These results are exploratory and are limited by the small number of participants and managed care organizations represented. No attempt was made to obtain a random or representative sample of managed care decision-makers, so the findings cannot be generalized beyond the study participants. However, a number of the findings are consistent with results reported by other investigators.
To obtain the target of 10 focus group participants, 29 prospective participants from the conference pre-registrant list were identified and contacted. Although eight men and three women met the inclusion criteria and agreed to participate, three of them were unable to attend, leaving a total of eight (i.e., six men and two women) focus group participants. These participants were on P&T committees that made pharmaceutical benefit decisions for over 500,000 enrolled lives.
To fulfill the research objectives, two focus groups with five participants each were planned. Potential participants were identified, based on their job titles, from among pre-registrants of a conference sponsored by the University of Arizona’s Center for Health Outcomes and PharmacoEconomic Research. They were contacted by telephone to determine interest in participation and eligibility. Specific inclusion criteria required that they: 1) be 18 years of age or older; 2) be in a position in which they make pharmaceutical benefit decisions; 3) be able to successfully communicate in English in a group setting; and 4) have signed written informed consent to participate. This project was conducted under the auspices of the University of Arizona’s Human Subjects Committee. The participants were provided with an honorarium.
The pattern of illness in the U.S. has shifted from mostly acute disease to one in which chronic conditions predominate. Although there are many diseases that can shorten life expectancy, it is more likely that a disease will have adverse health consequences that result in dysfunction and decreased well-being. Hence, patient self-reports of functioning and well-being, or health-related quality of life (HRQOL), are increasingly viewed as important measures of therapeutic outcome. Sanders and colleagues found that the reporting of quality-of-life therapeutic endpoints in randomized controlled trials increased more than 650% between 1980 and 1997.
Dozens of times each day, drug information specialists at Thomas Jefferson University Hospital (TJUH) contact physicians to suggest changes in their pharmaceutical product-related orders. These can be minor changes, such as sorting out misspellings, or they might be potentially life-saving changes, as in correcting the dose of an aminoglycoside, or alerting a physician to a possible drug interaction. On an annual basis, our drug information specialists contact physicians nearly 10,000 times per year (and we have been tracking these data for some time). It is fair to say that these numbers increase every year along with the number of products on our formulary and the complexity of the conditions of the patients who receive care at TJUH.
Modifications of the lipid and lipoprotein classification now identify LDL cholesterol below 100 mg/dl as optimal. What is now considered to be low HDL cholesterol has changed to values below 40 mg/dl, up from the previous 35 mg/dl. The optimal triglyceride level has been determined to be less than 150 mg/dl. The new guidelines suggest a comprehensive lipoprotein panel (total, LDL-C, HDL-C, and triglycerides) as the preferred initial test, rather than the previous recommendation of total cholesterol and HDL-C alone. The new guidelines also encourage a more rapid initiation of drug therapy, sometimes simultaneously with lifestyle modifications.
The withdrawal of cerivastatin (Baycol, Bayer) from the market for safety reasons posed a huge problem for P&T committees and all members of the health care team who uphold the safety of patients. It came in the face of a worldwide evolution to modern lifestyles that in the aggregate involve decreased exercise levels with a consequential rise in lipid levels. This rise in lipid levels puts into sharp focus the continued need to balance aggressive treatment for high lipid levels against the increased need to monitor the sometimes dire medical consequences of using this powerful class of medications. The purpose of this article is to address the proper balance between these two divergent foci.