NPSF Drug Safety Perspectives

Recently there has been a lot of discussion in the media and the general public about the safety of drugs being advertised and sold in the market. The Food and Drug Administration is considering imposing new restrictions in terms of advertising and labeling of pharmaceutical products. Congressional committees are considering holding public hearings to address this very critical health issue affecting millions of consumers in the United States.

In the summer of 1999, following the publication by the Institute of Medicine of the report To Err is Human, the National Patient Safety Foundation (NPSF) at the American Medical Association retained CWA Ltd. to coordinate the development of a National Leadership Agenda concerning the Safe and Appropriate Use of Medications. CWA Ltd. designed and facilitated a collaborative action-planning project, which brought together forty organizations and enabled the representatives of the stakeholders to converge to a collaborative action plan based on a two-day forum. This initiative was sponsored by a public-private partnership. The forum represented stakeholder interests throughout the pharmaceutical safety-chain.

The unprecedented cross section of stakeholders represented: healthcare clinicians, institutional providers, the pharmaceutical industry, pharmacists, consumer advocates, regulators, policy makers, public health professionals, patients and public interest groups. The goals of the project were:

  • Appreciate the diversity of viewpoints regarding the complex problem situation of drug safety;
  • Create a shared understanding of the “anticipated challenges” that the community of stakeholders will face in improving the situation;
  • Build consensus on an action plan for addressing the “system of challenges;” and
  • Forge a commitment to collaborative leadership.

Following the completion of the project a very comprehensive slide show presentation was prepared by CWA for the purpose of disseminating the findings and recommendations of the forum to the community of stakeholders. One of the key points made in the slide presentation is that pharmaceutical safety is a perfect case of a “systemic misadventure,” namely it cannot be improved without the utilization of a truly systemic approach. While many stakeholders participating in the forum were aware of the systemic nature of the problem situation, there seems to be no commitment to collaborative leadership espousing the systemic thinking required by the situation. So the issue of drug safety will most likely not be resolved in the near future unless a systemic perspective is implemented.

The project and the forum generated support for a commitment to collaborative leadership. Unfortunately, this commitment was not sustainable for a variety of reasons, the primary one being the incapacity of the stakeholders to communicate and take collaborative actions across organizational boundaries.
In light of the fact that drug safety has reemerged as a major national issue we are posting the slide show for viewing by the interested parties. If you would like to view the slide show please click here.

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