An intensive pharmacist-directed intervention designed to improve medication safety failed to reduce drug-related adverse event rates among patients post-hospitalization — a result that is indicative of the challenges inherent to this kind of intervention, experts argued.
Transitions from acute care hospitalization to home are a particularly dangerous period for older adults, particularly when they are prescribed new, high-risk medications; in fact, up to one-fifth of patients experience an adverse event within weeks of hospital discharge, with adverse drug events (ADEs) playing a major role, Jerry H. Gurwitz, MD, Meyers Primary Care Institute, Worcester, Massachusetts, and colleagues explained in JAMA Internal Medicine. To address this concern, Gurwitz and colleagues assessed the impact of a multifaceted pharmacist-directed medication safety intervention — including an in-home visit from the pharmacist, contact with primary care professionals, and educational materials.
Unfortunately, there was no observed lower rate of adverse drug-related incidents or clinically important medication errors during the post-hospitalization period associated with the intervention, the study authors reported; however, they added, study recruitment challenges and lower than expected numbers of adverse events overall among the study population may be to blame for the disappointing result.
“These study findings should not dampen enthusiasm for developing, testing, and refining interventions to enhance medication safety during the high-risk, post–hospital discharge transition period,” they wrote. “Such efforts are costly, challenging, and complex, and health care systems and payers require a clear understanding of the effectiveness of these interventions to make the investments and address the challenges inherent in implementing them. Rigorous evaluations are essential so that these important and necessary efforts can be improved on and promoted with confidence for widespread adoption.”
In a commentary accompanying the study, Tasce Bongiovanni, MD, MPP, and Michael A. Steinman, MD, both of the University of California, San Francisco, School of Medicine, observed that, “as this study illustrates, preventing adverse drug-related adverse events is hard.”
Bongiovanni and Steinman pointed out that several attempts have been made to improve prescribing quality and reduce posthospital ADEs by accompanying patients through their care transition, and yet “many have had disappointing results. [And] we now have this pharmacist-led, thoughtful, human-facing, intensive, primary-care-connected intervention that did not reduce ADEs among patients taking high-risk medications, and in fact struggled simply to recruit enough patients to participate. Something is not working.”
The National Action Plan for Adverse Drug Event (ADE) Prevention has identified three targets for reducing the risk of drug-related injuries — anticoagulants, diabetes agents, and opioids. In their study, Gurwitz and colleagues randomly assigned patients who were prescribed one of these three high-risk drug classes upon discharge to receive either a multifaceted clinical pharmacist intervention or medication safety educational materials in the mail (control).
The intervention included four components:
- An in-home assessment by a clinical pharmacist within four days of discharge from the hospital, consisting of medication review, observations of medication organization and administration, and in-depth discussions about challenges to safe medication use.
- Printed educational resources targeted to patients and their caregivers.
- Communication with the primary care team via the electronic health record regarding issues that were relevant to medication safety.
- A follow-up telephone call by the pharmacist to the patient/caregiver 14 days after the home visit.
The control group received publications through the mail containing information on high-risk medications relevant to individual patients.
Gurwitz and colleagues initially set out to recruit 500 participants 65 years of age and older who were prescribed at least one high-risk medication upon hospital discharge; however, despite lengthening the recruitment period and relaxing eligibility criteria from patients 65 years or older down to 50 years or older, the trial — conducted at a multidisciplinary practice in Massachusetts — only managed to enroll 361 patients (180 intervention, 181 controls) from June 2016 through September 2018.
The trial’s outcomes included adverse drug events in the 45 days after hospital discharge, as well as clinically important medication errors, preventable or ameliorable ADEs. Preventable ADEs were defined as drug-related injuries relating to, for example, errors in ordering, dispensing, administration, and use or monitoring. ADEs that were not preventable, but whose duration or severity could be reduced, were defined as ameliorable ADEs.
Among all of the participants in the trial, 100 (27.7%) experienced at least one adverse drug-related incident, while 65 (18%) experienced at least one clinically important medication error. When broken down according to group, there were 81 adverse drug-related incidents in the intervention group and 72 in the control group, as well as 44 clinically important medication errors in the intervention group and 45 in the control group.
Thus, Gurwitz and colleagues determined that the intervention had no significant effect on the per-patient rate of adverse drug-related incidents (unadjusted incidence rate ratio, 1.13; 95% CI, 0.83-1.56) or clinically important medication errors (unadjusted incidence rate ratio, 0.99; 95% CI, 0.65-1.49).
The most frequently identified types of ADES were gastrointestinal (41 in both groups), followed by cardiovascular (28), and kidney/electrolytes/fluid balance (20). Opioids were the most commonly implicated medication category in the intervention and control groups, followed by cardiovascular medications, anticoagulants, and diuretics.
“Clinical pharmacist-directed transitional care interventions are widely considered among the most promising approaches for improving medication safety following hospital discharge,” Gurwitz and colleagues wrote. “Patients who are prescribed high-risk medications, including anticoagulants, diabetes agents, and opioids at the time of hospital discharge should be an ideal population to target for such interventions. In this randomized clinical trial of a multifaceted, pharmacist-directed intervention, we did not observe a significantly lower rate of adverse drug-related incidents or clinically important medication errors among such patients during the immediate post-hospitalization period.”
In their commentary, Bongiovanni and Steinman suggested that while trying to lower the number of post-discharge ADEs in this population is important, it’s possible that health care professionals are looking for solutions in the wrong place.
“While careful and coordinated post-discharge follow-up should undoubtedly continue, we need to also more carefully consider the medications we are prescribing, especially at hospital discharge,” they wrote. “The best way to prevent ADEs is to not prescribe a drug that is not truly necessary in the first place. Therefore, we should focus on limiting nonessential medication changes or additions in the hospital setting. Does the patient really need a prescription for opioids, or could the acetaminophen that they are already using be as effective? Is a new antihypertensive essential? These changes will aid the robust work that is focused on deprescribing medications once the patient has transitioned home.”
They also suggested that the recruitment difficulties in this trial may speak to a larger issue of patient engagement, which may leave patients feeling disengaged from their care, particularly when it comes to medication prescribing: “Perhaps this study had a negative result not because pharmacists are not integral to medication planning, but because they need to be part of a larger system of care that centers the patient and caregiver in the process, empowering them to be active participants in medication prescribing and use.”
Bongiovanni and Steinman concluded by arguing that focus should be “all more heavily not just on swooping in to rectify adverse drug-related events after hospitalization, but rather decreasing nonessential medication prescribing and changes during the transition out of the hospital and engaging patients and their caregivers throughout. Solving the problem will require attention to judicious discharge prescribing and also systems-level changes that involve a team of clinicians and empower patients and caregivers to be at the center of and direct their care.”
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A pharmacist-directed intervention did not result in a decrease in post-hospitalization drug-related adverse events, though the analysis was underpowered due to recruitment difficulties.
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These results suggest that health professionals should look to descreases in non-essential prescribing and increases in patient engagement to bolster the success of post-hospitalization interventions for drug-related adverse events.
Michael Bassett, Contributing Writer, BreakingMED™
Gurwitz reported grants from the Agency for Healthcare Research and Quality (AHRQ) and personal fees from United Healthcare for service on the pharmacy and therapeutics committee outside the submitted work.
Steinman receives authorship royalties from UpToDate.
Cat ID: 728
Topic ID: 498,728,728,791,730,192,925
