Published: 7 September 2023
Publications
Restrictions on the supply, prescribing and administration of controlled drugs
Published: 7 September 2023
Prescriber Update 44(3): 64–66
September 2023
Note that this article describes restrictions on the supply, prescribing
and administration of controlled drugs, but is not about prescribing
periods.
The legislation
Controlled drugs are classified under the Misuse of Drugs Act 1975. The supply, prescribing and administration of controlled drugs are more restricted than for other medicines, reflecting the need to restrict access to, and minimise the misuse of, controlled drugs.1 Controlled drugs are classified into three schedules based on the risk of harm the medicine poses to individuals or to society by their misuse.2
Ministerial approvals and exemptions
Regulation 22(1) of the Misuse of Drugs Regulations 1977 (the Regulations) sets out further controls around the supply, prescribing and administration of certain controlled drugs. For these controlled drugs, anyone wishing to undertake these activities requires approval from the Minister of Health (see Table 1). There are some exemptions to this requirement, as defined in Regulation 22(2) (Table 2).
To confirm the classification of a medicine, refer to the Medsafe Classification Database.
Table 1. Classes of controlled drugs, with examples, that require ministerial approvala to supply, prescribe and administer
| Controlled drug classesb that require ministerial approval | Examples |
|---|---|
| Class A | Carfentanil Lysergic acid (essential precursor for manufacture of LSD) Lysergide (N,N-diethyllysergamide or lysergic acid diethylamide) Psilocybine |
| Class B1 or Class B2 | GGHB (gamma-hydroxybutyrate) MDMA (2-methylamino-1-(3,4-methylenedioxyphenyl) propane) |
| Class C1 | Cannabis plant |
- Some exemptions apply. See Table 2.
- Controlled drug classes are described in Schedules 1 to 3 of the Misuse of Drugs Act 1975.
Source: Misuse of Drugs Regulations 1977. URL:
www.legislation.govt.nz/regulation/public/1977/0037/latest/DLM54840.html
(accessed 21 July 2023).
Table 2. Controlled drugs that are exempt from requiring ministerial approval to supply, prescribe and administer
| Controlled drug (Class) | Description and conditions |
|---|---|
| Cocaine (A) | Cocaine, or anything to which any of clauses 2 to 5 of Schedule 1 of the Misuse of Drugs Act 1975 for the time being applies in relation to cocaine |
| Morphine or opium (B1) | Morphine or opium, or anything to which any of clauses 2 to 5 of Schedule 2 of the Misuse of Drugs Act 1975 for the time being applies in relation to morphine or opium |
| Medicinal cannabis |
Any of the following that have been assessed as complying with the minimum quality standard, and specified in a medicinal cannabis licence accordingly, under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019:
|
| Fentanyl (B1) |
Blanket approvals
Ministerial approvals (often referred to as ‘blanket’ approvals) have been granted for the supply, prescribing and administration of certain controlled drugs in defined circumstances (see Table 3).3 These blanket approvals are published in the New Zealand Gazette and define circumstances under which the blanket approvals apply.
Table 3. Blanket approvals granted for certain controlled drugs in defined circumstances
Click on the controlled drug to view the Gazette notice and the approved defined circumstances for prescribing, supplying and administering
| Controlled drug with blanket approval (Class) |
|---|
| Dexamfetamine (B1) |
| Ephedrine (B2) |
| Lisdexamfetamine (B2) |
| Methylphenidate (B2) |
| Pseudoephedrine (B2) |
| Sativex (B1) |
Source: Medsafe. 2023. Restrictions on the Supply, Prescribing or
Administration of Medicines under the Medicines Act 1981 and Misuse
of Drugs Regulations 1977. URL:
www.medsafe.govt.nz/profs/riss/restrict.asp
(accessed 21 July 2023).
Applying for ministerial approval
For all circumstances that are not covered by the exemptions or ‘blanket’ approvals, individual ministerial approval is required to supply, prescribe and administer controlled drugs listed in Table 1.
To prescribe a controlled drug listed in Table 1, a prescriber is required to provide evidence to support their decision to prescribe a particular controlled drug requiring ministerial approval. This evidence must be included as part of the application and should demonstrate the clinical reasoning for prescribing. Ministerial approvals are granted for a specific application and to a defined patient, or patient group.
Examples where individual ministerial approval is required:
- to investigate the efficacy of MDMA as part of a clinical trial
- to prescribe methylphenidate for an indication not specified in the ‘blanket’ approval for methylphenidate.
The Medicines Control branch of Medsafe administers the ministerial approval process. For information about the process for seeking approval, email: medicinescontrol@health.govt.nz
Guidance for supply chain licence holders
Controlled drugs that require ministerial approval must be authorised on a licence before the licence holder can undertake any activities.
Guidance for pharmacies
A pharmacy can only supply a controlled drug that requires ministerial approval in accordance with a valid ministerial approval (either a ‘blanket’ approval or an individual approval). It is the responsibility of the prescriber to specify the approval number and expiry date on prescriptions for individual approvals.
Importation of controlled drugs
If a particular controlled drug substance or dosage form is not available from the local supply chain, the controlled drug may need to be imported from overseas. Each consignment of controlled drug(s) imported into New Zealand requires a new ‘Licence to Import Controlled Drugs’. Importation also needs to comply with international obligations (eg, The International Narcotics Control Board requirements). For controlled drugs which require ministerial approval, ministerial approval must be granted before a Licence to Import Controlled Drugs can be issued. Refer to Table 4 for a list of entities and individuals who may import controlled drugs.
Table 4. Entities and individuals who may import controlled drugs
| Prescribers to whom ministerial approval was granted |
| Pharmacies in response to a valid prescription |
| A holder of a Licence to Deal in Controlled Drugs |
Sources:
Misuse of Drugs Act 1975. URL:
www.legislation.govt.nz/act/public/1975/0116/latest/DLM436101.html
(accessed 21 July 2023).
Misuse of Drugs Regulations 1977. URL:
www.legislation.govt.nz/regulation/public/1977/0037/latest/DLM54840.html
(accessed 21 July 2023).
To apply for a Licence to Import Controlled Drugs, an application form needs to be completed and submitted to the Medicines Control branch of Medsafe. Please email Medicines Control for the application form, and for any queries relating to importation of controlled drugs or ministerial approvals: medicinescontrol@health.govt.nz
References
- Ministry of Health. 2023. Controlled Drugs. URL: www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/controlled-drugs (accessed 14 August 2023).
- Misuse of Drugs Act 1975. URL: www.legislation.govt.nz/act/public/1975/0116/latest/DLM436101.html (accessed 15 August 2023).
- Medsafe. 2023. Restrictions on the Supply, Prescribing or Administration of Medicines under the Medicines Act 1981 and Misuse of Drugs Regulations 1977. URL: www.medsafe.govt.nz/profs/riss/restrict.asp (accessed 21 July 2023).
