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

2. 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.

3. 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.

4. 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

5. 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.

6. ETHICS

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

8. 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

9. 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

11. CODE OF CONDUCT Article 2: Abuse of Professional Privileges and Skills
Abuse of privileges conferred by law
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

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

13. Are they pharmacist ?

14. PHARMACY LEGISLATION IN MALAYSIA

15. 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)

16. 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

17. 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

18. 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

19. Counselling counter/ room - Comfortable & privacy

20. Dispensing/ Counselling counter

21. Poison cabinet & Dispensing counter

22. Medical store or Pharmacy ?

23. Inappropriate Pharmacist’s office

24. 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”

25. Poison cabinet
– under lock & key

26. IS IT SAFE ?

27. 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

28. 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

29. 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

30. Does Pharmacy Legislation ‘ENCOURAGE’ Professional Ethics?

31. 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

32. 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.

33. 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

34. 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

35. 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

36. 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

37. 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

38. Premise and Licences

39. 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

40. 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.

41. CONCLUSION

42. 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

43. 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)

47. 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

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

49. THANK YOU