New Zealand first to have OTC topical adapalene available in pharmacies

In August 2016, pharmacists in New Zealeand were given permission to supply adapalene without a prescription through reclassification. This is in line with both Singapore (approval March 2016) and the United States (approval July 2016).

For New Zealand and the United States, a major consideration was potential teratogenicity, with both countries considering non-prescription status was appropriate based on the evidence. Interestingly, Germany took a different approach, rejecting the adapalene reclassification earlier this year, despite having a pharmacy-only category that would have meant consumers had more opportunity for advice and health professional intervention than in the United States, which has no pharmacy-only or pharmacist-only category.

Unlike the United States and Germany, the New Zealand reclassification was driven by pharmacy rather than the manufacturer or distributor, with an application from Green Cross Health Ltd (who provide primary care services, including community pharmacy) and Natalie Gauld Ltd. The reclassification process in New Zealand is often fairly quick. Following submission of the application in January 2016 and consideration by the Medicines Classification Committee, approval for this reclassification was published in late June 2016, and pharmacists could supply from August 2016. This is because New Zealand does not have a special over-the-counter pack, which is common with new reclassifications. New Zealand’s ability to limit some medicines to supply only through the pharmacist provides an advantage of ensuring health professional contact for all supplies.

Logically, increasing access to adapalene is sensible. Guidelines recommend adapalene first-line in the forms of acne commonly presenting to pharmacy, and pharmacists are well informed on the topic. The reclassification will allow supply of both the adapalene cream (Differin) and the adapalene-benzoyl peroxide preparation (Epiduo). Pharmacist-only availability also provides a good opportunity for pharmacists to refer people with severe acne, scarring, or possible underlying causes, such as drug treatment or suspected polycystic ovarian syndrome, and discuss non-drug measures, e.g. washing and moisturising. Reclassifying adapalene might help reduce antibiotic use in acne. Early well managed use of adapalene may help control the acne, avoiding a need for a medical consultation and possibly prescribed topical or oral antibiotics. Surprisingly, Singapore chose to reclassify topical clindamycin and erythromycin for acne at the same time as their adapalene decision. In New Zealand, topical clindamycin reverted to prescription medicine over a decade ago after concerns about bacterial resistance.

Pharmacists will be able to provide advice to maximise benefit and minimise risk. For example, advice about using for short periods initially before building up to overnight use, and how to manage side effects if they occur. It would be interesting to compare the outcomes for patients with adapalene purchased without a prescription in New Zealand and the United States. I anticipate that pharmacist involvement will lead to better outcomes, such as patients remaining on treatment, since advice is particularly useful with this product. Comparing pharmacist management with medical management might be even more interesting.

This prescription to non-prescription reclassification highlights the continued progress in New Zealand with reclassification. Recent reclassifications include trimethoprim for uncomplicated cystitis, influenza vaccine, meningococcal vaccine, pertussis vaccine, shingles vaccine, naloxone and sildenafil. Some of these reclassified medicines can only be supplied by pharmacists who have successfully completed additional specified training.

Natalie Gauld

Auckland, New Zealand

Declarations of interest: Natalie Gauld receives consultancy fees for reclassification in New Zealand and internationally, including for most of the medicines listed in this letter.