Background: Hypertensive disorders of pregnancy (HDP) are associated with serious maternal and perinatal complications. For nonsevere hypertension, there is a lack of consensus regarding treatment during pregnancy and while breastfeeding. Further, there is considerable variability in guidelines for antihypertensive drug choices. As part of a Drug Safety and Effectiveness Network (DSEN)-funded project, we piloted a novel surveillance strategy in which community pharmacists recruited pregnant and breastfeeding women to monitor their blood pressure and medication use and to provide education on HDP.
Methods: Participating pharmacists were required to complete a certified training program, identify and recruit patients who were pregnant or breastfeeding, obtain informed consent, administer a patient questionnaire and complete an initial case report form for enrolled patients. Study outcomes included the feasibility of community pharmacists to enroll patients and carry out study-related documentation and follow-up. The criteria for success in this pilot study included the ability of pharmacists to recruit 10 participants per pharmacy.
Results: 178 community pharmacies across British Columbia agreed to participate in this feasibility study, of which 63 pharmacists completed the study training. Of these, only 21 pharmacists recruited at least 1 patient and 1 pharmacist met the success criteria. Overall, 51 patients were enrolled, 2 withdrew from the study and 7 patients were diagnosed with HDP. Antihypertensive medications used by patients included methyldopa and labetalol.
Conclusions: While postmarketing surveillance is an important tool for the assessment of drug safety in the pregnant and breastfeeding patient population, the feasibility of community pharmacists taking on this role was not successfully demonstrated.