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2014 News articles:


2012 News articles:


2011 News articles:


2010 News articles:






2014


PHARMAC will change the way it makes funding decisions from late 2015

(Published: 31 December 2014)



Pharmac has announced that it will make changes to the way it makes decisions about which medicines, vaccines and medical devices will be funded.


Current decision-making about funding

The community medicines and DHB hospital medicines and devices subsidised by the Government are listed on the Pharmaceutical Schedule. Pharmac has a process in place for making decisions about proposals to amend the Schedule with a view to funding new pharmaceuticals or widening access to pharmaceuticals that are already funded.


When considering these funding proposals, Pharmac assesses each proposed amendment against nine Decision Criteria, which include consideration of health need and assessment of cost-effectiveness. All proposals are prioritised against all other funding options according to these criteria.


Some medicines that are not subsidised under the Pharmaceutical Schedule can still qualify for funding (strict conditions apply) under the Named Patient Pharmaceutical Assessment (NPPA) mechanism. There are three ‘pathways’ under the NPPA: Unusual Clinical Circumstances, Urgent Assessment and Hospital Pharmaceuticals in the Community. Each of these pathways have different prerequisite requirements. In addition to these pathways, Pharmac will also consider funding in some other exceptional circumstances.


If an NPPA application for funding meets the relevant prerequisites under the NPPA Policy, it will be considered against aforementioned Decision Criteria.


What is going to change?

The nine Decision Criteria used by Pharmac in considering proposals to amend the Pharmaceutical Schedule as well as NPPA applications will be replaced with fifteen Factors for Consideration.


Among the changes are that the impact of proposals on a person, their family, whānau and the wider society, and on the broader health system will be considered in terms of need, health benefits, costs and savings, and suitability.


Also, the impact of decisions on Māori health with respect to the Treaty of Waitangi/Te Tiriti o Waitangi, as well as the health needs of Pacific people and other population groups experiencing health disparities will be explicitly included in the Factors for Consideration.


What does this change mean for patients?

It is unclear how the new Factors for Consideration will affect the outcome of funding decisions. The Factors will, however, widen the range of considerations that Pharmac will take into account when assessing funding applications.


In its Questions and Answers, Pharmac explicitly replies to the question whether previously unfunded medicines (including declined NPPA applications) could be funded because of the new decision-making framework: “While we do not expect that the use of these factors in themselves would require remaking of decisions, we are always willing to consider funding applications when new information is available.”


When is this change taking effect?

From late 2015 (no specific date is given). Until then the Decision Criteria will still be applied to funding decisions.


More information

The following Pharmac documents contain an explanation of the upcoming changes:


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Otago University: Thyroid cancer risk in New Zealand highest among Pacific women

(Published: 8 June 2014)



Just-published research shows Pacific women have the highest rates of thyroid cancer in New Zealand. One theory is that thyroid cancer rates among Pacific women will be largely among those born in the Pacific due to high consumption of iodine-rich seafood among children and young people living in the Pacific.


Read the press release from Otago University here.


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Potential shortage of Neo-Mercazole: temporary listing of an unapproved brand on the Pharmaceutical Schedule

(Published: 15 January 2014)



Patients may have noticed that the carbimazole they have obtained recently from their pharmacy is not the usual Neo-Mercazole they have been taking previously. We have received information that some patients have been supplied with carbimazole manufactured by the pharmaceutical company Remedica Cyprus.


A new formulation of carbimazole (AFT, 5 mg tablet) has temporarily been added to the Pharmaceutical Schedule as of 1 January 2014. This is the explanation provided by Pharmac:


“AFT has advised of a potential supply shortage of Neo-Mercazole (carbimazole) 5 mg tablets. To avoid an out-of-stock, an unapproved AFT brand will be temporarily listed from 1 January 2014. This product must be prescribed and supplied in accordance with section 29 of the Medicines Act 1981. Please note that wastage on the AFT brand may be claimed in accordance with rule 3.3.2. The Neo-Mercazole brand is expected to be back in stock in late January 2014.” (Pharmac, Update New Zealand Pharmaceutical Schedule: Effective 1 January 2014 - pdf, 592kb)


Secion 29 of the Medicines Act contains notification requirements for prescribing unapproved medicines.


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2012


Propylthiouracil listed on the Pharmaceutical Schedule under a Special Authority

(Published: 31 May 2012)



From 1 May 2012, the medicine Propylthiouracil is listed on the Pharmaceutical Schedule under a Special Authority (form SA1199). This means that Propylthiouracil 50 mg tablets will be fully funded, subject to Special Authority criteria for patients with hyperthyroidism who are intolerant of carbimazole or where carbimazole is contraindicated.


The Propylthiouracil brand supplied by AFT Pharmaceuticals is not (yet) approved by Medsafe. It must, therefore, be supplied and prescribed in accordance with the provisions of section 29 of the Medicines Act 1981.


For more information, see Pharmac's Notification (17 April 2012) and Clinicians' Newsletter (pdf, May 2012) for more information.


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Exceptional Circumstances scheme replaced by the Named Patient Pharmaceutical Assessment

(Published: 31 May 2012)



From 1 March 2012, PHARMAC's Exceptional Circumstances scheme has been replaced by the Named Patient Pharmaceutical Assessment (NPPA). Under the NPPA, authorised prescribers may apply for the funding of medicines not listed in the Pharmaceutical Schedule for named, individual patients.


For more information about the NPPA, see under Prescribing non-funded medicines.


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2011


Changes to Medicines Regulations enter into force: brand substitution by pharmacists

(Published: 21 August 2011)



On 1 August 2011, several changes to the Medicines Regulations 1984 entered into force. These changes include an amendment of Regulation 42(4).


Under new Regulation 42(4), a pharmacist may supply an alternative brand of medicine even if your doctor has written a specific brand of medicine on the prescription. A pharmacist may do this if the following conditions are met:

  1. your doctor has not marked the prescription “No brand substitution permitted” or with words of similar meaning; and
  2. the substituted brand contains the same active ingredient or active ingredients, and no other active ingredients; and
  3. the substituted brand is in the same dose form and strength as the prescribed brand; and
  4. there is no clinical reason why the substituted brand should not be supplied; and
  5. the pharmacist records the brand substitution on the prescription; and
  6. the pharmacist signs and dates the prescription; and
  7. the pharmacist informs the patient of the brand substitution.

If you have suffered from side effects from any brand of medicine, this should be enough to prevent the brand substitution as the condition under (d) will not be met. However, thyroid patients’ claims about the side effects of the new formulation of Eltroxin have not always been taken seriously by health professionals.


What can you do?


If you have reason to believe that your pharmacist might not give you your preferred brand, ask your doctor to write on the script:


  • the preferred brand of your medicine; and
  • ‘no brand substitution permitted’.

If you go to the pharmacy with your script, always check that you receive the correct brand.


More information


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Changes regarding brand substitution by pharmacists: update

(Published: 6 June 2011)



Last year, we reported that the Ministry of Health was considering changing the rules that allowed a pharmacist to substitute an alternative brand of a prescribed medication. The Government has since then approved these changes. The changes will take effect some time this year (exact date unknown).


More information


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Iodine tablets for healthy pregnant and breastfeeding women

(Published: 6 June 2011)



Iodine is essential for the development of the brain and nervous system of unborn babies and infants. Pregnant and breastfeeding women have an increased need for iodine and need to eat a well-balanced diet with iodine-containing foods such as well-cooked seafoods, low-fat milk products, eggs, some cereals and fortified bread. If salt is used, they should choose iodised salt. But even with such a well-balanced diet, it is difficult to get enough iodine from food alone.


For that reason, the Ministry of Health is advising healthy pregnant and breastfeeding women to supplement their diet and take a daily 150 mcg iodine-only tablet from confirmation of pregnancy until the discontinuation of breastfeeding. Fully subsidised iodine-only tablets are available from the brand NeuroKare at your local pharmacy. You can ask your doctor or midwife for a prescription.


The Ministry advises that its recommendations do not apply to women with pre-existing thyroid disease who should be individually managed to ensure normal thyroid function during pregnancy.


More information is available on the website of Medsafe and the Ministry of Health. Please, note that most information is written for healthy people without thyroid disease.


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2010


Goldshield: Renewal of Provisional Consent

(Published: 12 December 2010)



On 11 November 2010, the Minister of Health renewed the provisional consent to the sale, supply or use in New Zealand of Goldshield levothyroxine.
This provisional consent is again valid for two years and applies to both strengths that are currently available (50 and 100 mcg).


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Ministry of Health proposes changes regarding brand substitution by pharmacists

(Published: 7 June 2010)



In February 2010, the Ministry of Health published proposals to change the Medicines Regulations 1984 and the Medicines (Standing Order) Regulations 2002.


Currently, Regulation 42(4) of the Regulations requires a pharmacist to dispense the brand of medicine specified by the prescriber, unless the prescriber authorises substitution of another brand.


Among the reasons for changing the current Regulations, the Ministry states that "(t)here are a number of circumstances in which substitution may be required, such as where a discontinued or temporarily unavailable brand of medicine has been prescribed, or where changes to subsidy rules mean that a patient would otherwise have to pay the full cost of the prescribed brand.
Prescribing of non-subsidised brands is common (because computer systems have not been updated to show changes in subsidy rules) but is usually not intentional. 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."


Ministry of Health proposal


"It is proposed that regulation 42(4) be amended to allow a pharmacist to substitute an alternative brand of a prescribed medicine (but not a different medicine) provided:

  • there are no clinical reasons why substitution should not occur
  • the prescriber has not marked the prescription with a statement such as 'no brand substitution permitted', and
  • the pharmacist records details of the brand substitution on the prescription and informs the patient of the change of brand."

What does this mean for thyroid patients?


If these changes go ahead, it means that even if your prescription says Synthroid or Goldshield, the pharmacist can - legally - give you another brand such as Eltroxin (new formulation)! Considering that - in spite of more than 1,400 reports of adverse reactions - many pharmacists still deny that there is anything wrong with that brand, the condition that 'there are no clinical reasons why substitution should not occur' is not likely to stop certain pharmacists from giving patients a brand that they clearly do not want.


What can you do?


If you want to make sure that your pharmacy gives you the brand of medication that you want, ask your doctor to:

  • write the name of the desired brand on the prescription, and
  • indicate explicitly that no brand substitution is permitted.

The proposed changes are intended to take effect in the second half of 2010. We will keep on monitoring this.


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Goldshield packaging changed

(Published: 7 June 2010)



On 11 March 2010, Boucher & Muir (NZ) sent a letter to pharmacists about the packaging of Goldshield Levothyroxine.


As patients using Goldshield will know, the packaging of their levothyroxine mentioned Forley Generics Ltd and not Goldshield as the sponsor of these drugs. This has now changed.


Stocks of the 50mcg and 100mcg tablets of levothyroxine have already been released onto the market in the new packaging.


What has changed? Instead of Forley Generics, the packaging will now mention Boucher & Muir (NZ) Ltd t/a Goldshield Healthcare (NZ) as the sponsor of the levothyroxine.


Nothing else has changed! There have been no changes to the formulation of the tablets or the site of manufacture (in the UK).


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New manufacturer of Eltroxin (original formulation) in Canada

(Published: 7 June 2010)



As of 17 December 2009, GlaxoSmithKline is no longer manufacturing the original formulation of Eltroxin in Canada. The new manufacturer is Aspen and the distributor in Canada is Triton Pharma Ltd.


On our behalf, Allan Campbell (Temuka Pharmacy) has sought and received confirmation from Triton Pharma that at present this change will have no effect on the manufacturing process, site of manufacture, or ingredients. We can, therefore, reassure everyone that the Eltroxin currently made in Canada is still the same as the original formulation that used to be supplied and funded in New Zealand until mid 2007. We will keep on monitoring this.


When the Eltroxin manufactured by Aspen will come in from Canada is uncertain; that depends on the size of the stock of GSK made Eltroxin that Canada Drugs* has in storage. We also do not know yet whether the change in manufacturer will lead to any changes in the packaging. But the most important message is clear: the formulation of the tablets has not changed!


* Most patients in New Zealand that use the original formulation of Eltroxin, order it online from Canada Drugs at www.canadadrugs.com.


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New formulation of Nature-Throid

(Published: 7 June 2010)



RLC Labs Inc (Arizona, USA) has changed the formulation of Nature-Throid.
The new formulation of Nature-Throid contains the following ingredients:


active ingredients:
levothyroxine (T4) and liothyronine (T3) (USP Thyroid Powder manufactured by American Laboratories Inc., Omaha, Nebraska)


inactive ingredients:
lactose monohydrate*, microcrystalline cellulose NF, dicalcium phosphate USP, colloidal silicon dioxide NF, croscarmellose sodium NF, magnesium stearate NF, stearic acid NF. Clear film coat: opadry II 85F19316 (contains polyvinyl alcohol USP, talc USP and polyethylene glycol NF)


* Lactose monohydrate is present in traceable amount as a diluent in the USP Thyroid Powder.


What has changed? The old formulation contained sodium starch glycolate, which has been replaced with croscarmellose sodium for improved disintegration. In the clear film coat, hydroxypropyl methylcellulose (hypromellose) has been replaced by the opadry. Carnauba wax, used for the old formulation, is no longer required for polishing.


other changes: the new tablets now have the following imprints:


N on one side, 025 on the other side (16.25 mg)
N on one side, 050 on the other side (32.5 mg)
N over a score line and 1 under on one side, RLC on the other side (65 mg).


   


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