Remote extemporaneous compounding lab practical for pharmacy students during the COVID-19 pandemic.

BACKGROUND AND PURPOSE: Due to COVID-19 movement restrictions, institutes of higher learning had to deliver pharmacy curricula remotely. One major challenge was teaching practical lab skills, such as extemporaneous compounding, remotely due to the need for hands-on learning and its associated logistical requirements. EDUCATIONAL ACTIVITY AND SETTING: We present the approach to remote extemporaneous compounding teaching taken by three pharmacy schools: Monash University Malaysia, University of Michigan, and University of Maryland. Prior to delivery, students were either supplied with or asked to procure a set of easily accessible ingredients and equipment to conduct the extemporaneous practicals from home. We conducted lessons remotely using both synchronous and asynchronous delivery, and demonstrated, taught, and assessed practical lab skills using video conferencing modalities. FINDINGS: We successfully conducted remote teaching of extemporaneous compounding, where similar learning outcomes to the face-to-face implementation were achieved. At Monash University Malaysia, > 90% of students responding to the post-activity surveys found the remote extemporaneous sessions useful for their learning, and qualitative comments supported these views. Mean scores from the remote extemporaneous labs in 2021 were similar to those when conducted physically in 2019, supporting the effectiveness of the approach. The different approaches attempted by the three institutions highlighted the flexibility in implementation that can be considered to achieve similar outcomes. SUMMARY: Combining technology-based approaches with synchronous and asynchronous teaching and learning methods can successfully deliver extemporaneous compounding skills remotely.

Categorization and comparisons of drug recalls for manufacturers and compounders.

BACKGROUND: Ensuring the quality and safety of the pharmaceutical supply chain is a key policy focus vital to protecting the public from harmful or potentially harmful medications. Although the Food and Drug Administration (FDA) reports the number of recalled products per fiscal year and categorizes recalls based on product type and recall classification, these reports do not distinguish between manufactured and compounded products. OBJECTIVES: This research aims to categorize drug recalls based on the reason for recall and then to compare this reason between manufacturers and compounders. METHODS: All publicly available drug recall data were downloaded from the FDA Data Dashboard website on January 24, 2021. Two reviewers independently categorized the recalling firm, distribution pattern, and reason for recall, and a third reviewer resolved all conflicts. Descriptive statistics were reported for recall event classification, distribution, and recall reason for the full sample. Chi-square test of independence was used to assess categorical variables by facility type (manufacturer or compounder) as well as by event classification (class I, II, or III). A subgroup analysis was performed focusing on class I level recalls only, representing the most serious recall, and similar statistical procedures were performed. RESULTS: From June 8, 2012, to January 24, 2021, there were 12,343 drug products recalled; 6771 were from a manufacturer, and 5572 were from a compounder. Most recalls from both compounders and manufacturers were class II recalls with products being distributed to multiple states. Sterility assurance was the predominant reason for recall among compounders, whereas product quality was the most frequent recall reason for manufacturers. There were statistically significant differences in class I recalls between compounders and manufacturers and recall reason compared across recall classification. CONCLUSION: There was a statistically significant difference in the reason for a drug to be recalled, the distribution level, and the product class for manufactured and compounded products.

Distinguishing between compounding facilities and the development of the 503B bulk drug substance list.

The purpose of this commentary is to describe the differences between 503A and 503B facilities and the policies and restrictions for compounding from bulk drug substances. Due to the 2012 meningitis outbreak linked to compounded steroid injections, the landscape of pharmacy compounding was changed in the United States. This event led to the creation of two distinct types of compounding pharmacies, 503A and 503B facilities. 503B facilities are restricted from compounding using bulk drug substances unless they are on the Food and Drug Administration drug shortage list or appear on the 503B Bulk Drug Substance list. This commentary hopes to bring more attention to the development of the 503B Bulk Drug Substance list being developed by the FDA and to encourage practitioners and pharmacists to provide insight into the drug substances nominated for the list.

The role of outsourcing facilities in overcoming drug shortages.

BACKGROUND: The Drug Quality and Security Act passed in 2013 created a new voluntary category of compounders, referred to as outsourcing facilities. The regulatory landscape allows these facilities to compound on a larger scale in comparison with the typical compounding pharmacies, which positions them to potentially serve a role in overcoming drug shortages. OBJECTIVE: The purpose of this article is to identify the number of drug products on shortage as reported by the Food and Drug Administration (FDA) that were also compounded by outsourcing facilities. METHODS: All current and resolved drug shortages through January 27, 2020, as reported by FDA, were compared with the 503B product reports from July 2018 through June 2019 submitted to FDA by outsourcing facilities. The active pharmaceutical ingredient (API) and dosage form for each product on shortage were compared with the 503B product reports to identify similarities. RESULTS: There were 344 unique APIs on the FDA drug shortage list and 774 unique APIs on the 503B product reports. After comparison of the APIs on the drug shortage list with those on the product reports, 27% of unique APIs (74 of 272) were included on both lists, and of these, 18% (50 of 272) of the APIs on the drug shortage list were compounded by outsourcing facilities in the same dosage form as what was on shortage. CONCLUSION: The regulatory landscape positions outsourcing facilities to play an important role in providing access to medications while on shortage. However, when comparing the drugs on shortage as reported by FDA with the 503B product reports, there was minimal overlap. Additional research into why outsourcing facilities are not taking on a larger role in overcoming drug shortages should be explored.

Outsourcing facilities and their place in the U.S. drug supply chain.

The purpose of this commentary is to describe the ideal role of 503B outsourcing facilities in the U.S. drug supply chain. We also address the challenges that 503B outsourcing facilities are facing that limit their utilization and offer possible solutions. Section 503B outsourcing facilities are emerging contributors in compounding owing to their ability to compound large quantities of medication without requiring patient-specific prescriptions. As such, they play a valuable role in the U.S. drug supply chain. The use of outsourcing facilities to compound ready-to-use drug products is gaining traction in hospitals and other health care systems. Outsourcing facilities help hospitals that are facing time and cost constraints owing to the evolving regulatory landscape around compounding. Although outsourcing facilities are assets to the drug supply chain, there are several challenges to their use. The lack of a finalized 503B Bulks List has led to outsourcing facilities being overly cautious in compounding products using bulk drug substances. In addition, the time between Food and Drug Administration (FDA) inspections is undefined, and a lack of follow-up information regarding concerns identified during an inspection may result in uncertainties about the current state of the outsourcing facility. Health care providers, outsourcing facilities, and FDA need to work together to ensure that patients are provided the drugs they need in a safe and effective way.

Salary and entry-level requirements for pharmacy technicians compared with other health technologist and technician occupations in Maryland.

OBJECTIVES: Pharmacy technician programs are experiencing important transitions to new educational standards, an enhanced accreditation framework, and changing requirements by state boards of pharmacy. The requirements are highly variable from state to state and have practical consequences for the pharmacy workforce in terms of technician recruitment, retention, and satisfaction. Using the state of Maryland as a case report, the purpose of this analysis was to compare the requirements necessary to become either a pharmacy technician or another type of health technologist, including board licensure or registration; training, education or certification or both; and 2016 median salary as reported by the Bureau of Labor Statistics. DATA SOURCES: This analysis of salaries and job requirements for health technologists and technicians in the state of Maryland was conducted using the Standard Occupational Classification system and the Bureau of Labor Statistics wage data. SUMMARY: Nuclear medicine technologists have the highest median salary at $38.50 per hour. No relationship between increasing entry-level qualifications and salary was identified, but pharmacy technicians were found to have the lowest median salary at $15.10 per hour. Although 5 occupations have median salaries greater than $30, 9 have median hourly salaries less than $20, of which 5 have minimum qualifications mandated by statute and regulation. CONCLUSION: Pharmacy technicians have the lowest median salary compared with other health technologists and technicians in Maryland. With pharmacy technicians reporting low satisfaction with salary as a reason for intending to leave an employer, implementing mandatory minimum entry-level requirements without a corresponding increase in salary could lead to a reduction in applicants for positions.

Relationship between regulatory barriers to entry and pharmacy technician wages.

BACKGROUND: Pharmacy technicians are vital to the operation of pharmacies, and national pharmacy associations have advocated for mandatory education and training requirements. While these requirements may improve patient safety, there is a risk that laws and regulations which impose substantial education and training requirements on technicians could create barriers to entry which restrict the workforce and increase wages. OBJECTIVE: This study has two objectives: 1) Describe changes in barriers to entry and wages over time; and 2) Evaluate the correlation between changing barriers to entry and pharmacy technician wages. METHODS: Data come from Bureau of Labor Statistics Occupational Employment Statistics from 1997 to 2017 and National Association of Boards of Pharmacy Surveys of Pharmacy Law from 1997 to 2014. A barrier to entry was defined as adoption of registration, licensure, or certification. Wage data was adjusted to 2017 dollars using the Consumer Price Index. Ordinary least squares regression evaluated the correlation between the proportion of states which had at least one barrier to entry and wages. An interrupted time series model estimated the impact of adopting a barrier to entry on the trend in technician wages over time. RESULTS: Technician wages increased between 1997 and 2007 but remained flat between 2008 and 2017. A strong correlation was observed between the proportion of states which had at least one barrier to entry and technician wages (R2 = 0.93, p < 0.0001). However, the interrupted time series models did not identify any relationship between adoption of a barrier to entry and the trend in technician wages (p = 0.363). CONCLUSIONS: This research suggests adoption of legal/regulatory barriers to entry did not have a significant influence on the trend in technician wages over time. More research is needed to evaluate the impact of barriers to entry on non-wage practice variables, such as privileges and satisfaction.

Regulatory burden and salary for pharmacy technicians in the United States.

BACKGROUND: Education, training, and certification requirements for pharmacy technicians are determined by individual state boards of pharmacy resulting in heterogeneity in the entry-level requirements to practice in the United States (US). OBJECTIVE: To determine an association between state-level registration/licensure requirements and salary for pharmacy technicians. METHODS: All 50 states and the District of Columbia (DC) were categorized into two groups, high regulation (HR) or low regulation (LR). Salaries were compared using the 2016 hourly salary published by the Bureau of Labor Statistics (BLS). To adjust for cost of living, an index was created using median hourly salary and hourly wage needed to afford a two-bedroom rental for each state obtained from the National Low Income Housing Coalition (NLIHC) 2016 Out of Reach Report. Average median salary and the average salary-housing index (SHI) were compared using a student t-test. RESULTS: The sample included 23 H R states and 28 L R states. Salary differences were not significant despite regulatory requirements (LR: $14.74±$1.57; HR: $15.60±$1.80; p-value: 0.065). There was also no difference in SHI scores (LR: 0.83 ±â€¯0.15; HR: 0.88 ±â€¯0.19; p-value: 0.21). CONCLUSION: Despite increased regulatory burden in the HR states, income levels are not significantly higher.

Entry-level practice requirements of pharmacy technicians across the United States: A review.

PURPOSE: The results of a review of statutes and regulations to determine entry-level requirements for pharmacy technicians across the 50 states and the District of Columbia in terms of training and certification are reported. METHODS: Pharmacy practice acts in all 51 jurisdictions were reviewed to ascertain initial qualifications for training, certification, registration, and/or licensure of pharmacy technicians using the keywords technician, registration, licensure, training, education, and certification. One reviewer analyzed statutes and regulations in force as of March 2017. RESULTS: Among the 50 states and the District of Columbia, 86% (44 of 51) required pharmacy board registration and/or licensure in order to practice as a pharmacy technician; 55% (28 of 51) required no education/training or certification, 8% (4 of 51) required education/training only, 10% (5 of 51) required certification only, 14% (7 of 51) required education/training and certification, and 14% (7 of 51) required either education/training or certification. CONCLUSION: There is no consensus among the 50 states and the District of Columbia regarding entry-level requirements for pharmacy technicians, which range from no oversight to mandatory training/education with or without certification requirements. Several national organizations have set recommendations for minimal education/training and certification; however, there is no uniform acceptance across the United States.

Advancing the role of the pharmacy technician: A systematic review.

OBJECTIVES: To summarize the findings of a literature search on advancing the role of pharmacy technicians, including the types of training identified and the potential costs and benefits to both the technician and the pharmacy. DATA SOURCES: A literature search of Scopus, Embase, and Medline was conducted on January 11, 2017. STUDY SELECTION: Original research, research reports, case studies, or association reports were included for review. Articles were considered to be relevant based on identification of an advanced pharmacy technician role or addressing additional training/education for technician functions. DATA EXTRACTION: A standard data extraction form was used to collect study authors, article title, year published, journal title, study design, brief description of methods, primary outcome measures, advanced technician roles identified, additional education or training addressed, and additional costs and benefits identified in each article. RESULTS: A total of 33 articles were included for full review and data extraction. Study design varied, with 17 (52%) quantitative, 1 (3%) qualitative, 5 (15%) mixed-method, and 10 (30%) case study designs. Seventeen (52%) of the studies included were published after 2006. The mechanism of training was primarily through supervised on-the-job training, allowing technicians to assume administrative-based positions that facilitated a pharmacist-led clinical service, with either the pharmacist or the pharmacy receiving the greatest benefits. CONCLUSION: Although the literature supports technicians performing advanced roles in the pharmacy, resulting in either improved patient outcomes or opportunities for pharmacists to engage in additional clinical services, the benefits to the technician were primarily indirect, such as an increase in job satisfaction or a more desirable work schedule. If a technician is to take on additional roles that require completion of a formalized training or educational program, benefits that are more tangible may help to inspire technicians to pursue these roles.