Introduction to Pharmacy Law & Ethics (PDF)

INTRODUCTION TO LEGISLATIONS Shamin Saffian RELATED TO PHARMACY Faculty of Pharmacy UKM 1  An array of laws and regulations govern the profession & practice of pharmacy. ▪ Defines a set of respons...

INTRODUCTION TO LEGISLATIONS Shamin Saffian RELATED TO PHARMACY Faculty of Pharmacy UKM 1  An array of laws and regulations govern the profession & practice of pharmacy. ▪ Defines a set of responsibilities for pharmacists and others who are formally involved with medication use BACKGROUND Acts: Law that is passed by a legislative body Regulations: Rules that dictate how the legal provisions of the act should be applied 2  1. Registration of Pharmacists Act 1951 (Revised 1989) Registration of Pharmacists Regulations 2004 CURRENT 2. Poisons Act 1952 (Revised 1989) & Regulations 1952 LEGISLATIONS Poisons (Psychotropic Substances) Regulations 1989 RELEVANT TO 3. Sale of Drugs Act 1952 (Revised 1989) Control of Drugs and Cosmetics Regulations 1984 THE PRACTICE 4. Medicines (Advertisement and Sale) Act 1956 OF PHARMACY (Revised 1983) Medicine Advertisements Board Regulations 1976 5. Dangerous Drugs Act 1952, & Regulations 3 https://www.pharmacy.gov.my/v2/en/documents/registration-pharmacists-act-1951-and-regulations.html Google “registration of pharmacist act” 4 LEGISLATION 1 REGISTRATION OF PHARMACISTS ACT 1951 & REGULATIONS ▪An act relating to the establishment of a Pharmacy Board and the registration of pharmacists. ▪Contains provision of the following: Establishment of the Pharmacy Board, and its duties and powers Persons eligible for provisional & full registration Conditions prior to registration Limitations to use of certain titles – e.g. pharmaceutical chemist, pharmaceutist, chemist and druggist, pharmacist 5  PROVISIONAL REGISTRATION ▪Solely for the purpose of obtaining experience prior to full registration ▪Requirements: any qualifications specified in First Schedule any qualification deemed suitable for registration by the Minister ▪Experience required before applying full registration: Employed as a pharmacist to the satisfaction of the Board for not less than one year In premises listed in the Second Schedule 6 7 Check online for the most updated list https://www.pharma cy.gov.my/v2/en/con tent/list-training- premises- provisionally- registered- pharmacist-prp.html 8 9 https://www.pharmacy.gov.my/v2/en/documents/registration-pharmacists- act-1951-and-regulations.html 10 11 https://www.pharmacy.gov.my/v2/ms/entri/buku-log-latihan-ahli-farmasi-provisional-prp.html 12 FULL REGISTRATION ▪Requirements: Has gained experience as required, unless exempted by Board Has sat for, and passed the Pharmacy Jurisprudence Examination ▪ Sep 2004 - Immediately served with notice to serve in public service for a continuous period of not more than 3 years – unless granted reduction, exemption or postponement from the Minister. ▪ Change in policy as from Oct 2011 – compulsory service shortened to 1 year only (after 1 year as PRP) 13 TEMPORARY REGISTRATION ▪ For persons registered outside Malaysia, with written application. ▪ Exempted from provisional registration. ▪ Board issues a temporary registration certificate. ▪ Deemed to be a fully registered pharmacist. ▪ May be cancelled at any time by the Board. 14  1. Registration of Pharmacists Act 1951 (Revised 1989) Registration of Pharmacists Regulations 2004 CURRENT 2. Poisons Act 1952 (Revised 1989) & Regulations 1952 LEGISLATIONS Poisons (Psychotropic Substances) Regulations 1989 RELEVANT TO 3. Sale of Drugs Act 1952 (Revised 1989) Control of Drugs and Cosmetics Regulations 1984 THE PRACTICE 4. Medicines (Advertisement and Sale) Act 1956 OF PHARMACY (Revised 1983) Medicine Advertisements Board Regulations 1976 5. Dangerous Drugs Act 1952, & Regulations 15  LEGISLATION 2 POISONS ACT 1952 & REGULATIONS An act to regulate the importation, possession, manufacture, compounding, storage, transport and use of poisons. 16  LEGISLATION 2 ( CONT.) POISONS ACT 1952 & REGULATIONS ▪Includes provision of the following: Establishment of Poisons Board Classification of ‘poisons’ into schedules Importation, packaging, labelling and storing of poisons Sale & supply of poisons by retail & wholesale Licences, permits & authorizations Maintenance of records/ register for poisons 17 FIRST SCHEDULE (POISONS LIST) https://www.pharmacy.gov.my/v2/en/documents/poisons-list.html 18  Part I ▪ Examples of Group A Curare (>10%), mitragynine, strychnine (>1.2%), amidopyrine ▪ Examples of Group B Antibiotics, anti hypertensives, anticoagulants and other “prescription FIRST only drugs” SCHEDULE ▪ Examples of Group C Antihistamines, analgesics ▪ Examples of Group D Preparations for laboratory uses, non- medical preparations Back to Poisons Act 1952 19 CLASSIFICATION OF POISONS A. First Schedule (Poisons List) ▪ Part I : Group A, B, C and D ▪ Part II : Industrial, agricultural, horticultural chemicals ▪ Exempted preparations B. Second Schedule - Articles and preparations exempted from the provisions of this Act e.g. surgical dressings, plastics, glue, paints C. Third Schedule - Psychotropic substances e.g. diazepam, zolpidem 20  PRESCRIPTION FORM FOR GROUP B POISONS (POISONS ACT 1952) Date of Rx Address of prescriber Name & address of patient Total amount of medicine to be supplied & dose Number of times medicine Signature of may be dispensed prescriber 21  1. Registration of Pharmacists Act 1951 (Revised 1989) Registration of Pharmacists Regulations 2004 CURRENT 2. Poisons Act 1952 (Revised 1989) & Regulations 1952 LEGISLATIONS Poisons (Psychotropic Substances) Regulations 1989 RELEVANT TO 3. Sale of Drugs Act 1952 (Revised 1989) Control of Drugs and Cosmetics Regulations 1984 THE PRACTICE 4. Medicines (Advertisement and Sale) Act 1956 OF PHARMACY (Revised 1983) Medicine Advertisements Board Regulations 1976 5. Dangerous Drugs Act 1952, & Regulations 22 LEGISLATION 3 SALE OF DRUGS ACT 1952 CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 ▪“Drug” – includes any substance, product or article intended to be used or capable of being used on humans or any animal, whether internally or externally, for medicinal purposes ▪Establishment of the Drug Control Authority (DCA) ▪Registration of all pharmaceuticals (inc. traditional medicines) and notification of cosmetics ▪Licences and application procedures for those involved in dealing with pharmaceuticals e.g. manufacturer’s licence, wholesaler’s licence, import licence, clinical trial import licence 23 LEGISLATION 3 (CONT.) SALE OF DRUGS ACT 1952 CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 ▪Subregulation 7(1): No person shall manufacture, sell, supply, import, possess, administer any product unless, the product is a registered product; and the person holds the appropriate licence required and issued under these Regulations. ▪E.g. of registration number: MAL19976399X Codes: A: Scheduled Poisons X: Non-scheduled Poisons (OTC products) T: Traditional Medicines K/ KE: Cosmetics 24 HOW TO IDENTIFY MEDICINES THAT ARE REGISTERED WITH MOH? The categories of registered product are as follows: A – Controlled medicines X – Over the counter medicines (OTC) T – Natural Products/ Traditional Medicines N – Health Supplements H - Veterinary Product In addition, there may be administrative codes used by the National Pharmaceutical Regulatory Agency after the product category. The administrative code is: C – Contract Manufactured E – For Export Only (FEO) R – Packed and/or repacked S – Second source Y – Orphan products Z – Products gazetted as zero-rated under the Goods and Services Tax Act 2014, Goods and Services Tax (Zero-Rated Supplies) Order 2014. https://www.pharmacy.gov.my/v2/en/faq/how-identify-medicines-are-registered-moh.html 25 26  1. Registration of Pharmacists Act 1951 (Revised 1989) Registration of Pharmacists Regulations 2004 CURRENT 2. Poisons Act 1952 (Revised 1989) & Regulations 1952 LEGISLATIONS Poisons (Psychotropic Substances) Regulations 1989 RELEVANT TO 3. Sale of Drugs Act 1952 (Revised 1989) Control of Drugs and Cosmetics Regulations 1984 THE PRACTICE 4. Medicines (Advertisement and Sale) Act 1956 OF PHARMACY (Revised 1983) Medicine Advertisements Board Regulations 1976 5. Dangerous Drugs Act 1952, & Regulations 27  LEGISLATION 4 MEDICINES (ADVERTISEMENT AND SALE) ACT 1956 & REGULATIONS ▪An Act to prohibit certain advertisements relating to medical matters ▪Establishment of Medicines Advertisement Board (Lembaga Iklan Ubat) to approve and reject applications for advertisements relating to services, medicines and remedies ▪Board issue approval serial number to be displayed in every advertisement e.g. KKLIU 1379/2014 28 PROHIBITION OF ADVERTISEMENTS ▪Among others, include prohibition of advertisements relating to certain diseases – referring to any articles as a medicine, an appliance or a remedy for: a) Prevention and treatment of diseases and conditions as specified in the Schedule b) Practicing contraception among human beings c) Improving the condition or functioning of the human kidney or heart, or improving sexual performance or function d) Diagnosis of a disease specified in the Schedule 29 PROHIBITION OF ADVERTISEMENTS Schedule (20 diseases): Kidney diseases/ defects Drug addiction Heart diseases/ defects Hernia or rupture Diabetes Diseases of the eye Epilepsy or fits Hypertension Paralysis Mental disorder Tuberculosis Infertility Asthma Frigidity Leprosy Impairment of sexual function Cancer Venereal disease Deafness Nervous debility 30 31  1. Registration of Pharmacists Act 1951 (Revised 1989) Registration of Pharmacists Regulations 2004 CURRENT 2. Poisons Act 1952 (Revised 1989) & Regulations 1952 LEGISLATIONS Poisons (Psychotropic Substances) Regulations 1989 RELEVANT TO 3. Sale of Drugs Act 1952 (Revised 1989) Control of Drugs and Cosmetics Regulations 1984 THE PRACTICE 4. Medicines (Advertisement and Sale) Act 1956 OF PHARMACY (Revised 1983) Medicine Advertisements Board Regulations 1976 5. Dangerous Drugs Act 1952, & Regulations 33 LEGISLATION 5 DANGEROUS DRUGS ACT 1952 & REGULATIONS ▪An Act to regulate the importation, exportation, manufacture, sale and use of opium and other dangerous drugs and substances ▪Dangerous drugs – a special group of poisons with much tighter control e.g. morphine, cocaine, opium o Possession of amounts above a certain quantity considered as trafficking o Requires strict recording in hospitals o Severe penalties for offences against this Act. 34  1. Registration of Pharmacists Act 1951 (Revised 1989) Registration of Pharmacists Regulations 2004 CURRENT 2. Poisons Act 1952 (Revised 1989) & Regulations 1952 LEGISLATIONS Poisons (Psychotropic Substances) Regulations 1989 RELEVANT TO 3. Sale of Drugs Act 1952 (Revised 1989) Control of Drugs and Cosmetics Regulations 1984 THE PRACTICE 4. Medicines (Advertisement and Sale) Act 1956 OF PHARMACY (Revised 1983) Medicine Advertisements Board Regulations 1976 5. Dangerous Drugs Act 1952, & Regulations 35 NEW PHARMACY BILL 36 NEW PHARMACY BILL An omnibus Bill to replace Registration of Pharmacists Act, Poisons Act, Sale of Drugs Act and Medicines (Advertisement and Sale) Act Some proposed important transformation initiatives include Reclassification of medicinal products Liberalization of pharmacists’ practice license to > 1 premise Registration of pharmacy assistants More deterrent penalties on serious offences 37  38 https://www.nst.com.my/news/government-public-policy/2020/11/638463/poisons-amendment-bill-withdrawn-further-enhance-it 39  40 ETHICS IN PHARMACY PRACTICE Shamin Saffian Faculty of Pharmacy UKM  41 Case study: Ms. Izzy is starting a new medication for schizophrenia. The drug has a number of side effects, some of which can be serious. She asks you several questions about the purpose of the medication and possible side-effects. When you ask her what her doctor told her about the medication, she reports that he said, “I’ve got many patients on this drug. Your colleague, Wan is on this medication and he is fine” It is obvious to you that she is unclear about the purpose of the medication or any possible problems. You are concerned that Ms. Izzy may refuse to take the drug if told about possible side effects. What would you say to Ms. Izzy?  42 Ethics Ethics – a careful, systematic inquiry into the nature of morality, guidelines, or standards that give meaning and direction to the human community. Concerned with the duties and obligations one has to others and to him- or herself. Also concerned with the rights of individuals First code of ethics for medicine: Hippocratic Oath  43 Professional Ethics “The profession’s interpretation of the will of society for the conduct of the members of that profession augmented by the special knowledge that only members of the profession possess.” Determined by the members of the profession, taking into consideration the expectations of society. It is not law. However, ethics may be used by the professional body for disciplinary action. Not static but dynamic.  44 The Need for Ethics Helps in the decision-making process – provide a framework to use in resolving ethical questions Provides guidelines for directing the conduct of individual professionals Helps safeguard profession by ensuring highest degree of ethical practice by pharmacists Establishes a pattern of behaviour that society expects from members of the profession.  45 Ethical Principles ▪ Pharmacists have an ethical obligation to care for their patients. ▪ The following ethical principles can provide guidance to pharmacists on a daily basis as they face ethical situations: 1. Respect for autonomy 2. Nonmaleficence 3. Beneficence 4. Justice  46 1. Respect for Autonomy ▪ Autonomy – refers to a patient having the freedom to make choices for him/herself, as long as do not infringe on the rights and welfare of others ▪ Contrasts with the concept of paternalism, which suggests that the health care professional knows best.  47 1. Respect for Autonomy (cont.) ▪ The principle of autonomy is an important component of informed consent. ▪ Informed consent is composed of 5 elements: ✓ Competence ✓ Disclosure of information ✓ Understanding of information ✓ Voluntariness ✓ Authorization ▪ Medical confidentiality is an application of the principle of patient autonomy.  48 2. Beneficence ▪ Beneficence is the principle that health professionals should behave in the best interest of the patient. ▪ The benefits and harms of therapy must be balanced – have to be considered carefully by both patient and health professional ▪ In the delivery of pharmaceutical care, beneficence requires respect for the wishes and choices of patients and their families. ▪ May lead to conflict with respect to patient autonomy  49 3. Nonmaleficence ▪ The principle of nonmaleficence is commonly stated as “above all else do no harm”. ▪ Requires a health care professional to not act in any way that intentionally inflicts unnecessary harm/ injury to the patient. ▪ It is linked to the principle of beneficence. ▪ The principle of nonmaleficence can be violated in 2 distinct ways. For example, a) if pharmacists knowingly and intentionally cause a patient harm. b) if the pharmacist is negligent in his or her actions resulting in harm to the patient.  50 4. Justice ▪ Justice is an ethical principle that relates to fair, equitable, and appropriate treatment to everyone. ▪ Instructs that pharmacists demonstrate an equivalent amount of care to all patients. ▪ Demands that the focus be on patients and their medical needs, not on the financial impact on the healthcare professional. ▪ However, issues relating to justice may be complicated: For e.g. not all patients can afford drug treatment. What are health professionals’ responsibilities to the poor who need assistance?  51 Back to the case study… Ms. Izzy is starting a new medication for schizophrenia. The drug has a number of side effects, some of which can be serious. She asks you several questions about the purpose of the medication and possible side-effects. When you ask her what her doctor told her about the medication, she reports that he said, “I’ve got many patients on this drug. Your colleague, Wan is on this medication and he is fine” It is obvious to you that she is unclear about the purpose of the medication or any possible problems. You are concerned that Ms. Izzy may refuse to take the drug if told about possible side effects. What would you say to Ms. Izzy?  52 Back to the case study… Ms. Izzy is starting a new medication for schizophrenia. The drug has a number of side effects, some of which can be serious. She asks you several questions about the purpose of the medication and possible side-effects. When you ask her what her doctor told her about the medication, she reports that he said, “I’ve got many patients on this drug. Your colleague, Wan is on this medication and he is fine” It is obvious to you that she is unclear about the purpose of the medication or any possible problems. You are concerned that Ms. Izzy may refuse to take the drug if told about possible side effects. What would you say to Ms. Izzy?  53 Points for case study: ▪ Ms. Izzy does not understand the purpose/ side effects. ▪ No informed consent ▪ If she knew of side effects, she may not take the medication needed to treat her condition – beneficence ▪ The doctor exposed the friend’s name – confidentiality ▪ Fear of antagonizing the physician by acting contrary to their wishes - autonomy ▪ Autonomy would require you to tell her because she has a right to determine what happens to her body. May need to call the doctor to discuss how informed consent should take place.  54 Code of Ethics Code of ethics = set of minimum standards of professional conduct Some examples: 1. Hippocratic Oath of doctors 2. Declaration of Geneva (1948) 3. The International Code of Medical Ethics 1949 4. Declaration of Helsinki (1964) 5. US Pharmacy Oath –AACP 6. Code of Ethics (1852) – APA 7. Code of Ethics (1944) – RPSGB 8. Code of Ethics for Pharmacy (1997) – FIP  55 Malaysian Code of Ethics for Pharmacist 2018 56 57 58 59 60 61 62  63 DONE FOR NOW