SynthesisJournal of medical toxicology : official journal of the American College of Medical Toxicology2021
Pharmaceutical Compounding: a History, Regulatory Overview, and Systematic Review of Compounding Errors.
Synthesis in Journal of medical toxicology : official journal of the American College of Medical Toxicology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
42 citing papers in PubMed.
- Comparative Sensory Evaluation of Pediatric Liquid Omeprazole Formulations Available in the UK.Clinical drug investigation · 2026Trial
- Hidden Solid-State Transformation of Darunavir in Low-Temperature Hot-Melt-Extruded Granules: Implications for Pharmacy Compounding and Routine Quality Control.Pharmaceutics · 2026Article
- Hard Gelatin Capsules Compounded and Dispersed in Water in Pediatrics: Real Versus Theoretical Dose Administered.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Adverse drug events from paediatric use of extemporaneously compounded medicines in community pharmacy settings: a scoping review.BMJ paediatrics open · 2026Article
- Pharmacologic treatment of obesity in adults: Standards of care in overweight and obesity.BMJ open diabetes research & care · 2026Review
- Optimisation of Medicine Compounding Using Quality by Design Approach: Case Studies of Two Aqueous Cream Formulations.Pharmaceutics · 2025Article
- A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care.Drug delivery and translational research · 2025Review
- Smart Formulation: AI-Driven Web Platform for Optimization and Stability Prediction of Compounded Pharmaceuticals Using KNIME.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Global Rise of Compounded Weight-Loss Medicines: A Worrisome Trend.Journal of the Endocrine Society · 2025Article
- Extemporaneous Compounding, Pharmacy Preparations and Related Product Care in the Netherlands.Pharmaceutics · 2025Review
- Evolution of the Military Health System compounded drugs utilization and management.Journal of managed care & specialty pharmacy · 2025Review
- Development of 3D-Printed Chewable Gummy Tablets with Adjustable Ondansetron Content for the Treatment of Pediatric Patients.Pharmaceutics · 2025Article
- Weight Reduction with GLP-1 Agonists and Paths for Discontinuation While Maintaining Weight Loss.Biomolecules · 2025Review
- Safety of Compounded Medications.Cureus · 2025Article
- Extemporaneous dermatological compounding in hospital pharmacies, Northwest Ethiopia.Frontiers in public health · 2025Article
- Compounded glucagon-like peptide-1 receptor agonists for weight loss: the direct-to-consumer market in Colorado.Journal of pharmaceutical policy and practice · 2025Article
- The Formulation and Evaluation of Customized Prednisolone Gel Tablets Prepared by an Automated Extrusion-Based Material Deposition Method.Pharmaceutics · 2024Article
- Impact of Manufacturing Process and Compounding on Properties and Quality of Follow-On GLP-1 Polypeptide Drugs.Pharmaceutical research · 2024Article
- Trends in Shortages of Lead Chelators From 2001 to 2022.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study.Pharmacy (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMedications are compounded when a formulation of a medication is needed but not commercially available. Regulatory oversight of compounding is piecemeal and compounding errors have resulted in patient harm. We review compounding in the United States (US), including a history of compounding, a critique of current regulatory oversight, and a systematic review of compounding errors recorded in the literature.
methodsWe gathered reports of compounding errors occurring in the US from 1990 to 2020 from PubMed, Embase, several relevant conference abstracts, and the US Food and Drug Administration "Drug Alerts and Statements" repository. We categorized reports into errors of "contamination," suprapotency," and "subpotency." Errors were also subdivided by whether they resulted in morbidity and mortality. We reported demographic, medication, and outcome data where available.
resultsWe screened 2155 reports and identified 63 errors. Twenty-one of 63 were errors of concentration, harming 36 patients. Twenty-seven of 63 were contamination errors, harming 1119 patients. Fifteen errors did not result in any identified harm. DISCUSSION: Compounding errors are attributed to contamination or concentration. Concentration errors predominantly result from compounding a prescription for a single patient, and disproportionately affect children. Contamination errors largely occur during bulk distribution of compounded medications for parenteral use, and affect more patients. The burden falls on the government, pharmacy industry, and medical providers to reduce the risk of patient harm caused by compounding errors.
conclusionIn the US, drug compounding is important in ensuring access to vital medications, but has the potential to cause patient harm without adequate safeguards.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.