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Rapid Responses: Rapid Responses published:
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Regional ADR monitoring centres exist in the UK.
- Anthony R Cox (9 May 2003)
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Learning from Adverse Drug Events
- John Sandars (10 May 2003)
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The Pharmasearch Network in Italy
- Aurelio A. Sessa, Saffi Ettore Giustini, Francesco Salvo, Giovanni Polimeni, Achille Caputi (11 May 2003)
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Adverse drug reactions — defining terms
- Jeff Aronson (17 May 2003)
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Anthony R Cox, ADR Pharmacist West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham, B18 7BR.
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EDITOR, Dunn N draws attention to the virtuous activity of reporting suspected adverse drug reactions (ADRs) to the Yellow Card Scheme run by the Committee on Safety of Medicines (CSM).(1) He also makes reference to the French pharmacovigilance networkvwhich has 31 regional centres. It is important to note that the United Kingdom has 3 regional centres in England (2,3,4), one in Wales (5) and the recently established CSM Scotland. These centres have a valuable role providing local feedback to individual reporters and trusts, producing local bulletins, information on adverse drug reactions, educational material, and expert speakers. In addition they also undertake drug safety research. These centres are keen to develop relationships with health professionals within their areas and to encourage reporting of ADRs to the Yellow Card scheme. The addresses of the CSM centres can also be found in the British National Formulary. Anthony Cox
1. Dunn N. 10-minute consultation: Adverse drug event BMJ 2003;326:1018 2. CSM West Midlands. http://www.csmwm.org/ (accessed 7th May 2003) 3. CSM Mersey. http://www.liv.ac.uk/~druginfo/csm/ (accessed 7th May 2003) 4. CSM Northern. http://www.nyrdtc.nhs.uk/ (accessed 7th May 2003) 5. CSM Wales. http://www.uwcm.ac.uk/study/medicine/pharmacology/ttc/csm/ (accessed 7th May 2003) Competing interests: Wishes to see increased reporting to the Yellow Card scheme |
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John Sandars, GP and lecturer University of Manchester Manchester M13 9PT
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I read with interest " What you should do" following an adverse drug event. The importance of managing the patient and reporting the event is mentioned but the potential for learning from this event has been apparently been ignored. There is increasing concern about patient safety and medication use is a significant contributory cause of threats to patient safety [1][2]. These threats are mainly minor, with little harm to the patient, but they have the potential to cause more serious harm. The literature on patient safety suggests that minor threats to patient safety provide a valuable learning experience [3]. Why was the particular medication used in this patient? Were contraindications looked for before prescribing? Patient safety will not improve unless we learn from these events - the same problem will return to haunt both the patient and the doctor in the future, may be with more serious consequences. [1]Dovey, S, Green, L, and Fryer, G. F. Identifying Threats to Patient Safety in Family Practice.. Washington DC, The Robert Graham Center.2000. [2]Silk, N. An analysis of 1,000 consecutive UK General Practice Negligence Claims.(An abridged version was published in the November 2000 issue of Health Care Risk Report). Unpublished report from the Medical Protection Society. 2000. Leeds,Medical Protection Society. [3]Department of Health. An organization with a memory. London. Stationery Office.2000 Competing interests: None declared |
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Aurelio A. Sessa, Italian College of General Practitioners (SIMG) I-50125 Florence (Italy), Saffi Ettore Giustini, Francesco Salvo, Giovanni Polimeni, Achille Caputi
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Since January 1 2002, a collaboration has started between the Italian College of General Practitioners (SIMG) and the Department of Medicine and Pharmacology of the University of Messina (Co-ordinating centre) about adverse drugs reaction (ADR) surveillance. Every GP participating (250 throughout Italy) sends a copy of each ADR to the Co-ordinating centre that provides the GP with a personal and qualified comment of the ADR reported according to data retrieved from international literature. A casuality assessment of each ADR, according to Naranjo algorithmic rating scale is also provided. A bulletin about the state of art of the network is generated monthly. Up till 30 April 2003, 734 ADR were reported. 7.6% related to severe ADRs and 12% were not decribed in the explanatory leaflet. Skin (18.2%), digestive tract (17.2%) and central nervous system (16.5%) were the body systems most commonly involved. Patients over 65 comprised 46% of this series. 59.2% of ADRs were probable and 40.7% possible according to the Naranjo algorithm. The Pharmasearch network shows promise for future involvement of a growing number of GPs. The results confirm the importance of feed-back to reporters in order to stimulate ADR reporting. Competing interests: None declared |
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Jeff Aronson, Reader in Clinical Pharmacology Department of Clinical Pharmacology, Radcliffe Infirmary, Woodstock Road, Oxford OX2 6HE
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In the light of Dr Dunn’s paper, clarification of some terms used in the field of adverse drug reactions is necessary.[1] • An adverse event is an adverse outcome that occurs while a patient is taking a medicinal product or undergoing some procedure, but is not necessarily attributable to it. • A suspected adverse drug reaction is an adverse event that occurs while the patient is taking a medicinal product and that is suspected to be due to that product. • An adverse drug reaction is an event that results from an intervention related to the use of a medicinal product. • An adverse effect and an adverse reaction are the same thing, viewed respectively from the perspective of the medicinal product and the patient. [I use the term "medicinal product" here, rather than "drug", because of the implication that an adverse effect may be due, for example, to an excipient; however, the term "drug" is acceptable shorthand.] In this context I am uneasy about the use of the term "adverse drug event". This term was used sporadically in the 1980s and has been used with varying frequency since about 1992 (although rarely, compared with terms such as "adverse drug reaction"). It is supposed to mean an event that might be due to a drug but is not necessarily due to it, but the addition of the word "drug" to the term "adverse event" adds nothing helpful, and the whole term implies to the casual reader that an adverse drug event is an adverse drug reaction. Some use the term "drug-related adverse event", which is better, but still potentially misleading. It would be much better to say "suspected adverse drug reaction", and that is the term that is currently used on the CSM’s yellow card. This is also relevant to what is stated in the paper in the box on reporting adverse events in the United Kingdom, namely that "Adverse events should be reported on … yellow [cards]". That is not so; it is suspected adverse reactions that should be reported; if an adverse event clearly has nothing to do with the drug it should not be reported. To take an extreme example, for the sake of demonstration, if a patient who was taking part in a clinical trial was admitted to hospital with injuries after being attacked in the street, that would be recorded as an adverse event, but it would not be reported as a suspected adverse reaction; if it was thought that an effect of the drug had caused some behavioural change that provoked the attack, the behavioural change would be reported as a suspected adverse reaction. [As a minor point, since 1 April 2003, following its union with the Medical Devices Agency, the Medicines Control Agency (MCA) has been renamed the Medicines and Healthcare products Regulatory Agency (MHRA).] 1. Edwards IR, Aronson JK. Adverse drug reactions - definitions, classification, diagnosis, management, surveillance. Lancet 2000; 356: 1255-60. Competing interests: None declared |
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