Extemporaneous Compounding: Selective Pharmacists with Separate Skill

Abstract

Extemporaneous compounding takes place in community and hospital pharmacies. There are usually specialist compounding pharmacies in major towns and cities, but any pharmacy may undertake compounding as long as they have appropriate facilities according to state-based legislation (e.g. allocated clean bench, specific compounding equipment). Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly ‘sterile’ steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances.
 
 Article Type: Review

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

“…A defined training program should be accessible, and the completion of training should be documented. This applies to all preparation professionals, including those who are not actively involved in preparation activities (e.g., cleaning staff) [ 5 ].…”

“…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 ].…”

“…It was confirmed that the incidence of ADRs in infants is two-fold higher because the infant’s body is not physiologically mature [ 11 ]. The safety and efficacy of extemporaneous compound preparations used in health services to fulfill the special needs of patients are very dependent on the professionalism of the pharmacist [ 5 ].…”

Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022

“…For example, an oral tablet may contain inactive ingredients that should not be administered by the intravenous route [3]. While benefits of compounding from APIs include the avoidance of binders and the possibility of accessing drug substances that are not available in suitable commercial forms for the intended use of the compounded product [1,4,5].…”