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* From International Scientific Relations, Bayer, West Haven, CT.
Correspondence to: Glenn S. Tillotson, MSc, Director, International Scientific Relations, Bayer Corporation, 400 Morgan Lane, West Haven, CT 06516; e-mail: glenn.tillotson.b{at}bayer.com
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Abstract |
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Key Words: data collection • details • dissemination
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Introduction |
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It is generally regarded that clinical practice guidelines are a good thing. They are developed for a wide range of infections at many different levels by various groups, sometimes with differing criteria. It has become obvious over the last decade that with the exception of "purse-string holders," such as managed-care organizations, most guideline creators are fairly powerless to ensure the total implementation of their creation. Thus, some groups are becoming increasingly prepared to "deal with the devil" and ask the pharmaceutical industry for assistance.
From the perspective of the pharmaceutical industry, assisting in creating and implementing guidelines can be a wonderful opportunity; however, most clinical practice guidelines proffer a group or class of agents, instead of recommending specific agents such as a particular antimicrobial drug. In addition, the pharmaceutical industry is rarely involved other than as a sponsor in the development of practice guidelines. So, the level of "ownership" is somewhat diluted. As a consequence of these confounding issues, the industry finds itself between a "rock and a hard place." Money may be donated to help develop the guidelines, but there is otherwise no input into the process. The final outcome may have little or no specific product reference or relevance. The industry is then asked to help promulgate the new practice guidelines, which may advocate generic agents or competitor agents. This financial support is not inexpensive.
The world of anti-infectives is one in which guidelines can rapidly lose their relevance, mainly due to the emergence of resistant pathogens and/or the approval of new antimicrobials. Resistance issues can be parochial or national, but they must play a role in the local implementation of practice guidelines. But this assumes that physicians, ranging from those in community practice to those in the highest levels of academia, know both the likely etiology of an infection and the local susceptibility patterns to a range of antimicrobials that may be listed in guidelines. How they then select an appropriate agent may be driven by the managed-care organization or by personal opinion.
Assuming that the pharmaceutical companies wish to align themselves to a particular set of clinical practice guidelines, what specific activities can be undertaken that can aid their uptake? Dissemination of the published deliberations can be assisted by purchase of reprints or by the subsidy or underwriting of their distribution to physicians and health-care providers. Occasionally, companies can add their imprimatur to such reprints.
Development of supportive programs or information systems to reinforce the recommendations of the guidelines can be industry funded. These programs can be computer-based and designed so that symptoms or diagnosis fit specific criteria. The "new" guidelines can be highlighted so as to assist or remind the physician of the next steps in optimal patient management.
Discovery of key, pertinent data can be used in development of the guidelines. For example, the guidelines can reflect data from surveillance of susceptibility levels among relevant pathogens at both a local and national level. The recent remarkable rate of resistance emergence has been most comprehensively researched by industry-funded programs such as the Alexander Project (SmithKline Beecham), SENTRY (Bristol-Meyer Squibb; Princeton, NJ) (Rhone Poulenc Rorer; Collegeville, PA), and MYSTIC (Meropenen Yearly Susceptibility Testing Internation Collaboration; Astra Zeneca; Macclesfield, UK) among others. Other research programs that can aid the confirmation of guidelines relate to the presenting signs and symptoms of specific conditions. This specific aspect has been pursued with respect to chronic bronchitis and sinusitis. Both conditions have been shrouded in myth and legend and have only recently been the focus of concerted research into the true incidence of particular signs and symptoms. These "new" data can then be the basis of evidence-based disease management.
Data collection and management are paramount, given the evolving rate of antimicrobial resistance. One of the important features of any practice or disease management guideline is determined by the effectiveness from both clinical and health-outcome perspectives. There is little point in advocating new or different approaches if they are not audited, with results fed back to the relevant groups so that guidelines can be modified accordingly. The pharmaceutical industry can and does play a key role not only in creating, but also in funding various audit schemes. The data collected are included in software developed by and with the industry. Clearly, these exercises provide the funding company with the advantage of an early view of key data. If the results are contrary to hopes or expectations, these results may be used by the company’s personnel either to further reinforce the guidelines or to create new research programs or marketing strategies.
Discourse is the optimal way in which both opinion and facts can be directly reviewed and harmonized. These discussions occur at events that are funded in a collaborative fashion by multiple companies. In some instances, corporate representatives may be observers at these meetings. Following discussion and consensus, the outcomes will be published, and the publication will be distributed either directly or indirectly by the industry.
The resources of the "Top 20" companies of the US pharmaceutical industry are considerable. Presently, there are > 30,000 sales representatives, each of whom visits, on average, eight physicians daily. If these sales representatives work for 200 days each year, then it is reasonable to estimate that > 75 million "details" occur. In addition to the myriad of other methods of access to physicians (advertisements, direct mail, television, etc), these visits create an enormous opportunity for guideline developers and for the pharmaceutical industry.
Finally, it is also worth considering the diversity of anti-infective practice guidelines and how current they are in relation to medical practice. Good examples of disharmony are the various guidelines for community-acquired pneumonia around the world. Table 1 shows some of the disparity between what should be almost identical processes.
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Once the product-specific prejudices and fears are nullified, the future is promising for guideline developers and industry to collaborate on both creation and implementation of guidelines, constantly reassessing the evolving clinical practice guidelines.
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