N&P Flashcards
why are there controls on n& p
contain substance that are considered high risk and likely to be misused or abused
definition for cd
under mda- 1st schedule of mda
- preperations containing psychotropic substances, codeine and dextromethrophan under HPA ( TP )
mda under who, + in practice
and intended for
ministry of home affairs and enforced by cnb
in practise, minister of home affairs appoints HSA to administer control system that regulates lawful dealings in CDs
intended for controlling drug addiciton and abuse
mda prohibits what kind of actions
dealings
- manufacture
- import and export
- trafficking - including supply
- possession
- consumptions
exemptions ! in mdr
- lawful dealings of CD fr legitimate medical and scientific use
in order for lawful dealing of CD u need to ___
- have cd license
2. be a specified certain class of persons allowed to handle CDs under certain circumstances
how are the cds scheduled in the MDR
first schedule (S1) - cd in small qty or relatively low risk of being abused
s2 - high risk of abuse , also have use as medicine
s3 - have some use of medicine, relatively less risk of abuse than s2
s4 - high risk of abuse , little therapeutic value
how do u import or export or supply/ administer CDs
- CD(import) license to import
- CD ( export) license to export
^ on top of regular requirements - need CD license to supply - mainly inteded for wholesale supply
any person can import or export CD of section 1 without license
following persons can supply cds in schedule 1-3
- practitioner
- pharmacist
- person lawfully conducting retail pharmacy business
- nurse in charge of ward according to instructuons of doctor/ dentist
- person engaged in scientific education or research
- master of singapore flagged ship without doctor can supply to own crew members, to persons who can lawfully supply cds
for administering
- anyone can administer S1 to another person
- for s2 and s3 must be doctor/dentist or someone acting according to instructions of doctor or dentist
who can lawfully possess CDs
- person w cd license can possess cd specified in the license
- persons who can lawfully supply cd in s2 or s3 can posess
- master of sg flapped shit w/o doctor
- foreign ship port in sg
- if person has it for administration by instructions of practitioner , as long as cd not obtained by more than 1 doctor by fraud
( must have a prescription )
^ all can have s2 and s3
s1 anyone can have possession of it
posession of cd vs non cd
non cd even without prescription - posession is not unlawful
but for cd , poseesion without prescription ( fo rs2and s3 ) is unlawful
who else is generally allowed for lawful posession
- person in legitimate business of transporting cd between 2 parties who are also lawfully able to posess the cd
- person in lab engaged to examine the cd
- cnb officer in the course of his duty or for official purposes
cds in s2 and s3 can only be supplied if
- there is prescription - r11
- requisition order for wholesale type of supply - similar to signed order - r10
requisition order requirements
r10 of MDR- documents to be obtained by supplier
signed by person to whom it is supplied
name,address and profession or occupation of recipient
purpose for which drug supplied
total qty to be supplied
requirements for prescription
r11 of MDR- form of prescription
are repeats allowed for cd prescriptions
no but can be done in instalments
cd prescriptions cannot be dispensed unless
r12 of MDR
cd register must be kept of all records of movements of stocks of which 2 schedules of cd
and it must be done in what kind of book
2 and 4 - more tighter controls
bound book
cd register entries to be made how
chronological order
r14 , 15 ,
how long must cd documents and registers be kept of r
at least 3 yrs from the date of the last transaction
cd labels - for stock container
r13- marking of bottles and other containers
storage of cd
r20= storage of controlled drugs
cd disposal
r28
under hpa -tp which is subject to tighter controls
psychotropic substances in 1st schedule
which are mind altering and have potential for abuse
& products w opioids/ dextromethorphan
international trade and movement of psychotropic substances governed by
international conventions eg INCB
international narcotics control board
system of cross checkign all import export transactions involving such substances is for curbing diversion and illicit trade
importation requirements for pychotropic substances
- r6- obtain prior approval from authority for each consignment
psychotorpic substances importation for personal use
not allowed r52
exporter psychotropic substance requirement
r8 r9
need consignment
for psychotorpic and codeine, not needed for dextrometorphan
before approval granted, exporter must show that intended importer has approval from authorities in importing country
supply limits for codeine
r14
