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pharmaceutical-labels

Pharmaceutical Labels for Opiates: Important Labeling Factors

pharmaceutical-labelsAccording to Douglas Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research (CDER), “Opioids are important pain relieving medications that provide significant benefits when used appropriately, but they have significant risks associated with inappropriate patient selection and improper use, whether accidental or intentional.”

Throckmorton’s statement sums up how many physicians, pharmacists, and the FDA feel about the use of opiates across various patient populations. Of these three parties, pharmacies play one of the most pivotal roles in ensuring the safe use of opiate medications, particularly through the use of pharmaceutical labels that reflect the following aspects of the drugs’ administration.

  1. Indications and Usage

Due to the risks of misuse, abuse, and addiction, the primary focus for this factor is addressing limitations for opioid use. For example, opiates typically shouldn’t be dispensed on a PRN basis for occasional, low-level or mid-level physical pain that causes minor distress.

  1. Dosage and Administration

With this factor, the foremost considerations are patients’ opioid tolerance (e.g., opiate naive vs. highly tolerant), the problem of withdrawal in physically dependant patients, and dosage instructions, orders for users (e.g., swallow pill whole instead of scoring or chewing it).

  1. Dosage Forms and Strengths

Dosage forms and strengths of opioids should be clearly indicated on any type of container that holds opioid medications. For example, powerful Oxycontin comes in time-release tablets of 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, and 80mg that contain the active ingredient.

  1. Warnings and Precautions

Many long-acting and time-release opioids share the same warnings and precautions, particularly: negative reactions with other central nervous system (CNS) depressants, use in patients with depressed autonomic response, and use in patients with GI obstruction.

  1. Adverse Interactions

As with warnings and precautions, many opioids share the same adverse interactions, specifically: constipation, nausea, somnolence, dizziness, vomiting, pruritus, and sweating. These adverse reactions should be clearly listed on pharmaceutical labels for opiates.

  1. Drug Interactions

Here, the emphasis is on preventing deadly reactions from combining opioids with other CNS depressants (e.g., alcohol and benzodiazepines) and reduced efficacy of opiates due to improper medicinal combinations (e.g. opioids and partial agonist opioid analgesics)

  1. Use in Specific Populations

Pharmacy labeling for opiates should also address the use of the drugs in select patient populations. For example, Oxycontin can produce especially negative health outcomes for nursing mothers, geriatric patients, and patients with significant hepatic impairment.

Ordering Pharmaceutical Labels for Opiates

With us serving as your trusted supplier of pharmaceutical labeling, you can delegate the detail work of creating the right labels to us, while you focus on your pharmacy’s core practices. To inquire about readymade or custom pharmaceutical labeling, contact us today at (800) 325-6137. We look forward to answering your questions and providing the best solution!