Despite the importance of quality standards for drugs, many low and middle-income countries struggle with creating and enforcing mechanisms to ensure drug safety. There are two important considerations when assessing drug quality: 1) do the drugs meet quality standards? and 2) Are the drugs appropriately administered based on symptoms or diagnoses? A central challenge in drug safety is identifying the most effective ways to measure these two questions. A World Bank study in Kenya used standardized patients to explore what methods are most effective. This study was part of the Kenya Patient Safety Impact Evaluation (KePSIE), an ongoing study exploring if increased inspections will contribute to better patient safety.1 2

Standardized patients are often used to evaluate safety. Individuals are trained to go to a facility and present a standardized set of symptoms. They then record the providers’ diagnosis and collect any prescribed medications. This approach enabled the researchers to investigate if patients were prescribed appropriate drugs and then could test the prescribed drugs to assess compliance with quality standards.1 Using this methodology, the researchers found that of sixty selected samples, 17% did not meet specifications, and five of these had been inappropriately prescribed. The study concluded that the standardized patient approach appears to be an effective way to measure drug safety. The KePSIE study is ongoing, and the results will contribute to knowledge on how governance and surveillance can improve patient safety.

References:

  1. Wafula F, Dolinger A, Daniels B, Mwaura N, Bedoya G, Rogo K, et al. Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients. Drugs - Real World Outcomes [Internet]. 2017;4(1):53–63. Available from: http://link.springer.com/10.1007/s40801-016-0100-7
  2. Kenya: Patient Safety Impact Evaluation (KEPSIE) [Internet]. 2017 [cited 2017 Sep 8]. Available from: http://www.worldbank.org/en/programs/competitiveness-policy-impact-evaluation-lab/brief/kenya-patient-safety-impact-evaluation-kepsie