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Pharmacoepidemiology & Patient Safety Study Examples

Study Examples | Key Publications | Intro

These are among current studies being conducted at Center for Health Studies (CHS):

• Active Surveillance for Adverse Drug Reactions
• Prescribing Safely During Pregnancy
• Statin Use and Site-Specific Cancers, and Medication Use and Colorectal Cancer Risk

Active Surveillance for Adverse Drug Reactions

• Principal Investigator: Robert L. Davis, MD, MPH

Building on methodology developed in the Vaccine Safety Datalink Project, CHS researchers are collaborating with researchers from the Food and Drug Administration (FDA) and Harvard Pilgrim Health Plan to assess the capability of the Centers for Education and Research on Therapeutics (CERT) Network to perform active surveillance for adverse drug reactions. Using maximized likelihood sequential probability ratio testing, the researchers are studying the ability to find known associations between drugs and adverse events: coxibs and cardiac disease; cerivastatin and rhabdomyolysis; thiazolidenediones and congestive heart failure; and angiotensin converting enzyme (ACE) inhibitors and angiotensin antagonists and angioedema, as well as suspected, but not confirmed associations (amlodipine and renal failure; cetirizine and thrombocytopenia; and clemastine and serious dermatologic adverse reactions). In addition, they are evaluating several drugs and four specific categories of new-onset disease: allergic reactions and toxicity to the liver, blood, and kidneys. This project is part of a Group Health's contract with the CERT, funded by the Agency for Healthcare Research and Quality (AHRQ) at $46,000 over two years.

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Prescribing Safely During Pregnancy

• Principal Investigator: Robert L. Davis, MD, MPH

Most women take at least one medication while expecting, but the safety of most of these drugs is unknown for both mother and child. A lack of information about the types of drugs and patterns of prescription has limited research into safe prescribing during pregnancy. As part of the HMO Research Network's CERT, CHS researchers are studying outcomes among more than 100,000 babies born to pregnant women exposed to different categories of medications; they are contrasting them with infants born to unexposed pregnant women delivering during the same time period and geographic region. The investigators are assessing the absolute and relative risks for congenital malformations among babies born to women who are prescribed medications (specifically antidepressants, cardiovascular medications, or antibiotics) before and during pregnancy. The AHRQ funds this largest study ever conducted on this topic: a two-year, $300,000 project, with $28,000 to CHS.

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Statin Use and Site-Specific Cancers, and Medication Use and Colorectal Cancer Risk

• Principal Investigator: Denise M. Boudreau, PhD

Many commonly used medications are thought to alter cancer risk and prognosis. In many cases, there is strong biologic evidence to support this assumption, but population-based studies are lacking or inconsistent. With a two-year $100,000 grant from the National Cancer Institute (NCI), CHS investigators are evaluating whether certain commonly used medications alter cancer risk. Their effort is part of CHS program goals to understand the biology of cancer, address drug safety concerns, and improve cancer prognosis. They are testing several hypotheses, including the following:

• Statins, the popular cholesterol-lowering drugs, decrease the risk of breast, prostate, and colorectal cancer.
• Acid suppressants increase the risk of colorectal cancer.
• Antidepressants impair breast cancer prognosis.

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Study Examples | Key Publications | Intro