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Adverse Drug Event (ADE) Surveillance and Pharmacist Counseling

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January 31, 2024
Summary

Adverse events resulting from medications are a common occurrence that often go undetected, unreported, and unaddressed.1 The impact of outpatient adverse drug events (ADEs) on patients and health systems is substantial. ADEs result in more than 3.5 million physician office visits and 1 million U.S. emergency room visits annually.2 To minimize harm to patients from ADEs after newly initiated medications, the Brigham and Women’s Hospital system implemented and evaluated an automated telephone surveillance system with an option to transfer to a live pharmacist to screen for drug-related symptoms.

To evaluate the telephone surveillance system, Brigham and Women’s Hospital system conducted a cluster randomized trial, Calling for Earlier Detection of Adverse Reactions (CEDAR). CEDAR provided eligible patients with automated calls at one and four months after starting one of the selected target medications used to treat four common primary care conditions: hypertension, diabetes, depression, and insomnia. The primary outcome evaluated was physician documentation of any adverse effects resulting from the newly prescribed medication.2 The secondary outcome was whether the medication was discontinued due to an adverse effect identified via the phone call.

The Innovation team used chart review of ambulatory clinic patients to identify those who received a new prescription of one of the target medications. A total of 4,876 eligible patients were contacted via automated calls. Of the eligible patients successfully contacted, 776 patients (15.1%) responded and participated in the automated call. In all, 320 patients (6.6%) were transferred to the pharmacist based on their responses. Among these patients, the pharmacist documented discussing 1,021 potentially drug-related symptoms. After the pharmacist’s assessment, 188 (18.5%) of symptoms were assessed as “probably related” and 479 (47.1%) as “possibly related” to the new medication.

Patients who were included in the control group were also newly prescribed target medication but were seen at a clinic that was not offering the intervention. Compared with patients in the control group, patients receiving the intervention were significantly more likely to have adverse effects documented in their medical record, including documented adverse effects that led to discontinuation of the medication (277 versus 164 adverse effects, p < 0.0001; 177 versus 122 patients with medications discontinued with documented adverse effects, p < 0.0001). This suggests automated calls with the option for pharmacist counseling were effective at identifying ADEs.

The intervention team acknowledges there are challenges any organization should consider prior to implementation. One challenge associated with this intervention is the need for patients to opt-in to receive follow-up calls. Also, many patients often do not answer calls from unknown numbers as they be perceived robocalls.

Innovation Patient Safety Focus

Newly prescribed or changed medications may result in ADEs for up to 25% of patients.2 Unreported and unaddressed adverse events can lead to decreased medication adherence and/or hinder achievement of intended clinical outcomes.1 The intervention was designed to identify potential ADEs to newly prescribed medications which, in turn, may minimize harm to patients.

Resources Used and Skills Needed

To implement this intervention, organizations should consider the following action steps:

  • Engage multidisciplinary team to develop an interactive voice response (IVR) script that will meet the needs of the patient population.
  • Identify a vendor to implement the automated calling program.
  • Identify a team of ambulatory pharmacists to provide live counseling to patients, especially during evenings and weekends.
  • Identify pharmacists who meet the cultural and linguistic needs of the patient population.
Use By Other Organizations

The innovation team reports other organizations have implemented similar automated calling system interventions with an option for live pharmacist counseling based on the CEDAR project.

Date First Implemented
2015
Problem Addressed

Previous research on the impact of outpatient ADEs demonstrates the burden on patients and health systems. Unaddressed ADEs may lead to temporary or permanent organ damage, significant disability, hospitalizations, and increased costs for both the patient and the healthcare system.1 Outpatient ADEs have resulted in more than 3.5 million physician office visits and 1 million U.S. emergency room visits annually.2 Identifying potential ADEs in a timely manner minimizes harm and costs. Proactive approaches to identify outpatient ADEs provide an opportunity to address issues that may not otherwise be detected or reported.

While patients may more commonly seek pharmacists to answer questions or concerns about a medication, their role and skills in detecting, evaluating, and reporting ADEs are often underutilized in the ambulatory care setting.2 Pharmacists can solicit information from patients about symptoms related to potential adverse effects. If symptoms are identified, the pharmacist can assess symptoms and communicate concerns to physicians and other healthcare providers. Automated phone calls to patients with optional live pharmacist counseling leverages the expertise of the pharmacists while proactively identifying ADEs.

Description of the Innovative Activity

At routine ambulatory care visits, the innovation team identified eligible patients with a newly prescribed medication to treat hypertension, diabetes, depression, or insomnia. Eligible patients were offered an opportunity to receive an automated follow-up call with an option to speak to a live pharmacist for counseling at one month and four months post-prescription. Patients could opt out of receiving the follow up phone call.

At the one-month and four-month marks, patients received automated phone calls that used interactive voice response to help them answer questions regarding their experience taking the newly prescribed medication. Patients who reported experiencing symptoms and/or requested to speak with a pharmacist were transferred to a pharmacist for live counseling. Patient responses to the IVR survey were simultaneously emailed to the pharmacist The pharmacist assessed whether the symptoms experienced by the patient were “probably” or “possibly” associated with an adverse drug effect. The pharmacist would document the adverse drug effect in the medical record and alert the prescriber for follow-up.

Context of the Innovation

To address the challenge of timely identification of symptoms related to ADEs in the ambulatory care setting, Brigham and Women’s Hospital and North Shore Physicians Group developed a screening program to identify ADEs using automated phone calls with an option for live pharmacist counseling. Prior to the innovation, the common practice was to provide leaflets to patients with information about the newly prescribed medication and/or offering counseling at local pharmacies. The team identified a need to move beyond those methods to educate patients about potential ADEs. A proactive screening and surveillance program was developed to identify potential ADEs that otherwise often go undetected, unreported, and unaddressed.1 The innovation was designed to address the lack of proactive approaches for monitoring and detecting ADEs in most settings.1

Results

The innovation identified patients with probable or possible ADEs that may not have otherwise been detected or addressed: 4,876 clinic patients were eligible and were sent automated calls, and 776 (15.1%) patients answered and participated in the automated call. Of the respondents, 643 (82.9%) patients completed all questions in the IVR survey. Among those completing IVR surveys, 583 (75.1%) patients met the requirements to be transferred to a live pharmacist because they reported a potential side effect since starting the target medication and/or requested to speak to a pharmacist. Of those, 320 patients were transferred to the pharmacist, and the remaining 263 patients eligible for transfer either terminated the call or declined to speak to the pharmacist. Overall, the pharmacist documented discussing 1,018 potentially drug-related symptoms across the four targeted conditions. The pharmacist’s assessment of the potentially drug-related symptoms yielded 188 (18.5%) symptoms that were identified as “probably related” and 479 (47.1%) as “possibly related” to the patient’s new medication.

Compared with patients who were not offered the intervention, patients who received and participated in the automated call intervention were significantly more likely to have ADEs documented in the medical record by a physician. Specifically, 277 adverse events in the intervention group were documented as potentially related to the target medication versus 164 adverse events in the control group(p<0.0001). Subsequently, 177 patients in the intervention group versus 122 patients in the control group discontinued medication based on documented adverse effects (p<0.0001).

Planning and Development Process

The planning and development process for this screening and surveillance intervention began by creating an IVR survey. The survey included a consent script, birthdate verification, and a set of generic symptom questions as well as selected drug-specific questions. Because this intervention was a phone screen, questions required either a numeric or a dichotomous answer with the ability to skip a question. The IVR script was made available in English and Spanish and the system asked patients their language preference. The question set and associated logic were documented and then programmed into the IVR system.

The Innovation team identified 26 clinics to participate in the study. By random assignment, 13 clinics were assigned to the intervention group and 13 clinics were in the control group. Among patients, 5,143 eligible patients were identified by the electronic health record (EHR) for inclusion in the intervention group, and 5,985 eligible patients were identified by EHR for the control group. Clinics in the control group provided patient data for chart review to study outcome data, but no patients or providers were contacted. All patients over the age of 18 who received a prescription for one of the target medications at a participating clinic, who evidenced no history of having been prescribed the target medication within the two previous years, and who received a prescription for more than seven doses of the medication, were included. The intervention included English- and Spanish-speaking patients.

Patients who were seen at the intervention clinics and met the eligibility criteria were sent an informational mailing describing the study and provided a phone number to call if they wanted to opt out of receiving follow-up phone calls. One month after the prescription, patients who did not opt out received calls from the IVR system. Patients were called between 9 a.m. and 7 p.m. on a rotating schedule based on the availability of the pharmacist. Patients received up to ten calls over a two-week period, including at least one weekend day. After patients were reached via phone, they could opt out, provide verbal consent to continue the call, or hang up at any point during the call if they no longer wanted to participate.

Patients who provided verbal consent to participate in the phone call were guided through the IVR survey. If a patient provided a positive response to one of the symptom questions in the survey, they were asked whether they wanted to be transferred to a pharmacist for live medication counseling. Patients who did not provide a positive response to at least one of the symptom questions were given the option to request to speak to the pharmacist in case they had other medication-related questions or concerns.

The pharmacist documented the interaction with the patient, and any probable or possible ADE was documented in the medical record. The pharmacist followed up with the primary care physician, as needed.

Resources Used and Skills Needed

To implement this intervention, organizations should consider the following action steps:

  • Engage multidisciplinary team to develop an interactive voice response (IVR) script that will meet the needs of the patient population.
  • Identify a vendor to implement the automated calling program.
  • Identify a team of ambulatory pharmacists to provide live counseling to patients, especially during evenings and weekends.
  • Identify pharmacists who meet the cultural and linguistic needs of the patient population.
Funding Sources

Implementation of this innovation was supported by the Agency for Healthcare Research and Quality (AHRQ), Health Information Technology, Center for Education and Research of Therapeutics (CERT) grant number 1U19HS021094-01, part of AHRQ’s CERT funding mechanism.

Getting Started with This Innovation
  • Determine the clinical conditions to focus on as part of the development and implementation of the innovation.
  • Identify the commonly prescribed medications across the clinical conditions to incorporate into the automated system.
  • Develop criteria for identifying patients with a newly prescribed medication associated with one of the clinical conditions.
  • Identify a vendor to deploy the automated phone calls.
  • Determine the question set and corresponding logic model to develop the IVR survey.
  • Develop an opt-in or opt-out mechanism for patient participation in the intervention.
  • Identify pharmacists to provide live counseling—ideally pharmacists already embedded within the system.
Sustaining This Innovation

The following elements are key to sustaining the innovation:

  • Identify a team of pharmacists who are available evenings and weekends to counsel patients when patients are more likely to be available.
  • Inform and educate eligible patients of the benefits of participating in the intervention.
  • Tell patients when to expect follow-up calls to improve call acceptance rates.
References/Related Articles

Lambert, BL, Schiff, GD. RaDonda Vaught, medication safety, and the profession of pharmacy: steps to improve safety and ensure justice. J Am Coll Clin Pharm. 2022;5(9):981-987.

Schiff G, Mirica MM, Dhavle AA, Galanter WL, Lambert B, Wright A. A prescription for enhancing electronic prescribing safety. Health Aff (Millwood). 2018 Nov;37(11):1877-1883.

Steinman MA, Handler SM, Gurwitz JH, Schiff GD, Covinsky KE. Beyond the prescription: medication monitoring and adverse drug events in older adults. J Am Geriatr Soc. 2011 Aug;59(8):1513-1520.

Footnotes
  1. Salazar A, Amato MG, Shah SN, et al. Pharmacists’ role in detection and evaluation of adverse drug reactions: developing proactive systems for pharmacosurveillance. Am J Health Syst Pharm. 2023 Feb 15;80(4):207-214.
  2. Schiff GD, Klinger E, Salazar A, et al. Screening for adverse drug events: a randomized trial of automated calls coupled with phone-based pharmacist counseling. J Gen Intern Med. 2019 Feb;34(2):285-292.           
The inclusion of an innovation in PSNet does not constitute or imply an endorsement by the U.S. Department of Health and Human Services, the Agency for Healthcare Research and Quality, or of the submitter or developer of the innovation.
Contact the Innovator

Gordon Schiff, MD, gschiff@bwh.harvard.edu

Alejandra Salazar, RPH, asalazar3@partners.org

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