PRINCIPLES OF PHARMACY ETHICS

As.prof. Tolokova T.I.

Basic biomedical ethical responsibilities

benefiting the patient, supporting a patient’s right to self-

determination/autonomy, refraining from harming the patient, assisting and advocating on behalf of the

patient to ensure effective and safe healthcare,

protecting the patient’s medical privacy, maintaining professional competency and

knowledge

The ethical conflicts in pharmacy practice

allocation of time between dispensing and

clinical services;

patient advocacy responsibilities;

social, moral, or religious objections to

certain drug uses;

conflicts of interest with pharmaceutical

companies;

The ethical conflicts in pharmacy practice

drug diversion and abuse; healthcare resource stewardship

Why is pharmacy ethics important? A pharmacist’s primary responsibility is

to benefit patients and prevent harm by dispensing the right drug in the right amount and with complete use information. Failure to fulfill these responsibilities can lead to loss of disease control, disability, and/or death.

Why is pharmacy ethics important?

Adherence to both professional standards and a code of ethics is imperative if these problems are to be avoided.

Conflicts between dispensing and clinical services

Dispensing pharmacists spend much of their professional time interpreting, filling, and dispensing prescriptions. These functions require that the pharmacist reviews the prescription for proper drug use and dosage.

For all of dispensing services, pharmacists receive a fee, and the number of prescriptions filled becomes the primary measure of the pharmacist’s income, especially in a chain drug store setting.

When patients perceive a benefit from medication counseling, they can more easily tolerate disruptions in dispensing services.

Conflicts between dispensing and clinical

services When patients perceive a benefit

from medication counseling, they can more easily tolerate disruptions in dispensing services.

Patient advocacy

Training and specialized knowledge should be put to use to determine if the prescription is valid, beneficial, and safe.

A pharmacist also lacks the medical information that the physician has about the patient, and pharmacists often cannot take the time to inquire about the prescribing choices of a busy physician who may, in turn, resent the interference.

Two guiding principles may help the pharmacist in cases such as this: (i) the more severe the potential harm to the patient, the more the pharmacist should be motivated to intervene, and (ii) informing patients of any concern and advising them to seek further advice from their physician is always advisable.

Refusal to fill a prescription on the basis of social, moral, or religious objections

Pharmacists can have moral objections to the use of medications in many circumstances. The use of drugs for physician-assisted suicide is one such circumstance, and debates exist about whether pharmacists should fill these prescriptions, both in jurisdictions where the practice is legal and those in which it is not.

What is not condoned in most countries is a pharmacist refusing to return the prescription to the patient or telling a patient that it is morally forbidden to use the medication for the intended purpose.

The patient–pharmacist relationship: a patient’s autonomy and right to treatment and the duty of the pharmacist to benefit the patient and to refrain from harming someone seeking medication

Using prescription records to assist the marketing activity of pharmaceutical companies

Some large pharmaceutical companies pay

US pharmacies to mail material or call

patients about company drugs or competing

products. The materials and messages urge

patients to do such things as continue taking

a currently prescribed drug, switch to a new

form of the drug, or switch from a

competitor’s drug.

Using prescription records to assist the marketing activity of pharmaceutical companies Is there a conflict of interest

when pharmacists are paid to urge patients to take a particular brand of drug?

Pharmacists who are approached to participate in these programs need to place primary emphasis on protecting patients’ privacy interests and should only convey information clearly intended to promote health interests.

Drug diversion and abuse

Pharmacists increasingly suspect that when a patient presents a prescription for a controlled drug, it is for the purpose of diversion or abuse. Professional responsibilities in such a case often conflict.

Pharmacists have a duty to dispense opioid analgesics when the drug has been legally prescribed and is therapeutically appropriate for the patient. Alternatively, filling a narcotic prescription that is used abusively increases the risk of harm to the patient and perpetuates a dangerous threat to the public health.

Drug diversion and abuse

Since most pharmacists will face this kind of challenge, all should receive training that focuses equally on decision-making skills to detect drug abuse and diversion and also on the recognition of valid and appropriate prescriptions for controlled substances.

Medical resource stewardship

No system of healthcare is free of the burdens of cost and the fair and rational allocation of constrained resources. Pharmacists play a central role in these matters since they control or manage institutional drug formularies, which are systems designed to limit the choice of drugs that can be prescribed based on cost-effectiveness determinations.

A typical drug formulary decision involves selecting the least expensive among a class of drugs that provide the same or similar therapeutic benefit and risk. At times, however, the decision can involve whether or not to stock a particularly expensive drug.

Data collection must respect the right to

privacy Assuring a patient’ s privacy when clarifying

prescription details requires management of the risk of inadvertently being overheard by other customers during this process. This can happen if working from a computer screen removed from the area where prescriptions are received, unless specific efforts are made to avoid being overheard.

Risk management would identify that when a patient is collecting his/her prescription the pharmacist should ask the patient to state his/her address.

Data recording must be accurate

While it is critical that pharmacists

document interventions and advice,

commentary must be factually

accurate and free from any

accusation of innuendo or slander.

Data recording must be accurate

With the advent of advanced services, recording templates must direct the nature of information gathered by pharmacists. In addition, confirmation of the length of time for which records will be kept must be included in the process of collecting data.

Storage of data must be secure

Pharmacists are obliged to make sure personal data is not accessible to anyone other than employees (who will have signed confidentiality clauses) or to others involved in the patient’s care.

As with any organisation, pharmacies must ensure that back-up disks, laptops, fax rolls, printer ribbons, video tapes and all forms of CCTV must be destroyed appropriately before being included in regular waste.

Code of Ethics of Pharmacists of Ukraine

The purpose of the Ethics Code of Pharmacists of Ukraine (hereinafter – the Code) is a declaration of fundamental principles of the profession, which is based on moral obligations and values.

Code of Ethics of Pharmacists of Ukraine

The Code defines ethical standards of professional conduct and responsibility, which have to become exemplary guide for pharmacists in their relationships with society under conditions of market relationships, when the role and significance of the pharmaceutical profession increases.

Pharmacist in modern society

The main objective of the professional pharmaceutical activity of the area specialist is prevention of diseases, preservation and strengthening of human health.

Pharmacists in his practice on the matters of drugs and medical products promoting must comply with the legislation of Ukraine about advertising of drugs, medical equipment, methods of prevention, diagnostics, treatment and rehabilitation.

To promote development of health sphere, including pharmaceutical sector, and also improving of the profession image, pharmacists should actively participate in the activities of national and international civic and professional organizations .

Relations between pharmacist and patient

Pharmacist must:

• treat each patient with respect from meaning individual approach showing no preference or dislike;

• have psychological communication skills to be able to achieve confidence and mutual understanding between him and the patient;

• to act openly, honestly and objectively, without using in personal or their institution’s benefit lack of information and ignorance of the patient about drugs and medical products, not to place pressure on the patient (in whatever form) for their purchase.

Relationships between pharmacist and doctor

Pharmacist as a specialist of this sphere shall:

• inform the doctor about drugs and medical products, their availability, distinctions of pharmacotherapy and use of analogues;

• provide the doctor with complete information about the new preventive and diagnostic drugs and medical products;

• require from the physician to precisely follow the established regulations of writing drugs prescriptions;

• detect errors in drugs prescription and discuss them with the doctor.

Relationships between pharmacist and his colleagues

Pharmacist must build relationships with colleagues based on mutual respect, trust, abide by professional ethics.

Pharmacist should create and maintain favorable moral and psychological climate in the team.

Pharmacist must criticize incompetence and unprofessional actions of colleagues that may harm health of the population.

Pharmacist and scientific progress

Pharmacist must raise his professional level and skills.

Pharmacist should contribute to conducting of various studies aimed at increasing efficiency and accessibility of rendering pharmaceutical care.

When creating preclinical, clinical trials of drugs, registration, manufacture and their sales pharmacist must follow the requirements of international standards.

Clinical trials of new drugs should be carried out according to bioethical principles.

Pharmaceutical Information

Providing of pharmaceutical information in professional and public publications, any media, speeches of pharmacists at scientific conferences in the conditions of professional and practical activity should be subject to ethical rules and regulations, avoiding demonstration of advertising, self-promotion and unfair competition.

Pharmacist must give the patient comprehensive and accessible information on application, contraindications, side effects of drugs and medical products, even against his own or commercial interests of the institution.

New Pharmaceutical Technologies

Actions of pharmacists while developing of new drugs and medical products with use of the latest pharmaceutical technologies with interference into the human genome, at the cellular level should be determined by ethical and legal and legislative acts of Ukraine, recommendations and requirements of the WHO, Bioethics Committee of UNESCO, Commission on Bioethics, the requirements of good pharmacy practice: GLP, GCP, GMP, GPP and others.

Clinical trials of new drugs developed on the basis of new pharmaceutical technologies should be conducted in accordance with ethical principles of the Helsinki Declaration, GCP rules and relevant regulatory requirements.

Respect for the profession of pharmacist

The principle of respect for his profession must be maintained in all areas of pharmacist’s activity: professional, social, scientific, educational and any other and fully supported by every pharmacist. Unacceptable from a professional and ethical point of view is disrespect and negative statements about pharmaceutical profession.

Life position, the whole career, any activity of pharmacist should contribute to the prestige of the profession, preservation and increase of its best traditions.

The action of the Ethics Code of pharmacist

Pharmacist is responsible for the violation of norms and principles of professional ethics and deontology in front of the pharmaceutical community as well as of the current legislation of Ukraine, if the violation also related to its norms.

Revision, amendments and supplements to the Code must be carried out at congresses and conferences held by Health Organization of Ukraine, pharmaceutical community and pharmaceutical associations.

Community Council of representatives of professional public organizations and executive bodies shall monitor the way a pharmacist follows the Ethics Code.