FDA moving to strengthen drug safety program

Canadian pharmacists increase safety as well

The U.S. Food and Drug Administration have asked Congress to make changes as part of reauthorization of the Prescription Drug User Fee Act (PDUFA) that would significantly broaden and upgrade the agency's drug safety program.

The user fee program was first authorized in 1992. It adds industry funds to congressional appropriations to FDA to help the agency's human drug review program achieve performance goals by paying for additional staff. Over the years, the PDUFA programs have enabled the agency to dramatically reduce the review time for drugs and biological medications while increasing scientific consultations, clarifying issues involving drug development, and increasing oversight of postmarket safety.

FDA is requesting an increase of $29.3 million in user fees for a major boost to activities to ensure the safety of medications after they are on the market. The increased funds would be available for FDA drug safety activities for marketed medications throughout as long as they remain on the market and would increase FDA's drug safety capacity for surveillance, including hiring an additional 82 employees to perform post market safety work.

The agency also has recommended eliminating a statutory provision under which PDUFA fees may be used to assess safety issues only during the first three years after a product's approval. FDA also would use the added resources to adopt new scientific approaches and improve the utility of existing tools for detecting and preventing adverse events, such as obtaining access to the best available databases to better analyze drug safety signals.

Meanwhile, the Canadian Society of Hospital Pharmacists and the Institute for Safe Medication Practices Canada have signed a memorandum of understanding on their mutual commitment to collaborate to advance safe medication practices within the larger scope of patient safety.

The two organizations said they will collaborate to reduce the potential for medication-related adverse events by (1) raising awareness of issues relating to medication safety, (2) identifying and addressing system issues related to medication safety in hospitals, and (3) providing tools, information, and education pertaining to safe medication practices.

Steps to be taken

The agreement commits the two groups to working together to:

  • Promote best pharmacy practices based on the best research evidence on the optimization of medication use systems such as involving pharmacists in direct patient care; implementing safe drug distribution systems; expanding use of computer technology and automation; reviewing drug orders; using drug formulary systems; standardizing medication policies and guidelines; providing drug information/education to patients and healthcare providers; and reporting to the Canadian Medication Incident Reporting and Prevention System.
  • Provide recommendations to key stakeholders for system changes required to improve patient safety, such as packaging and labeling issues related to pharmaceuticals and error-prone medication use systems and procedures.
  • Provide timely information to hospital pharmacists on issues related to medication safety.
  • Deliver educational programs pertaining to safe medication practices to hospital pharmacists.
  • Undertake specific medication safety initiatives as appropriate.
  • Establish consistency in initiatives and messaging pertaining to safe medication use in hospitals.

Representatives of the two organizations are to meet at least annually to discuss areas of cooperation, identify priority areas, tackle safety issues, and review progress on common goals.