Of morals, ethics and law: the tripod of pharmacy practice
By Pharm. (Barr.) Steve Okoronkwo
The practice of pharmacy in Nigeria is very challenging. Indeed, the pharmacy profession is viewed by many as embattled, if not endangered, in Nigeria. Pharmacy, arguably, has the reputation among the professions of having the highest number of intruders and quacks. The pharmacist’s first-line competitors are not his or her fellow pharmacist but quacks masquerading as pharmacy professionals.
While pharmacists are trying to wrestle their profession from the grip of intruders, they are also faced with a more important obligation of ensuring that their practice conforms to global best practices. The international best practice of pharmacy is anchored on the trinity of norms – morals, ethics and law. This keynote address attempts to highlight and contextualize these concepts with a view to elucidating on the concepts. It espouses the place of each of these norms in the day-to-day practice of pharmacy while examining the nexus between these norms and how they affect the pharmacy practitioner.
WHAT ARE MORALS, ETHICS AND LAW?
Morals, Ethics and Law are distinct, yet related concepts. Morals are principles of right and wrong conduct; they define a person’s character. Man is said to obtain his morals from his interaction in society. On the other hand, morality connotes something that is embedded in nature itself, and enunciates personal principles which enable the individual to choose between right and wrong1. It has beenargued that morality is subjective, that it lacks the quality of being objective. What is moral to one person may be immoral to the other. Individual morality also changes with time and situations. Views on morality may differ from person to person and from one clime to another. Some people even inject religious elements into moral considerations.
Ethics, on the other hand, is the science of morals. It is a framework, a systematic and reasoned basis for making statements about morality.² To address a question from an ethical perspective is to reflect on the morality of a situation and weigh the impact on others of one’s action – whether one can justify one’s action to a higher authority.³ Ethical relativism posits that individuals must decide what is ethical based on their own feelings as to what is right or wrong. Accordingly, if a person meets his own moral standard in making a decision, nobody can criticize him or her for it. However, this theory has been criticized on the basis that an action that is generally thought to be unethical (e.g dispensing a generic in place of a brand and charging the patient for the brand) would otherwise be ‘ethical’ if the perpetrator thought that it was in fact ethical.
Ethics is an advanced expression of morality and is thus more sophisticated than morals. While morally one can support almost anything, ethics emphasizes a social system in which those morals are applied; therefore reason is required to ethically justify one’s action. Ethics point to standard or codes of behaviour expected by the group to which the individual belongs; it is a benchmark below which the individual is notpermitted to descend, otherwise he becomes a pariah liable to be ostracized from society.
An action is said to be unethical where it runs counter to a reason-based, systematic code of conduct that is agreed by members of a group. Such unethical conduct has been described as “in famous conduct in a professional respect.” In the English case of Allison v GeneralCouncil of Medical Educationand Registration (1894) 1QB750 where a medical doctor, Mr. Allison, engaged in extensive public advertising to attract patients, the Council considered such conduct as capable of bringing the entire medical profession into disrepute. In a case of infamous conduct in a professional respect brought against the doctor, the court stated that an infamous conduct in a professional respect is said to have occurred where a medical practitioner, in the pursuit of his profession, has done something with regard to it which would be reasonably regarded as disgraceful or dishonorable by his professional brethren of good repute and competency.
It is submitted that the definition of “infamous conduct” in a professional respect in Allison’s case could be adopted in the pharmacy profession. However, what constitutes the symptoms of an “infamous conduct” will depend on the norms of each profession and facts of each case.
Ethics operates at a higher pedestal than morality. Where there is a conflict between a person’s moral belief and the society’s ethics, the latter prevails. Ethics can call morality into question and cause it to change. Society requires a code of ethics in order to provide for order, prevent or minimize general or large-scale conflicts within society, reduce strife between individuals, and provide a basis for settling conflicts between competing values. According to Vivian Weil, “a profession’s ethical standards must be compatible with our common morality, but they go beyond our common morality. You could say that they interpret our common morality for the specific details of work of a particular occupational group.”
For example, though a lawyer’s personal moralsis to the effect that murder is reprehensible, the ethics of the legal profession demands that every person charged with murder must be offered a vigorous professional assistance in defence of the charge of murder. This has its underpinning in the sanctity of human life and the constitutional provision that an accused is presumed innocent until his guilt is established by a competent court of justice.y Untilsuch pronouncement, the moral opinion of the lawyer or that of any other person does not count.
Similarly, some pharmacists – especially those in corporate setting – are often confronted with the dilemma of carrying out corporate policies that are in direct conflict with their own deeply held personal values (for example, dispensing a “morning after” contraceptive). In the celebrated case of Pierce v Ortho Pharmaceutical Corporation 417 A. 2d 505(N.J. 1980), the corporation (Ortho) filed a drug application with the Food and Drug Administration (FDA) to test Loperamide on human beings. Evidence showed that Ortho acted lawfully and ethically in conducting all research relating to Loperamide in seeking the approval of FDA to test the drug on humans. Dr. Pierce (who was employed by the company as the Director of Medical Research) voiced her disappointment with Ortho’s decision to test the drug on human beings because she believed the high level of saccharin contained in the Loperamide (44 times greater than the level permitted by law in soft drinks) would pose danger to the subjects. She even cited the Hippocratic Oath which states,”I will prescribe regimen for the good of my patients according to my ability and my judgment and never do harm to any one”. Ortho relieved Dr. Pierce of her position. She sued Ortho to recover damages for wrongful termination. At the Supreme Court, the court upheld Dr. Pierce’s dismissal by Ortho. The court said: “An employee does not have a right to continued employment when he or she refuses to conduct research simply because it would contravene his or her personal morals. An employee at will who refuses to work for an employer in answer to a call of conscience should recognize that other employees and their employer might heed a different call”. The court also noted that “chaos would result if a single doctor (employee) engaged in research were allowed to determine, according to his or her individual conscience, whether a project should continue. To hold otherwise would seriously impair the ability of the drug manufacturers to develop new drugs according to their best judgment”. This landmark case and others of that ilk show the supremacy of ethics and law over morals. However, Cristina Alarconhas argued that a code of ethics should never replace individual conscience. According to the author, individual conscience must always underpin action, even in the presence of professional codes, standards or guidelines.¹¹
Law, according to Webster’s Collegiate Dictionary, is a binding custom or practice of a community, arule of conduct or action prescribed or formally recognized as binding or enforced by a controlling authority.¹²Law and ethics are usually misunderstood as the same. The correct position however is that law asserts supremacy over morals and ethics. For one thing, law is prescriptive and binding. Morals and ethics, on the other hand, are suggestive and oftentimes not binding; laws carry with them sanctions or punishments for violation; morals and ethical violations are frowned upon but do not exert finite sanctions.
However, law, ethics and morals are not diametrically opposed. Indeed, they are not mutually exclusive either. The separation of law on the one hand and morals and ethics on the other is oftentimes merely as to form than substance. Most laws represent a codification of morality, and it is precisely a breach of ethics that has prompted the enactment of many laws. Ethics therefore is the philosophical basis for laws, rules and regulations. ¹³
Pharmacy is a social profession and pharmacists often face situations that raise moral, ethical and legal considerations. Therefore, the question whether the conduct of a pharmacist is immoral, unethical or illegal cannot be answered in abstraction.It must be situated within the context and dialectics of the eternal interaction between morals, ethics and law.
CODES OF ETHICS: PHARMACY AS A SOCIAL PROFESSION
A Code of ethics, according to WiseGeek, is a set of guidelines designed to set out acceptable behaviour for members of a particular group, association or profession.¹t Codes of ethics clarify what social and moral behaviour is and is not acceptable by professional peers. Because they belong to a group, they are usually written out to avoid ambiguity. Society requires a Code of ethics to provide for order.¹u Codes of ethics are instruments of persuasion both for members of a profession and the public. They also enhance the sense ofcommunity among members of a group with common values and a common mission.
According to RichardT:”The very exercise of developing a code is in itself worthwhile; it forces a large number of people to think through in a fresh way their mission and important obligations they as a group and as individuals have with respect to society as a whole”.¹v Codes of ethics are tools which groups or organizations use to evaluate their members and to hold them accountable to a set of predetermined guidelines and standards.
According to International Pharmaceutical Federation (FIP)Statement of Professional Standards Codes of Ethics for Pharmacists, a profession is identified by the willingness of individual practitioners to comply with ethical and professional standards which exceed minimum legal requirements.¹w Codes of ethics of a profession therefore define acceptable behaviour for members, promote high standards of practice and provide a benchmark for members to use for self-evaluation. Codes of ethics establish a framework for professional behaviour and responsibilities and also serve as a vehicle for occupational identity.Code of ethics is a mark of occupational maturity.
The practice of pharmacy has the characteristics of an occupation as well as a profession. It is commonplace therefore for a person who is engaged in an occupation to refer to himself or herself as a professional – after all, a person’s profession could equally be his or her occupation. However, ethical obligations and guidelines distinguish professions from occupations. The question whether pharmacy is a profession argues the distinction between a profession on the one hand and a business on the other hand. This argument also stresses how the two are compatible within the role of a pharmacist and brings to the fore how a Nigerian pharmacist in particular can develop his or her professional characterand remain ethical in the chaotic practice environment dominated by quacks. Ethical commitment is a counter balance to commercialism and competitioninherent in pharmacy practice. Accordingly, profitability does not preclude the ideals of professionalism.
Ethics reflect the soul of each profession. Consistent ethical behaviour creates a positive image of the individual that extends to the image of the profession. Conversely, unethical practices and decisions create a negative image of and diminish trust and credibility about the individual; it then raises suspicion about the individual’s profession. The recognition of these facts prompted the issuance by the FIP of the statement of professional standardsrelating to codes of ethics for pharmacists. The FIP, by this statement,states andreaffirms the basis of the rules for and responsibilities of pharmacists. These obligations are rooted in moral principles and values, and are to guide the national associations of pharmacists in formulating their individual codes of ethics. The Codes of ethics are to guide pharmacists in their relationship with patients, other health professionals and the society generally. Whether the Code of ethics for pharmacists in Nigeria is in consonance with the FIP Statement of Professional Standard Codes of Ethics for Pharmacists is a moot point.Suffice it to note that a Code of ethics will not solve all ethical challenges. Further, ethical codes are fundamentally based on moral suasion. It is therefore not surprising that laws are enacted to aid the enforcement of morals and ethical codes, given the coercive nature of laws and regulations.
PHARMACY LAWS IN NIGERIA
Pharmacy law is generally defined as a body of information about drugs, drugs distribution and drug therapy.¹x The law sets out the responsibilities for pharmacists and for others who are formally involved with medications. Pharmacy law provides a mechanism through which adverse outcomes are reviewed by affording responsible persons an opportunity to account for their actions and avoid liability through satisfactory accounting.
Pharmacy Law exists for a purpose. Pharmacists, as professionals, enjoy a lot of prerogatives and employ a lot of discretion in their practices.In exercise of these discretions, pharmacists wield so much influence and power. Pharmacy Law mediates the interface between a pharmacist’s exercise of professional powers and discretion and the society’s interest. Legal regulations and restrictions on the use of drugs and on pharmacists show the peculiar nature of drug beyond mere commodity. Having laws regulating the activities of pharmacists is also a way of putting checks on the privileges which the society accords to those who practice pharmacy.
Pharmacy practice in Nigeria is regulated at the federal level. The Pharmacists’ Council of Nigeria (PCN) – which has the primary responsibility of regulating and controlling the practice of pharmacy in Nigeria in all its aspects and ramifications¹y is a creation of the Federal Government of Nigeria. Having one body, namely the PCN, controlling the practice of pharmacy in the entire federation assures of uniformity in the standard of practice throughout Nigeria.
Pharmacy laws in Nigeria are from a variety of sources. These laws and regulations are quite complex and numerous for complete assimilation by an average pharmacist. According to Adenika,the laws on pharmacy have grown unwieldy. The renowned author opines that these laws are bedeviled by overlap, repeated repeals and flagellations.²<” His observation is not surprising given that most of these laws came into being mostly during the military regime, which has been dubbed by many as the dark era of Nigeria’s political history. Be that as it may, the greatest challenges facing pharmacy laws in Nigeria are the twin but related factors of non-adherence (what may be termed inadvertent infractions) to the laws and ineffective implementation of sanctions by the regulatory bodies. It is postulated that the incorporation of ethical values into these laws will reduce the incidence of infractions.
A law is adjudged good or bad depending largely on its compatibility with thegeneral morality of the society. Similarly, the image of a society is enhanced by the extent of obedience to laws by its members. Aristotle(in Politics 1294936)posits: “But we must remember that good laws if they are not obeyed do not constitute good government. Hence there are two parts of good government one is the actual obedience of citizens to the laws, the other part is the goodness of the law which they obey”.²¹ While harmonization of the several laws on pharmacy is being pursued, it is more important that pharmacists adhere to the extant laws if pharmacy must retain its position in the league of respected professions in Nigeria.
THE CONFLICT OF MORALS, ETHICS AND LAW IN PHARMACY PRACTICE
The conflict between morals, ethics and law in the practice of pharmacy results in what has been dubbed the moral/ethical dilemma, ethical/legal dilemma or moral/legal dilemma. Conflicts between law and ethics or between morals and ethics is commonplace in every facet of pharmacy practice. Since the greater percentage of this audience is made up of community pharmacists, I will dwell more on the conflicts that occur in community pharmacy practice.
Community Pharmacy is the section of pharmacy practice that serves all pharmacists owners, managers and employees practicing in a community environment. The section members are pharmacists practicing in independent and chain settings,home healthcare, franchise or supermarket pharmacies, and office-based sites.²²
Community pharmacy, also known as retail pharmacy, represents one of the largest and special group categoriesin pharmacy practice. The community pharmacy section is the largest of the FIP sections.²³ In Nigeria, community pharmacists account for over seventy percent of all the registered pharmacists.²t
Pharmacists are the undisputed custodians of drugs. However, there is no segment of the pharmacy practice which fulfills this role of custodianship better than community pharmacy. Whereas the hospital pharmacist fills prescription generated from the particular hospital where he or she works – and may as a result be used to such class of drugs that are usually prescribed in that hospital – a community pharmacist stocks almost every drug, as he or she is likely to receive orders/referrals from various hospitals. While the hospital-based pharmacist may become an authority on certain classes of drugs, a community pharmacist needs to be a “Jack of all drugs and master of all”. The custodian’s role of the community pharmacist is quite challenging as he/she needs to keep abreast of new drugs introduced into the market almost on a daily basis. This challenge is made tougher given the poor implementation of the laws that attend drug regulation in Nigeria. Drugs and other regulated products are easily purchased without qualms. Moreover, with the out-of-stock syndrome prevalent in most hospitals and government-owned health institutions, there is always a spill-over of prescriptions to the community pharmacies. Conflict of morals and law may arise in the community pharmacist’s discharge of his/her professional duty because in an attempt to meet the various needs of the customers, patients, hospital and the community, the community pharmacist may stockeven unregistered drugs.
Pharm. (Barr.) Steve Okoronkwo, managing director, Altinez Pharma made this presentation during the 21st Annual National Conference of the Association of community Pharmacists (ACPN) Anambra State