Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Minister's response
- Dr Don Matheson (2 July 2004)
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Re: Minister's response
- Michael L Jenkinson (3 July 2004)
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Re: Minister's response
- David M Coulter (9 July 2004)
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Re: Minister's response
- Dr Simon C Roughan (9 July 2004)
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Dr Don Matheson, Deputy Director-General Public Health Directorate, Ministry of Health, New Zealand
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Dear Sir The Herxheimer et al letter published in the BMJ of the 3rd July 2004 is misleading in claiming that Medsafe, the New Zealand medicines regulator, is intending to stop funding the Intensive Medicines Monitoring Programme (IMMP). Medsafe and the University of Otago, (the centre where the IMMP is based), are still planning and discussing the pharmacovigilance services to be purchased through Medsafe’s contract with the University. While the future direction of the IMMP is one of the items under discussion, I can assure you that Medsafe, and the Ministry of Health, are committed to ensuring that New Zealand operates world-standard medicines safety systems now and into the future. In setting a future direction for pharmacovigilance in New Zealand, Medsafe will be working with both the University of Otago and our Medicines Adverse Reactions Committee (MARC) and a final decision is not expected for several months. A review of the functions of the IMMP conducted in 2003 by its new Director, identified that the programme needs to change to make it more effective, focused, and resource-efficient. The IMMP data collection and entry system relies heavily on paper-based data collection from a number of sources and is extremely labour intensive. The Minutes of the 114th, 115th and 117th meetings of the MARC, available from the Medsafe website www.medsafe.govt.nz, provide some evidence of why change to the IMMP methodology is required. 1 Since the IMMP was first established in 1977, the purchase and delivery of medical care in New Zealand, and the practice of pharmacovigilance internationally, have changed dramatically. It is hardly surprising that the review found the IMMP largely unable to cope with the demands and expectations of modern pharmacovigilance. In order to grow and develop, all programmes must be subject to review of their structure and performance and changes made to meet new challenges. It is unrealistic to expect that systems developed in the 1970s should remain largely unchanged in 2004. Medsafe agrees with the IMMP Director that the programme needs to change and is working with the University of Otago and the MARC to determine the types of pharmacovigilance services that should be purchased and provided in the future. I can assure the signatories of the Herxheimer letter that New Zealand is committed to strengthening its pharmacovigilance services to meet the demands of modern medicine. Medsafe intends to purchase relevant services to deliver a powerful pharmacovigilance presence in this country that supports New Zealand’s status as having one of the top three-adverse reactions reporting services in the world. The University of Otago and Medsafe are using the lessons learnt from the history of medicines safety monitoring in this country to inform our thinking about pharmacovigilance. However, while history can be used to inform decisions, looking backwards cannot be the sole basis of decision making, we must always look forward in order to move safely into the future. Dr Don Matheson
References: 1 http://www.medsafe.govt.nz/profs.htm. Adverse Reaction Reporting and IMMP. Minutes of the Medicines Adverse Reactions Committee. Competing interests: None declared |
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Michael L Jenkinson, Consultant Physician Queen Elizabeth, The Queen Mother Hospital, St Peters Road, Margate, Kent CT9 3AN
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Dear Sir I read the letter by Andrew Herxheimer et al published in the BMJ of the 3rd July 2004 and the reply by Don Matheson with interest. This is because of my own awareness of the service the New Zealand intensive medicines monitoring programme (IMMP) has, and can continue to provide, if resourced appropriately. Its ability to allow both long term monitoring in a geographically defined population and to contribute rapidly to international safety interests are great strengths. I did not feel that Don Matheson's reply conveyed fully to me the overall contents of the New Zealand Medicines Adverse Reactions Committee minutes he referred to. I felt the latest minutes were consistent with some of the concerns expressed in the original letter which Don Matheson did not address. Accordingly as a service to any interested readers I extract below a relevant section of the latest minutes of the 117th meeting[1]. "4.4.1 Review of the Intensive Medicines Monitoring Programme (IMMP report - ..) Issue .. of the IMMP conducted this review in order to determine whether the current work of the IMMP is sustainable with the available resource. In addition, the review provided a base from which to plan and prioritise the future work of the IMMP. The review concluded that, overall, the IMMP was attempting to perform too large an amount of work for the resource available. The high number of medicines on the IMMP, and the monitoring of two very large cohorts, resulted in an overloading of the system. It was concluded that it might be necessary to adapt the current IMMP methodology in order to perform studies within a shorter time frame. The IMMP review identified changes that need to be made to make the programme more effective, focused, and resource-efficient. Such changes include removing some medicines from the IMMP and restricting the amount of follow-up performed on the remaining medicines. Discussion The Committee noted the IMMP review. Members agreed that Medsafe should provide the MARC with details of how pharmacovigilance might be managed in the upcoming Joint Trans-Tasman Agency, for discussion at the June 2004 MARC meeting. Such a document may stimulate useful discussion about possibilities and improvements in the post-marketing surveillance of medicines in the future. Recommendation The Committee recommended that Medsafe provide members with details of how pharmacovigilance might be managed in the upcoming Joint Trans- Tasman Agency, for discussion at the June 2004 MARC meeting." References: 1 http://www.medsafe.govt.nz/Profs/adverse/Minutes117.htm. Adverse Reaction Reporting and IMMP. Minutes of the Medicines Adverse Reactions Committee. Accessed 3 July 2004 Competing interests: Chair, East Kent Hospitals Trust, Drugs and Therapeutics Committee. I have had no direct connection with the IMMP since 1979 |
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David M Coulter, Retired 264 Highgate, Roslyn, Dunedin 9001, New Zealand
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Dear Sir This letter is a response to the comments of Dr Don Matheson who wrote on behalf of the New Zealand Minister of Health concerning the Intensive Medicines Monitoring Programme. Having retired as a Research Associate Professor at the University of Otago and Director of the Intensive Medicines monitoring Programme (IMMP), I write on a personal basis and not on behalf of the University or the New Zealand Pharmacovigilance Centre (NZPhvC), which incorporates the IMMP, the spontaneous reporting programme known as the Centre for Adverse Reactions Monitoring (CARM) and the Intensive Vaccines Monitoring Programme. Dr Matheson stated that it is misleading for Herxheimer et al in their letter published in the BMJ of the 3rd July 2004 to report that Medsafe, the New Zealand medicines regulator, intended to stop funding the IMMP. At the time I wrote to Dr Herxheimer requesting his support, it was Medsafe’s declared intention to cease funding the IMMP as of 30 June 2004. Notice was given in a letter 4 March 2004. Because the University as employers need to give three month’s notice of termination of employment, the IMMP staff was advised shortly afterwards that their appointments would cease at the end of June. Medsafe’s intention was demonstrated further by the fact that they withdrew all the standard references to the IMMP from the latest issue of their publication Prescriber Update, and from their web site. Dr Matheson also states, “Medsafe and the University of Otago are still planning and discussing the pharmacovigilance services to be purchased through Medsafe’s contract with the University.” The contract expired 30 June 2004. So far there has been one ‘discussion’ with Medsafe held 26 May 2004. Apparently that meeting simply conveyed Medsafe's decision to relocate CARM to Wellington by 31 March 2005, and reinforced their intention to terminate funding for the IMMP, but with a proposal for a short-term extension of funding, which it seems will be less than before. The IMMP would not continue to be funded beyond this, but the university could be asked to undertake special pharmacovigilance research studies. All of this is somewhat at variance with the impression created by the above quote. Dr Matheson is also critical of the fact that the collection of data from the IMMP comes from multiple sources and is largely paper-based. That is correct, but the programme has no operational alternative. Most of the monitored medicines are new and are not subsidised. The central agency which pays for subsidised prescriptions (HealthPAC) does not keep records of medicines that are not subsidised with the exception of those classified as ‘controlled medicines’. On several occasions we have proposed to Medsafe that monitored medicines be included in the controlled medicines category, but this has not happened. The IMMP therefore cannot get details of prescriptions electronically from a single source and this is entirely due to the fact that Medsafe and/or the Ministry have not taken the action that would allow this. In addition there is a need for Medsafe to require prescribers to put the National Health Index number on all prescriptions. It is implied in Dr Matheson’s letter that the methodology of the IMMP has changed little from the 1970’s and that the programme has not adapted to the needs of modern pharmacovigilance. The many letters of support to the Director-General from experts around the world testify to the fact that the IMMP is regarded as being at the leading edge of modern pharmacovigilance. There is also the implied criticism, that because of the methodology, we have been unable to grow and develop. Perhaps the following figures, which have previously been supplied to the Director- General, should shatter that image. Prescription entries increased from 93,749 in 2000-2001 to 224,626 in 2002-2003. The four data processors not only enter these data, they send out the follow-up questionnaires and process the returns. I wonder if Dr Matheson could find another unit of comparable size and running cost that could enter such a massive amount of data so efficiently and with such a high degree of accuracy. His letter states, “It is unrealistic to expect that systems developed in the 1970s should remain largely unchanged in 2004.” That is quite correct. The IMMP methodology has both changed and grown dramatically. However, the essential principle remains the same: prescription records for monitored medicines are collected and the adverse events for these patients are retrieved from the prescribers. It is a very productive method of identifying new signals early. No doubt Medsafe substantially wrote the letter signed by Dr Matheson. I wrote to the Director-General in April with many concrete examples that lead me to conclude that Medsafe’s long term attitude, poor judgement and inaccurate statements had the potential to embarrass the Ministry. This seems to be the case, but it is my hope that this process can be halted. It is extremely wasteful. Competing interests: I have until recently been director of the IMMP. |
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Dr Simon C Roughan, Registered Health Practitioner 316 Riccarton Road, Upper Riccarton, Christchurch. New Zealand.
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The letter penned by Don Matheson is a lame response to the very genuine and articulate concerns regarding the loss of a valuable drug monitoring unit in New Zealand, known as the intensive medicines monitoring programme (IMMP): a concern voiced by the 35 signatories to the letter from Andrew Herxheimer. The writers of the open letter to the Health Minister deserve a more honest response, preferably from the Minister herself. Don's words are vague yet striving to be reassuring: essentially summarising that all will be well once the "review" takes place and you have all forgotten about the original impetus for the (IMMP)agency in the first place. Maybe Don is one of the Health Ministry's spin doctors. We are very familiar here in New Zealand with how this Helen Clark Labour Government regularly cover up the dismantling of proven health safety mechanisms such as the IMMP, to blur future health monitoring statistics, or future research. This appears to be a way of concealing from the public any blunders that their new baby "MedSafe" or the incompetence of their new Trans Tasman Agency, is likely to make, regarding adverse drug reactions on an unsuspecting public. The more diffuse the agency, the greater the blur of blame, and the public are again cheated out of any accountability, either by professionals or politicians. Of particular concern at present is the rushed introduction and rollout of an experimental nationwide Meningococcal Vaccination on the less advantaged in the population. The commitment of the New Zealand Government to this prototype vaccine, to which it has spent $200 million, and tied its future election hopes, is frightening. Possibly it doesn't want some agency such as the tried and true IMMP detecting and documenting the notable and considerable toxic disasters that will flow from this quickly-engineered politically-motivated vaccine push. To bury the IMMP in the shadows and mirrors that makes up the ever mushrooming Ministry of Health, will be at the cost of patients and the public. The New Zealand public, and patients on medication, want to see more, not less, attention paid to monitoring the safety of medicines and vaccines. They want a safe and transparent monitoring agency independent of the Ministry of Health. The loss of IMMP would considerably damage the current high standard of pharmacoviglilance in New Zealand. The reporting of deaths from adverse reactions to medicines is not easily accessed information in this country. Yet these deaths are ranked among the top six causes of mortality in the USA. It is much more difficult here in New Zealand to access documented specific adverse reactions that relate to our Maori and Pacific Island people too. Our politically correct (PC) Health Ministry doesn't encourage such statistics. Yet the IMMP is, in my view, the only drug monitoring system uniquely in place to protect our indigenous New Zealanders. I agree with Herxheimer et al that the closure of IMMP would put our Maori and Pacific Islanders at great risk, due in part to their genetic variants affecting drug metabolic pathways, and the loss of IMMP would consequently be a medical, social and political disaster. Competing interests: None declared |
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