Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals

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Despite their clinical significance, data on the operational standards and prescription patterns of such products in some Iraqi hospitals are still limited. Comprehending these elements is important to ensure safe and efficient compounding and to improve pharmacy services. Objective To evaluate the nature and extent of extemporaneous compounding preparations and explore the challenges of pharmacists’ ability to practice compounding services. Methods An observational, cross-sectional, multicenter study encompassing 25 hospital pharmacies and 70 pharmacists was conducted. A five-section checklist was used (pharmacist characteristics, nature and extent of extemporaneous compounding, requirements for extemporaneous compounding, challenges against compounding practice, and pharmacists’ opinions). Results Pediatricians requested orders was (45.76%), sterile preparations (69.56%) for compound dosage forms. The primary service was the reconstitution or processing of readymade commercial formulations (71.43%). Most of compounded preparations were labeled (92%). The compounding protocols depended on physician’s order (82.5%). Only (48%) of hospitals possess laminar airflow hoods for aseptic operations, whereas (72%) were equipped with personal protective equipment. The primary challenge against pharmacists was the lack of specific equipment or supplies (91.43%), their self-confidence in preparing products was (40.0%), and professional satisfaction was (34.29%). Conclusions The findings of this study indicate that most hospital pharmacies lack standardized extemporaneous preparation services and that pharmacists’ professional judgments and perceptions are influenced by their personal and workplace facilities. 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F1000Research 2025, 14 :1115 ( https://doi.org/10.12688/f1000research.168935.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Research Article Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] Rawasy Fadhil Abed https://orcid.org/0009-0005-3721-7080 1 , Manal Khalid Abdulridha 1 Rawasy Fadhil Abed https://orcid.org/0009-0005-3721-7080 1 , Manal Khalid Abdulridha 1 PUBLISHED 14 Oct 2025 Author details Author details 1 Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq Rawasy Fadhil Abed Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Manal Khalid Abdulridha Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Software, Supervision, Validation, Visualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS This article is included in the Health Services gateway. Abstract Background Extemporaneous compounding preparations are a critical component of pharmacy practice inside and outside hospitals, as they customize therapy to meet each patient’s unique needs. Despite their clinical significance, data on the operational standards and prescription patterns of such products in some Iraqi hospitals are still limited. Comprehending these elements is important to ensure safe and efficient compounding and to improve pharmacy services. Objective To evaluate the nature and extent of extemporaneous compounding preparations and explore the challenges of pharmacists’ ability to practice compounding services. Methods An observational, cross-sectional, multicenter study encompassing 25 hospital pharmacies and 70 pharmacists was conducted. A five-section checklist was used (pharmacist characteristics, nature and extent of extemporaneous compounding, requirements for extemporaneous compounding, challenges against compounding practice, and pharmacists’ opinions). Results Pediatricians requested orders was (45.76%), sterile preparations (69.56%) for compound dosage forms. The primary service was the reconstitution or processing of readymade commercial formulations (71.43%). Most of compounded preparations were labeled (92%). The compounding protocols depended on physician’s order (82.5%). Only (48%) of hospitals possess laminar airflow hoods for aseptic operations, whereas (72%) were equipped with personal protective equipment. The primary challenge against pharmacists was the lack of specific equipment or supplies (91.43%), their self-confidence in preparing products was (40.0%), and professional satisfaction was (34.29%). Conclusions The findings of this study indicate that most hospital pharmacies lack standardized extemporaneous preparation services and that pharmacists’ professional judgments and perceptions are influenced by their personal and workplace facilities. READ ALL READ LESS Keywords Extemporaneous compounding preparations, Pharmacy Practice, Pharmacists' Perspectives and Challenges Corresponding Author(s) Rawasy Fadhil Abed ( [email protected] ) Close Corresponding author: Rawasy Fadhil Abed Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2025 Fadhil Abed R and Abdulridha MK. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Fadhil Abed R and Abdulridha MK. Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.12688/f1000research.168935.1 ) First published: 14 Oct 2025, 14 :1115 ( https://doi.org/10.12688/f1000research.168935.1 ) Latest published: 14 Oct 2025, 14 :1115 ( https://doi.org/10.12688/f1000research.168935.1 ) Introduction Extemporaneous Compounding refers to the practice whereby a licensed pharmacist, licensed physician, or individual under the supervision of a licensed pharmacist combines, mixes, or modifies drug ingredients to formulate a medication customized for the specific needs of an individual patient. 1 Despite the widespread availability of commercial drugs, formulation of extemporaneous medications tailored to individual patient needs remains significant. 2 The increasing demand for compounded medications can be attributed to several factors, such as limited dosage forms, restricted dosages and strengths, lack of orphan drugs, need for specific combinations of active pharmaceutical ingredients (APIs), and shortages or discontinuation of commercial medications. 3 Compounding is an essential therapeutic option in various medical disciplines, particularly in pediatric patients, which is frequently overlooked by the pharmaceutical industry. 4 Extemporaneous products lack Food and Drug Administration (FDA) approval and do not receive premarket evaluations for safety, efficacy, or manufacturing quality. Substandard compounded medications may lead to considerable injuries. 2 , 5 Therefore, Compounding must occur in suitable facilities and environments using high-quality materials and appropriate equipment to reduce risks. 6 National organizations such as the United States Pharmacopeia Convention (USP), have sought to establish standards for the regulation of compounding. 7 A recent study (2023) found that insufficient equipment and facilities are the most prevalent challenges. In addition, inadequate space was identified as an obstacle. 8 A number of studies have evaluated extemporaneous preparations in different countries (but none are available in Iraq to the best of our knowledge) to evaluate the nature and extent of extemporaneous compounding preparations, and to explore the challenges against pharmacists’ ability to practice compounding services. Methods Study design This was an observational, cross-sectional, multicenter study conducted from February 2024 to June 2024. Study population The study population was a convenience sample of 70 pharmacists engaged in the preparation of extemporaneous formulations across 25 hospital pharmacies within six Iraqi hospitals. Participants selection criteria The study participants comprised employed pharmacists in a public hospital who were assigned exclusively to extemporaneous compounding preparation services for more than one year and were willing to participate in the study. Any employed pharmacist was assigned to another service in the hospital wards and hospitals in which extemporaneous preparations were not applicable or ordered on a daily basis were excluded. Data collection Data were acquired through in-person interviews with study participants, following their consent. A data collection sheet was used to gather the necessary information for the investigation. This included a five-section checklist (pharmacist characteristics, nature and extent of extemporaneous compounding, requirements for extemporaneous compounding, challenges against compounding practices, and pharmacists’ opinions). Data on the nature and extent of extemporaneous compounding were collected during researcher visits to the compounding pharmacies, and the survey questionnaire concerning characteristics, reasons for preparations, requirements, challenges, and pharmacists’ opinions was collected using self-reported validated questionnaires during the visits. The checklists were constructed after an intensive review of the previous studies. 7 , 9 – 11 The reliability of the questionnaire was determined through the calculation of Cronbach’s alpha value, which was found to be (0.797) for the challenges survey and (0.799) for the opinions survey, indicating good internal consistency. In addition, three expert academic pharmacists with Ph.D. degrees in pharmaceutical sciences assessed the internal validity of the checklists in a pilot study. . Statistical analysis Data were submitted to Microsoft Excel (2016) and analyzed using IBM SPSS Statistics version 26 (IBM Corp., Armonk, NY, USA). Descriptive statistics, including frequencies and percentages, were used to examine categorical variables. Opinions were classified as positive, negative, or neutral. Result Characteristics of participated pharmacist The characteristics of the 70 pharmacists enrolled in the study are presented in Table 1 . Table 1. Characteristics of participated pharmacist. Demographic characteristics N % Age 25-29 years 50 71.4 30-34 years 12 17.1 ≥35 years 8 11.4 Sex Male 20 28.6 Female 50 71.4 Experience Levels 1-3 years 55 78.6 4-6 years 8 11.4 ≥7 years 7 10.0 Compounding trained pharmacist Yes 59 84.29 No 11 15.71 Educational qualification Bachelor’s 47 67.1 Clinical Pharmacy Program 11 15.7 Diploma 2 2.9 Master 6 8.6 Ph.D. 4 5.7 The hospital Oncology Teaching Hospital 3 4.3 Children’s Central Teaching Hospital 25 35.7 Al-Yarmouk Teaching Hospital 8 11.4 Baghdad Teaching Hospital 8 11.4 Welfare Teaching Hospital of pediatrics 14 20.0 AL- Emamain Al-kadhimain Hospital 12 17.1 The ward Oncology 32 45.7 Pediatric 38 54.3 Assessment of nature and extent of extemporaneous compounding During the research period, 5546 prescriptions were collected and recorded. The prevalence of compounding practice was (8.71%). The compounded prescriptions were issued primarily by pediatricians (45.76%), followed by oncologists (36.65%). The findings also indicated that physicians’ orders constituted the primary source of compounding protocol used (82.5%) of the total requested orders. Most of the compounding dosage forms were sterile injection preparations (55.07%), whereas (22.15%) were oral liquids. Simultaneously, Sterile total parenteral nutrition (TPN) constituted (14.49%), while mouthwash accounted for (8.28%), Table 2 . Table 2. Characteristics of the prescriptions. No Statements Categories N % 1 Extemporaneous Compounding prescriptions Number of prescriptions available and verified 483 100 2 The number of prescriptions Total number of prescriptions 5546 100 Non-compounding prescriptions 5063 91.29 Compounding prescriptions 483 8.71 Pediatrics prescriptions 253 52.38 Oncology prescriptions 230 47.6 3 Prescriber specialty frequently requested compounding products Specialty Oncologist 177 36.65 Gastroenterologist 28 5.79 Paediatrician 221 45.76 Orthopedist 4 0.83 Hematologist 53 10.97 4 The common source of compounding protocol Source Physicians 66 82.5 USP 3 3.75 BP 4 5 Other 7 8.75 5 Type of pharmaceutical compounding dosage forms Sterile preparations Injection 266 55.07 TPN 70 14.49 Total 336 69.56 Non-sterile preparations Oral liquid 107 22.15 Mouth wash 40 8.28 Total 147 30.43 The current results revealed that the reasons for providing compounding, mainly “reconstitution or processing of ready-made commercial preparations that require the addition of an ingredient or ingredients” (71.43%). Also, that “ to prepare pediatric strength, which is commercially unavailable”, as (65.71%). Besides, “the unavailability of commercial dosage forms” represented (25.71%), as in Table 3 . Table 3. Reasons for extemporaneous compounding. No Statements Response N % 1 Medication is not commercially available. Yes 5 7.14 No 65 92.86 2 Medication that is currently in shortage or discontinued. Yes 8 11.43 No 62 88.57 3 The dosage form not commercially available. Yes 18 25.71 No 52 74.29 4 To prepare pediatric strength which is commercially unavailable. Yes 46 65.71 No 24 34.29 5 To prepare for geriatric strength, which is commercially unavailable. Yes 14 20.0 No 56 80.0 6 Reconstitution or processing of ready-made commercial preparations that require the addition of an ingredient or ingredients. Yes 50 71.43 No 20 28.57 7 Hypersensitivity to commercial products (Allergy to the excipients). Yes 0 0.00 No 70 100 8 Patient with orphan or rare diseases. Yes 4 5.71 No 66 94.29 9 Improve adherence to medications. Yes 14 20.0 No 56 80.0 Requirements for extemporaneous compounding Among the general requirements; “providing labels for final preparations” was a major requirement available represented (92%). Regarding the availability of “dedicated pharmacists responsible for extemporaneous preparation,” this was noted in (80%) of pharmacies. The availability of “designated areas specific for preparing extemporaneous medications” in each pharmacy was reported to (72%). Meanwhile, in (72%) of pharmacies, “all waste was disposed of in a correct and hygienic manner in accordance with ministerial guidelines”. Moreover, in (60%) “the area classified as a clean room (a sterile compounding environment)” was not available. Additionally, (100%) of the examined pharmacies had no standard compounding records Table 4 . Table 4. Statements of general requirements. No Statements Answer N % 1 Does the pharmacy have a dedicated pharmacist responsible for extemporaneous preparation? Yes 20 80 No 5 20 Not Applicable 0 0.0 2 Does the pharmacy have a designated area for preparing extemporaneous medication? Yes 18 72 No 7 28 Not Applicable 0 0.0 3 Is the area classified as a clean room (a sterile compounding environment)? Yes 0 0.0 No 15 60 Not Applicable 10 40 4 Is all waste disposed of in a correct and hygienic manner, in accordance with ministerial guidelines? Yes 18 72 No 7 28 Not Applicable 0 0.0 5 Does the compounding area have suitable lighting? Yes 19 76 No 6 24 Not Applicable 0 0.0 6 Do you store hazardous chemicals in a separate place? Yes 7 28 No 0 0.0 Not Applicable 18 72 7 Does the pharmacy labeling of final preparations. Yes 23 92 No 2 8 Not applicable 0 0.0 8 Does the pharmacy have compounding records? Yes 0 0.0 No 25 100 Not applicable 0 0.0 After assessment of laboratory requirements, the results indicated that (48%) of pharmacies possess a laminar airflow hood, while personal protective equipment is accessible in (72%) of pharmacies. There was an absence of particular equipment or supplies, with most pharmacies lacking Millipore filters, capsule-filling apparatus, and pH paper Table 5 . Table 5. Laboratory tools and equipment for compounding. No Statements N % General equipment and tools for sterile and non-sterile preparations 1 Purified water or sterile water 25 100 2 A refrigerator for cold storage 17 68 3 A sink for hand wash 16 64 4 Personal protective equipment PPE (sterile gowns, gloves, masks, goggles) 18 72 Equipment and tools for sterile preparations 5 A laminar airflow hood for aseptic manipulations 12 48 6 Millipore filter for aseptic preparations 0 0.0 Equipment and tools for non-sterile preparations 7 Balance 5 20 8 Measuring cylinders 4 16 9 Beakers (different sizes) 6 24 10 Stirring aid (glass, plastic, stainless) 2 8 11 Spatula (stainless steel or silicon) 5 20 12 Mortar and pestle (porcelain, glass, stainless) 6 24 13 Mixer or hand blender 4 16 14 Capsule filling equipment 0 0.0 15 Filter paper 4 16 16 pH paper 0 0.0 17 Hotplate Heater 3 12 18 Water bath 6 24 Challenges in extemporaneous preparation practice The results revealed “lack of specific equipment or supplies” in (91.43%) of responses, “lack of necessary ingredients (raw material)” and “compounding staff lack of skills/training” in (70.00%) of responses, also “limitations in continuing education programs or training opportunities” among (67.58%) of responses as major challenges facing the pharmacist. Besides, “unclear dosage calculations” (64.29%) were reported as additional challenge Table 6 . Table 6. Pharmacist’s response to the challenges questions. No Statements Answer N % Average score (SD) 1 Lack of specific equipment or supplies. Yes 64 91.43 1.1 (0.35) No 5 7.14 Do not know 1 1.43 2 Lack of necessary ingredients (raw material). Yes 49 70.00 1.37 (0.62) No 16 22.86 Do not know 5 7.14 3 Difficulty sourcing confident ingredients (raw material). Yes 33 47.14 1.6 (0.75) No 15 21.43 Do not know 22 31.43 4 Time constraints and workload pressure. Yes 26 37.14 1.71 (0.62) No 38 54.29 Do not know 6 8.57 5 Unclear dosage calculation. Yes 45 64.29 1.37 (0.52) No 24 34.29 Do not know 1 1.43 6 Lack of trust in the quality or safety of compounded formulation Yes 40 57.14 1.56 (0.71) No 21 30.00 Do not know 9 12.86 7 Limited Continuing education programs or training opportunities Yes 48 68.57 1.31 (0.47) No 18 25.71 Do not know 4 5.71 8 Compounding staff lack skills/training Yes 49 70.00 1.31 (0.5) No 20 28.57 Do not know 1 1.43 9 Insufficient budget allocation for some equipment Yes 38 54.29 1.59 (0.71) No 23 32.86 Do not know 9 12.86 10 Limited availability of trained personnel at all times Yes 17 24.29 1.94 (0.63) No 44 62.86 Do not know 9 12.86 11 Inadequate maintenance and repair services Yes 21 30.00 1.96 (0.75) No 31 44.29 Do not know 18 25.71 Pharmacists’ opinions about extemporaneous compounding Following assessment of the pharmacists’ opinions about extemporaneous compounding, most of the answers were positive. For example, (44.29%) of pharmacists strongly agreed that “extemporaneous preparation is important and useful to provide patient care”. The responses of (47.14%) were moderate agreed that there is “a need for periodic assessment of all pharmacists in the skill of extemporaneous compounding”. Moreover,” the development of compounding skills after graduation” was reported by (42.86%) of responses. Meanwhile, (51.43%) of respondents agreed that “a refreshing compounding course would be beneficial”. A “pharmacist’s self-confidence in preparing products” was revealed by (40.00%). while the agreement towards “professional satisfaction in preparing extemporaneous product” was reported by (34.92%). The “decrease in the cost for the patient” and “the compounding should be carried out by pharmacists only” were responses of (50.00%) pharmacists. Most (45.71%) agreed that “using extemporaneous preparations has no disadvantages”, Table 7 . Table 7. Pharmacist’s response to opinion statements. Strongly agree Agree Moderate agree Disagree Strongly disagree Total Average score (SD) 1. Extemporaneous preparation is important and useful for patient care N 31 22 15 1 1 70 4.13 (0.95) % 44.29 31.43 21.43 1.43 1.43 2. The pharmacy is adequately supplied with the necessary equipment N 2 10 25 17 16 70 2.5 (1.09) % 2.86 14.29 35.71 24.29 22.86 3. There is a need for periodical assessment of all pharmacists in the skill of extemporaneous compounding N 14 33 20 3 0 70 3.82 (0.79) % 20.00 47.14 28.57 4.29 0.00 4. High confidence in the quality of ingredients use in compounding N 4 23 28 7 8 70 3.11 (1.06) % 5.71 32.86 40.00 10.00 11.43 5. The skill in compounding has develop since graduation N 18 30 16 6 0 70 3.86 (0.91) % 25.71 42.86 22.86 8.57 0.00 6. A refreshing course of compounding would be beneficial N 19 36 11 3 1 70 3.99 (0.86) % 27.14 51.43 15.71 4.29 1.43 7. The space of compounding is adequate N 1 21 10 16 22 70 2.47 (1.26) % 1.43 30.00 14.29 22.86 31.43 8. High self-confidence in the ability to prepare extemporaneous product N 15 28 21 4 2 70 3.71 (0.97) % 21.43 40.00 30.00 5.71 2.86 9. High level of professional satisfaction in preparing extemporaneous product N 10 24 24 7 5 70 3.39 (1.08) % 14.29 34.29 34.29 10.00 7.14 10. Compounding can decrease the cost for the patient N 5 35 19 11 0 70 3.48 (0.84) % 7.14 50.00 27.14 15.71 0.00 11. The compounding should be carried out by pharmacists only N 15 35 12 8 0 70 3.81 (0.91) % 21.43 50.00 17.14 11.43 0.00 12. There are no disadvantages to using extemporaneous preparations N 4 32 28 6 0 70 3.49 (0.74) % 5.71 45.71 40.00 8.57 0.00 Discussion The prevalence of compounded medication in developing nations must be investigated to determine the urgency of compounding practices, as well as the risks and challenges to be described, especially for pediatric patients. 12 In the current study, both sex hospital-employed pharmacists were affiliated with extemporaneous compounding services, most of whom held a bachelor’s degree and had (1-3) experience years of experience. Most pharmacists received appropriate training before enrolling in practice services in the wards. Similar characteristics of affiliated employed pharmacists have been mentioned previously. 11 , 13 Enrolling Bachelor’s degree pharmacists may be attributed to the growing number of pharmacy graduates in recent years; comparable results have been reported previously. 10 , 13 Nature and extent of extemporaneous compounding Throughout the study period, a total of (5546) prescriptions were collected in the hospital wards, with only (8.71%) requesting compounding preparations, mostly issued by pediatricians; meanwhile, oncologists and hematologists were next in order. In consistent with the current findings, extemporaneous compounding accounted for (10.05%) percent of the total prescriptions in the Indonesian study. 14 The higher request for compounding services in oncology and pediatrics wards relative to other wards is likely attributable to the significant demand for treatment protocols; hence, the findings differ from those reported in previous studies regarding the level of requested compounding preparations. 13 , 14 The current finding indicates a deficiency in standardized procedures and protocols for compounding, as the majority of physician orders served as the primary source of preparation protocols. This result aligns with previous findings (94.2%) of Al-Khatib et al. 10 The four primary types of extemporaneous products available in national hospitals were injections, total parenteral nutrition (TPN), oral preparations, and mouthwash. More than half of the extemporaneous products reported in the current study were sterile injectable extemporaneous preparations. This percentage exceeds that previously reported worldwide. 10 , 15 Globally, injectable drugs are the most commonly administered pharmaceutical preparations for hospitalized patients. 16 Therefore, the involvement of hospital pharmacies in aseptic preparation is essential. 17 Inpatient care relies on hospital pharmacy staff to compound a diverse range of sterile preparations, such as antimicrobials, hydration fluids, parenteral nutrition, and antineoplastic agents. 18 Among the non-sterile compound preparations, oral liquids were the second most frequent compounded dosage formulations in the current study, and mouth washes were the least frequent. Previous studies have reported the preparation of liquid dosage forms inside hospital pharmacies. 14 , 15 Oral preparations consisted (28.7%) of compounded dosage forms in Jordanian compounding pharmacies. 10 This percentage is consistent with current status. Another current finding was the preparation of a magic mouthwash, which is commonly prescribed as a compounded medication in oncology wards. 19 The specific formulation of “magic mouthwash” typically necessitates a prescription and is customized to meet individual patient requirements, 20 highlighting the disparity between general accessibility and the specialized formulations needed for patients. Although the current study did not report solid dosage forms, the current results are in agreement with previously reported data. 10 Studies indicated that pharmacy compounding primarily involves dermatological products, mostly for outpatient needs. 21 , 22 This is probably due to the absence of requests for these products in hospital pharmacies. The present study identified numerous reasons for providing extemporaneous compounding in health institutions, highlighting the critical gaps in medication availability for patients and the importance of compounding in filling such gaps. The current findings revealed that the pharmacist’s responses regarding the unavailability of medications commercially were lower than the findings from previous studies, such as one study done by AlKhatib et al. reported the unavailability of medications commercially necessary for (87.9%) of the cases. 10 Also, in another study, (53%) of respondents engaged in practice because medications were unavailable commercially. 11 It was noticed that the availability of suitable alternatives within local community pharmacies may encourage physicians to prescribe alternative medications, rather than requesting compounded medications inside hospitals. Some national hospitals procure these missing medical items directly from the private sector’s pharmaceutical scientific bureau, 23 which may reduce the need for inpatient extemporaneous preparations. The unavailability of suitable dosage forms commercially in the current study, mainly liquid dosage forms, was reported by (25.71%), the finding was consistent with a previous study (22.9%). 10 A pan-European study included (34) countries by Vassal et al. (2021) indicated that around (27%) of oral anticancer drugs lack child-friendly formulations. 24 This finding was also observed in the current study, where compounding prescriptions were prepared mostly for pediatric strength compared to geriatric strength. The importance and necessity of compounding for pediatrics and geriatrics was mentioned in a previous study in Southwest Ethiopia, enrolling (104) pharmacists who prepared extemporaneous compounding, which was requested for preparing pediatrics (97.9%) and geriatrics (96.9%) dosage from. 25 Most FDA-approved dosage forms for adults are unsuitable for pediatric use; around (15%) to (80%) of all medications administered to hospitalized children are either unauthorized or utilized outside the parameters of their approved specifications (“off-license”). 26 The overall number of pediatric formulations constitutes a small fraction of the comprehensive therapeutic options necessary for effective pediatric treatment. Hence, the availability of high-quality medications, particularly tailored for children, continues to pose a significant barrier. 27 Generally, compounding preparations are not limited to certain age groups; newborns admitted to the neonatal care unit (NCU) also receive compound preparations. 28 The most common reason for providing compounding services reported in the current study was “reconstitution or processing of ready-made commercial preparations that require the addition of an ingredient or ingredients”, the agreement was up to (71.43%) of responses, which was higher than the previous study (42.7%). 29 The reason may be due to the fact that the predominant dosage forms prepared in hospital pharmacies were sterile preparations (e.g., TPN, chemotherapy). As mentioned earlier, inpatient care relies on a range of sterile products; vials were reconstituted with an appropriate liquid before administration as part of compounding preparations. 30 Finally, improving patient adherence to medications, including compounded preparations, is crucial for achieving the target therapeutic outcome, as noted in the current study. A similar percentage (22.7%) was stated previously as a reason for improving adherence in this study. 29 According to Khan et al. (2022), Milne and Bruss (2008) reported that over (90%) of pediatricians associated nonadherence of children to bitter and unpleasant medications. 27 Requirements for extemporaneous preparations A list of the general and specific requirements for practicing extemporaneous preparations is necessary for each hospital pharmacy. The 2012 epidemic associated with contaminated steroid injections from the New England Compounding Center (NECC) profoundly affected the development of standards and guidelines for compounding. This incident underscored the significant deficiencies in monitoring and safety, leading to legislative and regulatory modifications intended to avoid similar events in the future. 31 Therefore, the USP has instituted additional procedures and requirements for compounding non-sterile and sterile preparations to enhance compounding standards and mitigate the risk of patient harm. 32 Furthermore, specific precautions for healthcare personnel are essential in preparing hazardous drugs, as particles from highly toxic substances may be emitted into the environment. 33 Chemotherapy agents require dedicated facilities equipped with adequate ventilation, biosafety cabinet, and clean room (negative pressure). In addition, it requires highly trained personnel, robust documentation practices, well-defined procedures, and stringent quality control measures. 34 In developed countries, compounding pharmacies have access to such requirements. 6 However, access to these requirements was limited in the national hospital pharmacies, as many important elements of compounding sterile or non-sterile preparations at these hospitals did not comply with the global standards. In the current study, (80%) of the pharmacies had appointed pharmacists dedicated and responsible for preparing extemporaneous products. Generally, the risk in preparation tends to diminish when assigned pharmacists formulate liquid oral medications in compounding pharmacies. 35 A previous study found that the risk of contamination increased in extemporaneous products compounded by nurses or other medical staff compared to those prepared by pharmacists. 36 The current findings reveal that most examined pharmacies (72%) had designated areas for preparing extemporaneous products. However, none of the compounding areas could be classified as clean rooms (sterile environments). The contamination rates for the preparation of parenteral medication were found to be significantly higher in an uncontrolled environment than in a controlled environment. 36 In a recent observational study in 2025 stated that (95.5%) of sterile preparation errors were related to aseptic techniques, specifically lack of clean areas for preparation. 37 Another multinational cross-sectional survey encompassing 39 hospitals demonstrated that (77%) of these institutions complied with the USP clean room standards. 38 Implanting such standard requirements in Iraq may be difficult because insufficient finances are an ongoing problem. 39 Despite the aforementioned obstacles regarding the compounding areas, several other important requirements were handled properly by pharmacists in accordance with ministerial regulations. For example, most of the waste was disposed of correctly and hygienically, although some special waste containers or bins for chemotherapy or sharp waste were sometimes unavailable. Containment measures must be implemented to minimize the risk of occupational exposure among healthcare workers. 40 Additionally, the compounding area has a suitable lighting in the current finding, according to which the lighting fixtures must be positioned to ensure sufficient light for the compounding process and to enable verification at every compounding step. 41 In the current study, most pharmacies providing chemotherapy preparations stored the hazardous substances in a safe and separate place, and the practitioner pharmacies mainly assigned in oncology and pediatric wards received drugs on a daily basis by storing pharmacies in batches according to physicians’ orders. Additionally, all compounding products were dispensed directly to the patient, which may have limited contamination and unnecessary exposure. Another positive finding was that most hospital pharmacies appropriately labeled their products following ministerial guidelines. Khatib et al . stated that most pharmacies (97.3%) examined in their study were labeled the products, 10 similar percentage with the current study. Finally, among the multicenter pharmacies examined in the current study, there was a shortage in recording extemporaneous preparations, which is considered a critical requirement for documenting compounding preparations. This was also reported in Jorden study where (75.8%) of preparations were not recorded. 10 Pharmacies that provide compounding services should pay attention to the materials, equipment, and facilities used to produce a quality product. 6 As in the current study, the conventional tools used for compounding medicines were available in some pharmacies. However, the availability of tools and equipment varies from pharmacy to pharmacy and from hospital to hospital, and not all possess the necessary equipment for more complex compounding procedures. Sterility is essential in preparing pharmaceutical products, particularly those administered via injection or infusion, because contaminated products may result in significant infections. 42 The use of a laminar airflow hood and complete personal protective equipment (PPE), such as gloves, masks, and suits, are important factors in compounding practices to maintain the safety of patients and pharmacy staff. 43 Most of oncology wards and some pediatric wards in the current study were equipped with a laminar airflow hood (48%), a necessary laboratory requirement for aseptic manipulation. However, some pharmacies did not have a laminar airflow hood in some pediatric wards that prepared IV admixtures. Laminar airflow minimizes the risk of product failure caused by contamination and enhances employee safety. 44 Additionally, personal protective equipment (PPE) was available in most pharmacies; however, some oncology pharmacies did not use PPE when compounding drugs in the current study. These observations may indicate a higher risk of cross-contamination. The stability of pharmaceutical products is significantly influenced by temperature, which may result in their deterioration prior to expiration. Alanazi et al. in 2024 demonstrated that refrigeration provided enhanced stability for the majority of examined formulations. 45 Also, that the shelf life (t90%) of extemporaneously prepared methyl salicylate ointment was determined to be (131) days at room temperature (25°C ± 5°C) and (176) days when stored in a refrigerator (2°C–8°C). 46 The majority of pharmacies in the current study possessed refrigerators, although most compounded preparations were dispensed directly to the patients. Challenges in extemporaneous preparation practice and pharmacists’ opinions Despite previous studies related to other specific challenges encountered by pharmacists within different disciplines in Iraq, 47 , 48 the current study was unique in that it addressed the challenges that practicing pharmacists face in extemporaneous compounding. The most common challenge faced pharmacists in current responses was “lack of specific equipment or supplies”, which was also mentioned in the Ethiopian study in 2023, reporting (99%) response of 27 hospital pharmacists who agreed with such a shortage. 25 Additionally, the lack of some necessary raw ingredients to prepare extemporaneous preparations was confirmed as crucial challenge in current responses. A response in agreement with that of cross-sectional study using self-administered survey involving 203 pharmacists and pharmacy employees in Malatya/Turkey were (67.6%) of respondents declared a shortage of raw resources as a problem encountered in pharmacies. 21 Neutral responses in the current results were obtained for confident ingredient (raw material) sources. All raw ingredients utilized in extemporaneous formulations must possess a valid certificate of analysis from a reliable source or supplier prior to their usage in the compounding process. 49 The FDA alerts compounders against using glutathione-L-reduced powder supplied by Letco Medical, Decatur, Alabama to compound sterile injectable medications for patients due to recorded adverse effects. 50 Accordingly, it is necessary to obtain formulation ingredients from credible sources. In the current study, (64.29%) of pharmacists reported that the unclear dosage calculation was a challenge, as all prescriptions were handwritten, item (5). A similar issue was reported previously: incomplete or unreadable prescriptions from doctors were a problem for (67.8%) of participants. 21 Notably, such challenges can cause calculation errors, which pose the greatest risk of causing serious patient harm. 35 In Jordan, researchers demonstrated that two-thirds of the participants consistently communicated with physicians to verify the prescribed dosage. 51 Therefore, returning the prescription to the physician for revision or clarification of the prescription or utilization of electronic prescriptions might mitigate issues resulting from illegible handwriting. 52 The insufficient compounding skills or training due to limited continuing education programs and training opportunities, as well as limited availability of trained personnel at all times, particularly during night shifts, was another important challenge reported by pharmacists in the current study presented in items (7, 8, 10). Some pharmacists stated that hospitals perform only one training session before the compounding of chemotherapy. In addition, most of these training opportunities are performed at other hospitals outside the geographic area. To a lesser extent, a previous survey found that only (22.0%) of employees indicated that training programs were adequate. 21 Assefa et al . study in 2022 suggested that (16.3%) of participants believed inadequate skilled personnel were a challenge for compounding practice. 29 Hence, authorizing periodic continuing education programs and training is crucial for compounding pharmacists. Unexperienced staff members or a lack of knowledge among staff can increase the risk of medication errors. 53 A recent study in 2025 determined that the shortage of staff members was the primary reason for (100%) of errors connected to double checks, because the same healthcare workers calculated and prepare. 37 The two final challenges reported by compounding pharmacists were the shortage of financial resources to acquire some equipment within the hospital and a deficiency in maintenance and repair services, as mentioned in Items (9 and 11). Both related to the institution’s responsibility, particularly expensive supplies, such as biohazardous laminar hoods, were another challenge reported in the current study. Sterile products are generally costly because of the need for a sterile environment, specialized techniques, and equipment. 10 A previous survey conducted between 2017 and 2022, including an analysis of 141 warning letters issued to compounding pharmacies, found (6.38%) violations were of current good manufacturing practices regarding inadequate maintenance systems for aseptic system equipment. 54 Such problems may compromise a sterile environment and contribute to contamination. 55 Pharmacists’ opinions on some aspects related to extemporaneous compounding in the current study highlight three major concerns related to the importance of compounding preparations, pharmacist skills, the environment area, and the quality of the product. Regarding the importance of compounding preparations (Items 1, 10, 11, and 12), the pharmacists’ responses showed positive agreement about the importance of preparations for patient care, decreasing cost, and without any disadvantages, particularly when handled by skilled pharmacists with an acceptable level of professionalism. Pharmacists identified their objective of delivering comprehensive pharmaceutical care to patients as the main reason for compounding. 56 A previous study in Ireland stated that free-text responses revealed a predominant view that compounding is linked to individual patient needs and constitutes an element of pharmaceutical care, 22 findings is consistent with the current study. Additionally, the necessity and utility, based on the absence of commercially available alternatives, suitable dosage forms, or required dosages, are primary motivations for extemporaneous compounding. 10 About half (50%) of pharmacists’ viewpoints agreed that utilizing more extemporaneously made medications could be economically advantageous, as certain preparations are costly, and in-hospital preparation might reduce the financial burden on patients, particularly those with cancer. In agreement, other studies reported that (30%) and (20.9%) of participants suggested that compounded drugs are less expensive than commercially available alternatives, respectively. 29 , 56 Nationally, the public sector in Iraq provides medicines at no cost to some patients, including geriatrics, children under five years of age, and cancer treatments. 57 The responses agreed with the fact that pediatric and oncology patients were the most common patients who required compounding in the current study. Previous studies mentioned that (62.2%) to (69%) of participants believed that compounding should not be carried out, except by pharmacists and pharmacy employees, respectively. 21 , 58 Several studies have highlighted that pharmacists possess specialized expertise, training, and skills in compounding pharmaceuticals, rendering them distinctly competent compared to nurses or physicians. They comprehend pharmaceutical standards and laws, guaranteeing safe, effective, and customized drug formulations tailored to unique patient requirements, 17 , 59 an issues agreed by half of the pharmacists in the current study. A recent study in 2025 of three phases found that the error rate dropped to almost zero immediately after hiring and training six pharmacists to prepare IV preparations, highlighting pharmacists’ special role in reducing the risks associated with compounding. 37 Accordingly, the disadvantages of administering preparations to patients are a major concern, since low-quality compounded drugs can result in significant patient injuries, and extemporaneous products are not FDA-approved and do not undergo premarket review for safety, efficacy, or manufacturing quality. 2 , 60 Furthermore, patients experiencing adverse effects from compounded medications can submit medical malpractice and negligence claims against healthcare professionals. 29 The other element obtained from the current study responses related to pharmacist skills in items (3,5,6,8,9), agreement was positive with respect to periodical assessment of all pharmacists in their skills in extemporaneous compounding, as mentioned in a study performed in Sudan, where (53.4%) were agreed. 11 They also stated that their compounding skills developed after their national graduation, since extemporaneous skills are a competency required for entry-level pharmacist registration with the Pharmacy Council in many countries. 58 A further study revealed that most participants quickly acquire compounding skills through routine laboratory training; sustained proficiency relies on continuous engagement in compounding tasks and retained calculation skills. 61 Finally, an adequate supply of necessary equipment and the compounding space was not fully convenient to pharmacists’ opinions in the current study, as responded to items (2,4,7), despite their confidence in the quality of ingredients they used for preparations. The pharmacists declared that the Ministry of Health enhanced the quality by sourcing certain medications from large brand-name companies, particularly chemotherapy drugs. Numerous medical facilities have inadequate space for the preparation of sterile drugs. An insufficient space frequently hinders proper segregation, leading to potential mix-ups. 41 A qualitative study in the Karbala Governorate revealed that 50 percent of participants reported insufficient space for clinical pharmacists in the ward, as well as restricted places in pharmacy stores, outpatient pharmacies, and inpatient pharmacies, 23 highlighting the presence of problems regarding pharmacy spaces in other hospitals. Conclusion The findings of this study indicate that most of the extemporaneous preparation services within hospital pharmacies are available, particularly sterile products, despite the lack of standardization. However, the limited sample size and setting may not reflect nationwide practices; hence, future outcome-based studies are warranted to measure how extemporaneous compounding affects patient safety, treatment adherence, and cost savings to enrich the current findings. Ethical statements The authors declared that no clinical trials were used in the present study. The authors declare that no experiments on human or human tissues were performed in this study. The Research Ethical Committee approved the study at the College of Pharmacy, Mustansiriyah University (4928 In 27 Dec 2023) . Written consent was obtained from participating pharmacists. Data availability Underlying data Requirements for extemporaneous preparations practice: https://doi.org/10.5281/zenodo.16743548 . 62 Pharmacist survey (demographics, opinions, reasons, and challenges): https://doi.org/10.5281/zenodo.16743576 . 63 Prescription characteristics: https://doi.org/10.5281/zenodo.16743586 . 64 Data are available under the terms of the Creative Commons Zero v1.0 Universal . References 1. U.S. Food and Drugs Administration (FDA): Human Drug Compounding.[cited 2024 Nov 9]. Reference Source 2. Kircik L, Siegel DM: Clinical and Legal Considerations in Pharmaceutical Compounding. J. Clin. Aesthet. Dermatol. 2023 Aug 1; 16 (8): S23–S28. 3. Carvalho M, Almeida IF: The Role of Pharmaceutical Compounding in Promoting Medication Adherence. Pharmaceuticals. 2022; 15 (9): 1091. PubMed Abstract | Publisher Full Text | Free Full Text 4. 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Al-Fadel N, Mahmoud MA, Dabliz R, et al. : Implementation of safety standards of compounded sterile preparations in hospital pharmacies: A multinational cross-sectional study. Eur. J. Hosp. Pharm. 2016; 23 (6): 339–342. PubMed Abstract | Publisher Full Text | Free Full Text 39. Al-Jumaili AA, Younus MM, Kannan YJA, et al. : Pharmaceutical regulations in Iraq: From medicine approval to postmarketing. East Mediterr. Health J. 2021; 27 (10): 1007–1015. PubMed Abstract | Publisher Full Text 40. Perego G, Longobardo G, Baldisserotto A, et al. : Automated chemotherapy compounding: Process optimization for the preparation of admixture containing high-dose of cyclophosphamide. J. Oncol. Pharm. Pract. 2023 Sep 28; 29 (1): 208–210. PubMed Abstract | Publisher Full Text | Free Full Text 41. National Association of Pharmacy Regulatory Authorities (NAPRA): Guidance Document for Pharmacy Compounding of Non-Sterile Preparations. Ottawa, ON: NAPRA; 2017. Reference Source 42. Tyski S, Burza M, Laudy AE: Microbiological Contamination of Medicinal Products —Is It a Significant Problem? Pharmaceuticals. 2025; 18 (7): 1–30. PubMed Abstract | Publisher Full Text | Free Full Text 43. Kurniawan AH, Safrina U, Yusmaniar Y: The association between knowledge and implementation of good compounding practice among pharmacy practitioners at community pharmacies in Central Jakarta. JIFI. 2024; 22 (2): 214–223. 44. Sari YP: Design and Construction of a Mini Laminar Airflow Cabinet to Support Laboratory Activities in Aseptic Condition. J Ecol Eng. 2022; 23 (11): 281–285. Publisher Full Text 45. Alanazi AH, Alotaibi MB, Alharbi MS, et al. : Stability Analysis of Pharmaceutical Preparations under Different Storage Conditions. J. Med. Sci. Clin. Res. 2024; 12 (09): 17–20. Publisher Full Text 46. Makeen HA, Pancholi SS, Alhazmi HA, et al. : Stability Testing of Extemporaneous Preparation of Methyl Salicylate Ointment. J Heal Spec. 2018; 6 : 72–76. Publisher Full Text 47. Abbas KM, Abdulridha MK: Knowledge, Attitude and Practice of Pharmacist about Inpatient Medication Therapy Management Services: National Cross-Sectional Study. Int J Drug Deliv Technol. 2022; 12 (3): 1298–1304. Publisher Full Text 48. Mohammed MM, Fawzi HA: Assessment of anxiety and depression among professional healthcare workers during the COVID-19 pandemic – observational cross-sectional study. Pharmacia. 2024 Feb; 71 (71): 1–6. Publisher Full Text 49. United Republic of Tanzania, Ministry of Health, Tanzania Medicines and Devices Authority (TMDA): Guidelines for production of extemporaneous formulations and hospital based sterile preparations. Dodoma: TMDA; 2nd ed.2022 [cited 2024 Dec 31]. Reference Source 50. U.S. Food and Drugs Administration (FDA): FDA warns compounders not to use glutathione from Letco Medical to compound sterile drugs.[cited 2025 Jan 31]. Reference Source 51. Mukattash TL, Alzoubi KH, Abuirjie AM, et al. : Perceptions and attitudes towards off-label dispensing for pediatric patients, a study of hospital based pharmacists in Jordan. Saudi Pharm J. 2018; 26 (1): 20–24. PubMed Abstract | Publisher Full Text | Free Full Text 52. Alqahtani SS: Community Pharmacists’ Opinions towards Poor Prescription Writing in Jazan, Saudi Arabia. Healthcare. 2021; 9 (8): 1077. PubMed Abstract | Publisher Full Text | Free Full Text 53. Mulac A, Hagesaether E, Granas AG: Medication dose calculation errors and other numeracy mishaps in hospitals: Analysis of the nature and enablers of incident reports. J. Adv. Nurs. 2022; 78 (1): 224–238. PubMed Abstract | Publisher Full Text 54. Dmour I: Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022. J. Pharm. Innov. 2023; 18 (3): 965–979. PubMed Abstract | Publisher Full Text | Free Full Text 55. Ayazkhoo L, Sistanizad M, Darvishzadeh M, et al. : Strategic Insights and Practical Tips for Establishing the Aseptic Chemotherapy Drug Compounding Unit in a Tehran Hospital: A Comprehensive Guide to Operational Success. JMEDITEC. 2024; 3 (1): 40–44. Publisher Full Text 56. Zaid AN, Al-Ramahi R, Shahed Q, et al. : Determinants and frequency of pharmaceutical compounding in pharmacy practice in Palestine. Int. J. Pharm. Pract. 2012 Feb; 20 (1): 9–14. PubMed Abstract | Publisher Full Text 57. Al-Jumaili AA: Iraq Pharmaceutical Country Profile. Bagdad: Iraqi Ministry of Health, and World Health Organization; 2020. 58. Kristina SA, Wiedyaningsih C, Widyakusuma NN, et al. : Extemporaneous Compounding Practice By Pharmacists: a Systematic Review. Int J. Pharm. Pharm. Sci. 2017 Feb 1; 9 (2): 42–46. Publisher Full Text 59. Balogun OD, Ayo-Farai O, Ogundairo O, et al. : Innovations in drug delivery systems: A review of the pharmacist’s role in enhancing efficacy and patient compliance. World J Adv Res Rev. 2023; 20 (3): 1268–1282. Publisher Full Text 60. Qureshi N, Wesolowicz L, Stievater T, et al. : Sterile compounding: Clinical, legal, and regulatory implications for patient safety. J. Manag. Care Pharm. 2014; 20 (12): 1183–1191. PubMed Abstract | Publisher Full Text | Free Full Text 61. Mudit M, Alfonso LF: Analytical evaluation of the accuracy and retention of compounding skills among PharmD students. Am. J. Pharm. Educ. 2017; 81 (4): 64. PubMed Abstract | Publisher Full Text | Free Full Text 62. Abed RF, Abdulridha MK: Requirements for extemporaneous preparations practice. [Dataset]. Zenodo. 2025. Publisher Full Text 63. Abed RF, Abdulridha MK: Pharmacists survey (demographic, opinion, reason, challenges). [Dataset]. Zenodo. 2025. Publisher Full Text 64. Abed RF, Abdulridha MK: Characteristics of the Prescriptions. [Dataset]. Zenodo. 2025. Publisher Full Text Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 14 Oct 2025 ADD YOUR COMMENT Comment Author details Author details 1 Department of Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq Rawasy Fadhil Abed Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Software, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Manal Khalid Abdulridha Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Software, Supervision, Validation, Visualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (1) version 1 Published: 14 Oct 2025, 14:1115 https://doi.org/10.12688/f1000research.168935.1 Copyright © 2025 Fadhil Abed R and Abdulridha MK. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Fadhil Abed R and Abdulridha MK. Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.12688/f1000research.168935.1 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 14 Oct 2025 Views 0 Cite How to cite this report: Yuliani SH. Reviewer Report For: Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.5256/f1000research.186173.r424542 ) The direct URL for this report is: https://f1000research.com/articles/14-1115/v1#referee-response-424542 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 21 Nov 2025 Sri Hartati Yuliani , Sanata Dharma University, Depok, Indonesia Approved VIEWS 0 https://doi.org/10.5256/f1000research.186173.r424542 Introduction part In the first sentence, can you mention here the qualification of the individual who compounds medicine? Is "individual" here a technician? Methods part You have written the inclusion criteria for the participant, It is better ... Continue reading READ ALL Introduction part In the first sentence, can you mention here the qualification of the individual who compounds medicine? Is "individual" here a technician? Methods part You have written the inclusion criteria for the participant, It is better if you could write the exclusion criteria Discussion part: According to your analysis, will the pharmaceutical education qualifications according to your research findings be able to produce quality compounded preparations? Please add explanation about that? Are there any regulations regarding compounded preparations in Iraq so that the characteristics of compounded preparations are as found in this study? To clarify each discussion point, refer to the table associated with that point so that readers can understand more easily. Overall, this manuscript is good, the data is comprehensive and very well discussed Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Not applicable Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Compounding practice, pharmaceutical technology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Yuliani SH. Reviewer Report For: Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.5256/f1000research.186173.r424542 ) The direct URL for this report is: https://f1000research.com/articles/14-1115/v1#referee-response-424542 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Wiedyaningsih C. Reviewer Report For: Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.5256/f1000research.186173.r424537 ) The direct URL for this report is: https://f1000research.com/articles/14-1115/v1#referee-response-424537 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 07 Nov 2025 Chairun Wiedyaningsih , Universitas Gadjah Mada, Yogyakarta, Indonesia Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.186173.r424537 ABSTRACT: #Background should be more aligned with the research objectives. The background tends to describe prescribing patterns, standard operating procedures (SOPs), and clinical significance. The objectives, meanwhile, focus on the practices and challenges in preparing compounded medications. # ... Continue reading READ ALL ABSTRACT: #Background should be more aligned with the research objectives. The background tends to describe prescribing patterns, standard operating procedures (SOPs), and clinical significance. The objectives, meanwhile, focus on the practices and challenges in preparing compounded medications. # Methods. What is meant by an observation here? Did the researcher visit each hospital and closely observe the compounding activities using checklists and observation sheets? It is necessary to add information about how data is collected and analyzed. INTRODUCTION #How is the pharmaceutical system, particularly compounding services, structured in hospitals in Iraq? Does the laboratory/compounding service system differentiate between the compounding of non-sterile, sterile, and antineoplastic drugs? METHODS # If it is only a closed-ended quantitative questionnaire survey, is the number of 75 participants sufficient? Why did not conduct a qualitative or mixed method study and analysis? # In the Data Collection section, it is stated "Data were acquired through in-person interviews..." What does this mean? Are the questions in the questionnaire open-ended? # The researcher has stated that there are five sections on the checklist, but it is unclear what format the questions are. Are they open-ended or closed-ended? Is the data quantitative or qualitative? If the questions are closed-ended, it is also necessary to explain the answer options for each of the five sections of the checklist so that readers understand the direction of the available answer choices, as the results presented appear to focus on the compounding of sterile preparations. # In addition, it is also necessary to define operationally what is meant by considering the nature and extent of spontaneous compounding. #"REQUIREMENT FOR EXTEMPORANEOUS COMPOUNDING" The operational definition of this topic needs to be clarified. This is crucial because it relates to the questions and the available answer choices. The introduction should also explain the compounding regulations/guidelines available in Iraq. #Table 2. "Characteristics of the prescription" It is necessary to explain how the prescription was sampled and how it was evaluated. It also includes questions asked by researchers regarding the drug DOSAGE FORM of the extemporaneous compounding in the prescription. RESULTS #Data related to the characteristics of the hospital needs to be completed with: private/government hospital, type A/B?C (in terms of number of beds, facilities, etc.), , do all the hospitals studied provide antineoplastic compounding services? ..because this will affect the availability and type of compounding facility. # The most common requests for compounding come from pediatricians and oncologists. Is this because participating hospitals generally specialize in these specialties? It's also important to explain the characteristics of hospitals based on the availability of specialist doctors, as this certainly influences the type of compounding requests. #Studi Population. What are the job descriptions of each pharmacist? Are pharmacists multi-role, or are compounding pharmacists not allowed to perform other activities? Are human resources sufficient? #Table 3. Reasons for spontaneous medication compounding The stated reason for compounding is for the preparation of a geriatric patient. Which specialist requested this? # It is written “After assessment of laboratory requirements, the results indicated………..”What does the phrase "after assessment mean? Did the researchers inspect the compounding facility directly? # It also needs to be clarified whether each hospital's compounding lab is centralized or distributed across each ward. # on Table 5 Laboratory tools and equipment for compounding. - Why are the questions for sterile and non-sterile products combined (refrigerators, sinks, etc.)? Can the refrigerator and sink (for examples) be used together for sterile and non-sterile compounding? #Table 6. Pharmacists' responses to challenge questions. For question 4, "Time constraints and workload pressure," an explanation of the number of pharmacists per hospital based on the hospital type is needed, as well as the roles and responsibilities of these pharmacists. #Pharmacist opinion about extemporaneous compounding. The goal of the question needs to be clarified first, and what aspects are involved. There are many aspects that can be explored (e.g., guidelines, practice and evaluation of compounding results, facilities and infrastructure, etc.). This will elicit more answers if the question is qualitative. #Presentation of Table 7: Why must all categories be presented from agree, moderate, disagree, strongly disagree.? In the Results section? Actually, it can be simplified. # “The four primary types of extemporaneous products available in national hospitals were injections, total parenteral nutrition (TPN), oral preparations, and mouthwash”. What kind of question form does the result come from?. Is the injection in question also an antineoplastic preparation? DISCUSSION # Researchers have conducted quite a lot of comprehensive discussions, but there are some questions should be discussed. Did the doctor ask the pharmacist before writing the prescription? #It is worth discussing how the dosage has been calculated so far. #Why is the pharmacist not confident in the results of the compounding he made himself? #What kind of training is provided? Is it for all types of compounding (sterile, non-sterile, antineoplastic, and hazardous drugs?) Or is it specific training? Is training mandatory for all forms of compounding? # How do you categorize extemporaneous compounding based on its dosage form? Do you differentiate based on its physical form or route of use? Please pay attention to your sentence as follows. “Among the non-sterile compound preparations, oral liquids.................. Oral preparations consisted…….." # You discuss your research results with USP guidelines. When you develop questions, did you also refer to USP? Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Pharmacy Practice I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Wiedyaningsih C. Reviewer Report For: Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.5256/f1000research.186173.r424537 ) The direct URL for this report is: https://f1000research.com/articles/14-1115/v1#referee-response-424537 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Comments on this article Comments (0) Version 1 VERSION 1 PUBLISHED 14 Oct 2025 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 Version 1 14 Oct 25 read read Chairun Wiedyaningsih , Universitas Gadjah Mada, Yogyakarta, Indonesia Sri Hartati Yuliani , Sanata Dharma University, Depok, Indonesia Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Yuliani S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 21 Nov 2025 | for Version 1 Sri Hartati Yuliani , Sanata Dharma University, Depok, Indonesia 0 Views copyright © 2025 Yuliani S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Introduction part In the first sentence, can you mention here the qualification of the individual who compounds medicine? Is "individual" here a technician? Methods part You have written the inclusion criteria for the participant, It is better if you could write the exclusion criteria Discussion part: According to your analysis, will the pharmaceutical education qualifications according to your research findings be able to produce quality compounded preparations? Please add explanation about that? Are there any regulations regarding compounded preparations in Iraq so that the characteristics of compounded preparations are as found in this study? To clarify each discussion point, refer to the table associated with that point so that readers can understand more easily. Overall, this manuscript is good, the data is comprehensive and very well discussed Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Yes Are sufficient details of methods and analysis provided to allow replication by others? Yes If applicable, is the statistical analysis and its interpretation appropriate? Not applicable Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Compounding practice, pharmaceutical technology I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Yuliani SH. Peer Review Report For: Pharmacy Practice of Extemporaneous Preparations; A Comprehending Operational Services within Some Iraqi Hospitals [version 1; peer review: 1 approved, 1 approved with reservations] . F1000Research 2025, 14 :1115 ( https://doi.org/10.5256/f1000research.186173.r424542) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/14-1115/v1#referee-response-424542 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Wiedyaningsih C. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 07 Nov 2025 | for Version 1 Chairun Wiedyaningsih , Universitas Gadjah Mada, Yogyakarta, Indonesia 0 Views copyright © 2025 Wiedyaningsih C. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions ABSTRACT: #Background should be more aligned with the research objectives. The background tends to describe prescribing patterns, standard operating procedures (SOPs), and clinical significance. The objectives, meanwhile, focus on the practices and challenges in preparing compounded medications. # Methods. What is meant by an observation here? Did the researcher visit each hospital and closely observe the compounding activities using checklists and observation sheets? It is necessary to add information about how data is collected and analyzed. INTRODUCTION #How is the pharmaceutical system, particularly compounding services, structured in hospitals in Iraq? Does the laboratory/compounding service system differentiate between the compounding of non-sterile, sterile, and antineoplastic drugs? METHODS # If it is only a closed-ended quantitative questionnaire survey, is the number of 75 participants sufficient? Why did not conduct a qualitative or mixed method study and analysis? # In the Data Collection section, it is stated "Data were acquired through in-person interviews..." What does this mean? Are the questions in the questionnaire open-ended? # The researcher has stated that there are five sections on the checklist, but it is unclear what format the questions are. Are they open-ended or closed-ended? Is the data quantitative or qualitative? If the questions are closed-ended, it is also necessary to explain the answer options for each of the five sections of the checklist so that readers understand the direction of the available answer choices, as the results presented appear to focus on the compounding of sterile preparations. # In addition, it is also necessary to define operationally what is meant by considering the nature and extent of spontaneous compounding. #"REQUIREMENT FOR EXTEMPORANEOUS COMPOUNDING" The operational definition of this topic needs to be clarified. This is crucial because it relates to the questions and the available answer choices. The introduction should also explain the compounding regulations/guidelines available in Iraq. #Table 2. "Characteristics of the prescription" It is necessary to explain how the prescription was sampled and how it was evaluated. It also includes questions asked by researchers regarding the drug DOSAGE FORM of the extemporaneous compounding in the prescription. RESULTS #Data related to the characteristics of the hospital needs to be completed with: private/government hospital, type A/B?C (in terms of number of beds, facilities, etc.), , do all the hospitals studied provide antineoplastic compounding services? ..because this will affect the availability and type of compounding facility. # The most common requests for compounding come from pediatricians and oncologists. Is this because participating hospitals generally specialize in these specialties? It's also important to explain the characteristics of hospitals based on the availability of specialist doctors, as this certainly influences the type of compounding requests. #Studi Population. What are the job descriptions of each pharmacist? Are pharmacists multi-role, or are compounding pharmacists not allowed to perform other activities? Are human resources sufficient? #Table 3. Reasons for spontaneous medication compounding The stated reason for compounding is for the preparation of a geriatric patient. Which specialist requested this? # It is written “After assessment of laboratory requirements, the results indicated………..”What does the phrase "after assessment mean? Did the researchers inspect the compounding facility directly? # It also needs to be clarified whether each hospital's compounding lab is centralized or distributed across each ward. # on Table 5 Laboratory tools and equipment for compounding. - Why are the questions for sterile and non-sterile products combined (refrigerators, sinks, etc.)? Can the refrigerator and sink (for examples) be used together for sterile and non-sterile compounding? #Table 6. Pharmacists' responses to challenge questions. For question 4, "Time constraints and workload pressure," an explanation of the number of pharmacists per hospital based on the hospital type is needed, as well as the roles and responsibilities of these pharmacists. #Pharmacist opinion about extemporaneous compounding. The goal of the question needs to be clarified first, and what aspects are involved. There are many aspects that can be explored (e.g., guidelines, practice and evaluation of compounding results, facilities and infrastructure, etc.). This will elicit more answers if the question is qualitative. #Presentation of Table 7: Why must all categories be presented from agree, moderate, disagree, strongly disagree.? In the Results section? Actually, it can be simplified. # “The four primary types of extemporaneous products available in national hospitals were injections, total parenteral nutrition (TPN), oral preparations, and mouthwash”. What kind of question form does the result come from?. Is the injection in question also an antineoplastic preparation? DISCUSSION # Researchers have conducted quite a lot of comprehensive discussions, but there are some questions should be discussed. Did the doctor ask the pharmacist before writing the prescription? #It is worth discussing how the dosage has been calculated so far. #Why is the pharmacist not confident in the results of the compounding he made himself? #What kind of training is provided? Is it for all types of compounding (sterile, non-sterile, antineoplastic, and hazardous drugs?) Or is it specific training? Is training mandatory for all forms of compounding? # How do you categorize extemporaneous compounding based on its dosage form? Do you differentiate based on its physical form or route of use? Please pay attention to your sentence as follows. “Among the non-sterile compound preparations, oral liquids.................. Oral preparations consisted…….." # You discuss your research results with USP guidelines. When you develop questions, did you also refer to USP? Is the work clearly and accurately presented and does it cite the current literature? Yes Is the study design appropriate and is the work technically sound? Partly Are sufficient details of methods and analysis provided to allow replication by others? Partly If applicable, is the statistical analysis and its interpretation appropriate? Partly Are all the source data underlying the results available to ensure full reproducibility? Yes Are the conclusions drawn adequately supported by the results? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Pharmacy Practice I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (0) Wiedyaningsih C. 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