Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
New Model of ADR Monitoring In Indian Medical Institutions
- Vikas Dhikav (2 July 2005)
-
Drug Safety and Regulation: Clostridium difficile, antibiotics and PPIs
- Michael I Carter, Jane Murkin (16 July 2005)
-
Drug safety project in Germany (AMSP). Adverse drug reactions in psychiatry
- Detlef Degner, Renate Grohmann,Eckart Rüther (26 July 2005)
|
|
|||
|
Vikas Dhikav, Resident All India Institute of Medical Sciences, New Delhi-110029, INDIA
Send response to journal:
|
The adverse drug reaction monitoring is a tedious and complex process, which is most wanted but is underdone at best. Historically, spontaneous drug reporting has been its backbone. Indeed this kind of reporting by the astute physicians has often provided plausible hint of the suspected link regarding the causality. Spontaneous Adverse Drug Reaction Monitoring Spontaneous adverse drug reaction monitoring has become inculcated in governmental drug regulation around the world1-2. Main problem is however that the numbers of participating physicians are very less and the numbers of reports sent are low3. Even in the countries, which are the members of the WHO Pharmacovigilance program originated, report annually only about 200 or more ADRs per million inhabitants and the percentage of reporting physicians does not go beyond ten percent4-5. In many counties, however, the reporting rates are much lower2. It does not give the exact information about the frequency of adverse effects. Underreporting delay the signal detection and cause underestimation of the size of the problem. Accumulating evidence suggests that physians attitude to their National ADR Monitoring Program are a significant determinant of reporting rates1, most physicians consider monitoring of adverse drug reactions just a paper work, unconnected with their routine clinical work. In India, junior doctors report most cases of spontaneous monitoring3, which may not be adequately experienced in assessing the severity and determining the causality. Senior physicians are seemingly uninterested. Being busy is one explanation offered by these clinicians. All sorts of biases may therefore influence reporting. Intensive Adverse Drug Reaction Monitoring Intensive drug reaction monitoring on the other hand, is based upon the systematic evaluation of the link between adverse effect and drug in a systematic fashion. Pharmacologists in India usually carry it out. Moreover it is a full time business requires big manpower and economic resources, affording which may not always be possible for a developing country like India. The yield of this type of surveillance is low and often the reports are considered to be suboptimal as pharmacologists collect the data passively largely on the basis of observations made by clinicians. Unfortunately, because of the disinterest by the physician community, the burden often lies on the shoulders of pharmacologists. Score of causality given by the physians are very high as opposed to causality assessment method evaluated by full time clinical Pharmacologists6. Falsies of the both systems are therefore, well recognized. Indeed a recent metanalysis of the large number of studies have shown that 80% of the reporting is sub optimal6. Coupled with the meager report rate, this means that we actually may know little about the exact scenario. Various other means of improving the yield have met with variable success. Recent suggestion of incorporating postal monitoring in ADR monitoring in India has also met limited success7. Combined Approach A plausible solution to this problem therefore appears that both these systems should be integrated. Physians routinely use record detailed history and perform elaborate physical examination. This they call as “case work up”. If not formally involved in drug monitoring, while recording patient details; they just note whether or not the patient is sensitive to some drug or not. In case he\she is found to be so this is written on the front page of the history sheet or case sheet, as it is known here in India. Physicians while performing the detailed work up of their patients can note down the salient details required for monitoring of adverse drug reactions on a separate page meant to be ‘ADR sheet’ in the existing history sheet. It should be printed before hand and contain details like drug, dose, diagnosis and duration and their own assessment of causality. Other points like name, age, sex, socioeconomic status are well record routinely, therefore can be avoided. This should not be taken to be a different approach of recording ADR data as, there is evidence that all national ADR monitoring centres do not use the WHO proforma strictly and local variants of this are used. This is just the recording of essential data in the most concise manner. Although no evidence is available to suggest that these proforma are better then the one recommended by WHO, they are used because they are handy and provide necessary details. Similarly, on outpatient department cards adverse drug reaction data may be recorded by the attending physicians on a separate small column. The necessary details mentioned above should be printed on the OPD cards in a concise manner. Pharmacologists, while on there routine visits to wards (in hospital patients) or OPDs should evaluate such cases before or after physician’s assessment. Thus both pharmacologists and physicians should make their independent assement, which should later be compared. Potential advantages of the combined approach are- · Improved quality of ADR reports, as they would be properly discussed · Increased yield of ADRS reports as both pillars of pharmacovigilance would be working together · Physician and pharmacologist cooperation and mutual education · Health professional education can be achieved · Patient education can be done · Indigenous data would be generated · Prevention of ADRs can be done References 1.Belton KJ et all-Eur J-Clin Pharmacol 1997; 52: 423-427. 2.Meyboom RHB-Detecting adverse drug reactions: Pharmacovigilance in the Netherlands. Netherlands Pharmacovigilance foundation. pp-61-17, 1998 3.Balasubramanium S, Gogtay SN, Kshirsagar NA-Mortality due to adverse dug reactions in a large hospital. Natl Med J Ind, 12:300, 1999 4.Rawlings MD-Pharmacovigilance: paradise lost, regained or postponed? J Royal Coll Physicians, 21: 29-41, 1999 5. Vander Kbauw MM, Strickler BHch, Herrings RMC, Cost WS, Velkenberg HA, Vilson JHP-A population based case control study of drug-induced anaphylaxis. Br J Clinc Pharmacol 35:400-408, 1995 6. G. Miremont, F haramburu, Begad B, Pere JC, Dangoumau. Adverse drug reactions: Physician’s opinions versus causality assessment method-Br J Clinic Pharmacol. 46:285-289, 1994 7. Balasubramanium S, Gogtay SN, Kshirsagar NA-Postal survey as a method of ADR monitoring in India-letter to editor. Pharmacoepdemiol & Drug Safety; 9:21,2000 Competing interests: None declared |
|||
|
|
|||
|
Michael I Carter, Consultant Anaesthetist Luton & Dunstable Hospital NHS Trust, Jane Murkin
Send response to journal:
|
Drug Safety and Regulation: Clostridium difficile, antibiotics and PPIs. Dear Editor, Patrick Waller et al (Drug Safety and Regulation. BMJ 331, 2nd July 2005, p4,5.) write about the responsibilities of the pharmaceutical companies and the regulating agencies such as UK’s Medicines and Healthcare products Regulatory Agency to improve the safety of the drugs that are licensed for our prescription. Although Cox 2 inhibitors and SSRIs have been the high profile drugs under the spotlight in recent months, there are others which may be of greater concern. NICE guidance came out for the use of the Proton Pump Inhibitors (PPIs) in 2000 on the treatment of dyspepsia. In January 2005 in our hospital, a deceased patient record audit of 50 patients identified 20 who were on PPIs. Twelve of the 50 patients had had Clostridium difficile isolated in recent months, and 8 of these had been taking PPIs. 43 patients received one or more antibiotics, 29 received three or more. (cephalosporins 27, Augmentin 19, metronidazole 19, clarithromycin 14, and 5 or fewer for nine other antibiotics). Studies in Plymouth in 2003 and Montreal in 2004 indicated that PPI use, especially long term, compounded with other precipitators such as multiple antibiotic usage and nasogastric feeding, more than doubled the incidence of Clostridium difficile. As a profession, we have the responsibility to follow the advice of agencies such as the National Institute for Clinical Excellence over our prescribing habits, and to audit the effects of our treatments on our patients. At the Luton & Dunstable Hospital we are looking at blocks of 50 deceased patients’ records using some of the Trigger Tools recommended by the Institute for Healthcare Improvement. This audit has led to several improvements already, and highlighted the rapidly increasing popularity of PPIs in the treatment of the infirm elderly who are most at risk of Clostridium difficile infection. Although some of these patients with Clostridium difficile have died due to the organisms’ effects, we have not had the new North American strain identified here yet. Yours sincerely Dr Michael I Carter MA MB BChir DA FRCA Consultant Anaesthetist Jane Murkin RGN, RM Patient Safety Manager Luton & Dunstable Hospital NHS Trust 1. Proton Pump Inhibitors as a risk factor for Clostridium difficile diarrhoea. R. Cunningham, B. Dale, B. Undy, N. Gaunt. Journal of Hospital Infection (2003) 54, 243-245. 2. Risk of Clostridium difficile diarrhoea among hospital inpatients prescribed proton pump inhibitors: cohort and case-control studies. S. Dial, K. Alrasadi, C. Manoukian, A Huang, R. Menzies. Canadian Medical Association Journal. July 6, 2004; 171, 33-38. 3. National Institute for Clinical Excellence. Technology Appraisal Guidance- No.7. Guidance on the use of Proton Pump Inhibitors in the Treatment of Dyspepsia, July 2000. Competing interests: None declared |
|||
|
|
|||
|
Detlef Degner, Dr. Department of Psychiatry,University of Göttingen,Germany, Renate Grohmann,Eckart Rüther
Send response to journal:
|
The relevance of drug safety has become increasingly important in clinical practice and with regard to economic aspects. The benefits of drugs are connected and limited with the risks of adverse drug reactions (ADR). The AMSP ("Arzneimittelsicherheit in der Psychiatrie") project is an innovative, independent and multinational drug safety program in Germany,Switzerland,Austria and Hungary.From 1993 until now,about 190000 patients were monitored (30000 patients in the last year) in 55 psychiatric hospitals. Aims of the AMSP study group are the continous assessment and analysis of severe ADR in psychiatric inpatients under naturalistic conditions. The goals of the study are the collecting,rating,and interpretation of informations on type and frequency of ADR associated with psychotropic drugs and to indentify specific risk factors and drug interactions.The overall incidence of severe ADR of antidepressants was 1.4% (antipsychotics 1.1%) of exposed patients. The data of this "real-life" setting of routine treatment are a completion to results of controlled clinical trials and to safety programs of governments. Competing interests: None declared |
|||