10/04/2017. While we had no reasons to object the decision to list AstraZeneca’s Betaloc CR brand of metoprolol succinate long-acting tablets, we raised our concerns about sole supply arrangements and continuity of supply.
22/02/2017. We strongly support the proposed changes to the Pharmaceutical Schedule to fund the provision of influenza vaccine (flu vaccine) in community pharmacies to people 65 years and over and pregnant women. These changes will make use of the additional skills of vaccinating pharmacists, and support an integrative care model.
13/12/2016. Our submission covered pack size preference, that preference should be given to a company who can supply a pharmaceutical across the different strengths, the issues very plain and generic packaging can cause, required shelf-life of pharmaceuticals, out of stock arrangements and recalls.
6/12/2016. We believe that community pharmacies should become Authorised Providers to provide increased access to NRT service for patients attempting to quit smoking, including the benefit of the ‘walk-in’ no appointment service that community pharmacies offer.
28/10/2016. We supported the addition of pirfenidone capsules to the Pharmaceutical Schedule for the treatment of idiopathic pulmonary fibrosis. We ask that PHARMAC lists the 63 capsule pack of pirfenidone to prevent wastage of this medicine. If it is not possible to list this alternative pack size then please apply the wastage or original pack rule to pirfenidone to reduce this significant financial risk to community pharmacies when they dispense this potentially life changing medicine.
We supported the addition of Harvoni and Viekira Pak, as these treatments would provide funded access to major advances in Hepatitis C treatment for New Zealanders infected with the disease. We raised concern about these products being listed in Section B of the Schedule as XPharm items, as this means pharmacies would not be able to claim subsidy as alternative distribution arrangements would be put in place by PHARMAC. PHARMAC received a lot of feedback regarding the proposed direct distribution mechanism for the hepatitis C treatments from the pharmacy sector. We have been advised that this feedback will result in some changes being made to the originally proposed distribution mechanism.
We supported the decision to widen the access for longer term azithromycin treatment to include the prevention of exacerbations of non-cystic bronchiectasis for children, and mycobacterium avium intracellular complex infections, and agreed that for short courses of azithromycin should be limited for specific indications only. We however raised concerns regarding the administration of the subsidy by endorsement for short courses, as in the past subsidy by endorsement has proven to be problematic, as the endorsement is often absent from the prescription. Our view was that the prescribing of short courses of azithromycin should remain a responsibility of best practice through prescribing guidelines rather than requiring an endorsement by the prescriber.
We supported the intention of the proposal to widen access for particular patient groups to certain Special Foods however, this proposal provides another example of community pharmacies carrying the burden of some Schedule changes. We reminded Pharmac that community pharmacies are losing money when dispensing Special Foods and cannot sustain the ongoing loss through the provision of special foods to their patients. We requested an acknowledgement in the schedule that special foods are not fully reimbursed into pharmacy and a mechanism, like the product premium, to formalise the current situation whereby pharmacists pass on funding shortfalls on special foods to their patients.
We responded to Pharmac’s proposal for allowing community funded medicines (initially vaccines) and devices to be distributed directly to primary care providers. We believe that patients already have excellent access to medicines in General Practice through the existing mechanisms and wanted to understand how the approach outlined would improve patient access and safety. The Guild’s view is that it is vital that a distinct separation exists between prescribing and dispensing of a medicine. Community pharmacy is an important gatekeeper of medication safety. Changing the system so that some of that supply came from GPs would be hugely inefficient, as this would involve distribution of smaller orders to many more sites with no expectation of improvement in patient safety or adherence and in fact potentially the opposite.
We supported the listing of a registered brand of sodium phenylbutyrate granules that will provide a treatment for patients with rare urea cycle disorders, as currently it is available in New Zealand as a section 29 medicine only. We were pleased to see that this medicine would be listed only after Medsafe grants its registration. We requested that this medicine is funded as an original pack (OP) or the wastage rule applied as it is a very high cost medicine. As it is packaged as a bottle of loose granules, we would expect that there would be no other option for dispensing other than as an OP.
We drew PHARMAC’s attention to the issue of price support for when proposals are likely to result in a significant price drop for a medicine. In the case of this proposal, the price drop for these medicines had the potential to impact both pharmacies and patients. We requested that PHARMAC insist that manufacturers provide ‘price support’. This would ensure that patients have ready access to the medicines they need and that wholesalers and pharmacies will not be financially disadvantaged when they keep stock on hand in advance of the prescription being presented.
We requested that PHARMAC consider the labelling of medicines as part of their tender process and only select or purchase those products that will result in clarity in the pharmacy and for the patient. We believe that providing more detailed labelling preferences to suppliers will result in reduced harm from medication errors and help to improve patient safety.
We supported the widening of access for the diphtheria, tetanus and pertussis (Tdap) vaccine. We requested for pharmacists to be funded as well as other primary care providers to provide this vaccine. PHARMAC stated they were working closely with the Ministry of Health and the DHBs to consider this.
We requested that the wastage rule be applied for a new listing for glycopyrronium bromide for terminally-ill patients and also requested PHARMAC review the original pack status for several high cost medicines having amendments made to their Schedule restrictions. While PHARMAC did not apply the wastage rule in this instance, they stated they would reconsider this decision should information be provided to show that significant wastage was occurring.
We supported the proposal to list Nitrolingual Pump Spray. We had received significant feedback from members concerned about patients unable to effectively use the Glytrin brand.
We requested pack size alignment with the Schedule e.g. a 90-day supply for stat medicines. We asked PHARMAC to consider the impact of formulation and wastage in their decisions, and also the safety implications of generic packaging. We requested a funding mechanism to compensate community pharmacy for out-of-stock situations.
We were supportive of the funding of two new treatments for this disease. We were concerned at the potential for community pharmacy to be left with part-packs of one of the medicines and requested the wastage rule or original pack dispensing be applied to this. PHARMAC applied the wastage rule to this medicine.
We supported the wide range of treatments that would be made accessible to patients. Many of these medicines were very high cost (up to $6532 per pack) and we were concerned at the potential financial risk this posed to community pharmacy. We requested the wastage rule be applied to five of these medicines, and we were successful with this request.
We supported the removal of Special Authority restrictions for the six medicines listed in the proposal (e.g. bicalutamide, mycophenolate) as it would result in greater efficiencies for all involved – prescribers, PHARMAC, pharmacists and patients. We also supported the widening of funded access to eight medicines including isotretinoin and acitretin.
Pharmac has released its tender document for 2014/15, inviting tenders for the supply of certain pharmaceuticals to DHB hospitals and community pharmacies.
We had concerns regarding the potential for wastage of lenalidomide and thalidomide, as these are very high cost medicines. We requested that either the wastage rule or original pack dispensing be applied to these listings. PHARMAC applied the wastage rule to lenalidomide.
We were supportive of the increased availability to patients for this medicine. We had concerns regarding generic prescribing and asked PHARMAC why the two forms of erythropoietin (alfa and beta) were not considered generically equivalent. We asked for Special Authority approval to coincide with normal prescribing practice of three months. PHARMAC applied the wastage rule to this medicine.
We agreed that the proposal would be of benefit to patients as it would give them access to an increased range of subsidised NSAIDs. We had concerns about the endorsement requirement for diclofenac 50mg dispersible tablets and the potential burden that it placed on community pharmacy when prescriptions are incomplete. We requested PHARMAC make prescribers aware of the endorsement requirement to ensure that patients received a fully funded medicine.
We supported the proposal to fund a registered melatonin product for the treatment of secondary insomnia in children and adolescents. We requested that PHARMAC produce a “Frequently Asked Questions” document should the proposal go ahead, to provide information on changing dose to a modified release tablet, and whether patients could expect to experience any differences in treatment. We supported the proposal to add the stat dispensing rule to buspirone and encouraged PHARMAC to see if there were other medicines that could safely be moved to the stat list.
We agreed that there needs to be some means of discretionary funding for patients with exceptional circumstances who need medicines that are not listed on the Schedule or are for other indications. We expressed concern about the movement of funding from NPPA to rare disorders, which had the potential to impact on an already unsustainable pharmaceutical supply channel.
We broadly supported the proposal which would result in shifting the distribution back to the pharmacy wholesaler, ensuring the use of the wholesale-to-pharmacy chain which is important for both the viability of wholesalers and community pharmacy. Our concerns were around communication to patients about the change to distribution and the time-frame of Special Authority approvals which were short.
We got feedback from members on this which showed strong opposition to any further listings of unregistered medicines. We commented on the increasing number of unregistered medicines being funded by PHARMAC, safety issues, and the extra costs incurred by both community pharmacy and pharmaceutical wholesalers. We maintained there needs to be adequate reimbursement to community pharmacy to cover these costs and stated Section 29 should be a specific service with a handling fee multiplier in the PSA.
We supported the proposal to enter a new sole supply arrangement with Novartis so that the brand familiar to community pharmacy and patients remained funded. We did not support the statement that PHARMAC will not consider original pack funding as part of this proposal or that doing so would result in increased spending. We believed that it was the appropriate time to consider the issue of original pack (OP) dispensing, when the new sole supply arrangement for a medicine is being negotiated.
The outcome wasn’t in our favour. Pharmac stated “The OP rule only allows OP dispensing if the Pharmaceutical is packed in a container from which it is not practicable to dispense lesser amounts, which is not the case for NRT".
We had several concerns regarding this proposal. We asked Pharmac to consider: direct communication from PHARMAC to the pharmacies who have an intestinal transplant patient, direct funding for disposal of returned medicines, application of original pack (OP) or wastage rules for Prograf and Tacrolimus Sandoz, the complexity of the brand switch, which should be reflected in the application of at least two brand switch fees (BSF), the ability of pharmacies to claim for any undispensed part-packs of Prograf at the end of the transition period.
Pharmac agreed to apply a single BSF, to have direct communication with pharmacies to support them and to apply the wastage rule to the Prograf brand.
We requested that consideration was made to a supplier who is able to supply a product that contains sufficient overage of paracetamol liquid that the pharmacy can use the entire volume that they have paid for (due to the feedback from members on the viscosity of the current paracetamol 120mg/5ml liquid). We noted in the contents of Schedule Six that there were details of the process for a recall of a hospital medicine, but nothing similar for community medicine recalls.