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ASHP's Scheckelhoff Speaks at FDA Meeting

Kate Traynor

Douglas Scheckelhoff, M.S., director of pharmacy practice sections for the American Society of Health-System Pharmacists (ASHP), provided the following comments to FDA's Counterfeit Drug Task Force at a public meeting in Bethesda, Md., on Oct. 15.

ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, HMOs, long-term care facilities, home care agencies, and other components of health care systems. I am pleased to provide you with ASHP’s views on the serious problem of counterfeit drugs entering the nation’s drug supply chain.

In June of this year, ASHP adopted a policy that encourages the FDA to develop and implement regulations to restrict or prohibit licensed drug distributors from purchasing legend drugs from unlicensed entities and to accurately document the original source of drugs and chain of custody from the manufacturer to the pharmacy. My comments today and ASHP’s written comments in response to the Federal Register notice will discuss how that policy relates to the work of the FDA Counterfeit Drug Task Force.

Over the next few minutes I would like to comment on four areas that are addressed in the interim report. They include regulatory and legislative issues, industry and health care professional issues, technology issues, and public education.

Regulatory and Legislative Issues. Most consumers have no idea of the scope and complexity of the drug distribution chain and its business components, particularly the buying and selling of products between wholesalers. ASHP remains extremely concerned about vulnerabilities in the pharmaceutical supply chain, particularly with respect to secondary distributors. While these entities may perform a role in providing needed medications in some select situations, ASHP believes that stronger state and federal oversight may be needed.

Any changes to federal law and regulation should be patterned after recent legislation enacted in Florida. Florida’s new law begins to address the lack of authenticating and documenting the chain of custody of a product from the originating manufacturer. This is particularly important with respect to the high-risk drugs identified by the state as being prone to counterfeiting.

Recent discussions by ASHP’s policy recommending Councils noted the need for uniformity in state regulation of a national standard in order to maintain the integrity of the drug supply. However, we should be sensitive to the unintended consequence of the creation of new barriers in distributing prescription drugs, particularly with respect to legitimate returns of unused product from pharmacies.

ASHP does not believe that paper pedigrees are an optimal solution to the counterfeiting problem. However, ASHP believes that the development of a limited, uniform list of drugs considered to be at high risk for counterfeiting, determined by the FDA, should be a priority. Products on this list should not be shifted around among wholesalers. This list could be maintained through a paper system in the interim, with the eventual goal of developing an electronic pedigree for all drugs.

In terms of augmenting state pharmacy practice acts, ASHP believes that attempting to rely on state boards of pharmacy to improve control over wholesalers will require 49 additional states to take action similar to Florida and therefore will be inconsistent and potentially delayed. In the mean time, counterfeiters will simply move to states with fewer restrictions and controls.

Boards of pharmacy and state health departments do not have the resources needed to effect the needed changes at the state level, and effective anti-counterfeiting measures will be slow in coming. The FDA should become more involved in controlling wholesalers.

Industry and Health Care Professional Issues. Electronic means and systems for alerting pharmacists to counterfeit products already exist through professional organizations. For example, ASHP maintains an email list of over 23,000 members who receive news items from us on a weekly basis. The development of a new, independent counterfeit drug alert network is not needed since these other systems exist and the cost of populating e-mail addresses and keeping contact information current for such a system would be prohibitive.

ASHP stands ready to provide rapid alerts to members and hospital pharmacy departments about counterfeit drug incidents, which is in keeping with our longstanding partnership to the FDA’s MEDWatch reporting system.

Pharmacists should be the focal point for patient contact, education, and follow-up when a product is suspected of being counterfeit. Training materials should also be developed to educate pharmacy and product-receiving staff, with information on how to screen product packaging and what steps to take when they find a suspicious product.

Technology Issues. ASHP believes that applying technology for overt security methods will be of limited value to most pharmacists as a means of verifying authenticity. The reality is that most hospital pharmacies stock more than 1,500 distinct products from hundreds of vendors. It would be virtually impossible for pharmacy staff to be knowledgeable about the specific overt methods for each company and product. In addition, many experts agree that overt security methods should be changed at least annually to keep ahead of counterfeiters. All of these factors contribute to the complexity of the problem.

Covert security methods may be of some value as a means of authenticating product, but only when the product is suspect. Whatever technologies are adopted need to be practical and inexpensive for use at the pharmacy level. Funds might be better spent on technology for a universal electronic pedigree for drug products facilitated through some form of machine-readable coding on drug packaging.

Public Education Issues. Public education activities should focus on overall public awareness of the counterfeiting problem, but generally not focus on specific products. Messages should alert patients to be on the lookout for problems such as different looks, taste, or packaging of drugs and should instruct consumers to bring these problems to the attention of their pharmacist. Perhaps public education programs focusing on product integrity could be the focus of next year’s National Pharmacy Week campaign.

ASHP appreciates the opportunity to present its views at this public meeting.