Saturday, July 25, 2009

Analgesic Med Guides – A Public Health Failure

Medication (Med) Guides, along with package inserts and “black box” warnings, are among the strongest policy enforcement tools available to the FDA, short of pulling drugs off the market. Unfortunately, Med Guides are unlikely to be effective unless changes are made in their development and use. [Boxed warnings were discussed in our blog post 7/20/09.]

A Medication Guide is a paper handout or brochure provided to patients with prescriptions for drugs that are considered to have serious risks of adverse events, such as due to misuse, abuse, or overdose in the case of certain analgesics. The FDA has considered such Guides, which are developed by drugmakers but approved by the agency, as integral components of their REMS (Risk Evaluation and Mitigation Strategies) requirements for opioid analgesics. For example, the FDA is currently permitting propoxyphene-containing analgesics to remain on the market in the U.S. [see our posting 7/12/09] but requiring Medication Guides for patients. A Medication Guide is an essential educational ingredient of the new FOCUS REMS program for Onsolis [see prior posting 7/17/09].

Med Guides Largely Ineffective

Are such Guides appropriate and effective educational tools for increasing safe use of the respective products? In a comprehensive investigation, Wolf et al. [2006] analyzed literacy qualities of all 40 Medication Guides existing at the time, and also assessed their acceptance among a group of primary care patients (n=251). They found that the average reading level of the Guides was 11th-to-12th grade; none of them met federal recommendations of 6th-to-8th grade level. Most of the Guides also were deemed unsuitable because they failed to provide summary information or limit the scope of content. Accordingly, less than a quarter (23%) of patients in the study reported having used the Guides as a source of information (less than 1 of 6 patients with low literacy levels).

Another study examined critical safety information provided to patients on isotretinoin (Accutane®) and estrogen prescriptions [LaPointe et al 2006]. Investigators found that despite patients (n=500) having received required information handouts and expressing confidence in their knowledge of major risks, their responses on a test of their actual understanding were no better than if they had just guessed.

Healthcare System Fails to Educate

In a best-case scenario, patients should receive vital information about their medications from their healthcare providers; at the least to clarify whatever written materials are provided [Howland 2009]. Yet, an observational study found that busy healthcare providers often fail to adequately instruct patients and communicate even the most critical information regarding prescribed medications [Tarn et al. 2006]. Possible adverse effects were addressed merely one-third of the time; timing and quantity of dose were discussed only 55% of the time. This might expectedly contribute to misunderstandings by patients leading to noncompliance and/or medication misuse, which could be harmful or even fatal in the case of opioids.

Communication by pharmacists at the point of distribution also might be an important source of information for patients. Yet, a recent survey among 1,025 practicing pharmacists in 20 states across the U.S. found that 29% were not familiar with Medication Guides; 60% stated that risk-minimization programs have a negative impact on the daily practice of pharmacy, although many acknowledged it was a necessary duty [Lee et al. 2008].

FDA Needs to Rethink Its Role

From the limited evidence to date, it seems apparent that the FDA’s Medication Guides program is inadequate. Handing patients pieces of paper, even if the patients can read and understand them, is not the same thing as education. Healthcare providers and pharmacists apparently are not fulfilling educator roles (nor are they compensated for such activities). Clearly, the FDA needs to rethink its approach to patient (and caregiver) education, or any mandated REMS programs will be doomed to failure. This also raises the question of whether the FDA should be responsible for such education in the first place, or would that role be better assigned to another government agency or outside enterprise specializing in such education? What do YOU think?

ADDENDUM: FDA Hosts Workshop on Better Communication
Apparently, the FDA recognizes the troubled state of its communication programs for consumers and will be hosting a special workshop titled, “Providing Effective Information to Consumers About Prescription Drug Risks and Benefits.” This will be held September 24-25, 2009 in the Washington, DC, area and is open to the public. However, registration must be received by August 17th and seats are limited — an agenda will not be available until September 21st (just 3 days before the workshop). For complete information, see the Federal Register notice [or, see Docket No. FDA–2009–N–0295].

References: [noted but not linked above]
> Howland RH. What should patients be told about their medications? J Psychosoc Nurs Ment Health Serv. 2009;47(2):17-20.
> LaPointe NMA, Pappas P, Deverka P, Anstrom KJ. Patient receipt and understanding of written information provided with isotretinoin and estrogen prescriptions. J Gen Int Med. 2007;22:98-101.
> Lee LY, Kortepeter CM, Willy ME, Nouriah P. Drug-risk communication to pharmacists: assessing the impact of risk-minimization strategies on the practice of pharmacy. J Am Pharm Assoc. 2008;48(4):494-500.
> Tarn DM, Heritage J, Paterniti DA, et al. Physician communication when prescribing new medications. Arch Intern Med. 2006;166(17):1855-1862.
> Wolf MS, Davis TC, Shrank WH, Neuberger M, Parker RM. A critical review of FDA-approved Medication Guides. Patient Educ Couns. 2006;62(3):316-322.