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U.S. Department of Health and Human Services


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Counterfeit Drugs Task Force February 2004 Update - EDUCATING THE PUBLIC AND HEALTH PROFESSIONALS

A. Consumers 

1. What FDA sought comment on:

As the sophistication of the "final product" drug counterfeiting operations has increased, the public needs to be more aware of ways to identify the risk of counterfeit drugs, receive instructions on ways to minimize the chance of receiving fake products and to identify potential counterfeits.

2. What comments said:

The comments stated that it is imperative that consumers be encouraged to be more proactive in managing their health and be given useful tools to be vigilant to help avoid potential counterfeit drugs. Consumers should be educated to be aware of noticeable differences in their medication, the packaging, or any adverse events. In addition, consumers should understand the important role that their pharmacist and healthcare providers can play in identifying, reporting, and responding to counterfeit drug events. However, the comments warned that care should be taken in any education campaign to not unnecessarily alarm the public.

3. Discussion:

Despite the growing sophistication of counterfeit drug threats, many consumers are not fully aware of these risks. The Agency, in conjunction with consumer and patient advocates, as well as industry representatives is eager to find additional creative ways to educate the public of the potential threat of counterfeit drugs. The messages should alert consumers to the risk, offer ways consumers can recognize the signs of a potentially counterfeit product, teach them how to reduce the risk of exposure and tell them what to do if they suspect they have encountered one. Of course, FDA wants to strike an appropriate balance in the need to proactively educate consumers without causing unnecessary alarm that could interfere with their use of prescribed drug regimes. Most important, it is critical to focus awareness, and education programs should focus on issues that consumers can control.

FDA has an ongoing educational campaign that is intended to educate consumers about the risks of buying medicines online. FDA intends to reaffirm this message and focus the educational campaign on teaching safe purchasing methods. Particular focus will be placed on encouraging the public to seek out the Verified Internet Pharmacy Practice Site (VIPPS) seal when purchasing from an online pharmacy.

In addition, stakeholders indicated that there is a need for better, timelier, accurate information about specific counterfeit situations. FDA plans to create a counterfeit drug resource page on our website. The objective of this webpage is to concentrate customized education tools into a resource library that can empower individual stakeholder groups.

4. FDA Conclusions:

Educating the consumers about the risks of counterfeits is a critical piece in the effort to stop counterfeits from entering the stream of commerce.

  • FDA plans to develop additional, multi-layer, consumer-oriented educational materials that will help them learn about counterfeits, what to watch for, and where to turn for useful information if they think they have encountered a suspected counterfeit;
  • FDA plans to re-launch the FDA public service announcement (PSA) campaign for best online buying practices to educate consumers about how to buy drugs online safely, and risks to avoid in online purchasing;
  • FDA plans to house on its www.fda.gov website a comprehensive, consumer-friendly online library that will contain both general and specific counterfeit drug information. It will also contain targeted educational materials for various interest groups that discuss counterfeit issues generally. In addition, the agency intends to develop a new FDA anti-counterfeiting resources icon to increase familiarity with the issue.


B. Pharmacists and Other Health Care Professionals

1. What FDA sought comment on:

  • Pharmacists need improved tools to receive information and to educate themselves about how to handle these situations and to keep abreast of current counterfeit events. They need to know how to identify and counsel consumers who might have received counterfeit products.
  • Physicians, nurses and other health professionals also have contact with consumers taking pharmaceuticals and can help identify and counsel patients that could have accessed a counterfeit. This will require these groups keep up to date on current counterfeit events and know steps to take to report situations if a counterfeit is suspected.

2. What the comments said:

Groups representing pharmacists and pharmacies recognize the need for pharmacists to take a leadership role in the identification of counterfeits, prevention of their introduction into the distribution chain, and education of consumers about counterfeits.

The healthcare community indicated that awareness and education campaigns are important if its health professionals are to be active participants in the fight against counterfeit drugs.

3. Discussion:

Pharmacists and health professionals can play a major role in helping identify counterfeits and preventing their introduction into the distribution chain. FDA has been working with pharmacy and medical professional groups to develop educational materials for pharmacists and other healthcare professionals, including doctors, nurses, and physician assistants.

4. FDA Conclusion:

FDA plans to enhance its educational programs for pharmacists and other heath professionals about their role in minimizing exposure to, identifying, and reporting counterfeits.

  • FDA intends to work with pharmacy and health care professional groups to develop materials to help educate their profession on the risk of counterfeits, what to do in case a counterfeit is suspected and ways to aid in educating consumers. This will include development of clear, concise messages and protocols, as well as the establishment of a delivery mechanisms that will help them learn about the threat of counterfeits, what to watch for, and where to turn for useful information in the case of a suspected counterfeit;
  • FDA intends to encourage pharmacy and health care professionals to become partners in the agency's newly established Counterfeit Alert Network;
  • FDA intends to expand its outreach efforts by presenting at or participating in conferences and by publishing articles in professional journals and periodicals that target audiences of doctors, nurses, pharmacist and hospital administrators to educate them about counterfeits and raise awareness of the risks;
  • FDA intends to work with health professional trade groups to identify or improve data collection/ reporting systems that could help identify counterfeits as they enter the stream of commerce (i.e., include appropriate questions on the ER patient admission questionnaire that might help diagnose usage of a counterfeit drug.)