ABSTRACT
BACKGROUND: Several organizations have raised concerns about the excessive secrecy maintained by regulatory authorities around the world, in particular in the European Union, France, UK, Canada and Australia. However, limited research has assessed the provision of information by regulatory authorities. This study aimed to assess the type and availability of information provided on the regulatory authorities' websites. METHODS: Regulatory authorities' websites in six countries (USA, Canada, UK, France, Australia and New Zealand) and at the European level (European Medicines Evaluation Agency) were surveyed by two reviewers between October 2005 and March 2006. The survey instrument included 16 criteria organized in 3 domains: information on marketed drugs, information on assessment of drugs and information on drug safety. RESULTS: There was a great variability in the level of information provided. Several medicine agencies did not provide basic information on marketed drugs, such as the summary of products' characteristics. Information on registration dossiers was scant on most websites except that of the US Food and Drug Administration. The European Medicines Evaluation Agency, the French agency and the Canadian agency released public assessment reports that contained only summarized information of registration data. Only one country, Canada, provided full access to pharmacovigilance data. The periodic safety update reports that companies have to provide regularly to regulatory authorities were not available in any country. CONCLUSION: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.
Subject(s)
Disclosure/standards , Internet/standards , Product Surveillance, Postmarketing/standards , Adverse Drug Reaction Reporting Systems/legislation & jurisprudence , Adverse Drug Reaction Reporting Systems/standards , Australia , Canada , Disclosure/legislation & jurisprudence , Drug Industry/legislation & jurisprudence , Drug Industry/methods , Drug Industry/standards , Drug-Related Side Effects and Adverse Reactions , Europe , European Union , Humans , Internet/legislation & jurisprudence , New Zealand , Pharmaceutical Preparations/standards , Product Surveillance, Postmarketing/methods , United States , United States Food and Drug Administration/legislation & jurisprudence , United States Food and Drug Administration/standardsSubject(s)
Cisapride/adverse effects , Drug Labeling/standards , Gastrointestinal Agents/adverse effects , Patient Education as Topic/standards , Adverse Drug Reaction Reporting Systems/standards , Canada , Contraindications , Drug Industry , Humans , Pamphlets , United States , United States Food and Drug AdministrationSubject(s)
Hypoglycemic Agents , Internet , Thiazoles , Thiazolidinediones , Chromans/therapeutic use , Drug Industry , Humans , Hypoglycemic Agents/therapeutic use , Ligands , Pioglitazone , Rosiglitazone , Thiazoles/therapeutic use , Troglitazone , United States , United States Food and Drug AdministrationABSTRACT
Burnout is a potentially serious dilemma which any practicing pharmacist may encounter. Various suggestions have been proposed to prevent burnout. An alternative approach is presented which involves the pharmacist in a nontraditional role. Pharmacists participate in a 3-month rotation within the Idaho Drug Information Service and Regional Poison Control Center. Pharmacists involved in this rotation believe it is extremely important for expanding their professional roles and preventing burnout.
Subject(s)
Burnout, Professional/prevention & control , Pharmacy Service, Hospital , Stress, Psychological/prevention & control , Drug Information Services , Hospital Bed Capacity, 100 to 299 , Humans , Idaho , Poison Control CentersABSTRACT
The authors report two cases of anaphylactic reaction to zomepirac. A brief discussion of anaphylactic reactions to other nonsteroidal antiinflammatory agents, for example, tolmetin and sulindac, is included. The authors note that first exposure to the NSAIDs usually produces few, if any, adverse effects in patients who later suffer severe reactions.
Subject(s)
Analgesics/adverse effects , Anaphylaxis/chemically induced , Drug Hypersensitivity/etiology , Pyrroles/adverse effects , Tolmetin/adverse effects , Adult , Female , Humans , Middle Aged , Tolmetin/analogs & derivativesABSTRACT
A case of acute ethylene oxide intoxication is described in which neurological involvement was present. Three recurrent seizures over a period of an hour were observed in a 43-year-old female. The patient continued to complain of malaise and inability to perform minor motor tasks up to one week after discharge. Neurological evaluation conducted three weeks after toxic exposure was completely normal. A two-month follow-up showed the patient to be asymptomatic without recurrence of symptoms.
Subject(s)
Ethylene Oxide/poisoning , Acute Disease , Adult , Brain Diseases/chemically induced , Female , HumansABSTRACT
The Idaho Drug Information Service has been in operation since 1972. During this time, five different files and manual methods of filing have evolved. As a result of confusion over indexing terms, information became lost within the filing systems, and the files fell into disuse. A reorganization of the files was undertaken in an attempt to develop a filing system that would be functional and efficient. Methods of manual filing are briefly reviewed. A computerized on-line key word indexing system for information storage and retrieval was initiated. The development and operation of the Drug Information Retrieval Terminal System (DIRTS) is described completely. At this time, DIRTS is fully operational. The system has eliminated the previous problems encountered with the manual filing systems, and user response has been good.
