Revised: 4 December 2020
Compliance
Use of Unapproved Medicines and Unapproved Use of Medicines
- Overview
- Summary for prescribers
- Summary for consumers
- Summary for pharmacists
- Summary for suppliers of unapproved medicines
- The need for unapproved medicines in New Zealand
- Section 25 of the Medicines Act 1981
- Section 29 of the Medicines Act 1981
- Further information on supply
Overview
The Medicines Act 1981 (the Act) requires that Ministerial consent (delegated to Medsafe) is given before any medicine can be sold, supplied, distributed or advertised in New Zealand. These medicines are often referred to as ‘approved medicines’.
However, some patients may require treatment with medicines for which consent has not been granted (better known as, and referred to on this page as, ‘unapproved medicines’). Also, medicines may need to be used for different indications or in different ways to the approved use (as described in the medicine’s data sheet). The Act includes provisions that allow unapproved medicines to be obtained or administered, and for approved medicines to be used outside their approved use.
The provision in the Act (section 29) that allows the sale or supply of unapproved medicines to registered medical practitioners only (not all authorised prescribers), requires that the supplier notify information about the supply to the Director-General of Health (delegated to Medsafe).
The Code of Health and Disability Services Consumers' Rights (Code of Rights) places obligations on the provider of services (the authorised prescriber in this case). The provider has the responsibility to ensure all treatment meets ethical and professional standards. The consumer also has the right to be fully informed. If the use of a medicine is unapproved, the consumer should be advised, and the provider should discuss the evidence to support the use and any potential associated safety concerns. The consumer should also be made aware when an unapproved medicine is used that information will be held and sent to the Director-General of Health (delegated to Medsafe).
More information on the approval of medicines
Summary for prescribers
An authorised prescriber is anyone with prescribing rights as authorised by the Health Practitioners Competence Assurance Act 2003 and includes nurse practitioners, optometrists, dentists, registered midwives, and designated prescribers.
A medical practitioner is a health practitioner registered with the Medical Council of New Zealand as a practitioner of the profession of medicine.
To prescribe is the process of advising and authorising the use of a medicine for someone, usually in writing.
Authorised prescribers can:
- prescribe an approved medicine for an unapproved use
- obtain an unapproved medicine for a known patient under their care (eg, direct importation or by requesting a pharmacy compound a medicine) but cannot prescribe unapproved medicines supplied from within New Zealand under section 29 of the Medicines Act 1981.
Medical practitioners can:
- prescribe an approved medicine for an unapproved use
- obtain an unapproved medicine for a known patient under their care (eg, direct importation, by requesting pharmacy compound a medicine)
- prescribe unapproved medicines that have been manufactured in New Zealand or imported into New Zealand under section 29 of the Medicines Act 1981.
All prescribers need to be aware that:
- supply of an unapproved medicine or an approved medicine for an unapproved use requires patient consent and must comply with the Code of Health and Disability Services Consumers' Rights.
- patients supplied with an unapproved medicine under section 29 must be advised that information about the prescribing will be kept by the importer and supplied to the Ministry of Health.
- some medicines that are controlled drugs cannot be used for an unapproved use without Ministerial approval. Contact Medicines Control.
Code of Health and Disability Services Consumers' Rights
Medical Council of New Zealand statement on informed consent
Summary for consumers
- Medicines go through an assessment and approval process before they can be supplied in New Zealand. This is to ensure that the medicines supplied meet the required standards of quality and are safe and effective. These are known as approved medicines.
- Sometimes your healthcare professional (prescriber) may need to use an unapproved medicine or an approved medicine in a new way.
- If this is the case, the prescriber must explain to you what is being prescribed and why, and you must give your consent if you agree. This is required under the Code of Health and Disability Services Consumers' Rights.
- If you agree to be given an unapproved medicine (sometimes called a section 29 medicine), information about the supply must be held by the manufacturer or importer, and a subset of this sent to Medsafe, Ministry of Health. Your prescriber will tell you about this.
Code of Health and Disability Services Consumers' Rights
Health navigator information on unapproved medicines
Summary for pharmacists
- Prescriptions for medicines supplied under section 29 of the Act can only be written by medical practitioners.
- Section 29 of the Act requires the patient to be known at the time of supply. On this basis, supply on a Practitioner’s Supply Order is not possible. However, there may be some exceptional circumstances, eg, with snake anti-venom, when holding an emergency supply in stock may be essential for patient safety. In these circumstances, the pharmacist should ensure the medical practitioner agrees to supply the required details retrospectively.
- If the pharmacy is the importer of the medicine, then all information required to be held by the Act must be kept by the pharmacy and monthly notifications of supply made to Medsafe.
- If the section 29 medicine is obtained from a wholesaler, then the required information about the supply must be provided to the wholesaler for forwarding back to the importer.
- If the medicine has reached the end of its shelf life before use, information on its destruction should be sent back to the importer.
Summary for suppliers of unapproved medicines
- A Licence to sell medicines by wholesale is normally required.
- Section 42 of the Medicines Act 1981 requires that product specifications and certificates of analysis for every batch imported must be held.
- Information about the supply of every unit must be held.
- A subset of the information required to be held under the Act must be supplied to Medsafe each month.
- Pharmacists that import unapproved medicines for supply to their patients cannot supply other pharmacies with these medicines unless they have a wholesale licence.
The need for unapproved medicines in New Zealand
The need to provide access to unapproved medicines in New Zealand includes the following reasons.
- There will be medicines (both branded and generic) available overseas that may have acceptable quality, efficacy and safety, but approval to supply these medicines has not been sought in New Zealand.
- There will be approved medicines in New Zealand that have indications or doses approved elsewhere, which have not been applied for in New Zealand.
- There will also be medicines where use in adults has been approved, but not in children or some other specific patient population.
Section 25 of the Act permits authorised prescribers to procure, administer or arrange the administration of an unapproved medicine.
Section 29 permits the sale or supply of an unapproved medicine to a medical practitioner for the treatment of a patient under that medical practitioner’s care, provided the Director-General of Health (delegated to Medsafe) is notified of that supply.
Section 25 of the Medicines Act 1981
The exemption provisions in Section 25 allow all authorised prescribers to "procure the supply of any medicine" for a particular patient in their care. The term "any medicine" can include both approved and unapproved medicines. However, the authorised prescriber must always be working within their scope of practice.
"Procure the supply" permits the authorised prescriber to obtain a medicine by direct importation, or by requesting that a pharmacy compound a specific medicine for a known patient. An authorised prescriber may only procure the medicine after determining that a patient under their care requires that medicine (ie, the medicine cannot be obtained prospectively).
This exemption provision also allows an authorised prescriber to use an approved medicine for an unapproved use. For example, in an unapproved patient population, or with an unapproved dosage regimen, or for an unapproved indication or against a contraindication.
There is no requirement to provide any information to the Ministry of Health/Medsafe when an approved medicine is used for an unapproved use or if an authorised prescriber imports a medicine to treat his/her patient.
Regardless of whether the authorised prescriber uses approved or unapproved medicines, they must provide care of an adequate professional and ethical standard as described in the Code of Health and Disability Consumers' Rights.
Section 29 of the Medicines Act 1981
The provisions in section 29 of the Act only apply to medical practitioners. Section 29 provides access to unapproved medicines that have been imported into New Zealand by licensed wholesalers and pharmacies or that have been manufactured in New Zealand by a licensed medicines manufacturer.
The Act requires medical practitioners to send information back to the importer or manufacturer of the unapproved medicine. The importer/manufacturer must then hold (store) the information.
Information that must be sent back to, and held by, the importer or manufacturer is:
- the name of the medical practitioner
- the name of the patient
- information about the medicine supplied
- the date and place of supply.
Importers/manufacturers are required to send a subset of this information to the Director-General of Health (delegated to Medsafe) in the month following supply.
The subset of information that must be reported to Medsafe, via the Section 29 notification form, is:
- information about the medicine supplied: brand, active ingredient, strength, dose form, pack size
- the number of packs of each product supplied
- month and year of supply.
Section 29 Notification Form (Microsoft Word document, 26 KB, 1 page)
Under the Health Information Privacy Code, Rule 3, the medical practitioner must advise the patient that:
- information about supply of the patient’s medicine will be forwarded to the medicine manufacturer or importer in New Zealand
- the medicine manufacturer or importer will forward a subset of that information to Medsafe, and the information will be recorded on a database as a requirement of the Medicines Act.
When a medical practitioner uses unapproved medicines supplied under section 29, they must provide care of an adequate professional and ethical standard as described in the Code of Health and Disability Consumers' Rights.
Medical Council of New Zealand statement on informed consent
Additional information to support the quality, safety or efficacy of an unapproved medicine should be requested from the importer.
Further information on supply
Pharmacists
What are the responsibilities for pharmacy importers?
If a pharmacy is the importer of an unapproved medicine, it is the pharmacy’s responsibility to ensure that the information specified in section 29 of the Medicines Act is held by the pharmacy, and that a subset of this information is supplied monthly to Medsafe. The pharmacy should also hold a copy of the specifications for the medicine, and certificates of analysis for every batch imported, as required by section 42 of the Medicines Act.
Can pharmacists access unapproved medicines from wholesalers?
Medsafe has no objection to supply of unapproved medicines from the importer via a wholesaler through a legitimate, secure supply chain. This allows faster and more convenient access to the medicine for patients.
However, if a pharmacist obtains an unapproved medicine from a wholesaler then that wholesaler should be given all the information required, according to section 29, to allow the wholesaler to meet its obligations on reporting back to the manufacturer or importer.
What about medicines that need to be held for emergency-use?
It is recognised that emergency supplies of some rarely used medicines, such as, rabies vaccine, may need to be readily available in a clinical setting. Medsafe has no objection to this, but does expect pharmacies to ensure these medicines are appropriately handled and either the details of supply are reported back if the medicine is used, or information on destruction is reported back if the product reaches the end of shelf life before it is used.
Who can pharmacists supply unapproved medicines to?
Pharmacists can only supply unapproved medicines to patients under the provisions in section 29 of the Act on the authorisation of a medical practitioner. Regardless of the classification of the ingredients in an unapproved medicine, medical practitioner authorisation is required before that medicine can be supplied.
One of the conditions associated with supply of an unapproved medicine under the provisions in section 29 of the Act is that the patient is known at the time of supply. On this basis, supply on a Practitioner’s Supply Order is not possible. However, there may be some exceptional circumstances, eg, with snake anti-venom, when holding an emergency supply in stock may be essential for patient safety. In these circumstances, the pharmacist should ensure the medical practitioner agrees to supply the required details retrospectively. Pharmacists who import an unapproved medicine for a known patient cannot then supply any remaining stock to another pharmacy.
Other suppliers
Who can import an unapproved medicine for supply in New Zealand?
Usually only entities with a wholesale license to sell medicines that includes import and supply of unapproved medicines in the scope of the licence can import an unapproved medicine for supply to a medicinal practitioner under section 29 of the Act.
What are the requirements for importers of unapproved medicines?
Importers should ensure that they hold the product specifications and certificates of analysis for each batch imported, as required by section 42 of the Act.
Importers are also required to hold the information required by section 29 of the Act, and to submit the specified subset of this supply information to Medsafe as soon as possible in the month following supply. Section 29 Notification Form (Microsoft Word document, 26 KB, 1 page)
It is a breach of the Act for the importer of the medicine not to submit information on supply to Medsafe as soon as possible after the end of each month.
Importers must reconcile the number of units of an unapproved medicine supplied with the patient supply information, or destruction information, held.
Section 29 supply may be audited as part of the audit for a Wholesale licence.
Can an importer supply an unapproved medicine to a pharmacy via the wholesale supply chain?
Medsafe has no objection to supply of unapproved medicines from the importer via a wholesaler through a legitimate, secure supply chain. This allows faster and more convenient access to the medicine for patients. However, information about the supply must still be sent back through the supply chain to the importer. Importers must reconcile the number of units of an unapproved medicine supplied with the patient supply information, or destruction information, held.
How can overseas companies supply unapproved medicines to New Zealand?
Overseas suppliers must use New Zealand licensed wholesalers or pharmacies to import their unapproved medicines. The New Zealand importer must then hold the required information and supply the subset to Medsafe.
Other questions
Can I advertise an unapproved medicine?
No. Section 20 of the Medicines Act 1981 prohibits this.
Can I advertise an unapproved use for an approved medicine?
No. Section 20 of the Medicines Act 1981 prohibits this.
If I am a medical practitioner and I obtain an unapproved medicine from within NZ for a patient, do I need to submit a section 29 notice to Medsafe?
No. The New Zealand manufacturer or the importer is responsible for notifying Medsafe; however, they will require you to supply them with the information.
