Open letter to Annette King, Minister of Health, New Zealand
http://www.100md.com
《英国医生杂志》
EDITOR—We learn with great concern that Medsafe , a part of your ministry, intends to stop funding the intensive medicines monitoring programme (IMMP) next year.
In its 27 years' work the IMMP has contributed very valuably to the safety of medicines in New Zealand and worldwide. Drug regulatory agencies in other countries and professionals working on the safety of medicines have admired and envied it because it has so successfully identified previously unrecognised adverse reactions, measured risks, and identified risk factors. For example, it enabled New Zealand to lead the world in taking regulatory action over agranulocytosis due to mianserin and liver toxicity due to nefazodone.1 2
Many drug disasters have shown that it is unsafe to rely only on spontaneous reporting of suspected adverse drug reactions. Such systems are essential, but the data they provide mostly suffer from gross under-reporting and other biases and are usually hard to interpret. There is a great need to support and develop techniques such as computerised drug safety monitoring (the GP research database in the United Kingdom), prescription event monitoring in the United Kingdom, and IMMP in New Zealand. The loss of IMMP would substantially damage pharmacovigilance internationally.
Patients and the public want to see more, not less, attention paid to monitoring the safety of medicines. We believe that the cost of the programme is a small price to pay for the safety of your citizens. Its achievements are considerable, although for most of its life it has employed only one half-time medical researcher. Adverse reactions to medicines result in an enormous cost to health and social services budgets and to patients and their families, as numerous studies across the world have shown. A report from the United States put deaths from adverse reactions among the top six causes of death there.3-5 It has been estimated that 15-20% of the health budget goes to the management of adverse drug reactions. The IMMP should be seen as a cost-effective investment in the welfare of your people.
We are also concerned for the wellbeing of the 800 000 or so Maori and Pacific Island people in whom specific genetic variants affect drug metabolic pathways. The IMMP is the only drug monitoring system in place to protect these people. Its closure would, we believe, put these groups at added disadvantage and would be a medical, social, and political oversight.
We see the proposed closing down of the IMMP as a serious blow to pharmacovigilance in New Zealand and internationally and we hope that you will avoid this. The IMMP has been very productive and has helped make the New Zealand Pharmacovigilance Centre one of the most effective in the world. It should be not only allowed to continue but strengthened so that it can reach its full potential and contribute even more to the safe use of medicines.
Andrew Herxheimer, emeritus fellow
UK Cochrane Centre London N3 2NL andrew_herxheimer@compuserve.com
Affiliations and competing interests are available on bmj.com Also a response is expected from the minister and will be posted on bmj.com as soon as possible.
This letter is signed by 34 others given in alphabetical order by country: Australia: Peter R Mansfield; Belgium: Marc Bogaert; Canada: Joel Lexchin, Giulia Muraca, Nancy Olivieri, Barbara Mintzes, Thomas L Perry, James M Wright; Croatia: Bozidar Vrhovac; France: Nicholas Moore; Germany: Heiner Berthold, Bruno Mueller-Oerlinghausen, Peter Sch?nh?fer; India: Nilima Kshirsagar; Italy: Silvio Garattini; Japan: Hirokuni Beppu, Rokuro Hama; Netherlands: Leo Offerhaus, Kees van Grootheest; Norway: Graham Dukes; South Africa: Karen Barnes; Spain: Joan-Ramon Laporte; Sri Lanka: Krisantha Weerasuriya; United Kingdom: David Healy, Robin Ferner, Nick Freemantle, Martin Kendall, Alain Li Wan Po, Joe Collier, Stephen Evans, Jeffrey Aronson, Saad Shakir; United States: Peter Lurie, Sidney Wolfe.
Competing interests: AH—none declared. See bmj.com for co-authors.
References
Coulter DM, Edwards IR. Mianserin and agranulocytosis in New Zealand. Lancet 1990;336: 785-7.
Nefazodone. WHO Pharmaceuticals Newsletter 2003 No 1. www.who.int/medicines/library/pnewslet/news2003.pdf
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279: 1200-5.
Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 1997;277: 307-11.
White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics 1999;15: 445-58.
In its 27 years' work the IMMP has contributed very valuably to the safety of medicines in New Zealand and worldwide. Drug regulatory agencies in other countries and professionals working on the safety of medicines have admired and envied it because it has so successfully identified previously unrecognised adverse reactions, measured risks, and identified risk factors. For example, it enabled New Zealand to lead the world in taking regulatory action over agranulocytosis due to mianserin and liver toxicity due to nefazodone.1 2
Many drug disasters have shown that it is unsafe to rely only on spontaneous reporting of suspected adverse drug reactions. Such systems are essential, but the data they provide mostly suffer from gross under-reporting and other biases and are usually hard to interpret. There is a great need to support and develop techniques such as computerised drug safety monitoring (the GP research database in the United Kingdom), prescription event monitoring in the United Kingdom, and IMMP in New Zealand. The loss of IMMP would substantially damage pharmacovigilance internationally.
Patients and the public want to see more, not less, attention paid to monitoring the safety of medicines. We believe that the cost of the programme is a small price to pay for the safety of your citizens. Its achievements are considerable, although for most of its life it has employed only one half-time medical researcher. Adverse reactions to medicines result in an enormous cost to health and social services budgets and to patients and their families, as numerous studies across the world have shown. A report from the United States put deaths from adverse reactions among the top six causes of death there.3-5 It has been estimated that 15-20% of the health budget goes to the management of adverse drug reactions. The IMMP should be seen as a cost-effective investment in the welfare of your people.
We are also concerned for the wellbeing of the 800 000 or so Maori and Pacific Island people in whom specific genetic variants affect drug metabolic pathways. The IMMP is the only drug monitoring system in place to protect these people. Its closure would, we believe, put these groups at added disadvantage and would be a medical, social, and political oversight.
We see the proposed closing down of the IMMP as a serious blow to pharmacovigilance in New Zealand and internationally and we hope that you will avoid this. The IMMP has been very productive and has helped make the New Zealand Pharmacovigilance Centre one of the most effective in the world. It should be not only allowed to continue but strengthened so that it can reach its full potential and contribute even more to the safe use of medicines.
Andrew Herxheimer, emeritus fellow
UK Cochrane Centre London N3 2NL andrew_herxheimer@compuserve.com
Affiliations and competing interests are available on bmj.com Also a response is expected from the minister and will be posted on bmj.com as soon as possible.
This letter is signed by 34 others given in alphabetical order by country: Australia: Peter R Mansfield; Belgium: Marc Bogaert; Canada: Joel Lexchin, Giulia Muraca, Nancy Olivieri, Barbara Mintzes, Thomas L Perry, James M Wright; Croatia: Bozidar Vrhovac; France: Nicholas Moore; Germany: Heiner Berthold, Bruno Mueller-Oerlinghausen, Peter Sch?nh?fer; India: Nilima Kshirsagar; Italy: Silvio Garattini; Japan: Hirokuni Beppu, Rokuro Hama; Netherlands: Leo Offerhaus, Kees van Grootheest; Norway: Graham Dukes; South Africa: Karen Barnes; Spain: Joan-Ramon Laporte; Sri Lanka: Krisantha Weerasuriya; United Kingdom: David Healy, Robin Ferner, Nick Freemantle, Martin Kendall, Alain Li Wan Po, Joe Collier, Stephen Evans, Jeffrey Aronson, Saad Shakir; United States: Peter Lurie, Sidney Wolfe.
Competing interests: AH—none declared. See bmj.com for co-authors.
References
Coulter DM, Edwards IR. Mianserin and agranulocytosis in New Zealand. Lancet 1990;336: 785-7.
Nefazodone. WHO Pharmaceuticals Newsletter 2003 No 1. www.who.int/medicines/library/pnewslet/news2003.pdf
Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279: 1200-5.
Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA 1997;277: 307-11.
White TJ, Arakelian A, Rho JP. Counting the costs of drug-related adverse events. Pharmacoeconomics 1999;15: 445-58.