Abstract
Introduction:
Pharmacy services in hospitals are designed to meet the needs of all patients. This is undoubtedly one of the most complex services provided by hospitals. In government hospitals, including those in Ethiopia, pharmacies mainly serve as drug stores and dispensaries. To the best of our knowledge, this study is the first to assess and ensure better quality assurance for hospital pharmacy services in Ethiopia. Therefore, the objective of this article was to assess the current status of the quality assurance of pharmacy services in hospitals.
Methods:
A cross-sectional survey was conducted. The data were collected from hospital pharmacy heads using the Kobo Collect mobile application and then exported to the Statistical Package for Social Science (SPSS) version 25 for analysis. Descriptive statistics for categorical variables are presented as percentages and frequencies.
Results:
All (100%) of the studied hospital pharmacies had a qualified pharmacy director and worked in the pharmacy full-time. Only 40% had a drug information center and a functional drug formulary committee. All pharmacies had their own disposal facilities but did not regularly dispose of expired or unfit medications. The results revealed that all hospital pharmacies did not have a responsible body delegated for quality evaluation.
Conclusion:
The findings of this study clearly show that quality assurance services in hospital pharmacies are compromised. The findings can be used to identify areas of improvement and develop strategies to enhance the quality of hospital pharmacy services.
Introduction
The hospital pharmacy is a crucial division that handles the distribution and delivery of medicines, surgical supplies, and medical supplies. 1 Hospital pharmacy quality assurance ensures that pharmacy services are appropriate, effective, and efficient. 2 Pharmacists have a historic and continuing investment in the development of methodologies to assure the quality of pharmacy services in hospitals. 3 Hospital pharmacy services are designed to meet the primary needs of all consumers. Implementing different committees (such as adverse drug reaction (ADR) committees, drug and therapeutics committees (DTCs), and drug formulary committees), providing drug information services (DISs), evaluating, taking measures, reporting ADRs, inspecting the quality of medications, developing formularies with other health professionals, and evaluating patient satisfaction are key components of pharmacy services. 4 Providing pharmacy services in a hospital is undoubtedly one of the most complex tasks. 5 Thus, advanced hospital pharmacy services are needed because they play an important role in patient compliance, and the health sector can improve dramatically. These can also increase patient satisfaction, decrease professional work overload, and prevent patients from waiting in line at the pharmacy. Hospital pharmacies can improve their service by implementing digital technologies. However, thus far, digital technology has not been adopted in most Ethiopian hospital pharmacies. 6
The elements of pharmacy services that are critical to safe, effective, innovative, and cost-conscious medication use in hospitals and health systems should be practiced in each hospital pharmacy. 7 Everyone involved in the delivery of pharmacy services should be made aware of the mission, goals, and scope of the services. 8 In collaboration with other healthcare professionals, pharmacists are responsible for drug formulary management. 9 All hospitals should develop a hospital-specific pharmaceutical list composed of medicines, medical supplies, medical equipment, and laboratory reagents that are prioritized as vital (V), essential (E), or nonessential (N). Additionally, a hospital pharmacy should prepare nonsterile medications such as prescription-based ointments and creams and bulk preparations (e.g., hand rubs, hydrogen peroxide, alcohol of different strengths, and gentian violet), which are not available commercially but are needed for patient care. 10 As the ultimate users of services, consumers have the right to expect accurate and timely delivery of prescription products and information. Thus, consumer satisfaction is the final determinant of success in pharmacy services. 11
The role of pharmacists as members of the health care team has expanded beyond conventional medication dispensing. Recently, pharmacists have started working as clinical pharmacists in hospital wards to provide direct patient care services. Clinical pharmacy is common in Ethiopia. Clinical pharmacy services are patient-centered services designed to promote the rational use of medications, specifically to enhance the therapeutic effect, reduce risk and cost, and respect patient choice. 12 They identify drug therapy needs and problems, propose care plans, recommend medication choices, and monitor medication outcomes. Clinical pharmacists should actively engage in ward rounds, morning sessions, and seminars to contribute to patient care decisions. These activities are performed both as part of the multidisciplinary team and as pharmacy-only activities. In pharmacy-only rounds, pharmacists are also expected to communicate with patients and provide patient medication counseling. 10 Additionally, the provision of drugs and therapeutic information (DTI) is among the most fundamental responsibilities of clinical pharmacists.13,14 To be an effective provider of DTI, the pharmacist must exercise excellent oral and written communication skills.10,13,14 There is published literature describing the positive impact of clinical pharmacists’ contributions to patient care by providing DISs, drug therapy reviews, ADR reporting and monitoring, and patient counseling. However, awareness and acceptance of these services across the world are not the same. For instance, the role of the clinical pharmacist is highly accepted and appreciated in many developed countries, whereas in developing countries, it is still in its infancy. 14
The DTC is responsible for promoting safe, rational, and cost-effective use of pharmaceuticals by providing guidelines to pharmacies, clinical departments, and hospital management. 10 Currently, medication-related harm is a common healthcare issue, causing hospitalization, increased length of stay, and increased mortality and morbidity. Medication safety is a WHO health priority, and increased focus is required to address this long-standing issue. 15 Each hospital should implement medication safety programs, including ADR monitoring and reporting, performing medication reconciliation activities, identifying high-alert medications, and implementing new and existing national standards and systems. 10 Currently, the healthcare system is moving toward value-based purchases of professional services. Value is often described as the balance between quality and costs, and thus, we can enhance value by improving quality while controlling costs. 16
According to different investigations, the money spent on purchasing medicines by governments is very large; between 40% and 60% of a country’s overall public health budget is normally allocated to the purchase of drugs by governments. 17 Additionally, in developed countries, drug purchase costs will consume 50%–90% of healthcare budgets. 18 Despite such heavy spending, one-third of the world’s population lacks access to essential medicine—up to one-half in Asia and Africa. A major reason for this adverse situation is poor drug management systems. 17 To our knowledge, this research is the first investigation to assess and ensure better quality assurance for hospital pharmacy services in Ethiopia. Therefore, the objective of this article was to assess the current status of the quality assurance of pharmacy services in hospitals.
Materials and methods
Study area and design
The study was performed in selected Amhara regional hospitals. The Amhara Region is located in the northwestern part of Ethiopia between 8°45′ and 13°45′ North latitude and 36°20′ and 40°20′ East longitude. 19 The region has a total of 15 zones, including the city administration. Additionally, the region has a total of 87 hospitals, 876 health centers, and 16,000 health posts. 20 There are eight referral hospitals in the Amhara regional state. Among them, five were located in the northwestern part of the region. 21 The study was conducted on five selected hospital pharmacy services. Of those, two were university teaching hospitals, and three were general hospitals. Three hospitals from the general hospital were selected by lottery. However, two university teaching hospitals were selected purposefully. We included all hospital pharmacy heads (directors) as the study population. Pharmacy professionals other than pharmacy heads were excluded from this study. A cross-sectional study was conducted between March and May 2023.
Data collection tools and procedures
A structured English version of the self-administered questionnaire was adapted from different studies 4 with some modifications. The questionnaire was designed to assess the organizational structure, size, service, equipment, safety, facility, and regulations of the hospital pharmacy services. The questionnaire was customized to fit the context and objectives of the study and was developed using the Kobo tool. Then, the questionnaire was programmed into Kobo Toolbox software. The participants were asked for consent for their willingness to participate in the study. The tool was clearly elucidated and shared with hospital pharmacy heads via Telegram. After that, the questionnaire was completed by participants (using a self-administered method on the Kobo tool link). We addressed potential sampling biases and developed the questionnaire to be clear, relevant, and easy to understand. Furthermore, to ensure the validity of the survey, a questionnaire was pretested before actual data collection with six pharmacy professionals. An ethical clearance letter was obtained from the Ethical Review Committee of the School of Pharmacy on February 21, 2023.
Data processing and analysis
The data were collected from hospital pharmacy heads using the Kobo Collect mobile application. Before conducting the analysis, all questionnaires were checked for completeness, cleaned manually, coded, entered into Excel 2007, and then exported to the Statistical Package for Social Science (SPSS) version 25 for analysis. In addition to one expert in pharmaceutical analysis and quality assurance, a second expert in pharmacoepidemiology and social pharmacy was involved in the research supervision process. The questionnaire was captured in a two-point response option of yes or no. Correct answers were given a score of 1; any wrong answers were given a score of 0. Descriptive statistics for categorical variables are presented as percentages and frequencies.
Results
As shown in Table 1, 25 questions related to the distribution frequency of organizational structure were included. Of those, seven questions were not implemented (said “no”) by all hospital pharmacies. The results showed that hospital pharmacies fulfilled less than half (42.3%) of the distribution frequency of organizational structure quality assurance indicators. Most of the studied hospital pharmacies had round-the-clock services, and the pharmacists were working there. All of the studied hospital pharmacies conducted research on patient satisfaction with pharmaceutical services but did not publish it in a reputable journal. In all the studies, hospital pharmacies assessed the quality of drugs using visual inspection but did not have a visual inspection checklist or a responsible body delegated for quality evaluation. Moreover, none of the studied hospital pharmacies used barcodes for quality assurance. Overall, only 40% of hospital pharmacies had a functional ADR committee, and only 60% of DTCs frequently met. All of the studied hospital pharmacies had a functional drug formulary committee, but only 40% of them established the committee regularly.
Distribution frequency of indicators of organizational structure quality assurance standards in hospital pharmacies.
As described in Table 2, 16 questions were included under the distribution frequency of size, equipment, and safety facility quality assurance standard indicators in hospital pharmacies. Of those, half (50%) of the questions were implemented (said “yes”) by all hospital pharmacies. However, five questions were not implemented (said “no”) by all hospital pharmacies. The results revealed that hospital pharmacies fulfilled half (50%) of the distribution frequency of equipment, facilities, and drug safety quality assurance indicators. Only 40% of the hospital pharmacies had appropriate physical and constructional conditions. However, 60% of the studied hospital pharmacies had sufficient cabinets for the storage of drugs. All hospital pharmacies were not inspected by legal authorities periodically. The pharmacy directors were not provided training for staff to store toxic, narcotic, or flammable drugs. Even though all hospital pharmacies had their disposal facilities, expired and unfit medications were not disposed of regularly.
Distribution frequency of equipment, facility, and drug safety quality assurance standard indicators in hospital pharmacies.
As mentioned in Table 3, 32 questions were included under the distribution frequency of drug requirements. Of those, 12 of the questions were implemented (said “yes”) by all hospital pharmacies. However, six questions were not implemented (said “no”) by all hospital pharmacies. The results revealed that hospital pharmacies fulfilled one-third (33.3%) of the distribution frequency of drug requirement quality assurance indicators. Most of the necessary and emergency drugs for inpatients were dispensed in a timely manner, and medical equipment for inpatients and operating rooms was provided in a timely manner. Even though drugs were delivered according to the written orders of prescribers, the initials or full names of the dispensers were not written on the prescription when the drug was delivered to the patient. None of the studied hospital pharmacies had pharmacopeia.
Distribution frequency of drug requirement quality assurance standard indicators in hospital pharmacies.
As shown in Figure 1, the results revealed that Mekane Selam General Hospital, Quality Assurance had the best quality assurance effect on the organizational structure of the hospital pharmacy. However, the Tibebe Ghion Specialized Hospital had the best quality assurance performance on the distribution frequency of drug requirements at the hospital pharmacy. In general, the results showed that there was no significant difference between specialized (university teaching) and general (nonuniversity teaching) hospitals in terms of hospital pharmacy services. However, pharmacy services in teaching hospitals seemed to be more advanced and involved cooperation with affiliated medical schools. Furthermore, teaching hospitals were more likely to have pharmacists provide information about the safety of the medications used.
The overall performance of hospital pharmacy quality assurance.
Discussion
This study provides an overview of the quality assurance of hospital pharmacy services in Ethiopia. All of the studied hospital pharmacies had a qualified pharmacy director who worked in the pharmacy full-time. A similar study performed in Ethiopia revealed that almost all (93.3%) hospital pharmacies had a qualified pharmacy directorate. 10 The pharmacy directors were responsible for overseeing all aspects of medication management and ensuring compliance with regulatory standards. They play a crucial role in promoting safe and effective medication use within the hospital setting. 22 Ethiopia’s guidelines state that hospital pharmacies should have at least one of the following: a pharmacy services director, a pharmacy unit coordinator, and a pharmacist. 10 More than half (80%) of the studied hospital pharmacies provided around-the-clock services. However, only 60% of the pharmacists in the studied hospital pharmacies provided adequate care. The minimum frequency of this service in our study area may be due to different reasons, such as a shortage of clinical pharmacists, an increased burden of disease, and inefficient health systems. Moreover, the reduction in motivation may cause clinical pharmacists to neglect round-the-clock services. Hospital pharmacies must address this issue promptly to ensure the safety and well-being of patients. An organizational chart was presented for all of the studied hospital pharmacies, which is comparable to the results of a study performed in Iran. 4 All of the hospital pharmacists in charge had formal communication with the hospital administrators. The results of this study are consistent with those of previous studies on hospital pharmacy quality assurance systems. 4
Even if all hospital pharmacies detected the quality of drugs using visual inspection, there was no visual inspection checklist and no responsible body delegated for quality evaluation. The absence of this checklist could lead to inconsistencies in drug quality assessments across hospital pharmacies. Therefore, implementing a visual inspection checklist and assigning a specific department or individual to take responsibility for quality evaluation could help to ensure uniformity and accuracy in assessing drug quality. Moreover, hospital pharmacies did not use barcodes for a quality assurance program. This could be due to a lack of staff training about how to apply and use barcodes. A similar study revealed that hospital pharmacy services did not use barcode technology. 4 Barcode systems have automated and on-site testing functions in health care delivery services. In addition to verifying product identity, the system checks the manufacturer’s expiration date to reduce the risk of dispensing near-expired or expired medications to the patient. 23 A study conducted to evaluate the feasibility of barcodes for quality assurance programs revealed that barcode systems indicated that the correct medication had been dispensed. Hence, this basic automated system is suggested for dispensing to ensure hospital pharmacy programs. 24 It can also reduce hospital pharmacy dispensing errors.4,25 Furthermore, according to a study performed from 2001 to 2006, the use of barcodes reduced 517 adverse medication events annually due to incorrect dispensing. As a result, $2.20 million is saved annually. 25 In general, incorporating barcodes into hospital pharmacy services can enhance the efficiency and accuracy of medication tracking for quality assurance purposes.
Fewer than half (40%) of the hospital pharmacies had a functional ADR committee for monitoring and evaluating ADRs. This limiting number revealed the underreporting of ADRs, potentially putting patients at risk. Hence, strengthening this committee in all hospital pharmacies is beneficial for ensuring patient safety and improving overall healthcare quality. 10 Our study showed that all hospital pharmacies had a functional DTC. However, only 60% of the hospital pharmacies’ DTCs were reported to have regular meetings. A study on the quality of pharmacy services in government hospitals in Addis Ababa, Ethiopia, revealed that all but one of the hospital pharmacies had DTC, but only 40.0% of them were reported to have regular meetings. 26
Based on our study, all hospital pharmacies had separate stores for drugs and equipment but were not inspected periodically by legal authorities to observe clean, well-lit, and well-ventilated areas. All of them had a refrigerator where special medications, such as temperature-sensitive drugs, were stored appropriately. This finding is comparable to that of a study performed in a hospital pharmacy quality assurance system. 4 Furthermore, all pharmacies did not have proper equipment for nonsterile medications. However, a similar study performed in Iran showed that 30% of hospital pharmacies had proper equipment for nonsterile medications. 4 The limitation of proper equipment could lead to contamination and compromise patient safety. As a result, hospital pharmacies should invest in the necessary equipment and provide training to professionals to ensure the proper preparation of nonsterile medications. This study revealed that the pharmacies did not have standard pill counters. Another similar study showed that 42.1% of the pharmacies did not have tablet-counting trays. 26 Moreover, all of the studied hospital pharmacies had their own disposal facilities but did not regularly dispose of expired and unfit medications. This indicates that the disposal facilities were not used efficiently. This may be due to the reduction in professionals’ interest in taking responsibility and the absence of a functional DTC who will dispose on time. Building a regular and efficient disposal system is a milestone for patient safety and prevents environmental harm.
In all studied pharmacies, drugs are delivered according to the written orders of prescribers, but dispensers did not write their initials or full names on the prescription when the drug was delivered to the patient. In a similar study, in 80% of the pharmacies, dispensers did not write their name on the prescription when the drug was delivered to the patient. 4 The dispensers should write their names on prescriptions to ensure accountability and proper communication with patients. Our results revealed that pharmacies had a line where nearly exclusive drugs were delivered to other health facilities. This connection can reduce medication waste and enhance stock control. It also encourages cooperation across various healthcare organizations to efficiently control their stock. In this study, only one pharmacy director informed patients about the appropriate use of drugs through brochures or posters, but none of them had pharmacopeia. Purchasing the updated pharmacopoeia at the Ethiopian hospital level is not accessible, affordable, or common. However, pharmacists need to have access to pharmacopeia to ensure accurate medication dispensing and patient safety.
The results revealed that the overall quality of both the specialized and general hospital pharmacies was poor. This could also be the spread of COVID-19 and the war between the federal government of Ethiopia and the Tigray People’s Liberation Front. Moreover, the study revealed that health facilities obtained very few pharmaceutical products from the Ethiopian Pharmaceuticals Supply Agency (EPSA). According to one study on the inventory management practices of the EPSA, only 16 (14.81%) of the orders exceeded 80% of the total orders placed by branch hubs. Therefore, the possibility of stockouts and supply interruptions was greater in the agency. 24 Additionally, according to one qualitative study, the respondent said that “EPSA did not provide the medicines we requested in type and quantity.” 25 These issues were bottlenecks for ensuring the quality of hospital pharmacies. In general, this study revealed that the pharmacy services in all of the studied hospitals faced multiple structural deficiencies. This is demonstrated by the fact that the quality parameters given by pharmacies were not adequate because the average means of each hospital service were nearly half. Therefore, hospital pharmacy services should be strengthened to enhance patient satisfaction.
Limitations of the study
Some limitations were identified in this study. This study may not be comprehensive enough to capture all aspects of the quality assurance system in hospital pharmacies. The findings may not be representative of all hospitals in the region or of other regions in Ethiopia. Additionally, since the data were collected from five hospital pharmacy heads, the sample size could not be calculated.
Conclusion
The study assessed selected hospital pharmacy services in Ethiopia, focusing on their organizational structure, facility, safety, and drug requirements. All hospital pharmacies had a qualified pharmacy director who worked in the pharmacy full-time. All the studied hospital pharmacies conducted research on patient satisfaction. However, they did not publish in reputable journals. All studied hospital pharmacies assessed the quality of drugs using visual inspection but did not have a visual inspection checklist or a responsible body delegated for quality evaluation or barcodes for quality assurance programs. The pharmacies had a functional refrigerator for the storage of special medications, but they did not have appropriate equipment for nonsterile medications. However, most necessary and emergency drugs are dispensed in a timely manner in the inpatient ward. The findings of this study clearly show that quality assurance services in hospital pharmacies are compromised. This investigation provides valuable insights into the quality assurance system of hospital pharmacy services in the Amhara Regional State, Ethiopia. The findings can be used to identify areas of improvement and develop strategies to enhance the quality of hospital pharmacy services. Additionally, this study may help improve the overall quality of healthcare delivery in the region.
Supplemental Material
sj-docx-1-smo-10.1177_20503121241272738 – Supplemental material for Assessment of the hospital pharmacy quality assurance system in selected hospitals in the Amhara Regional State, Ethiopia
Supplemental material, sj-docx-1-smo-10.1177_20503121241272738 for Assessment of the hospital pharmacy quality assurance system in selected hospitals in the Amhara Regional State, Ethiopia by Yeniewa Kerie Anagaw, Melaku Getahun Feleke, Endalew Temesgen Mekuriaw, Melese Legesse Mitku, Liknew Workie Limenh, Zemenu Wube Bayleyegn, Minichil Chanie Worku, Tewodros Denekew, Derso Teju Geremew and Wondm Ayenew in SAGE Open Medicine
Footnotes
Acknowledgements
We would like to extend our gratitude to the hospitals included in this study for allowing us to conduct this study. Additionally, we would like to extend our special thanks to the study participants.
Author contributions
All authors made a significant contribution to the work reported, whether in the conception, study design, execution, acquisition of data, analysis, and interpretation, or all these areas; took part in drafting, revising, or critically reviewing the article; agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.
Data availability statement
All relevant data are included in the paper.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Ethics approval and consent to participate
An ethical approval letter was obtained from the Ethical Review Committee of the School of Pharmacy, College of Medicine and Health Sciences, University of Gondar (ERB/SOP/52/21/2023). Then, the letter was submitted to each hospital directorate. To enhance cooperation, the hospital pharmacy directors were informed about the study objectives through a letter written by the Ethical Review Committee. Privacy and confidentiality were strictly maintained throughout the entire process.
Informed consent
Written informed consent was obtained from each hospital pharmacy head, and written permission was obtained from the hospitals to conduct this study.
Trial registration
None.
Supplemental material
Supplemental material for this article is available online.
References
Supplementary Material
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