{"title":"Adverse reaction assessment in Thailand.","authors":"K Sriwatanakul, P Pothisiri","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In Thailand, 5 years ago, the Ministry of Public Health set up the National Adverse Drug Reaction Monitoring Center for collecting, analysing and compiling all evidence related to drug hazards. Between March 1983 and December 1985, 790 reports on adverse drug reactions have been received, of which 711 could be analysed. Adverse drug reactions are commonly reported with the antibiotics, other anti-infective agents, analgesics and antipyretics, and anti-inflammatory drugs. Most of the reported reactions are related to skin reactions and gastrointestinal disorders. It is unquestionable that such voluntary reporting is more useful qualitatively than quantitatively. Even though there are a lot of problems facing us in assessing adverse drug reactions, it is a necessity to have the programme running and improving as time goes by. There is an urgent need for well-trained personnel to perform such tasks.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"105-9"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Prescription-Event Monitoring. Recent experience with 5 NSAIDs.","authors":"N S Rawson, W H Inman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The principles and methods of Prescription-Event Monitoring (PEM) are presented and illustrated by a study of general practice notes of 55,642 patients, who were prescribed one of five non-steroidal anti-inflammatory drugs (NSAIDs). PEM showed the expected side effects and a low incidence of serious adverse reactions. The general pattern of events during and following treatment was, with few exceptions, very similar. The incidence of side effects that have led to the withdrawal of three of the drugs from the market was extremely low. Complications of peptic ulcer were uncommon and deaths from this cause were rare. No difference was apparent in the incidence of serious gastrointestinal complications during or after stopping treatment or changing to another NSAID.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"79-82"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Importance of valid measurements of benefit and risk.","authors":"W O Spitzer","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Without good measurement of both the risks and benefits of drugs, perceptions are bound to be distorted. Similarly, interpretations of findings are likely to be inappropriate, thus leading to decisions by regulatory bodies that are less than optimal. When measuring health phenomena in populations, both numerators and denominators must be determined to permit calculation of prevalence (frequency at a given time), incidence (frequency of new events over a specified period of time), mortality and case-fatality rates. Attribution of an adverse drug reaction to a particular drug can be the most demanding challenge for the clinician, the scientific investigator and the regulator. Criteria that must be met to establish a link between an apparent adverse drug reaction and an incriminated product include, biological plausibility, chronological and timing relationships, specificity, and response to dechallenge and to rechallenge. Acceptable chronology requires that a drug be shown to be taken before the onset of the adverse effect, not after symptoms have appeared. The unmet challenge of measuring benefit is more difficult than the measurement of harm. The need for valid measurements of risk and benefit remains compelling and urgent.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"74-8"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Post-marketing surveillance in New Zealand.","authors":"I R Edwards","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In early 1977, the Intensive Medicines Monitoring Programme (IMP) was instigated for selected medicines with novel chemistry or pharmacology and those expected to be widely used. Pharmacists are requested to record the patient and prescribing doctor's details along with the medicine dose and duration of the prescription. Doctors are asked to send details of any unexpected clinical events. Doctors' spontaneous returns are low and have been supplemented by regular surveys. Now a new self-carboned prescription form has recently been introduced upon which doctors indicate if events have occurred. Since trial introduction of the new system the rate of event reporting in the test areas has increased 15-fold. In view of this, the duplicate prescription system will be introduced to the whole country over the next 3 years. In the past, the IMP has been used to follow up signals of new adverse events, to establish adverse drug reaction profiles and to establish risk-benefit indications.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"83-5"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Special problems of adverse reaction assessment in Indonesia.","authors":"M P Sihombing, V H Gan, R Widya","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Limited experience with adverse drug reaction (ADR) monitoring in Indonesia is one of the difficulties faced in the developing programme. Problems which arise are related to data collection, quality of reporting, reaction-type reported, and assessment of cause-effect relationships, in addition to problems related to personnel and other factors.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"95-8"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Allergic and pseudoallergic reactions to non-narcotic analgesics.","authors":"B A Peskar","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pulmonary side effects are relatively rarely observed with analgesics and anti-inflammatory drugs. However, some patients react to the ingestion of such drugs with bronchoconstriction and asthmatic attacks. In only a small percentage of these patients is a true allergic mechanism underlying the pulmonary reaction to the drugs. In most of the patients the basis for the pulmonary side effects is pseudoallergic. The molecular mechanism of pseudoallergy is not completely understood. However, several hypotheses have been put forward, such as drug-induced stimulation of kinin receptors, activation of the complement system or interference with eicosanoid biosynthesis. The last hypothesis is attractive, since it could explain the similar sensitivity of such patients to drugs which are completely different chemically. It is not known, however, if the crucial drug effect on arachidonic acid metabolism is inhibition of synthesis of a bronchodilator eicosanoid such as prostaglandin E2 or increased synthesis of bronchoconstrictor eicosanoids such as leukotrienes.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"10-3"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14234333","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Role of the toxicology laboratory in the treatment of acute poisoning.","authors":"B R Hepler, C A Sutheimer, I Sunshine","doi":"10.1007/BF03259828","DOIUrl":"https://doi.org/10.1007/BF03259828","url":null,"abstract":"<p><p>The modern toxicology laboratory can play an important role in the evaluation of poisoning. In order to appreciate the nature and extent of this role, several essential elements necessary to an acute care toxicology service should be considered. When an ongoing and effective dialogue between clinicians and the toxicology laboratory staff is established, and a broadly based analytical approach is applied to the analysis of the appropriate biological fluids, a dynamic and viable toxicology service will result. How these elements work together to facilitate this service will be discussed, based primarily on experience in a large teaching hospital. This experience indicates that if the elements necessary to provide laboratory support in the investigation of an alleged poisoning are in place, the toxicology laboratory plays an important role in ensuring optimum and effective patient care.</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 1","pages":"61-75"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/BF03259828","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14660778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulatory decisions and the pharmaceutical industry.","authors":"E S Snell","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>National regulations on medicines are generally accepted as an important mechanism for ensuring that only medicines of adequate quality, safety and efficacy are available in the community. However, there are potential adverse effects of such regulations which should be kept within limits as far as possible. The recent history of non-steroidal anti-inflammatory drugs (NSAIDs) with withdrawal of 9 drugs in 6 years suggests that something is wrong with the current system and that improvements are needed. Attention is drawn to 3 key areas. Firstly, that a number of general conditions are important in the relationship between regulators and pharmaceutical companies. Secondly, the long life cycle of a medicine contains 2 phases for regulatory decisions--pre-marketing and post-marketing--but there is a discrepancy in the data, criteria and standards used in each. A new medicine is licensed on the basis of a large amount of accurate, scientific laboratory and clinical data, but, of necessity, before experience is available from general field use. Hence, research continues after marketing in respect of efficacy and safety in the new situation of ordinary field use. Usually this enables refinements to be made in methods of use and sometimes very useful new formulations or dramatic new uses of the drug are discovered. Testing for efficacy is accurate and becoming further refined by measuring the quality and duration of life provided by medicines. Suspicions of rare serious reactions are easily raised by a few anecdotal reports but are much more difficult to test, as accurate data are not available.(ABSTRACT TRUNCATED AT 250 WORDS)</p>","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"130-6"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Why Medical Toxicology?","authors":"S. Pond, L. Prescott, L. Goldfrank","doi":"10.1007/BF03259823","DOIUrl":"https://doi.org/10.1007/BF03259823","url":null,"abstract":"","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 1","pages":"1-2"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/BF03259823","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"52283760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Non-narcotic analgesics today: an update on benefits and risks. Proceedings of a symposium. Yogyakarta, Indonesia, February 23-26, 1986.","authors":"","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77871,"journal":{"name":"Medical toxicology","volume":"1 Suppl 1 ","pages":"1-155"},"PeriodicalIF":0.0,"publicationDate":"1986-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"14938001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}