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U.S. Department of Health and Human Services

Drugs

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Counterfeit Drug Task Force Report October 2003 - POTENTIAL OPTIONS FOR IMPROVING PRESCRIPTION DRUG SECURITY

Based on what it has heard and reviewed to date, the FDA Task Force on Counterfeit Drugs is listing a series of preliminary options with the goals of:

  • Preventing the introduction of counterfeit drugs and biologics into the U.S. drug distribution chain;
  • Facilitating the identification of counterfeit drugs and biologics;
  • Minimizing the risk and exposure of consumers to counterfeit drugs and biologics; and
  • Avoiding the addition of unnecessary costs to the prescription drug distribution system, or unnecessary restrictions on lower-cost sources of drugs.

The potential options are premised on several interim conclusions reached by the Task Force. First, there is no single "magic bullet" against the growing number of sophisticated counterfeiters; rather, a multi-pronged strategy to secure the drug supply could be much more difficult for counterfeiters to overcome than any single method. It could also be less costly, because a “one-size-fits-all" approach is unlikely to work for all parts of the complex prescription drug supply system. Second, although drug counterfeiters today are more sophisticated and better organized than ever before, there are many new technologies and approaches that have the potential to prevent and contain counterfeit drug threats. While most of these new approaches have not yet been fully developed, implemented, and tested, they hold the promise of a more secure drug distribution system in the years ahead. Third, because many of these promising ideas have not been fully developed, the Task Force believes that an opportunity for broad public comment is essential to guide its further work.

The Task Force notes that these options are not mutually exclusive. In general, these options could be implemented together or independent of each other.

 A. Technology

The Task Force heard from many groups and individuals. According to what we have heard, appropriate long term goals for the use of technology include achieving an electronic pedigree and incorporation of authentication measures for all drug products. However, due to the emerging nature of many of these technologies, a phased in approach for their implementation should be considered. With this in mind, the adoption of one or more of the following options concerning the use of technology to deter and detect counterfeit drugs, by the Federal government or the private sector, as appropriate, might reduce the likelihood of counterfeit drugs from entering the U.S. drug distribution system and/or reaching a U.S. consumer:

1. Package all finished dosage form drugs in unit of use packaging as appropriate for the particular product (e.g., tablet, multi-dose vial) at the point of manufacture, as is now done in many nations;

2. Use tamper evident packaging from the point of manufacture, with labeling that notes the tamper evident feature, for all dosage forms, active pharmaceutical ingredients (APIs), and bulk chemicals;

3. Incorporate for all drug products at least two types of validated anti-counterfeiting technologies into packaging and labeling at the point of manufacture with at least one of these technologies being covert (i.e., not made public, and requiring special equipment or knowledge for detection) using a phased in approach starting with those products at high risk of being counterfeited and where the introduction of counterfeit product poses a serious health risk;

4. Incorporate for all drug products a taggant, chemical marker, or other unique characteristic(s) into the manufacturing process that is only identifiable with the use of sophisticated analytic technologies using a phased in approach starting with those products at high risk of being counterfeited and where the introduction of counterfeit product poses a serious health risk;

5. Create an electronic database of drugs and biologics for authentication purposes, which consists of photographs of the product, packaging and labeling information, and the anti-counterfeiting measures utilized in the packaging, labeling, and product itself;

6. Achieve the goal of the pedigree requirements by phasing in track and trace technology (i.e., electronic pedigree) for all drugs and biologics starting at a case and pallet level for products at “high risk of being counterfeited” and progressively including all products at the case, pallet, and package level. The technology should have an integrated infrastructure that is able to track and trace products at all points in the distribution chain from manufacturer to end user;

7. On an interim basis, because the technologies described above may take several years to implement, all drugs and biologics “at high risk of being counterfeited”, should be tracked and traced either (1) By limiting the number of transactions of the product (e.g., shipping the product from the manufacturer either (a) directly to the retailer or health care entity, (b) to the retailer or health care entity through a single licensed wholesaler who would sell the product directly to retailers or health care entities, (c) identifying steps that multiple wholesalers can implement to reduce the risk of counterfeit introductions), or (2) By using available track and trace technology, identifying the drug at least at the case and pallet level, and preferably at the product level, throughout the distribution system;

8. Issuance of an FDA guidance document concerning the appropriate use of anti-counterfeiting technologies as well as the FDA application and review process for incorporating or changing taggants, chemical markers, or other unique characteristic(s) of the product;

9. Issuance of an FDA guidance document concerning physical site security and supply chain integrity.

 B. Secure Business Practices and Regulatory Requirements

The Task Force heard that the state requirements for licensure of wholesale distributors need to be updated and that the standards for certain business practices among the entities involved in the U.S. drug distribution system are insufficient. The following options, based on what we have heard, relate to secure business practices that affect the ability to deter and detect counterfeit drugs:

10. Continue to work with NABP to update their Model Rules for Licensure of Wholesale Distributors, using the Florida statute as a model where appropriate, in the following areas: requirements for licensure, qualifications of employees (especially those who handle drugs), storage and handling of drugs, site security (both for facilities and information), inspection and examination of drugs, record keeping, availability of records to inspectors and law enforcement personnel, due diligence with respect to business partners and contractors, administrative subpoena power, and criminal penalties; update FDA regulations under 21 CFR 205, as appropriate, to make it consistent with updates to the NABP Model Rules for Licensure of Wholesale Distributors;

11. Develop sets of “secure business practices” which would be voluntarily adopted by manufacturers, wholesalers, repackagers, and pharmacies. Best practices would be identified in areas such as: employee qualifications, security of physical facilities and information systems, package disposal, dealings with business partners and contractors, inspection and examination of products, record keeping, etc.;

12. Designate, by entities such as manufacturers, wholesalers, re-packagers, and pharmacies, an individual or team to coordinate security and anti-counterfeiting activities. Such activities would include quality improvement, monitoring and use of anti-counterfeiting technologies, and regular review of the entities security and anti-counterfeiting measures;

13. Timely sharing with FDA, by manufacturers, of relevant market tracking and trending data and the analysis of these data for use as a means of identifying counterfeit or diverted product in the marketplace.

 C. Rapid Alert and Response Systems

The Task Force heard that there is a need to strengthen the systems used for reporting by, and alerting of, stakeholders and the public as to the existence of counterfeit drugs. The following options, based on what we have heard, relate to alerts systems for counterfeit drugs.

14. Enhance the MedWatch Alert System for use as a tool to receive and disseminate timely information about counterfeit drug products, especially identification of suspect drug product;

15. Create a counterfeit alert network through use of existing, or newly developed, communication tools that allow reception, dissemination, and sharing of information about counterfeit drugs in a timely manner (e.g., to pharmacists, manufacturers, wholesalers, and law enforcement and public health officials);

16. Further enhance FDA’s internal processes for responding to and investigating reports of suspected counterfeit products.

 D. Education and Public Awareness

The Task Force heard from many sources that there is a great need to increase awareness and education of stakeholders and the public concerning counterfeit drugs. The following options, based on what we have heard, address these issues:

17. Increase the efforts of the FDA, other government agencies, and appropriate private sector partners to educate consumers and health care professionals on how to reduce the risk of obtaining counterfeited drugs before an event occurs. Helpful messages could include: (1) what is a counterfeit drug and why U.S. consumers and health care professionals should be vigilant, (2) the dangers of buying drugs over the Internet or from other unknown entities, (3) good purchasing practices that will decrease the chances of encountering counterfeits, and (4) legitimate ways to obtain drugs (e.g. federal or state purchasing programs, private sector purchasing programs for low income consumers);

18. Educate consumers and health care professionals on how to identify counterfeit drugs (including how to recognize anti-counterfeiting technologies on packages, labeling, and drug products themselves) and what to do when they believe they have identified a counterfeit product;

19. Assure flexibility as agency officials determine their outreach approach and create a set of pre-established consumer and professional outreach plans that can be utilized if deemed appropriate (based on risk analysis) after counterfeits are detected in the stream of commerce;

20. Provide outreach efforts appropriate for the diverse elements of the U.S. drug distribution system. We find that individual strategies for educating and increasing awareness should be considered for diverse stakeholders including: consumers, pharmacists, wholesalers, repackers, doctors, nurses, the media, and public health officials. These creative strategies could take the form of public service announcements, educational fliers and communication tools that can be distributed by pharmacists and PBMs, toll-free numbers on labels; permanent messaging on appropriate industry and private group websites to establish a permanent presence, as well as many other potential tools.

21. Explore ways of improving and coordinating agency and industry messages and efforts to address and contain a counterfeit event. Though a drug manufacturer is not responsible for the creation of a counterfeit of its products, ensuring health professionals are well informed about the event and protecting the public from it should be a shared public policy goal.

 E. International Issues

The task heard that counterfeiting of drugs is commonplace in many countries. The global nature of counterfeiting suggests that American stakeholders should work with foreign stakeholders to better coordinate their anti-counterfeiting efforts. The following options, based on what we have heard to date, relate to these issues:

22. Strengthen international cooperation in law enforcement efforts, identification of counterfeit products, use of anti-counterfeiting technologies, and education of stakeholders and consumers;

23. Develop global standards for (a) the packaging of final dosage forms and API’s, (b) the use of tamper evident packaging, (c) product pedigrees, (d) the use of anti-counterfeiting measures, and (e) the use of track/trace technologies.