Stability and consistency of compounded oral liquid levothyroxine formulations.

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 Administration-registered 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.

Effects of Bariatric Surgery Observed in Postmortem Toxicology Casework.

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.

Trends in potentially abused medications returned during medication take-back days.

OBJECTIVE: To observe rates of returns and to identify trends in returns of potentially abused medications during medication take-back events. METHODS: A retrospective cross-sectional study was conducted of returned medications during medication take-back days from 2013 to 2016 based on a partnership between local law enforcement and a school of pharmacy in a rural South Carolina town. Data collected on returned items included active ingredients, estimated quantity, and prescription fill date if available. The medications were classified by therapeutic class and further identified drugs of potential abuse according to National Institute of Drug Abuse classifications. Descriptive statistics were used to analyze the data collected. RESULTS: In 2013, 742 different medications were returned, and 64 (8.63%) were potential drugs of abuse. In the years 2014-2016, 117 (11.43%) returned medications were potential drugs of abuse. In 2017, 40 (13.27%) returned medications were potentially abused drugs. Opioid analgesics were the most common potentially abused medication returned, accounting for 51.6%, 62.4%, and 65% of potentially abused medications returned in 2013, 2014-2016, and 2017, respectively. The other most common potentially abused returned medications were benzodiazepines (10.9%, 12.8%, 7.5%). The return of hypnotic medications increased over the study period from 0% in 2013 to 12.5% of potentially abused medications in 2017. The return of other medications such as loperamide and dextromethorphan varied over the study period. CONCLUSION: The rate of potentially abused medications returned steadily rose over the period of the study. Heightened awareness and increased opportunities for proper disposal including the placement of permanent drug disposal locations may account for the decreased number of prescriptions returned following 2013.

The Needs and Opportunities for Medication Disposal Programs.

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.

Effect of the human chorionic gonadotropin diet on patient outcomes.

OBJECTIVE: To report a case of left lower extremity deep vein thrombosis (DVT) and bilateral pulmonary embolisms in a patient who initiated the human chorionic gonadotropin (HCG) diet 2 weeks prior to presentation. CASE SUMMARY: A 64-year-old white female presented with leg swelling and shortness of breath. Lower extremity ultrasound revealed left leg DVT, and a computed tomography angiogram revealed bilateral pulmonary embolisms. A complete history and physical examination were unremarkable for any risk factors for acute thrombosis, with the exception of the initiation of the HCG diet approximately 2 weeks prior to presentation; the patient was taking 20 sublingual drops of HCG twice daily. Results of her hypercoagulable workup were negative. Upon admission, therapy was started with enoxaparin 120 mg subcutaneously twice daily and warfarin 5 mg orally once daily. According to the Naranjo probability scale, initiation of the HCG diet was a probable cause of our patient's adverse effects. DISCUSSION: The HCG diet has very few efficacy studies and no significant safety studies associated with its use. Six relevant studies were identified for assessment of efficacy, and only 1 was associated with a significant weight reduction in the HCG diet study population. All of these studies evaluated the use of the HCG diet via injections of the hormone and significant calorie restriction, which is known as the Simeons method. Currently marketed HCG products include sublingual drops, lozenges, and pellets, but none of these methods has an evidence-based efficacy and safety standard. CONCLUSIONS: 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.