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

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.

Characteristics of participated pharmacist

The characteristics of the 70 pharmacists enrolled in the study are presented in Table 1.

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.

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.

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.

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.

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.

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.

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 <797> 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.