Pharm Law - Narcotics & Psychotropics Flashcards
what kind of additional controls are imposed on psychotropic and narcotic drugs?
preparations containing psychotropic substances, and certain opioid drugs (codeine, DMT)
under the health product act (health product regulations)
AND
under misuse of drugs act (misuse of drug regulations)
AND
international trade and movement governed by international conventions OVERSEEN by international narcotics control board + CNB and MHA
what are the specific regulations for additional control of psychotropic drugs under health products regulation
1) R6: import of therapeutic products containing psychotropic substances
2) R8: export
3) R52(1)(a): import of therapeutic products for personal use without importers license not applicable to products containing psychotropic substances
what are the specific regulations for additional control of opioid drugs under health products regulation
1) R9: export of codeine cough prep
2) R14: restriction on supply by retail sale of codeine cough prep
3) R52(1)(b): import of therapeutic products for personal use without importers license not applicable to codeine and dextromethorphan exceeding max quantities
what are provisions for lawful dealings in controlled drugs under misuse of drugs reg?
PART II R3-9: exemption from certain provisions of Act
PART II R10-18: documentation and record keeping
what are some products containing psychotropic substances specified in first schedule
phenobarbital (barbiturate)
diazepam (benzodiazepine)
mazindol (cns stimulant)
what does R6 of health products regulation entail
importer needs to obtain hsa approval for psychotropic substances
what does R8 of health products regulation entail
exporter needs to obtain hsa approval AND show that intended importer has approval from authorities in importing country
for psychotropic substances
what does R9 of health products regulation entail
exporter needs to obtain hsa approval for codeine cough preparations
what does R52(1)(a) of health products regulation entail
cannot import psychotropic substances without hsa license for psychotropic substances
what does R52(1)(b) of health products regulation entail
cannot import psychotropic substances without hsa license for codeine or dextro exceeding limits specified in seventh schedule
what does R14 of health products regulation entail
qualified practitioner or pharmacist supplying codiene cough prep by retail sale must
- not supply more than 240ml (liquid) or 355mg (base) to an individual within 7 days
- provide professional counselling
- record purpose of tx
which bodies in charge of misuse of drugs act
MHA = appoints HSA to administer control systems to regulate lawful dealings in CD
CNB
prohibitions in misuse of drugs act (according to schedule)
S5: trafficking: sell, give, adminster, transport…
S6: manufacture
S7: import/export
S8a: possession
S8b: consumption (including self admin)
what does the misuse of drugs regulations do
provide lawful CD dealing through
- licensing
- specifying certain classes of persons to handle CD under certain circumstances
what are CDs scheduled under S1
preparations containing small qty or formulated in a manner as to have relatively low risk of being abused
what are CDs scheduled under S2
high risk of abuse
but also uses as medicines
ibuprofen, oxycodone, morphine…
what are CDs scheduled under S3
uses as medicine
but relatively less risk of abuse compared to S2
benzphatamine, phendimetrazine, pipadrol
what are CDs scheduled under S4
high potential for abuse
little therapeutic value
poppy straw, non medicinal opium
what does r2 state in misuse of drugs regulations
records (register) must be in the form of a bound book and not loose leaf compilation
what does r3 state in misuse of drugs regulations
any person can import/export CD in S1 without a CD license.
any person can have in possession CD in S1
what does r4 state in misuse of drugs regulations
persons with CD license can
- manufacture
- import
- export
- supply (mainly wholesale)
- possession of CD
CD specified in the license
what does r5 state in misuse of drugs regulations
other provisions for lawful possession of CD
- person engaged in legitimate business of transporting CD or conveying CD to persons who can lawfully possess them
- person in lab when engaged to examine a CD
- CNB officer on duty/official purposes.
what does r6 state in misuse of drugs regulations
any person can administer CD in S1 to another patient
person acting according to instructions of doctor or dentist can administer CD in S2 or S3 to the patient
doctor or dentist can administer CD in S2 or S3 to his patient
what does r7(1) and r8(1) state in misuse of drugs regulations
practitioner, pharmacist, or person lawfully conducting a retail pharmacy business can manufacture or compound CD in S1,2,3
what does r7(2) and r8(2) state in misuse of drugs regulations
any of the following can supply CD in S1,2,3
- practitioner
- pharmacist
- person lawfully conducting retail pharmacy business
- nurse in charge of hospital ward, when administering CD to patients according to instructions of dr/dentist
- person in charge of lab engaged in scientified education or research
what does r7(4) and r8(4) state in misuse of drugs regulations
master of a singapore flagged shipped that does not have its own doctor can supply CD in S1,2,3
- to own crew members
- to persons who can lawfully supply CD.
what does r9(1) state in misuse of drugs regulations
person who can lawfully supply CD in S2 or S3 according to r7(2) and r8(2) can have in his possession the corresponding CD.
what does r9(2) state in misuse of drugs regulations
any person can have in his posession CD in S2 or S3 for administration according to instructions of the practitioner
- CD not obtained from more than one practitioner concurrently by fraud.
what does r9(4) state in misuse of drugs regulations
master of ship can have in his possession CD in S2 or S3 as required for the ship’s medical supplies.
- Singapore flagged ship without own doctor
- foreign ship in Singapore port
what does r10(2) state in misuse of drugs regulations
requisition order for CD in S2 or S3 (to purchase)
must be:
- signed by recipient
- state name, address, profession of recipient
- specify purpose for which CD is requited AND quantity
what does r11(1) state in misuse of drugs regulations
prescription for CD in S2 or S3 must be:
- ink or otherwise indelible
- specify prescriber name and address
- dated and signed by prescriber with his usual signature
- carry declaration (if for vet or dent use)
- specify name and address of patient
- specify dose to be taken
IF CD in preparation: specify form, strength, quantity (words and figure) OR number (words and figure) of dosage units to be supplied
IF CD NOT in preparation: specify qty (word and figures) of CD to be supplied.
FOR CD dispensed in instalments: specify amt of instalments of total amount to be dispensed, and interval to be observed when dispensing.
(NO REPEATS FOR CD PRESCRIPTIONS)
what does r12(1) state in misuse of drugs regulations
CD prescriptions cannot be dispensed
- before date stated on prescription OR later than 30 days after date stated on prescription
- if prescriber address NOT in SG
what does r13 state in misuse of drugs regulations
containers of CD (other than CD in S1, or dispensed by or on a prescription) must be labelled
- if not preparation, show total amount of CD in container
- if preparation in unit dosage form = show amount of CD in each dosage unit and number of dosage units in container
- if preparation NOT in unit dosage form, show total amt of preparation in container and percentage of each CD in preparation
what does r14(1)(a) state in misuse of drugs regulations
entries made in chronological order
as specified in fifth schedule (or sixth schedule in hospital wards)
what does r14(1)(b) state in misuse of drugs regulations
entries for each different strength of preparation of each CD to be recorded together as one set, separately from entries for other CD of different strengths or preparations
what does r15(a) state in misuse of drugs regulations
class of CD to which entries on a page relate must be stated at the head of that page
what does r15(b) state in misuse of drugs regulations
entries must be made on the day of transaction (or latest the next day)
what does r15(c) state in misuse of drugs regulations
not allowed to cancel, obliterate or alter entries
corrections to be made by dated marginal note or footnote
what does r15(d) state in misuse of drugs regulations
entries must be made in ink or otherwise indelible
what does r15(e) state in misuse of drugs regulations
register must not be used for any other purpose other than recording CD
what does r15(g) and (h) state in misuse of drugs regulations
to keep separate registers for each separate premises, and each register to be kept at the premises to which it relates
what does r17 and r18(3) state in misuse of drugs regulations
all documents and records relating to receipt or supply of CD must be retained for at least 3 years after the date of transaction
what does r20 state in misuse of drugs regulations
storage and safekeeping
all stocks of CD other than those in S1 must be kept under lock and key in premises under control of person who is authorised to supply those CD
key must be in personal possession of authorised person at all times
what does r28 state in misuse of drugs regulations
disposal requirements
S2 and S4 CD must only be destroyed in presence of and following directions given by a CD inspector
CD inspector will endorse entry in CD register documenting date of destruction and quantity of CD destroyed.
