Pharmaceutical Management Agency
“Make life easier, always think generically”
Dabigatran and Patient Safety
Dabigatran Since the introduction of dabigatran (Pradaxa) on the Pharmaceutical Schedule on the 1st July 2011, there have been some reports of bleeding among patients being transitioned onto dabigatran.
Preliminary analyses of these bleeding reports suggests that elderly patients (age over 75 years), patients with low body weight or impaired renal function are more at risk of bleeding. Some bleeding events were also related to inadequate monitoring of INR before patients were switched from warfarin to dabigatran and the inappropriate use of the higher dose (150mg twice daily) of dabigatran in patients older than 80 years of age. Before prescribing dabigatran you should ensure that you are fully conversant with the relevant literature including: • the Medsafe datasheet available on the Medsafe website (www. medsafe.govt.nz); • information on dabigatran available via the PHARMAC and BPAC websites (www.pharmac.govt.nz/ and www.bpac.org.nz ). If a patient is well controlled on warfarin, there is no particular reason to change to dabigatran at least in the short term.
Extension of varenicline Special Authority approval period
The expiry date of the the varenicline’s Special Authority approval will be extended from three to five months from 1 October 2011 to give patients in this situation more time to return to their clinician and get another prescription before the Special Authority expires. This change does not extend the subsidised length of treatment, which remains at a maximum of 3 months’ subsidy for each Special Authority approval. Extending the approval period is in response to PHARMAC receiving a number of requests to grant additional Special Authority approvals for varenicline where the original Special Authority expired prior to the patient’s full course of medication being dispensed. In most of these cases the patient’s prescription was also no longer valid to access subsidy as more than 90 days had passed, but by the time a new prescription was issued the Special Authority had expired.
Pharmaceutical Management Agency - Clinicians’ Newsletter - October 2011
Restriction of access
Sulindac Mylan has increased the price of its sulindac (Daclin) tablets 100 mg and 200 mg from 12 October 2011. The subsidy for these presentations is not increasing to match the price and so patients will have to pay a part charge. However, patients with a valid Special Authority approval will continue to access sulindac fully subsidised..
Pramipexole hydrochloride - delay in listing Due to a delay in the production of stock for the New Zealand market, the listing of all strengths of pramipexole hydrochloride (Dr Reddy’s Pramipexole) tablets has been delayed until further notice.
Items of Interest
Trastuzumab and sunitinib – amended Special Authority criteria Some minor amendments regarding clinical definitions have been made to the Special Authority criteria applying to trastuzumab and sunitinib for clarification purposes and are expected to reduce confusion and administrative burden for prescribers and pharmacists. The changes are from 1 October 2011 and are not expected to materially change the funded access to either of these pharmaceuticals. Please refer to the October 2011 Pharmaceutical Schedule Update on the PHARMAC website for further information.
Out of Stock
Sustanon – out-of-stock situation Due to a global manufacturing issue Sustanon ampoules (testosterone esters) will be out-of-stock until late 2011. Merck Sharpe and Dohme (MSD) are handling this situation with the help of Pzifer’s DepoTestosterone (testosterone cypionate) long-acting injection. Please note that Depo-Testosterone is a 10 ml multi-dose vial containing 100 mg per ml (1,000 mg per vial) of testosterone cypionate. Full prescribing information is available on the Medsafe website at: http:// www.medsafe.govt.nz/profs/datasheet/d/Depotestosteroneinj.pdf
For more information and assistance contact MSD’s Medical Services Manager Mischa Winnard on (09) 5236107.
Changes to Schedule Rules
Close Control rule amendment The Close Control rule in the Pharmaceutical Schedule will be amended from 1 October 2011. PHARMAC and DHBs consulted on proposed changes to the Close Control Rule in February 2011. The resulting changes to the Close Control Rule are relatively minor, and are as follows:
• Removing the need to write “Close Control” or “CC” for monthly dispensing into Community Residential Care and Age Related Residential Care provided the patient’s NHI and name of the institution or facility is included on the prescription. • Allowing patients in Age Related Residential Care or Community Residential Care to have an initial trial period (determined by the prescriber) for new medicines or a change of dose. This is a new issue raised during the consultation process. • Differentiating the use of Trial Close Control (a one-off shorter dispensing period for new medicines or a change in dose) from ongoing Close Control by annotating the prescription with “Close Control Trial”, “CCT” or “Trial Period” and also noting the period of supply specified. • Amending the format of the current Close Control rule definition to make it easier to read. These changes will be effective from 1 October 2011. All other aspects of the Close Control Rule remain the same.
Clarithromycin 500mg tablets - pharmacist approval to substitute To ensure supplies of clarithromycin during stock shortages of the 250 mg tablets of Klacid and Klamycin, pharmacists have been approved to substitute the clarithromycin 500 mg tablets for the 250 mg tablets from 14 September 2011 until further notice. Prescriptions need to be annotated by the pharmacist and will need to be endorsed accordingly. Please refer to the PHARMAC facsimile of 14 September 2011 located on the PHARMAC website for further details. (www. pharmac.govt.nz)
The listing date of Apo-Clarithromycin 250 mg tablets has been brought forward to 1 October 2011. We have been informed that Apotex’s stock will be available from mid October.
Special Authority approvals by dietitians Dietitians will be able to complete initial and renewal applications for Special Authority approvals for patients under their care from 1 October 2011. Dietitians will only be able to apply for Special Authorities for Special Foods listed in Section D of the Pharmaceutical Schedule and multivitamins (Paediatric Seravit) powder and vitamins (Vitabdeck) cap (fat soluble vitamins A, D, E K).
At this stage only manual (paper) applications will be able to be processed. It is anticipated that later this year dietitians will be able to complete electronic Special Authority applications. General Practitioners who are not yet vocationally registered may reapply for Special Authority applications for their patients under the recommendation of a dietitian. They must include the name of the dietitian and the date contacted on the Special Authority application. There are no changes for vocationally registered General Practitioners.
Special Authority Forms
Following an influx of out-dated forms, Sector Services have issued a reminder to prescribers to ensure they have the latest Special Authority forms downloaded from the website. Alternatively prescribers can also use the online electronic system. For example Isotretinoin.
Pharmaceutical Management Agency - Clinicians’ Newsletter - October 2011
Pharmaceutical Management Agency
What’s cooking in Prescription Kitchen?
PHARMAC has been involved in a new and innovative way to deliver medical education to clinicians. Prescription Kitchen, the first in a series called HealthQ, was a collaboration between PHARMAC, BPACnz and Mobile Surgical Services that provided an innovative way to deliver continuing medical education (CME) to health professionals. As part of this, a live and interactive CME session was held on Thursday 5 May and screened on Sky TV.
Special Authority vigilance
Special Authority is the mechanism PHARMAC uses to target medicines to people who need them most. The system is only as good as our ability to ensure it is used properly, so we routinely commission audits to check the system is being used as intended. During the course of an audit into the Special Access process (which is similar to the Special Authority process) for the ADHD drug Ritalin SR, we became aware of some irregularities around some doctors’ use of the forms. Having identified particular concerns in relation to two doctors, we made a complaint to the Medical Council, whose Professional Conduct Committee decided to lay charges against the doctors before the Health Practitioners’ Disciplinary Tribunal. The charge against one of the doctors was withdrawn after he acknowledged that he had completed some of the criteria in the special access forms in error in the context of a busy practice. The charges against another doctor, Dr John Anthony Hanne of Auckland, proceeded to a tribunal hearing. During the course of the hearing the tribunal agreed to the withdrawal of the charges after Dr Hanne agreed to make a statement accepting that his actions fell below the standards of optimal practice, that he regretted the errors, and that he will take more care with completing forms in future. The full decision can be found at http://www.hpdt.org.nz/Default. aspx?tabid=293. PHARMAC will continue to commission regular audits of Special Authority Processes.
Let the facts speak for themselves?
Pharmaceutical Management Agency
When we live in a world where evidence is meant to trump opinion, you’d think facts were all that’s needed to convince others of the strength of an argument. But facts can be mistakenly connected to other facts, leading to incorrect interpretations. We’ve seen a bit of this around the topic of PHARMAC lately. Take this statement for example: “New Zealand’s per capita spending on pharmaceuticals is below the OECD average.” The statement is undeniably true. But what does it mean, and is it good or bad? If you are a pharmaceutical lobby group calling for more funding for medicines, the meaning put around this fact is a claim that spending more on medicines leads to better health outcomes (despite the report citied1 showing the United States, which has the highest prices and highest per capita spend on pharmaceuticals, also has the highest mortality from preventable diseases). From PHARMAC’s point of view, the fact that we spend less per capita on pharmaceuticals is pretty good. Because New Zealand’s population health outcomes are broadly in line with OECD averages, the fact illustrates the value for money PHARMAC achieves for our medicine funding system. Here’s another fact: “New Zealand’s mortality from preventable diseases has been improving faster than the OECD average.” We think this fact is a good thing. It also comes from the same report the industry
>> • Patients with severe genetic diseases (inborn errors of metabolism) will have easier access than before. • Children who need specialised infant formulae will need to follow international guidelines – these require people to try simpler and cheaper formulae before more complex and expensive formulae. We have received the most feedback from people about changes to adult sip feeds. They come in two types – ready-made liquid preparations and powdered versions that need to be mixed with water. The ready-made versions have been more expensive for PHARMAC to fund. We’ve had advice that the powdered and ready-mixed versions of these products are pretty much the same, so we think it’s reasonable to pay the same subsidy for both. Powdered drinks will be fully subsidised, and people can choose to pay the difference if they opt for the ready-made liquid products. In making the funding changes, we’ve thought about people with particular needs like those who are tube fed and rely on liquid feeds for their full nutrition (known as enteral feeds). We’ve created rules so that tube-fed patients can have ready-mixed enteral feed preparations fully funded and not have to pay a part-charge. We’ve also worked to ensure that access to funded Special Foods is appropriately targeted so that the people who are in genuine clinical need receive funded products. Full details and patient information about the changes are available at http://www.pharmac.govt.nz/patients/SpecialFoodsChanges
Te Matatini and Whˉ nau Hauora Village a
This first session focused on the current Pharmaceutical Schedule changes to Special Foods, and supplemented the other medical education that is occurring. The Sky TV session, compered by veteran A PHARMAC-led initiative was a major drawcard broadcaster Ian Fraser, involved live panel discussion with expert at the Te Matatini o te clinicians as Rā national kapa haka festival in Gisborne on 16-20 February.well as pre-recorded video clips and opinion pieces in order to provide as dynamic an approach to CME as possible. PHARMAC worked with a range of groups including Tairawhiti District There was also the Health Board, Plunket, National Heart Foundation, Te Hotu Manawa opportunity for health professionals to text or email questions they Māori, Quit Group, Māori Pharmacists Association, Turanganui a Kiwa had for the panel both in advance of the show, health and Midlands Health Network to create a as well asHauora its screening. Health professionals, including GPs, Whānau during paediatricians, geriatricians and dietitians were sent an ‘invite’ to tune Village for the duration of the festival. in to the screening. Services offered included men’s heart health checks, diabetes We will be monitoring the response to Prescription Kitchen. Should screening, well child checks, cancer services including cervical this first session screening, nutrition and physical activity guidance and smoking be successful, a further two Sky TV based sessions may cessation advice and support. Specialist services be developed for other medical subject matter during 2011. included sexual health and oncology (cancer) expertise, medications advice and counselling, all provided by senior Māori clinicians. The village concept was extremely popular, with 2,500 people visiting the Village (out of approximately 50,000 people attending the festival). PHARMAC and the festival organisers put a lot of effort into creating an environment where people felt safe and welcomed and were willing to take part in the various services on offer. This meant that, despite being set up in little more than a tent in a field, highly professional services were offered in a setting that made people feel at ease and well cared for. Services provided during the festival included: • 303 men had their heart and diabetes status checked (of these, 145 were considered high risk – greater than 15% chance of a heart event)
– save this date
The PHARMAC Forum is coming – make a note of this date: 17 February 2012. The Forum has become an important part of PHARMAC’s business and getting stakeholder input to our work. For the next Forum, we’re looking at additional opportunities for getting input from consumers and front line health professionals, in particular pharmacists and General Practitioners. We plan on holding regional ‘mini-Forums’ later in 2011, which will give people a further opportunity to contribute to the discussion around Forum topics. We’ll provide more information, including dates, about these mini-Forums in the near future.
has been using to promote its case that it is a bad thing that New Zealand spends less on pharmaceuticals. Unfortunately such recent comments haven’t had a lot of factual backing. Rather, these arguments need to be unpicked and corrected, something that is readily done using documents easily obtained through our website or from other sources. And that’s a fact.
• 200 women had diabetes checks • 20 women had cervical smears
PHARMAC Seminar Series – Upcoming Seminars
The PHARMAC Seminar Series provides high quality educational seminars for a range of health professionals. The seminars are held in Wellington and the cost to attend is $100 + GST. PHARMAC covers the cost of travel, including flights, to and from the seminar and provides catering on the day. For further information on the seminars below, and to register for a place, head to our website: www.seminarseries.pharmac.govt.nz
“A MAN WITH A CONVICTION is a hard man to change. Tell him you disagree and he turns away. Show him facts or figures and he questions your sources. Appeal to logic and he fails to see your point.” -Leon Festinger
• 200 contacts were made with families with young children The Village concept emphasised the idea that healthcare is a concern for families as a whole, not just for individuals. Many of the people seen at the Village did not have regular contact with health professionals. Two of the women who had cervical smear tests had never had one before. ISSN 1179-7401
Measuring The Health Of Nations: Updating An Earlier Analysis Ellen Nolte and C. Martin McKee Health Affairs, 27, no. 1 (2008): 58-71 doi: 10.1377/hlthaff.27.1.58
PHARMAC and its partners in the Whānau Hauora Village feltthe Government agency responsible for deciding which medicines are subsidised for New Zealanders. PHARMAC is the It manages spending concept, bringing together a range of services working together on pharmaceuticals for the District Health Boards, and ensures that a comprehensive list of medicines (the Pharmaceutical Schedule) is subsidised for New under one roof, worked extremely well. The concept of a health Zealanders. village is an exercise they are keen to repeat at future festivals and Level 9, 40 Mercer Street, PO Box 10-254, Wellington 6143, New Zealand Contact: PHARMAC, the Whānau Hauora Village has been invited back to be part of the Te Phone: +64 (0)4 460 4990 - Fax: +64 (0)4 460 4995 - www.pharmac.govt.nz Matatini festival in 2013.
PHARMAC publishes a quarterly email newsletter, inPharmation, that includes news and updates on developments around PHARMAC and pharmaceutical issues. If you would like to receive inPharmation, contact firstname.lastname@example.org.
Rheumatic Fever (Part II – Invitation Only) Palliative Care
Please not we will be identifying and inviting registrants for these seminars from the relevant high risk areas.
All health workers involved in palliative care in the primary care setting, in particular GPs, practice nurses and pharmacists.
Update on Special Foods Diabetes, Pre-Eclampsia and Pregnancy Complications Adolescent Health
This seminar is suitable for GPs, dieticians, nurses and pharmacists.
This seminar is a repeat and is aimed towards LMC practitioners or practitioners providing care to women during pregnancy. (This is a repeat seminar).
All health workers involved in caring for young people, but especially relevant for GPs, practice nurses and counselors working in the community. (This is a repeat seminar).
ISSN 2230-4703 (Print) ISSN 2230-4711 (Online) Special Authority Queries: 0800 243 666 General Questions: 0800 66 00 50 (9am – 5pm Monday to Friday) Online version of Prescriber newsletter: http://www.pharmac.govt.nz/healthpros/CliniciansNews Inpharmation newsletter: http://www.pharmac.govt.nz/patients/ourviews/inpharmation. Newsletter feedback: email email@example.com Please note this is not a complete reference to all changes occurring from 1 October 2011, for the full reference; please consult your Update to the Pharmaceutical Schedule.
Pharmaceutical Management Agency Clinicians’ “Make life easier, always think generically” Newsletter October 2011 Dabigatran and Patient Safety Dabigatran Since the introduction of dabigatran (Pradaxa) on the Pharmaceutical Schedule on the 1st July 2011, there have been some reports of bleeding…
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