|Counterfeit drugs (WHO/EDM, 1999, 61 p.)|
|6. Specific measures|
The pharmaceutical industry
The pharmaceutical industry has a great part to play in the detection, control and eradication of counterfeiting of drugs. Legitimate drug manufacturers should be encouraged to:
- develop measures, such as the introduction of security systems including the use of security tags, to prevent the counterfeiting of their products
- secure their own stocks of medicines and packaging materials in order to prevent their diversion to illegal manufacturers and packagers
- survey regularly their own and the national drug distribution channels with a view to detecting the presence of any counterfeiting of their products; drug manufacturers whose products have been counterfeited should be encouraged to share this information willingly with the national DRA and law enforcement agents so that it may be used as evidence in court proceedings, in which they could be witnesses
- avoid promoting drugs in a way that results in demands that cannot be met by their own supply system, thereby leaving a gap which could be exploited by counterfeiters.
The importers of pharmaceuticals should take the necessary steps to:
- ensure that the drugs which they import are being manufactured legitimately in the countries of manufacture
- establish and maintain necessary confidence in the sources of the drugs which they import, and remain satisfied with the integrity and authenticity of the drugs which they import and sell
- be aware of and take into account any security arrangements (such as special printing) used in the country of purchase
- establish and maintain an audit trail of the imported drugs back to the original manufacturer or wholesaler
- obtain certificates for imported drugs that comply with the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce, whenever available
- conduct visual inspection and other analytical checking procedures on the drugs they import to assure themselves of their legitimacy
- maintain records of supplies to wholesale distributors to facilitate recall in the event of counterfeit drugs being detected among their own stocks
- report all relevant details of any detected counterfeit drugs to the national DRA.
The wholesalers and retailers of pharmaceuticals should take the necessary steps to:
- purchase drugs from legitimate sources only
- avoid purchasing, selling or supplying any drug suspected of being counterfeit or of which the quality, efficacy or safety are in any way in doubt
- carry out visual inspection and other non-analytical methods of checking the quality of drugs, including checks on the quality of the labelling and packaging materials, and the name and address of the manufacturer
- maintain an audit trail of the drugs they purchase
- in the case of wholesalers, maintain an audit trail of drugs sold to permit the recall of any counterfeit drugs detected, where necessary
- employ suitably qualified persons, preferably pharmacists, to fill supervisory and managerial posts in drug procurement
- report to the national DRA any suspected counterfeit drugs in the national distribution channels; the products concerned should be withheld from supply.
All health care providers should be drawn into the fight against counterfeit drugs. Prescribers should be on the alert for any failure of treatment that might be attributable to a particular drug(s), since this could signal the presence of a counterfeit. The suspected presence of counterfeits should be reported to the national DRA, which should collect and analyse samples.
Associations of health care professionals should encourage their members to use only authorized sources of drug supply. They should establish effective communications with the national DRA for the purposes of exchanging information on suspect counterfeits in the national drug distribution channels. They should also impose severe sanctions on any of their members found guilty of manufacturing, distributing, supplying or selling counterfeit drugs.
Mobilizing the community
Nongovernmental or community-based organizations, such as consumer associations, should be informed about the problem of counterfeiting, and the possible presence of counterfeit drugs in the national drug distribution channels. They should be provided with information on methods of detecting counterfeit drugs and the procedures to follow when making reports to the relevant authorities on any detected counterfeits.
The general public should be encouraged to become involved in the fight against drug counterfeiting. Education and information campaigns directed to the public should be established. Consumers should be encouraged to report to the national DRA or the police any suspect products and/or illegal or unauthorized drug manufacturers and distributors they may encounter.
Consumers could also be encouraged to report to their prescribers or physicians: (1) any lack of improvement in their health status in spite of their compliance with prescribed treatment regimens; and (2) all adverse reactions experienced during treatment (unexpected adverse reactions might indicate that the drug used was a counterfeit).