Mitigating Risks from Non–FDA-Approved Drugs

Tim Casey

St. Louis—In a presentation titled Mitigating Risks from Non–FDA-Approved Drugs, presenters explained that thousands of drugs not approved by the US Food and Drug Administration (FDA) are available, accounting for a total of 72 million illegal prescriptions per year and posing serious risks to customers and health plans.

Patti Gasdek Manolakis, PharmD, president of PMM Consulting LLC, said most healthcare professionals are unaware of the situation. According to a 2006 report, 91% of community pharmacists believed all prescription drugs were FDA-approved. However, in 2010, Dr. Manolakis took an audience response poll of approximately 100 managed care pharmacists and medical directors and found that 33% admitted they had misperceptions about the indicators of FDA approval.

Dr. Manolakis said pharmacists routinely prescribe and dispense drugs although they are unaware of the drug’s status and safety risks. Unapproved drugs bypass the FDA approval process and normally have issues related to labeling. She referenced morphine concentrated oral solution that indicated a 20 mg per 5-mL dose rather than a 20 mg per 1-mL dose, despite the remainder of the label appearing similar to that of the approved dose.

Dr. Manolakis warned that unapproved drugs could be unsafe, ineffective, and noncompliant and are routinely associated with medication errors and product mix-ups. Yet, they remain popular because of their profitability.

“These pose real risks to our patients,” Dr. Manolakis said. “It’s a big issue…We all need to do our part.”

Chris Stewart, manager of pharmacy professional affairs at Humana Inc, warned that health plans and pharmacy benefit managers should care about unapproved drugs for several reasons. They are a public health issue and can be unsafe, ineffective, and of poor quality, and contain misleading labeling information. In addition, there are financial costs, including direct medication costs, indirect costs (adverse drug events, errors, morbidity/mortality), compliance, audits, and Medicare Part D coverage issues.

Mr. Stewart added that health plans should use a number of data sources to build formularies and must validate their status. If the drugs cannot be validated, plans must make judgments and question why the products are on the formulary.

“This critical assessment is one of the most important factors,” Mr. Stewart said.

Dr. Manolakis said another problem is that formulary decisions are often made at the ingredient level but unapproved drugs are product specific. She also mentioned that there are common products that are unapproved, including cough/cold combination products, pain medications, dermatologic drugs, sedation drugs, hormone replacement therapies, nitroglycerin tablets, and otic, ophthalomic, and other topical medications.

Some policies perpetuate the growth of unapproved drugs, according to Dr. Manolakis. For instance, core groups of drugs are automatically included on formularies as are all generic or repackaged products.

Mr. Stewart said that understanding the Medicare coverage gap changes is important, as well. In the Medicare coverage gap discount program, applicable brand-name drugs are eligible for a nearly 50% discount if they meet the definition of a Part D drug and are associated with a participating manufacturer labeler code. Brand-name drugs are defined as those whose approval is based on a new drug application or a biologics license application. Furthermore, they are on the formulary or treated as such through an exception or appeal.

The changes also include a standard 7% coverage of generic drugs in the coverage gap for those drugs that meet the definition of a Part D drug. Generic drugs are approved based on an abbreviated new drug application.

If drugs are inaccurately identified as FDA approved, there are several consequences, Mr. Stewart said, among them compliance issues such as improperly administering the new Part D benefit, and inaccurately processing claims, financial issues concerning rejected prescription drug events, increased retroactive adjustments, and manufacturer discount payments and dispute resolution, and increased coverage determinations leading to increased administration costs, and beneficiary dissatisfaction and confusion.

“Make the effort to educate and develop a standard of care,” Mr. Stewart said. “Make sure FDA approval status is part of that.”

To reduce the demand for unapproved products, Dr. Manolakis said companies must be more stringent in checking FDA approvals, educating healthcare professionals, colleagues, patients, and people involved in distribution, and reporting adverse drug events to the FDA.—Tim Casey