Three country comparison of selected safety information in the prescribing information for rosiglitazone [avandia]

A meta-analysis of 42 clinical trials published in 2007 found an increased risk of cardiac ischemia with the use of rosiglitazone [Avandia]. A communication from rosiglitazone's manufacturer indicated that safety revisions would be made the drug's prescribing information in Saudi Arabia. This prompted a comparison between selected safety information in the prescribing information for the drug available in the U.K., U.S. and Saudi Arabia. Three pharmacists conducted a comparison of selected safety information from the most recent prescribing information for rosiglitazone available in the U.K., U.S. and Saudi Arabia including the Arabic translation of the prescribing information available in The Kingdom. Differences in opinion or interpretation of the information contained in the prescribing information from the three countries were resolved by consensus. The prescribing information in Saudi Arabia for the drug was last revised in 2007. This information was amended in the U.K. and U.S. in March 2008 and July 2008 respectively. Compared to the U.K. and U.S. prescribing information the Saudi Arabian prescribing information there were differences in contraindications cardiac ischemia information, facture risk, and concomitant use with insulin. Saudi Arabian prescribers and patients should have access to the same safety information as their counterparts in the U.K. and U.S. In this three country comparison differences were found in the number and strength of selected categories of safety information for rosiglitazone. Information is provided on how to access the most current revisions of the prescribing information for drugs approved in Saudi Arabia that are also available in the U.K. or U.S. on the Internet at no charge

Promoting therapeutic information to the medical stsff: the evidence based-formulary

The potential of the hospital formulary system to guide physicians in prescribing the best drugs has not been realized. We describe a model for the transfer of clinically relevant research information about drugs to prescribers with the goal of improving prescribing behavior. A key element of the coordinated implementation model is that; physicians practice within an environment where competing influences affect prescribing behavior; drug advertising is one important influence. Clinically relevant research about drugs is necessary, but by itself is not sufficient to ensure its use. We propose a formulary organized by licensed indications and based on the evidence-based paradigm as a central element in an ongoing process to improve prescribing behavior by promoting the use of clinically relevant research

International drug information notes: the risks of calcium channel blockers

Publication of two epidemiological studies [1.2] and a meta-analysis [3] demonstrating an association between calcium channel blockers and an increased risk of myocardial infarction [MI] and excess mortality raised a contentious debate about the safety of these drugs in the united states. Central to the debate were the validity of epidemiological research in showing an association between calcium channel blockers and harm and a formal request made to the U.S. food and drug administration [FDA] to add a warning label to all calcium channel blockers marketed in the U.S. reflecting the finding of these three studies. Below is an edited version of the letter written to FDA commissioner David A. Kessler M.D.J.D. on November 9, 1995 requesting a warning be added to the official product labeling of all calcium channel blockers marketed in the U.S.

Therapeutic redundancy as a measure of formulary system effectiveness

to investigate the assumption that formilary quality is reflected in the number of redundant therapeutic agents in competitive markets. This inquiry assumes that a formulary system that requires strict adherence to the published clinical research evidence in the drug selection process will minimize the number of redundant therapeutic agents in competitive drug markets by balancing manufacturers promotional influences. Possible explanations for redundant therapeutic products are discussed. Design: a telephone survey was used to compare the number of histamine-2 blockers, angiotensin converting enzyme [ACE] inhibitors, and the number of drugs added to formularies in 1993 in ten randomly selected an four nonrandomly selected university associated teaching hospitals to a similar institution in Saudi Arabia. the difference in the number of histamine -2 blockers in surveyed hospitals formularies and our formulary ranged from no difference in two hospitals to a difference of three more drugs in three institutions. For the ACE inhibitors, the range was from no difference in one hospital surveyed to three more drugs in two hospitals. The proportion of new drugs added to formularies in surveyed hospitals ranged from 25% to 92% versus 37% in our hospital. a formulary system that bases the drug selection process on strict adherence to the published clinical research evidence may reduce the number of drugs in highly competitive therapeutic classes in the formulary. Promotional influence is one possible explanation for redundant therapeutic agents seen in some surveyed hospitals formularies

Amoxicillin-clavulanic acid: a case study in the evaluation of drug advertising

There is an absence of objective source of drug information in developing countries, as a result drug advertisement may be the prescriber's primary source of drug information. Several factors have been reported as affecting physician prescribing behavior, including advertising. The prupose of advertising, its validity, and cost will be examined. An advertisement for Augmentin[R] [amoxycillin/clavulanic acid] appearing in the January 1993 Saudi Medical Journal is presented as a case study in the evaluation of drug advertising. To goal of evaluating the Augmentin[R] advertisement is to compare the claims made by the manufacturer with what of objective scientific sources. In the evaluation reported here we could not find literature documentation from accepted scientific sources supporting the claims made in the Augmentin[R] advertisement. The extent to which this kind of advertising contributes to the inappropriate use of antibiotics is unknown. A simple model for evaluating an antibiotic drug advertisement is suggested

drug evaluation process at king faisal specialist hospital and research centre

With increasing concern about controlling the rising cost of drugs, the drug evaluation process becomes an important element in specifying and selecting the safest and most efficacious over clinically comparable and more expensive drugs. The drug evaluation process used by the Drug Information Service at King Faisal Specialist Hospital is described, the philosphy of evidence based drug information is introduced, an major issues in the drug evaluation process are discussed. Guidelines for prparing different types of drug evaluations are presented and examples are given when appropriate