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.

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.

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.

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.

Tackling the challenges of nanomedicines: are we ready?

PURPOSE: This review provides an overview of the proceedings of the symposium "Tackling the Challenges of Nanomedicines: Are We Ready?" organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars. SUMMARY: The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit. CONCLUSION: Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars.

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.

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.

Third Consensus Development Conference on the Safety of Intravenous Drug Delivery Systems-2018.

PURPOSE: The Third Consensus Conference on the Safety of Intravenous Drug Delivery Systems was convened to evaluate the benefits and risks of available systems and assess ongoing threats to the safety of intravenous drug delivery. SUMMARY: The Third Consensus Conference on the Safety of Intravenous Drug Delivery Systems convened in Chicago, Illinois in November 2018. An expert panel of healthcare providers with experience in medication quality and safety, pharmacy and nursing operations, information technology, and/or sterile compounding led the conference. An experienced audience of approximately 30 healthcare leaders provided feedback to the panel via preconference survey and during the conference. Additionally, expert speakers presented on a range of issues, including the effects of drug shortages, the impact of standards and guidelines, and patient and administrator perspectives on the importance of intravenous drug delivery safety. CONCLUSION: At the end of the conference, the expert panel concluded that manufacturer ready-to-use products remain the safest intravenous drug delivery system due to their many benefits and low overall risk profile. The panel identified various ongoing threats to the safety of intravenous drug delivery, with major concerns including the impact of drug shortages and lack of intravenous product standardization. Finally, the panel agreed upon a series of statements designed to advance the safety of intravenous drug delivery in healthcare institutions.

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.

A Comparison of Error Rates Between Intravenous Push Methods: A Prospective, Multisite, Observational Study.

OBJECTIVES: Current literature estimates the error rate associated with the preparation and administration of all intravenous (IV) medications to be 9.4% to 97.7% worldwide. This study aims to compare the number of observed medication preparation and administration errors between the only commercially available ready-to-administer product (Simplist) and IV push traditional practice, including a cartridge-based syringe system (Carpuject) and vials and syringes. METHODS: A prospective, multisite, observational study was conducted in 3 health systems in various states within the United States between December 2015 and March 2016 to observe IV push medication preparation and administration. Researchers observed a ready-to-administer product and IV push traditional practice using a validated observational method and a modified data collection sheet. All observations were reconciled to the original medication order to determine if any errors occurred. RESULTS: Researchers collected 329 observations (ready to administer = 102; traditional practice = 227) and observed 260 errors (ready to administer = 25; traditional practice = 235). The overall observed error rate for ready-to-administer products was 2.5%, and the observed error rate for IV push traditional practice was 10.4%. CONCLUSIONS: The ready-to-administer group demonstrated a statistically significant lower observed error rate, suggesting that use of this product is associated with fewer observed preparation and administration errors in the clinical setting. Future studies should be completed to determine the potential for patient harm associated with these errors and improve clinical practice because it relates to the safe administration of IV push medications.

Board of Pharmacy Practices Related to Medication Errors and Their Potential Impact on Patient Safety.

State boards of pharmacy are generally responsible for the governance of the practice of pharmacy. While the regulatory process and methods for accomplishing this task may vary by state, all boards of pharmacy must address medication errors committed by pharmacists. The National Association of Boards of Pharmacy (NABP) has recommended that state boards of pharmacy implement best practices and enforcement actions that are aimed to promote patient safety and reduce medication errors. The current study was designed to identify and compare current corrective action practices among boards of pharmacy in response to medication errors. An electronic survey regarding board policies and anticipated board actions in response to hypothetical medication error scenarios was sent to boards of pharmacy for completion. Approximately 45% of pharmacy boards responded. Survey responses demonstrated that corrective actions and consequences were levied against pharmacists inconsistently among state boards. Corrective action plans and process improvement components were lacking in a majority of state board of pharmacy practices. Medication safety education for pharmacists and for members on boards of pharmacy was insufficient in many states. Responses to hypothetical error scenarios indicated that most board actions are educational and punitive in nature, rather than focusing on systems improvement.

A Review of Best Practices for Intravenous Push Medication Administration.

In 2015, the Institute for Safe Medication Practices (ISMP) released safe practice guidelines for adult intravenous (IV) push medications. ISMP's most recent set of guidelines has added to a growing list of recommendations from professional groups on the safe use of IV medications. These recommendations and guidelines vary with regard to their audience, scope, and terminology. In some ways, these variations may contribute to confusion and delayed adoption of the standards. This report attempts to provide clarity about the rationale and background regarding the need for practice improvement, discussion of various guidelines, and practice mitigation strategies to improve patient safety.

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.

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.

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.

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.