The appropriate use of medications is a central aspect of health care. Each year, basic science research and biotechnology produce new treatments which hold the promise of major clinical benefit. However, these interventions also carry risks which must be rigorously measured and evaluated against the treatment’s efficacy. Drugs are also a growing component of health care expenditures, and more attention is being drawn to the relation between the costs of medication and their benefits.

In 1998, the BWH Department of Medicine created the Division of Pharmacoepidemiology and Pharmacoeconomics to facilitate a wide range of activities related to the use and outcomes of medications, addressed from a variety of interdisciplinary perspectives. Its mission is to bring together the various specialties of medicine, epidemiology, biostatistics, health services research, and the social sciences to evaluate the effectiveness of existing and new prescription drugs in relation to their risks and costs; to study how medications are used by physicians and patients; and to develop methods to optimize prescription drug use.

Research goals

  • Using very large populations of patients, study the use of specific medications and clinical outcomes to identify and quantify adverse events and desired clinical outcomes;
  • Develop advanced methods in epidemiology, biostatistics, and informatics to detect and evaluate important signals of potential drug safety problems, as well as to compare the therapeutic results of alternative treatment strategies;
  • Define patterns of medication prescribing by physicians, and use (compliance) by patients;
  • Analyze the influence of health system factors (policies, coverage and reimbursement differences) on the quality of medication use;
  • Design, implement, and test innovative programs to improve the appropriateness of prescribing by physicians, and medication use by patients.

Unique attributes

The Division brings together clinicians with a variety of clinical backgrounds (e.g., primary care, geriatrics, rheumatology, cardiology, nephrology), with the skills of quantitative science (e.g., epidemiology, biostatistics) and other relevant disciplines (e.g., health policy, law, computer science, decision analysis, social science). Most division faculty have advanced degrees in several of these fields, providing a rich interdisciplinary environment for the study of medication use and outcomes. The group has developed advanced relational databases of all drug exposures and clinical encounters for several million patients, and has research relationships with governmental and private-sector insurers that provide access to several million others. Data are hosted and analyzed on an extensive network of secure computers with 10 terabytes of storage capacity.

Areas of excellence

In its first 10 years of existence, the Division has become known internationally as a center of excellence in pharmacoepidemiology research; its faculty have generated over 300 papers in the medical literature on drug risks, benefits, cost, and policy. It has become a major training site for doctoral and post-doctoral students from the Harvard School of Public Health, other Harvard graduate programs, and advanced trainees from other universities all over the world. It is the primary university site collaborating with the nation’s largest health insurer and the largest pharmacy company, and has developed research relationships with several Fortune 500 employers to analyze or perform intervention studies on their medication benefit programs.

Major accomplishments of Division faculty

  • Development of new methodologies for computer-intensive analysis of very large datasets of prescriptions and clinical encounters to identify drug risks;
  • Quantification of the risk of adverse events following use of specific drugs or drug classes (e.g., statins, biologics, anti-Parkinsonian agents);
  • Evaluation of government policies affecting medication use to define their clinical and economic consequences;
  • Definition of important confounders that can distort the results of observational studies of drug effects;
  • Elucidation of the prevalence and predictors of poor adherence to prescribed regimens (non-compliance);
  • Creation, implementation, and evaluation of educational outreach programs (“academic detailing”) to improve prescribing in primary care, teaching hospitals, and nursing homes;
  • Assessment of the cost-effectiveness of particular medications and drug-use strategies;
  • Implementation of a randomized controlled trial of changes in drug coverage policies in thousands of patients, to measure effects on compliance and clinical outcomes;
  • Analyses of the effects of intellectual property law on the development, utilization, and costs of medications.