As popularity of the HCG diet continues to increase, so do the potential adverse events associated with the management of weight loss via an unproven strategy. Patient safety information regarding this dieting strategy should be recognized by medical professionals.
The continued increase in the usage of medications has led to a variety of negative consequences, including adverse effects on our environment and an increase in misuse/abuse of these products. Improper disposal of unused medications results in significant effects to wildlife and the potential to adversely affect human cells. Increases in misuse/abuse have resulted in significant increases in emergency department visits for drug-related issues. Drug overdose is now the leading cause of accidental death in the United States. Education of both health care providers and the general public about these issues and the proper disposal of unused medications is crucial.
Objective: With consideration of the narrow therapeutic index of levothyroxine (LT4), the objective of this study was to investigate the stability and consistency of compounded oral liquid formulations of LT4. Methods: Six pharmacies and 6 student pharmacists provided compounded oral liquid formulations of LT4. Pharmacies used their standard compounding best practice including addition of excipients, labeling, and storage instructions. The student pharmacists were required to have completed all academic compounding training and were provided instructions and materials. All analyses were performed at the Pharmaceutical Education and Research Center, a Food and Drug Administrationeregistered pharmaceutical sciences laboratory. The compounded products were assayed for percent of labeled strength (%LS) of LT4 on days 3, 6, 13, 20, 27, and 34. Each compounding pharmacy and student pharmacist subsequently prepared a second compounded product sample approximately 30 days later to simulate a refill prescription. Results: Individual product assays on days 3, 6, 13, 20, 27, and 34 demonstrated a range in variation of %LS from 12% to 47% (mean 26.5%). Wide variations of %LS of LT4 were observed between compounding sources. The assays for all products on day 3 demonstrated a range for %LS of LT4 from 77% to 113%, and those on day 34 ranged from 30% to 97%. Assay comparison of the original compounded product (month 1) to the refill compounded product (month 2) varied from 1% to 58%. Variations in excipients and flavorings were also present. One sample contained liothyronine and was not used for evaluation. These variations may be secondary to aliquot sampling of a suspension or product degradation. Conclusion: Compounded oral liquid LT4 products are unlikely to deliver the precise prescribed dosage and reliable product performance when administered to patients.
Bariatric surgery has been on the rise and patients often have multiple indications for pre- and post-operative pharmacotherapy. Procedures target the stomach and/or small intestine and affect weight loss through restriction, malabsorption, or a combination of the two. The absorption and/or metabolism of drugs via the gastrointestinal tract could be altered by different mechanisms. Several cases at the North Carolina Office of the Chief Medical Examiner’s Toxicology Laboratory (NCOCME) have raised questions about the potential impact of these procedures on the disposition of drugs in the body and how that altered disposition may affect cause and manner of death. Overmedication and postmortem redistribution are not enough to explain the phenomena seen in some NCOCME bariatric surgery-related casework. Case examples include a 46-year-old female with a history of Roux-en-Y gastric bypass (RYGB) who suffered a witnessed collapse. Toxicological findings included elevated concentrations of oxymorphone at 0.49 mg/L in vena cava blood. A 67-year-old female, who died from vomiting and bacterial gastritis one day after placement of two intragastric weight-loss balloons, had elevated concentrations of duloxetine at 1.4 mg/L in the iliac vein blood and 9.3 mg/kg in the liver. Her medication was strictly controlled by her sister and gastric contents were without intact tablets or residue at autopsy.
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