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Safety Alerts

International Group Pushes for 9 New Drug Labeling, Packaging Guidelines to Improve Safety

An internationally accepted set of best practices for drug labeling and packaging, aimed at reducing medication errors, could be getting closer as reported in Drug Topics July 2 2018.

Global regulators met last week at the FDA’s White Oak Campus in Silver Spring, MD, to discuss the use of technologies to reduce errors and the need for the establishment of an international barcode standard.

Cosponsored by FDA and the International Medication Safety Network (IMSN), the group was made up of of medication safety organizations and advocates from over 20 countries.

Nine Recommendations

Summit participants agreed that guidelines are needed regarding the presentation of critical label information to address look-alike labels. They concluded that logos and highly stylized graphics detract from the readability of the label. They also suggested review of existing guidelines and consideration of the following best practices related to drug labeling and packaging:

  1. Include both the per mL and the per container quantity, not the per mL quantity alone, when presenting the concentration for injectables.
  2. Use metric units for products, and eliminate ratio expressions.
  3. Eliminate potentially error-prone abbreviations and dose designations on labels, such as U for units, IU for international units, or trailing zeros (e.g., 1.0) to express strength.
  4. Prominently display cautionary statements on carton and immediate container labels of neuromuscular blockers, potassium chloride concentrate injection, methotrexate, and other selected error-prone medications.
  5. Use contrasting label backgrounds for the printing on glass ampules, and recommend font size and label orientation, to improve readability.
  6. Physically link or integrate diluents with drugs that are powders.
  7. Increase the adoption of ready-to-use/ready-to-administer syringes, premixed IV solutions, unit-dose packaging, and other more efficient, safer packaging, while considering the overall cost of implementation.
  8. Develop product-specific world safety standards; for example, standard packaging for non-oncologic methotrexate to prevent accidental daily use and overdoses.
  9. Include barcodes on packages so they can be scanned at the bedside or other locations where medications are dispensed or administered by healthcare providers.

Drug Interactions with Herbal Products and Biotin

A recent review article in the British Journal of Clinical Pharmacology highlights the clinical importance of herb-drug interactions. Patients may poorly respond to therapeutic agents or develop toxicity due to severe interactions, which may increase the cost of treatment and/or lead to or prolong patient hospitalization. Multiple herbal-drug combinations were reviewed.  See https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.13490 for the full article.

In November the FDA issued an alert on suspected cases of biotin interfering with critical lab results, with one extreme case associated with a patient's death.  Biotin is suspected of interfering with a lab test that measures troponin,  a biomarker that when elevated helps clinicians diagnose heart attacks, The results of the test were falsely low.   Patients taking high doses of biotin should always inform their physician and pharmacist so this can be recorded in the medication list.

John Kessler