Revised: 14 May 2013
Publications
Media Releases for 2000
| 24 Nov 2000 | Finger Pricking Devices |
| 16 Jun 2000 | New Zealand study on oral contraceptives published |
| 3 Apr 2000 | Medsafe Urges Caution for Some Users of St. John's Wort |
| 24 Mar 2000 | Prepulsid Alert |
| 22 Mar 2000 | Distribution of Rezulin Under Review |
| 17 Mar 2000 | New Zealand Stock Not Affected By Recall |
| 15 Mar 2000 | Easier Access to Nicotine Replacement Therapies |
| 20 Jan 2000 | Ministry Looking to Close Legal Loophole |
24 November 2000
Finger Pricking Devices - Ministry reinforces the use of Accepted Good Practice
Diabetes New Zealand and the Ministry of Health are reminding health professionals of the current accepted good practice for taking blood samples with finger pricking devices.
Advice was issued by Diabetes New Zealand two years ago and was widely reported. However, it appears from a recent survey conducted by the Ministry of Health that the advice, aimed at minimising the risk of transmission of infection, is not always being followed.
Finger pricking devices are used by individuals such as people with diabetes to test their own blood sugar levels. They are also used in doctors' surgeries, clinics, marae healthcare services and some laboratories to collect small blood samples from a number of clients. The devices commonly resemble a ballpoint pen and contain a sharp, spring loaded lancet which momentarily pierces the skin.
Dr Bob Boyd, the Ministry's Chief Advisor, Safety and Regulation said that the commonly accepted practice is for patients using their own devices to keep the same lancet loaded in the device for several tests and then safely dispose of it, replacing it with a new sharp sterile lancet.
When health professionals use finger pricking devices for testing more than one patient, commonly accepted good practice is to either use a separate disposable sharp lancet for every client, or to use a spring-loaded device from which all parts which come into contact with the client's skin are detachable and are disposed of each time. Only some brands of the spring-loaded finger prickers are suitable for use on more than one person. It is not good practice to substitute an individual patient device for this purpose.
Dr Boyd said that Diabetes New Zealand have done a great job trying to raise the standards of health professional practice, and there has been some publicity in the past. However, a recent survey of hospitals suggests the advice has not been implemented.
"It is disappointing to find that despite the previous publicity and despite our heightened awareness of possible blood-borne illnesses, some health professionals are not following good practice advice."
"The development and refinement of medical technology, allied with increased awareness about the risks of transmission of disease through shared equipment, has seen the development of equipment designed specifically for safe use on more than one person. In this case it is no longer appropriate to re-use the equipment and depend on attempted disinfection between cases, when there are safer devices readily available.
"Health professionals must ensure they keep up to date on currently accepted good practice methods, and that they are using the appropriate equipment for the situation. If they are in any doubt about the equipment they are using they should throw it out and replace it with modern equipment."
Dr Boyd said that the same advice applied to the home, where several family members may be tempted to use the same finger-pricking device for monitoring their blood sugars. Everyone should have their own device. Don't share needles and don't take unnecessary risks.
There is a documented, but extremely small risk of transmitting hepatitis B from someone who is a carrier of the disease by the use of single finger pricking devices on more than one person. While the Ministry is not aware of anyone in New Zealand having contracted hepatitis B in this way, it has occurred overseas.
Over the past ten years there have been four episodes reported worldwide of Hepatitis B infection being transmitted through use of individual-use devices on more than one person. Three of those episodes were in America and one in Europe. In each of these cases only the lancet had been replaced and it was reported that the nurse had not changed gloves between tests.
Dr Boyd said ensuring the quality and safety of health care required individual commitment and systemic action.
"All of us working in the health sector have to ensure quality is built into everything we do in our professional lives, and that we build quality improvement into our systems."
Dr Boyd said the forthcoming Health and Disability Services (Safety) Bill would provide a regulatory framework for safety and quality assurance. Other initiatives such as the Health Professionals Competency Assurance Bill were also designed to ensure the quality and safety of health services.
More information is available: Information for health professionals
16 June 2000
New Zealand study on oral contraceptives published
The Ministry of Health is today releasing the results of a study published in The Lancet examining the risk of death from pulmonary embolism in women taking oral contraceptive pills.
The research, commissioned from Otago University Professor of Preventive and Social Medicine David Skegg and colleagues by the Ministry of Health, shows that 17 women taking oral contraceptives died of a pulmonary embolism - a blood clot in the lungs - between 1990 and August 1998. Since the study was commenced a further three cases have been reported, bringing the total deaths to 20 between 1990 - 1999.
The study concludes that for every 100,000 women taking the pill, one woman per year will die from venous thromboembolism - a blood clot in the veins. Given usage in New Zealand these results indicate that two New Zealand women may die each year from blood clots associated with taking oral contraceptives.
Published in The Lancet today the study was yesterday considered by the independent Medicines Adverse Reactions Committee, which advises the Ministry of Health's Medsafe division.
Both have reiterated the advice that women keep taking the pill and discuss any concerns with their general practitioner or family planning clinic.
Medsafe spokesman Dr Stewart Jessamine said the committee examined the results of Professor Skegg's study in conjunction with other international literature. It concluded that although the number of deaths is higher than previously reported or estimated, the results are similar to those found in a British study.
"Clearly each of these deaths is a tragedy for the families concerned and I want to acknowledge that and extend to them our sympathy.
"Although this will be no consolation at all to those already affected, this comparability with overseas results suggests that overall the risks are not significantly greater than thought. It is in this context that the Medicines Adverse Reactions Committee and Medsafe have concluded that as long as women are fully informed of the risks they should continue to have the right to choose to take whichever oral contraceptive they wish."
Blood clots are associated with both second and third generation oral contraceptives.
"Professor Skegg's research is consistent with the results published in earlier studies that third generation pills containing gestodene or desogestrel are approximately twice as likely to cause blood clots as second generation pills containing either levonorgestrel or norethisterone," Dr Jessamine said.
Blood clots occur in the veins of the leg where they may cause a blockage. In some cases pieces of the clot dislodge and travel to the lung - a pulmonary embolism. Treatment of blood clots involves admission to hospital and ongoing treatment to thin the blood. Some patients are left with ongoing problems such as pain and swelling at the site of the blood clot in the legs.
Dr Jessamine said the study supported the need for doctors to continue to advise women about the benefits and risks of taking oral contraceptive pills; and to assess each woman carefully for risk factors.
Some of the risk factors for blood clots are a previous blood clot, a close family member who has had a blood clot, being overweight, bad varicose veins, cancer, recent surgery and being immobilised.
"While changing a woman over to a second generation pill can be expected to reduce her risk of a blood clot by half, some women prefer third-generation pills. The available evidence is that women are already making informed decisons on the basis of the information we have provided - since 1996 the use of third generation pills has dropped by over 50% and they now account for only 35-40% of the market," Dr Jessamine said.
"Studies confirm that for most women the oral contraceptive is an extremely safe and reliable form of contraception. We believe a rigorous application of informed consent is the best option and the Medicines Adverse Reactions Committee has advised that it is not necessary to remove these pills from the market or restrict access in some other way, The decision to re-iterate our earlier advice is based on a reassessment of all of the available information and we would advise women to continue taking their contraceptive pill and to talk to their general practitioner or family planning clinic if they have any concerns about the product they are taking," Dr Jessamine said.
Doctors are being alerted to the research, reminded of the risks and advised to take careful histories and give full information before prescribing oral contraceptives. Medsafe is re-issuing a consumer safety leaflet, reactivating an 0800 number for women seeking more information and carrying out some print advertising.
The 0800 number is 0800 930039
3 April 2000
Medsafe Urges Caution for Some Users of St John's Wort
People taking St John's wort should be careful as the herbal remedy can interfere with some medicines making them less effective, the Ministry of Health said today.
St John's wort (Hypericum perforatum) is widely used for the symptoms of depression.
Senior Medical Advisor at Medsafe, Dr Stewart Jessamine, said a number of papers had recently been published demonstrating that St John's wort can speed up the body's ability to break down certain medicines making them less effective.
Patients taking medications for the treatment of epilepsy, HIV / AIDS, who are on blood thinning medication or who have had an organ transplant, and are also taking St John's wort are particularly susceptable to changes in effectiveness of their medication and should see their doctor as soon as possible.
Patients who are taking St John’s wort together with a number of other medications including anti-depressants (such as Prozac or Aropax), migraine treatments (such as Imigran), or oral contraceptives may also need to have their medication reviewed and should see their doctor in the near future.
Dr Jessamine said that "patients taking medications should not stop St John's wort without consulting their doctor, because the prescribed medicine may become too potent and the dose of the medication may need to be adjusted."
In the United Kingdom two cases of heart transplant rejection have been reported which are due to an interaction between cyclosporin, a powerful medicine used to prevent organ rejection, and St John’s wort.
Dr Jessamine said "several cases of possible effects on antidepressants and St John’s wort have been reported in Australia. However, Medsafe have only received two reports in New Zealand, none of which were serious."
St John’s wort is widely used and it has been estimated that in Europe alone millions of people have used this natural remedy. Several quality studies have also been published which demonstrate that serious side effects to St John’s wort are very rare. No deaths from St. John's wort have been reported in any country and the limited number of reports of side effects in the world literature would appear to support the trial findings.
The reports that St John’s wort can interfere with some medicines used in the treatment of serious medical conditions has the potential to have very significant health consequences for a small number of patients. In response to the potential risk Medsafe has produced and distributed to doctors, pharmacies, complementary healthcare practitioners and retailers a large number of consumer information leaflets.
Medsafe has also worked closely with manufacturers, packers and distributors of St John’s wort in New Zealand.
"The complementary healthcare industry has been responsive to our concerns and endorse the information provided in our leaflets. The industry bodies have also acted very responsibly and have proposed to add cautionary labelling statements to their products to ensure that consumers are informed about the risk of interaction with some medicines," Dr Jessamine said.
Ron Law, Executive director of the National Nutritional Foods Association (New Zealand) said the information distributed by Medsafe is a balanced review of the literature and is fully supported by the complementary healthcare industry.
Working closely with Medsafe on this issue has been a positive experience for both the industry and, I believe, Medsafe. Our response to this emerging safety issue clearly demonstrates the maturity of the industry in New Zealand and that self-regulation for this sector is a viable option." Mr Law said.
Mr Law stated said Medsafe was to be congratulated on its co-operative approach to dealing with the issue of St John's wort. "I believe that the model of inclusive discussion represents an important change in the relationship between Medsafe and the complementary healthcare manufacturing sector."
More information is available: Information for health professionals and consumers
24 March 2000
Prepulsid Alert
Controls around the use of the medicine Prepulsid minimise the risk of it being prescribed to people most at risk of the drug's known side effects.
Medsafe's reassurance follows news that Janssen Pharmaceutica has agreed to stop distributing the medicine in America. Prepulsid (generic name cisapride) is used to treat severe gastro-intestinal conditions.
Janssen's decision followed America's Food and Drug Administration receiving 341 reports of heart rhythm abnormalities including 80 deaths associated with its use. Most of these side effects occurred in patients taking Prepulsid with other medications known to increase the risk of heart rhythm problems, or in people with medical conditions which predispose them to abnormal heart rhythms.
In America, Prepulsid will continue to be available from general practitioners until July and thereafter on the recommendation of gastro-enterologists.
Medsafe spokesman Dr Stewart Jessamine said there were stricter controls on Prepulsid in New Zealand. A specialist's recommedation was required before a GP's prescription would be Government funded.
"Medsafe has also advised GPs and specialists of the possible side effects of Prepulsid in publications in 1997 and February 2000," Dr Jessamine said.
Medsafe's latest advice warned against prescribing Prepulsid to people taking medications which may;
- interfere with how the body handles cisapride, such as erythromycin, fluconazole, clarithromycin
- cause heart rhythm disturbances themselves, such as amniodarone
Medsafe also advised doctors not to prescribe Prepulsid to patients with medical conditions predisposing them to heart rhythm disturbance or to patients with liver problems.
Between 100,000-150,000 New Zealanders use Prepulsid. Worldwide, 190 million patients have been prescribed cisapride since it was first introduced in 1988.
New Zealand's Centre for Adverse Reactions Monitoring at Otago University has received 19 reports of adverse effects to Prepulsid since 1991. None of these adverse effects resulted in death and only one case involved heart rhythm disturbance.
Dr Jessamine said in light of the decision in America, Medsafe would again review the safety of Prepulsid in conjunction with the Medicines Adverse Reactions Committee.
"In the interim we would like to assure patients that prescribers in New Zealand are aware of the need to avoid prescribing Prepulsid to people most at risk.
"People taking Prepulsid should discuss with their doctor if they have any risk factors and whether Prepulsid is the most appropriate medication for their condition the next time their prescription is due for renewal," Dr Jessamine said.
For further information contact Sue McCabe, Media Advisor, 04 496 2167 or 025 495 989
22 March 2000
Distribution of Rezulin Under Review
Distribution of the diabetes medicine, Rezulin is now under review in New Zealand, following recent concerns the drug may cause toxic liver damage.
Rezulin was approved for distribution in New Zealand in January, but has not yet been sold or marketed in this country. It has however, been supplied to 12 patients - 10 under clinical trials and two at the special request of their doctor.
The manufacturers, Parke-Davis/Warner-Lambert today advised Medsafe it would not proceed with distribution of the product in New Zealand, following the withdrawal of Rezulin from the US market. The manufacturer is also contacting the prescribers involved in New Zealand clinical trials to advise them of the withdrawal.
Senior Medical Advisor, Dr Stewart Jessamine says Medsafe will now be collecting information with a view to considering revoking the consent.
"As part of the approval process, Medsafe had taken into account the fact that Rezulin's use elsewhere had been restricted after it was found to cause liver damage in some patients.
"The Medicines Assessment Advisory Committee will now be reviewing the data and on-going safety data which has subsequently been collected."
"Although it was recognised that Rezulin can cause liver damage, evidence at the time showed that this occurred in a small number of patients, (less than 0.5%) and the risk of serious liver damage occurring was significantly reduced by regular monitoring of blood tests of liver functions."
"The prescribing information for Rezulin stated a number of requirements for monitoring of liver tests in order to minimuse the risk to acceptable level."
Dr Jessamine said it is highly likely the clinical trials will be stopped immediately as a result of today's withdrawal.
For more information contact: Selina Gentry, Media Advisor, ph: 04-496-2483 or 025-277-5411
BACKGROUND: The approval process for new medicines in New Zealand
If a company wishes to market a medicine in New Zealand, the legislation (Medicines Act 1981) requires that the company must obtain the consent of the Minister. The Medicines Assessment Advisory Committee (MAAC) is the Ministerial advisory committee which evaluates new medicines on behalf of the Minister. The MAAC consists of clinicians in a number of specialist fields. The MAAC meets four times a year.
The committee evaluates data submitted by the company which examines the safety, quality and efficacy (effectiveness) of the product. The applications are in a common format utilised by European medicines regulatory agencies. New Zealand applies the same standards for clinical trials and manufacturing processes to demonstrate safety, quality and efficacy as other OECD regulators, including the UK and EU.
If the MAAC is satisfied that an application meets the required standards it makes a recommendation to the Minister that the product can be approved.
The MAAC may add conditions to this approval or require that changes to prescribing information or labelling are made before the product can be finally approved. In addition to completing any actions recommended by the Committee, Medsafe also evaluates labelling to ensure that it complies with the New Zealand regulatory requirements. It is only after a new medicine has been recommended for approval by the MAAC, and Medsafe has approved labelling and resolved any outstanding issues that the Minister grants approval for the product.
The Ministerial decision to grant consent for the distribution of a medicine is published in the New Zealand Gazette. The gazette is published weekly. As with many regulatory decisions, the Ministerial authority to accept recommendations from the MAAC and to approve medicines has been delegated to a Chief Advisor in the Ministry of Health.
17 March 2000
New Zealand Stock Not Affected By Recall
Travellers to Australia who may have purchased Herron Paracetamol, a product currently being recalled, are advised not to use the paracetamol and to contact Regional Health Limited on freephone 0508 650 938.
Herron Pharmaceuticals is recalling all paracetamol products in Australia, following the discovery of a tampered package in a Brisbane (Queensland) supermarket.
The company had previously distributed products in New Zealand, however this stopped six months ago. Any stock still available in New Zealand is not affected by the recall.
Herron Pharmaceutical Chief Executive Officer Euan Murdoch said "Our primary concern is for the safety of our consumers."
"At this stage only one package has been discovered to have been tampered with. We are acting responsibly and recalling all paracetamol products as a precautionary measure."
"There is no evidence at this stage to suggest that any paracetamol products outside Brisbane, or any other Herron products are effected in any way."
For more information contact: Selina Gentry, Media Advisor, ph: 04-496-2483 or 025-277-5411
For more information about the recall contact Regional Health Limited Freephone 0508 650 938.
15 March 2000
Easier Access To Nicotine Replacement Therapies
Health Minister Annette King announced today the Government was making it easier for smokers to gain access to nicotine replacement therapies.
Mrs King said NRTs would soon be able to be sold through smoking cessation clinics run by medical practitioners, nurses, pharmacists or psychologists. Previously they could only be obtained from pharmacies or on a doctor's prescription.
Medsafe, the medicines regulatory body of the Ministry of Health, had recommended a reclassification of nicotine replacement therapies under the Medicines Act 1981, to allow gums, patches, inhalers, sublingual tablets and nasal spray to be supplied through smoking cessation clinics run by appropriate registered health professionals, she said.
"The new policy removes one more obstacle for smokers wishing to kick the habit in the butt.
"The Government has taken a strong stance on smokefree policies and we think this initiative will give extra help to smokers who want to quit the habit," Mrs King said.
Improving access to smoking cessation therapies is a major World Health Organisation (WHO) initiative. In New Zealand, the National Health Committee, National Heart Foundation, Cancer Society, Health Funding Authority and some Independent practitioners associations have expressed support for improved access to nicotine replacement therapies.
Mrs King said she hoped NRTs could be available at selected smoking cessation clinics by mid-April.
For more information, contact John Harvey (04) 471 9305.
20 January 2000
Ministry Looking to Close Legal Loophole
The Ministry is looking at options to prevent pharmacists from dispensing prescriptions medicines to consumers overseas without a doctor's prescription.
Ministry Senior Medical Advisor Dr Stewart Jessamine says a recent courtcase highlighted a limitation in the law which allows pharmacist to use the Internet to dispense medicines without presciption to individuals overseas.
He said in this situation, the only contact with the pharmacist is via the internet and the consumer has not consulted a medical practitioner nor has a valid prescription.
Dr Jessamine says that many prescription medicines can be dangerous if not used appropriately and as such, New Zealand law restricts access to consumers who have sought advice and consultation from a medical practitioner.
Both the Ministry of Health and the Pharmaceutical Society believe that selling prescription medicines directly to consumers is dangerous and both ethically and professionally wrong.
Dr Jessamine says the law is clear on the provision of prescription medicines to consumers in New Zealand and to ensure public safety the Ministry of Health would prosecute any New Zealand based practitioner who supplied prescription medicines without a valid medical practitioner's prescription.
The gap in New Zealand law has international ramifications for New Zealand and highlights the issue of enforcing restrictions for medicines which carry significant risks of either adverse reactions or abuse.
Many consumers order medicines over the Internet that require a prescription in their own country and can be stopped at the border by Customs. In the past 12 months USA customs officals are reported to have siezed over 1 million tablets of medicines imported over the internet.
The options to be considered in light of the outcome of the case include appealing the decision and looking at making regulations or legislation to ensure New Zealand law appropriately controls this practice.
For more information contact:
Selina Gentry Media Advisor, 04-496-2483, 025-2775411
Richard Griffin, Pharmaceutical Society, 04 8020030
Background information
The decision was released 23 December 1999. The case was heard in the district court in Auckland.
The Ministry has now released the medicines seized to Mr Bell in accordance with the Court's decision.
The court case was an appeal by Peter Bell, Auckland pharmacist against the Ministry's decision to seize medicines which he had been supplying over the Internet. The issue that was the subject of the appeal was whether the Medicines Act 1981 prohibited pharmacists from supplying prescription medicines direct to consumers (overseas) without a prescription.
The medicines were seized on 23 November 1999. Over 1000 original packs of prescription medicines were seized. They included a wide variety including medicines for hair loss, impotence, weight loss, antidepressants, diabetes, hormone replacement, fluid retention, prostate, high blood pressure, antibiotics, oral contraceptives, epilepsy and asthma.
Of the medicines seized the Ministry understands there were 100 packages destined for overseas.
The Ministry's seizure was appealed within the seven days allowed by statue.
The Ministry is aware of a growing number of sites (at least 30 in New Zealand) that are involved in similar activities. The Ministry is continuing to monitor and investigate activities in this area. Where any breaches of legislation are discovered the Ministry would consider prosecutions.
The Pharmaceutical Society is considering whether, despite the finding, a pharmacist who supplies prescription medicines to anyone without a prescription is in breach of professional ethics.
