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Revised: 14 May 2013

Media Releases for 2002

26 Nov 2002 New Standing Order Regulations will Provide Greater Consistency
12 Nov 2002 Ministry of Health urges people using Felo ER to see their GPs
27 Sep 2002 New Hormone Replacement Therapy guidelines supported
26 Jul 2002 Paroxetine Mesylate - High Court rejects Challenge
17 Jul 2002 Study highlights potential risk following prolonged use of oestrogen-only HRT
12 Jul 2002 Information for HRT prescribers
10 Jul 2002 Hormone Replacement Therapy Risks Known, Acted On.
7 Jun 2002 Proposed NZ-Australia Therapeutic Products Agency
21 Mar 2002 New advice about oral contraceptives

26 November 2002

New Standing Order Regulations will Provide Greater Consistency

New health regulations coming into force next month will provide a strengthened framework for delegated powers to nurses and some other healthcare workers, to supply and administer medicines.

Standing Order Regulations, announced by the Ministry of Health today, are written instructions issued by a medical practitioner or dentist which authorise people such as registered nurses, paramedics and physiotherapists, to supply and administer certain medicines.

The main aim of the regulations is to allow greater consistency and assist those involved to show the line of responsibility for getting and administering medication is traceable to written instructions authorised and signed by the responsible person (usually a medical practitioner) and agreed to by all the staff involved.

A uniform approach will also help ensure safe and efffective treatment of patients.

The Ministry is now encouraging doctors and dentists to develop written protocols for standing orders in accordance with the Ministry's Standing Order Guidelines.

Standing orders are commonly used in hospitals, public health services, sexual health services, ambulance services and primary rural health services, but application of standing orders varied among providers and there was a lack of clarity over whether they were legally permissible under the Medicines Act 1981.

Ministry of Health Chief Advisor Nursing Frances Hughes, said the regulations will greatly assist nurses because they will now be able to function within a clear legal framework.

Ms Hughes said many hospitals already worked under standing orders. "Now that we're going to get national consistency around the country regarding standing orders it will reduce nurses' vulnerability, and will let them be sure they're practising in a legal manner."

In 2000 the Ministry issued a consultation document on proposals to establish standing order regulations, which will come into force on December 19, 2002.

ENDS

For more information contact:
Kim Purdy
Media Advisor
Government & Sector Relations\Communications
Corporate & Information Directorate
Ministry of Health
DDI: 04 496 2483
Mobile: 025 277 5411
Fax: 04 496 2010

http://www.moh.govt.nz
mailto:kim_purdy@moh.govt.nz


Questions and Answers

What is a standing order?

A standing order is a written instruction issued by a medical practitioner or dentist, in accordance with the regulations, authorising specified class of persons engaged in the delivery of health services to supply and administer any specified class or description of prescription medicines or controlled drugs to any specified class of persons, in circumstances specified in the instruction, without a prescription. A standing order does not enable a person who is not a medical practitioner or dentist to prescribe medicines - only to supply and/or administer prescription medicines and some controlled drugs.

Who can issue standing orders?

Any of the following people can issue a standing order:

Who can work under standing orders?

A person who is permitted to supply or administer medicines pursuant to a standing order must be engaged in the delivery of a health
service. They may include, for example:

Any standing order permits or empowers people to supply or administer medicines; it cannot require them to. In every case it will be a matter of professional judgement by the person concerned as to whether he or she does supply or administer medicines pursuant to a standing order. This subject it's not covered in detail in these guidelines. Where the employer or health organisation has a written policy relating to the standing orders, that policy should record the agreement of the management of the health provider and those who will supply medicines under that standing order. However, working under standing orders may be part of the person’s duties as an employee, independent contractor, or may be governed by contract.

What is the process?

All staff potentially affected by the standing order should be identified in the development of the standing order. It is recommended
that the standing order be developed in consultation with the staff that will be expected to work under that standing order, or
representatives of those staff. The regulations require that the issued standing order is provided to:

What medicines can be administered and supplied in accordance with a standing order?

The following medicines can be administered and supplied in accordance with a standing order:

The Regulations require that the standing order list:


12 November 2002

Ministry of Health urges People using Felo ER to see their GPs

[See also 3 Oct 2003 Media Release - Medsafe removes restrictions on Felo ER 5 and 10mg]

People taking Felo ER, a medicine being recalled by Pacific Pharmaceuticals Ltd, should see their GP about an alternative treatment as soon as possible, the Ministry of Health said today.

Dr Stewart Jessamine, spokesman for the Ministry's medicines safety authority (Medsafe), said patients should continue taking Felo ER until they can change to another treatment prescribed by their doctors.

Felo ER, which contains the active ingredient felodipine, is used for the treatment of high blood pressure and/or stable angina. About 50,000 people in New Zealand take the medicine. It is manufactured in Europe by Siegfried Ltd and supplied in New Zealand by Pacific Pharmaceuticals Ltd.

"The reason we're asking people to keep taking their medicine until they've seen their doctor is because the risks of untreated angina and/or high blood pressure are greater than the risks of continuing treatment," Dr Jessamine said.

He noted that there is no evidence from adverse reactions monitoring in Germany and New Zealand that Felo ER is harmful.

"Pacific Pharmaceuticals Ltd will reimburse doctors for one GP visit for each patient in relation to this recall. If further visits are required, these will have to be paid by the patient. Doctors and pharmacies have access to adequate supplies of alternative medicines, including a fully funded brand of felodipine, called Plendil ER."

Pacific Pharmaceuticals Ltd, in co-operation with the Ministry of Health, issued a patient-level recall for all Felo ER tablets after the Ministry received new information questioning the effectiveness of the medicine.

Dr Jessamine said the German Regulatory Authority recently raised doubts about the integrity of the Felo ER bioequivalence studies. These studies were used by Pacific Pharmaceuticals Ltd to support an application to register it as a new medicine in New Zealand.

Medsafe reviewed the documentation provided by the German authority and concluded there were major problems with the quality of the original bioequivalence study information.

"The quality failures occurred in crucial clinical areas and are such that the Felo ER bioequivalence studies cannot be regarded as accurate and must be discarded," Dr Jessamine said.

"Without these studies there is no compelling evidence for the effectiveness of Felo ER, and there is concern that it may not offer the same degree of protection from the complications of high blood pressure and angina as other brands of felodipine.

"The European manufacturer has commissioned new studies, which will be completed early next year. Until Medsafe has assessed this data, Felo ER will not be sold in New Zealand."

Felo ER can only be prescribed by a doctor and is dispensed monthly.

Letters and pamphlets outlining the product recall and the Ministry of Health's advice were sent to health professionals and patients today. Copies of this material are available on the Medsafe web site. An 0800 patient advice number -- phone 0800 18 18 16 -- has been set up by Pacific Pharmaceuticals Ltd, and will operate from 7am 13th November. The recall notice will also be carried in newspapers on Thursday 13th November 2002.


Questions and Answers

What is Felo ER?

It is a calcium-channel blocker with the active ingredient felodipine. It has been approved for the treatment of hypertension and chronic stable angina.

When was it approved in New Zealand?

February 2000.

How many people take Felo ER in New Zealand?

An estimated 50,000 people.

Who are the people most likely to be taking Felo ER?

Anyone with high blood pressure or angina. This is more likely to occur in people aged 40 years and over and generally in more men than women. Both high blood pressure and angina generally occur more frequently in older age groups.

What should anyone taking Felo ER do now that the drug has been recalled?

Patients should see their GPs so their medication can be changed to a different product. Patients should not stop taking Felo ER tablets until this changeover is complete.

Will patients have to pay doctors' fees when they see their GP for alternative treatment?

No, Pacific Pharmaceuticals Ltd will reimburse doctors for one GP visit per patient in relation to the recall. The General Medical Subsidy (GMS), a patient subsidy paid by the Ministry of Health for each visit an eligible patient makes to a doctor, will be provided for any visits made with respect to this medicines recall. To claim the GMS subsidy, doctors should submit claims in the normal manner for patients who visit them as part of the recall.

What about prescription costs at the pharmacy?

As a result of the Felo ER recall, Pharmac will fully fund Plendil ER, an alternative medicine containing felodipine. Patients will still have to pay the usual prescription charge at the pharmacy, depending on their Community Services Card or High User Health Card status. This charge will range from no cost, $3 or up to $15.

How many products are now available in New Zealand with the ingredient felodipine?

With the withdrawal of Felo ER, the AstraZeneca Ltd-supplied medicine Plendil ER is the only product in New Zealand.

Will there be enough Plendil ER to cover patients changing from Felo ER?

Yes, AstraZeneca have assured Medsafe that they can supply the New Zealand market.

Why has Felo ER been recalled?

Medsafe has received information indicating that the European bioequivalence study data used to establish the efficacy of Felo ER was not reliable. Until Medsafe is reassured about the data used, the product will not be sold in New Zealand.

Who conducted the Felo ER bioequivalence studies?

European company Clin-Pharm Research Ltd (CPR) conducted several bioequivalence studies on felodipine in Switzerland. These studies form the basis of the approval for Felo ER in a number of markets.

How many countries sell Felo ER?

Two, Germany and New Zealand. The German Regulatory Authority and Medsafe fully evaluated the bioequivalence studies and evidence of manufacturing quality before granting consent to market Felo ER. While Felo ER has only be sold in two countries (Germany and New Zealand), several other European countries have used the European mutual recognition scheme, to recognise the German Regulatory Authority decision and approve Felo ER for sale in their country.

Have there been any adverse reactions caused by Felo ER?

To date there is no evidence in New Zealand or Germany that the drug has caused undue or unexpected harm to people taking it. Felo ER has been widely distributed in Germany for the last two or three years.

How were problems with the Felo ER bioequivalence studies discovered?

Concerns were raised when the Dutch regulatory authorities reviewing an application to approve Felo ER under the European mutual recognition scheme noticed that the Swiss authority, which is responsible for licensing the CPR site, had not approved some aspects of CPR's research activities. Because of irregularities, the Dutch authorities asked Germany to audit the site. During this audit, which happened after CPR was declared bankrupt, it was discovered that much of the original documentation had been destroyed. The audit of the remaining material, however, showed there were a number of quality, accuracy and validity problems with the testing methods used in the bioequivalence studies to demonstrate the effectiveness of Felo ER.

What did Medsafe do after it learned of problems with the studies?

Medsafe got a copy of the audit from the German authorities, evaluated the data and concluded that the effectiveness of Felo ER could not be assured. As a result of these findings, Medsafe instructed Pacific Pharmaceuticals to stop supplying Felo ER and recall the medicine.

What did the German Regulatory Authority do?

It suspended marketing authorisation for Felo ER in Germany. In addition, the expert advisory committee of the European Medicines Evaluation Agency has recommended that the licences for any products approved under the mutual recognition scheme be revoked.

Who is responsible for checking the validity of the Felo ER bioequivalence studies?

The company that commissioned CPR to do the studies was Swiss-based Siegfried Ltd. It is responsible for checking the validity, accuracy and quality of the studies.

Why didn't Medsafe pick up the problems with the bioequivalence studies?

During its evaluation process Medsafe reviews the raw data that demonstrates the medicine's effectiveness. In this case, the problem is not necessarily that the results of the bioequivalence studies are wrong. The problem is that the quality of the testing system that generated the results cannot be guaranteed. In keeping with international practice, Medsafe does not actively review the quality systems used by the company performing a bioequivalence study during its evaluation process. Rather, it is assured that a company meets the required quality standards by requiring that the site is licensed and audited either by Medsafe or some other competent regulatory authorities. In the Felo ER case, the Swiss government licenced CPR as a company that met good research practice guidelines and had proper quality control systems. Because of this, Medsafe and the German authority accepted that CPR's quality control systems met international standards. The audit has revealed that while CPR had proper systems in place that met international standards when it was first issued with a licence, by the time it conducted the Felo ER studies it was not applying the quality controls appropriately.

Who is responsible for recalling the product?

Pacific Pharmaceuticals Ltd, because it is the New Zealand distributor and owns the rights to the product in New Zealand.

What happens to the product now?

The Director-General of Health has issued a formal notice under Section 36 of the Medicines Act 1981 seeking further information from Pacific Pharmaceuticals Ltd to establish the efficacy of the product. This is expected to be provided in the first quarter of 2003 after new European biostudies currently underway have been completed.

Can Felo ER be sold in the interim?

No. Pacific Pharmaceuticals Ltd has been prohibited from selling or supplying all Felo ER tablets until Medsafe is satisfied of the safety and efficacy of the product, or a decision is made under Section 35 of the Medicines Act 1981 to revoke the approval of Felo ER.

What should patients do with unused tablets?

All unused tablets should be given to pharmacists when patients pick up their replacement medicine.


Timeline of recent events relating to Felo ER

Tuesday, September 24, 2002: Medsafe receives information that raises concerns about the bioequivalence study data relating to Felo ER.

Friday, September 27: Medsafe faxes a written request to the German Regulatory Authority (BfArM) asking for more information.

Wednesday, October 9: BfArM emails its report highlighting the deficiencies in quality control and quality assurance in the biostudy operation to a Medsafe employee who is on leave. Consequently, Medsafe officials do not receive the report until October 18.

Friday, October 25: Medsafe receives response from the company that commissioned the bioequivalence studies, Siegfried, via Pacific Pharmaceuticals Ltd, to the BfArM audit report.

Wednesday, October 30: Medsafe finishes evaluating the BfArM report on the German audit findings relating to Felo ER.

Friday, November 1: Pacific Pharmaceuticals advised of Medsafe concerns.

Monday, November 4: Health Minister Annette King, under Section 36 (3) of the Medicines Act, sends a notice to Pacific Pharmaceuticals prohibiting it from continuing to supply Felo ER.

Tuesday, November 5: Director-General of Health Dr Karen Poutasi issues a formal notice under Section 36 (1) seeking further information from Pacific Pharmaceuticals to establish the efficacy of the product.

Tuesday, November 5: Medsafe sends a letter to Pacific Pharmaceuticals under regulation 50 (1) (b) of the Medicines Regulations, advising it to recall Felo ER.

Tuesday November 12: Letters advising doctors and pharacists of the recall are sent out.

For further information contact:

Marama Ellis
Media Advisor
Ministry of Health
DDI: 04 496 2067
Mobile: 025 802 622
Fax: 04-496-2010

http://www.moh.govt.nz
mailto:marama_ellis@moh.govt.nz

ENDS


27 September 2002

New Hormone Replacement Therapy Guidelines Supported

The Ministry of Health welcomes the new guidelines on combined hormone replacement therapy released today.

"Since the release of the Women’s Health Initiative study in June 2002 that demonstrated that the risks of combined HRT outweigh the benefits, practitioners have waited patiently while the Guidelines Group and the Medicines Adverse Reactions Committee completed a review of the literature on the safety of HRT," said Medsafe senior advisor Dr Stewart Jessamine.

"The advice issued today by these two committees give clear and unambiguous advice to practitioners that use of HRT should be for a limited number of indications and in most women for a limited period of time."

The key messages from MARC support and extend the advice issued by the guidelines group to inform practitioners and consumers that:

"In light of this new advice the Ministry of Health is recommending that all women on HRT should be reviewed at the time of their next prescription to determine the reasons why they are using HRT and to be advised of the risks and benefits of continued therapy to allow them to make an informed choice.” Dr Jessamine said.

The MARC and Guidelines Group advice will be distributed by Medsafe, to every prescriber and pharmacy in the country. Messages will be sent out next week.

The Guidelines Group document and covering letter, and MARC advice is available on the Medsafe website: www.medsafe.govt.nz/Profs/PUarticles/HRTLtrToDr.htm

ENDS

For further information contact:
Kim Purdy
Media Advisor
Government & Sector Relations\Communications
Corporate & Information Directorate
Ministry of Health
DDI: 04 496 2483/025 277 5411
Fax: 04 496 2010

http://www.moh.govt.nz
mailto:kim_purdy@moh.govt.nz


26 July 2002

Paroxetine Mesylate - High Court Rejects Challenge

A challenge to procedures used by Medsafe to evaluate a generic version of an antidepressant drug has been rejected by the High Court.

The challenge was brought by GlaxoSmithKline (GSK) against Medsafe's procedures in assessing the safety and efficacy of a generic version of paroxetine mesylate - an antidepressant from a category of medicines called selective serotonin reuptake inhibitors SSRIs. ( www.medsafe.govt.nz/profs/datasheet/p/paroxetinemesylatetab.pdf)

The outcome of that challenge provides reassurance that Medsafe can, and does, apply rigorous procedures to evaluate the safety, quality and efficacy of medicines, says Medsafe Manager, Clare Van der Lem. Medsafe's evaluation is performed to internationally defined standards and requirements.

The court case dealt with Medsafe's handling of an application for Paroxetine Synthon. The application was supported by substantial chemical, pharmaceutical, pre-clinical and bioavailability data, which in Medsafe's view was adequate to establish the product’s quality, safety and efficacy.

In its evaluation process, Medsafe examined safety data demonstrating that the safety of the generic version of paroxetine mesylate (Synthon) did not rely solely on the available toxicological data for GSK’s paroxetine hydrochloride. The toxicology of Synthon’s paroxetine mesylate and its accompanying impurities has been investigated in properly designed pre-clinical tests as normally applied to the development of any new chemical entity. The multi-volume data from these trials have been supplied and in Medsafe's view, they adequately establish the safety of Synthon’s paroxetine mesylate as used in Paroxetine Synthon tablets.

In addition to safety data, Medsafe also examined data demonstrating that Paroxetine Synthon and Aropax (GSK’s Paroxetine hydrochloride) are bioequivalent with respect to the pharmacologically active entity paroxetine, i.e. the same amounts of the active substance are absorbed to the same extent. Ms Van der Lem says these data indicate that Paroxetine Synthon will have the same clinical effect as Aropax.

GSK questioned the Medsafe evaluation by providing additional data which claimed there were theoretical risks with paroxetine mesylate. Medsafe considered the GSK data and, in keeping with Medsafe's normal practice to ensure that all medicines which are approved are of acceptable safety, quality and efficacy, a decision was made to refer the Medsafe evaluation and the GSK data to the Medicines Assessment Advisory Committee (MAAC), which is an independent expert advisory committee, for advice. The Medsafe evaluation and the GSK data were tabled at the MAAC meeting held in September 2001.

The MAAC confirmed the Medsafe evaluation and recommended that the paroxetine mesylate be approved. If GSK had not questioned the process, at this stage, paroxetine mesylate would have been recommended for approval.

Medsafe repeatedly asked GSK for safety data demonstrating actual risk, but none was forthcoming.

GSK then lodged judicial review proceedings in the High Court against the Ministry of Health, the Minister of Health, AFT Pharmaceuticals Limited and PHARMAC in relation to the decision of the Minister's delegate decision to approve paroxetine mesylate as a new medicine. This had the effect of delaying implementation of the recommendation for approval.

The key issues at the centre of the case were:

GSK asked the Court to quash the decision to approve paroxetine mesylate for distribution. GSK said that, in giving approval, the Minister’s delegate

Justice Young rejected all five grounds of challenge.

The Court stated that it could not rule on the science but that the important point was that Medsafe, MAAC, Generic Sub-Committee (GSC) and the Minister's delegate all considered GSK’s science propositions regarding paroxetine mesylate and rejected, on science grounds, GSK’s views on safety and efficacy and related matters. The evaluation process followed for paroxetine mesylate was robust and ensured that all information that GSK provided was properly considered. The judgement vindicated all the Ministry's actions and commended Medsafe and the MAAC in doing their utmost to consider and assess all the issues raised by GSK. The judgement notes that Medsafe and the Minister's delegate have the responsibility under the Medicines Act to obtain the facts and to make a decision based on those facts regarding new medicines.

The judgement also awarded full costs against GSK in respect of all four defendants, including increased costs for the Ministry of Health, the Minister of Health and AFT Pharmaceuticals based on the fact that the case involved special complexity and significance.

Ms Van der Lem says Medsafe is satisfied that paroxetine mesylate meets the required safety, quality and efficacy standards for a medicine to be distributed in New Zealand. In addition, it is important to note that paroxetine mesylate has been approved by a number of other major regulatory authorities . Some of these approvals have also been challenged by GSK, but none of these challenges have been upheld to date.


17 July 2002

Study Highlights Potential Risk Following Prolonged Use of Oestrogen-Only HRT

Women taking oestrogen-only hormone replacement therapy should discuss with their doctors the risks and benefits of long term treatment with oestrogen at their next visit, Ministry of Health spokesperson Dr Stewart Jessamine said today.

This advice follows the publication of a United States Cancer Institute (NCI) study examining the risk of developing ovarian cancer in women using oestrogen-only hormone replacement therapy (HRT).

Dr Jessamine said "previous research on whether oestrogen-only HRT was associated with an increase in the risk of developing ovarian cancer has been inconclusive."

"While the NCI study does not provide a definitive answer, it does suggest that there may be a small increase in the chance of developing ovarian cancer for women who have taken oestrogen-only HRT for 10 or more years. The study found that in women who had taken oestrogen-only HRT continuously for 10 or more years, ovarian cancer developed in 6 per 10,000 women per year, compared to 4 in 10,000 women per year for women of a similar age who were not taking any form of HRT."

Dr Jessamine said; "the study contains a number of potential flaws which limit the weight that can be given to the findings. As the study was conducted on patients first treated in the 1970's using higher doses of oestrogen than are used nowadays, it is difficult to extrapolate the findings of this study to patients currently on oestrogen-only HRT. Further research is still needed to determine whether the small increase in risk of ovarian cancer reported in this study persists at the lower doses of oestrogen used in modern treatment regimens."

Oestrogen-only HRT is quite different from the combination HRT that was the subject of the recently published Women’s Health Initiative study, as only one hormone (oestrogen) is used. Oestrogen-only HRT is predominately used in NZ only by women who have had a hysterectomy and is used less commonly than combination HRT (oestrogen and progesterone).

"The NCI study raises the possibility that prolonged oestrogen-only HRT may be associated with an increase in the risk of developing ovarian cancer. Until we have more thoroughly reviewed all the research on this subject, and sought advice from our expert advisory committee, the NCI study is insufficient to lead to the Ministry issuing new prescribing advice on oestrogen-only HRT." Dr Jessamine said.

"The study is further evidence, however, that prolonged use of any form of HRT should only take place on the basis of a careful assessment of the risks and benefits for each individual. In the light of the information published in recent studies, doctors should certainly be discussing with their patients the risks and benefits of prolonged HRT as set out in the NZ Guidelines for HRT prescribing. These guidelines, promulgated by the NZ Guidelines group, already advise prescribers not to routinely use HRT for prolonged periods in menopausal women." Dr Jessamine said.

The guideline, which was updated as recently as 2001, is already scheduled for review following publication of the WHI study. Dr Jessamine said: "The Ministry will now be asking the NZ Guidelines group to include consideration of the NCI study in this review".

Products used for oestrogen-only HRT include:
Patches Tablets
Climara
Estraderm TTS
Femtran
Estrofem
Ethinyloestradiol Tab
Premarin
Progynova

12 July 2002

Information for HRT Prescribers

Medsafe has forwarded information to around 1000 doctors and pharmacists bringing their attention to the recent Women's Health Initiative study into Hormone Replacement Therapy.

The recipients of the information are health professionals who are already linked into Medsafe's Prescriber Update electronic notifications.

Medsafe wants to reassure all prescribers that the New Zealand Guidelines Group guideline on 'Appropriate Prescribing of HRT' issued to all prescribers in June 2001 already reflects most of the new information found in the WHI study.

The Ministry of Health will be working with the New Zealand College of General Practitioners and the New Zealand Medical Association to ensure this message is reiterated to all prescribers.

Pharmaceutical company Wyeth has also sent out information about the study directly to all doctors in New Zealand.

A copy of the information contained in the Medsafe message has been included below.

ENDS

For more information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989.

Message from Medsafe
12 July 2002

Hormone Replacement Therapy (HRT) study - Women's Health Initiative
You may be aware of the recent news that the combined HRT treatment arm of the Women's Health Initiative (WHI) study has been prematurely halted. Further information about this study, and an accompanying editorial, is available on the JAMA web site:

http://jama.ama-assn.org/issues/v288n3/ffull/joc21036.html
http://jama.ama-assn.org/issues/v288n3/ffull/jed20042.html

In response to this news, the Ministry of Health issued a media statement on 10th July 2002: www.medsafe.govt.nz/hot/media.htm#10 July 2002

The New Zealand Guidelines Group (NZGG) has also released a media statement:
http://www.nzgg.org.nz/news/HRT_media_release.cfm

Medsafe and the Ministry of Health would like to reassure prescribers that the NZGG guideline on 'Appropriate prescribing of HRT' (issued to all prescribers in June 2001) already reflects most of the new information found in the WHI study, such as concerns about HRT, breast cancer and venous thromboembolism.

The NZGG has had a preliminary look at the guideline in light of the WHI study findings, and advises that they may need to review the data on stroke and heart disease in low-risk women. It is anticipated that if the HRT guideline does need updating, only minor changes will be required.

Copies of the Guideline are available from the NZGG: phone (04) 471 4180 - or go to
http://www.nzgg.org.nz/library/gl_complete/gynae_hrt/index.cfm


10 July 2002

Hormone Replacement Therapy Risks Known, Acted On

ACTION has already been taken in New Zealand to counter an increased risk of women suffering breast cancer or heart disease as a result of taking hormone replacement therapy, the Ministry of Health says.

Overnight news stories from Europe and the United States report the results of the Women's Health Initiative study which found older women without menopausal symptoms taking combined hormone replacement therapy (HRT) were at greater risk of breast cancer and cardiovascular disease.

The National Institute of Health in the United States announced that it would discontinue the study of combined oestrogen and progestogen because of the increased risk of invasive breast cancer in women taking part.

Ministry spokesman Dr Bob Boyd said any woman currently taking HRT who has concerns should continue taking the medication and discuss it with their health professional during their next scheduled visit. The risks and benefits will vary for each woman and should be weighed up on an individual basis.

Dr Boyd noted the study looked at a group of older women without menopausal symptoms taking HRT - not the group usually prescribed HRT in New Zealand.

"Guidelines for prescribing HRT, first written in 1993, were revised last year by the New Zealand Guidelines Group on the suggestion of women's health campaigner Sandra Coney. Copies of the updated guideline were sent to all prescribers in June and July 2001. They were also publicised in Medsafe's quarterly Prescriber Update.

"The revised guidelines made it clear that, contrary to some earlier claims, HRT did not have a role in the prevention of heart disease. They also reinforced the message that longer-term use might be associated with an increased risk of breast cancer diagnosis."

"The Medicines Adverse Reactions Committee also discussed the issue, and requested a letter go to HRT manufacturers asking them to amend any datasheets which claimed HRT could help prevent heart conditions. The Ministry also requested the datasheet warn against starting HRT in women with heart conditions. The letter was sent in the last quarter of 2001. "

Dr Boyd said HRT was not recommended for routine use, but was still the single most effective treatment for symptoms like hot flushes, in helping prevent bone loss and is very effective in treating established osteoporosis.

"We were expecting new research results at the time the guidelines were being updated, and anticipated these studies would reinforce the advice. In fact results have come through earlier than we anticipated. We will again be putting this issue on the MARC agenda for further discussion," Dr Boyd said.

ENDS

For more information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989
www.moh.govt.nz


7 June 2002

Proposed NZ-Australia Therapeutic Products Agency

Proposals for a new agency to regulate therapeutic products for New Zealand and Australia are outlined in a discussion paper released today by Medsafe, a unit of the Ministry of Health.

The discussion paper sets out proposals for establishing a joint agency and for the regulatory scheme it would administer. "The New Zealand Government has not yet made a final decision on whether to proceed with a joint agency, or on the specifics of the regulatory scheme. However, it is clear that regulatory change is required in New Zealand regardless of whether a joint agency is established because New Zealand's current regulations for medicines, medical devices and dietary supplements are outdated" said Medsafe spokesperson, Dr Stewart Jessamine.

"If a joint agency does go ahead, new legislation will be required in both Australia and New Zealand as well as a Treaty between the two countries. The new Agency is therefore unlikely to commence operation until mid-2004 and new controls would not come into effect until that time" said Dr Jessamine.

Dr Jessamine said that New Zealand and Australia would benefit from combining their technical expertise and hence their capacity to regulate a diverse and increasingly sophisticated range of products, including medicines, medical devices, and complementary healthcare products such as vitamin, mineral and herbal preparations. A joint agency would enhance trade opportunities by providing a one-stop shop for companies to gain approval to enter both markets. The new agency would be accountable to both the Australian and New Zealand Governments, and both countries would have an equal voice in the governance of the agency.

The joint agency would administer risk-based regulatory controls for therapeutic products so that prescription medicines and higher risk devices such as heart valves and pacemakers would be subject to tighter control than low risk products such as vitamins, herbal products, dressings or dentures. "Consumers would continue to be able to buy a wide range of low risk products from health food stores, supermarkets and pharmacies as they can at present", Dr Jessamine said.

All therapeutic products would be required to meet minimum standards of safety, quality and effectiveness. "The sorts of measures being proposed here are in line with world-wide trends in therapeutic product regulation" Dr Jessamine said. "They would help to address issues such as product design and quality, adequacy of labelling and consumer information, and truthfulness in advertising".

The public is encouraged to make submissions on the proposals to help inform the development of a new regulatory scheme. Submissions should be sent to the Ministry of Health by 2 August 2002. Officials will report back to the Government in late 2002 on the proposals, the views expressed in the submissions, and a cost benefit analysis of the impact of the proposals. The Government will then make a final decision about whether to proceed with the joint agency.

The discussion document is available on the Joint Therapeutic Products Agency Project website, this Website or from the Ministry of Health.

Ends.

A proposal for a trans-Tasman agency to regulate therapeutic products

This discussion paper seeks comment on proposals by New Zealand and Australian officials to set up a trans-Tasman agency to regulate therapeutic products.  It provides information on the establishment and governance of the agency, and the regulatory framework that would apply to medicines, medical devices and complementary healthcare products.

Submissions close on 02 August 2002 and should be forwarded to:
Team Leader, JTA Project Team, Medsafe, PO Box 5013, Wellington
E-mail:  susan_martindale@moh.govt.nz
Fax:  04 496 2229

Due to its length (195) pages, the discussion paper is provided in three parts:  the cover (a graphic), the Executive Summary (17 pages), and the full text (including Executive Summary).

These documents have been saved as pdf files.  You will need to have Adobe Acrobat to read pdf files.  Adobe Acrobat can be downloaded for free from http://get.adobe.com/reader.

Date Title Closing Date for Comments PDF File
June 2002 A proposal for a trans-Tasman agency to regulate therapeutic products - Cover not applicable Click here for PDF File
June 2002 A proposal for a trans-Tasman agency to regulate therapeutic products - Executive Summary 2 August 2002 Click here for PDF File
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21 March 2002

New Advice About Oral Contraceptives

The Ministry of Health wants women taking the oral contraceptive pills Estelle 35/35ED and Diane 35/35ED, to visit their local doctor or nurse after studies showed women taking them have an increased risk of blood clots, Ministry spokesperson Dr Stewart Jessamine said today.

"Our advice to women taking these pills is to visit their health practitioner before they start their next pack of pills or pick up their next prescription. Women need to discuss the risks and benefits of the pill with their health practitioner before making any decision to stop or change their preferred method of contraception."

Dr Jessamine said this new information would clearly be distressing for the estimated 25,000 women currently taking Estelle or Diane and he encouraged women to talk about any concerns they have about the safety of their oral contraceptive with their health practitioner.

Dr Jessamine said the Medicines Adverse Reactions Committee asked Medsafe to issue the advice to women after reviewing a recently published United Kingdom study.

The study shows that the risk of blood clots (or venous thromboembolism) with contraceptive pills containing oestrogen and cyproterone acetate is at least as great as that with third generation oral contraceptives.

"Estelle and Diane are the only medicines containing oestrogen and cyproterone acetate currently available in New Zealand."

For every 100,000 women aged 15-44 years who are not taking an hormonal contraceptive, between five and ten will develop a blood clot in one year.

"The risk of blood clotting is three to four times higher for women taking a second generation pill, for example Monofeme, Levlen ED and Triquilar, and six to eight times higher for third generation pills such as Femodene, Marvelon, Melodene, Mercilon and Minulet."

"For women taking pills containing cyproterone acetate the risk is possibly eight times higher. That means the risk for Estelle and Diane is at least as high as that of third generation pills."

Dr Jessamine said Medsafe has provided GP and family planning clinics with updated patient information leaflets.

In addition, it has issued prescribing advice to doctors, midwives and pharmacists recommending that they confine the use of Estelle and Diane to women with conditions such as polycystic ovary syndrome, hirsutism (abnormal hair growth) and other androgen-dependant diseases such as pronounced acne.

ENDS

For more information contact:
Hayley Brock
Media Advisor
(04) 496 2115, 025 495 989
http://www.moh.govt.nz.html

Background

How many women are estimated to be taking Estelle 35, Estelle 35ED, Diane 35 or Diane 35ED?

Approximately 25,000 women are taking these medications, with the majority taking Estelle as it is subsidised.

Are there any figures on how many women in New Zealand have been on Estelle or Diane and suffered blood clots?

Up until November 2001 The Centre of Adverse Reactions Monitoring had received 18 reports of blood clotting occurring in women taking oral contraceptives containing cyproterone acetate. Fifteen of those 18 women had developed a pulmonary embolism, however none were fatal.

Of these, 18 women 10 had been prescribed the medication for contraceptive purposes, five for the reduction of acne problems, and two for irregular menstruation. In one case the reason for prescribing is not recorded.

When are Estelle and Diane usually prescribed?

Diane and Estelle are approved for the treatment of androgen-dependant diseases (such as pronounced acne and abnormal hair growth), polycystic ovary syndrome and for oral contraception in women with these conditions.

What will be the prescribing advice from now on?

Prescribers have been advised to prescribe Estelle and Diane only to women with disorders such as polycystic ovary syndrome, abnormal hair grown, pronounced acne and as a contraception for women with these conditions. The Medicines Adverse Reactions Committee has recommended that women with mild acne should not commence on a cyproterone-containing oral contraceptive as first line contraception.

Prescribers have also been advised to review the appropriateness of Estelle and Diane for patients already taking them.

Prescribers should fully advise patients of the risks of blood clotting and take into account the personal and family history of the woman before prescribing Estelle or Diane, or any other contraceptive.

New Zealand is the first, and so far only, country to advise women about the risk of blood clots posed by pills containing cyproterone acetate.

What does the prescriber have to take into account?

Before prescribing a contraceptive, or reviewing the current choice of contraceptive, a doctor should discuss the options and explain the risks and benefits of contraception with a patient. The doctor and patient can then make an informed choice on the best contraceptive option.

This latest information gives doctors and patients further information necessary to make informed decisions.

What is Medsafe doing to publicise the updated advice?

Medsafe has provided the following material:

All four items have been sent to family planning clinics, Family Planning Association offices, Women's Health Action, the Plunket Association, private maternity hospitals, gynaecology departments of public hospitals, general practitioners and specialists, registrars, midwives and hospital and retail pharmacies.

Copies of this material are available from the Medsafe website: www.medsafe.govt.nz/hot/contraceptives.asp

Why weren't these brands of pills incorporated into the advice given to women about third generation pills in 1996?

Previous advice issued in 1996 and 1999 on the safety of the oral contraceptive pill has successfully led to major changes in medical practice and prescribing behaviour in this country.

The advice issued back then to patients and doctors, that third generation pills carry a small increased risk of blood clots over other oral contraceptive pills, did carry information about pills containing cyproterone acetate. This advice asked doctors to inform women about the risks of oral contraceptives and consider prescribing second-generation pills for women seeking oral contraception. That advice did not specifically comment on the risk of clots with Diane and Estelle, as the data on risk published at that time was insufficient.

Information further defining the risk for pills such as Diane and Estelle began to accumulate in 1999 with the major study which conclusively demonstrated increased risk only being published in late 2001. The study was reviewed by the Medicines Adverse Reactions Committee in December 2001. The articles and leaflets were then written, consulted on, peer reviewed and released this week.

It is important to note use of third generation pills in New Zealand significantly decreased since the advice was first issued. It is now common practice in this country for doctors to advise women about the benefits and risks of taking oral contraceptive pills and to assess each woman carefully for risk factors.

What is a blood clot?

The blood clots associated with using oral contraceptives occur in the veins of the legs. They cause a blockage in the vein. On rare occasions pieces of the clot dislodge and travel to the lungs. Clots in the legs or lungs are called venous thromboembolism or VTE. While most women recover completely from VTE, some have ongoing health problems. A small number of women have died.

These blood clots in the veins are not the same as the clots that you can see in menstrual blood when you have your period.

How often do blood clots occur with oral contraceptives?

Blood clots only happen very occasionally in women using oral contraceptives, and deaths from blood clots are even more rare. The risk of having a blood clot depends on a number of factors. It increases with age and it also depends on what kind of oral contraceptive is being taken.

Most oral contraceptives contain both oestrogen and a progestogen. These are called combined oral contraceptives. Depending on the type of progestogen in the pill, they are known as either second or third generation contraceptive pills. There are also pills containing cyproterone, which are used to treat conditions caused by an excess of the hormone androgen like pronounced acne. These cyproterone-containing pills provide contraception as well. Another type of oral contraceptive is the progestogen-only pill, also known as the mini-pill.

Women can have blood clots when they are not using oral contraceptives. For every 100,000 women aged 15-44 who are not taking the pill, approximately 5-10 will develop a blood clot in one year.

Taking a combined oral contraceptive increases this very small risk of developing a clot by 3-4 times if you are on a second generation pill, 6-8 times if you are taking a third generation pill, and possibly over 8 times for those on pills containing cyproterone. Women using progestogen-only pills are at little or no increased risk of blood clots.

Which pills are which?

Progestogen-only pills: Femulen, Microlut, Microval, Noriday, Cerazette
Second generation pills: Brevinor, Brevinor-1, Levlen ED, Loette, Microgynon 20ED/30/30ED, Monofeme, Nordette, Norimin, Synphasic, Trifeme, Triphasil, Triquilar ED
Third generation pills: Femodene, Marvelon, Mercilon, Minulet, Melodene
Anti-androgen pills: Diane35/35ED, Estelle 35/35ED
Pills containing 50mcg oestrogen and progestogen: Biphasil, Microgynon 50ED, Nordiol, Norinyl-1, Ovral.

How often are blood clots fatal?

Of those women who get a blood clot, about 3% will die. As combined oral contraceptives are used by many women in New Zealand, two deaths a year from blood clots would be expected in this country.

During 1990 – 2001, 20 women in New Zealand using combined oral contraceptives are known to have died of a blood clot in the lungs. Of those who died, 15 were using third generation pills and 2 were using pills containing cyproterone. There is a risk of death with second generation pills but it is lower

What increases the risk of blood clots?

Some of the risk factors for blood clots are:

Your risk of having a blood clot can also be temporarily increased, for example by a long flight, childbirth, being immobilised by injury or illness, or by having surgery. Women who have had a previous blood clot should not take a combined oral contraceptive. You should tell your doctor if any of these risk factors apply to you.

What are the symptoms and what should I do about them?

The symptoms of a blood clot in the leg are swelling, tenderness and pain, but a blood clot may occur without symptoms. Breathlessness and sharp chest pain can occur with a blood clot in the lungs. These symptoms can also occur for other reasons.

If you develop any of these symptoms, you should see a doctor immediately. You should be particularly alert to these symptoms if you have a risk factor for blood clots.

If you get a blood clot, your doctor may refer you to hospital for tests and treatment with blood-thinning medication. Treatment may last for several months and some women may have ongoing problems such as pain or swelling.

Who can I discuss this information with?

You should discuss your risk of blood clots with your doctor. If together you decide your risk on a combined oral contraceptive is too high, there are a number of different types of contraceptives available, including the progestogen-only pill and non-hormonal barrier methods such as condoms. You should discuss with your doctor which type is likely to suit you best. You have a right to expect your doctor to explain this information in a way that you can understand.
Remember that blood clots are rare events in healthy women taking the contraceptive pill. Serious consequences are even less likely to occur. Your risk will be reduced even further if you see a doctor immediately if you get any symptom of a possible blood clot.

Where else can I get information?

Consumer information including symptoms of a clot can be found on the Medsafe website at www.medsafe.govt.nz/Consumers/leaflets/oralcontraceptives.asp
Information for doctors can be found at www.medsafe.govt.nz/hot/contraceptives.asp

Other organisations to contact:
The New Zealand Medical Association
Shani Naylor
Communications Manager
(04) 472 4741
027 284 1081

Family Planning Association
Jan Kerr-Smith
Communications Coordinator
(04) 384 4349
021 915 107

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