Ethical and Legal Issues in Pharmacy
Name
HCA322
Instructor
December 16, 2013

Back in the 1990’s, the baby boomer generation stepped into their middle age years. Since it is not uncommon for people to begin having health issues at this age, there became a larger demand for healthcare services, and a huge demand for more prescription medications. The demand that was placed on the pharmaceutical industry brought about an urgent need for the teaching of professional ethics in schools of pharmacy. The measures taken in response to this demand were very necessary as the public now places such high expectations on pharmaceutical professionals, and rightfully so. They have access to both lifesaving and life-ending drugs and they possess knowledge that the common person finds intimidating. Patients feel a sense of vulnerability with all of the aspects involved with the industry that they may not understand such as the electronic transmission of information, electronic records, e-scripts, delivery and the complexity of health interventions, along with legal limitations, the many different medical specializations and the sharp rise in the use of generic pharmaceuticals (Klepser, et. al., 2008) It is possible that a pharmaceutical professional may find themselves in vulnerable positions as well, feeling trapped between their own personal ethics and the liabilities placed on them by their profession. They may find themselves sometime questioning as to whether they can fully uphold them. Furthermore, new drug regimens have increased in complexity, generating such related professional challenges as drug interactions, drug product selection, and therapeutic drug interchanges, suggesting new professional roles and relationships for pharmacists (Buerki & Vottero,2002).
Physicians and patients depend on and expect pharmacists to fill their prescriptions for treatment as prescribed. Pharmacists are specialists in the field of chemistry and medicinal compounds and have a duty and responsibility to the patient and physician to render information honestly and without bias, about drug interactions or side effects for the medications received (ACCP, 2009). According to Pozgar, G., medication errors are foremost in the cause of medical injuries via adverse reactions (2010). In keeping with the imperative duty of care and responsibility, most modern pharmacies keep electronic medication profiles to monitor medication drug interactions.
A more recent role placed on pharmacists is insurance companies reimbursing pharmacists for administering vaccines to patients in the pharmacy. The American Medical Association has expressed that it has reservations about the pharmacists’ duties of care overstepping into the physician’s realm of practice and engaging in, “the practice of medicine”. When this occurs, it has the potential to violate the pharmacists’ code of ethics, legally limiting their rights to deliver the levels of care in dispensing of medicine for which they are more qualified than their counterparts are, and even limit their rights and protections to do so (Forrester & Griffiths, 2010). Currently, there are emerging situations where the pharmacist’s scope of practice is expanding to become more interactive with the patient, acting as both a medical consultant and as a sort of “gatekeeper” between the physician and the patient, rendering them into more of a team-based approach to the patient’s care. The current legal and professional guidelines do not clearly define the rights, duties and responsibilities of the pharmacist in these situations. This leaves gray areas open to interpretation by participants in each situation as it arises, which is an area of concern for the legal and ethical responsibilities of the pharmacist.
Pharmacists take six or more years of graduate and/or post-graduate education and specialization training; the Pharmacist is then required to take an oath, revised in 2009, by The American Pharmacists Association. The “Oath of a Pharmacist” sworn by the graduates is as follows (ACCP, 2009):
I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow: • I will consider the welfare of humanity and relief of suffering my primary concerns • I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients. • I will respect and protect all personal and health information entrusted to me. • I will accept the lifelong obligation to improve my professional knowledge and competence. • I will hold myself, and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct. • I will embrace and advocate changes that improve patient care. • I will utilize my knowledge, skills, experiences, and values to prepare the next generation of pharmacists;
I take these vows voluntarily with the full realization of the responsibility with which, I am entrusted by the public.

The Pharmacists’ Oath provides for the pharmacist, a realization of their duties and responsibilities to the welfare of the communities they serve. As moderator with highly specialized training, it outlines the expectations placed on them by their profession and their patients. There is also the reminder that there are both triumphs and trials with moral and ethical issues relative to the profession. In addition, The American Pharmaceutical Association adopted a code of ethics for pharmacists to follow in conjunction with the Pharmacist’s Oath. For the most part, the ethical codes resemble the standards of patient relationships with other medical professions in relation to things such as autonomy, honesty, integrity, dignity, respect, maintaining professional competence, the patient-pharmacist’s covenantal relationship, and societal needs. Pharmacists can find themselves in a gray area with their duty to their employer, other healthcare professionals and the public in their “obligations for research integrity” (Klepser, 2008). The pharmaceutical industry which the pharmacists depend on is wrought with unethical practices. They sometimes conduct clinical trials with pharmacists under contract to conduct studies and articles with results that are not always factual, conducted with bias, in an unethical manner. The bias becomes clearly evident when an advertisement for a particular drug has motivated a patient to make a doctor’s appointment in order to get the specific prescription. A pharmaceutical representative’s version of facts can influence a physician with that same information, and then, subsequently it trickles down to become the problem of the pharmacist. The pharmacist then is faced with the decision to either fill the prescription as prescribed or to counsel the patient on the facts about the medication, which could be taken as disrespect to the physician who ordered it. There is the contention that it is the pharmacist’s responsibility once the prescribing physician transmits the prescription (ACCP, 2008). However, in “Pharmacists and Industry: Guidelines for Ethical Interactions,” it argues that once the physician approves the dispensing of the prescription, any problems from the clinical trials are those of the pharmacists (ACCP, 2009). The Oath of a Pharmacist provides guidelines for dealing with such a situation, as well as the expanding role as clinical consultant in the statement, “I will apply my knowledge, experience and skills to the best of my ability to assure optimal outcomes for my patients. “However, even though a pharmacist can provide counsel, they cannot legally change anything outside of notifying the physician (Downing v. Highland Pharmacy, 2008).
There are also issues concerning the moral convictions of the pharmacists when there is involvement with emergency contraception, drugs for assisted suicide or when dispensing drugs to a suspected addict is a concern. For example, some pharmacists, for religious reasons, do not believe in abortion or birth control. The Code of Ethics counsels them to be moral, legal, and professional, which, in reality, are all very subjective traits. However, Robin Wilson for the American Journal of Law and Medicine reports, “in the United States District Court for the Western District of Washington, the Court held that the regulation required pharmacists to engage in conduct that their religious beliefs defined as murder and thus violated their right to exercise freedom of religion” (2008). The ruling provides for the right of the pharmacist to refuse to fill a prescription as long as they refer the customer to another pharmacy that will fill the prescription. Additionally, if the pharmacist works for a pharmacy where the owner does not believe in birth control, they must follow the owner’s convictions as their duty to the employer.
There are many reasons why the many legal and professional restrictions imposed upon pharmacists must change. The rise of the pharmaceutical industry has pharmacists encountering numerous dilemmas, most of which stem from professional and legal limitations externally imposed upon them. Regardless of their increasing levels of competence the pharmacists cannot completely fulfill the duties and responsibilities set forth by their oath. They cannot always prevent unnecessary deaths or the unintended yet known adverse effects within the communities they serve. The Code of Ethics must continue to evolve as the pharmacists’ scope of practice evolves. Failure to do so will not insure patients the best outcomes; rather they will endanger the most important ethical principal of medicine-beneficence.

References
American College of Clinical Pharmacy [AACP].(2009). Oath of a pharmacist. Retrieved from http://www.aacp.org/resources/academicpolicies/studentaffairspolicies/Documents/OATHOFAPHARMACIST2008-09.pdf American College of Clinical Pharmacy [AACP]. (2008). Pharmacists and Industry: Guidelines for ethical interaction. Pharmacotherapy, 2008.Vol. 28 (3): 410-420. Retrieved from http://www.accp.com/docs/positions/positionStatements/Guidelines_for_Ethical_Interactions.pdf

Buerki, Robert A., and Vottero, Louis D. (2002) Ethical Responsibility in Pharmaceutical Practice, 2nd Edition. Retrieved from http://www.pharmacy.wisc.edu/sites/default/files/content/american- institute-history-pharmacy/resources-teaching/EthicResp.pdf

Forrester, K., & Griffiths, D. (2010).Essentials of law for health professionals.Sydney: Mosby Elsevier.Retrieved from Google Books.

Klepser, M.et.al. (2008). Ethical issues related to clinical, translational and health system research. White paper.Pharmacotherapy 2008. 28(10):229 e-243 e. Retrieved on October 2, 2011 from http://www.accp.com/docs/positions/whitePapers/Pharm2810_ACCP-ResearchEthics.pdf American Medical Association (AMA), (2008). The Founding of the AMA. Retrieved October 7, 2011, from http://www.ama-assn.org/ama/pub/about-ama/our-history/the-founding-of-ama.shtml

Pozgar, G. D., &Santucci, N. (2010). Legal and Ethical Issues for Health Professionals
Sudbury, Maine : Jones and Bartlett Publishers.

Wilson, R. (2008). Essay: The Limits of Conscience: Moral Clashes over Deeply Divisive Healthcare
Procedures. American Journal of Law and Medicine, 34(1), 41-63. Retrieved October 8, 2011, from Research Library. (Document ID: 1664468541).