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Medicine availability is an important aspect of providing good quality healthcare. Some medicines are available in doses that are not suitable for a specific population group such as children or geriatric patients. Manipulation of the existing medication is undertaken instead. Studies on the practices, frequency and extent of extemporaneous compoun...
Contexts in source publication
Context 1
... there were no proof of records kept on regular calibration of electronic weighing scales (76%) and maintenance (72%). The pharmacy personnel were asked how often the following listed records (Table 3) were included in the documentation of their pharmacy.Documentation for compounding comprised of a manufacturing batch record and are always kept (80%), and compounding formula and procedures at 72% (Table 3). A logbook of all compounded items is always kept (64%). ...
Context 2
... there were no proof of records kept on regular calibration of electronic weighing scales (76%) and maintenance (72%). The pharmacy personnel were asked how often the following listed records (Table 3) were included in the documentation of their pharmacy.Documentation for compounding comprised of a manufacturing batch record and are always kept (80%), and compounding formula and procedures at 72% (Table 3). A logbook of all compounded items is always kept (64%). ...
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Citations
... 13,14 Compounding pharmacies are able to prepare liquid formulations of medications for children which optimize dosing and palatability, but they require resources and oversight, which make implementation challenging. 15 Recognition of the importance of HAIs in children is increasing in sub-Saharan Africa, 16,17 as confirmed by the survey results. Most hospitals reported formal IP&C programs, including programs for hand hygiene. ...
... Selected diagnostic tests are provided on the X axis. The percentage of 4 potential payment sources for each test is shown on the Y axis and calculated as the number of respondents indicating that source of payment was used divided by the number of respondents (range[15][16][17][18][19] who answered the survey item. Respondents could indicate more than one payment source for a diagnostic test. ...
Objective. The Children’s Hospitals in Africa Mapping Project survey was developed and implemented to assess the readiness of hospitals in sub-Saharan African to respond to emergencies, epidemics, and pandemics affecting children. Methods. This sub-study analyzed 56 survey questions that characterized the hospitals and assessed resources for diagnosis, treatment, and prevention of community-acquired infections and healthcare-associated infections (HAIs). Results. Twenty-four sites were recruited and 20 (from 15 countries) completed the survey in 2018 to 2019. Overall, 90% to 100% of sites reported that diagnostic assays were available for malaria, tuberculosis, and HIV. Periodic shortages of antibiotics, antimalarial drugs, and vaccines were reported by 45%, 25%, and 20% of sites, respectively. Sites reported formal programs for infection prevention and control (79%), monitoring HAIs (17%), and antimicrobial stewardship (53%). Conclusions. Opportunities to improve care for hospitalized African children were identified. These included resources for HAI surveillance and antimicrobial stewardship which can facilitate epidemic and pandemic preparedness.
... Drug compounding is common practice in tertiary hospitals in SSA countries with most pharmacists sufficiently proficient in it. 69 Furthermore, the WHO showed that compounded HU was effective and 3.6 times cheaper than commercially available hydroxyurea in hospitals, and 5-10 times cheaper than in the retail market. 28 However, compounded sterile preparations pose the risk of microbial contamination to patients. ...
Objective
Sickle cell disease is a lifelong illness affecting millions of people globally, but predominantly burdensome in sub-Saharan Africa, where most affected children do not live to adulthood, despite available evidence-based interventions that reduce the disease burden in high-income countries.
Method
We reviewed studies evaluating evidence-based interventions that decrease sickle cell disease-related morbidity and mortality among children living in sub-Saharan Africa. We used the Joanna Briggs scoping review methodological framework and grouped identified evidence-based interventions into preventative pharmacotherapeutic agents, newborn screening and comprehensive healthcare, disease-modifying agents, nutritional supplementation, systemic treatment, supportive agents and patient/carer/population education.
Results
We included 36 studies: 18 randomized controlled trials, 11 observational studies, 5 before-and-after studies and 2 economic evaluation studies, with most of the studies performed in West African countries. Included studies suggest evidence-based interventions effectively to reduce the common morbidities associated with sickle cell disease such as stroke, vaso-occlusive crisis, acute chest syndrome, severe anaemia and malaria infection. Evidence-based interventions also improve survival among study participants. Specifically, our review shows hydroxyurea increases haemoglobin and foetal haemoglobin levels, a finding with practical implications given the challenges with blood transfusion in this setting. The feasibility of implementing individual interventions is hampered by challenges such as affordability, accessibility and the availability of financial and human resources.
Conclusion
Our review suggests that regular use of low-dose hydroxyurea therapy, sulphadoxine–pyrimethamine chemoprophylaxis, L-arginine and Omega-3 fatty acid supplementation and establishment of specialist stand-alone sickle cell clinics could reduce the sickle cell disease-associated morbidity and mortality in sub-Saharan Africa countries.
... The requirements of GCP include use of appropriate ingredients, equipment, and premises for compounding and storage; maintaining sanitation and hygiene during preparation; applying quality control activities; involvement of qualified personnel; and documentation. 13 Environmental surfaces in healthcare settings include furniture and other fixed items inside and outside of patient rooms and bathrooms, such as tables, chairs, walls, light switches, etc. These surfaces are likely to be contaminated with the COVID-19 virus and must be properly cleaned and disinfected to prevent further transmission. ...
Background
Surface disinfection of healthcare facilities with appropriate disinfectants is among the infection control strategies against the spread of coronavirus disease 2019 (COVID-19). As sodium hypochlorite solution (SHS) is a commonly used surface disinfectant, its preparation and proper use should be given a due attention. The current study aimed at assessing the practice of Addis Ababa public hospitals in the preparation and use of SHS.
Methods
A cross-sectional observational study was employed to assess the adequacy of disinfectant solution preparation and use. Checklists were used for data collection. Descriptive statistics were used for data analyses, and categorical variables were described by frequencies and percentages.
Results
Out of the twelve public hospitals included in the study; only three hospitals checked the potency of the working SHS. Majority of the hospitals (8 hospitals) stored the concentrated SHS products in cool, dry, and direct sunlight protected places. It was only in one hospital where appropriate personal protective equipment was used during the preparation and quality control activities. Surfaces were not cleaned in all hospitals before disinfection; and the rooms were ventilated only in 2 hospitals during the application of the disinfectant solution.
Conclusion
The study revealed that the preparations of SHS in the public hospitals did not comply with most of the requirements of good compounding practice. Moreover, standard practices were not maintained in majority hospitals during the use of SHS for surface disinfection. As a control strategy in the spread of COVID-19 and other infections, appropriate corrective actions shall be implemented in the studied hospitals to mitigate the limitations observed in the preparation and use of SHS.
... Compounding is an important activity of pharmacists that aims to provide dosage forms or certain doses of unavailable medicine among licensed drugs [2]. Extemporaneous preparations remain widely used, especially for pediatric patients [3,4], patients with rare diseases [5,6], patients who require special dosage forms [7] or certain doses/strengths, and dermatological patients [8,9]. Compounding is performed by various pharmaceutical services, including in pharmacies, hospitals, and health centers [3,10]. ...
Extemporaneous preparations are still widely prescribed for pediatric patients with special treatments of certain doses and/or combinations of drugs. Several problems related to extemporaneous preparations have been linked to the incidence of adverse events or a lack of therapeutic effectiveness. Developing nations are facing the challenges of compounding practices. The prevalence of compounded medication in developing nations must be explored to determine the urgency of compounding practices. Furthermore, the risks and challenges are described and explained through investigation and collection of numerous scientific articles from reputable databases, including Web of Science, Scopus, and PubMed. Pediatric patients need compounded medication related to the appropriate dosage form and dosage adjustment. Notably, it is important to observe extemporaneous preparations in order to provide patient-oriented medication.
... Similarly, small-scale local pharmaceutical manufacturing facilities have a significant contribution to global healthcare as they supply healthcare supplies and extemporaneous preparations; which otherwise may not be the focus areas for large-scale pharmaceutical companies. (6,7) Ethiopia is the second-most populous country in Africa with increasing demand for pharmaceutical products. However, the production of e-ISSN: 2321-6794 [2] pharmaceutical products in Ethiopia is quite small and covers not more than 15 to 20% of the national demand for essential medicines. ...
Background: there is growing concern that medicines supplied to most of the developing countries are of substandard quality. Along with the establishment of strong regulatory systems for ensuring compliance and regulatory law enforcement, manufacturing facilities need to work to implement dependable systems at each stage of the production process to ensure the safety, efficacy, and quality of their products. Objective: the aim of this study was to assess the level of compliance with regulatory requirements by small-scale pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia. Material & Method: A cross-sectional observational study was conducted using a structured questionnaire and checklist to assess the level of compliance of small-scale local pharmaceutical manufacturing facilities to regulatory requirements and also to identify the challenges faced by the manufacturing facilities. Result: This study indicated that the overall implementation status of regulatory requirements in the local small-scale pharmaceutical manufacturing companies is far below the minimum standard set by WHO and the national regulatory authority. Basic on specific regulatory requirement elements compliance: requirements related to QA were 26.9, requirements related to personnel qualification were 38.1, requirements related to Quality control were 25.9, and requirements related to sanitation and hygiene were 15.3. Of the total regulatory requirements, only 26.1% were found to be implemented. Major challenges faced by the local small-scale pharmaceutical manufacturing industry for the implementation of regulatory requirements were: human resource capacity constraints, limited investment, limited support from Governments and other stakeholders, and poor infrastructure. Conclusion: The study demonstrated that level of regulatory requirements implementation in the local small-scale pharmaceutical manufacturers is far below the minimum standard set by the national regulatory authority. Important gaps were reported particularly in materials management, production operations, quality control, and sanitation and hygiene.
... Extemporaneous compounding typically occurs when a regulatory body-approved drug is unavailable, or a licensed practitioner prescribes an appropriate dosage form for a patient's medical needs which is not available. Also, it may occur in the case of adjusting the product's strength suitable for adult use, where the prescriber needs a lower strength for pediatric patients [5]. The limited knowledge available to support the stability and shelf life of such items is a major problem emerging from this practice. ...
Aims: The aim of this study was to evaluate different quality control parameters and the stability of the carvedilol compounded extemporaneous suspensions over three months at room temperature. Methodology: The carvedilol compounded extemporaneous suspensions were prepared in our lab in a manner consistent with how they are prepared for pediatric patients at the hospital pharmacy. The suspensions were stored at room temperature and analyzed immediately and at 1, 2 and 3 months. Suspensions were monitored for changes in organoleptic properties, pH, particle size, zeta potential, viscosity, sedimentation volume, drug content and drug dissolution. Results: The results demonstrated that the carvedilol compounding protocol used in this study was reliable and able to prepare 1.67 mg/mL of carvedilol suspension by using carvedilol commercially available tablets and Ora-blend as a suspending vehicle. Also, the extemporaneously compounded suspension maintained acceptable quality attributes when stored for three months at room temperature. Conclusion: The extemporaneously compounded suspension enables pediatricians to administer a variable dose, which adapts to every patient’s needs, and gives the possibility of treatment when the liquid dosage form is not available.
... In addition Open Access *Correspondence: desta4best@gmail.com School of Pharmacy, Jimma University, Oromia, Ethiopia to manufacturing in the licensed pharmaceutical industries, extemporaneous compounding is the essential source of medication availability, especially for personalized healthcare [1][2][3][4]. ...
Background
Pharmaceutical compounding ensures access of individuals with specific requirements to individualized therapy. However, there is an inconsistency of compounded medication quality. Therefore, advancing the rational use of compounded medication is essential for patient safety and medication effectiveness.
Objective
The presented study was aimed to investigate the healthcare practitioners’ knowledge, perception, and practice of extemporaneous compounding and its contribution to the prevalence of antimicrobial resistance.
Method
A descriptive cross-sectional survey using a structured questionnaire was conducted. The study participants were 300 healthcare practitioners working in Jimma University Medical Center, hospital pharmacies, and community pharmacies in Jimma and Mettu Town, Southwest Ethiopia.
Results
Most respondents were pharmacists (62.7%) and first-degree holders (48.3%). The majority of them had experience in administering (57.7%), preparing (38%), prescribing (21%), and repackaging and labeling (14%) compounded medications. Commonly they request compounded medications when prepackaged products (77.7%) and needed dosage regimens (72.3%) were not available in the market. However, most of them believed that compounded medications might lack quality (49%) and had poor patient compliance (40.7%). Moreover, they fear that inappropriate preparation processes (75%) and under-dose administration (59%) of compounded medication might contribute to the development and prevalence of antimicrobial resistance.
Conclusion
Most healthcare practitioners practice rational use of compounded medications and strongly agree that inappropriate compounding of antimicrobials contributes to antimicrobial resistance development.
... In this study, ointments and creams took the larger share of dosage forms from the compounded preparations, which is in agreement with findings from similar studies. 19,24,28,29 The presentations of dermatological preparations in the form of these dosage forms may be due to the nature of skin lesions (dry or oozy) diagnosed on patients and easier availability of diluting agents: white petrolatum and nivea cream ® , as indicated from the result For personal use only. ...
Background:
Skin diseases are among the major contributors of disease burden in Ethiopia affecting individuals of all age. Extemporaneous compounding of topical medications serves as a necessary option to treat skin diseases when manufactured medications could not meet specific patient needs. Different classes of drugs are commonly used for the treatment of dermatologic diseases. Failure to periodically assess the prescribing pattern and patient needs may lead to inappropriate planning and implementation that ultimately compromise the service. Periodic prescription analysis for compounded medications helps to monitor the prescription pattern with respect to medication selection, disease condition, dosage form types and other relevant parameters. The current study was conducted to analyze the pattern of compounding prescriptions for dermatologicals in ALERT hospital.
Methods:
A cross-sectional design was conducted by retrospectively evaluating compounding prescription records of January and July, 2021. A total of 460 prescriptions in the hospital community pharmacy were systematically selected. Data related to disease pattern, product selection and dosage form type were extracted and analyzed. Data analysis was done using software for the statistical package for social science version 25.0.
Results:
A total of 441 prescriptions containing dermatological products for compounding were analyzed. Most patients were female (62.8%) and aged 30-64 years (44.0%). Psoriasis (36.2%), acne vulgaris (15.3%), and rosacea (13.4%) were the top 3 skin diseases for which the compounding preparations were prescribed. Salicylic acid (38.0%) was the most frequently prescribed drug followed by betamethasone (20.2%); while white petrolatum (47.2%) was the most common diluting agent used for compounding.
Conclusion:
Psoriasis was the major dermatologic disease for compounding prescriptions and salicylic acid was the most frequent product used in compounding for treatment of the prescribed skin diseases.
... Описано дослідження практики виготовлення ЛЗ лікарняною аптекою в провінції Лімпопо (Південна Африка). Джерелом прописів ЛЗ є попередній досвід та наукова література, а гарантією їх якості є оформлена документація з вказівкою назви ЛЗ, технології виготовлення, умов та термінів зберігання [18]. В Індонезії виготовлення ліків відбувається в аптеках, лікарнях, приватних клініках, центрах здоров'я. ...
... Іншою групою ЛЗ, поширеною в практиці виготовлення лікарняними аптеками, є розчини для хіміотерапії та інші стерильні розчини для внутрішньовенного введення [14][15][16]18]. ...
Compounding medicines preparation is part of the proper pharmaceutical supply of the population. Unfortunately, its volumes in Ukraine have been declining recently, but the spread of medicines production in privately owned pharmacies indicates the prospects of this activity type.
The aim of the work was the analysis of the current state of medicines compounding and its legislative regulation in foreign countries, formulation of the main directions of the Ukrainian legislation reforming on this issue.
The materials of the research were scientific publications in peer-reviewed foreign journals with using bibliosemantic method, the method of generalization and systematic data analysis.
The analysis of publications concerning the practice of medicines preparation in foreign countries showed its volume increasing. In most countries, such activities are an integral part of pharmaceutical care and the provision of medicines to the population. Along with conventional pharmacies, the widespread medicines compounding in hospital pharmacies. The structure of drug production differs in each country. According to the Global Market Insights report for 2018, the main therapeutic areas in the structure of compounding medicines market were hormone replacement therapy, analgesia, dermatology, specialized drugs and parenteral nutrition. The regulatory framework governing the medicines compounding was reviewed in the last few years. The EU updated the PIC/S Guide and approved the second version of the EU Council Resolution on the medicines compounding. To control the spread of sterile medicines serial preparation in the United States since 2013 this activity is controlled by the FDA. Compliance with GMP requirements is a mandatory requirement for the serial preparation of sterile medicines abroad.
Thus, the development of medicines compounding is a promising area of pharmaceutical activity. Despite the reduction in the number of compounding pharmacies, Ukrainian pharmacies are also involved in the preparation of specific medicines. A number of regulatory documents, the requirements of which are similar to international ones, regulates the quality control of compounding medicines. However, to comply with modern world trends, it is necessary to review and update this legislation.
... Despite the rapidly developing market of finished medicines in foreign countries, extemporal dosage forms (EDF) have not lost their significance. Analysis of their assortment had shown that the most popular compounding preparations are used to treat different dermatological diseases (Masupye et al., 2015;Kristina et al., 2017;Buurma et al., 2003). Dermatological preparations hold the main part of EDF in Sweden, Palestine, the United States, the Netherlands (Kristina et al., 2017), Bulgaria and Greece (Dimitrov et al., 2015). ...
... Dermatological preparations hold the main part of EDF in Sweden, Palestine, the United States, the Netherlands (Kristina et al., 2017), Bulgaria and Greece (Dimitrov et al., 2015). They occupied the second place in the tertiary hospital complex in the Limpopo Province, South Africa (Masupye et al., 2015). Indispensable are compounding ointments in the treatment of dermatological diseases in Spain (Sanchez-Regana et al., 2013) and in the Dutch community pharmacies (Buurma et al., 2003). ...
... The fundamental question in the possibility of further compounding medicines preparation is their compliance with modern quality requirements. The occurrence of unwanted or toxic side effects on the body arises due to the lack of standard protocols for their preparation, and the presence of a minimum amount of information on their stability and storage conditions (Masupye et al., 2015;Kristina et al., 2017;Buurma et al., 2003). ...
Semi-solid compounding dosage forms always were popular in the treatment of dermatological diseases all over the world. These medicines are often prepared using industrial production ointments. One of them is the tetracycline hydrochloride ointment with the addition of procaine hydrochloride, sulfanilamide, and sulphur for external use. Since the literature data contains a small amount of information on the methods of quantitative analysis of compounding medicines, the aim of our study was the development of the chromatographic method for the ointment components assay. During the research, HPLC method was developed for the simultaneous assay of studied ointment active ingredients. The procedure was tested on the UPLC due to its advantages. Good separation of sulfanilamide (tR = 0.53 min), procaine hydrochloride (tR = 2.76 min) and tetracycline hydrochloride (tR = 6.50 min) was obtained. Total uncertainty value of the method doesn't exceed its maximum. The study of the method linearity in the concentration range from 2.34 × 10⁻⁶ g/ml to 3.00 × 10⁻⁴ g/ml for each component showed good results. Parameters of precision and accuracy of the method meet the established criteria. The obtained RSD values were quite low and indicate good reproducibility of the method. Thus the developed method can be used for the ointment analysis and its chemical stability studies.
