Electronic DrugAlthough the issue of patient safety is not new, it is finally beginning to receive the attention it has long {deserved. Unfortunately, as has been demonstrated repeatedly, it usually takes fatal events and negative publicity to precipitate action.

This historical review discusses some milestones that led to the current awareness of the scope of the problem of medication errors and concludes with current and potential strategies to improve safe prescribing for ambulatory patients. Successful approaches for significant improvement will require multiple system enhancements and innovations rather than exhortations for individual prescribers to “try harder.” These solutions include the use of the most recent evolutionary improvement—the Medicare Prescription Drug, Improvement, and Modernization Act of2003, which has the potential to profoundly enhance the safety of medication usage in ambulatory care.
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EMERGING AWARENESS OF PATIENT SAFETY

Problems relating to medication safety and the avoidance of potential errors have been in the news headlines almost daily, ever since the publication of the Institute of Medicine’s 2000 watershed report, To Err Is Human. Patient safety improvements have historically followed on the coattails of tragedy, as exemplified by the following events:

  • In 1937, the “Elixir of Sulfanilamide” contained the solvent diethylene glycol and killed 105 children. This incident dramatized the need for pre-marketing drug safety, contributing to the congressional amendment of the Federal Food, Drug and Cosmetic Act.
  • Chloramphenicol was isolated and introduced into clinical practice in 1947. By 1950, aplastic anemia (a fatal blood dyscrasia) was identified as an adverse drug event (ADE) resulting from chloramphenicol; this event brought about an increased awareness of the need to report ADEs. By 1954, the American Medical Association (AMA), in collaboration with the American Heart Association and the National Pharmacy Association for Surveillance, began the first postmarketing surveillance efforts to publicize ADEs.
  • In 1961, thalidomide, which had been prescribed to pregnant women, was discovered to have caused phocomelia (absent or deformed limbs) in 10,000 babies born in western Europe. In 1962, the U.S. Food and Drug Administration (FDA) began post-marketing surveillance for ADEs and subsumed the AMA’s process. The Pharmaceutical Manufacturers Association (PMA), now PhRMA, formed the Commission on Drug Safety.
  • In the 1970s, Senator Edward Kennedy led hearings on drug problems, and Ken Melmon, a leading clinical pharmacologist, led the Joint Commission on Prescription Drug Use. There was a growing interest in clinical trial design and methods regarding drug efficacy.
  • The 1980s saw growth in spontaneous reports and safety surveillance, starting with 12,000 reports per year at the beginning of the decade and increasing to 250,000 reports by the end of the decade. Drugs recalled around this time included Bendictin® (Merrell Dow), a medication for morning sickness; Phenformin® (Ciba-Geigy)for diabetes; and Zomax® (McNeil), an early nonsteroidal antiinflammatory drug (NSAID) for arthritis.
  • In 1985, the Anesthesiology Patient Safety Foundation began to conduct a thorough re-engineering of the principles of general anesthesia, with a resultant plummeting of intraoperative mortality rates that have yet to be widely replicated elsewhere in medicine. A similar re-engineering of systems for prescribing safety is overdue.
  • The 1990s brought to the forefront the potential for drug interactions via cytochrome (CYP) drug-metabolizing enzymes, first presented with erythromycin’s effect on terfenadine (e.g., Seldane®, Aventis), resulting in the cardiac arrhythmia torsades de pointes. Hepatotoxicity and the use of acetaminophen as an over-the-counter medication were also discussed.
  • In 1994, Betsy Lehman, a health news reporter for the Boston Globe, died of cardiac complications from a fourfold overdose of a chemotherapeutic agent for breast cancer at the Dana Farber Institute. The case caught public attention as evidence that such medical errors can occur even to the best informed of consumers at prestigious institutions.
  • The dangerous absence of reliable systems to support the safe delivery of health care finally began to be recog­nized in the mainstream media in the year 2000 with the release of To Err Is Human. Systems supporting safety in outpatient prescribing remain part of a growing field of error-prevention efforts.
  • Since 2000, the risk of hypertension associated with phenylpropanolamine (PPA) (e.g., Dexatrim®, Contac®) and the lack of cardioprotective benefits of hormone replacement therapy have been frequently debated. viagra soft
  • The year 2004 saw a cascade of emerging information about the cardiovascular risks and limited gastrointestinal benefits of the cyclooxygenase-2 (COX-2) agents compared with the nonselective NSAIDs. The implications of these events have not yet been fully realized.