narcotics Flashcards
what regulation provides additional controls for import of therapeutic pdts containing psychotropic substances under the Health Products (Therapeutic Products) Regulations?
R6
what regulation provides additional controls for export of therapeutic pdts containing psychotropic substances under the Health Products (Therapeutic Products) Regulations?
R8
what regulation provides additional controls for import of therapeutic pdts for personal use without importer’s license not applicable to pdts containing psychotropic substances under the Health Products (Therapeutic Products) Regulations?
R25(1)(a)
what regulation provides additional controls for export of codeine cough preparations under the Health Products (Therapeutic Products) Regulations?
R9
what regulation provides additional controls for restrictions on supply by retail sale of codeine cough preparations under the Health Products (Therapeutic Products) Regulations?
R14
what regulation provides additional controls for import of therapeutic pdts for personal use without importer’s license not applicable to codeine and dextromethorphan exceeding maximum quantities under the Health Products (Therapeutic Products) Regulations?
R25(1)(b)
What is the purpose of the Misuse of Drugs Regulations?
to control drug addiction and abuse
provisions for lawful dealings for medical use
what provisions provides for exemptions from certain provisions of Act under the Misuse of Drugs Regulations?
Part II (R3-R9)
Part II, containing regulations 3-9
what provisions provides for additional control for documentation and record keeping under the Misuse of Drugs Regulations?
Part III (R10-R18)
Where are products containing “psychotropic substance” specified under the Health Products (Therapeutic Products) Regulations?
products containing “psychotropic substance” are specified in the First Schedule
e.g.
- phenobarbital (barbituate)
- diazepam (benzodiazepine)
- mazindol (CNS stimulant)
importer must obtain HSA’s approval before importing ech consignment of any pdt containing psychotropic substance
R6
import of therapeutic pdts for personal use (i.e. without license) NOT allowed for products containing psychotropic
R52(1)(a)
i.e. any person who wishes to import pdts containing psychotropic substance for personal use will have to apply for importer’s license from HSA
exporter (i.e. wholesaler) must obtain HSA’s approval before exporting each consignment of any product containing psychotropic substance
R8
before approval is granted, exporter must show that intended importer has approval from authorities in importing country
- part of international agreemt on psychotropic substances to ensure that pds are legally permitted to be brought into importing country before they leave exporting country
what products are under opioid drug controls?
products containing certain opioids:
- codeine (codeine cough preparation)
- dextromethorphan
opioid drug controls are imposed to curb/reduce local abuse problems
Import for personal use (i.e. without license not allowed for pdts containing codeine or dextromethorphan (exceeding limits specified in the Seventh Schedule)
R52(1)(b)
exporter (i.e. wholesaler) must obtain HSA’s approval before exporting each consignment of codeine cough preparation
R9
R14: qualified practitioner/pharmacist supplying codeine cough preparation by retail sale
must NOT supply more than stated amt to any indiv within a period of 7 days:
- total of 240mL (in liquid form)
- total of 355mg of codeine (as base) [in solid form]
must provide professional counselling on use of preparation
must record purpose of treatment for which the preparation was supplied
export of codeine cough preparation
R9
- obtain HSA’s approval for each consignment to be exported
what is the purpose of the Misuse of Drugs Act?
intended to conrol “dangerous or otherwise harmful drugs”– “controlled drugs” (CD)
provisions for lawful dealings in CD for medical and scientific uses
under Misuse of Drugs Regulations
Who is in charge of Misuse of Drugs Act?
Minister for Home Affairs
- administered and enforced by Central Narcotics Bureau (CNB)
define controlled drug under Misuse of Drugs Act s2
CD: any substance or product… specified in… the First Schedule or anything that contains any such substance or product…
Define “traffic” or “trafficking” under Misuse of Drugs Act s2
“traffic”/”trafficking” includes selling, giving, administering to (another person), transporting, sending, delivering, distributing
what section provides aprohibitions for import and export of CD under the Misuse of Drugs Act?
S7
what section provides prohibitions for “trafficking” of CD (incl ss) under the Misuse of Drugs Act?
S5
what section provides prohibitions for possession of CD under the Misuse of Drugs Act?
S8(a)
what section provides prohibitions for consumption of CD (incl self-administration) under the Misuse of Drugs Act?
S8(b)
what section provides prohibitions for manufacture of CD under the Misuse of Drugs Act?
S6
misuse of drugs regulations
- provides for some exemptions to general prohbitions under Misuse of Drugs Act
- to allow lawful dealings in CD for medical and scientific uses (e.g. ss by doctors for treatmt of pts, dispensing by pharmacists, ss for laboratory testing)
- Minister for Home Affairs appoints HSA offficers to administer control system taht regulates lawful dealings in CD
How does Misuse of Drugs Regulations provide for lawful dealings in CD
- through licensing i.e. CD license
- by specifying certain classes of persons allowed to andle CD under certain circumstances
Regulations also specify controls and requirements to be met in the course of those lawful dealings
why are CD scheduled under Misuse of Drugs Regulations?
for purposes of access control
what drugs are specified in the First Schedule (S1) of Misuse of Drugs Regulations?
preparations containing CD in small quantities or formulated in such manner as to have relatively low risk of being abused
what drugs are specified in the Second Schedule (S2) of Misuse of Drugs Regulations?
mostly CD that have high risk of abuse but also have uses as medicines
e.g. ibuprofen, morphine, oxycodone
what drugs are specified in the Third Schedule (S3) of Misuse of Drugs Regulations?
includes some CD that have uses as medicines but relatively less risk of abuse compared to CD in S2
e.g. benzphetamine, phendimetrazine, pipradrol
what drugs are specified in the Fourth Schedule (S4) of Misuse of Drugs Regulations?
mainly CD that have high potential for abuse and also of little therapeutic value
e.g. cannabinol, concentrate of poppy-straw, non-medicinal opium
person with CD license can manufacture CD specified in license
R4 (MoDR)
practitioner, pharmacist or “person lawfully conducting a retail pharmacy business” can manufacture or compound CD in S1, S2 or S3
r7(1) and r8(1) [MoDR]
person with CD (import) license can import CD specified in license
r4 (MoDR)
person with CD (export) license can export CD specified in license
r4 (MoDR)
any person can import or export CD in S1 (without CD license)
r3 (MoDR)
person with CD license can supply CD specified in license
r4 (MoDR)
in practice, license to supply mainly intended for wholesale supply
who can supply CD in S1, S2 or S3 [r7(2) and r8(2), MoDR]
- practitioner
- pharmacist
- “person lawfully conducting a retail pharmacy business”
- nurse in charge of hosp ward, when administering CD to pt according to instructions of doctor or dentist
- person in charge of laboratory engaged in scientific education or research
master of a (Singapore-flagged) ship that does NOT have its own doctor can supply CD in S1, S2 or S3: to own crew members & to persons who can lawfully supply CD
r7(4) and r8(4) [MoDR]
provisions for lawful administration of CD
r6 (MoDR)
- doctor/dentist can administer CD in S2 or S3 to his pt
- person acting according to instructions of doctor/dentist can administer CD in S2 or S3 to the pt
- any person can administer CD in S1 to another person
person with CD license can have in his possession CD specified in the license
r4 (MoDR)
person who can lawfully supply CD in S2 or S3 [according to r7(2) & r8(2)] can have in his possession the corresponding CD
r9(1) [MoDR]
master of ship can have in his possession CD in S2 or S3 as required for the ship’s medical supplies:
- a (Singapore-flagged) ship that does not have its own doctor
- a foreign ship in port (in Singapore)
r9(4) [MoDR]
any person can have in his possession CD in S2 or S3 for administration according to instructions of practioner
r9(2) [MoDR]
- provided CD were not obtained from more than one practitioner concurrently by fraud
any person can have in his possession CD in S1
r3 (MoDR)
other provisions for lawful possession of CD
r5 (MoDR)
- person engaged in (legitimate) business of transporting CD or conveying CD to persons who can lawfully possess those CD
- person in laboratory when engaged to examine a CD
- CNB officer, when in the course of his duty or for official purposes
Misuse of Drugs Regulations state that CD in S2 or S3 can only be supplied in accordance with:
- requisition order (for wholesale-type of supply)
- prescription (for retail supply to pts)
requisition order for CD in S2 or S3
r10(2) [MoDR]
- must be signed by recipient
- must state name, address and profession of recipient
- must specify purpose for which CD is required, and total quantity to be supplied
prescriptions for CD in S2 or S3
r11(1) [MoDR]
- must be in ink or otherwise indelible
- must specify prescriber’s name and address
- must be dated and signed by prescriber with his usual signature
- must carry declaration if for dental or veterinary use
- must specify name and address of pt
- must specify dose to be taken
- if CD is a preparation, must specify form (and strength) of preparation to be supplied
- if CD is a preparation, specify quantity (in words and figures) of preparation or number (words and figures) of dosage units to be supplied
- if CD is not a preparation, specify quantity (words and figures) of CD to be supplied
- for prescription to be dispensed in instalments, must specify no. of instalments of total amt which may be dispensed, and intervals to be observed when dispensing
NOTE: NO repeats for CD prescriptions
CD prescriptions cannot be dispensed:
r12(1) [MoDR]
- before date stated on prescription or later than 30 days after date stated on prescription
- unless prescriber’s address is in Singapore
CD register must be kept to record all movements of stocks of CD in S2 and S4
- must be in the form of a “bound book” and NOT a “loose leaf” compilation– r2 [MoDR]
- entries in register must be made in chronological order– r14(1)(a) [MoDR]
format of CD register should follow that specified in Fifth Schedule
r14(1)(a) [MoDR]
- in hosp wards, can be in simpler format specified in Sixth Schedule
entries for each different strength or preparation of each CD to be recorded together as one set, separately from entries for other CD of different strengths or preparations
r14(1)(b) [MoDR]
CD register:
- class of CD to which entries on a page relate must be stated at the head of that page
- entries must be made on the day of transaction (or latest the next day)
r15(a) ; r15(b) [MoDR]
CD register:
- not allowed to cancel, obliterate or alter entries, and only make corection by way of dated marginal not or footnote
- entries must be made in ink or otherwise indelible
r15(c) ; r15(d) [MoDR]
CD register:
- register must NOT be used for any other purpose other than recording CD
- to keep separate registers for each separate premises, and each register to be kept at the premises to which it relates
r15(e) ; r15(g) & (h) [MoDR]
record keeping:
all documents and records relating to recipt or supply of CD must be retained for (at least) 3 yrs after the date of transaction
r17 & r18(3) [MoDR]
labellling:
containers of CD (other than CD in S1 or CD dispensed by or on a prescription of a practitioner) must be labelled
r13 (MoDR)
- if CD is NOT a preparation, total amt of CD in container must be labelled
- if CD is a preparation in unit dosage form, show amt of CD in each dosage unit and number of dosage units in container
- if CD is a preparation NOT in unit dosage form, show total amt of preparation in container and percentage of each CD in preparation
storage:
requirements for storage and safekeeping of CD
r20 (MoDR)
- 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
- the key must be in personal possession of authorised person at all times
disposal:
requirements for disposal of CD
r28 (MoDR)
- CD in S2 and S4 must only be destroyed in the presence of, and in accordance with directions given by a CD inspector
- CD inspector will endorse entry in CD register documenting date of destruction and quantity of CD destroyed
