Ethics In Dispensing: How Does Pharmacy Legislation Encourage Professional Ethics? C Ragupathy Naidu State Deputy Director of Health (Pharmacy ) Johor, Malaysia

ETHICS discipline dealing with what is good and bad with moral duty and obligation. concerns the values that lie behind them, the reasons people give for them and the language used to describe them.

DISPENSING a process in which the pharmacist or the pharmacist assistant (under the direct supervision of the pharmacist) interprets the physician’s requirements on the prescription and subsequently supplies the medicines for the treatment of his patient(s). includes all the relevant activities that occur between the time the prescription is presented at the counter to the time the prescribed items of requested medicines are issued to the client.

DISPENSING Receiving and confirming order Checking prescription and interpretation Verifying and consulting (if relevant) Removing medicines for issue and assembling Billing / selling and counter checking Issuing medicines to the client with clear instructions and counseling

LEGISLATION a group of laws that have the force of authority by virtue of their promulgation by an official organ of a state or other organization.

ETHICS

CODE OF CONDUCT FOR PHARMACISTS AND BODIES CORPORATE by THE PHARMACY BOARD OF MALAYSIA

CODE OF CONDUCT embodied the minimum standards of proper conduct and professionalism for guidance of practitioners serve as a reference when the Board considers cases of misconduct in a professional sense form the basis of the roles and responsibilities of pharmacists provide guidance to members in relation to professional conduct

CODE OF CONDUCT ( In relation to dispensing ) Article 1: Neglect or disregard of Professional Responsibility 1.4 Dispensing When any doubt arises in the interpretation of a prescription accepted by a pharmacist, he shall consult the prescriber and shall not alter the prescription unless with the approval of the prescriber or in an emergency

CODE OF CONDUCT Article 2: Abuse of Professional Privileges and Skills 2.1. Abuse of privileges conferred by law 2.1.1. Sale or supply of drugs and medical devices shall only be made in the course of bona fide treatment Shall not sell or supply any drug or medical device where he has any reason to doubt its safety, quality or its therapeutic value, and shall not condone or assist in the dispensing, promotion, or distribution of such drugs or devices

CODE OF CONDUCT 2.1.2. Abstain from abusing the privileges conferred under the Dangerous Drugs Act 1952 and its Regulations 2.1.4. Accountability From a moral and ethical point of view, he is expected to exercise professional accountability 2.1.5. Covering A pharmacist shall not allow any other person to use his license to cover the sales activity in poison or dangerous drugs

Are they pharmacist ?

PHARMACY LEGISLATION IN MALAYSIA

ACTS Poison Act 1952 (Revised 1989) Sale of Drugs Act 1952 (Revised 1989) Registration of Pharmacists Act 1951 (Revised 1989) Medicines ( Advertisement and Sale ) Act 1956 (Revised 1983) Dangerous Drug Act 1952 (Revised 1989)

REGULATIONS Poison Regulations 1952 Poisons ( Psychotropic Substances ) Regulations 1989 Control of Drugs and Cosmetics Regulations 1984 Registration of Pharmacists Regulations 2004 Dangerous Drug Regulations 1952

Poison Act 1952 ¥ S(12)(1)(a) - Control of compounding of poisons for use in medical treatment N A registered pharmacist or a person working under his immediate personal supervision shall dispense, compound or mix the poisons for the purpose of medical treatment ¥ S(16) - Sale of poisons by retail N A licensed pharmacist retailing poisons on the premise specified in a license

Poison Act 1952 ¥ S(21)(1)(c) - Group B Poisons N A licensed pharmacist shall sell or supply Group B poisons, as a dispensed medicine on a prescription ¥ S(24) - Prescription Book N All dispensed prescriptions shall be recorded in Prescription Book

Counselling counter/ room - Comfortable & privacy

Dispensing/ Counselling counter

Poison cabinet & Dispensing counter

Medical store or Pharmacy ?

Inappropriate Pharmacist’s office

Poison Regulations 1952 ¥ R(6) - Manner in which poisons are to be stored N All poison shall be stored in a room or cupboard under lock and key set apart for the keeping of poisons ¥ R(12) - Labeling of dispensed medicine N Dispensed medicines shall be labeled as required by laws, as “Controlled Medicine”

Poison cabinet – under lock & key

IS IT SAFE ?

Poisons (Psychotropic Substances) Regulations 1989 R11 - control on the sale and supply of psychotropic substance for medical or dental treatment of a particular patient psychotropic substance can be sold and supplied by a licensed pharmacist or a pharmacist in the public service upon a complete prescription as described in subsection 2 R17 - control of dispensing, etc. of psychotropic substance dispensing, compounding and mixing of psychotropic substance for medical treatment shall be done by a licensed pharmacist or a pharmacist in the public service

Poisons (Psychotropic Substances) Regulations 1989 R19 - records for purposes of medical, dental or animal treatment all dispensed psychotropic substance shall be recorded on the day of dispensing R24 - control of storage of psychotropic substance psychotropic substance shall be stored in locked cabinet / room by a pharmacist and can only be unlocked by him during dispensing / keeping / stock checking

Poisons (Psychotropic Substances) Regulations 1989 R28 - labeling requirement for purposes of medical, dental or animal treatment psychotropic substance sold as dispensed medicine shall be labelled with date, name & strength of substance, direction of use, full name & address of both pharmacy and patient

Does Pharmacy Legislation ‘ENCOURAGE’ Professional Ethics?

DISPENSING: Legislation and Ethics Present legislation, more or less, covers all area of pharmacists’ dispensing In the event where a registered pharmacist is found to be guilty of infamous or disgraceful conduct in a professional sense by the Board, he is still punishable under the legislation

Registration of Pharmacists Act 1951 ¥ S17- Inquiry, restoration into register and removal from register by the Board (1) If it comes to the knowledge of the Board that a registered pharmacist— (b) has been convicted of any offence which, in the opinion of the Board, renders him unfit to be on the register or of any offence under this Act or under any written law in force in Malaysia relating to poisons, dangerous drugs or therapeutic substances; or (c) has been guilty of infamous or disgraceful conduct in a professional sense, the board may inquire into the case and may if it thinks fit impose any of the punishments under S18A.

Registration of Pharmacists Act 1951 ¥ S18A – Punishments (1) The board may, at the conclusion of an inquiry, may impose any of the following punishments: (a) order the name of the registered pharmacist to be removed from the register; (b) order the name of the registered pharmacist to be suspended from the register for such period as it may think fit; or (c) order the registered pharmacist to be reprimanded

Cases Under The Poison Act 1952, Sale Of Drugs Act 1952 (Revised 1989) And Its Regulations Sale of unregistered products Sale of Group B poisons without prescriptions Poisons kept not under lock and key Previously, cases involved indiscriminate sale of cough mixtures Illegal sale of psychotropic drugs

Year Number of cases Cases involved 2005 4 - supply of dextromethorphan over the counter without records - sale of Viagra ( counterfeit ) - selling poisons without supervision 2006 11 supply of dextromethorphan over the sale of psychotropic agents without records and supervision controlled medicine not kept under lock and key 2007 (Jan - June) 68 - under investigation

The Poison Act 1952 ( Revised 1989 ) S26. Licenses (2)(a) a Type A license issued to a pharmacist to import, store and deal generally by wholesale and retail or by wholesale only or by retail only, subject to this Act, in all poisons

The Poison Act 1952 ( Revised 1989 ) S26. Licenses (5) The Licensing Officer may, in his discretion, refuse to issue any such license or may cancel any such license previously issued: Provided that any person aggrieved by the refusal of the Licensing Officer to issue a license or by the cancellation of a license may appeal to the Minister whose decision shall be final

Premise and Licences

Cases Brought Before The Malaysian Pharmacy Board Basically cases under S17(1)(b) ie. when a pharmacist convicted of any offence which, in the opinion of the Board, renders him unfit to be on the register Under S17(1)(c) ie. when a pharmacist has been guilty of infamous or disgraceful conduct in a professional sense

Issue: Unethical dispensing Some retail pharmacists have a serious potential conflict of interests On one hand, they are professionals, expected to be knowledgeable about drugs and to dispense medicines in a responsible and ethical manner, on the other hand, their income depend on the sales of products Advertising creates a demand that the pharmacist can supply and make a profit “If I don’t sell them, they’ll just go to my competitor down the street.” Hence, they resort to unethical practices.

CONCLUSION

There is a link between legislation and ethics – as provided in S17(1)(b) and (c) in the legislation In Malaysia. the legislation ‘ENCOURAGES or COMPELS’ fellow pharmacists to abide by the ethics indirectly At the present moment, the pharmacy legislation supports the present professional code of ethics in Malaysia

Future Scenario Increase in number of pharmacists Probably dispensing separation would be given in the near future to pharmacists in the private sector (public sector already has dispensing separation)

Challenges Patients are knowledgeable ( ICT age, Internet ), more demanding in their requests Tendency for pharmacists to behave unethically due to stiff competition and survival as the number of pharmacist would have increased tremendously

Remedy Legislation and ethics alone is not sufficient to reduce or eradicate unethical practice, we need greater enforcement.

THANK YOU