INNOVATIONS in pharmacy (Iip - E-Journal)
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RETRACTED: Medication Risk Management
Full text linkThis article has been retracted: please see INNOVATIONS in pharmacy retraction policy (https://pubs.lib.umn.edu/index.php/innovations/policies). This article has been retracted by the Editor and Publisher due to the inappropriate use of previously published work.
Historically, the FDA has interpreted the requirement that a drug must be “safe” to mean that the benefits of a drug outweigh its risks. The determination was made on a “categorical” basis, where the totality of risks was weighted against the totality of benefits when considered for the purposes outlined in the drug product’s labeling. If a drug did not meet this criterion, it was not approved or its label was rewritten to narrow the conditions for use. This logic was endemic in the FDA for most of the 20th century. On average, two to four drugs over each 5-year period were withdrawn from the marketplace after post-marketing surveillance data uncovered new risks. Similarly, on occasion, the FDA would require some special “tool” or intervention to improve a product’s safety profile. Harm associated with medication remains the second most common type of incident in hospitals, as reported by the Clinical Excellence Commission. Health services actively review medication safety. The vast majority of medication errors result in no injury. A minor injury may result, for example, in a patient needing an increased level of monitoring. Even if incidents result in minor injury, managers and staff still take any errors very seriously, reviewing the actions around the incident and making improvements as a result. FDA’s new concepts for risk management amount to a “cultural shift” in the logic of drug approval and the FDA’s role. The key events that led to this change can be traced to a series of reports that highlighted the need for improved medical safety. In 1999, the IOM released a report entitled, “To Err is Human.” This report reviewed the nature and cause of medication errors, estimating that up to 98,000 people died each year due to these errors. In their assessment, the IOM included both adverse drug reactions and human errors in drug administration. The report captured the attention of news reporters and the government. Headlines proclaimed alarm at the larger number of fatalities caused by medical errors. Consequently, there was a government-wide initiative started to develop methods and institute procedures to reduce medical errors. Statements made by FDA officials regarding some of these withdrawals suggested that the FDA no longer believed that passive oversight and re-labeling drugs with new warnings was sufficient. Furthermore, the FDA no longer believed that it was sufficient to identify safe conditions of use in the label and that healthcare professionals and patients had to comply with advocated directions of use for the drug to remain on the market.
Article Type: Commentar
How Similar are Pharmacy Students and White Blood Cells? Curricular Content Reinforced Through Personification
Full text linkDescription: This initiative sought to evaluate the use of personification to reinforce immunology concepts among pharmacy students. A two-part question posed to first year pharmacy students asked if they could physically become two white blood cells (WBCs), which would they choose and why. Students received instruction in immunology prior to providing their feedback. Demographics included campus of enrollment and gender designation. Student ratings 1 to 5 reflected approval levels toward this activity’s usefulness (1: least; 5 most).
Key Findings: One hundred and ten of 117 students selected two WBCs they would physically become if possible (94%). Less than two-thirds of students were female (63%) and the Columbia campus featured approximately a quarter of the students (24%). The most and least common WBCs chosen, as first selections by campus and gender, were statistically significant being neutrophils and basophils, lymphocytes and eosinophils, respectively. The median approval values of the WBC personification activity by campus and gender were similar and did not reach statistical significance, 4.5 and 5, respectively.
Conclusion: Pharmacy students commended the personification activity for helping them learn the roles and responsibilities of WBCs. Unique and insightful rationales for the choices made for WBCs persisted among the students. In light of these favorable reviews, this type of activity can be adapted to other areas of pharmacy education.
Article Type: Not
Preceptor Fidelity to the Creation of Precepting-Focused Continuing Professional Development Learning Plans
Full text linkObjectives: To determine preceptor fidelity to the creation of continuing professional development (CPD) learning plans for improvements in clinical teaching. To determine topics of interest for preceptor development programming with a focus on clinical teaching skills.
Methods: An online CPD program focusing on the reflect and plan stages was launched. The online program introduced preceptors to CPD, encouraged preceptors to review student feedback, and required completion of a CPD precepting plan. Preceptors were provided four guided questions to develop their plans. Preceptor fidelity to the creation of a CPD plan to improve precepting skills was rated as: 1) having a plan for improving a precepting skill, 2) having a plan for improving precepting, but not skill-based, or 3) having a plan lacking a precepting focus. Topics of precepting improvement were identified.
Results: Of the 491 preceptors who completed CPD plans, 46.2% of the plans were skill-based. Of those, 59.5% of the CPD plans included specific learning items. Only 3.9% of preceptors submitted non-precepting focused CPD plans and the remaining 49.9% of CPD plans were non skill-based, but precepting focused. Giving feedback was the most frequently listed topic with 45.8% of preceptors including it in their CPD plans.
Conclusions: This online precepting CPD program successfully guided preceptors in developing CPD plans that have the potential to improve student learning experiences. Future precepting CPD programs will need to provide direction on the use of skill-based objectives. Further investigation is needed to determine the effectiveness of the program in changing precepting behavior.
Article Type: Original Researc
A Practice Based Behavioral Health Management Registry (BHMR): Implementation, Structure and Content
Full text linkPrevious commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the difficulties of establishing the credibility of trial-based and modeled claims for therapy interventions. Claims for interventions in behavioral health are no exception. A recent report by The Kennedy Forum emphasizes the need for a system of measurement-based care using validated scales to assess the need for and response to therapy. To accomplish this, The Kennedy Forum proposed a core set of outcomes measures for behavioral health interventions. This core set provides the context for a proposed Behavioral Health Management Registry (BHMR). The purpose of this commentary is to describe the structure and content of the BHMR. The BHMR provides access to nine symptom rating scales for depression, mania, anxiety, PTSD, panic attacks, alcohol use, drug abuse and somatization, together with supplementary questions to capture socio-demographic characteristics of patients, pain experience and opioid use, medical marijuana, DSM-V criteria for PTSD diagnosis and sleep experience. As such, with patient and physician inputs over the course of treatment, the BHMR provides an evidence base for physician practices and health care decision makers to evaluate behavioral health interventions by tracking the cumulative response to therapy. In addition, the BHMR captures the perception of the patients as to whether or not their therapy has led to any substantive improvement in activity limitations, symptoms and quality of life. A particular focus of the BHMR is on monitoring and evaluating the impact of interventions on the overall experience of pain as well as tracking pain intensity and functional status by body location. This is important given the prevalence of pain and its association with conditions such as depression and anxiety. The BHMR can also support monthly reports to the practice to summarize patient throughput, the response to care by target pain patients and profiles of opioid use and abuse. The BHMR can be customized to meet the needs of individual practices.
Article Type: Commentar
Pharmacists’ Knowledge, Perceptions, and Practices Regarding Herbal Medicine
Full text linkIntroduction: With the increase of herbal medicine sales and a lack of reliable information available to consumers, it is important for pharmacists to be knowledgeable about these products and have the ability to effectively counsel on their uses and risks. The purpose of this study was to: 1) assess community pharmacists’ knowledge, perceptions, and practices regarding herbal medicines, 2) understand the impact pharmacists may have on their patients’ herbal medicine use, and 3) gauge what practices could be improved.
Methods: An anonymous survey was distributed to community pharmacists through email, social media, and in-person at local pharmacies. The survey consisted of general background questions, questions assessing perceptions and practices regarding herbal medicine, and a ten-question true/false quiz to assess knowledge. Survey data was collected and assessed using Qualtrics and Excel.
Results: Of the 127 community pharmacists who completed the survey, only 34% were confident in their ability to effectively counsel patients on herbal medicines. Approximately 50% of pharmacists reported never or rarely asking patients about herbal medicine use and 80% reported never or rarely documenting herbal medicine use. Only 25% of pharmacists reported that they always discuss side effects and 19% reported that they always discuss herb-drug interactions when patients are using herbal medicines. The average quiz score assessing knowledge of herbal medicines was 6.06 out of 10.
Conclusions: It is important for community pharmacists to be knowledgeable about herbal medicines and prepared to educate patients to ensure safe medication use. Pharmacists need to acknowledge the use of herbal medicine in their patients and always discuss potential side effects and herb-drug interactions. It is also important that pharmacists know where they can find reliable information on herbal medicines and use evidence-based resources when possible.
Article Type: Student Projec
Patients as Teachers of Cultural Sensitivity in Pharmacy Education
Full text linkIntroduction: Cultural sensitivity training among pharmacy students is required by the Accreditation Council for Pharmacy Education, but little data exists on effective practices for teaching these concepts. The goal of this case study was to describe the process and determine if integration of a patient-led Cultural Sensitivity Panel into the required didactic curriculum impacts pharmacy student perceptions of their own cultural competence.
Description of case: A special population was defined based on the CAPE competencies requiring students demonstrate sensitivity and responsiveness to culture, race/ethnicity, socioeconomic status, gender, sexual orientation, spirituality, disability, and other aspects of diversity and identity. Patients representing various special populations, such as veterans, the Deaf and hard of hearing population, the LGBT community, were invited to participate in a Cultural Sensitivity Panel for two consecutive years. Panelists shared information they wish future healthcare professionals understood about the population they represented and participated in a question and answer session. Pre- and post-surveys were conducted to assess the impact of the panel on student perceptions of cultural competence.
Results: Over two years, 138 students completed surveys. More than 95% of students agreed or strongly agreed that a cultural sensitivity panel is a worthwhile experience, and that the panel would help them change behaviors that may be culturally insensitive. Student perceptions of their own cultural competence significantly improved between the pre- and post- surveys; ethnicity, age and gender significantly impacted responses (p<.05). Key themes of responses to open-ended questions included learning about effective communication (64%), new resources for diverse patient populations (28%), addressing barriers to care (21%), the importance of patience and empathy (18%), and incorporating a patient’s background into their care (18%).
Exploration of case impact: Use of a cultural sensitivity panel provides patients with their own voice in discussing barriers to the provision of health care and thus mitigates the inherent bias and limitations of faculty members teaching about cultures and populations they do not represent.
Conclusion: This novel approach of integrating a Cultural Sensitivity Panel into the didactic curriculum positively impacted student perceptions of their own cultural competence and may improve culturally competent provision of care among pharmacy students.
Article Type: Case Stud
Type 2 Diabetes Prescribing Habits Amongst Providers to an Underserved Population
Full text linkIntroduction: Type 2 diabetes mellitus (T2DM) affected over 30 million individuals in the United States as of 2015. Due to the national diabetes guidelines recommending drug selection based on several patient specific factors and varying formulary restrictions, prescribers are often inundated when selecting treatment. Currently, limited evidence is available regarding the primary factors influencing prescribers’ drug therapy selection.
Objectives: The purpose of this study was to identify factors that influence providers during T2DM medication selection.
Methods: The study was conducted with providers at a large, academic, safety net health system. All prescribers were sent an electronic, optional and anonymous survey. Prescribers treating T2DM in non-pregnant adult patients were the only prescribers assessed. Factors evaluated were: cost, A1c, comorbidities, adherence, weight, tolerability, patient limitations, and use of guidelines.
Results: A total of 86 prescribers responded, yielding a response rate of 31%. The respondents included physicians (56.3%), nurse practitioners (21.8%), medical residents (18.4%), and fellows (3.4%); with the majority practicing in internal or family medicine (47.1%). The most frequently prescribed T2DM medications included: metformin (83.8%), insulin (78.1%), and sulfonylureas (64.8%). Cost and A1c elevation were two of the major factors influencing prescribing of metformin (94.1% and 81.2%), insulin (57.4% and 69.6%), and sulfonylureas (81.2% and 89.9%) respectively. Due to cost concerns, respondents reported rarely or never prescribing glucagon-like peptide-1 agonists (GLP-1RA) and sodium-glucose co-transporter-2 inhibitors (SGLT2i) despite recognizing benefits on diabetes related comorbidities.
Conclusion: Although current literature from the national guidelines encourages the use of GLP-1RA and SGLT2i as first-line options after metformin in T2DM, these classes of medications were not reported among the most commonly prescribed despite providers correctly identifying positive medication attributes such as cardio- and nephroprotection and weight loss. However, cost of these medications appears to outweigh the benefits when selecting medication therapy.
Article Type: Original Research
 
Malaria Perceptions among Medicine Vendors in Buea Community: An Assessment of Knowledge of Malaria and Conditions of Antimalarial Drug Dispensing
Full text linkBackground: Lack of knowledge of rational use of antimalarial drugs among medicine vendors is a serious problem, notably in areas of intense transmission. These misunderstandings increase the risks of resistance and adverse drug reactions. This study aimed to assess knowledge of malaria and environments wherein medicine vendors dispense antimalarials in the Buea community.
Methods: Administration of a community-based cross-sectional survey of a random sample of 140 medicine vendors living within the Buea community occurred between March and June 2017. The survey sought to obtain information from medicine vendors on their general knowledge of malaria as well as their dispensing practices. Statistically significant findings were associated with p ≤ .05.
Results: The majority of participants were aware that use of insecticide – treated bed nets (ITNs) and maintenance of a clean environment equate to effective malaria prevention efforts. Alternatively, only one-third of participants correctly attributed the causative organism of malaria to being protozoan. Participants employed within drugstore settings had less knowledge of malaria than their hospital/community counterparts did. A directly proportional relationship existed between the amount of experience that participants had in their respective disciplines with an increased knowledge of malaria overall.
Conclusion: These findings reveal fluctuating knowledge of malaria among study participants. Reported antimalarial dispensing practices also warrants room for improvement. Routine monitoring and evaluation to prevent emergence of resistant strains to current efficacious antimalarials remains paramount.
Article Type: Original Researc
Establishing Credibility for Medical Marijuana: The Proposed Prometheus Dispensary Registry for Botanical Cannabis
Full text linkA previous commentary in INNOVATIONS in Pharmacy argued that, given the lack of evidence for outcomes in medical marijuana, outside of a handful of randomized clinical trials and even fewer observational studies, good clinical practice points to the need for monitoring patients who received cannabis through certified medical marijuana dispensaries. The commentary noted the lack of standards for monitoring cannabis patients and the lack of feedback from the dispensary to providers. Botanical cannabis administration was occurring in, effectively, an evidence vacuum. More to the point, dispensary owners and investors seem uninterested in establishing a robust evidence base for cannabis outcomes. Given the range of conditions and symptoms presented by patients, to include the prevalence of multiple symptoms together with the range of potential cannabis formulations, dosing regimens and delivery options, a failure to monitor patients over the course of their exposure to cannabis in not acceptable. The purpose of this commentary is to report on a proposed on-line registry structure proposed by Prometheus Research for medical marijuana dispensaries in the US. The registry tracks and reports on patients over the course of treatment with botanical cannabis with the focus on severe or chronic non-cancer pain, severe nausea, persistent muscle spasms and seizures, together with prevalent comorbidities – fatigue, anxiety, depression and sleep. This is the first time a registry has been developed for dispensaries in the United States as a model for a robust evidence base to support botanical cannabis as a therapy option.
Article Type: Commentar
RETRACTED: The New Era of Pharmacists in Ambulatory Patient Care
Full text linkThis article has been retracted: please see INNOVATIONS in pharmacy retraction policy (https://pubs.lib.umn.edu/index.php/innovations/policies). This article has been retracted by the Editor and Publisher due to the inappropriate use of previously published work.
Ambulatory care pharmacy practice is defined as the provision of integrated, accessible healthcare services by pharmacists who are accountable for addressing medication needs, developing sustained partnerships with patients, and practicing in the context of family and community. This is accomplished through direct patient care and medication management for ambulatory patients, long-term relationships, coordination of care, patient advocacy, wellness and health promotion, triage and referral, and patient education and self-management. The ambulatory care pharmacists may work in both an institutional and community-based clinic involved in direct care of a diverse patient population.
A variety of specialty clinics are available for allergy and immunology, pulmonology, endocrinology, cardiology, nephrology, neurology, behavioral health, and infectious disease. Such services for this population may exist as a primary care clinic or an independent specialty clinic, typically in a PCMH, which is instrumental in coordinating care between various providers. Once a practice site is identified, it is important to establish a strong, trusting, and mutually beneficial relationship with the various decision-makers (e.g., administrators, providers) involved with the clinic. If pharmacy services are currently in existence, the pharmacy director may be able to identify and initially contact the appropriate person. If another pharmacist is providing clinical services, this person would be a resource to help determine areas for expansion of patient care and to whom to direct the proposed business plan.
Additional individuals to consider as an initial point of contact include the clinic manager, clinic medical director, or administrative assistant to either of these persons. If the clinic setting is affiliated with a medical school, it may be necessary to contact the Department of Family Medicine head.
Article Type: Commentary