Private Sector Plan for Quality: Patient Information Leaves Women Waiting

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Women's Health Activist Newsletter
January/February 1997

by Lisa Cox

Have you ever come away from the doctor's office or the pharmacy with a prescription for which there is little accompanying information? Do you wish that you knew more about how to take your medication properly; if there are other drugs or foods which adversely affect your prescription; or if there are any serious side effects you should know about before taking your prescriptions?  Do you wish that your health care provider or pharmacist talked to you more about your prescriptions and gave you a brief fact sheet about the drugs you are taking?  

The Network guesses that the answer to all of these questions is a resounding "yes" and we share your wish for more information about prescription drugs.  That is why for the past 25 years the Network and its founders have advocated for the wide and mandatory distribution of patient prescription medication information. Recently, the Network participated on a Congressionally appointed panel charged with creating a voluntary plan to make medication guides a reality. While the Network was happy to sit at the table and advocate for useful patient information, we could not support the final "Action Plan for the Provision of Useful Prescription Medication Information" because it fell short of Network standards, lacking crucial elements needed to best serve women. Missing from the final plan were the following:

• All consumer medication information must be consistent with FDA approved labeling, based on the strength of well-conducted clinical trials.
• Implementation of any plan must include an ongoing, objective, professional advisory group with the authority to monitor the plan's quality and ensure its success.
• The plan must set in place guidelines to improve the ways in which patient information is communicated orally, both by prescribers and dispensers.

Although the Network was initially wary of the ability of a voluntary program of patient information to succeed, we participated on the Steering Committee nevertheless, encouraged by the prospect of creating a decent plan.  Since the 1970's, when the Network succeeded in getting the FDA to require patient package inserts in oral contraceptive and ERT packages, we have continued to push the pharmaceutical manufacturers, prescribers and dispensers of medication, (as well as the FDA) to increase the quality and quantity of both written and oral communication to patients. The need for this information stems from well documented public health problems including drug interactions and high numbers of drug-related injuries and hospitalizations.

Several times during the past two decades, the FDA has tried to mandate a system of "medication guides" for all prescription drugs. The Network has always supported these efforts. However, at every juncture, industry has stymied these efforts, preferring to leave patients ignorant about the drugs they are taking.  Most recently, the FDA proposed a voluntary "MedGuide" plan in 1995.  Anti-FDA lawmakers and those opposed to patient information guides attempted to prevent the plan from going forward. A compromise created a "Steering Committee" made up of health care providers, voluntary health organizations, consumer groups, publishers of patient information, representatives from pharmacies, and pharmaceutical companies.

The Steering Committee was charged with creating an action plan which would result in useful prescription drug information received by at least 75% of the public by the year 2006. If accepted by the Secretary of Health and Human Services, Donna Shalala, the action plan would preclude any rulemaking on "MedGuides" by the FDA.

The proposed action plan does not meet these standards. The Network believes that not meeting these standards has far-reaching negative implications for women's health. For instance, the proposed action plan allows information about unapproved uses for drugs to be distributed to consumers.  This means that women could potentially receive more information about these "off-label" uses than about crucial instructions for FDA-approved uses.  Women already know the harm that can be caused by promotion of unapproved uses and are all too aware of the potential consequences.

Further, the proposal is inadequate in addressing the need for improved oral counseling guidelines. All practitioners and pharmacists have a responsibility to educate their patients about prescription medications. This is especially crucial for women, who take more prescription medications than men.

The Action Plan has been submitted to Health and Human Services Secretary Donna Shalala, who must review the plan within 30 days and accept it, reject it, or recommend modifications.  The Network is hopeful that the Secretary can provide some needed positive progress forward and that we can finally put useful patient prescription drug information into the hands of consumers.

Lisa Cox is the Network's Program Director.


Date Published: 
Mon, January 06, 1997