Published: 19 October 2016

Committees

Comments on Agenda Items for the 57^th meeting of the Medicines Classification Committee to be held on 1 November 2016

A total of 19 submissions commenting on agenda items for the 57^th meeting were received. It has been decided that the comments for the 57^th meeting will not be published due to the complications of requests for confidentiality at a time when this mechanism is being reviewed. Instead, a brief summary of the comments is provided.

Eleven comments on the proposed update to the guidance document titled ‘How to change the legal classification of a medicine in New Zealand’ and other MCC processes, were received (agenda item 5.3). The comments were from six professional bodies, four industry organisations and one medicine reclassification consultant.

A number of comments supported the publication of reference lists, supporting documents and appendices to improve transparency. However, a similar number of comments opposed publication of these documents, stating concern that increased transparency could negatively impact on patient access to medicines, and submissions provided may be plagiarised due to publication of intellectual property.

Overall, the comments supported electronic submissions, publication of comments, the proposed criteria for objections, the determination of valid objections by the Group Manager of Medsafe via advice from the Secretariat, publication of supporting documents for objections, and the ten days allowed for lodging an objection.

The comments regarding observers supported either a completely open meeting to allow all interested parties to attend, or a completely closed meeting to allow for uninfluenced recommendations to be made. Some comments also supported the ability to supply new information at the meeting, as new information may arise in the time between submission and the meeting date, whereas others supported the opportunity to review and comment on any new information. A variety of comments received on the proposed decision parameters considered the proposals were too extensive or did not cover off everything that should be considered by the MCC.

Four comments were received regarding the proposed change to the medicine reclassification processes regarding prescription medicine to restricted medicine switches (agenda item 5.4). Two comments were from professional bodies, one comment was from an industry organisation and one comment was from a medicine reclassification consultant. All four comments supported the proposal.

One comment on the review of the classification of codeine was received (agenda item 5.5). This comment was from a professional body. The comment opposed the up scheduling of all codeine-containing products to prescription medicine status, however, it supported the reclassification of pharmacy only medicines to restricted medicine status.

Three comments on the reclassification of bifonazole were received (agenda item 6.1). All three comments were from professional bodies. Two comments supported the proposal. However, one comment opposed the proposal, stating that the submission lacked clinical information regarding bifonazole use in pregnant women and relevant drug interaction studies.

Six comments were received regarding the proposed reclassification of selected oral contraceptive pills (OCP) as a prescription medicine (agenda item 6.4). Five comments were from professional bodies and one comment was from a member of the public.

Four comments supported the proposal. Common themes of the supporters included: a comprehensive screening tool is essential as a mechanism should be in place to refer women who do not meet the criteria to their healthcare professional; a collaborative approach between pharmacists and medical practitioners is encouraged; the proposal would increase the access to oral contraception; and the risk:benefit profile of OCPs are similar to other restricted medicines.

One comment raised concerns regarding the proposal, including: the proposal will prevent opportunistic medical interactions; it is unconvincing that OCPs as prescription medicines is a barrier to access; and this proposal is primarily attractive to women who can afford the OCP supplied as a medicine without a prescription rather than addressing the priority groups (young girls and women, Maori and Pasifika groups). The comment noted that pharmacists would have an incentive not to decline OCPs to patients, as women would only be charged for the consultation and OCP upon supply of the medicine.

The comment that did not support the proposal as is, however, stated there were fewer safety concerns with a change to the proposal to 12 months between prescriptions from a medical practitioner.

Five comments were received regarding the classification of betaine (agenda item 7.1). Two comments were from professional bodies, two comments were from industry organisations and one comment was from a member of the public. All comments were opposed to the proposal, with some considering that the indications incorporated into the proposed classification statement would only be appropriate for a prescription medicine, and others noting that the current unscheduled status of betaine allows for its use in many dietary supplements and natural health products.

Two comments were received regarding the proposed reclassification of deoxycholic acid (agenda item 8.1.d). One comment was from an industry organisation and one comment was from a member of the public. All two comments were opposed to the proposal, however, they supported the classification proposal if it were to only apply to injections, which would have to be captured in the classification wording.

One comment supported the proposed classifications of the new chemical entities listed (agenda item 8.1) except for flubromazolam (agenda item 8.1.f). This comment was from a professional body, which suggested that as a benzodiazepine derivative, flubromazolam should be classified under the Misuse of Drugs Act 1975 as a class C5 controlled drug.

Three comments were received regarding the reclassification of paracetamol (agenda item 8.2.1.b). The comments were from a professional body, an industry organisation and a member of the public. Two comments were opposed to the proposal; one comment did not support the harmonisation of the Australian and New Zealand schedules, and one comment considered that the current classification already aligned with the Australian schedule, with the exception of combination products containing ibuprofen. One comment supported the proposal as is.

Comments relating to agenda items 6.2 and 6.3 regarding the reclassification of melatonin have not be included as these items have been withdrawn by the original submitters.