Pharmacy Law - Controlled Drugs Flashcards
Preparation for Y3S2 PR3150 Assessment
State the general rationale for the Misuse of Drugs Act and Misuse of Drugs Regulations.
Health products containing substances considered ‘high risk’ are likely to be misused and addictive
Additional controls are therefore needed - Controlled Drugs
What is the Misuse of Drugs Act
Narcotics Control Law - MHA and CNB
What is a controlled drug?
Any drug under the FIRST SCHEDULE Part 1, 2, 3
Difference between Misuse of Drug ACT and REGULATIONS
- Act - Prohibitions against handling
- Regulations - Provides some exemptions to general prohibitions in the Act to allow lawful dealings in legitimate medical use
The Four Schedules of Misuse of Drugs Regulations
First Schedule (S1) -> preparations containing CDs in small quantities or formulated in such manner as to have relatively low risk of being abused
Second Schedule (S2) -> mostly CDs that have high risk of abuse but also have uses as medicines
Third Schedule (S3) -> includes some CDs that have uses as medicines but relatively less risk of abuse compared to CDs in S2
Fourth Schedule (S4) -> mainly CDs that have high potential for abuse and also of little therapeutic value
Who can lawfully supply controlled drugs in S1, S2, S3?
- Practitioner
- Pharmacist
- “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 administer controlled drugs?
- 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 4 main legal requirements for prescription of controlled drugs to allow for supply?
- CDs in S2 or S3 can only be supplied in accordance with prescription - r11
a) must be in ink or otherwise indelible
b) must specify prescriber’s name and address
c) must be dated and signed by prescriber with his usual signature
d) must carry declaration, if for dental or veterinary use
What are additional requirements for prescriptions of controlled drugs that is based on person’s own handwriting?
e) must specify name and address of patient
f) must specify dose to be taken
g) if CD is a preparation, must specify form (and strength) of preparation to be supplied
h) if CD is a preparation, specify quantity (words and figures) of preparation or number (words and figures) of dosage units to be supplied
i) If CD is not a preparation, specify quantity (words and figures) of CD to be supplied
j) 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
Controlled drug documentation must be…
a) must be in the form of a “bound book” and not a “loose leaf” compilation – r2
b) entries in register must be made in chronological order - r14
c) format of register – follow fifth schedule – r14(1)(a)
d) 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 - r14(1)(b)
e) class of CD to which entries on a page relates must be stated at the head of that page – r15(a)
f) entries must be made on the day of transaction (or latest the next day) – r15(b)
g) not allowed to cancel, obliterate or alter entries, and only make correction by way of dated marginal note or footnote – r15(c)
h) entries must be made in ink or otherwise indelible – r15(d)
i) register must not be used for any other purpose other than recording CDs – r15(e)
j) to keep separate registers for each separate premises, and each register to be kept at the premises to which it relates - r15(g) & (h)
What are the labeling requirements for controlled drugs?
- 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.
How should controlled drugs be stored?
- All stocks of CDs (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 – r20
- The key must be in personal possession of authorised person at all times
How should Controlled Drugs be disposed?
CDs in S2 and S4 must only be destroyed in the presence of, and in accordance with directions given by, a CD inspector – r28
* Returned by patient
* Expired
* Shelf-life reduced, e.g. due to improper storage conditions
* Signs of deterioration, e.g. change in colour
CD inspector will endorse entry in CD register documenting date of destruction and quantity of CDs destroyed
