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AZMAN YAHYA PRINCIPAL ASSIST. DIRECTOR PHARMACEUTICAL SERVICES ( ENFORCEMENT)

PHARMACY JURISPUDENCE. AZMAN YAHYA PRINCIPAL ASSIST. DIRECTOR PHARMACEUTICAL SERVICES ( ENFORCEMENT) www.pharmacy.gov.my. 1.Registration of Pharmacists Act 1951 1.1 Registration of Pharmacists Regulations 1953. 2.Poisons Act 1952 (Amended 1989)

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AZMAN YAHYA PRINCIPAL ASSIST. DIRECTOR PHARMACEUTICAL SERVICES ( ENFORCEMENT)

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  1. PHARMACY JURISPUDENCE AZMAN YAHYA PRINCIPAL ASSIST. DIRECTOR PHARMACEUTICAL SERVICES ( ENFORCEMENT) www.pharmacy.gov.my

  2. 1.Registration of Pharmacists Act 1951 1.1 Registration of Pharmacists Regulations 1953 2.Poisons Act 1952 (Amended 1989) 2.1 Control of poisons (psychotropic substances) Regulations 1989 2.2 Poisons Regulations 1952

  3. 3.Sale of Drugs Act 1952 3.1 Control of Drugs & Cosmetics Regulations1984 4. Dangerous Drugs Act 1952 4.1 Dangerous Drugs Regulations 1952 5. Medicines (Sale and Advertisement) Act 1956 5.1 Medicine Advertisement Board Regulations 1976

  4. POISONS ACT 1952 (Amended 1989) Define “Poison”? S2 Any substance specified by name in the first column of Poison List and includes any preparation,solution, compound, mixture or natural substance, containing such substance, other than an exempted preparation or article or preparation in Second Schedule.

  5. POISONS ACT 1952 (Amended 1989) FIRST SCHEDULE POISONS LIST PART I PART II EXEMPT (PART I) GROUP A,B,C,D

  6. Poisons List First Schedule Part I Poisons P Group A Poisons Group B Poisons Group C Poisons Group D Poisons

  7. Poisons List First Schedule Part II Poisons

  8. POISONS ACT 1952 (Amended 1989) FIRST SCHEDULE Group A -s20 eg adrenaline (see table) Group B -s21 (b) by regd. Medical practitioner regd dentist or vet officer for medical treatment of his patient, s21 (c ) licensed pharmacist as a dispensed medicine and via precription as in s21(2) eg. allupurinol

  9. POISONS ACT 1952 (Amended 1989) FIRST SCHEDULE eg. Antibiotic Gp A other than Gp.B,C,D and Pt II Gp.B p’ceutical dosage forms and vet prep for inclusion in animal feed Gp.C ENT prep,lozenges,external Gp.D Lab use Pt.II Premix in animal feed

  10. POISONS ACT 1952 (Amended 1989) FIRST SCHEDULE eg. Sodium hydroxide Pt I Gp C - Prep. For therapeutic /diagnostic use Pt II 12% and over unless Pt I or exempted Exempt Under 12%

  11. POISONS ACT 1952 (Amended 1989) SECOND SCHEDULE - articles and preparations exempted eg.glue, varnishes THIRD SCHEDULE -Psychotropic substances eg. Diazepam other subs. Structurally derived from 1,4- benzodiazepine exept pirenzepine, flumezenil

  12. POISONS ACT 1952 (Amended 1989) “Dispensed medicine” defined in S2 1) Medicine supplied by regd med pract /regd dentist/vet surgeon as s 19 2) Medicine supplied for purpose of medical, dental or animal treatment by a licensed pharmacist on the premise specified in his licence

  13. POISONS ACT 1952 (Amended 1989) Import of poisons-requires licence s8 Who issue licence? Licensing officer as in s26(1) Which licences? s26 (2)(a)Type A -regd.pharmacist, s26(2)(b)Type B -fit and proper for W/sale,s26(2)(c)Type C-fit and proper for retail Gp.F,s26(2)(d) Type D fit and proper for retail Pt II, Type E- to import large qty. NaoH.

  14. TYPE OF LICENCES • Type A – for Pharmacist (free) • Type B – fit and proper person for • wholesale only(RM100) • Type C – listed seller (RM10) • Type D – fit and proper person for retail • only (RM20) • Type E - import Sodium Hyroxide • (RM100)

  15. POISONS ACT 1952 (Amended 1989) Wholesale defined in s 2 Which licences? Type A and Type B What consitute w/sale? Transactions of poisons as stated in s15(2) (a) -(j) W/sale record: s15(3) Poison w/sale Book as in r26 Poisons Reg.’52

  16. SALE BY WHOLESALE • Record in wholesale sale book • Puchaser’s written order

  17. POISONS ACT 1952 (Amended 1989) Retail sale defined in s 2 Which licences? Type A ,Type D s16 -retail sale of poisons s18(1)(b), s18(1)(c ) SALE /SUPPLY of Pt.II poisons s19- sale/supply by regd.med.pract/ dental/ vet for purpose of medical/ dental/animal treatment of his patient only

  18. POISONS ACT 1952 (Amended 1989) Record of retail sale or supply 1) Poison Book -for Gp D only s23 2) Prescription Book s24 Particulars to record: date,name of patient and address, name and qty. of medicine

  19. POISONS ACT 1952 (Amended 1989) Drug Enforcement Officer (DEO) Pharmacist in public service appointed as DEO s31(1) Powers of DEO: investigate s31(2), take statements s.31(4)-(7), enter,search,detain s 31(8)

  20. POISONS ACT 1952 (Amended 1989) Penalities s32(1) Failure to keep any book / false entry - Fine not exceedingRM5000 or imprisonment not exceeding 2 yrs or both. s32(2) Fine not exceeding RM3000- 5000 or imprisonment not exceeding - 1-2yrs or both

  21. POISONS REGULATIONS 1952 r4 Import by post : - for personal/family use - not more than once a month - not more than for 1 month’s use - to name the poison and state qty.

  22. POISONS REGULATIONS 1952 Labelling of poisons: On storage r 9 - name of poison, word “POISON” in red or red background. Sale of Pt I Poisons (other than dispensed medicine): r 10 - Word “POISON” in English, Malay, Chinese, Tamil, Name of poison, Name & address of seller , “For External Use Only”, “Not to be Taken”

  23. POISONS REGULATIONS 1952 r11 Labelling of Pt II Poisons on sale : Name of Poison “Poisonous”:Not To be Taken” in English, Malay, Chinese, Tamil Name & Address of seller

  24. POISONS REGULATIONS 1952 r12(1) Labelling of Dispensed Medicine : Name & Address of seller Name of Medicine Name & Address of Patient Adequate directions for use Date and Ref.no.to entry into Prescription Book To label with the words “Controlled Medicine” or “Ubat Terkawal”

  25. POISONS REGULATIONS 1952 r12(3) Dispensed medicine for external : To label “Not To Be Taken”/”For External Use Only” in English, Malay, Chinese, Tamil and in red or red backgroud. R13 labelling of certain gases

  26. Supply of poisons in hospitals and institutions s7(3)(a) & s7(3)(b) PA’52 exempts from provisions in Act but subject to provisions in Regulations. r3 PR’52 exempts regulations 4 to 22 of hospitals & institutions BUT subject supply of poisons to Regulation 23.

  27. Supply of poisons to out-patients in Govt. hospitals etc r.23 (1) Only via Prescription by a registered medical practitioner for the purpose of medical treatment.

  28. r23Keeping of Record in Govt. hospitals etc. a) Record to be readily traced b) Record to be kept for 2 years

  29. r23(i )to (iv) Particulars to record for supply of poisons a) name and quantity of poison b) date of supply c) name and address of patient d) name of supplier or prescriber

  30. r23(4) Labelling of containers a) name and address of institution b) name of medicine c) with the words “Controlled Medicine” or “Ubat Terkawal” d) Poison supplied from veterinary hospital to be labelled “For animal treatment only”

  31. r24 Supply of medicines containing poison for use in the wards/other sections (both govt & private) must be upon a written order signed: by a registered medical practitioner, or by a nursing sister, or by a hospital assistant (who is authorised in writing by a registered medical practitioner of the institution) in charge of a ward or other section of the institution. r24(1) meaning of institutions for purpose of r24,r25 -any hospital,infirmary,dispensary,clinic,nursing home etc.

  32. r25-Storage of Poisons in institutions Poisons stored under a person appointed for the purpose by the institution. Poison to be stored in a cupboard reserved solely for storage of poisons. Inspected at regular intervals of time not exceeding three months by a registered pharmacist/ other appointed person.

  33. POISONS (PSYCHOTROPIC SUBSTANCES) REGULATIONS 1989 What is Psychotropic Substance? Anything found in Third Schedule of the Poisons Act 1952 (see s30PA’52) eg : Clobazam ,Pentazocin Diazepam and 1,4-benzodiazepines Barbiturates,Phentermine

  34. POISONS (SODIUM HYDROXIDE) • REGULATIONS 1962 • Permit to purchase and use sodium • hydroxide • Stated quantity • Fee RM20

  35. POISONS (PSYCHOTROPIC • SUBSTANCES) REGULATIONS 1989 • Import, export, manufacture, • compound, dispense, sell, supply, • administer and possess/ • Fine RM10,000 or 4 years • imprisonment

  36. Control on supply of psychotropic substance for medical/dental or animal treatment (r 11) r11(1) To be sold or supplied by regd med pract, regd dentist Div.I, vet surgeon or licensed pharmacist upon a prescription. Validity of presciption: not more than 90 days after the date of prescription (r11(3)(d) and can be repeated for 3 times (r11(2)(e). Keep prescription for 2 years (r11(7).

  37. Control on supply of psychotropic substance for purposes other than medical/dental or animal treatment (r 12) r12(2)(b) Control on quantity and frequency Seller/supplier to obtain: ( i ) buyer’s signature in supply register or signed written order ( ii ) written attestation

  38. Permit to purchase & use psychotropic subs. r14(a) ,(b) - To whom? Professional person/tradesman and game warden r15(1) to (7) How to apply? Control of administration Who can administer psychotropic substance? Regd med pract, regd dentist, vet surgeon , person acting in accordance with the direction of the former.(r16)

  39. Control of dispensingetc psychotropic substance r 17 Only by licensed pharmacist / pharmacist in public service Control of manufacture of psychotropic substances r 18 Only by licensed pharmacist / pharmacist in public service / person under immediate personal supervision of the former who will check and endorse in writing such weighing, measuring or mixing.

  40. Storage of Psychotropic Subtances (r24) A) To be stored in a oom,cabinet, safe or receptacle which shall remain locked B) Keys to be kept by authorised person to possess C) Store to be sufficient security to prevent theft or diversion

  41. Record for Purposes of medical,dental or animal treatment Record entitled Prescription Register for Psychotropic Substances (r19) Particulars of record: - true particulars to be entered on the day psy.subs is supplied - date , name and strength of psy.subs. qty.supplied, name and address of patient - qty received, total stock, name & address of supplier and date of receipt

  42. Record for Purposes other than medical, dental or animal treatment Record entitled Supply Register for Psychotropic Substances (r20) Particulars of record: name & address of purchaser, date,name, strength & quantity, purpose(r2(a) and ref.no of written order (r2(b). r20(b): purchaser signed in the supply register/ by written order

  43. Record of manufacture entitled Production Register of Psychotropic Substances (r20) Particulars of record: date & amount used,p’cetical dosage form & strength/unit dose, theoretical yield & batch no., actual yield, total units used in Q.C, total units for sale/supply.

  44. Keeping & Maintainance of Register (r22) Separate part of the register with respect to each type of psychotropic substances in chronological order. No cancellation,obliteration or alteration of an entry. Correction by way of marginal note or a footnote and to be dated.

  45. Form of register (r23) In the form of a bound book or in the form which has the written approval of the Licensing Officer To be preserved for a period of two years from the date of the last entry in such register

  46. Disposal of Psychotropic Substances (r25) To be disposed in the presence and in accordance with the instruction of a Drug Enforcement Officer (DEO) Particulars to be entered in the register and acknowledged by DEO ‘dispose’ -bury, burn or otherwise to prevent recovery.

  47. Labelling of Psychotropic Substances On storage -r 26 For purpose other than medical, dental / animal treatment -r27 For purpose of medical, dental /animal treatment -r28

  48. Prohibitory Order of Minister -r29 EXEMPTIONS : For pharmacy assistants/ medical assistants r32, Master of Ship r33, Fees for Government officers r34 PENALTY: s30(5) Poisons Act 1952 : Fine not exceeding Rm10,000 or imprisonment not exceeding 4 yrs or both

  49. SALE OF DRUGS ACT 1952 (Amended 2000) s2 New definition: “drug” includes any substance, product or article intended to be used or capable, or purported or claimed to be capable, of being used on human or animal, whether internally or externally, for medicinal purpose.

  50. SALE OF DRUGS ACT 1952 (Amended 2000) s2 New definition: “medicinal purpose” (a) alleviating, treating, curing or preventing a disease or pathological condition or symptoms of disease, (b) diagnosing a disease or ascertaining the existence, degree, extent of physiological or pathological conditions

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