MedGuide Requirements Need To Be Overhauled, Pharmacy Groups Tell FDA

FDA's use of Medication Guides is being challenged by pharmacy groups just as the documents are taking on growing importance as a cornerstone of the agency's new safety powers.

The agency has had the authority to require Medication Guides since issuing a final rule on the subject in 1998, but legislation passed last fall features Medication Guides as a central component of the Risk Evaluation and Mitigation Strategies that FDA can now make firms implement.

Pharmacies have always chafed under MedGuides, and a routine Paperwork Reduction Act filing by FDA recently allowed them the opportunity to formally critique the program and suggest revisions.

Not only are the guides repetitive and overwhelming for patients, the comments from 12 pharmacy organizations said, but the guides also create an administrative burden for pharmacists and have no proven track record of being effective.

The comments did not address REMS, but any strengthening of MedGuide requirements will likely be met with more consternation from pharmacy groups.

However, because the distribution of the guides is now a legally binding responsibility for sponsors, drug firms will have an incentive to make dispensing them a smoother process. And the requirement that all REMS be periodically evaluated means that the agency will likely have more information to address the question of how effective MedGuides actually are (¹ (Also see "Fluoroquinolone REMS Will Survey Patients, Doctors on Understanding of Risk" - Pink Sheet, 14 Jul, 2008.), p. 9).

Straying From Its Original Intent

According to the agency, MedGuides inform patients about "the most important information they should know about these products in order to use them safely and effectively."

When FDA issued a final rule on MedGuides in 1998, it stated that the guides may be required for "a small number of products" and "the FDA anticipates that on average, no more than five to 10 products per year would require such information."

By 2004, there was a short list of 20, right on target with the agency's intentions. But in 2005, FDA began approving guides for entire classes of medications. By 2006, 36 guides had been approved, which applied to over 80 prescription entities, translating into over 1,400 individually manufactured prescription drug products.

"We believe that the FDA has allowed the MedGuide program to expand so that it no longer operates as it was originally designed," Walgreens' comments said. "Indeed, rather than help educate patients about the potential risks posed with the use of prescribed medications, the MedGuide program is now so expansive that it may actually dilute patients' attention to important medication information."

The growing number of guides has spawned a whole host of problems for pharmacists, patients and manufacturers.

For example, under the current system, FDA allows drug manufacturers to attach MedGuides to the prescription product container, include them within the prescribing information, or provide a toll-free number that allows pharmacists to order hard copies of the guides. More often than not, the National Association of Chain Drug Stores told FDA, MedGuides are not attached to the drugs and the responsibility is placed on pharmacists to collect them.

"Unfortunately, the expanding MedGuide program, and the requirement that pharmacists provide a MedGuide to patients or their caregivers each time they dispense a prescription for which a MedGuide is required, has become a significant burden on pharmacists' time, workflow and ability to provide direct patient care," the American Pharmacists Association said.

Drowning In A Sea Of Information

In addition to MedGuides, patients are also given Consumer Medicine Information provided by the pharmacy, Patient Information Sheets from FDA, and Patient Package Inserts from the manufacturers. Altogether, the documents could leave patients with more than 20 pages of information.

Not only is the amount of information overwhelming and repetitive for patients, but most of it is not written in a consumer-friendly way, and organizations complained that the guides often stressed the risk of the medication over the benefit.

Even more troubling, according to seven pharmacy organizations that submitted comments as a group, is that the content of the different information given to patients sometimes conflicts.

The quality of additional patient information leaflets that pharmacies distribute is another area of friction between the groups and FDA, with firms trying to preclude agency regulation of that area as well (² (Also see "Pharmacy Leaflets Become Focus For Patient Safety; IoM, FDA Finalize Standards" - Pink Sheet, 24 Jul, 2006.), p. 13).

Among the other burdens of MedGuides, they must be given to patients each time they fill or refill a prescription, inundating patients with repetitive information and placing an unwarranted administrative burden on pharmacists, the comments said.

According to APhA, today more than 300 million prescriptions per year for over 10,000 separate drug products are subject to the MedGuide program's requirements.

"Despite hearing from industry and provider groups that the program is seriously flawed, FDA continues to underestimate the burden faced by pharmacists in complying with the program," NACDS maintains.

While the program continues to expand in an "unchecked manner," the agency's estimate of 0.0014 hours per MedGuide has not been changed since 1998, NACDS points out.

Do MedGuides Even Work?

Many comments question the effectiveness of MedGuides, and even challenge FDA to conduct research to gauge their usefulness.

"The retail pharmacy supply chain is unaware of any research which demonstrates that Medication Guides improve the public's awareness of medication risks," writes the conglomeration of pharmacy organizations. "Nor are we aware of evidence that demonstrates that significant risks have been avoided, that adherence rates have been affected or that health outcomes have been improved as a result of patients receiving Medication Guides."

In preparation for a MedGuide meeting held in June 2007, APhA received feedback from nearly 400 pharmacists, 75 percent of whom said the program is working poorly and is burdensome. Only 33 percent said that they felt MedGuides was a valuable tool in counseling patients.

Each organization that commented pointed out the usefulness of a standardized form. For example, in 2005, all manufacturers of prescription antidepressants formed a coalition to print and distribute hard-copy tear-off pads of MedGuides which could be dispensed with any antidepressant medication. However, the coalition dissolved in 2006 and since then, each manufacturer has had to supply individual MedGuides.

Wanted: New MedGuide Regulations

Pharmacies gave FDA a laundry list of recommendations on how to improve MedGuides. The most common were:

• Evaluate the usefulness and effectiveness of MedGuides: FDA should evaluate whether patients read the guides; assess whether the information is easily understood; find out whether the information is already available to the patients; and research patients' views of the program.

• Assess the length and content of MedGuides: Not only should the MedGuide format be standardized for all drugs and classes, FDA should also assess whether the guide and other patient information should be consolidated into one document to eliminate redundancy. Organizations also suggested simplifying the language in the guides to make them more accessible.

• Eliminate the need to provide MedGuides with refill prescriptions: Providing MedGuides for prescription refills creates "unnecessary work" for pharmacists and can add to the perception that the guides are nothing more than routine. Eliminating the requirement would also reduce the amount of repetitive information patients receive.

• Allow pharmacies to send MedGuides by electronic mail: The two- to 20-page MedGuides would be easier to handle for patients and pharmacists if FDA permitted their e-mailing. This is consistent with the agency's desire to increase electronic filings and electronic distribution of information. Plus, the ability to contact a patient in the case of a recall would be enhanced if they could be contacted electronically.

• Create a single MedGuide for an entire class of drugs: Since drugs in the same class share the same risks, it makes sense to have class MedGuides. It will also make it easier for pharmacies to order, store and distribute the guides. MedGuides based on classes would streamline the system, improve the logistics and decrease administrative burden and storage issues.

- Lauren Smith ([email protected])