Question Can a consumer-targeted, pharmacist-led educational intervention reduce prescriptions for inappropriate medication among community-dwelling older adults?
Findings In this cluster randomized trial that included 489 older adults, the percentage achieving discontinuation of a targeted inappropriate prescription at 6 months was 43% among patients receiving the intervention vs 12% receiving usual care, which represents a significant difference.
Meaning A pharmacist-led intervention has the potential to reduce prescriptions for inappropriate medication in older adults.
Importance High rates of inappropriate prescribing persist among older adults in many outpatient settings, increasing the risk of adverse drug events and drug-related hospitalizations.
Objective To compare the effectiveness of a consumer-targeted, pharmacist-led educational intervention vs usual care on discontinuation of inappropriate medication among community-dwelling older adults.
Design, Setting, and Participants A cluster randomized trial (D-PRESCRIBE [Developing Pharmacist-Led Research to Educate and Sensitize Community Residents to the Inappropriate Prescriptions Burden in the Elderly]) that recruited community pharmacies in Quebec, Canada, from February 2014 to September 2017, with follow-up until February 2018, and randomly allocated them to intervention or control groups. Patients included were adults aged 65 years and older who were prescribed 1 of 4 Beers Criteria medications (sedative-hypnotics, first-generation antihistamines, glyburide, or nonsteroidal anti-inflammatory drugs), recruited from 69 community pharmacies. Patients were screened and enrolled before randomization.
Interventions Pharmacists in the intervention group were encouraged to send patients an educational deprescribing brochure in parallel to sending their physicians an evidence-based pharmaceutical opinion to recommend deprescribing. The pharmacists in the control group provided usual care. Randomization occurred at the pharmacy level, with 34 pharmacies randomized to the intervention group (248 patients) and 35 to the control group (241 patients). Patients, physicians, pharmacists, and evaluators were blinded to outcome assessment.
Main Outcomes and Measures Discontinuation of prescriptions for inappropriate medication at 6 months, ascertained by pharmacy medication renewal profiles.
Results Among 489 patients (mean age, 75 years; 66% women), 437 (89%) completed the trial (219 [88%] in the intervention group vs 218 [91%] in the control group). At 6 months, 106 of 248 patients (43%) in the intervention group no longer filled prescriptions for inappropriate medication compared with 29 of 241 (12%) in the control group (risk difference, 31% [95% CI, 23% to 38%]). In the intervention vs control group, discontinuation of inappropriate medication occurred among 63 of 146 sedative-hypnotic drug users (43.2%) vs 14 of 155 (9.0%), respectively (risk difference, 34% [95% CI, 25% to 43%]); 19 of 62 glyburide users (30.6%) vs 8 of 58 (13.8%), respectively (risk difference, 17% [95% CI, 2% to 31%]); and 19 of 33 nonsteroidal anti-inflammatory drug users (57.6%) vs 5 of 23 (21.7%), respectively (risk difference, 35% [95% CI, 10% to 55%]) (P for interaction = .09). Analysis of the antihistamine drug class was not possible because of the small sample size (n = 12). No adverse events requiring hospitalization were reported, although 29 of 77 patients (38%) who attempted to taper sedative-hypnotics reported withdrawal symptoms.
Conclusions and Relevance Among older adults in Quebec, a pharmacist-led educational intervention compared with usual care resulted in greater discontinuation of prescriptions for inappropriate medication after 6 months. The generalizability of these findings to other settings requires further research.
Trial Registration ClinicalTrials.gov Identifier: NCT02053194
Randomization and Allocation Concealment
A 1:1 allocation ratio was assigned by an independent statisti- cian and random number generator using nonstratified block sizes of 2 for participating pharmacies. Blinding pertained to both the individual and cluster levels. The trial was labeled as a “medication safety study for older adults.” Because the in- tervention was educational in nature, masking was not pos- sible; however, pharmacists and patients were blinded to group allocation by being told that the intervention would be deliv- ered sometime during the next year. Pharmacists were blinded to other participating pharmacies.
Pharmacies in the intervention group were provided with patient educational brochures and the prototype pharmaceu- tical opinion by research assistants during visits to the phar- macies, and encouraged to distribute educational materials to both patients and their prescribers. Educational material for patients consisted of a drug-specific brochure, distributed by pharmacists in person or by mail, containing information about why the medication may be inappropriate, potential alternative treatment options, and, for patients prescribed sedative-hypnotics, a visual tapering protocol20 (available at https://www.deprescribingnetwork.ca/patient-handouts). Educational material for physicians was packaged in the form of an evidence-based pharmaceutical opinion that pharmacists could use or adapt during communication with each participant’s physician2 1 (available at https://www .deprescribingnetwork.ca/pharmaceutical-opinions). In Quebec, the pharmaceutical opinion is a legal and reim- bursable pharmacist-initiated act aimed at facilitating pharmacist-physician communication.22 A standardized evidence-based pharmaceutical opinion was designed with elements requested by physicians and pharmacists during testing, including a clear rationale for why deprescribing was being recommended; evidence about drug harms; credible sources of recommendations; a choice of safer therapeutic alternatives; and personalized participant data.21 The inter- vention materials were distributed to each participating phar- macist in the intervention group immediately after random- ization. Pharmacists in the control group provided usual care for 6 months. Usual care consisted of patients receiving nor- mal care delivered in everyday practice without any educa- tional materials supplied to pharmacists.
The primary outcome was complete cessation of prescription fills for any of the 4 medication classes 6 months after ran- domization, measured at the level of the participant. Discon- tinuation was disaggregated by drug class, defined as the ab- sence of any prescription renewal at 6 months, sustained for at least 3 consecutive months, and lack of substitution to an- other inappropriate drug class. Prescription renewals were de- termined using pharmaceutical drug claims records. Twoinvestigators, blinded to group allocation, independently assessed outcomes.
Secondary outcomes included assessment of the delivery of the educational brochures to the patients by their pharmacists; the prevalence, timing, and type of pharmaceutical opinions sent by the pharmacists to the patients’ primary care physicians; the effect of the educational material on participants’ beliefs about the use of their inappropriate medications and their intent to discuss cessation with their physician or pharmacist; the effect of the pharmaceutical opinion on the prescribing physician’s behavior; participant- physician encounters to discuss inappropriate prescriptions; and participant improvement in selfefficacy to discontinue medication. These data were collected from patients and pharmacists 6 months after randomization during in-person inter- views. The effect of the intervention on participants’ beliefs about the use of inappropriate medications and selfefficacy to discontinue medication are not reported here. Data on the timing of the distribution of the pharmaceutical opinion were not available. Because tapering was recommended for patients receiving the sedative-hypnotic drug class only, sedative- hypnotic users were asked whether a tapering conversation occurred, if tapering was attempted, and if there were barriers to deprescribing.