Improving over-the-counter medication safety for older adults: A study protocol for a demonstration and dissemination study

BACKGROUND: Adverse drug events (ADEs) associated with over-the-counter (OTC) medications cause 178,000 hospitalizations each year. Older adults, aged 65 and older, are particularly vulnerable to ADEs. Of the 2.2 million older adults considered at risk for a major ADE, more than 50% are at risk due to concurrent use of an OTC and prescription medication. OBJECTIVES: To refine the intervention and implementation strategy through diagnostic and formative evaluation; to evaluate the effectiveness of the intervention for preventing misuse of high-risk OTC medications by older adults; and to evaluate the implementation of the intervention in community pharmacies. METHODS: A system redesign intervention to decrease high-risk OTC medication misuse will be tested to reduce misuse by improving communication between older adults and community pharmacists via the following features: a redesign of the physical environment to sensitize older adults to high-risk OTC medications, and the implementation of a clinical decision tool to support the pharmacist when critically evaluating the older adult's health status. The study will be conducted in three phases: a participatory design phase, a beta phase, and a test phase. The test phase will be conducted in three mass-merchandise stores. A total of 144 older adults will be recruited. A pre (control)/post (intervention) test will determine the effectiveness of the intervention. The primary outcome will be a comparison of proportion of older adults who misuse OTC medication from baseline to post-intervention. The process of implementation in the community pharmacy setting will be evaluated using the taxonomy proposed by Proctor et al. The participatory design phase has been approved by the institution's IRB (2016-0743). PROJECTED IMPACT: It is anticipated that this project, which focuses on achieving systems-based improvement in an underemphasized area of the medication use process, will reduce ADEs associated with inappropriate OTC medication use in older adults

Improving medication safety in varied health systems

Non peer reviewe

Using Think Aloud Protocols to Assess E-Prescribing in Community Pharmacies

Introduction: Think aloud protocol has rarely been used as a method of data collection in community pharmacies.Purpose: The aim of the report is to describe how think aloud protocols were used to identify issues that arise when using e-prescribing technology in pharmacies. In this paper, we report on the benefits and challenges of using think aloud protocols in pharmacies to examine the use of e-prescribing systems.Methods: Sixteen pharmacists and pharmacy technicians were recruited from seven community pharmacies in Wisconsin. Data were collected using direct observation alongside think aloud protocol. Direct observations and think aloud protocols took place between January-February, 2011. Participants were asked to verbalize their thoughts as they process electronic prescriptions.Results: Participants identified weaknesses in e-prescribing that they had previously not conceived. This created heightened awareness for vigilance when processing e-prescriptions. The main challenge with using think aloud protocols was due to interruptions in the pharmacies. Also, a few participants found it challenging to remember to continue verbalizing their thought process during think aloud sessions.Conclusion: The use of think aloud protocols as method of data collection is a new way for understanding the issues related to technology use in community pharmacy practice. Think aloud protocol was beneficial in providing objective information on e-prescribing use not solely based on pharmacist’s or technician’s opinion of the technology. This method provided detailed information on a wide variety of real time challenges with e-prescribing technology use in community pharmacies. Using this data collection method can help identify potential patient safety issues when using e-prescribing and suggestions for redesign

Exploring Barriers to Medication Safety in an Ethiopian Hospital Emergency Department: A Human Factors Engineering Approach

Objective: To describe challenges associated with the medication use process and potential medication safety hazards in an Ethiopian hospital emergency department using a human factors approach. Methods: We conducted a qualitative study employing observations and semi-structured interviews guided by the Systems Engineering Initiative for Patient Safety model of work system as an analytical framework. The study was conducted in the emergency department of a teaching hospital in Ethiopia. Study participants included resident doctors, nurses, and pharmacists. We performed content analysis of the qualitative data using accepted procedures. Results: Organizational barriers included communication failures, limited supervision and support for junior staff contributing to role ambiguity and conflict. Compliance with documentation policy was minimal. Task related barriers included frequent interruptions and work-related stress resulting from job requirements to continuously prioritize the needs of large numbers of patients and family members. Person related barriers included limited training and work experience. Work-related fatigue due to long working hours interfered with staff’s ability to document and review medication orders. Equipment breakdowns were common as were non-calibrated or poorly maintained medical devices contributing to erroneous readings. Key environment related barriers included overcrowding and frequent interruption of staff’s work. Cluttering of the work space compounded the problem by impeding efforts to locate medications, medical supplies or medical charts. Conclusions: Applying a systems based approach allows a context specific understanding of medication safety hazards in EDs from low-income countries. When developing interventions to improve medication and overall patient safety, health leaders should consider the interactions of the different factors. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties". Treatment of Human Subjects: IRB review/approval required and obtained   Type: Original Researc

Use of the Term Elderly

Using the term elderly for a person who is robust and independent as well as for a person who is frail and dependent says little about the individual

Evaluation of a Patient Perspective Module in a Required Medication Safety and Quality Course at a College of Pharmacy

Objectives: To develop and evaluate the impact of a module discussing the patient's perspective on medication errors in a required medication safety course at a college of pharmacy. Methods: Students were required to read Josie's Story, a true story written by a mother after her daughter died from a medical error, and attend an in-class discussion regarding the book. A questionnaire, which employed a pre-post retrospective method and extracted items from the Caring Ability Inventory, was then administered to measure the change in students' perceptions of patient care. Additional questions gathered students' perceptions of the assignment, their personal experiences with the topic, and the importance of medication safety. Results: 120 out of 138 students (response rate = 87%) completed the questionnaire. 56% of students indicated they would be more likely to speak with a patient directly about a medication error after reading the book, whereas only 3% were less likely, and 42% indicated they were just as likely. Most students (59%) reported that they felt more motivated to learn about medication safety after reading Josie's Story. Implications: This course previously addressed strategies to prevent medication errors. Successfully adding a component that introduces how a medication error impacted a patient and her family may help motivate students to recognize the importance and need for a culture of safety, personalize how medication errors impact patients, and provide a venue for students to gain patient centeredness and caring skills.   Type: Original Researc

Evaluation of a Patient Perspective Module in a Required Medication Safety and Quality Course at a College of Pharmacy

Objectives: To develop and evaluate the impact of a module discussing the patient's perspective on medication errors in a required medication safety course at a college of pharmacy. Methods: Students were required to read Josie's Story, a true story written by a mother after her daughter died from a medical error, and attend an in-class discussion regarding the book. A questionnaire, which employed a pre-post retrospective method and extracted items from the Caring Ability Inventory, was then administered to measure the change in students' perceptions of patient care. Additional questions gathered students' perceptions of the assignment, their personal experiences with the topic, and the importance of medication safety. Results: 120 out of 138 students (response rate = 87%) completed the questionnaire. 56% of students indicated they would be more likely to speak with a patient directly about a medication error after reading the book, whereas only 3% were less likely, and 42% indicated they were just as likely. Most students (59%) reported that they felt more motivated to learn about medication safety after reading Josie's Story. Implications: This course previously addressed strategies to prevent medication errors. Successfully adding a component that introduces how a medication error impacted a patient and her family may help motivate students to recognize the importance and need for a culture of safety, personalize how medication errors impact patients, and provide a venue for students to gain patient centeredness and caring skills.   Type: Original Researc

Assessing Unmet and Latent Demand for Pharmacists at the State Level

Background: Past reports suggest that a near balance has been reached in the supply and demand for pharmacists in the US. Although data on the level of supply of pharmacists is available, there is no continuous and systematic tracking of the level of demand (unmet and latent) for pharmacists at state level. Unmet demand, an established construct in pharmacy workforce, is important to measure the number of vacancies and assess pharmacist shortage consistently over time. Latent demand or potential demand is a novel construct and has never been measured in pharmacy workforce. With the increase in supply, it is important to measure the potential demand that could be budgeted in pharmacies in the near future. Objective: The objective of this study was to measure the unmet and latent demand for pharmacists and explore the association between latent demand and workload characteristics in community and hospital pharmacies in Wisconsin in 2011-12. Methods: The study used a cross-sectional, descriptive survey design. A sample of community pharmacies (n=1,064) and hospital pharmacies (n=126) licensed in Wisconsin in 2011-12 was identified. Key informants (managers/owners) of sampled pharmacies were sent a one-page cover letter explaining the purpose of the study and requesting participation and a three page survey form. The main outcome measures of the study were total number of FTE pharmacist positions vacant, presence of adequate staff size, additional number of FTE pharmacist positions needed to attain adequate staff size, prescription volume, daily census, hospital size and number of hours prescription department is open. Descriptive statistics were calculated for all the pharmacies collectively, then separately for community and hospital pharmacies. Pharmacy setting, vacancies and workload characteristics of pharmacies with and without latent demand were compared using chi-squared test of independence and/or t-test. Sample weights were calculated and used in all the analyses to weigh the estimates to all pharmacies in Wisconsin. Results: Overall response rate to the survey was 50.1%. Of the total number of FTE pharmacist positions budgeted in Wisconsin, 54.3 FTE positions (1.5%) were reported vacant in 2011-12. Approximately 28.2% of the community and hospital pharmacies reported the presence of latent demand. Latent demand was significantly associated with higher workload in community pharmacies and larger bed size in hospital pharmacies. Conclusion: There appeared to be a balance between the supply and demand for pharmacists in Wisconsin in 2011-12. There is a potential for additional FTE positions (latent demand) to be budgeted in pharmacies to attain adequate pharmacist staff size. It is important to consistently track the level of unmet and latent demand for pharmacists in Wisconsin and combine this information with other workforce characteristics to guide the decision making of pharmacy workforce planners and pharmacy managers.   Type: Original Researc

A Pilot Study of Decision Factors Influencing Over-the-Counter Medication Selection and Use by Older Adults

Background and objectives: Despite their availability without prescription, OTC medications pose a risk for significant harm for older adults due to higher likelihood of polypharmacy, drug interactions, and age-related physiological changes. The purpose of this study is to identify the individual decision factors that influence how older adults select and use over-the-counter medications. Methods: A pilot study was conducted with 20 community-dwelling older adults. Older adults met the interviewer at a regional mass merchandise store where they were given both pain and insomnia standardized scenarios. Participants described how they would select and then hypothetically use a given medication to treat the problem described in the scenario. Results: OTC medication selection and reported use were influenced by several person-level decision-making factors including: personal beliefs/knowledge about OTCs, assessment of the ailment, and medical constraints. Conclusion: The findings from this investigation provide direction for interventions to address unsafe OTC medication selection by older adults

Role of Toll-Like Receptor (TLR) 2 in Experimental Bacillus cereus Endophthalmitis

Bacillus cereus causes a uniquely rapid and blinding intraocular infection, endophthalmitis. B. cereus replicates in the eye, synthesizes numerous toxins, and incites explosive intraocular inflammation. The mechanisms involved in the rapid and explosive intraocular immune response have not been addressed. Because Toll-like receptors (TLRs) are integral to the initial recognition of organisms during infection, we hypothesized that the uniquely explosive immune response observed during B. cereus endophthalmitis is directly influenced by the presence of TLR2, a known Gram-positive pathogen recognition receptor. To address this hypothesis, we compared the courses of experimental B. cereus endophthalmitis in wild type C57BL/6J mice to that of age-matched homozygous TLR2-/- mice. Output parameters included analysis of bacterial growth, inflammatory cell (PMN) infiltration, cytokine/chemokine kinetics, retinal function testing, and histology, with N≥4 eyes/assay/time point/mouse strain. B. cereus grew at similar rates to108 CFU/eye by 12 h, regardless of the mouse strain. Retinal function was preserved to a greater degree in infected TLR2-/- eyes compared to that of infected wild type eyes, but infected eyes of both mouse strains lost significant function. Retinal architecture was preserved in infected TLR2-/- eyes, with limited retinal and vitreal cellular infiltration compared to that of infected wild type eyes. Ocular myeloperoxidase activities corroborated these results. In general, TNFα, IFNγ, IL6, and KC were detected in greater concentrations in infected wild type eyes than in infected TLR2-/- eyes. The absence of TLR2 resulted in decreased intraocular proinflammatory cytokine/chemokine levels and altered recruitment of inflammatory cells into the eye, resulting in less intraocular inflammation and preservation of retinal architecture, and a slightly greater degree of retinal function. These results demonstrate TLR2 is an important component of the initial ocular response to B. cereus endophthalmitis