Published: 7 March 2019
Publications
The Medsafe Files – Episode nine: Patients importing medicines for personal use
Prescriber Update 40(1): 12–13
March 2019
Medsafe frequently receives queries from patients who want to import medicines
for personal use. This article is a reminder about the requirements for
authorised prescribers when patients request assistance in releasing medicines
held at the border.
Background
Medsafe, in conjunction with the New Zealand Customs Service, operates a border programme for imported medicines.
When a prescription medicine is imported for personal use, Medsafe writes to the importer (eg, the consumer) to inform them that authorisation must be obtained from an authorised prescriber before the imported medicine can be released. The letter includes an authorisation form with the details of the imported medicine for the prescriber to sign.
Personal importation
There are two main categories of imported medicines for personal use: those that are purchased over the internet from an overseas website and those that are sent from an overseas family member or medical clinic.
Medicines purchased over the internet
Medicines are frequently purchased over the internet for reasons of cost or confidentiality. Medsafe strongly discourages this practice because the quality of the medicine cannot be assured. These medicines may be of poor quality, sub or super potent, contaminated, adulterated or counterfeit. Even though the medicine may appear to come from a pharmacy in a well-regulated country, this is frequently not the case. The medicine may in fact come from a sophisticated rogue website engaged in fraudulent activity.
Authorisation is required for any imported medicine that contains an ingredient classified as a prescription medicine in New Zealand. Medicine classifications are listed in the Classification Database, available at https://medsafe.govt.nz/profs/class/classintro.asp. A medicine may be available in New Zealand in certain strengths without a prescription, but requires a prescription if the strength, recommended daily dose stated on the label, or pack size exceeds a limit specified in the Classification Database. Common examples where this may occur are vitamin D, zinc, and vitamin A. Authorisation is required before these medicines can be released to the importer.
Medicines sent from an overseas family member or medical clinic
People who have moved to New Zealand or are visiting may prefer to source their medicines from their home country. Although these medicines may have been lawfully prescribed and dispensed in their originating country, authorisation from a New Zealand authorised prescriber is required before the medicine can be released.
Authorisation requests
The border pharmacist provides the details of the imported medicine(s) on the authorisation form. To authorise release of an unapproved imported medicine to the patient, the prescriber must be satisfied that it is clinically appropriate to do so. The prescriber must carefully weigh up the benefits and risks of using the unapproved medicine, and discuss this with the patient. The prescriber must comply with all relevant health codes and professional standards, and should also obtain informed consent1,2.
Further information about unapproved medicines is available on the Medsafe website (www.medsafe.govt.nz/profs/RIss/unapp.asp). See also ‘The Medsafe Files – Episode Eight: Section 29 Medicines’ in the December 2018 issue of Prescriber Update (www.medsafe.govt.nz/profs/PUArticles/December%202018/MedsafeFiles8Section29.htm).
Medsafe recommends that if the medicine, or a clinically acceptable alternative, is available in New Zealand then it should be used in preference to an unapproved imported medicine.
Providing authorisation
Prescribers choosing to authorise the imported medicine should complete and sign the authorisation form and return it directly to Medsafe. Use of a practitioner’s ID stamp will expedite the process. By signing the form the prescriber indicates that they have considered the risks and benefits of the unapproved medicine, and decided that it is appropriate for the medicine to be released to the patient.
Medsafe is not a pharmacy and does not dispense medicines or apply pharmacy labels with dosage instructions. Medsafe cannot divide a pack. If the amount imported exceeds 3 months’ supply (or 6 months’ supply of oral contraceptives), or the pack size makes the product a prescription medicine, it cannot be supplied directly to the patient. However, with the prescriber’s agreement, the medicine can be released to the prescriber to be dispensed in compliance with medicines legislation.
For further information, contact: medclearance@health.govt.nz
References
- Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights) Regulations 1996. URL: www.hdc.org.nz/your-rights/about-the-code/code-of-health-and-disability-services-consumers-rights/ (accessed 11 January 2019).
- Medical Council of New Zealand Statement: Good Prescribing Practice. November 2016. URL: www.mcnz.org.nz/assets/News-and-Publications/Statement-on-good-prescribing-practice.pdf (accessed 11 January 2019).
