A consumer-targeted, pharmacist-led, educational intervention to reduce inappropriate medication use in community older adults (D-PRESCRIBE trial): study protocol for a cluster randomized controlled trial.
ABSTRACT: Medication safety for older persons represents an ongoing challenge. Inappropriate prescriptions--those with a high risk of evidence-based harm--persist in up to 25% of seniors, and account for a significant proportion of avoidable emergency department visits. This project is the sequel to the EMPOWER study, in which a novel consumer-targeted written knowledge transfer tool aimed at empowering older adults to act as drivers of benzodiazepine de-prescription resulted in a 27% reduction of inappropriate benzodiazepine use at 6-month follow-up (number needed to treat (NNT)?= 4). Failure to discontinue in the EMPOWER study was attributable to re-emerging symptoms among participants, prescribing inertia, and lack of knowledge and skills for substituting alternate therapy among physicians and pharmacists. To maximize de-prescription of inappropriate therapy, educational medication-risk reduction initiatives should be tested that simultaneously include patients, physicians and pharmacists. The objective of this trial is to: 1) test the beneficial effect of a new de-prescribing paradigm enlisting pharmacists to transfer knowledge to both patients and prescribers in a 2-pronged approach to reduce inappropriate prescriptions, compared to usual care and 2) evaluate the transferability of the EMPOWER study concept to other classes of inappropriate prescriptions.We intend to conduct a 3-year pragmatic cluster randomized parallel-group controlled trial to test the effect of the new de-prescribing intervention compared to usual care for reducing 4 classes of inappropriate prescriptions from the 2012 Beers criteria among 450 community-dwelling older adults with polypharmacy. Inappropriate prescriptions will include benzodiazepines, sulfonylurea hypoglycemic agents, first generation antihistamines and non-steroidal anti-inflammatory drugs. The study population is community-dwelling older adults recruited from community pharmacies in Quebec, Canada. The intervention was developed based on a systematic review of the evidence for each medication. Participants in the experimental group will receive the written educational program following randomization and have their pharmacist send their physicians an evidence-based pharmaceutical opinion to recommend de-prescription and be followed for a year. The control group will be wait-listed for 6 months.System change to effectively reduce medication risk among community-dwelling seniors requires a coordinated approach targeting physicians, pharmacists and patients. This trial will test the feasibility and effectiveness of a tripartite approach to de-prescribing.Registered via ClinicalTrials.gov on 31 January 2014, identifier: NCT02053194.
Project description:<b>Background: </b>In Lebanon, difficulties in accessing medications are due to two main barriers, mainly: high cost and the lack of medication safety, related to poor-quality (irrational) prescription and use. The objective of this work is to suggest guidelines to implement a unified medical prescription in Lebanon. These guidelines are expected to promote medication safety and decrease pharmaceutical expenditures in the Lebanese context.<br><br><b>Methods: </b>The Order of Pharmacists of Lebanon (OPL) developed a comprehensive set of guidelines for physicians and pharmacists, including a detailed workflow process to improve the use of the unified medical prescription. The guidelines were presented to the Lebanese Ministry of Public Health (MOPH).<br><br><b>Results: </b>The project covered prescription guidelines to physicians (handwritten and electronic-prescriptions), and medication dispensing and generic substitution guidelines to pharmacists. Prescription guidelines included all required information about both the prescribing physician and the patient with the maximum of details, comprehensibility, and caution regarding specific populations/co-morbidities/co-prescriptions. Dispensing guidelines included details for safe and appropriate treatment dispensing, pearls for medications' counseling and generic substitution, as well as specific consideration for at-risk populations or those with concomitant medications and co-morbidities. Finally, a suggested workflow clarified the process for improving the unified medical prescription.<br><br><b>Conclusions: </b>The implementation of the guidelines should now be formally evaluated, to assess if they achieve the aims to reduce prescribing and dispensing errors, to improve the quality of medicines' prescription and use, the patient care, and the interaction between all stakeholders.
Project description: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.
Project description:OBJECTIVES:The use of unnecessary or excessive medications (inappropriate polypharmacy) is a major health challenge among older adults which is driven by several factors. This study aims to provide in-depth descriptions of the physician's role in the development of inappropriate polypharmacy among older adults in Iran. DESIGN:Qualitative content analysis of interviews, field notes and other relevant documents available (eg, medical records). Data collection and analyses were done concurrently to guide the sampling process. SETTING:Three purposively selected referral hospitals in Tehran, Iran. PARTICIPANTS:A total of 7 physicians, 10 older adults, 3 caregivers and 3 pharmacists with a median age of 54 (IQR 23) years were recruited through convenience sampling. RESULTS:Emerged categories included misdiagnosis, inappropriate prescribing, insufficient patient education, poor communication, unprofessional behaviour and limited perspectives which highlight the role of physicians in the development of inappropriate polypharmacy among older adults in Iran under the main concept of poor medical practice. CONCLUSION:This study provides valuable insight on the role of physicians in the development of inappropriate polypharmacy among the elderly in the healthcare setting in Iran by exploring the viewpoints of physicians, patients, caregivers and pharmacists. Physicians can be an influential factor in tackling this challenge through proper diagnosis, prescription, patient education and follow-up. In Iran, physicians' practice styles are affected by potentially adverse factors such as the novelty of geriatric medicine, lack of a referral system, patient unfamiliarity with the system and lack of a monitoring system for multiple prescriptions. Furthermore, clinics tend to be overcrowded and visit fees can be low; in this setting, lack of physician assistants leads to limited time allocation to each patient and physician dissatisfaction with their income.
Project description:Polypharmacy and inappropriate medication prescriptions are associated with increased morbidity and mortality. Most interventions proposed to improve appropriate prescribing are time and resource intensive and therefore hardly applicable in daily clinical practice.To test the efficacy of an easy-to-use checklist aimed at supporting the therapeutic reasoning of physicians in order to reduce inappropriate prescribing and polypharmacy.We assessed the efficacy and safety of a 5-point checklist to be used by all physicians on the internal medicine wards of a Swiss hospital by comparing outcomes in 450 consecutive patients aged ?65 years hospitalized after the introduction of the checklist, and in 450 consecutive patients ?65 years hospitalized before the introduction of the checklist. The main measures were the proportion of patients with prescription of potentially inappropriate medications (PIMs) at discharge, according to STOPP criteria, and the number of prescribed medications at discharge, before and after the introduction of the checklist. Secondary outcomes were the prevalence of polypharmacy (? 5 drugs) and hyperpolypharmacy (? 10 drugs), and the prevalence of potentially inappropriate prescribing omissions (PPOs) according to START criteria.At admission 59% of the 900 patients were taking > 5 drugs, 13% ? 10 drugs, 37% had ? 1 PIM and 25% ? 1 PPO. The introduction of the checklist was associated with a significant reduction by 22% of the risk of being prescribed ? 1 PIM at discharge (adjusted risk ratios [RR] 0.78; 95% CI: 0.68-0.94), but not with a reduction of at least 20% of the number of drugs prescribed at discharge, nor with a reduction of the risk of PPOs at discharge.The introduction of an easy-to-use 5-point checklist aimed at supporting therapeutic reasoning of physicians on internal medicine wards significantly reduced the risk of prescriptions of inappropriate medications at discharge.
Project description:Currently, far too many older adults consume inappropriate prescriptions, which increase the risk of adverse drug reactions and unnecessary hospitalizations. A health education program directly informing patients of prescription risks may promote inappropriate prescription discontinuation in chronic benzodiazepine users.This is a cluster randomized controlled trial using a two-arm parallel-design. A total of 250 older chronic benzodiazepine users recruited from community pharmacies in the greater Montreal area will be studied with informed consent. A participating pharmacy with recruited participants represents a cluster, the unit of randomization. For every four pharmacies recruited, a simple 2:2 randomization is used to allocate clusters into intervention and control arms. Participants will be followed for 1 year. Within the intervention clusters, participants will receive a novel educational intervention detailing risks and safe alternatives to their current potentially inappropriate medication, while the control group will be wait-listed for the intervention for 6 months and receive usual care during that time period. The primary outcome is the rate of change in benzodiazepine use at 6 months. Secondary outcomes are changes in risk perception, self-efficacy for discontinuing benzodiazepines, and activation of patients initiating discussions with their physician or pharmacist about safer prescribing practices. An intention-to-treat analysis will be followed.The rate of change of benzodiazepine use will be compared between intervention and control groups at the individual level at the 6-month follow-up. Risk differences between the control and experimental groups will be calculated, and the robust variance estimator will be used to estimate the associated 95% confidence interval (CI). As a sensitivity analysis (and/or if any confounders are unbalanced between the groups), we will estimate the risk difference for the intervention via a marginal model estimated via generalized estimating equations with an exchangeable correlation structure.Targeting consumers directly as catalysts for engaging physicians and pharmacists in collaborative discontinuation of benzodiazepine drugs is a novel approach to reduce inappropriate prescriptions. By directly empowering chronic users with knowledge about risks, we hope to imitate the success of individually targeted anti-smoking campaigns.ClinicalTrials.gov identifier: NCT01148186.
Project description:BACKGROUND:Multimorbidity is a global health challenge that is associated with polypharmacy, increasing the risk of potentially inappropriate prescribing (PIP). There are tools to improve prescription, such as implicit and explicit criteria. OBJECTIVE:To estimate the prevalence of PIP in a population aged 65 to 74 years with multimorbidity and polypharmacy, according to American Geriatrics Society Beers Criteria® (2015, 2019), the Screening Tool of Older Person's Prescription -STOPP- criteria (2008, 2014), and the Medication Appropriateness Index -MAI- criteria in primary care. METHODS:This was an observational, descriptive, cross-sectional study. The sample included 593 community-dwelling elderly aged 65 to 74 years, with multimorbidity and polypharmacy, who participated in the MULTIPAP trial. Socio-demographic, clinical, professional, and pharmacological-treatment variables were recorded. Potentially inappropriate prescribing was detected by computerized prescription assistance system, and family doctors evaluated the MAI. The MAI-associated factors were analysed using a logistic regression model. RESULTS:A total of 4,386 prescriptions were evaluated. The mean number of drugs was 7.4 (2.4 SD). A total of 94.1% of the patients in the study had at least one criterion for drug inappropriateness according to the MAI. Potentially inappropriate prescribing was detected in 57.7%, 43.6%, 68.8% and 71% of 50 patients according to the explicit criteria STOPP 2014, STOPP 2008, Beers 2019 and Beers 2015 respectively. For every new drug taken by a patient, the MAI score increased by 2.41 (95% CI 1.46; 3.35) points. Diabetes, ischaemic heart disease and asthma were independently associated with lower summated MAI scores. CONCLUSIONS:The prevalence of potentially inappropriate prescribing detected in the sample was high and in agreement with previous literature for populations with multimorbidity and polypharmacy. The MAI criteria detected greater inappropriateness than did the explicit criteria, but their application was more complex and difficult to automate.
Project description:Many medications pose greater health risks when prescribed for older adults, compared with available pharmacologic and nonpharmacologic alternatives. We sought to quantify the frequency and cost of potentially inappropriate prescribing for older women and men in Canada.Using data for 2013 from the National Prescription Drug Utilization Information System database, which contains prescription claims from publicly financed drug plans in all provinces except for Quebec, we identified the frequency of prescribing and cost of potentially inappropriate medications dispensed to provincial drug plan enrollees aged 65 years or more. Potentially inappropriate prescriptions were defined with the use of the American Geriatrics Society's 2012 version of the Beers Criteria for potentially inappropriate medication use in older adults.For the 6 provinces with relatively complete data coverage (British Columbia, Alberta, Saskatchewan, Manitoba, Ontario and Prince Edward Island), 37% of older people filled 1 or more prescription meeting the Beers Criteria. A higher proportion of women (42%) than men (31%) filled potentially inappropriate prescriptions. The highest rates of prescribing of potentially inappropriate medications were among women aged 85 or more (47%). Benzodiazepines and other hypnotics were the leading contributors to the overall frequency of and sex differences in prescribing of potentially inappropriate drugs among older adults. We estimated that $75 per older Canadian, or $419 million in total, was spent on potentially inappropriate medications outside of hospital settings in 2013.Prescribing of potentially inappropriate medications for older adults is common and costly in Canada, especially for women. Multipronged and well-coordinated strategies to reduce the use and cost of potentially inappropriate drugs would likely generate significant health system savings while simultaneously generating major benefits to patient health.
Project description:<h4>Aim</h4>To assess patients' knowledge about prescription medicines they are taking and their view on how much community pharmacist counseling contributed to their knowledge.<h4>Methods</h4>An observational study was designed to obtain information about patients' knowledge, their view on pharmacist counseling, and physicians'/pharmacists' provision of information. This study used a specifically designed questionnaire, which served as an interview guide. 400 patients picking up a prescription medicine were structurally interviewed upon leaving one of the 20 randomly chosen Slovenian pharmacies. The interviews took place in November and December 2013.<h4>Results</h4>Patients were familiar with general information about the medicines and their application (93%-100% of patients). Knowledge about considerations (16% of patients) and adverse effects (20% of patients) was limited. Factors associated with patient knowledge were physicians'/pharmacists' adequate provision of information (?=0.259), patient's age (?=- 0.149), patient's education (?=0.100), and prescription type (?=-0.104). Patients' responses were mostly consistent with the Summaries of Product Characteristics (72%-96% of responses). However, 42% of responses to the question about taking medicine with meals were incorrect. Pharmacists routinely informed the patients about medication purpose, dose, application rate, and timing of medication (in 72%, 89%, 89%, and 77% of cases, respectively). Other information was rarely offered. Patients with new prescriptions received significantly more counseling (pharmacist counseling score 5.9, 5.2, and 4.7 of maximum 10 for new, regular, and refill prescriptions, respectively, P=0.001) and obtained adequate labeling (69%, 26%, and 17% of patients for new, regular and refill prescriptions, respectively, P<0.001) than patients with regular or refill prescriptions.<h4>Conclusion</h4>Patients were familiar with basic information about administration of their prescription medicines, but lacked knowledge about medication safety. This could be attributed to pharmacist counseling, which primarily focused on medicine use instructions.
Project description:Overdoses of prescription or illicit opioids claimed the lives of 116 Americans each day in 2016, and the crisis continues to escalate. As healthcare systems evolve to address the crisis, the potential of pharmacists to make a positive difference is significant. In addition to utilizing available prescription drug monitoring programs to help prevent diversion of opioids, practicing pharmacists can be alert for signs of opioid misuse by patients (e.g., multiple prescriptions from different physicians) as well as inappropriate prescribing or hazardous drug combinations that physicians may not be aware of (e.g., opioid analgesics combined with benzodiazepines). They can also supply patients with information on risks of opioids, proper storage and disposal of medications, and the harms (and illegality) of sharing medications with other people. Increasingly, pharmacies are sites of distribution of the opioid antagonist naloxone, which has been shown to save lives when made available to opioid users and their families or other potential bystanders to an overdose; and pharmacists can provide guidance about its use and even legal protections for bystanders to an overdose that customers may not be aware of. Pharmacists can also recommend addiction treatment to patients and be a resource for information on addiction treatment options in the community. As addiction treatment becomes more integrated with general healthcare, pharmacies are also increasingly dispensing medications like buprenorphine and, in the future, possibly methadone. Pharmacists in private research labs and at universities are helping to develop the next generation of addiction treatments and safer, non-addictive pain medications; they can also play a role in implementation research to enhance the delivery of addiction interventions and medications in pharmacy settings. Meanwhile, pharmacists in educational settings can promote improved education about the neurobiology and management of pain and its links to opioid misuse and addiction.
Project description:Background:Rational use of medications and monitoring of prescriptions in elderly patients is important to decrease the number and duration of hospitalizations, emergency medical consultations, mortality, as well as medical costs. Purpose:To identify potentially inappropriate medications (PIMs) and potential prescription omissions (PPOs), and determine their prevalence based on the Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) v2 criteria and Screening Tool to Alert doctors to Right Treatment (START) v2 criteria for patients aged >65 years. Methods:This cross-sectional study was conducted in two rural counties in Romania based on electronic prescriptions for chronic conditions (EPCCs) issued from 30 days to 90 days by a specialist or general practitioner. Collected EPCCs were evaluated by an interdisciplinary team of specialists based on 26 STOPP v2 criteria and 10 START v2 criteria. Results:PIM prevalence was 25.80% and PPO prevalence was 41.72% for 646 EPCCs. The mean age of patients was 75 years and the mean number of drugs per EPCC was four. The most frequently identified PIMs were treatment duration (6.65%), theophylline administration (5.72%), drug indication (4.64%), cyclo-oxygenase-2 non-steroidal anti-inflammatory drugs (1.39%), and zopiclone prescription (0.77%). Statins (24.76%), beta-blockers (8.04%), and beta-2 agonist/antimuscarinic bronchodilators (5.88%) were the most frequently identified PPOs. Conclusion:PPOs were more prevalent than PIMs for elderly populations living in the two rural counties in Romania we studied. Health practitioners (family physicians, specialists, and pharmacists) should focus on prophylactic and curative considerations when prescribing agents to decrease the morbidity and mortality of elderly rural Romanian patients.