This information is to provide clarity for New Zealand health practitioners about the difference between the legal requirements for prescribing and the subsidisation of pharmaceuticals, including prescription medicines.
The Medicines Act 1981 defines three classification categories for medicines.
- Prescription medicine
- Restricted medicine (also referred to as pharmacist-only medicine)
- Pharmacy-only medicine.
Medicines in each of these classification categories are listed in the First Schedule to the Medicines Regulations 1984 and amendments. Medicines not listed in the classification schedules are referred to as general sale medicines. These medicines may be sold from any outlet.
A prescription medicine may only be sold, supplied, or administered, in accordance with a prescription given by an authorised prescriber [an authorised prescriber is a nurse practitioner, an optometrist, a practitioner (dentist or medical practitioner), a registered midwife or a designated prescriber], veterinarian or delegated prescriber. Prescription medicines may also be supplied or administered under the (Medicines (Standing Order) Regulations 2002).
A restricted medicine may be sold by retail or supplied in circumstances corresponding to retail sale only by a pharmacist in a pharmacy or hospital. Restricted medicines may be supplied by an authorised prescriber, or under a standing order.
A pharmacy-only medicine may be sold by retail or supplied in circumstances corresponding to retail sale only in a pharmacy or hospital. Pharmacy-only medicines may also be supplied by an authorised prescriber, or under a standing order.
Under the Medicines Act, prescribing authority is only required for prescription medicines. There is no requirement under legislation for prescriptions to be given for other classes of medicines to enable them to be sold, supplied or administered. However, we recommend that the other classes of medicines, are supplied or administered by suitably qualified staff within organisational protocols.
However, a prescriber may issue a prescription for a non-prescription medicine in order for the patient to receive a subsidy. The next section provides a brief explanation of ‘prescriptions’ for subsidy.
PHARMAC decides which community pharmaceuticals are subsidised. ‘Pharmaceutical’ is an umbrella term – it includes medicines, therapeutic medical devices, or related products or related things. While some pharmaceuticals can legally be supplied without a prescription, PHARMAC uses ‘prescriptions’ as the main way for people to receive a subsidy. PHARMAC’s rules for subsidy apply on top of any legal requirements under the Medicines Act.
Through listing pharmaceuticals on the Pharmaceutical Schedule (the Schedule) in sections B to I, PHARMAC applies the subsidies for pharmaceuticals in community. The way patients receive a funded pharmaceutical is mainly through the dispensing of that product on a prescription, although there are some exceptions.
Not all pharmaceuticals on the Schedule are prescription medicines as defined by the Medicines Act 1981. Some pharmaceuticals on the Schedule are classed as restricted, pharmacy-only or general sale medicines for the purposes of sale, supply or administration. Some prescription and non-prescription medicines are not listed on the Pharmaceutical Schedule and there is no subsidy for these products, even if a prescriber has requested it on a prescription.
PHARMAC manages not only which medicines are subsidised, but when and how subsidies are provided. This can include placing funding restrictions on pharmaceuticals, called Special Authorities, which can only be applied for by certain prescriber groups, or on the recommendation of certain prescriber groups. PHARMAC does this so that it can target the funding for that pharmaceutical to the people most likely to benefit. This means that even if a prescriber can legally prescribe certain pharmaceuticals, they will also need to ensure that they have obtained a Special Authority approval for their patient to receive a subsidy. In some cases, this will mean they will have to consult with another prescriber who meets the prescriber restrictions in the Schedule.