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The FDA May Change Pharmacists’ Access to Prescribing Information

A Website Would Replace Paper Package Inserts
Stephen Barlas

The apparent intention of the Food and Drug Administration (FDA) to require pharmacists to get drug prescribing information (PI) from a website, instead of via paper inserts with the package,1 probably means increased counter time per prescription and interrupted workflow. “We are concerned that health care practitioners, particularly pharmacists, are going to be burdened with the costs of implementation and needed staffing changes in order to accommodate this measure,” says Michael R. Cohen, RPh, MS, ScD (hon), FASHP, President of the Institute for Safe Medication Practices (ISMP).

The FDA proposal anticipates that pharmacists would use an existing FDA website (labels.fda.gov) to find the PI. Pharmacists who have access to compendia published by electronic health records vendors will not have to access the FDA site. But those “drug information” software programs cost money, and many pharmacies don’t even have e-prescribing systems, much less access to labeling information produced by companies such as First Databank.

Then there are the pharmacists without Internet access, probably more numerous in rural areas. They would be able to call a toll-free number maintained by the manufacturers. The question, of course, is how fast the PI would be sent to the pharmacist. “At the very least, manufacturers should have to make this information available in real time via fax-on-demand or email,” says Kevin N. Nicholson, RPh, JD, Vice President of Public Policy and Regulatory Affairs for the National Association of Chain Drug Stores. He also wants the FDA to require manufacturers to notify health care providers when the PI changes.

Kiran Krishnan, Vice President for U.S. Regulatory Affairs at Apotex Corporation, says requiring a manufacturer to maintain a toll-free telephone service 24 hours a day, seven days a week, “may not be conducive.” He adds, “In addition, a reasonable time should be granted to the drug-product manufacturer to provide the prescribing information. Apotex is recommending 10 business days as an appropriate amount of time to ‘promptly respond.’”

The FDA estimates the new requirement would save manufacturers somewhere between $52 million and $164 million a year over 10 years because they won’t have to print and distribute paper PI. The annualized costs range from $47 million to $89 million and would mainly be incurred by pharmacies via initial capital costs to access the information and increased search time to find it. Pharmacies could order single or multiple copies of the paper PI when arranging for a shipment of drug from the distributor. They would then incur copying costs as well.

The FDA isn’t motivated by a desire to transfer wealth from pharmacies to manufacturers. Instead, it wants to get information about label changes to pharmacists and physicians as quickly as possible. Now, when a pharmaceutical manufacturer applies for and receives permission to add new indications or warnings to a drug label (and hence its PI), it can take months for that new information to be printed and reach the pharmacist. Making that information available immediately to physicians and pharmacists is seen as a way to cut medication errors.

The Government Accountability Office (GAO) published a report in July 2013 charting the number of changes made annually to drug labeling.2 In calendar year 2010, the FDA reported 747 changes to drug labeling; this number increased to 975 in 2011 and to 1,357 in 2012. “Because it takes time to print new labeling and incorporate it into new drug packaging, some drugs that have already been shipped to their distribution points might be on the market with labeling that is out of date,” the GAO stated.

Of course, pharmacists already use public and private websites occasionally to access drug information. The National Library of Medicine maintains the DailyMed website and the FDA houses Drugs@FDA. It is not clear how Drugs@FDA and labels.fda.gov differ. Many hospitals and chain pharmacies rely on electronic compendia generally made available by private third parties such as First Databank, Cerner Multum, and Medi-Span, which in turn sell that information to software vendors such as Epic and McKesson, to name a few.

Not only is labels.fda.gov not as data-rich as the private third-party software, it isn’t that easy to use, either. “The system is deeply flawed and will almost certainly lead to harmful or fatal medication errors,” states the ISMP’s Cohen.

If the FDA really wants to upgrade its labels.fda.gov site, perhaps it ought to contract with one of the compendia companies. They get the same drug-labeling information from manufacturers as the FDA, but they add value by expanding on that information—for example, coding adverse reactions based on severity. Giving labels.fda.gov to a private contractor would be expensive. But if cutting down on medication errors is the FDA’s goal, the expense would be worth it.

Author bio: 
Mr. Barlas is a freelance writer in Washington, D.C., who covers issues inside the Beltway. Send ideas for topics and your comments to sbarlas@verizon.net.

References

  1. Food and Drug Administration. Electronic distribution of prescribing information for human prescription drugs, including biological products. Fed Regist 2014;79;(243):75506–75527.Available at: http://www.gpo.gov/fdsys/pkg/FR-2014-12-18/pdf/2014-29522.pdf. Accessed April 27, 2015.
  2. Government Accountability Office. Electronic drug labeling: no consensus on the advantages and disadvantages of its exclusive use. July 2013;Available at: https://www.gao.gov/assets/660/655760.pdf. Accessed April 27, 2015.