Special Topics in Pain: Opioids
Caveat emptor: Erroneous safety information about opioids in online drug-information compendia.
Author(s): Talwar S R, et al.
Journal: Journal of Opioid Management. 2016; 12(4): 281-288. 34 references.
Reprint: Sonia R Talwar, PharmD, Global Health Science Center, The Medicines Company, Parsippany, New Jersey.
Faculty Disclosure: Abstracted by N Walea, who has nothing to disclose. Please see original article for disclosures.
Objective: Review and evaluate the latest advances and newest information in the area of Opioids
Editor’s Note: Today, virtually everyone goes to the internet for information. If you prescribe opioids, read this about the potentially deadly misinformation on the internet.
Class: communications: Caveat emptor: Erroneous safety information about opioids in online drug-information compendia.
Online drug-information compendia (ODIC) can be valuable to health care professionals (HCPs) and consumers as they are readily available resources for user-friendly information on drug products, including opioid analgesics. A recent survey among HCPs reported that over 45 percent use a smartphone to access drug information. There has been a commensurate increase in consumers accessing prescription drug information online (23% in 2011 vs 35% in 2013). Given the growing reliance upon drug summaries provided by ODIC and heightened safety concerns about opioids, it is essential that the information is correct, complete, and up-to-date.
In an effort to ensure consistent product information and enhance the safe and appropriate use of extended-release and long acting (ER/LA) opioid analgesics the FDA required each ER/LA opioid analgesic's Full Prescribing Information (FPI) be updated with safety-related changes in April 2014. It is reasonable to expect ODIC to be motivated to incorporate the changes in a timely manner.
For this study, seven ODICs were identified that met inclusion criteria: Epocrates; Facts & Comparison: A to Z Drug Facts; Gold Standard: Clinical Pharmacology; Medline Plus; Medscape Reference; UpToDate; and WebMD. Five of these contained summaries based on drug substances and two had summaries by drug product. Five compendia were aimed at HCPs, whereas two targeted consumers.
Pharmacists with expertise in drug information independently compared material referencing the FPI, paying particular attention to warnings, precautions, adverse reaction, and drug interaction as the products of interest were all opioid analgesics.
Errors were categorized according to a relevant topic based on the FPI or a general descriptive theme. These were indications and usage, dosage and administration, safety, pharmacology, technical information, abuse potential, reference support, miscellaneous, off-label information, special patient populations, and patient education. The errors within each subcategory were then classified as omitted (information from FPI was entirely missing), incomplete (some information was provided but was not materially complete), inaccurate (information provided was inconsistent with the FPI), and other (misinformation that cannot be classified per the other categories).
After identification of errors, letters were sent to the editors of each ODIC requesting correction of identified errors. Two months after the letters were sent requesting corrections, the ODIC were re-examined to determine whether content-correction requests had been implemented.
Across the seven OCIC reviewed, a total of 859 errors were identified and categorized. Categories containing > 10 percent of the identified errors included Safety (30%) and Patient Education (15%). Twenty percent of errors were classified as omitted, 29% as incomplete, and 20% as inaccurate. The remaining 31% were classified as other. The number of errors identified were 28 in indications and usage, 64 in dosage and administration, 255 in safety, 63 in pharmacology, 79 in technical information, 78 in abuse potential, 50 in reference support, 18 in miscellaneous, 30 in off-label information, 63 in special patient populations, and 131 in patient education.
The resolution status (i.e., Resolved [correction of identified content]; Partially Resolved [content correction was made in part, but error still remains]; and Unresolved [content correction was not made]) of the total errors showed only 28% were resolved. Of the 568 errors remaining unresolved 19.9% were classified as omitted, 27.8% as incomplete, 18.3% as inaccurate and 34.0% as other. Categories containing > 10 % of unresolved errors included Safety (28%), Patient Education (16%), Abuse Potential (11%), and Technical Information (10%).
Given the varying degree of clinical detail contained in the drug summaries reviewed across the ODIC and access differences across potential target audiences (HCPs vs consumers), meaningful and representative compendium-to-compendium comparisons of identified misinformation cannot be made. The identified errors across the seven ODIC are, therefore, presented in totality rather than individually.
Given the growing reliance upon drug summaries provided by ODIC and heightened safety concerns about opioids, it is essential that the information is correct, complete, and up-to-date. The use of inaccurate drug information may result in preventable patient harm, such as life-threatening overdose with opioids, as well as medicolegal consequences for HCP, for healthcare institutions and systems and for compendia themselves. Therefore, HCPs and consumers seeking reliable on-label drug product information should consult multiple sources including a product's FPI, which has been reviewed in detail and approved by the FDA.