Brand substitution proposed

Pharmacists may soon be allowed brand substitution as a routine, albeit with certain restrictions.

The Ministry of Health is seeking to amend regulation 42(4) of the medicines regulations to allow pharmacists to substitute an alternative brand of a prescribed medicine, provided there are no clinical reasons why substitution should not occur.

The proposal is part of planned wider amendments to medicines regulations under the Medicines Act 1981 to modernise the regulatory framework for therapeutic products and ensure adequate safeguards for consumers, while reducing barriers to innovation in the health sector. It addresses several long-pending issues.

The medicines regulation 42(4) currently requires a pharmacist to dispense the brand of medicine specified by the prescriber, unless the prescriber sanctions substitution of another brand. Prescribers are permitted to issue substitution authorities to allow pharmacists to substitute in specified circumstances.

While some prescribers choose to do this, many don’t, with the consequence the pharmacists must seek their authority to substitute a different brand.

Brand substitution is required in cases where a discontinued or temporarily unavailable brand has been prescribed, or where changes to subsidy rules mean a patient would otherwise have to pay the full cost of the prescribed brand where a fully subsidised equivalent is available.

The ministry says prescribing of non-subsidised brands, though not usually intentional, is common because practice management systems have not been updated to show changes in subsidy rules (See How to please your pharmacist, p8).

Seeking authority to substitute on a case-by-case basis is inefficient for both the pharmacist and the prescriber, and not substituting can be costly for the patient.

Consultation on the issue in 2002 indicated many supported substitution by pharmacists, along with suggestions it should be subject to certain conditions.

The ministry says, since 2002, the prescribing landscape has changed and Pharmac has instituted sole supply arrangements for a number of medicines. This has tended to increase the number of instances where the pharmacist is required to contact the prescriber to seek authority to substitute in order to supply a subsidised brand.

In certain circumstances a prescriber (or patient) may wish a particular brand to be supplied. The ministry says this could be catered for by allowing a prescriber to mark the prescription to indicate substitution is not authorised.

The Pharmaceutical Society strongly supports the proposal. In its submission to the consultation document, the society says the current legislation stems from the days when medicines in the Drug Tariff (now the Pharmaceutical Schedule) were listed by generic name. 

Pharmac’s Pharmaceutical Schedule only subsidises particular brands, and the brand that is subsidised changes frequently. Further, the sole supply contracts now almost completely dictate which brand a patient will receive.

“Unfortunately doctors and their prescribing [software] are often not up with the play and frequently prescribe discontinued or non-funded brands – at a cost and inconvenience to patients and to pharmacists having to get the prescription changed,” the society says.

Other proposed changes to medicines regulations and the pharmaceutical society’s view on them is available on www.pharmacytoday.co.nz  RK

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