They are classified into four distinct categories based on their safety, potential for misuse, and the level of professional advice required for their purchase:
Prescription medicines: Generally require a valid prescription from an authorised prescriber before they can be dispensed, unless a specific ‘except when’ provision permits pharmacist supply without a prescription.
Restricted medicines (pharmacist-only): Available over the counter without a prescription. Must be sold following a consultation with a registered pharmacist, who determines that the medicine is appropriate for the patient.
Pharmacy-only medicines: Can be sold over the counter from a licensed pharmacy. The pharmacist does not have to be directly involved in the sale but must maintain professional oversight.
General sale medicines: Can be sold from a wide range of retail outlets, including supermarkets and service stations.
New Zealand has reclassified a number of medicines with the aim of improving timely access to treatment while maintaining patient safety, enabling appropriately trained pharmacists to supply certain prescription medicines directly to eligible patients without the need for a prescription, provided the conditions specified in the medicine’s classification are met.
The ‘except when’ provision
Some medicines in New Zealand are classified as prescription medicines, with an ‘except when’ provision included in their classification.
This means the medicine ordinarily requires a prescription, except when all specified conditions are met.
Importantly, the medicine itself remains classified as a prescription medicine, with the ‘except when’ provision creating a limited exception to the usual prescription requirement.
If any condition is not met, the medicine can only be supplied on a valid prescription.
The conditions are specific to each medicine and may include requirements such as pharmacist training or accreditation, patient eligibility criteria, pack size restrictions, age limits, and documentation requirements.
Examples of prescription medicine classifications with an ‘except when’ provision are shown below.
| Ingredient | Conditions (if any) | Classification |
|---|---|---|
| Nitrofurantoin | except when supplied for oral use containing 100 mg per dose unit when sold in a pack of 10 solid dosage units to a woman aged 16-65 years for the first-line empiric treatment of an uncomplicated urinary tract infection by a registered pharmacist who has successfully completed the Pharmaceutical Society of New Zealand training in the treatment of urinary tract infections. | Prescription |
| Allopurinol | except when provided for the prophylaxis of gout to people who meet the clinical and eligibility criteria of an approved training program, when provided by pharmacists who meet the requirements of the Pharmacy Council and the Pharmaceutical Society of New Zealand Incorporated training programme, for a maximum of 3 months’ supply | Prescription |
Other medicines with an ‘except when’ provision include the emergency contraceptive (levonorgestrel), sildenafil, trimethoprim, certain oral contraceptives, and melatonin.
The Medicines Classification Committee may recommend that additional training or accreditation be required as a condition of a medicine’s classification, together with any other conditions, including limiting the amount (pack size) a pharmacist can supply without a prescription, or the age of a patient a pharmacist can supply to.
When prescription medicines are supplied under the ‘except when’ provision, the pharmacist who completed the consultation is recorded as the prescriber in pharmacy management software.
The relevant training programmes specify the consultation, documentation, recording and consent requirements that pharmacists must meet.
The ‘except when’ provision improves timely access to treatment by allowing appropriately trained pharmacists to manage selected common conditions and supply certain prescription medicines without a prescription, while maintaining appropriate safeguards for patient safety.
What is the MCC?
The Medicines Classification Committee (MCC) is an advisory committee established under the Medicines Act 1981 to provide recommendations to the Minister of Health (or their delegate) on medicines classifications.
The MCC meets twice a year to consider any new medicines for classification along with any submissions to reclassify current medicines
Did you know?
The ‘except when’ provision improves timely access to treatment by allowing appropriately trained pharmacists to manage selected common conditions and supply certain prescription medicines without a prescription, while maintaining appropriate safeguards for patient safety.
Anyone can make a submission to reclassify a medicine, and anyone can provide feedback on proposed reclassifications.
This ensures the MCC considers the wide-ranging, and sometimes varied, views of the healthcare sector and public.
The MCC also considers medicine classifications adopted internationally, particularly in Australia, when assessing potential reclassifications.
This ensures we are constantly considering global trends for medicine classifications, while keeping in mind what would be best for New Zealand.
Consultation is an important part of any classification recommendation made by the MCC, with six weeks usually allowed after the publication of committee meeting agendas to receive comments from the public, health professionals, professional groups and pharmaceutical companies about the proposed submissions to reclassify current medicines. classification. PGNZ regularly participates in this process.
