THE CODE OF ETHICS AND STANDARDS FOR PHARMACY PRACTICE IN KENYA

Second Edition

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GLOSSARY Abbreviations: cGMP: current Good Manufacturing Practice FIP: International Pharmaceutical Association PSK: Pharmaceutical Society of Kenya QA: Quality Assurance WHO: World Health Organization

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Definitions: Authorized person: a registered pharmacist who is responsible for the release of a batch of a finished product for sale or distribution Community pharmacy: a retail outlet pharmacy Complainant: a person who is aggrieved by a pharmacy service Dosage form: a completed pharmaceutical product, e.g. tablet, capsule, injection, elixir, syrup, suppository Dress code: a protective clothing or dress worn by staff to establish corporate identity and/or distinguish from customer Drug: any preparation for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of recipient Finished product: a product that has undergone all stages of production, including packaging in its final container and labeling Mankind: includes human beings, plant or animal and the environment Medicine: any pharmaceutical product in a dosage form Pharmaceutical product: any preparation for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of recipient Protective dress: a dress code and may include an overcoat, goggles, headgear, gloves, or any other dress for protecting self from pharmaceutical product or contaminant and vice versa Registered pharmacist: a duly registered pharmacist in accordance with the Pharmacy & Poisons Act Cap 244

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THE CODE OF ETHICS AND STANDARDS FOR PHARMACY PRACTICE PREAMBLE Pharmacy is a study of drugs, the manner in which the drugs are discovered, developed, manufactured or processed into dosage forms and eventually safely used to restore or maintain good health. The Good Pharmacy Practice principles are based on the pharmaceutical care given by a pharmacist. The Practice of Pharmacy is founded on principles which require that national standards are set for the promotion of health, the supply of medicines, medical devices, patient self care, and for improving prescribing and usage of medicines .The Pharmacist is a healthcare professional with knowledge and expertise, on medicines, for promoting and maintaining good health, in order to avoid ill health and, where appropriate, to acquire, handle and distribute and make the best rational use for the benefit of mankind. A profession is identified by the willingness of individual practitioners to comply with ethical and professional standards, which exceed minimum legal requirements. The scope of the pharmacy profession is wide and diverse. It requires consultation amongst pharmacists as a basis for giving services to the public and as a yardstick for self-assessment, judgement and aspiration to higher standards of service. The vital element in the philosophy of good pharmacy practice is the commitment of the pharmacy profession throughout the world to promoting excellence in practice for the benefit of those served. The public and other professions will judge the profession on how its members translate that commitment into practice. This code of Ethics and Standards recognizes legal provisions and provides a bridge to moral obligations and values. Therefore it will be necessary to update them regularly in order to keep them in conformity with changing trends and the expectations of the public. The role of the pharmacist has changed significantly in recent years. Whilst the fundamental ethical principles remain essentially the same this Code of Ethics and Standards has been reviewed to reaffirm and state publicly the principles that form the basis of the roles and responsibilities of pharmacists. These principles based on moral obligations and values, are established to enable PSK through its Code of Ethics and Standards for Pharmacy Practice as a guide for pharmacists in their relationship with patients, fellow pharmacists other healthcare professionals and society in general. The Pharmaceutical Society of Kenya (PSK) being the legitimate professional organization for pharmacists in this country is obliged to observe this philosophy. In reviewing the First Edition of the PSK Code of Ethics and Standards, an international perspective was taken into consideration by adopting guidelines and recommendations of the International Pharmaceutical Federation (FIP)

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Principles: In the practice of the profession: 1. The pharmacists prime responsibility is the good of the individual and mankind. 1.1 Obligations: i. ii. iii. iv. To be objective and provide service with integrity To put the good of the individual before personal or commercial interests (including financial interest). To promote the individuals right of access to safe and effective treatment. To promote healthy lifestyle and access to good healthcare

1.2 Standards: The pharmacist: i. ii. iii. iv. Satisfies himself or herself that the service is for the good of the individual. Discourages/dissociates from any act or commercial proposal or arrangement with the public or prescribers that would interfere with the freedom of choice of treatment Promotes activities geared towards ensuring patient adherence to prescribed medication regimen Assures the quality of medicines and medical supplies provided to patients by procuring these products only from reputable sources, paying regard to the storage conditions before purchase and subsequent chain of supply of the medicines concerned. Promotes safe and rational use of medicines Safeguards the right of patients to appropriate information and advice on medicines under use, the objective being to tailor that information for each individual. Co-operates with governmental and other regulatory authorities as well as with pharmaceutical manufacturers in the detection of the circulation of substandard and counterfeit medicines and in measures designed to prevent such circulation. Isolates and withholds from supply any sub-standard or counterfeit medicinal product(s) and co-operates in investigations to detect the source.

v. vi. vii.

viii.

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ix.

Participates in activities and programmes aimed at promoting good health

2. The pharmacist shows the same dedication to all. 2.1 Obligations: i. ii. iii. To show respect for life and human dignity. To offer services without bias To strive to serve each individual according to personal circumstances

2.2 Standards: The pharmacist: i. ii. iii. iv. Advocates the sanctity of life and as deemed necessary, counsels the concerned individual and refers if necessary, to competent personnel in accordance with the law Recognizes special needs of the handicapped, disabled and disadvantaged members of the society. Refrains from expressing his/her emotions publicly regarding certain illnesses and prescribed medicines Offers service without regard to race, gender, age, and religious belief

3. The pharmacist recognises the individuals right to freedom of choice of treatment. 3.1 Obligations: i. ii. To ensure that where the pharmacist is involved in developing care and treatment plans, this is done in consultation with the individual where applicable. To recognise the individuals preference with regard to treatment management and seeks more information on particular choice including alternative medicine in order to advice accordingly.

3.2 Standards: The pharmacist: i. ii. Utilizes all available opportunities to discuss and/or issues relating to medication with patients. Should maintain, medication history records of all patients Page 6 of 20

iii. iv. v. vi. vii. viii.

Shall act in a manner that does not suggest bias or preference to a particular prescriber, hospital or supplier Shall carefully record a brief history of the patient complaints and current treatment, if any, and arrive at a possible diagnosis and management. Shall establish whether the patient or the patients immediate family members have any history of adverse drug reactions Uses professional discretion to refer the patient to see competent health personnel in the relevant speciality at the earliest opportunity. Shall provide emergency treatment when requested but also refer the patient to competent health personnel in the relevant speciality at the earliest opportunity. Shall take time to educate the patient on rational use of drugs.

4. The pharmacist recognises and safeguards the individuals right to privacy and confidentiality. 4.1 Obligations: i. Not to disseminate information, which identifies individual, without informed consent or due cause. the

4.2 Standards The pharmacist i. Shall zealously guard the confidentiality and privileged information of the patient ii. Keeps records of patients securely iii. Refrains from discussing patients condition with other parties except the competent health personnel in the relevant speciality to whom he/she refers the patient. iv. Where it is professionally prudent, counsels the patient or refers to a trained or competent counsellor. 5. The pharmacist co-operates with colleagues and other professionals and respects their values and abilities. 5.1 Obligations: i. To co-operate with colleagues, and other professionals in efforts to promote good health and treat and prevent ill health.

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ii.

To recognize and respond to special needs which colleagues may have from time to time and which may have bearing on the image of the profession of pharmacy

5.2 Standards: The pharmacist: i. Recognizes skills and disciplines within the profession and seeks advice or refers the patient as appropriate. ii. Participates effectively in patient management iii. Contributes effectively in matters of public health. iv. Makes himself/herself invaluable to other health professionals. v. Recognizes any deficiencies affecting a colleague in the practice of pharmacy and using his own judgment or wisdom approach the colleagues and/or reports to PSK 6. The pharmacist acts with honesty and integrity in professional relationships. 6.1 Obligations: i. ii. To act with conviction and conscience. To avoid practices, behaviour or work conditions that could impair professional judgement.

6.2 Standards: The pharmacist: i. ii. iii. iv. v. vi. vii. Is sober and must not work under the influence of addicting, psychotropic or mood altering substances Is a good citizen and a responsible member of the community Safeguards and upholds the laws of the land. Is neat and decently dressed in the course of his duty and in public forums Desists from any trade malpractices for the purpose of influencing customers and acts of impropriety Acts with tact and professional integrity where he/she foresees a conflict between the profession and the public. Must neither agree to practice under any conditions that would compromise professional independence of judgment nor impose such conditions on other pharmacists Page 8 of 20

7. The pharmacist serves the health needs of the individual, the family the community, society, and the environment. 7.1 Obligations: i. ii. To recognize the responsibilities associated with serving the needs of the individual on the one hand and society at large on the other. To recognise the responsibilities associated with the need to protect, preserve, and enhance the environment

7.2 Standards The pharmacist: i. ii. iii. iv. v. vi. vii. viii. Shall initiate and ensure that dialogue with the patient always include, where necessary, matters of public health education Should be in the forefront in matters of public health advocacy with regard to prevailing public health concerns Should be a keen observer of any signs of ill health and advice patients accordingly Serve clients with respect, courtesy and with dignity Shall provide patients with the privacy they require Advise patients to complete medication Advice the patient to return unused medicines and medical devices for safe disposal. Actively participates in environmental protection which includes Safe disposal of returned and expired medicines and Promotion of the use of biodegradable packaging material Maintains appropriate patient records and a profile of medications taken by patients

ix.

8. The pharmacist maintains and develops professional knowledge and skills. 8.1 Obligations: i. To ensure competency in each pharmaceutical service provided by continually updating knowledge and skills.

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The pharmacist: i. ii. iii. iv. v. vi. vii. Participates in continuous self improvement professional Programmes Keeps abreast of current medical matters including subscription to relevant journals Demonstrates authority in therapeutic sciences Participates in health education matters including professional seminars Must have access to current reference materials in connection to his/her line of practice Seeks and avails information freely from and to colleagues respectively Should include his/her name on the label of dispensed medicines.

9. The pharmacist ensures continuity of care in the event of labour disputes, pharmacy closure and conflict with personal moral beliefs. 9.1 Obligations: To refer a patient to another pharmacist. To ensure that when a pharmacy closes, the patients are informed of the pharmacy to which their records, if held, have been transferred. 9.2 Standards The pharmacist: i. ii. iii. Informs patients of the opening and closing hours of his/her pharmacy On duty should have his/her name displayed. Establishes a working relationship with a colleague on locum basis to ensure continuity of services subject to patients consent. i. ii.

10. The pharmacist provides emergency pharmaceutical services

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10.1 Obligations i. To ensure prompt therapy/medications requiring emergency services to individuals

10.2 Standards The pharmacist: i. ii. iii. Should stock adequate emergency drugs including low cost essential service medicines Should be accessible at all times Should display his/her contact outside official working hours. -END-

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APPENDIX I STANDARDS FOR PHARMACY PRACTICE A. COMMUNITY PHARMACY PRACTICE 1. LEGAL REQUIREMENTS i. ii. 2. 3. Should be duly registered Should comply with regulatory requirements

LOCATION Must be accessible PREMISES 3.1 General i. ii. iii. iv. Outlook should be professionally presentable. Well maintained and ventilated Provide for sitting/waiting space. Have acceptable Hygiene & Sanitation standards

3.2 OTC area i. ii. iii. Adequate storing facilities with shelving Adequate security Orderly

3.3 Dispensary i. ii. iii. iv. v. vi. Lock and Key cabinets/Facility for controlled medicines Orderly Work desk, slab and wash hand basin Measuring cylinder, weighing scale, jars, spatula, scissors Mortar and pestle Tablet counter

3.4 Consultation room i. ii. iii. iv. v. Sitting place Examination couch Lock & Key Cabinet/Facility for keeping patient records Weighing machine Height measure Page 12 of 20

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Relevant diagnostic equipment

EQUIPMENT i. ii. Refrigerators designated for medicines Adequate equipment for process undertaken.

5.

SERVICES Provide safe drinking water in relation to taste, colour.

6.

PERSONNEL 6.1 Pharmacist i. ii. iii. iv. Should be registered by the relevant regulatory authority Needs to display his/her name on the dress code. Should be able to communicate effectively with clients Ensure that pharmacy assistants are well trained for their job assignments

6.2 Support staff i. ii. 7. Need to wear clean dress code Should be adequately knowledgeable for the assigned duties

LIBRARY Should be equipped with current reference materials

8. RECORDS & DOCUMENTATION Have a defined system B. WHOLESALE PHARMACY PRACTICE: 1. LEGAL REQUIREMENTS i. ii. 2. LOCATION Must be accessible Should be duly registered Should comply with regulatory requirements

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3. PREMISES i. ii. iii. General Outlook should be professionally presentable. Well maintained and ventilated Provide for sitting/waiting space.

4. EQUIPMENT i. ii. 5. SERVICES Provide safe drinking water in relation to taste, colour. Refrigerators designated for medicines Adequate equipment for process undertaken.

6. PERSONNEL i. Pharmacist a. Should be registered by the relevant regulatory authority b. Needs to display his/her name on the dress code. c. Should be able to communicate effectively with clients d. Ensure that pharmacy assistants are well trained for their job assignments ii. Support staff a. Need to wear clean dress code b. Should be adequately knowledgeable assigned duties 7. LIBRARY Should be equipped with current reference materials 8. RECORDS & DOCUMENTATION Have a defined system for the

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C.

HOSPITAL PHARMACY PRACTICE 8. LEGAL i. ii. 9. Should be duly registered Should comply with regulatory requirements

LOCATION Must be accessible

10.

PREMISES 10.1 i. ii. iii. iv. 10.2 i. ii. iii. iv. v. vi. General Outlook should be professionally presentable. Well maintained and ventilated Provide for sitting/waiting space. Have acceptable Hygiene & Sanitation standards Dispensary Lock & key cabinets for controlled medicines Orderly Work desk, slab and wash hand basin Measuring cylinder, weighing scale, jars, spatula, scissors Mortar and pestle Tablet counter

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EQUIPMENT i. ii. Refrigerators designated for medicines Adequate equipment for process undertaken.

12.

PERSONNEL 12.1 i. ii. iii. Pharmacist Should be registered by the relevant regulatory authority Needs to display his/her name on the dress code. Should be able to communicate effectively with clients

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iv. 12.2 i. ii. 13.

Ensure that pharmacy assistants are well trained for their job assignments Support staff Need to wear clean dress code Should be adequately knowledgeable for the assigned duties

LIBRARY Should be equipped with current reference materials

8. RECORDS & DOCUMENTATION Have a defined system 9. STANDARDS OF IN-PATIENT PHARMACY PRACTICE i. Participate in clinical ward rounds ii. Provide appropriate or relevant pharmaceutical information to other healthcare workers

C.

INDUSTRIAL PHARMACY PRACTICE 1. LEGAL REQUIREMENTS i. ii. iii. 2. 3. Should be duly registered as a manufacturer of pharmaceuticals Should comply with QA and current Good Manufacturing Practices standards Should comply with all other regulatory requirements relevant to the pharmaceutical industry

LOCATION Should be accessible. BUILDING/PREMISES i. ii. iii. Have adequate environmental controls Have acceptable Hygiene and Sanitation standards Comply with minimum requirements on storage and warehousing

4.

LABORATORY & EQUIPMENT Page 16 of 20

i. ii. 5.

Adequately equipped for the processes undertaken QC lab SERVICES Provide the following: i. ii. iii. Adequate environmental controls Adequate hygiene & sanitation i.e. ventilation, quality of air, particles Defined quality system or quality policy

6.

PERSONNEL i. Adequate number and qualified human resource / personnel. ii. Release of batch for sale should be done by d authorised person who shall be a registered pharmacist.

7. 8.

LIBRARY Should be equipped with current reference books, journals or periodicals RECORDS & DOCUMENTATION Defined system for keeping records/documents

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APPENDIX II HANDLING OF COMPLAINTS AND PROCEDURE FOR DISCIPLINARY ACTION PROCEDURE Making of a Complaint: 1. Anyone who is not satisfied with the pharmacy services can lodge a complaint 2. A Complaint is valid for investigation if reported within twelve months of its occurrence and is written and signed with name, contact address and telephone. Receipt of a complaint 3. Complaint shall be received by the PSK secretariat 4. The complaint is forwarded to the Legal & Ethics committee 5. The Committee shall sort out and categorise the complaints into Criminal, socio-medical, professional negligence/misconduct, Professional illiteracy or petty complaints Communication with the person to against whom the complaint is lodged 6. The committee communicates with the pharmacist to whom the complain is levied within 3 months of receiving the complaint 7. Concerned pharmacist is obliged to respond within 4 weeks from date of letter by registered mail The Deliberations of the Committee 8. Response by the pharmacist and complaint evaluated to determine next 9. Course of action or mode of discipline. 10. The committee after written response or expiry of notification shall determine whether to invite him/her in person. 11. The pharmacist shall oblige to the decision of the committee. MODES OF DISCIPLINE The modes of discipline will depend entirely on the alleged breach. This will fall into any of the categories bellow: i. Criminal; ii. Social-medical; iii. Professional negligence iv. Professional illiteracy v. Petty complaints

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10.1 10.2 10.3

Criminal Referred to the lawful authorities police for legal action Medical Recommend medical attention Social i. ii. iii. Perform group diagnosis (clarify) Recommends council to liase with relevant ministries Carry out counselling

11. THE VERDICT The verdict shall be communicated in writing within seven days of to the concerned parties and signed by Chairman of the Disciplinary Committee 12. APPEALS AND ARBITRATION Any Pharmacist who has been a subject matter under this Code of Ethics and Standards and who is aggrieved of the decisions taken as a process of the deliberations and findings shall have the right of appeal. i. ii. iii. iv. v. vi. vii. Make the application of appeal in writing citing the grounds of appeal within seven of the ruling The PSK Council shall also select three members to sit on the Arbitration Board one of whom shall be elected to chair the deliberations Select two representatives to represent on an arbitration board The Arbitration Board shall make its own rules The findings of the arbitration shall be presented to the Council which shall make the final ruling within 3 months If the aggrieved party is not satisfied, the matter may be settled in a Court of Law in Kenya

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12. COMPLIANCE i. ii. It is expected that Pharmacists will jealously guard the principles of voluntary or self-compliance. When this is not possible, the PSK Council will handle all kind of complaints from fellow pharmacists, members of public and any matters after the courts of law have determined the case except to the extend of matters pertaining to this code of ethics and Standards. -EndMonday, July 26, 2004

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