PHARMACY JURISPUDENCE AZMAN YAHYA PRINCIPAL ASSIST DIRECTOR PHARMACEUTICAL

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

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 2

3. Sale of Drugs Act 1952 3. 1 Control of Drugs & Cosmetics Regulations 1984 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 3

POISONS ACT 1952 (Amended 1989) Define “Poison”? S 2 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. 4

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

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

Poisons List First Schedule Part II Poisons 7

POISONS ACT 1952 (Amended 1989) FIRST SCHEDULE Group A -s 20 eg adrenaline (see table) Group B -s 21 (b) by regd. Medical practitioner regd dentist or vet officer for medical treatment of his patient, s 21 (c ) licensed pharmacist as a dispensed medicine and via precription as in s 21(2) eg. allupurinol 8

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 9

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% 10

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 11

POISONS ACT 1952 (Amended 1989) “Dispensed medicine” defined in S 2 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 12

POISONS ACT 1952 (Amended 1989) Import of poisonsrequires licence s 8 Who issue licence? Licensing officer as in s 26(1) Which licences? s 26 (2)(a)Type A regd. pharmacist, s 26(2)(b)Type B -fit and proper for W/sale, s 26(2)(c)Type C-fit and proper for retail Gp. F, s 26(2)(d) Type D fit and proper for retail Pt II, Type E- to import large qty. Nao. H. 13

TYPE OF LICENCES • Type A – for Pharmacist (free) • Type B – fit and proper person for wholesale only(RM 100) • Type C – listed seller (RM 10) • Type D – fit and proper person for retail only (RM 20) • Type E - import Sodium Hyroxide 14 (RM 100)

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 s 15(2) (a) -(j) W/sale record: s 15(3) Poison w/sale Book as in r 26 Poisons Reg. ’ 52 15

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

POISONS ACT 1952 (Amended 1989) Retail sale defined in s 2 Which licences? Type A , Type D s 16 -retail sale of poisons s 18(1)(b), s 18(1)(c ) SALE /SUPPLY of Pt. II poisons s 19 - sale/supply by regd. med. pract/ dental/ vet for purpose of medical/ dental/animal treatment of his patient only 17

POISONS ACT 1952 (Amended 1989) Record of retail sale or supply 1) Poison Book -for Gp D only s 23 2) Prescription Book s 24 Particulars to record: date, name of patient and address, name and qty. of medicine 18

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

POISONS ACT 1952 (Amended 1989) Penalities s 32(1) Failure to keep any book / false entry Fine not exceeding. RM 5000 or imprisonment not exceeding 2 yrs or both. s 32(2) Fine not exceeding RM 3000 - 5000 or imprisonment not exceeding - 1 -2 yrs or both 20

POISONS REGULATIONS 1952 r 4 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. 21

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” 22

POISONS REGULATIONS 1952 r 11 Labelling of Pt II Poisons on sale : Name of Poison “Poisonous”: Not To be Taken” in English, Malay, Chinese, Tamil Name & Address of seller 23

POISONS REGULATIONS 1952 r 12(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” 24

POISONS REGULATIONS 1952 r 12(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. R 13 labelling of certain gases 25

Supply of poisons in hospitals and institutions s 7(3)(a) & s 7(3)(b) PA’ 52 exempts from provisions in Act but subject to provisions in Regulations. r 3 PR’ 52 exempts regulations 4 to 22 of hospitals & institutions BUT subject supply of poisons to Regulation 23. 26

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

r 23 Keeping of Record in Govt. hospitals etc. a) Record to be readily traced b) Record to be kept for 2 years 28

r 23(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 29

r 23(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” 30

r 24 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. r 24(1) meaning of institutions for purpose of r 24, r 25 -any hospital, infirmary, dispensary, clinic, nursing home etc. 31

r 25 -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. 32

POISONS (PSYCHOTROPIC SUBSTANCES) REGULATIONS 1989 What is Psychotropic Substance? Anything found in Third Schedule of the Poisons Act 1952 (see s 30 PA’ 52) eg : Clobazam , Pentazocin Diazepam and 1, 4 benzodiazepines ine Barbiturates, Phenterm 33

POISONS (SODIUM HYDROXIDE) REGULATIONS 1962 • Permit to purchase and use sodium hydroxide • Stated quantity • Fee RM 20 34

POISONS (PSYCHOTROPIC SUBSTANCES) REGULATIONS 1989 • Import, export, manufacture, compound, dispense, sell, supply, administer and possess/ • Fine RM 10, 000 or 4 years imprisonment 35

Control on supply of psychotropic substance for medical/dental or animal treatment (r 11) r 11(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 (r 11(3)(d) and can be repeated for 3 times (r 11(2)(e). Keep prescription for 2 years (r 11(7). 36

Control on supply of psychotropic substance for purposes other than medical/dental or animal treatment (r 12) r 12(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 37

Permit to purchase & use psychotropic subs. r 14(a) , (b) - To whom? Professional person/tradesman and game warden r 15(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. (r 16) 38

Control of dispensing etc 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. 39

Storage of Psychotropic Subtances (r 24) 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 40

Record for Purposes of medical, dental or animal treatment Record entitled Prescription Register for Psychotropic Substances (r 19) 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 41

Record for Purposes other than medical, dental or animal treatment Record entitled Supply Register for Psychotropic Substances (r 20) Particulars of record: name & address of purchaser, date, name, strength & quantity, purpose(r 2(a) and ref. no of written order (r 2(b). r 20(b): purchaser signed in the supply register/ by written order 42

Record of manufacture entitled Production Register of Psychotropic Substances (r 20) 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. 43

Keeping & Maintainance of Register (r 22) 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. 44

Form of register (r 23) 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 45

Disposal of Psychotropic Substances (r 25) 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. 46

Labelling of Psychotropic Substances On storage -r 26 For purpose other than medical, dental / animal treatment -r 27 For purpose of medical, dental /animal treatment -r 28 47

Prohibitory Order of Minister -r 29 EXEMPTIONS : For pharmacy assistants/ medical assistants r 32, Master of Ship r 33, Fees for Government officers r 34 PENALTY: s 30(5) Poisons Act 1952 : Fine not exceeding Rm 10, 000 or imprisonment not exceeding 4 yrs or both 48

SALE OF DRUGS ACT 1952 (Amended 2000) s 2 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. 49

SALE OF DRUGS ACT 1952 (Amended 2000) s 2 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 50

SALE OF DRUGS ACT 1952 (Amended 2000) s 2 New definition: “medicinal purpose” (c) contaception, (d) inducing anaesthesia, (e) maintaining, modifying, preventing, restoring or interfering with, the normal operation of a physiological function, (f) controlling body weight (g) general maintainance or promotion of well-being 51

SALE OF DRUGS ACT 1952 (Amended 2000) s 2 New definition “sell/sale”: To delete the words “refers only to sale for human consumption or use” s 17 - to include the word “animal” after every word “human” 52

SALE OF DRUGS ACT 1952 (Amended 2000) s 12(1)New Penalty for Act & Regulations Individual: Fine not exceeding RM 25, 000 or imprisonment not exceeding 3 yrs or both. 2 nd and subsequent offence: Fine not exceeding RM 50, 000 or imprisonment not exceeding 5 yrs or both 53

SALE OF DRUGS ACT 1952 (Amended 2000) s 12(2)New Penalty for Act & Regulations Body Corporate: Fine not exceeding RM 50, 000. 2 nd and subsequent offence: Fine not exceeding RM 100, 000 Amendment of r 30 Control of Drugs & Cosmetics Regulations 1989 - subsection (2) deleted. 54

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Amendments 2001 r 2 -new definition : “possess for sale” includes keeping or storing for sale or supply or having in possession knowing that the product is likely to be sold or exposed for sale r 7(1) to include the word “ possess for sale” 55

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Part I: Definitions of product, cosmetics herbal remedy etc (r 2) Part II: Drug Control Authority (r 3) Part III: Control of manufacture, sale, supply, possess for sale and import (r 7) (a) product to be registered (b) person to be licensed (r 8) Registration of products 56

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Part III: r 9 - Register of products r 9(3)- Any person may inspect the register. r 12 (a) (b) (c) (d) : Licences manufacturer’s licence wholesaler’s licence clinical trial import licence 57

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Part III: r 14 DCA can refuse licence r 15(1)-(6) DCA gives exemptions r 16 DCA may issue certification r 17 DCA may suspend, cancel or revoke registration /licence. 58

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Part IV: Provides for GMP (r 19, r 20, r 21, r 22, r 23, r 24, r 25) Part V: r 26 - Power of Enforcement officer to enter, seize product, palnt, equipment, book, documents 59

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Part V: r 27 - Records of transactions Importer & W/saler: proper records kept for 5 years W/sale particulars to record date, name & address of purchaser, name & qty of product, Regn No, Invoice No/D. O 60

CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 Part V: r 28 - Reporting ADR r 29 - DCA directives for product recall and disposal is binding otherwise the person commits an offence. 61

DANGEROUS DRUG ACT 1952 What is Dangerous Drug ? Anything found in the First Schedule of Dangerous Drugs Act 1952 eg: Morphine, pethidine, fentanyl 62

DANGEROUS DRUG ACT 1952 Purpose of the Act: see preamble Scope of the Act: As for licit & international control, the competent authority is the Pharmacy Division MOH which collaborate with INCB. Powers to Director of Pharmaceutical Services given under s 44 DDA to control import, export, mfg, sale & use (s 12, 19, 20, 22) 63

DANGEROUS DRUG ACT 1952 Control of illicit activities relating to DD Enforcement by Police/Customs Specific sections on investigations & court actions (s 26 to s 42) 64

DANGEROUS DRUG ACT 1952 Amendments 1) Definition s 2 “licensed pharmacist” means registered pharmacist who is the holder of Type A Licence issued under th Poisons Act 1952. (1998) 2)s 12 - New fine RM 100, 000 (1998) 3)Part III First Schedule amended to include Amphetamine, Methamphetamine (1997), Ketamine 65

DANGEROUS DRUG ACT 1952 Amendment 2001 1) To delete no. 1 in Part V of First Schedule DDA ‘ 52 The implications: Requires an export authorisation besides an import authorisation (s 12) Eg. To export codeine preparations requires an export authorisation. To import such preparation requires an import authorisation. 66

DANGEROUS DRUG ACT 1952 Latest amendments 1) Gazette 2004 2) Amend Third Schedule 3) Registered Products containing pholcodeine and its equiv. 4) As Group C to control as dispensed medicine 67

DANGEROUS DRUGS REGULATIONS 1952 AUTHORITY r 4 - to manufacture DD r 5 - supplying , procuring & advertising for sale r 6 - Possession of DD r 8 - Persons to possess & supply DD r 9 - to manufacture & retail DD 68

DANGEROUS DRUGS REGULATIONS 1952 - r 11 - To be supplied only via a valid prescription - r 12 (3) Can be repeated thrice if indicated by presriber - r 12 (4)To mark date of supply on prescription - r 14 - marking of packages and bottles 69

DANGEROUS DRUGS REGULATIONS 1952 RECORD of DD 1) Licensed Pharmacist : Record for W/sale r 15(1)(a) to record entry in Form of register ( see Part I and Part II Registers in Second Schedule) 2) Licensed Pharmacist : Record for retail sale r 15(2)(b) to record in Prescription Book and to make entry of Ref. No. into Part. II Register (DD supplied) and Part I Register (DD obtained) 70

DANGEROUS DRUGS REGULATIONS 1952 RECORD of DD 1) Registered Medical Practitioner/ Dentist( private hospitals and clinics) r 15(2)(a) Day Book and Separate Book 71

Preservation of records of dangerous drugs: Keep for 2 years from date of last entry eg. Records include registers, records, books, prescriptions, signed orders and other documents. 72

DANGEROUS DRUGS REGULATIONS 1952 WHOLESALE LICENCE R 18 -To apply licence for wholosale dealing EXEMPTIONS s 25 DDA’ 52 - Exempts travellers r 25 DDReg’ 52 - Exempts regulations for preparations of Third Schedule (but not r 15(8) and r 16) Implicatioons of r 25 DDR’ 52: Codeine preparations are controlled as Group C Poisons under PA’ 52. To be supplied as dispensed medicine. 73

• DANGEROUS DRUGS (HOSPITAL ETC) (GENERAL EXEMPTION) ORDER 1952 • r 2 - Exempts from the operation of DDReg’ 52 for govt. hospitals/clinics for DD in Part III of First Schedule DDA’ 52 74

DD (Hospitals, etc) General Exemption Order 1952 Control of Dangerous Drugs in Public hospitals : SCHEDULE A 1) Orders for supply to be signed by pharmacist or doctor 2) -Supplies to be received and kept by pharmacist - To record DD obtained as Part I Register, separate page for ecah class of DD 3)-To dispense prescription per patient per ocassion -Presription to be in writing, dated and signed/initialled by doctor, 75 state name of patient/R. N

. . . Public hospital: 4) –To stamp/ mark the prescription as proof of dispensing -Dispensing to be recorded as the date, name of doctor/prescriber, name of patient or R. N. 5) Keep prescriptions for 2 years 6) Stock DD in wards/outpatient, To supply on written requisition of sister i/c who keeps under lock & key, to mark requisition and keep in dispensary and a copy to sister i/c. 76

. . . Public hospital: SCHEDULE B: 1) Supply to ward to be obtained by/ on written order of doctor. 2) Supplies to be received by matron/senior HA/ senior nurse who keep under lock & key To record DD obtained as in Part I Register, Separate page for each class of DD. 3) Matron/HA/nurse to administer in accordance with directions of doctor. 77

Disposal of Dangerous Drug: To be disposed as required by the Environmental Quality (Scheduled Wastes) Regulations 1989 The authorised person shall furnish particulars with respect to any stock to the Director General of Health. R 15(1)(e) 78

MEDICINES (ADVERTISEMENT & SALES) ACT 1956 What constitutes an advertisement? See definition s. 2 Which advertisement is controlled? Advertisement of article(medicine, appliances or remedy) skill/service. How is the control? For prevention/ treatment/ diagnosis of diseases/ conditions of human body 79

MEDICINES (ADVERTISEMENT & SALES) ACT )1956 Who is the authority? Medicine Advertisement Board (MAB) What is the role of MAB? Approval of Advertisement Any exemption? S 3 advertisement published by govt. 80

MEDICINES (ADVERTISEMENT & SALES) ACT 1956 s 3 : Absolute prohibition to take part in publication of advertisement, to lead to the use of articles for purpose of (a) prevention/treatment of diseases & conditions of human beings as in Schedule (b) practising contraception (c ) improving the condition/ functioning of kidney, heart, sexual function/performance (d) diagnosis of disease as in Schedule. (see Schedule - list of 20 diseases) 81

MEDICINES (ADVERTISEMENT & SALES) ACT 1956 s 4: Prohibit advertising abortion s 4 A: Prohibit advertising skill or service except s 4 A(aa): Minister approval for professional body s 4 A(bb): MAB approval for private clinic/radiological/ medical lab. s 4 B: Prior approval from MAB to advertise article to prevent/ treat/ diagnose other conditions of human body. 82

MEDICINE (ADVERTISEMENT & SALE) ACT 1956 s 6: to label active ingredients in Malay/ English for sale of substances recommended as medicine. MEDICINES ADVERTISEMENT BOARD REGULATIONS 1976 Procedure for MAB approval (KKLIU) r 5, r 6, r 7, r 8 83

MEDICINES (ADVERTISEMENT & SALES ACT 1956) Penalty s 5: 1 st conviction: Fine not exceeding RM 3, 000 or imprisonment not exeeding 1 year or both 2 nd and subsequent: Fine not exceeding RM 5, 000 or impriosnment not exceeding 2 yrs or both. 84