cleared to prescribe different drugs, but in Dave’s case despite him being a pharmacist he was not ascribed to give the patient the Esmya tablet. This is clearly a violation of the stipulated rules.
Relevant professional standards:
There are several relevant professional standards that arise in the case study, which have been violated according to the standards of ethics and performance required by pharmacists. The first professional standard as a pharmacy is the obligation to implement a professional judgment, Responsible Pharmacists Regualtion (2008). All pharmacists must adhere to this standard because it is a way to keep the pharmacists in check. It is evident that Dave wants to provide the best medication to the patient, but he has an obligation as a pharmacist to make sure that he performs his duties in a professional manner, Prescott, J., Becker, G., & Wilson, S. E. (2014). It was unprofessional for him to prescribe a drug that he is not qualified to prescribe, Royal Pharmaceutical Society of Great Britain, (2000). The other pharmacy professional standard in the case study is that the pharmacists should ensure that the patients are their first concern Rafieian-Kopaei, M. (2012). This professional standard has not been violated especially by Dave. It is clear that Dave is concerned about the welfare of his patient to the point that he is risking his credibility to prescribe a drug that he isn’t accredited to issue. This shows that the patients are Dave’s first priority.
Persons/Groups Affected:
Many patients want the most effective type of treatment and every patient has a right to get the best form of treatment that suits them. The first person affected by these issues is me as the owner of the community chemist. The lack of stock control in the pharmacy gives the wrong message to the customers that the pharmacy does not have enough drugs to treat the community. The patients may eventually feel as if the chemist does not have all the necessary treatments that they require. As the owner of the company and Dave’s employer, I am accountable in case of any error done by my employee. According to the UK Medicine Act 1968, now the Human Medicine Regulation 2012, any gross misconduct done by the employee of any pharmacy is accounted for by the owner of the pharmacy and the employee. The members of the community are also affected by the decisions made by Dave. The members perceive the pharmacy as a safe place to get the right kind of medication and the medication that they prefer especially when it comes to birth control pills, Freymann, H., Rennie, T., Bates, I., Nebel, S., & Heinrich, M. (2006). The lack of a specific kind of drugs sends the wrong message to the community members. Even more damaging is finding out that the pharmacist prescribing a certain drug is not legally and professionally obligated to do so. This eventually affects the reputation of the pharmacy among the community members, Chaar, B. B. (2009).
Other Factors to be considered:
Decide what action you would need to take in this situation (if any); then using suitable language, explain the implications of your decision to your colleague, Dave:
The first action I need to take as the owner of the chemist it to install a stock control system. The system will ensure that there won’t be any specific drugs missing when the patients ask for them. It will also ensure that I can monitor the drugs in my pharmacy and check their expiry date to prevent selling expired medicine to the patients, Walker, R. (2011). The next appropriate action to take is to report Dave to the pharmacy board. This is important as it enables me to get ahead of the narrative. The narrative, in this case, is the probability that Dave would have prescribed a drug to a patient that he is not qualified to prescribe. This is clearly violating the pharmacy rules, and the most ethical thing to do as the owner of the pharmacy is to report the incident. Medicine, Ethics, and Practice (2017)
The decision to report my colleague, Dave to the pharmacy board will have many implications for him Appelbe, G. E., and Wingfield J. (2013) The first implication is that it will ensure that he understands that the rules have to be followed despite having the best interest. This will teach him that there is no excuse for violating rules with the justification that someone is doing the right thing. The second implication that my decision will have on Dave is that it will ensure that he follows protocol despite the circumstances. This is important because if I were not at the pharmacy at the time Dave was contemplating on supplying the medication, he would have supplied the drugs without my consent. This would have put the pharmacy in jeopardy in the future, Cooper, R. J., Bissell, P., & Wingfield, J. (2007). The third implication is that Dave will never trust me again for reporting him to the board and he may blame me for losing his license.
Referring to all the facts that you know concerning the scenario, justify your decision and indicate what, if any, additional action you will take:
The main facts that are evident in this case scenario are the fact that the pharmacy does not have a stock control system and the gross misconduct shown by Dave. Considering these case scenarios my first obligation as a pharmacist is to ensure that the patient gets the best medication from the pharmacy, Williams А, G. М. (2012). The inability of the pharmacy to know the exact number of drugs available has prompted me to install a stock control system. This problem will also prevent the scenario of a pharmacist prescribing an alternative drug to the one the customer does not want. Having a good stock control system will also monitor the drugs available for use and the expired ones, Sosabowski, M. H., & Gard, P. R. (2008). This will ensure that all patients are satisfied with the services offered by the pharmacy. The second fact from the case study is the gross misconduct shown by Dave. Looking at this scenario, it may seem like my decision to report Dave to the pharmacy board as harsh and unworthy, Benson, A., Cribb, A., & Barber, N. (2009). Looking at this scenario, it is justifiable to report him to the board of pharmacists because there are many ways to look at Dave’s behavior. The different situations that may arise from Dave’s behavior are that it might have been the first time that he was prescribing drugs that he was not qualified to prescribe or he has been doing the same thing on most occasions. It is justifiable to report Dave to the board to ensure that his actions do not go unpunished and to set an example to other pharmacists who are behaving in such a manner, Patricia Benner and Christine Tanner, (2009). Having weighed up on the options, I have my decisions are based on the patient’s welfare to get the best medication for their illness. The additional action that I might take concerning this matter is to ensure that the next pharmacist I hire I will take time to outline the rules and regulations that are adhered to by the pharmacy board. This will ensure that the next employee will not make the same mistake Dave or other mistakes in the future.
References:
Appelbe GE, Wingfield J, editors. Dale and Appelbe’s Pharmacy and Medicines Law. Pharmaceutical Press; 2013.
Benson, A., Cribb, A., & Barber, N. Understanding pharmacists’ values: A qualitative study of ideas and dilemmas in UK pharmacy practice. Social Science & Medicine, 2009, 68(12), 2223-2230.
British Pharmacopoeia Commission, Great Britain. Medicines Commission, General Medical Council (Great Britain). British Pharmacopoeia 2000. Bernan Press (PA); 2000.
Chaar, B. B. Professional ethics in pharmacy practice: developing a psychometric measure of moral reasoning. Pharmacy world & science, 2009, 31(4), 439-449.
Cooper, R. J., Bissell, P., & Wingfield, J. Dilemmas in dispensing, problems in practice? Ethical issues and law in UK community pharmacy. Clinical Ethics, 2007, 2(2), 103-108.
Freymann, H., Rennie, T., Bates, I., Nebel, S., & Heinrich, M. Knowledge and use of complementary and alternative medicine among British undergraduate pharmacy students. Pharmacy World and Science, 2006, 28(1), 13-18.
Gallagher, C. T. Building on Bloom: A paradigm for teaching pharmacy law and ethics from the UK. Currents in Pharmacy Teaching and Learning, 2011, 3(1), 71-76.
Patricia Benner RN, Christine Tanner RN, editors. Expertise in nursing practice: Caring, clinical judgment, and ethics. Springer Publishing Company; 2009 Mar 16.
Prescott, J., Becker, G., & Wilson, S. E. Moral development of first-year pharmacy students in the United Kingdom. American journal of pharmaceutical education, 2014, 78(2), 36.
Parliament UK. The Medicine Act 1968.
Parliament UK. The Human Medicine Regulation Act, 2012
Parliament UK. The Responsible Pharmacists Regulation. Standards and guidance. 2008
Royal Pharmaceutical Society. Medicine, Ethics, and Practise. A professional guide for pharmacists. Pharmaceutical Press. 2017.
Rafieian-Kopaei M. Medicinal plants and the human needs. Journal of HerbMed Pharmacology. 2012;1
Royal Pharmaceutical Society of Great Britain. Medicines, Ethics, and Practice: A Guide for Pharmacists. Royal Pharmaceutical Society of Great Britain; 2000.
Sosabowski, M. H., & Gard, P. R. Pharmacy education in the United Kingdom. American journal of pharmaceutical education, 2008, 72(6), 130.
Walker, R. Clinical Pharmacy, and Therapeutics E-Book. Elsevier Health Sciences; 2011.
Williams А, G. М. PRM-Associated Endometrial Changes (PAEC). ESMYA (ulipristal acetate). Pathologist’s guide. Med Inform Serv Preglem SA Geneva (Switzerland); 2012.