Ceramah by JKN Selangor

The following notes are taken from the lecture on Poisons Act 1952, Poisons Regulations 1952, and Poisons (Psychotropic Substances) Regulations 1989 by Mr. Tan from Bahagian Perkhidmatan Farmasi, JKNS.

1. In answering some questions, we need to classify a particular poison first.
Try to find these poisons in the poisons list (1st schedule)--it is not that straightward!
[Scroll down for answers]

Salbutamol
Ephedrine
Amoxycillin
Heparin
Chlopheniramine
Prednisolone
Sodium cyanide
Benzocaine
Pholcodine
Cresol, methyl phenol, hydroxy toluene, thymol
Progesterone
Sulphaguanidine
BCG vaccine
Antitetanus

2. Some 'guidelines' to help us recognise/remember the psychotropic substances:

Minor tranqulisers, e.g. 1,4-benzodiazepines, clobazam, zolpidem, zopiclone

Sedatives, e.g. barbiturates

Appetite suppresants, e.g. phentermine

Strong analgesics, e.g. buprenorphine, pentazocine

3. In the 3rd Schedule of PA52: Psychotropic Substances,
substances structurally derivated from 1,4-benzodiazepines include midazolam, alprazolam...

4. Draft a format for........
The Prescription Register for Psychotropic Substances
In accordance with r19 & r22 of P(PS)R89:

Name and Strength of Psychotropic Substance:______________________

Date Supplied/Administered/Received	Serial No.	Name & Address of Patient/Supplier	Quantity Supplied/Administered/Received	Balance Stock
[Chronological order]

4. 'Tips' from Mr. Tan ( 'if you don't know this, sure lose mark'; 'take my word, sure come out')
PA52
s5- Sale of poisons by wholesale
s19- Supply of poisons for the purpose of treatment by professional men
s21(2)- Form of prescription for Group B Poisons
s24(1)- The prescriptioin book
s30- Control of import, export, manufature, sale etc of psychotropic substances

PR52
r12(a)- Labelling of dispensed medicine
r21 & r22- Prescription register for psychotropic substances
r23- Supply to outpatients in government hospitals
r26 & 27- Labelling of psychotropic substance for sale (for purpose other than medical, dental, or animal treatment)

5. In answering questions, don't use short form for acts (i.e. don't write PA52, but write 'Poisons Act 1952'; but can write 's11' (for section 11) and 'r3' (for regulation3).

Answers
[Read as 'For salbutamol, look under Adrenaline and other substances structurally derived from phenethylamine']

Salbutamol-Adrenaline and other substances structurally derived from phenethylamine
Ephedrine- Ephedra, alkaloids of
Amoxycillin- Antibiotics
Heparin- Anticoagulant substances
Chlopheniramine- Antihistamines
Prednisolone- Cortisone, hydrocortisone
Sodium cyanide- Hydrogen cyanide
Benzocaine- Local anaesthetics
Pholcodine- Narcotics
Cresol, methyl phenol, hydroxy toluene, thymol- Phenols
Progesterone- Sex hormone
Sulphaguanidine- Sulfonamides
BCG vaccine- Vaccines, sera, toxoids...
Antitetanus- Vaccines, sera, toxoids...

MPS Tutorial on Forensics Exams

Acknowledgement: Credit goes to Elaine for the content of this post =)
Best of luck to all who are siting for the exams!!

Format

• Duration: 3 ½ hours


• MCQ (50 questions; 1 mark each)
  
  
  
  • Tests us on the understanding of pharmacy legislations
  
  
  • SAQ (5 questions; 10 marks each; 50 marks in total)
    
    
    
    • For each 10 marks question, approximately “20 points” are needed.
    
    
    • Tests us on the application of pharmacy legislations
    
    
    Passing mark: 50
  
  
  
  

Miscellaneous Notes

1. Btw government pharmacists are REGISTERED and not LICENSED =) Licensed pharmacists are private sector people.


2. In the Third Schedule of the DD (list of “exemptions” from DDA; as given by DDR 25)), everything would be a PS (eg. methadone, morphine and pethidine) EXCEPT (codeine, diphenoxylate and pholcodeine; which are Group C) and opium (which is Group B).


3. In law, shall means “wajib”.


4. What is the difference between drug, poison, non-poison, psychotropic substance and DD?
   

• Drug (see definition in SODA) → … substance, product… internally or externally for medicinal purposes.


• Poison (anything in First Schedule of PA)


• Non-poison (by definition, anything NOT in First Schedule of PA eg. PCM and LMS)


• Psychotropic substance (anything in Third Schedule of PA)


• DD (Anything in First Schedule of DD)


• THEREFORE, drug consists of poisons, non-poisons, PS and DD (these are sub-sets of drug) as all these are within the definition of → … substance, product… internally or externally for medicinal purposes.

5. How to differentiate between “poisons book” and “prescription book”?

• Prescription book – for dispensed medicine (Group B and C)


• Poisons book – OTHER than dispensed medicine (eg. drugs for research purposes).

Q: Explain the supply of injection morphine sulphate for the purpose of medical treatment. [FOCUS on this question, likely to come out again]

• What is the “guiding factor” of this question?
  
  
  
  • Classification of injection morphine sulphate → psychotropic substance under the third schedule of the PA 52.
  
  
  • NOT DD drug (because injection morphine sulpate is a “preparation” and not raw material (eg. morphine powder) → Note: read DDR third schedule (R25).
  
  
  • Therefore, we are to supply it in accordance to PPSR.
  
  
  • NOTE: We will not get marks if you jumble up everything, ie. explain the supply of injection morphine sulphate using PPSR and DDR. Shows that we “tembak”.
  
  
  • Explain what’s “for the purpose of medical treatment”. PPSR R. 11 (SR 1 – 7).
  
  
  • What else to mention in the answer: R 19 (recording), R 22, 23(register), R 28 (labeling).
  
  
  • NOTE: For each regulation, just explain in your own words (no need to say stuff like “notwithstanding” etc.)
  
  
  
  

NOTE: The following is a variation of the above question:

Q: Explain the sale of injection morphine sulphate for wholesale supply

• What is the “guiding factor” of this question?
  
  
  
  • PPSR R 12 states that “… other than medical treatment” → this implies WHOLESALE.
  
  
  • Everything in which the “end user” is not a patient is WHOLESALE. Eg. of “end user” being a patient = retail.
  
  
  • Therefore, explain using PPSR R. 12 (SR 1 – 2), R 20 (records for wholesale), R 22, 23 (register for wholesale), R 26, 27 (labeling for wholesale).
  
  
  
  

Q: Explain in relation to poisons (i) immediate personal supervision; (ii) dispensed medicine.

• NOTE: Always start with definition/interpretation. Use PA.

(i) Immediate personal supervision (S2 (2))

(ii) Dispensed medicine (S2 (1))

• There are 2 parties involved in dispensed medicine:
  
  
  
  • Pharmacists (S16?)
  
  
  • Non pharmacists (S19)
  
  
  • Also talk about group B medicine (S21 (1b,c)) and group C medicine (b)
  
  
  • How about recording and labeling of dispensed medicine; and contrasting between government and private settings?

	Government	Private
Recording	PR 23 (3)	PA S 24 (SS1a – d)
Labeling	PR 23 (4)	PR 12 (a – e)
NOTE: How about for the psychotropic drugs’ recording and labeling?	Speaker said “almost the same for GOV and PVT”.

• NOTE: PR 23 (outpatient), 24 (inpatient) and 25 (storage) is for GOV hospitals BUT PR 24 ALSO applies for PVT hospitals.


• How about immediate personal supervision?
  
  
  
  • S12, 19.
  
  
  
  

Q: Explain the requirements for a person to become a pharmacist.

• ROPA (S6, 6A, 6B, 8, 11A – F)


• ROPR (R6, 8, 12)


• NOTE: Basically for this question, just expound on the necessary qualifications, experience, and don’t forget the necessary forms/documents to be sent in/fees if any, etc. → how to become a full-fledged registered pharmacist (FRP). Also talk about who registers us (Pharmacy Board) and to whom do we APPLY to be registered (the “registrar” (ie. the Director of Pharmaceutical Services).

Q: Explain the procurement and supply of morphine powder at a government hospital.

• The government has 2 means of procurement/obtainment:
  
  
  
  • from a licensed wholesaler (local) DDR 5
  
  
  • importation (DDA S20)


• For the supply, refer to:
  
  
  
  • DDHGEO.
  
  
  • Explain using Schedule A (Order 1 – 9). In Order 2, is stated “part 1 of the second schedule” → the register (as mentioned in DDR 15). DRAW this out.
  
  
  
  

Q: What are the contraventions relating to drugs and products?

• NOTE: Contravention means any person who does not follow/obey/comply to directive issued by…)


• SODA – drugs (S 10, 11)


• CDCR – products (R7, 8, 28, 29).


• NOTE: (i) Who issues licences under CDCR? (Director of Pharmaceutical Services); (ii) Who registers products? (DCA; not BPFK!)

Q: What are the prohibitions regarding medical advertisements?

• S3, S4, 4A, 4B


• NOTE: MASA prevents improper advertisements but not the SALE. (For SALE, go back to SODA/CDCR).


• NOTE: Diseases in the schedule, strictly CANNOT advertise. But for other diseases, eg. osteoporosis, MAB may consider and give approval. Hence, Anlene® can advertise that its milk helps prevent osteoporosis or whatever


• NOTE: The label of product is an advertisement!