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The key to minimizing drug-related medical mishaps is getting current, accurate information to the point of care precisely when it’s needed, according to an expert who spoke at the annual meeting of the American Academy of Dermatology.
Miami Beach, Fla. - The key to minimizing drug-related medical mishaps is getting current, accurate information to the point of care precisely when it's needed, according to an expert who spoke at the annual meeting of the American Academy of Dermatology.
“The problem is, the information is expanding so rapidly that it’s extremely difficult to keep up-to-date. We need to find more efficient ways of getting information to both the healthcare provider and patient,” says Howard I. Maibach, M.D., professor of dermatology, University of California, San Francisco, School of Medicine.
Drugs that have become available since World War II have clearly revolutionized healthcare, he says, “But not without a cost - considerable morbidity and mortality.”
In this regard, the Institute of Medicine has estimated that 44,000 to 98,000 Americans annually die from adverse drug reactions (ADRs). Somewhat similarly, a Swedish population-based study showed that approximately 3 percent of randomly selected deaths involved suspected fatal ADRs, most commonly involving anti-thrombotic drugs (Wester K, Jönsson AK, Spigset O, et al. Br J Clin Pharmacol. 2008;65(4):573-579).
Since World War II, he adds, cooperation between the pharmaceutical industry and regulatory agencies worldwide has produced increasing numbers of effective drugs.
And unlike before World War II, most of these drugs have convincing evidence that they're effective,” Dr. Maibach says.
Additionally, “We must also consider all the other medications that are used but not approved.” Examples include drugs that were introduced before 1962, and unapproved copies of approved drugs. Natural and herbal products further complicate the situation, Dr. Maibach says.
The result is “a quadratic equation in terms of the relationship of one medication to another,” he says.
Medication guides given to patients list what is generally known about the interactions of each prescription drug with others. However, Dr. Maibach says, such guides include only well-established research.
“And it often takes quite a while for us to figure out what to put on that computerized interaction sheet. There is an enormously complex literature slowly building up of the things we know less about, that don’t appear in the package insert,” he says.
Moreover, Dr. Maibach says, the complexity of the legal, scientific and regulatory interaction between drug sponsors and regulators worldwide means that, “There’s often a lag of many years between when we’ve figured out what we should be doing, and when we get that information into the insert.”
This lag is particularly perilous, he says, in light of the fact that between 1982 and 2000, 60 percent of drugs worldwide required post-approval dosing changes, according to the World Health Organization (Saggar S, Maibach HI. Cutan Ocular Toxicol. 2007;26(3):171-180). Dermatologic drugs that underwent labeling changes between 1985 and 2000 include acyclovir, dapsone, erythromycin, itraconazole and isotretinoin, to name a few, Dr. Maibach adds.
Furthermore, only half of reported ADRs occur in the first seven years of marketing (Lasser KE, Allen PD, Woolhandler SJ, et al. JAMA. 2002;287(17):2215-2220).
“Certain populations are clearly not yet addressed as adequately as we would like in the standard package insert.”
For example, he says elderly patients process drugs relatively slowly, and they’re usually on several drugs simultaneously.
“There’s even less literature to help deal with the very young because it is much more difficult to get data for them” than for the elderly.
Ideally, Dr. Maibach says, published reports say that whenever a drug is being prescribed or dispensed, providers at the point of care need to know not only the drug’s indication, duration and treatment plan, but also the following information:
Although electronic health records (EHRs) have begun meeting some of these needs, he adds, they ultimately will require more user-friendly “smart” features and interactive functionality than they currently offer. Overall, Dr. Maibach says, “Healthcare providers at the point of care need more quantitative data at their fingertips to prevent drug-related morbidity and mortality.”
Prescribers, payers, manufacturers and pharmacies also must continue increasing their level of pharmacovigilance, he adds, and the efficiency of healthcare informatics.
For prescribers, Dr. Maibach suggests conservative prescribing (Schiff GD, Galanter WL, Duhig J, et al. Arch Intern Med. 2011;171(16):1433-1440).
“When practical,” he says, “start one drug per visit. Minimize frequent switches.” Generally, Dr. Maibach recommends using relatively few drugs for a given indication - but knowing how to use them expertly. Educating patients about dosing requirements and drug interactions is also a must, he says.
Disclosures: Dr. Maibach has authored or co-authored several textbooks regarding evidence-based prescribing and ADRs.