Pharmacy Leadership Amid the Pandemic: Maintaining Patient Safety During Uncertain Times.

The relentless surges of global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections that caused the Covid-19 disease had pressured researchers and regulators to develop effective treatments quickly. While studying these therapies amid the pandemic, threats to patient care were reported, including (1) maintaining adequate safeguards as clinical effectiveness and safety data evolves, (2) risks from online counterfeit medications, and (3) disruption of the global pharmaceutical supply chain. This article discusses these patient safety threats and suggests strategies that promote patient safety, foster medication intelligence, and mitigate drug shortages. As the world continues to develop safe and effective treatments for Covid-19, patient safety is paramount. In response to the World Health Organization (WHO) Global Safety Challenge: Medication Without Harm, leaders must establish effective approaches to improve medication safety during the pandemic. Successfully integrating these leadership strategies with current practices allows pharmacy leaders to implement robust systems to reduce errors, prevent harm, and advocate for patient safety.

Guidelines for Leading a Safe Medication Error Reporting Culture.

Background: A safe medication error reporting culture is one that promotes, fosters, and rewards the reporting of errors and events across the spectrum of harm (none to significant harm). For this culture to develop, leaders must key department cultural norms. These cultural norms include making employees feel psychologically safe to report errors, and to establish a culture of error review and follow-up that complies with best practices. Objective: This article reviews how pharmacy leaders can establish this environment by describing (1) setting an appropriate vision for safety as a priority; (2) establishing and actively supporting the concept of psychological safety; and (3) implementing medication error review that support an effective safety culture. Finally, the article discusses a case where the relationships between psychological safety, safety culture, and reporting culture are described. Methods: This article reviews the literature and authors' experiences in designing a safety culture for a pharmacy department. Concluson: A safe reporting culture requires leaders to be humble, engage their staff in dialogue, objectively measure culture, consistently provide feedback, and empower its people. Employing these leadership traits with best practices can improve overall medication safety and the quality of patient-centered pharmacy services.

Current Threats to Maintaining a Secure Pharmaceutical Supply Chain in an Online World.

Background: Maintaining integrity of the pharmaceutical supply chain is critical to providing medications that are free from adulteration (counterfeit, substandard or unapproved medications), making them safe for patient use. Purchasing pharmaceuticals through the Internet can be associated with a risk of receiving adulterated medicines. Objective: The objective of this study was to review the current threats to maintaining a secure pharmaceutical supply chain, specifically focused on Internet-based procurement of medications. Methods: A review of the literature was conducted along with collating important up to date resources and other publications that provide foundational information to understanding the risks and prevention strategies for online purchasing of pharmaceuticals. Conclusion: The information provided in this article helps to properly inform pharmacy leaders to the resources available to protect against the risks of on-line purchasing of pharmaceuticals.

One Chance for Your Best First Impression: Tips for New Pharmacists.

Background: New practitioner pharmacists enter the workplace with an array of knowledge and skills ready to engage in patient care. However, obtaining a first postgraduate position or earning a desired promotion poses a challenge when the candidate pool is filled with many similarly skilled professionals. Objective: Educate new practitioner pharmacists on ways to pitch their new skills and make a memorable first impression among their competition. Methods: This article aims to (1) enhance their career prospects by practicing their soft skills, (2) develop strategies to build credibility and creating a personal brand and (3) describe efforts to showcase their professional identity. Conclusions: Preceptors and mentors can help by providing effective feedback to new pharmacists in efforts to improve performance and enhance soft skills.

Drug Pricing Transparency: The New Retail Revolution.

As spending on medications in the United States increases with each passing year, the need for drug pricing transparency by manufacturers also increases. Drug spending, excluding rebates and discounts, was $309.5 billion in 2015, up 8.5% from 2014. Drug pricing transparency has been a topic of debate across the health care system. This column reviews the issue of drug pricing and emphasizes the need for transparency in this area. We will discuss factors that influence drug pricing, policies and ways to reduce the rising costs of drugs, and the role of pharmacy leaders in managing this problem. A multitude of factors are driving the country to spend more and more on medications; pharmacy leaders can employ various strategies to counteract this escalation of drug prices. After reviewing this article, the pharmacy director will have an increased ability to address drug pricing issues with stakeholders as they develop patient-centered pharmacy services.

Determining Current Insulin Pen Use Practices and Errors in the Inpatient Setting.

BACKGROUND: The use of insulin pens in the inpatient setting has continued to be a controversial decision. Insulin pens provide several advantages, but given significant reports of medication errors, several organizations have issued alerts to caution users about safety concerns. A survey was conducted to assess the prevalence of insulin pen use and current utilization trends in the inpatient setting. METHODS: The 31-question guided-logic survey was developed based on review of primary literature regarding insulin pen utilization and evaluated by a panel of medication safety experts from a variety of health care settings. The survey was sent electronically to subscribers of medication safety organizations. RESULTS: The survey was completed by 474 respondents. Approximately three fourths of respondents indicated insulin pens were on formulary at their institution (n = 332; 74%). Of those who have had insulin pens on formulary, 15% (n = 49) are no longer using them. The most common reasons for not utilizing pens were cost and safety concerns. Pens were reported to be stored in the pharmacy prior to administration (n = 230; 78%) and in a patient's bin (n = 202; 69%) afterward. More than half of respondents use two patient identifiers on the pen and label with a bar code. Approximately 30% reported that an insulin pen has been used on more than one patient at least once in their institution, while 6% were not sure. CONCLUSION: Insulin pens are widely being used in the inpatient setting. Various mitigation strategies are employed to reduce the risk of harm associated with insulin pen use. Health care professionals believe insulin pens are clinically useful and can be used safely in the inpatient setting. Many organizations and expert panels disseminate best practices in an effort to help ensure their safety. Further studies are needed to assess and validate the risk mitigation strategies identified through this research.

Nontraditional Career Opportunities for Pharmacists.

The changing landscape of health care mirrors that of health-system pharmacy, with pharmacists' scope of practice and provider status being the most significant changes. This creates new roles and opportunities; many of these roles are considered to be nontraditional in today's practice. This article reviews some new roles for pharmacy leaders that provide different career options and pathways. Nontraditional career opportunities discussed include expanded consulting roles in pricing analytics and drug pricing programs (contracting, 340B programs), pharmacogenomics patient consult services and clinics, specialty drug pharmacies, and compounding pharmacy services. To continue to develop high-performing pharmacy departments, pharmacy directors should recognize these roles and ensure they are clearly defined and managed. With the advent of these nontraditional opportunities, pharmacy departments can further expand their ability to provide advanced patient-centered pharmacy services.

Using Contemporary Leadership Skills in Medication Safety Programs.

The discipline of studying medication errors and implementing medication safety programs in hospitals dates to the 1970s. These initial programs to prevent errors focused only on pharmacy operation changes - and not the broad medication use system. In the late 1990s, research showed that faulty systems, and not faulty people, are responsible for errors and require a multidisciplinary approach. The 2013 ASHP Statement on the Role of the Medication Safety Leader recommended that medication safety leaders be integrated team members rather than a single point of contact. Successful medication safety programs must employ a new approach - one that embraces the skills of all health care team members and positions many leaders to improve safety. This approach requires a new set of leadership skills based on contemporary management principles, including followership, team-building, tracking and assessing progress, storytelling and communication, and cultivating innovation, all of which promote transformational change. The application of these skills in developing or changing a medication safety program is reviewed in this article.

Big Data: Implications for Health System Pharmacy.

Big Data refers to datasets that are so large and complex that traditional methods and hardware for collecting, sharing, and analyzing them are not possible. Big Data that is accurate leads to more confident decision making, improved operational efficiency, and reduced costs. The rapid growth of health care information results in Big Data around health services, treatments, and outcomes, and Big Data can be used to analyze the benefit of health system pharmacy services. The goal of this article is to provide a perspective on how Big Data can be applied to health system pharmacy. It will define Big Data, describe the impact of Big Data on population health, review specific implications of Big Data in health system pharmacy, and describe an approach for pharmacy leaders to effectively use Big Data. A few strategies involved in managing Big Data in health system pharmacy include identifying potential opportunities for Big Data, prioritizing those opportunities, protecting privacy concerns, promoting data transparency, and communicating outcomes. As health care information expands in its content and becomes more integrated, Big Data can enhance the development of patient-centered pharmacy services.

Review of the 2015 Drug Supply Chain Security Act.

The integrity of the pharmaceutical supply chain is threatened by medication counterfeiting, importation of unapproved and substandard drugs, and grey markets - all of which have the potential to distribute drug products with the potential for serious harm. On November 27, 2013, President Obama signed into law Title II of the Drug Quality and Security Act, now known as the Drug Supply Chain Security Act (DSCSA). Over the next 10 years, the DSCSA will require the pharmaceutical supply chain to implement medication tracking and tracing; serialization, verification, and detection of suspicious products; and strict guidelines for wholesaler licensing and reporting. This article reviews the important aspects of the DSCSA and outlines the role of health-system pharmacy leaders in ensuring compliance to the DSCSA. By verifying that medication supplies are free from adulteration and tampering, the DSCSA serves as a foundational law to ensure quality in providing patient-centered pharmacy services.

Development and Assessment of a Medication Safety Measurement Program in a Long-Term Care Pharmacy.

OBJECTIVE: Medication errors continue to be a major issue in the health care system, including in long-term care facilities. While many hospitals and health systems have developed methods to identify, track, and prevent these errors, long-term care facilities historically have not invested in these error-prevention strategies. The objective of this study was two-fold: 1) to develop a set of medication-safety process measures for dispensing in a long-term care pharmacy, and 2) to analyze the data from those measures to determine the relative safety of the process. DESIGN/SETTING/PARTICIPANTS: The study was conducted at In Touch Pharmaceuticals in Valparaiso, Indiana. To assess the safety of the medication-use system, each step was documented using a comprehensive flowchart (process flow map) tool. Once completed and validated, the flowchart was used to complete a "failure modes and effects analysis" (FMEA) identifying ways a process may fail. Operational gaps found during FMEA were used to identify points of measurement. The research identified a set of eight measures as potential areas of failure; data were then collected on each one of these. RESULTS: More than 133,000 medication doses (opportunities for errors) were included in the study during the research time frame (April 1, 2014, and ended on June 4, 2014). Overall, there was an approximate order-entry error rate of 15.26%, with intravenous errors at 0.37%. A total of 21 errors migrated through the entire medication-use system. These 21 errors in 133,000 opportunities resulted in a final check error rate of 0.015%. CONCLUSION: A comprehensive medication-safety measurement program was designed and assessed. This study demonstrated the ability to detect medication errors in a long-term pharmacy setting, thereby making process improvements measureable. Future, larger, multi-site studies should be completed to test this measurement program.

Incorporating Pharmacy Scholarship to Management Responsibilities.

Practice advancement demands innovation. Amidst professional change, pharmacy leaders have the opportunity to collaborate with colleagues to develop transformational ideas, implement these solutions, and share those successes with professionals around the state, country, and world. Scholarship, defined as contributing to the literature through publications, presentations, and other writings, is an ideal way to advance innovation within the profession. It is critical for pharmacy leaders to build scholarship into their professional workflow. Ensuring that successful projects are published or presented may translate into shared best practices. Many pharmacy leaders may find it difficult to participate in scholarship activities because of their busy schedules. This column serves to outline recommendations on how to effectively incorporate writing for publications, making presentations, and other scholarly work into the role of pharmacy leaders and managers. To reduce the barriers to scholarship, pharmacy leaders role can apply project management principles to their work and identify projects that otherwise would not be published and support their development.

Managing Conflict: A Guide for the Pharmacy Manager.

Managing conflict among a variety of people and groups is a necessary part of creating a high performance pharmacy department. As new pharmacy managers enter the workforce, much of their success depends on how they manage conflict. The goal of this article is to provide a guide for the pharmacy director on conflict in the workplace. By evaluating each type of conflict, we can learn how to respond when it occurs. Resolving conflict requires a unique and individualized approach, and the strategy used may often be based on the situational context and the personality of the employee or manager. The more that pharmacy leaders can engage in conflict resolution with employees and external leaders, the more proactive they can be in achieving positive results. If pharmacy directors understand the source of conflicts and use management strategies to resolve them, they will ensure that conflicts result in a more effective patient-centered pharmacy service.

Pharmacists' familiarity, utilization, and beliefs about Health Information Exchange: a survey of pharmacists in an Indiana pharmacy organization.

OBJECTIVE: To gauge pharmacists' familiarity, utilization, and beliefs about Health Information Exchange (HIE). METHODS: A survey questionnaire was developed by the authors in Qualtrics (Provo, UT) and administered to 358 Indiana Pharmacists Alliance (IPA) members via e-mail listserv in May and August 2013. The questionnaire consisted of 18 questions on familiarity, utilization, and beliefs about HIE. RESULTS: The response rate was 19% (67/358). Pharmacy practice experience of respondents ranged from 0 to 5 years (18%, n = 12) to more than 20 years (61%, n = 41). More than one-half (70%) of respondents practiced in hospital settings. Many respondents (75%) were familiar with the concept of HIE; 54% currently use some type of HIE technology. Nearly all respondents felt that data in electronic health records (EHRs) should be shared between pharmacists and other health care providers. Respondents identified improved coordination of care as the greatest potential benefit, and difficulty implementing and maintaining technology as the greatest barrier of HIE. CONCLUSION: Many respondents were familiar with HIE and in favor of sharing patient records between providers. Respondents agreed that HIE has the potential to improve coordination of care but were concerned about implementing and maintaining technology. Larger pharmacy samples should be studied to determine how the results of this study compare to pharmacy populations at state and national levels.

Assessing the Costs of Intravenous Push Waste in Intraoperative Areas Through Observation: A Multi-site Study.

INTRODUCTION: The costs associated with proper disposal, management, and regulatory compliance of controlled substances in healthcare systems are substantial. In the context of the current opioid crisis, and given the high abuse potential of controlled substances, it is imperative that waste is minimized and waste procedures are followed to ensure safe disposal of controlled substances. This study aims to quantify the costs associated with fentanyl, hydromorphone, morphine, midazolam, and ketamine waste in intraoperative areas through a multi-site observational analysis. METHODS: The study used an observational design across various hospital procedural and post-procedural units in the Southwest Florida region of the United States. Automated and non-automated workflows for wasting controlled substances were compared. As with a previous study conducted by Hertig et al., waste was evaluated as (1) the quantity (mg/µg) of medication disposed defined as 'pharmaceutical waste' or 'product waste' (PW); and (2) workforce time associated with the waste disposal process defined as 'workforce time waste' (WTW). Secondary measures include workforce costs associated with the waste disposal process. The product waste analysis was conducted between October and December 2023. The workforce time waste analysis was examined over a 10-day period in January and February 2024. A yearly extrapolation model was applied to cost data. RESULTS: The findings revealed substantial costs linked to both PW and WTW, emphasizing the financial burden of controlled substance waste. Study data validated previous literature describing the extent of fentanyl, hydromorphone, and morphine waste while documenting significant amounts of midazolam and ketamine waste. The combined annual waste cost for the two study hospitals was estimated at US$56,557, with workforce time accounting for 36%-50% of this total cost. CONCLUSION: This study provides vital insights into the financial and operational impact of medication waste in procedural and post-procedural areas, supporting ongoing efforts to minimize waste, ensuring the safe and effective use of controlled substances. Future research should explore the impact of medication waste across diverse healthcare settings and the cost implications associated with pharmacy professionals in the waste compliance process.

Risk control drives risk assessment and risk review: A cause and effect model of pharmaceutical drug recall on patient safety.

Background: Pharmaceutical drug recall is a relentless issue that is composed of multidimensional criteria. The distinct criteria that contributed to drug recalls have been identified in previous literature; however, there is limited information regarding the causal relationships between each criterion. Highlighting key influential aspects and criteria of pharmaceutical drug recall is critical in addressing this ongoing issue and promoting patient safety. Objective: The objective of this study is as follows: (1) identify critical criteria of pharmaceutical drug recalls for improvements, (2) determine the interrelationships among the criteria, and (3) define the causal relationships of pharmaceutical drug recall and provide theoretical insights and practice recommendations to minimize risks associated with pharmaceutical recalls and maximize patient safety. Design: This study proposes five aspects and 42 criteria to identify the impact of pharmaceutical drug recalls on patient safety by evaluating the interrelationships between the criteria by employing the fuzzy decision-making trial and evaluation laboratory method. Methods: A group of 11 professionals across the pharmaceutical industry, hospitals, ambulatory care, regulatory authority, and community care settings were selected for interviews. Results: Risk control is the influencing aspect of pharmaceutical drug recalls that has the most substantial impact on risk assessment and risk review; it generates medium effects on risk communication and technology. Risk assessment, risk communication, and risk review demonstrated comparative weak interrelationships, while risk communication exhibits a weak unidirectional effect on risk review. Finally, risk assessment exerts a weak influence on technology application and development. Product contamination, product subpotent or superpotent, injury to patients, product not sterile or impure, and system detectability of hazards have the strongest influence in the causal group of pharmaceutical drug recalls. Conclusion: The study shows that risk control drives risk assessment and risk review in the pharmaceutical industry manufacturing process. To achieve patient safety, this study suggests focusing on risk control strategies, as this aspect displays the most substantial effect on influencing other critical risk management aspects such as risk assessment and risk review.

Pharmacy Student Perceptions and Knowledge of Online Pharmacy Use.

Objective. Currently, there is no set of accreditation standards for integrating the dangers of illegal online pharmacies into Doctor of Pharmacy (PharmD) curricula. As a result, many pharmacists are unable to recognize the differences between a legal and illegal online pharmacy or educate patients on the dangers of online pharmacies. The objectives of this study were to assess gaps in student pharmacists' knowledge and to assess the impact of adding education regarding online pharmacies into PharmD programs.Methods. A pre- and postsurvey design was developed. Data were collected through an electronic questionnaire distributed to second-year pharmacy (P2) students to evaluate student knowledge gaps at baseline and after education on illegal online pharmacies.Results. A total of 102 students responded to the presurvey, with 93 (91%) consenting to participate. Out of 100 respondents to the postsurvey, 84 (84%) students consented. Approximately 87% (81/93) of respondents indicated some awareness of prescription medications being purchased online. Most students (89%, 77/86) stated that they do not believe the university has provided adequate curriculum on illegal online pharmacies and counterfeit medications. After receiving education on the relevant topics, 64% (55/85) stated they now felt their education was adequate.Conclusion. Although pharmacy students were aware of the existence of illegal online pharmacies, they were not aware of the significance of this patient safety issue or how to accurately identify suspicious websites. It is imperative that PharmD programs incorporate formal education on the risks that illegal online pharmacies pose to patient and medication safety.

Effects of Fear and Humor Appeals in Public Service Announcements (PSAs) on Intentions to Purchase Medications via Social Media.

The increasing prevalence of online purchase of medications, specifically via social media platforms, poses significant health risks due to high chances of such medications being substandard and falsified (SF). The current study uses a 2 (persuasive appeal: fear vs. humor) x 3 (message repetition) mixed factorial experiment to investigate the effectiveness of persuasive appeals (on intentions to purchase medications online via social media referrals, mediated by psychological reactance (threat to freedom and anger), attitudes toward the public service announcements (PSAs), and viral behavioral intentions. ANOVA results showed the superiority of humor appeals compared to fear appeals in (1) reducing psychological reactance, (2) igniting favorable responses to the PSA, and (3) marginally reducing the intentions to purchase medications vial social media despite lower online engagement intentions (viral behavioral intentions). Pre-existing risk perceptions moderated these differences. A moderated serial mediation model, conducted using PROCESS models, was examined to assess the mechanism by which persuasive appeals and risk perceptions interact in influencing purchase intentions. Findings are discussed theoretically in regard to extending the psychological reactance model within the digital environment and practically in terms of public health, brand protection, and law enforcement recommendations.

Pharmacists' perceptions and attitudes toward drug importation into the State of Florida.

BACKGROUND: The Department of Health and Human Services and the Food and Drug Administration released the Safe Importation Action Plan in July 2020 detailing methods to import medicines from Canada to combat increasing drug costs. In November 2020, Florida became the first state in the United States to create and propose an importation plan from Canada. This study examines the proposal submitted by Florida, Florida pharmacists' perceptions of the program on patient safety, and Florida pharmacists' thoughts on the pharmacy operational impact. METHODS: This was a cross-sectional study utilizing an electronic questionnaire sent to pharmacist members of the Florida Pharmacy Association. The survey incorporated closed-ended and open-ended questions. The results from the study were reported and analyzed through descriptive statistics, qualitative and quantitative data. RESULTS: Two-hundred and forty-four pharmacists responded to the survey. Of those respondents, 25% stated they had no knowledge about Florida's drug importation plan. Less than 12% of respondents stated they would trust the safety and quality of imported medicines. Seventy percent of pharmacists expressed concerns regarding the changes required in pharmacy operations to increase medicine safety. About half of the respondents questioned whether this plan would promote cost-savings as intended. CONCLUSION: Florida pharmacists believe the drug importation plan does not address all aspects of patient and medicine safety and expressed concerns regarding logistical operations of a pharmacy. This article highlights those concerns and acts as a summons to action.

Evaluation of pharmacists' awareness of illegal online pharmacies and perceived impact on safe access to medicines.

Background: An estimated 95% of all online pharmacies operate unlawfully. Illegal online pharmacies distribute substandard and falsified medical products that may result in patient harm and suboptimal treatment, leading to an overall mistrust of medications, healthcare providers, and health systems. As medication experts, pharmacists are trusted to guide patients in selection of safe and effective medication therapy. Objective: The objective of this study was to determine gaps in knowledge and recognition of the negative clinical and safety impacts associated with illegal Internet pharmacies by licensed pharmacists. Methods: A 37-question electronic survey was developed and distributed to pharmacists across the United States by email via a database from the American Pharmacists Association. Descriptive statistics was utilized to analyze data. Results: A total of 347 pharmacists from across the United States responded to at least one question in the survey. In all, 58% of pharmacists reported a lack of confidence in their ability to counsel patients on the identification of illegal pharmacy websites. Fewer than 60% of pharmacists were able to accurately identify the legitimacy of a webpage based on visual characteristics. In addition, 75% of pharmacists reported being unfamiliar with resources available to help consumers identify safe and legitimate online pharmacies. Conclusion: Integration of the topic into pharmacy education curricula, training on available resources, and additional research into the prevalence and impact of illegal pharmacy websites are necessary to ensure that pharmacists and other healthcare professionals are adequately prepared to protect their communities from the threat of illegal online pharmacies.