Patient counseling may be enforced by FDA

Many pharmacists may not know it, but there are federal (and many individual state) requirements requiring pharmacists to offer written or oral patient counseling beyond label information - covering the basics such as directional use, general precautions, and side effects - when filling a prescription, though enforcement of these measures has been admittedly lacking.

But the Food and Drug Administration's (FDA) most recent patient survey on this topic is putting the spotlight back on the ways and means of counseling enforcement.

The agency's latest patient survey was conducted in 1996. And while it hasn't yet been published in full, some preliminary results are out, and the news isn't all bad. Overall, 67% of responding patients said they did receive some form of written drug information from their pharmacy, an increase from 54% from a 1994 survey.

Goals for patient information are unmet

But the agency is concerned that goals set forth in the January 1997 Action Plan for the Provision of Useful Prescription Medicine Information, by the federal Department of Health and Human Services (HHS) may not be met. Those goals call for 75% of all patients by 2000 and 95% by 2006 to receive drug information with their prescriptions.

That provision grew out of the Omnibus Budget Reconciliation Act of 1990, which at that time required pharmacists to provide oral counseling to Medicaid patients, a rule that most state legislatures or state pharmacy boards expanded to all patients getting a prescription. Also in 1996, the HHS Inspector General reviewed all state pharmacy boards to see whether counseling laws were being enforced and found it to be "minimal."

On the brighter side, the same report found that the great majority of state boards have adequate educational programs telling pharmacists about the requirements.

Meanwhile, the latest FDA patient survey notes that while the 1990 Act targeted oral counseling, the majority of information disseminated today is written, a fine point the agency is prepared to live with based on its preliminary findings. More to the point, the FDA notes that voluntary pharmacist efforts, and those put out by drug makers and pharmacy associations, are steadily growing, while the numbers of patients who directly ask for this type of information remains small.

Still, the report offers some tangible recommendations that could lead to greater enforcement, including collaboration between the FDA and state boards to review the type of information pharmacists are giving patients, followed by similar collaboration between state boards and the Health Care Financing Administration to review and develop enforcement guidelines and performance measures.

The FDA has been taking comments on the subject from citizen groups and pharmacy associations, and plans to solicit more opinion before implementing any solid changes.