Safety testing could prevent adverse drug reactions, reduce costs

Testing new medications can be risky, especially without an effective monitoring program. A study, published in Medical Care, evaluated the impact drug safety monitoring could have on detecting unsafe medications, improving patient care and controlling medical costs.

Many counties lack drug safety programs due to budget constraints. In the study, researchers examined three instances of major adverse drug events that led to medications being taken off the market.

“Three recent cases in which serious safety issues led to medication withdrawals illustrate the potential return on investment of building a more effective pharmacovigilance surveillance system,” wrote Krista F. Huybrechts, PhD, of Brigham and Women's Hospital, Boston, and colleagues. "Our analyses demonstrate a pivotal and economically justifiable role for active pharmacovigilance in protecting the health of the public."

Each of the three cases showed early signs of medication risks but went unnoticed and continued to affect patients, leading to avoidable complications and costs. The cases included the "COX2 inhibitor" rofecoxib used for arthritis, which increased risks of acute myocardial infarction and affected 27,500 patients. The second incident included 190 cases of a serious complication called rhabdomyolysis from the cholesterol-lowering drug cerivastatin. The third incident included 264 cases of liver failure caused by the diabetes drug troglitazone.

The cost associated with these cases was calculated at $773 to $884 million for rofecoxib, $3 to $10 million for cerivastatin and $38 to $63 million for troglitazone.

"It is clear that major adverse drug events are not rare," wrote Huybrechts and colleagues "Investment in active drug surveillance offers protection against the occurrence of such events, which are bound to recur. These examples illustrate a critical and economically justifiable role for active adverse effect surveillance in protecting the health of the public.”