Getting to Better Prescription Drug Information
In addition to alchemy, medicine, botany, astrology and the occult, the great Renaissance polymath Paracelsus was a master of sound bites. His statement, “all drugs are poisons” certainly grabs your attention.1 But what does it mean? That people should avoid all medications? Certainly not. Paracelsus devised quite a few medicines himself. He meant that when it came to medications, you have to be careful. Used correctly, they can save lives. Used wrongly, they can kill.
Five hundred years later, two articles in this issue of JGIM show how modern drug regulators, researchers, doctors and patients continue to grapple with Paracelsus’ concern about medications.
In the first article, Cooper Bailey, et al.2 focus on an obvious—but surprisingly understudied—way to maximize the benefit and minimize the harms of medications: improving the instructions on pill bottles so patients take them correctly. The authors tested whether enhanced pill bottle instructions—previously shown to help English-spea ...
- Avorn J. Powerful medicines: The benefits, risks and costs of prescription drugs. New York: Random House; 2005.
- Cooper Bailey S, Sarkar U, Hm Chen A. Evaluation of language concordant, patient-centered drug label instructions. J Gen Intern Med. 2012; doi:10.1007/s11606-012-2035-3.
- Wolf M, Davis T, Curtis L. Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use. Med Care. 2011;49:5. CrossRef
- Wolf M, King J, Wilson E. Usability of FDA-approved medication guides. J Gen Intern Med. 2012 ; doi:10.1007/s11606-012-2068-7.
- Aikin K, O’Donoghue A, Swasy J, Sullivan H. Randomized trial of risk information formats in direct-to-consumer prescription drug advetisements. Med Decis Making. 2011;31:E23–33. CrossRef
- Fischhoff B. Communicating risks and benefits: An evidence-based user’s guide. In: Brewer N, Downs J, eds. U.S. Food and Drug Administration, U.S Department of Health and Human Services; 2011
- Nicolson D, Knapp P, Raynor D, Spoor P. Written information about individual medicines for consumers. Cochrane Database Syst Rev. 2009(11).
- Cohen R, Brown R. The US Food and Drug Administration’s Risk Evaluation and Mitigation Strategy (REMS) Program in practice: does it really inform patients and limit risk? Am J Kidney Dis. 2012;59:3. CrossRef
- Schwartz L, Woloshin S, Welch H. The drug facts box: providing consumers with simple tabular data on drug benefit and harm. Med Decis Making. 2007;27.
- Schwartz LM, Woloshin S. Lost in transmission—FDA drug information that never reaches clinicians. N Engl J Med. 2009;361:1717–20. CrossRef
- Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public. A national randomized trial. Arch Intern Med. 2011;171:1463–8. CrossRef
- Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009;150:516–27.
- Woloshin S, Schwartz L, Tremmel J, Welch H. Direct to consumer drug advertisements: what are Americans being sold? Lancet. 2001;358:1141–6. CrossRef
- Woloshin S, Schwartz L, Welch H. The value of benefit data in direct-to-consumer drug ads. Health Affairs 2004:W234–45.
- Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med. 2011;155:87–96.
- U.S. Food and Drug Administration. Disclosing risk information in consumer-directed print advertisements: Brief summary, Example of fictitious highlights of prescribing information, Example of fictitional highlights of prescribing information (based on proposed physician-labeling rule) translated in consumer-friendly language and formatted for use in consumer directed. February 4, 2004. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm. Accessed August 10, 2012.
- Kritz FL. FDA on drug ads: less is more. Washington Post. 2004;10:2004.
- Stacey D, Bennett C, Barry M, Col N, Eden K, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011(10).
- Minutes of the risk communication advisory committee. FDA . April 30 – May 1, 2009 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM190625.pdf.
- Public Law 111 – 148. Patient Protection and Affordable Care Act. Section 3507. Enacted March 23, 2010.
- Getting to Better Prescription Drug Information
Journal of General Internal Medicine
Volume 27, Issue 12 , pp 1582-1584
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