Maria E. Berbakov’s research while affiliated with University of Wisconsin–Madison and other places

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Publications (13)


Evaluating the Sustained Effectiveness of a Novel Pharmacy-Based Intervention to Reduce Older Adult Misuse of Over-the-Counter Medications: A Case for Non-Significance
  • Article

January 2025

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2 Reads

Research in Social and Administrative Pharmacy

Aaron M. Gilson

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Jamie A. Stone

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Maria E. Berbakov

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[...]

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Engineering Resilient Community Pharmacies: A Protocol for Exploring an Integrative Approach to Medication Safety (Preprint)

November 2024

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5 Reads

BACKGROUND The increase of people with complex chronic health conditions is stressing the U.S. healthcare delivery system. Community pharmacies play a role in ensuring patients’ safe medication use for chronic care management, but their efforts are undermined by volatile work demands and other system barriers. OBJECTIVE This study seeks to conceptualize, design, implement, and test a MedSafeMapTM for the community pharmacy setting to enhance pharmacists’ and technicians’ abilities to either avoid, or to quickly identify and recover from, medication errors before patient safety is endangered. METHODS Aim 1: Four rounds of observations within the six pharmacy sites will be conducted to parse out areas MedSafeMap could address. Two rounds of interviews with a different one pharmacist and technician from each of the sites will be used to expand upon areas of interest identified during the observations. Aim 2: Focus groups with pharmacists and technicians will aid in the design of MedSafeMap components. Simulation-based research will be utilized to test MedSafeMap components with standardized patients in complex care managament scenarios. Aim 3: MedSafeMap will be implemented into pharmacies. Observations using WOMBAT for time and motion study will aid in understanding how MedSafeMap impacts pharmacy staff workflow. RESULTS As of November 15th, 2024, all six pharmacy sites have been recruited and three of four rounds of observations have been completed. Interviews have been conducted with 12 pharmacists and 11 technicians from the study sites. Preparations for Aim 2 are in the works as Aim 1 analysis continues. CONCLUSIONS The MedSafeMap is an innovative approach that will be used by pharmacists and pharmacy technicians to better navigate the complex tasks in the pharmacy, and to facilitate communication with both patients and clinicians, while safely providing medications to complex patients with chronic health conditions.


Older Adult Misuse of Over-the-Counter Medications: Effectiveness of a Novel Pharmacy-Based Intervention to Improve Patient Safety

October 2024

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34 Reads

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2 Citations

Journal of Patient Safety

Objectives Older adults’ (ages ≥65) inappropriate over-the-counter medications (OTC) use is prevalent, comprising Drug-Age, Drug-Drug, Drug-Disease, and Drug-Label types. Given that pharmacies sell many OTCs, structurally redesigning pharmacy aisles for improving patient safety (Senior Safe) was conceived to mitigate older adult OTC misuse, using Stop Signs and Behind-the-Counter Signs for high-risk OTCs. This study determined whether Senior Safe reduced high-risk OTCs misuse, while secondarily evaluating misuse changes for all OTCs. Methods A randomized controlled trial design matched and randomly allocated 20 health system community pharmacies to control or intervention groups. All 288 study participants completed an OTC choice task in which they chose a hypothetical symptom scenario (pain, sleep, cough/cold/allergy), selected an OTC, and described how they would use it at symptom onset and if symptoms persisted or worsened. Reported OTC use was evaluated for each misuse type. Intervention and control sites were compared for each misuse type using multivariate modeling. Results For high-risk OTCs, Drug-Age and Drug-Drug misuse were more likely in control sites (OR = 2.752, P = 0.004; OR = 6.199, P = 0.003, respectively), whereas Drug-Disease and Drug-Label misuse had too few occurrences in intervention sites for statistical comparisons. For all OTCs, only Drug-Age misuse was more likely for control sites (OR = 5.120, P = 0.001). Adults aged 85+ years had the greatest likelihood of all misuse types. Conclusions Results demonstrated that older adults frequently reported multiple misuse types, highlighting safety concerns. Senior Safe reduced high-risk OTC misuse, especially for older adults younger than 85 years. Cumulatively, these findings provide insights into practice recommendations supported through regulatory guidance.


Figure 1. Participant self-described over-the-counter (OTC) use outcomes.
Prevalence of Participant (n = 144) Health Conditions From Adapted Older Americans Resources and Services List
Misuse for Typical and Persistent/Worsening OTC Selections by Symptom Scenario
Prevalence of Each Drug-Label Misuse Category for Typical and Persistent/Worsening OTC Selections Drug-label misuse categories n (%) Typical OTC selections with drug-label misuse (n = 77)
The High Prevalence and Complexity of Over-the-Counter Medication Misuse in Older Adults
  • Article
  • Full-text available

September 2024

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36 Reads

Innovation in Aging

Background and Objectives Older adults (≥65 years) are the largest consumers of over-the-counter (OTC) medications and exceptionally vulnerable to the risks of these medications, including adverse drug events (ADEs). However, little is known about how older adults select and use OTCs. This is the first multi-site study designed to prospectively quantify the type and intended use of OTCs selected by older adults in community pharmacies where products are purchased. Research Design and Methods Older adults (n=144) were recruited from 10 community pharmacies from a Midwestern health system. Participants were given hypothetical symptoms and asked to select one or more OTCs for self-treatment. They were asked to report how they would use the products at symptom onset and when symptoms persisted or worsened. They also reported their current medication list and health conditions. Participants’ OTC selections were evaluated for four types of misuse: drug-age, drug-drug, drug-disease, and drug-label. Results Of the 144 participants, 114 (79%) demonstrated at least one type of misuse when describing how they would use their OTC selections at symptom onset. Drug-drug and drug-label misuse had the highest prevalence. Overall, 26 (18%) and 28 (19%) participants showed only drug-drug or drug-label misuse, respectively. Notably, 55 (38%) of participants demonstrated misuse in two or more misuse categories. Misuse potential was exacerbated when participants described treating persistent or worsening symptoms. Discussion and Implications The results highlight the high prevalence and complexity of OTC misuse in older adults and the need for additional work to improve OTC safety.

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Fig. 1. EPIS Implementation Framework. The four contextual levels of the EPIS Framework-Outer Context, Inner Context, Bridging Factors, and Innovation Factors-were used to code pharmacy staff interviews and generate themes surrounding Innovation-Values Fit.
Leadership Support for Patient Safety Initiatives.
Linking Inner Context and Innovation Factors: Examining a pharmacy-based intervention through the eyes of pharmacy staff

August 2024

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19 Reads

Exploratory Research in Clinical and Social Pharmacy

Introduction: Community pharmacies, as unique and accessible healthcare venues, are ideal locations to implement interventions aiming to improve patient care. However, these interventions may increase workload or disrupt workflow for community pharmacists, technicians, and other staff members, threatening long-term sustainment. There are growing calls from the field of implementation science to design for intervention sustainment and maintenance by maximizing innovation fit. Senior Safe™, an intervention to facilitate safer over-the-counter (OTC) product selection by older adults, serves as a case study to examine the congruence between Innovation Factors and community pharmacy Inner Context constructs and their implications for workload and sustainment. Methods: Using the Exploration, Preparation, Implementation, Sustainment (EPIS) framework, this qualitative study identified factors surrounding Senior Safe implementation. Semi-structured interviews were conducted with staff from pharmacies where Senior Safe was implemented. Two coders independently analyzed interview transcripts using deductive analysis based on EPIS constructs. Thematic analysis was used to generate three themes that encapsulated innovation fit. Results: Nineteen pharmacy staff members participated, with the majority reporting no significant change in their workload or workflow due to Senior Safe. Interview feedback supported a pre-existing culture of the healthcare system to engage patients, of leadership commitment to patient safety initiatives, and of an amplified role of pharmacy technicians. Discussion and Conclusion: Pharmacy staff interviews revealed congruence between Innovation Factors and Inner Context that likely yielded intervention workload neutrality. This study highlighted the importance for researchers to consider maintenance and sustainability when designing and implementing an intervention and the critical influence of culture and leadership support during this process.



Figure 1
Project Structure Guided by the AHRQ RFA 5-Step Methodology
Aim 1 Observation and Interview Coding Scheme Levels Comparison of WAD and WAI Teams of Pharmacists & Technicians • Interpersonal communication, including verbal and nonverbal • Teamwork skills, including leadership and situation awareness
Engineering Resilient Community Pharmacies: Exploring an Integrative Approach to Medication Safety

January 2024

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42 Reads

Introduction: The increase of people with complex chronic health conditions is stressing the U.S. healthcare delivery system. Community pharmacies play a role in ensuring patients’ safe medication use for chronic care management, but their efforts are undermined by volatile work demands and other system barriers. Methods: This study seeks to conceptualize, design, implement, and test a MedSafeMapTM for the community pharmacy setting to enhance pharmacists’ and technicians’ abilities to either avoid, or to quickly identify and recover from, medication errors before patient safety is endangered. Discussion: The MedSafeMap is an innovative approach that will be used by pharmacists and pharmacy technicians to better navigate the complex tasks in the pharmacy, and to facilitate communication with both patients and clinicians, while safely providing medications to complex patients with chronic health conditions.


OLDER ADULT MISUSE OF OVER-THE-COUNTER MEDICATIONS: BENEFITS OF A NOVEL PHARMACY-BASED INTERVENTION

December 2023

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46 Reads

Innovation in Aging

Older adults’ inappropriate use of over-the-counter medications (OTCs) is prevalent and comprises: (1) Drug-Age misuse – medication risks due to advanced age, (2) Drug-Drug misuse – medication interactions, (3) Drug-Disease misuse – contraindications with health conditions, and (4) Drug-Label misuse – deviations from label instructions. Since pharmacies are ubiquitous sources of OTC accessibility and medication safety expertise, a structural redesign of pharmacy aisles (Senior SafeTM) was conceived to mitigate older adult OTC misuse. A central feature of Senior Safe is the use of Stop Signs for high-risk OTCs and Behind-the-Counter Signs (BTC) for particularly high-risk OTCs. Given the signage’s practical importance, this study’ principal aim was to determine whether Senior Safe reduced misuse of Stop Sign/BTC OTCs. Twenty pharmacies from a mid-Western healthcare system were matched and randomly allocated to either control or intervention groups, from which 288 older adults were recruited (ages 65-91). Participants’ reported OTC use for a symptom scenario (pain, sleep, cough/cold/allergy) was evaluated to determine whether it fulfilled the four misuse types. Misuse occurrences between intervention/control sites were compared using multivariate modeling. Drug-Age and Drug-Drug misuse frequencies were significantly lower in intervention sites (Coef.=-1.012, p=.004; Coef.=-1.702, p=.004, respectively), while Drug-Disease and Drug-Label misuse had too few occurrences in intervention sites for statistical comparisons. Also, adults aged 85+ had the greatest likelihood of all misuse types. Senior Safe shows substantial benefit reducing high-risk OTC misuse, which is important particularly for vulnerable adults ages 85-91. Future research should document intervention mechanisms contributing to lower older adult OTC misuse.


THE HIGH PREVALENCE OF OVER-THE-COUNTER MEDICATION MISUSE IN OLDER ADULTS: RESPONSE TO THE CHPA-GSA NATIONAL SUMMIT

December 2023

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29 Reads

Innovation in Aging

Older adults (65+) are the largest consumer of over-the-counter (OTC) medications and disproportionately prone to adverse drug events (ADEs). Despite perceptions that OTCs are generally safe, OTC misuse can lead to ADEs. However, as identified through the Consumer Health Products Association (CHPA) and Gerontological Society of America (GSA) National Summit, little is known about OTC misuse in older adults. This is the first muti-site study to prospectively quantify how older adults select OTCs in community pharmacies where products are typically purchased. Older adults (n=144) were recruited from 10 community pharmacies. Participants were given hypothetical symptoms and asked to select one or more OTCs. After selection, they were asked to report how they would use the product, their home medications, and their health conditions. OTC selections were evaluated for the following misuse categories: 1) drug-age (Beers Criteria), 2) drug-drug (interactions with home medications), 3) drug-disease (health conditions), and 4) drug-label (product’s indications and directions). At least one type of misuse was identified in 114 (79%) older adults, with 57 (40%) demonstrating misuse in >1 category. Overall, 363 total instances of misuse were identified (x̄=3.18 per participant). There was high prevalence of drug-drug and drug-label misuse, as 107 (74%) demonstrated misuse in one or both categories. The results highlight OTC misuse frequency and complexity in older adults. Knowing older adults’ OTC misuse prevalence is critical for understanding medication-associated risks and developing effective interventions. Importantly, these results are a first step toward addressing the research gaps identified by CHPA and GSA.



Citations (4)


... In these cases, the pharmacists have a responsibility to start discussing with the patient issues that might help create awareness towards the effects of abusing these OTC drugs, explaining to the patient that OTC products are sometimes dangerous when used in the wrong ways. This poses a challenge that needs good interaction between the patient and the medical personnel, not to mention the virtue of patience coupled with empathy to not discourage patients from their daily activities due to the risk factors seen in patients [9]. ...

Reference:

The Role of Pharmacists in Ensuring the Safe and Effective Use of Over-The-Counter (OTC) Products in Retail Pharmacies
Older Adult Misuse of Over-the-Counter Medications: Effectiveness of a Novel Pharmacy-Based Intervention to Improve Patient Safety
  • Citing Article
  • October 2024

Journal of Patient Safety

... 21,26,27 Strategies that engage stakeholders, such as participatory design, usercentered design, and community-based participatory research, help researchers to maximize fit and develop sustainable projects that are informed by and meet the needs of the population. [28][29][30][31] One such intervention is Senior Safe™, a community pharmacy redesign that aids older adults in selecting safer over-the-counter (OTC) products, which warns that "what is familiar is not always safe." 32,33 Through a pharmacist expert-curated selection of safer OTCs to treat cough/cold/allergy, sleep, or pain symptoms, Senior Safe helps to support older adult agency when selecting products. 34 The intervention also encourages interaction between older adults and pharmacy staff with signage and moving a subset of unsafe products to behind the pharmacy counter. ...

Adapting a Community Pharmacy Intervention to Improve Medication Safety
  • Citing Article
  • November 2023

Journal of the American Pharmacists Association

... The researchers in those studies revealed that OTC medications should be used with caution, adhering to manufacturer's instructions to prevent the risk of serious side effects. Some studies found that controlling OTC medications is challenging for most countries (9)(10)(11). On a global scale, the misuse of OTC medications has increased and has been identified as a public health concern (11). ...

Elevating Safe Use of Over-The-Counter Medications in Older Adults: A Narrative Review of Pharmacy Involved Interventions and Recommendations for Improvement
  • Citing Article
  • June 2023

Drugs & Aging

... 21,26,27 Strategies that engage stakeholders, such as participatory design, usercentered design, and community-based participatory research, help researchers to maximize fit and develop sustainable projects that are informed by and meet the needs of the population. [28][29][30][31] One such intervention is Senior Safe™, a community pharmacy redesign that aids older adults in selecting safer over-the-counter (OTC) products, which warns that "what is familiar is not always safe." 32,33 Through a pharmacist expert-curated selection of safer OTCs to treat cough/cold/allergy, sleep, or pain symptoms, Senior Safe helps to support older adult agency when selecting products. 34 The intervention also encourages interaction between older adults and pharmacy staff with signage and moving a subset of unsafe products to behind the pharmacy counter. ...

Effectiveness and sustainment of a tailored over-the-counter medication safety intervention in community pharmacies: A randomized controlled trial
  • Citing Article
  • June 2022

Research in Social and Administrative Pharmacy