On September 4, 2013, the US Department of Health and Human Services (HHS) posted a notice in the Federal Register indicating the department's intention to take action to monitor and reduce adverse events related to prescription drug use. HHS also posted a draft of its National Action Plan for Adverse Drug Event Prevention. Interested parties are urged to read the plan and comment via email or postal mail to the Department of Health and Human Services, Office of Disease Prevention and Health Promotion, Attn: Draft National ADE Action Plan, 1101 Wootton Parkway, Suite LL100, Rockville MD 20852.
Why is the ADE action plan important? According to the government's own data, 82% of Americans used at least one drug or dietary supplement in 2006 and 29% used five or more prescription drugs. HHS believes that, given appropriate action, a significant number of harms potentially caused by anticoagulants, opioids, and insulin can be prevented. Doubtless, the action plan will result in innumerable meetings of government officials; it's also likely that doctors and patients will find themselves and their prescriptions under greater government scrutiny. However, despite the increased bureaucratic churn and possible invasions of patient privacy, some good may come from the greater awareness of the fact that drugs have side effects, and that more judicious use of drugs may reduce the overall incidence of these side effects.
Anticoagulants have many side effects, some of which are limited to specific populations, and others of which are risks for everyone taking them. Some individuals have an adverse immune reaction to heparin known as thrombocytopenia; this reaction can be fatal, but can be predicted by performing an ELISA, and avoided by selecting an alternative drug. Researchers in Australia have designed a pharmacovigilance system that may be useful in the US in avoiding preventable bleeding events linked to anticoagulants in the elderly.
More research from Australia indicates that doctors often prescribe opioids for non-cancer pain relief without attempting to relieve patients' pain with safer, less addictive drugs. Canadian researchers are organizing a systematic review of the safety profile of opioids; information from this review should be useful in informing future prescribing decisions. Researchers in New Jersey recommend periodic urine tests of patients taking these risky drugs in order to ensure that appropriate levels of medication are being taken.
With diabetes on the rise in the US, insulin and other diabetes-related drugs and biologicals are of particular concern. A recent study of the use of insulin pumps in children found an increasing number of malfunctions and adverse events (including deaths) over the past several years. Researchers from the University of Oklahoma College of Pharmacy note the differing safety profiles of insulin alternatives and assert, "a patient-specific approach is critical in identification of the optimal medication regimen for elderly patients with diabetes." Indeed, a patient-specific approach, together with detailed knowledge of risk profiles of various treatment alternatives, is likely the best way to reduce adverse drug events of all kinds.