Pharmaceutical Security Institute

Source Pharmaceutical Security Institute, Vienna, Virginia, 2006. 

Pharmaceutical Security Institute. 2002. Available at www.psi-inc.org [Accessed March 2, 2004]. 

Wehrli (1997) stated case reports from Australia, the United States and the United Kingdom and the activities of the Pharmaceutical Security Institute (PSl), which was founded by the majority of ethical pharmaceutical companies and operates under the auspices of the International Federation of Pharmaceutical Manufacturers Association (IFPMA). Wehrli further indicated that an API may be counterfeited in one country, passed by a circuitous route into another for formulation, from there to a third country where the product is sold. 

Applicants are free to solicit advice from individual Member States and according to various surveys conducted by the European Federation of Pharmaceutical Industries and Associations, they often do. Apart from the FDA, these surveys reveal, the EU Member States most often consulted are Germany, France, Sweden and the United Kingdom. Flowever, it is often important to secure a pan-European advice. Article 51 of Council Regulation EEC/2309/93 requires the EMEA to provide the Member States and the institutions of the Commimity with the best possible scientific advice on any question relating to the evaluation of the quality, the safety and the efficacy of medicinal products for human... 

The present book is rooted in a lecture on chemical process safety at graduate level (Masters) at the Swiss Federal Institute of Technology in Lausanne. It is also based on experience gained in numerous training courses for professionals held at the Swiss Institute for the Promotion of Safety Security, as well as in a number of major chemical and pharmaceutical companies. Thus it has the character of a textbook and addresses students, but also addresses professional chemists, chemical engineers or engineers in process development and production of fine chemicals and pharmaceutical industries, as support for their practice of process safety. 

Doctors working for the Mexican Institute of Social Security (IMSS) or the Institute of Social Security and Services for Government Workers (ISSSTE) are considered to be government officers, and therefore are not allowed to receive gifts or donations from pharmaceutical companies. 

The demand for researchers who focus on the clinical pharmaceutical sciences has exceeded the supply. Individuals graduating from CPS programs have secured successful careers within academic, industrial, and governmental institutions (Fig. 2). Academic institutions are major employers of CPSs within the clinical or basic science divisions in the various health-related schools. The CPSs unique blend of clinical and research skills allow these individuals to develop interdisciplinary collaborations and thus are aggressively sought by research... 

Significant deficiencies in the security and control of samples have been well documented. " " In fact, it has been estimated that just over half of samples actually reach patients. Samples may be used by prescribers and staff, or they may be diverted. Personal use of drug samples by physicians and other healthcare providers raises ethical concerns and is not without risk." Limaye and Paauw described three medical residents who self-prescribed antimicrobials and were subsequently diagnosed with Clostridium difficile infection." Tong and Lien reported self-medication with samples and distribution of samples to nonphysicians by almost 60% of pharmaceutical representatives surveyed at a Canadian family practice office. A contributing factor to some of these issues is that institutional or facility sample policy and procedures are often absent, or compliance is poor. One institution found only 10% compliance when the inventory of samples was compared with the required written documentation. Even after an educational program in which the policy was explained to the house staff, a second audit found only 26% compliance. " Poor compliance with policy and procedure may jeopardize patient safety, as well as put the institution at risk for JCAHO recommendations or Board of Pharmacy penalties. 

Drug sampling is a controversial marketing technique used to promote pharmaceuticals. Pharmacists should be encouraged to get involved in efforts to promote safe and appropriate use of samples and ensure control and security. Clinics and institutions should have and enforce policies and procedures for managing samples. Control-... 

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