10.1 Controlled drugs

Controlled drugs (CDs) include prescribed medicines which are classified as either A, B or C. The handling and prescribing of controlled drugs is more tightly controlled than prescribing of other medicines, reflecting the need to restrict access to, and minimise the misuse of, controlled drugs.

More information on the classes of controlled drugs, their restrictions and other requirements are available on the Ministry of Health website and in full in the schedules of the Misuse of Drugs Act 1975.

Standard - what we'll be assessing on Evidence to provide for assessment

10.1 The practice provides safe systems for prescribing, storage, handling, administration and documentation of controlled drugs in accordance with the:

  • Misuse of Drugs Act 1975
  • Misuse of Drugs Regulations 1977.
  • Policy and procedure for the storage and management of controlled drugs, including controlled drugs in an emergency/clinic/doctor’s bag, if applicable.
  • Evidence of the use of an approved controlled drugs register, if applicable.
  • Describe storage and documented recording of controlled drug prescription pads, if applicable.

Storage and custody (safekeeping) of controlled drugs

The Misuse of Drugs Regulations 1977, clause 28, specifies how to store and safely manage controlled drugs:

  • CDs are to be kept in a locked cupboard, or a locked compartment, that is constructed of metal or concrete or both, and that, in the case of a cupboard or compartment installed in a building after the commencement of these regulations, is of an approved type (cabinets/safes constructed with 10mm steel and bolt down holes for fixing).
  • Ensure that the cupboard or compartment is securely fixed to, or is part of, the building.
  • Ensure that the key of the cupboard or compartment is kept in a safe place when not in use.

Monitoring controlled drugs in an emergency/clinical and/or doctor’s bag
A small amount of controlled oral or injectable stock drugs, for example, morphine, may be kept on hand in the clinical and/or emergency bag for ‘as required’ use.

Any medication stock of this nature needs to be recorded accurately and managed as usual for safety, transparency and auditing purposes. There must be a system for checking the expiry dates of all drugs in clinical/doctors’ bags and/or emergency bags.

A clinical/emergency/doctor’s bag containing controlled drugs is acceptable provided it is in the personal possession of the clinician concerned.

All health care professionals in legal possession of controlled drugs have a professional duty of care to take all reasonable steps in maintaining safe custody of controlled drugs. When not in use, the bag must be kept out of sight from the public in a locked cupboard or vehicle.

If clinicians wish to carry controlled drugs in their bag, the following points must be complied with:

  • Another team member needs to witness the stocking of the bag from the controlled drug stock and record an entry in the controlled drug register.
  • The controlled drugs must be stored in a lockable receptacle, which can only be opened by the person to whom the regulation applies. A digital combination lock is a convenient solution.
  • Each clinician must keep a record in the register for the controlled drugs carried in their bags. The clinician is responsible for those drugs.
  • Administration of a controlled drug to a patient must be recorded in the controlled drug register and in the PMS.
  • If a controlled drug has expired, the clinician must return it to the practice stock awaiting destruction. If there is no practice stock, then the expired controlled drug needs to be destroyed directly from the bag and witnessed by an authorised person. Both scenarios must be recorded in the register.

Balances shall be undertaken six monthly and at the time of obtaining new stock. The stock record, quantity stock account, and explanation of variations shall be entered on the page of the controlled drug register relating to the controlled drug or form of controlled drug to which the information refers.

Pasifika child gets a vaccination
GP gives a Pasifika child an injection

Policy and procedure for the storage of controlled drugs

The policy and procedure for the storage of controlled drugs must include:

  • Storage and custody
  • Controlled drug register management (including transactions of all required details)
  • Stocktaking process and frequency
  • Process for monitoring emergency/clinic/doctor’s bags
  • An e-prescribing process (if applicable)

NB: Your practice policies/procedures, need to adhere to the general structure suggested here.

Approved controlled drugs register

If the practice holds or administers controlled drugs then team members are required to keep a controlled drug register that documents the details of all transactions and includes a running balance of stock.

Accurate documentation enables the practice to track who receives controlled drugs and to prevent the theft or misappropriation of controlled drugs. Practices are encouraged to have a process for receiving, storing and disposal of controlled drugs returned by patients.

If the practice maintains a controlled drug register, the team must:

  • Keep the register in a neat and orderly manner in a secure place
  • Keep the register for a period of four years following the date of the last entry made in it.

All movements of a controlled drug, including those in the doctor’s /clinical/emergency bag, must be recorded in the controlled drug register, legibly and indelibly.

The appropriate entries relating to any transaction regarding controlled drugs must be made in the register no later than the next business day following the day on which that transaction took place.

Any mistake in any entry may be corrected by a marginal note or footnote giving the correct particulars and containing, as part of the note, the date on which the note is written (and initials of the person making the entry).

The practice must have a process for the identification and destruction/disposal of expired controlled drugs and the relevant actions must be documented in the controlled drug register.

The following details are required for each transaction in a controlled drug register:

  • Date of transaction, for example, receipt, administration, stock take or destruction of the medicine
  • Name and address of person from whom received; or name of patient; or name and address of person supplied; or form from which or into which the CD was made; or declaration ‘physical stocktaking’
  • Prescription number; or order number; or time of administration or destruction of medicine
  • Number in
  • Number out
  • Balance
  • Name of authority/prescriber
  • Received, issued, dispensed, or administered by
  • Initials/signature of person making entry or checking balance (preferably two signatures). It is recommended that controlled drug administration be witnessed wherever possible – this means seeing the drugs being received, issued, dispensed, administered or destroyed and signing as a witness. y

Controlled drug prescription pads

Controlled drug prescription pads and forms must also be kept secure (usually in the controlled drugs cabinet or a locked cupboard) and recorded for monitoring. The practice will need to be able to describe how the team members store and monitor the use of controlled drugs prescription pads. There must be a process for notifying relevant authorities if controlled drug prescriptions are found to be missing.

Legislative history
The Misuse of Drugs Act was passed by the New Zealand Parliament into law in 1975. On 11 December 2018, the  Government passed the Misuse of Drugs (Medicinal Cannabis) Amendment Act, which amended the existing law to permit terminally ill patients to use marijuana without risk of prosecution.

In March 2019, Misuse of Drugs Amendment Act 2019 added the synthetic cannabinoids as Class A drugs. It was passed and came into force in August 2019. The Act is a key step in addressing synthetic drug harm and implementing a health-based approach to drug possession and use.

The Act made three key changes:

  • classified the synthetic cannabinoids AMB-FUBINACA and 5F-ADB as Class A drugs
  • affirmed the Police discretion to prosecute for possession and use of controlled drugs
  • enabled temporary class drug orders to be issued

Prescribing controlled drugs with NZePS means GPs are no longer required to handwrite prescriptions for controlled drugs on the triplicate form. A prescription for the supply of a controlled drug “on a paper form that is electronically generated by the controlled drug prescriber from [NZePS]” may be accepted if it is printed with a barcode on a separate prescription form to that of noncontrolled drugs and signed by the prescriber. The Ministry of Health will give practices the ability to use NZePS for controlled drugs on a practice-by-practice basis.

The Ministry of Health has introduced new rules to make it easier to provide electronic prescriptions to support virtual care. This is especially important during the Covid-19 pandemic when exchanging paper prescriptions between prescriber, patient and pharmacy is burdensome, challenging and unsafe. Please see the resources below or visit the Ministry of Health website for more information.