Code of Pharmaceutical Ethics

Code of Pharmaceutical Ethics: Definition, ethical principles, ethical problem solving, registration, code of ethics for Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath.

PHARMACEUTICAL JURISPRUDENCE

Alok Bains

2/5/202412 min read

Code of Pharmaceutical Ethics: Definition, ethical principles, ethical problem solving, registration, code of ethics for Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath.

Definition

Any moral values developed by society or individuals are ethics. But there is a difference between morals and ethics. Ethics is framed or developed by any external source but not by the government. These external sources may be society, office administrators, organizational heads, company directors, etc. It is expected individuals will observe these ethics in society and at the workplace. Ethics and culture vary from society to society, from organization to organization, from country to country, and from region to region.

Ethical Principles

The Pharmacy Council of India (PCI) has established a code of ethics for pharmacists in India. These ethical principles are designed to guide the conduct of pharmacists and ensure the delivery of safe and effective healthcare services. The ethical principles include:

  • 1. Commitment to Patient Welfare: Pharmacists are expected to prioritize the well-being of patients. This includes providing accurate information about medications, ensuring proper dispensing practices, and offering counseling on the safe and effective use of medications.

  • 2. Confidentiality: Pharmacists must respect the confidentiality of patient information. Patient records and information should be handled with care, and disclosure should only occur with the explicit consent of the patient or as required by law.

  • 3. Professional Competence: Pharmacists are required to maintain and enhance their professional competence. This involves staying informed about advancements in pharmaceutical sciences, participating in continuing education, and continually improving their knowledge and skills.

  • 4. Integrity and Honesty: Pharmacists are expected to uphold the highest standards of integrity and honesty. This includes providing accurate information, avoiding conflicts of interest, and conducting professional activities with transparency.

  • 5. Respect for Autonomy: Pharmacists should respect the autonomy and choices of patients. They should involve patients in decision-making processes related to their health and medications.

  • 6. Professional Collaboration: Pharmacists are encouraged to collaborate with other healthcare professionals to ensure comprehensive and coordinated patient care. Effective communication and teamwork are essential for promoting positive health outcomes.

  • 7. Avoiding Exploitation: Pharmacists should not exploit patients, colleagues, or other healthcare professionals for personal gain. This includes avoiding practices that could compromise professional judgment or lead to conflicts of interest.

  • 8. Continuing Professional Development: Pharmacists are expected to engage in continuous learning and professional development activities to stay updated on new developments and contribute to the improvement of pharmacy practice.

  • These ethical principles guide pharmacists in various practice settings, including community pharmacies, hospitals, research institutions, and the pharmaceutical industry. It is important for pharmacists to be aware of and adhere to these principles to ensure the highest standards of professionalism and patient care.

  • Ethical Problem Solving Ethical problem-solving for pharmacists generally involves applying ethical principles to address dilemmas or challenges encountered in daily practice. Pharmacists are expected to use their professional judgment and ethical reasoning to resolve complex situations. Here are general steps that pharmacists may take when faced with ethical dilemmas:

  • 1. Identification of the Ethical Issue: Recognize and clearly define the ethical issue or dilemma at hand. This may involve conflicts between principles, values, or professional responsibilities.

  • 2. Consultation and Collaboration: Seek advice and collaborate with colleagues, healthcare professionals, or superiors when facing ethical challenges. Discussing the issue with others can provide different perspectives and insights.

  • 3. Consideration of Ethical Principles: Evaluate the situation in light of ethical principles such as patient welfare, confidentiality, honesty, integrity, and respect for autonomy. Consider how each principle applies to the specific case.

  • 4. Legal and Regulatory Considerations: Be aware of and consider relevant laws and regulations governing pharmacy practice. Ensure that proposed solutions align with legal requirements.

  • 5. Reflection on Professional Values: Reflect on personal and professional values that may influence the decision-making process. Identify potential biases and strive for objectivity in decision-making.

  • 6. Decision-Making: Make a well-reasoned decision based on a balance of ethical principles, professional values, and legal considerations. Choose a course of action that is in the best interest of patient welfare and aligns with professional standards.

  • 7. Documentation: Document the ethical decision-making process, including the identified issue, the considerations taken into account, and the chosen course of action. This documentation can serve as a record of the pharmacist's commitment to ethical practice.

  • 8. Continuous Learning and Improvement: Reflect on the outcomes and consequences of the decision. Consider how the experience can contribute to ongoing professional development and learning. Use ethical challenges as opportunities for growth.

  • It's important to note that while the PCI provides a broad framework in its code of ethics, individual pharmacists may develop specific policies or guidelines to address ethical problem-solving in the context of their practice settings.

Registration

In India, the registration of pharmacists is governed by the Pharmacy Council of India (PCI) and the State Pharmacy Council. PCI is the statutory body responsible for regulating pharmacy education in the country. The State Pharmacy Council is the statutory body responsible for regulating pharmacy practice in the state. The registration process ensures that individuals meet the necessary qualifications, education, and training to practice as pharmacists. The following are the key steps involved in the registration of pharmacists in India:

  • 1. Education: Completion of a recognized pharmacy education program. It is either Diploma in Pharmacy or Bachelor of Pharmacy (B.Pharm).

  • 2. Internship: Successful completion of a period of practical training or internship. The internship is conducted under the supervision of a registered pharmacist in an approved hospital for diploma in pharmacy candidates. The internship is conducted under the supervision of a approved chemist in an licensed pharmaceutical industry for Bachelor of pharmacy candidates.

  • 3. Licensing Exam (Exit Exam): Passing the licensing examination for diploma holders conducted by the Pharmacy Council of India. The examination is known as the Pharmacist Qualifying Examination and is held to assess the competence of candidates.

  • 4. Application for Registration: After successful completion of education, internship, and the licensing exam, individuals can apply for registration with the State Pharmacy Council.

  • 5. Documentation: Submission of the required documents, including educational certificates, internship completion certificates, licensing exam results, and other relevant details.

  • 6. Payment of Fees: Payment of the prescribed registration fees as per the rules of the respective State Pharmacy Council.

  • 7. Verification and Approval: The State Pharmacy Council or Pharmacy Council of India verifies the documents and qualifications submitted by the candidate. Once satisfied, the council approves the registration.

  • 8. Issuance of Registration Certificate: Upon approval, the registered pharmacist is issued a registration certificate. This certificate serves as proof of the individual's eligibility to practice as a pharmacist in the respective state or territory.

  • 9. Renewal of Registration: Registered pharmacists are required to renew their registration periodically as per the rules and regulations of the State Pharmacy Council.

Pharmacists need to adhere to the code of ethics outlined by the Pharmacy Council of India, which includes principles related to professional conduct, patient care, confidentiality, and other aspects of ethical practice.

CODE OF PHARMACEUTICAL ETHICS

Pharmacist in Relation to His Job

Scope of Pharmaceutical services: A pharmacy is a licensed premise to sell, compound, and dispense medicines under the supervision of a registered pharmacist. Pharmacists must provide reasonable comprehensive pharmaceutical services. He must dispense medicines without undue delay. He must provide emergency services willingly around the clock.

Conduct of Pharmacy: The pharmacy must be properly arranged. Arrangements in the pharmacy must support providing a working environment free from accidental error, and accidental contamination during the dispensing and compounding/ supply of medicines. The pharmacy must have a professional appearance so that patients can recognize it easily. It should be clear to patients and their attendants that the practice of pharmacy is carried out on these premises. Signboards, wording on business, notices, stationary, and other materials of pharmacy should be of proper size. Any type of exaggeration should be avoided. These all should be in a restricted manner. Qualification displayed on name plates of pharmacists should be limited. Pharmacists should not be distinguished based on their qualifications.

Display of qualification may develop undue panic and anxiety among patients and their attendants. A notice must be displayed stating various services available such as E.S.I.S (Employee State Insurance Scheme) or any other government or private-sponsored scheme.

The pharmacy must have one head pharmacist to look after the work of other pharmacists and other activities of the pharmacy. He will be responsible for maintaining proper standards of pharmacy working and conduct. The owner of the pharmacy should not interfere in the working of the pharmacy and in the maintenance of standards of pharmacy working by pharmacists. Any type of interference will be considered as developing unethical practices.

Handling of Prescription: A prescription from the patient or his attendant should be received by the pharmacist himself without any facial expression. Pharmacists should not show astonishment or facial judgment upon receipt of a prescription. Any type of facial expression may develop anxiety in the patient and his/her attendant. Pharmacists should not comment on or discuss about merit or demerit of prescription and its therapeutic efficacy. These things may also shake the faith of patients in medical practitioners. This psychology of the patient may adversely affect the therapeutic effect of the medicines prescribed. Pharmacists must be careful while answering any quarry from patients or attendants. Pharmacists' answers to queries should not harm the reputation of medical practitioners. He should not disclose any information about the prescription to anyone. He can disclose it if there is the demand of law of land. Even he should not disclose it to the patient.

Pharmacists should not add, omit, or substitute any ingredient of a prescription without the consent of the prescriber. Pharmacists can alter formulation if it is purely a demand of pharmaceutical art and does not affect the therapeutic value of the prescription. If there is any error in the prescription like therapeutic incompatibility, overdose, or contraindication then the prescription should be returned to the prescriber. But while returning, pharmacists must be careful that this return should not harm the reputation of medical practitioners.

The prescription is referred back to the prescriber in the best interest of the patient. Prescription should be refilled only after instruction from the patient. Pharmacists should obey the refill instructions of the prescriber.

He must advise patients and instruct them to take medicines as per instructions from medical practitioners and written prescriptions.

Handling of Drugs: Pharmacists must dispense prescriptions correctly by using proper measuring and weighing ingredients as per formulation. He should use standard weights and measures for weighing and measuring ingredients. He should not adopt visual estimation to measure and weigh ingredients. Pharmacists should stick to using standard quality drugs that must qualify for pharmacopeia standards. Spurious, misbranded, adulterated, substandard drugs and unethical preparations should not be dispensed in pharmacies.

Poisonous drugs, additive or habit-forming drugs, narcotic drugs, and abusive drugs should be handled very carefully and judiciously. These drugs should only be dispensed if there is proper reason that drugs will not be misused and have been prescribed by a registered medical practitioner.

Apprentice Pharmacists: Student pharmacists are admitted to the hospital to work as apprentice pharmacists under registered pharmacists. Registered pharmacists should provide full facilities to student pharmacists. He should properly guide and train student pharmacists so that student pharmacists can work as independent pharmacists after completion of prescribed training. Training certificates should be issued only after assuring that student pharmacists have acquired the knowledge, technique, and skill to work as self-dependent pharmacists.

Pharmacist in Relation to His Trade

Price Structure: Pharmacists should charge fair prices to patients without undue taxing patients. Price should decided to keep the following parameters: quantity and quality of medicines and medical appliances supplied, labor and skill involved in the preparation of medicines and medical appliances, and sufficient remuneration to be paid to pharmacist.

Remuneration to pharmacists depends upon their qualifications, experience, skill, and labor of pharmacists utilized and the risk involved.

Fair trade practice: Pharmacists should not involve themselves in cutthroat competition with fellow pharmacists or any other pharmacy. He should not offer any prize or gift or any kind of temptation to patients or medical practitioners.

He should not knowingly charge lower prices for medicines and medical appliances. Especially lower prices than charges by fellow pharmacists or any other pharmacy. Prescriptions intended to be dispensed by a specific pharmacist should not be dispensed by another pharmacist. Pharmacists should guide patients to visit that specific pharmacy. Pharmacists should not copy labels, trademarks, symbols, or signs of any other pharmacy or pharmacist.

Drug Purchase: Pharmacists should purchase drugs from reputed and genuine suppliers. Spurious drugs or substandard drug manufacturers, dispensers, suppliers, distributors, or sellers should not be helped and encouraged by pharmacists.

Drugs Hawking: Door-to-door sales of drugs and medicines should not be promoted. No attempt should be made to ask for orders from door to door. Self-service in pharmacy should also not be allowed. Door-to-door order collection, door-to-door sale of drugs, or self-service in pharmacy will develop self-medication in patients. Self-medication is highly objectionable, highly undesirable, and the most dangerous practice for patients. Consuming medicines without expert advice and expert supervision may put the life of the patient in danger.

Advertisement and display: Pharmacists and pharmacies develop display materials, promotional literature, or folders. These materials are released in print media, visual media, or displayed in pharmacies and clinics, etc to promote the sale of medicine and medical appliances. These advertising materials should not be undignified and should not contain the following

  • 1. Any warning, design, drawing, diagram, etc that degrades or downgrades another pharmacy, pharmacist, group of people or any individual

  • 2. Direct or indirect degrading references to any product, remedy, treatment, or supplier

  • 3. Misleading or exaggerated claim

  • 4. The word “cure” for any symptom of diseases or disorders

  • 5. Guaranteed therapeutic efficacy

  • 6. Appeal to fear

  • 7. Money refund if there is no cure for the disease

  • 8. Gift, prize, competition, or any other similar schemes

  • 9. Reference to medical practitioner or hospital

  • 10. Use of terminology “Doctor”, “Dr” or “Nurse” for any medicine or medical appliance.

  • 11. Any reference to sexual weakness, loss of virility, and premature aging

  • 12. Any reference to introverted person lack of sexual nature.

Above said points should not be displayed as display materials in the pharmacy. Contraceptive preparations or contraceptive appliances should not be displayed except approved by the government and bearing the words “Family Planning Requisites.” There should not be any lustful, obscene, vulgar, and indecent publication for sale. This type of publication has a very bad effect on the moral welfare of the nation.

Alok Bains

Pharmacist in Relation to Medical Profession

Limitation of Professional Activity: It is expected that medical practitioners do not practice pharmacy and own drug stores. Medical practitioners also practice pharmacy by decoding prescriptions and owning drug stores or pharmacies will bring their monopoly in the medical field. It will have a detrimental effect on the pharmaceutical profession. Medical practitioners’ time consumed for this activity is not in the interest of patients. Thus in return, it is also expected that pharmacists will not be involved in diagnosis and advise patients to cure disease and to prescribe medicine.

Under no circumstances pharmacist will diagnose disease, prescribe medicine, or practice medicine. He should not involve himself in these entire activities even request from his patron. In an emergency or accident, a pharmacist may provide first aid to the patient in the absence of a medical practitioner.

Pharmacists should not recommend any specific medical practitioner to patients.

Clandestine Arrangements: The pharmacist should not offer any commission, gift, or any other advantages to the medical practitioner to recommend his pharmacy, dispensary, or drug store.

There should not be any secret understanding between pharmacists and medical practitioners.

Liaison with the public: The pharmacist is a link between a medical practitioner and a patient. Thus pharmacists must equip themselves with recent advancements in medical and pharmaceutical fields. He should regularly read books, journals, and magazines to update himself with recent developments. So that he could advise patients regarding new dosage forms, new medicines available, and other pharmaceutical matters color, flavoring agents, vehicles, etc.

His up-to-date knowledge also helps me to guide and educate patients and people regarding the healthy and sanitary conditions of living to protect them from diseases and disorders

By all these activities pharmacists play an important role to contribute in nation building activities. Pharmacists should always try to acquire information to promote their knowledge to contribute their share in learning advancement.

A pharmacist acquires various personal information of patients while providing pharmaceutical services. He should not disclose any information about the patient to any other person even on request of his patron. His eminent character and conduct should be unshakable. He should not betray the confidence of the patient and his patron in the pharmacist. He can disclose this information on demand of law.

Alok Bains

Pharmacist in Relation to His Profession

Professional Vigilance: Pharmacists should not only be law-abiding, they should also avoid doing anything disrespectful to society and their profession. He should also convince and motivate others to fulfill provisions of pharmaceutical and other laws, provisions, rules, and regulations. He should not be afraid of to bring miscreants or villainous to the notice of law enforcement agencies even if he is a member of his profession.

Pharmacists must extend their help and cooperation to their fellow members regarding technical know-how, scientific information, or any other lawful need. He must be vigilant to unlawful and unwanted personnel and professionals in the pharmacy profession. He should also do all necessary to remove these personnel and professionals out from the profession. This act of pharmacists will help to maintain a fair name and tradition of the pious and noble pharmacy profession.

Law-Abiding Citizen: Pharmacists must be rational, modern, and well-informed outlook along with obedient to the law.

He should try hard to obey law of land in every phase of life. He should not divide his life activity into compartments. Pharmacist is unit whole.

Relationship with Professional Organisation: Pharmacists should join professional organizations. He must extend his help and cooperation to achieve the aim and objective of the organization. In a professional organization, he should do needful to inculcate corporate life in his professional colleagues and moral well-being in pharmacists. However, no activity should be against the code of pharmaceutical ethics. His activity must be conducive to improving the scientific and professional knowledge of fellow pharmacists in a professional organization.

Decorum and Propriety: Decorum is the idea of dignity and propriety is the essence of someone or the taste and morals of someone. Pharmacist’s activities and deeds should be in line to maintain the decorum and propriety of the pharmaceutical profession. Pharmacist activity should not bring discredit or find fault in his profession or himself.

Pharmacist’s oath.

  • · I swear by the code of ethics of the Pharmacy Council of India, in relation to the community, and shall act as an integral part of the healthcare team.

  • · I shall uphold the laws and standards governing my profession.

  • · I shall strive to perfect and enlarge my knowledge to contribute to the advancement of pharmacy and public health.

  • · I shall follow the system which I consider best for Pharmaceutical care and counseling of patients.

  • · I shall endeavor to discover and manufacture drugs of quality to alleviate the sufferings of humanity.

  • · I shall hold in confidence the knowledge gained about the patients in connection with my professional practice and never divulge unless compelled to do so by the law.

  • · I shall associate with organizations that have their objectives for the betterment of the profession of Pharmacy and make contributions to carry out the work of those organizations.

  • · While I continue to keep this oath unviolated, May it be granted to me to enjoy life and the practice of pharmacy respected by all, at all times.

  • · Should I trespass and violate this oath, may the reverse be my lot.

Alok Bains