WK12 Additional Controls on Controlled Drugs (Pharm Law) Flashcards
Who is in charge of the Misuse of Drugs Act?
Who enforces it?
- Under the charge of Minister for Home affairs, and administered and enforced by Central Narcotics Bureau (CNB)
What is the Misuse of Drugs Act for?
What is the definition of controlled drugs
Misuse of Drugs Act:
- Narcotics control laws
- Under the charge of Minister for Home affairs, and administered and enforced by Central Narcotics Bureau (CNB)
- Intended to control drug addiction and abuse, particularly for substances that are known to be addictive and have high risk of abuse
- Defines “controlled drug” as:
o “any substance or product which is for the time being specified in Part 1, 2, or 3 of the First schedule or anything that contains any such substance or product” - pass a bill in the parliament, president have to sign in
What are the differences between the Misuse of Drugs Act and the Misuse of Drugs Regulation?
- Misuse of Drugs Act generally “prohibitive” –> prohibitions against any handling of CDs
o Manufacture, import/export, supply, possession, consumption - Misuse of Drugs Regulation provides for some exemptions to general prohibitions in Misuse of Drugs Act
o Needed to allow lawful dealings of CDs for legitimate medical and scientific uses
o Minister for Home Affairs appoints Health Sciences Authority officers to administer control system that regulates lawful dealings in CDs
- Act → pass a bill in the parliament, president have to sign in
Regulation → doesn’t go through parliament or president, made by regulation body e.g. MOH, HSA, interpretation of the act → more practical
Who administer and enforce the Misuse of Drugs Regulation?
HSA officers
What are the type of CDs in the different schedules?
CDs further scheduled:
- First schedule (S1) → preparations containing CDs in small quantities / formulated in such manner as to have relatively low risk of being abused
- (Small amt/low risk of abuse) - Second schedule (S2) → mostly CDs that have high risk of abuse but also have uses as medicines
- (High risk of abuse + med use) - Third schedule (S3) → includes some CDs that have uses as medicines but relatively less risk of abuse compared to CDs in S2
- (low risk of abuse + med use) - Fourth Schedule (S4) → mainly CDs that have high potential for abuse and also of little therapeutic value
- (high risk of abuse)
Who can lawfully supply CDs on S1,2,3?
Misuse of Drug Regulations – Supply:
Any of the following can lawfully supply CDs in S1, S2 orS3 (these are exemptions)
- Practitioner
- Pharmacists
- “Person lawfully conducting a retail pharmacy business”
- Nurse in-charge of hospital ward, when administering CD to patient according to instructions of doctor or dentist
- Person in-charge of laboratory engaged in scientific education or research
Who can lawfully administer CDs?
Administration of CDs:
Any of the following can lawfully administer CDs:
- Doctor or dentist can administer CDs in S2 or S3 to his patient
- Person acting according to instructions of doctor or dentist can administer CDs in S2 or S3 to the patient
- Any person can administer CDs in S1 to another person
What are the drug examples in the different schedules?
Schedules of CDs (non-exhaustive):
S1 (low risk/small amt):
- codeine & pholcodine (not more than 100mg per dosage unit with a total concentration of not more than 2.5%)
- diphenoxylate – diarrhea med
S2, mostly opioids (high risk + med use):
- Hydrocodone
- Hydromorphone
- Morphine
- Methadone
- Amphetamine → stimulant, ADHD have problems concentrating, mental stimulant
S3 (low risk + med use) :
- Chlorphentermine
S4 (high risk):
- Cannabis
What are the legal requirements of writing a CD Prescription? (10+ rules)
CD Prescription – Legal Requirements:
CDs In S2 or S3 can only be supplied in accordance with prescription
- Must be in ink (black or blue) or otherwise indelible (that cannot be removed)
- 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 patient
- Must specify dose to be taken e.g. 2 tablets
- If CD is a preparation, must specify form (and strength) of preparation to be supplied
- If CD is a preparation, specify quantity (words and figures) of preparation or number (words and figures) of dosage units to be supplied)
- 14 (fourteen) - If CD is not a preparation, specify quantity (word and figures) of CD to be supplied
- For prescription to be dispensed in instalments, must specify amount of instalments of total amount which may be dispensed, and intervals to be observed when dispensing
- No repeats for CD prescriptions
- CD prescriptions cannot be dispensed
o Unless prescriber’s address is in Singapore
o Before date stated on prescription or later than 30 days after date stated on prescription - Partial supply of CDs – not much practiced in Singapore
- Instead, multiple prescriptions issued with appropriate dates
E.g.
Apple 5 mg tablet, ii OM x 1/52
Total quantity to supply: 14 (fourteen) of Apply 5 mg tablets
Which schedule of CDs can only be supplied in accordance to prescription?
S2 and S3
What are the requirements for documentation of CDs? (10+ rules)
Documentation of CDs:
CD register must be kept to record all movements of stocks of CDs in S2 and S4 (but rarely S4)
- Must be in the form of a “bound book” and not a “loose leaf” compilation
- Entries in register must be made in chronological order
- Format of register – follow fifth schedule
- Entries for each different strength or preparation of each CD to be recorded together as one set, separately from entries for other CDs of different strengths or preparations
- Class of CD to which entries on a page relates must be stated at the head of that page
- Entries must be made on the day of transaction (or latest the next day)
- Not allowed to cancel, obliterate or alter entries and only make correction by way of dated marginal note or footnote
- Entries must be made in ink (black or blue) or otherwise indelible
- Register must not be used for any other purpose other than recording CDs
- To keep separate registers for each separate premises, and each register to be kept at the premises to which it relates
*All documents and records relating to receipt or supply of CDs must be retained for at least 3 years after date of transaction
Part I: Only receiving (from supplier)
Part II: Focus on supplying (to patients), but minimal details on receiving
* Received write in red
For wrong entry:
* Add * beside the wrong line
* Sign
* Rewrite the whole line again
What are the part I and II of the CD register?
Part I: Only receiving (from supplier)
Part II: Focus on supplying (to patients), but minimal details on receiving
* Received write in red
How to write for wrong entry in the CD register?
For wrong entry:
* Add * beside the wrong line
* Sign
* Rewrite the whole line again
What are the labelling requirements for CDs?
Labelling Requirements for CD:
* Have to show total amount of CD in the container
* In practice, this is already done as good practice for all drugs, regardless if CD or not
What are the storage and safekeeping requirements of CDs?
Storage and Safekeeping of CDs:
- All stocks of CDs (S2,3,4) (Other than those in S1) must be kept under “lock and key” in premises under control of person who is authorised to supply those CDs
- The key must be in personal possession of authorised person at all times (usually hang around the neck)
