Retention of Sterile Compounding Knowledge Among Pharmacy Technicians

Abstract

Background: Patient safety is in jeopardy due to a rise in the preparation of adulterated parenteral products with poor technique identified as a significant contributing factor. Pharmacy technicians perform an overwhelming majority of aseptic compounding practices; however, this group’s progressive loss of aseptic technique knowledge has not been documented. Objective: The purpose of this correlational research study was to investigate the association between sterile compounding knowledge and years in the field controlling for formal training in sterile compounding techniques. Methods: An assessment tool of fundamental sterile compounding content was electronically distributed to sterile compounding technician members of pharmacy organizations in the southeastern United States. A multiple regression was conducted to predict sterile compounding knowledge from number of years in the field and prior years of formal compounding training. Results: Sixty-eight assessments were returned complete. The overall model was significant (P < .0005), explaining 22% of the variance in knowledge retention. Years in the field was the only significant predictor (P < .001). Each additional year of work experience was associated with a 0.18 drop in the assessment score. Conclusions: The longer pharmacy technicians remain in the field, the more aseptic technique knowledge they will lose. Modeling of poor sterile compounding techniques in the workplace may promote loss of competency of the skill. As a result, a plan to address continuing education for pharmacy technician sterile compounders is necessary to ensure patient safety.

Introduction

Patient safety is a principal concern for all medical professionals. Over the years, infectious outbreaks originated by contaminated parenteral products have led to substantial patient injury or even death. All pharmacy professionals, including pharmacy technicians, must continually demonstrate a high understanding of the rules and regulations associated with the compounding of sterile products. Several studies have shown that poor technique or failure to follow current standards or protocols can lead to patient injury or even death.^1-3 From 2001 through 2013, 19 outbreaks of infections were identified linked to compounded sterile products. At least 1000 patients were affected, some resulting in death. Violations in aseptic technique and insufficiencies in aseptic procedures were consistent factors in the cases.¹ Additionally, from January 2000 to November 2012, 11 infectious occurrences stemming from tainted medications, ultimately affecting 207 patients and leading to 17 deaths, were confirmed.² Several issues with sterile measures were discovered. In 2012, the New England Compounding Center prepared and distributed vials of methylprednisolone contaminated with Exserohilum rostratum, an exceedingly deadly fungus due to insufficient quality control measures and inadequate compounding practices. At a minimum, one step in the sterile compounding process is missed in 100% of intravenous preparations.³ These data reinforce the importance of pharmacy compounders mastering the skill of aseptic compounding and remaining abreast of changes in the discipline.⁴ The only state requiring sterile compounding training or continuing education hours for technicians making compounded sterile products is Texas. Additionally, uniform prerequisites for the employment of pharmacy technicians are currently nonexistent.^5,6

Knowledge Retention

In a comparative study by Eley and Birnie⁷ among Doctor of Pharmacy (PharmD) students, 62 students were instructed to compound metoprolol capsules. One year later, 30 of those students volunteered to complete the same assignment. Of the volunteer group, 81% failed to show mastery of the skill compared with 10% of the initial group. In only 1 year, an overwhelming percentage of students lost the knowledge to complete the skill. Throughout the available literature, the importance of continued exposure to aseptic training practices can be found.^8,9 Mudit and Alfonso⁹ determined a need for frequent exposure to compounding tasks for retaining knowledge among Doctor of Pharmacy students. Many researchers confirm that confidence in the ability of the pharmacy professional is just as important as knowledge degrades over time,^10,11 possibly due to faulty modeling by peers.

Theoretical Framework

Albert Bandura’s social cognitive theory is founded on the belief that individuals model behaviors seen in their environment, influencing portions of their learning and understanding.¹² Several researchers expound on the benefits of learning via observation in medical professions.^13,14 Furthermore, the observation of subpar behaviors has a similar, but negative alternative response. Erasmus et al¹⁵ identified behavior of others as a possible factor of hand hygiene noncompliance among health care workers in a hospital environment. Consistent exposure to inadequate skills and behaviors, as may be occurring in the practice of sterile compounding, may have adverse effects over time that subsume and replace previously learned competencies, potentially leading to a loss in knowledge retention. The constructs of reinforcement and expectation also influence the loss of expertise. Failure to be corrected about unsatisfactory processes encourages the continuation of such practices and creates a sense of expected acceptance of all compounded products. The social cognitive theory framework can be used to explain why the deterioration of sterile compounding knowledge occurs over time. This model provides a framework for the development of pertinent questions to describe the current status of technician education in aseptic compounding and the possible need for continuous training post-program completion. As such, the theory can serve to emphasize those areas where pharmacy technology can improve to certify patient safety. The knowledge sterile compounding pharmacy technicians possess is just as important. However, no literature addresses knowledge retention of fundamental aseptic compounding in pharmacy technicians. As such, research is needed to establish how well pharmacy technicians maintain sterile compounding information over time.

Methods

A quantitative correlational analysis was performed to evaluate knowledge retention of pharmacy technician sterile compounders. The A.T. Still University Institutional Review Board granted permission to conduct this study. Attempts at finding a validated assessment to test aseptic technique knowledge were unsuccessful due to a gap in literature about the subject. Therefore, a preexisting test instrument was modified, tested for reliability and validity, and used to assess an association between test scores, years in the field, and training hours.

Instrumentation

The instrument test consisted of questions prepared by the researcher accompanied by a validated knowledge assessment consisting of a total of 35 questions formatted in REDCap (Table 1). Before beginning the knowledge assessment, participants answered questions pertaining to current sterile compounding technician work status, the number of years they had worked as a sterile compounding technician, and the number of hours of formal training they had completed. Demographic questions including sex and the highest level of education completed were collected to determine if the target population was representative of the general population. The sterile compounding written assessment was created by Dr Earnest Powell, Director of Pharmacy of Doctors Hospital Pharmacy, who used it to evaluate the didactic knowledge of sterile compounding procedures of technicians at that hospital. Each question was specifically written to address the standards and regulations set forth by United States Pharmacopeia Chapter 797.¹⁶

Table 1.

Assessment Content.

Most common source of contamination

Certification of laminar airflow workbench

IVA seal placement

Beyond-use date of opened single-dose bags

Beyond-use-date of multiple-dose vials

Proper gowning and gloving

Proper syringe selection

Identification of primary engineering controls

Hood cleaning protocol

Penetration of multi-dose vials

Proper disposal of empty vials

Interpretation of medication orders

Procedures for drug reconstitution

Airflow of the laminar airflow workbench

Proper handwashing

TPN preparation

Critical sites of pediatric supply items

Coring and milking techniques

Proper cleaning of the workbench

ISO environments

Order of events for anteroom preparatory procedures

Parts of a syringe

Abbreviations: IVA, intravenous admixtures; TPN, total parenteral nutrition; ISO, International Organization for Standardization.

Reliability and validity measures for the assessment were not conducted by the instrument’s author. Therefore, a panel of pharmacy professionals was assembled to review the test to calculate the content validity ratio for each question and the overall content validity index for the entire instrument. The panel consisted of a program chair of an accredited pharmacy technology program, a clinical pharmacist at a local hospital, and a pharmacy technician sterile compounder. The validity scoring session was held via Zoom conference with each participant evaluating each question as the researcher shared the test on the screen. Each panelist rated the necessity of the information contained in each question. All questions had sufficient content validity based on a content validity ratio measurement >0 but <1. The overall assessment content validity index was 0.98, also acceptable.¹⁷

Pilot Study

A pilot survey was created using the information obtained from the panel of pharmacy professionals. Topics on the assessment included handwashing, garbing, flow rates, powdered drug reconstitution, and expiration dates. A request for participation was sent in October 2020 along with the survey link, including the informed consent and instrument, to 20 pharmacy technician compounders who were not members of the targeted state organizations. The communication included the recruitment email and survey link intended for dissemination to the sample population. Data collection lasted 2 weeks. Seventeen participants completed the assessment for a response rate of 85%. The collected data were entered into SPSS, and Cronbach’s α was calculated to determine the instruments’ internal reliability. The instrument had an acceptable level of consistency as determined by a Cronbach’s α of .71.

Participants

Convenience sampling was used to acquire study participants. Participants were eligible for recruitment if they were at least 17 years of age, pharmacy technician members of their state’s pharmacy organization, and currently working as sterile compounders. Members of a state organization not working as sterile compounders were excluded.

Data Collection

The principal investigator (PI) asked the primary state’s pharmacy organization vice president to access the listserv and electronically submit the survey/assessment to the pharmacy technician members. Data collection occurred over 8 weeks. As participants completed the survey, responses were stored in REDCap until recovered for cleaning and analysis. Once the survey was active, the PI monitored response rates to ensure the recommended sample size for statistical power was reached.¹⁸ A suitable target number each week was 12 completed surveys. When response rates lagged, the PI requested the targeted state’s pharmacy organization vice president send the reminder email to the pharmacy technician members. Going into week 4, fewer than 48 responses had been collected; the PI sought the participation of pharmacy professional organizations in neighboring states to increase the sample size using the same recruitment methodology. Multiple regression assumptions were assessed before analyzing the data. A regression analysis was conducted to determine the significance of the hypothesized model.

Statistical Analysis

Using SPSS, descriptive statistics for the continuous dependent variable, test score, were evaluated and described within each of the categorical independent variables along with the 2 continuous independent variables. A regression analysis was conducted to determine the overall significance of the model. Complete fitness of the model was assessed after conducting the analysis, allowing independent variables to be evaluated for influence on the dependent variable.

Results

Seventy assessments were attempted in REDCap (Table 2). Two tests were excluded due to failure of completion or submission. The final sample size was 68 submitted assessments with no missing data. The majority of participants were female (n = 55, 80.9%), while the most common education level among participants was a program diploma (n = 29, 42.6%). Missing data and univariate outliers were examined using frequency counts, standardized residuals, and boxplots. There were outliers found in the hours of formal training variable, but they were determined to be valid responses and were kept in the data set.

Table 2.

Descriptive Statistics for Sterile Compounding Assessment Scores.

	n	Total N %	M	SD
Training hours	68	100	75.71	56.73
Years of experience	68	100	9.18	7.04
Total score	68	100	24.07	2.72
Sex
Male	13	19.1	22.92	1.50
Female	55	80.9	24.35	2.88
Education level
High school	10	14.7	23.60	2.27
Program diploma	29	42.6	23.72	2.71
Associates degree (2 years)	25	36.8	24.56	2.77
Bachelor’s degree (4 years)	4	5.9	24.75	3.86

Abbreviations: M, mean; SD, standard deviation.

The number of training hours among participants ranged from 0 to 240 hours. The number of years in the field ranged from 1 to 28 years, and assessment scores ranged from 18 to 30 points. Higher scores were observed for females and those with bachelor’s degrees (mean [M] = 24.35, standard deviation [SD] = 2.88) compared with males (M = 22.92, SD = 1.50). Participants with bachelor’s degrees averaged higher scores on the assessment (M = 24.75, SD = 3.86) followed closely by associate degree holders (M = 24.56, SD = 2.77). Those with programmatic diplomas (M = 23.72, SD = 2.71) and high school graduates (M = 23.60, SD = 2.77) scored somewhat lower.

The multiple regression model statistically significantly predicted knowledge retention, F(2, 65) = 10.54, P < .0005, adjusted R² = .22 (Table 3). This effect size was medium, according to Cohen.¹⁹ Therefore, the null hypothesis can be rejected. Length of experience is a statistically significant predictor of knowledge retention (P < .001). For every additional year in work experience, the knowledge test score decreases by 0.18 points. The number of formal training hours was found to be nonsignificant to the prediction.

Table 3.

Multiple Regression Results for Prediction of Sterile Compounding Assessment Scores.

Test scores	B	95% CI for B		SE B	β	R 2	ΔR2
		LL	UL
Model						.25	.22***
Constant	25.09***	23.88	26.29	.60
Hours of formal training	.009	−.002	.02	.005	.18
Years in the field	−.18***	−.27	−.10	.04	−.47***

Abbreviations: Model, “Enter” method in SPSS Statistics; B, unstandardized regression coefficient; CI, confidence interval; LL, lower limit; UL, upper limit; SE_B, standard error of the coefficient; β, standardized coefficient; R², coefficient of determination; ΔR², adjusted R².

^***P < .001.

Discussion

According to the multiple regression results, length of time in the field is a strong indicator of knowledge retention. With every additional year in the pharmacy, the test score decreased by 0.18 points, a moderate amount. Over 10 years, the technician knowledge assessment score can be expected to decrease by 1.8 points, a more substantial cumulative total. Even a slight loss of competency is a significant concern in sterile medication compounding because every aspect of the sterile compounding process is critical to patient safety. Introduction of contaminants to the final product is possible from preparation to production to administration. Improper beyond-use-dating exposes a patient to potentially ineffective or harmful medication. The findings of this study should be of interest to all pharmacy staff.

Scant research about pharmacy technician knowledge and practice prevents specific comparison with previous studies. Therefore, interpretation and context of study results are based on research conducted with other health care professionals. Unfortunately, poor knowledge retention of skill-specific competencies among health professionals is well documented.^20,21 Cardiopulmonary skills of first responders diminished in as little as 90 days, while knowledge assessment scores of nurses who completed an advanced trauma nursing course were not significantly different from the pre-course assessment scores 3 months after the course ended. The results of this study align with what is understood of other medical professionals. Loss of information occurs over time in many areas of health care.

It is possible knowledge loss occurs over time due to the modeling of actions witnessed in the environment. Albert Bandura’s social cognitive theory is founded on the concept that people replicate behaviors seen in their surroundings, influencing their learning and understanding. However, experiences and expectations equally affect how a person may behave.¹² As new pharmacy technicians assimilate with the pharmacy staff, the opportunity to replace a strong skill set with one less skilled arises. Over time modeling of behavior subsumes the original behavior, eventually resulting in a loss of knowledge of correct technique. Failure to be corrected when performing improper skills encourages poor conduct, eventually shifting the norm lower. Employers forgoing training of new and current employees are doing a disservice to themselves as well as to patients. The desire among workers to exhibit top-tier skills varies among the staff members. Those not stimulated to maintain their abilities adversely affect the whole business. In health care, this outcome cannot be tolerated.²²

Reducing the loss of knowledge over time may require mandatory continued education for aseptic sterile compounding pharmacy technicians at predetermined intervals to ensure proper technique and improve patient safety. Implementation of knowledge retention strategies in the workplace may prevent knowledge loss. Providing incentives for staying current with sterile compounding practices, such as access to continuing education credits or monetary bonuses, could be effective. Additionally, appointing a person to oversee knowledge retention activities, including identifying employees exhibiting a decline in their work performance, may be necessary.²³

Limitations

Since all communication with participants was indirect, it is possible some technicians were missed, which may negatively affect the study results by decreasing the sample size and biasing the type of pharmacy technician who responded. Participants volunteered to take part in the study. Technicians with more confidence in their sterile compounding knowledge may have felt more inclined to complete the assessment. Direct access to participants could possibly have improved response rates, thus increasing the results’ generalizability. Additionally, the study focused on the pharmacy technician sterile compounder; therefore, though possibly relatable, the results may not be generalizable across other allied health professions.

A lack of uniformity in protocols may also have affected results. Since state boards of pharmacy are afforded the authority to interpret many sterile compounding regulations as they desire, some protocols may differ among institutional pharmacy practices. To mitigate these issues, the assessment covered foundational sterile compounding content, not subject to interpretation. The threat of research reactivity was unavoidable due to the nature of the study. The assessment topic was targeted, leading to inevitable participant awareness of what the researcher was assessing. While participants were advised to refrain from using outside resources during the assessment, it is not possible to know if participants followed this suggestion. Of course, researching the answers defeats the purpose of the assessment. The distribution of participant scores was analyzed to minimize this effect. No outliers were found. Last, the limitation of participant attribution bias may also have negatively affected results. All conclusions were made based on the variables assessed in the study. The researcher made every effort to include the most relevant variables for analysis to produce the most parsimonious but salient regression models.

Delimitations

Participants were delimited to sterile compounding technician members of pharmacy organizations located in the United States’ Southeastern region. The assessment tool created for this study was based on the 2008 USP 797 standards.

Recommendations for Future Research

Information about how well pharmacy technicians retain sterile compounding knowledge over time was absent in the literature. However, the need for these professionals to maintain a high level of sterile compounding knowledge is critical for patient safety. A relationship between knowledge retention and years working in the field has been established by this study’s result. Future studies should be conducted to examine other potential influencing variables, particularly the technician’s educational or certification status in relation to knowledge retention. Completing an accredited pharmacy training program, becoming nationally certified or specifically certified in compounded sterile preparation can potentially influence the retention of aseptic technique and other germ-free compounding information.

Longitudinal studies following new pharmacy technician graduates assessing their knowledge at scheduled intervals may provide evidence of when that knowledge begins to decline such that timely intervention may be implemented. Patient safety is the chief concern of the pharmacy. Should future studies support the need for continuing education and training for pharmacy technician sterile compounders, these curricula need to be developed, implemented, and evaluated.

Conclusion

Contamination of parental products has increased over time. With each incidence, the safety of the patient is threatened. Pharmacy technicians are significant contributors to patient care. Those who perform aseptic compounding duties are expected to demonstrate mastery of those skills consistently. While the loss of aseptic technique knowledge in pharmacist students has been well documented, no such research has been conducted on the pharmacy technician sterile compounder. This study was the first to examine and document the degree of sterile compounding knowledge loss over time of the pharmacy technician.

The results from this study indicate a relationship between retention of sterile compounding knowledge and length of experience. With every additional year working in the field, more critical compounding information is forgotten. Not only does this place the integrity of each product into question, but also it jeopardizes the lives of each recipient.

As a result of this study, it is crucial more attention is given to continued sterile compounding training for pharmacy technicians. Yearly validation testing measures may not be sufficient. Furthermore, it is recommended other influencing factors be investigated, such as the type of educational training and possession of professional certifications. Obtaining pharmacy-specific certifications alone or in conjunction with completing an accredited pharmacy technician program could reduce the loss of compounding knowledge over time and improve patient safety. Last, institution of the yearly completion of aseptic compounding continuing education hours for all preparers and overseers of sterile compounding should be considered to further ensure the refreshing of knowledge and protection of patient safety.