Question

If you were a member of the drug development committee at a pharmaceutical sponsor, how would you draft a package insert indication for a new lipid lowering drug that is proven more potent than atorvastatin. The new drug is called lowerstatin.

Answer 1

Package insert:

Printed materials available in the legal pharmacologic description of a drug, subject to detailed regulatoryspecifications, including approved chemical and proprietary names, description and classification, clinicalpharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drugabuse and dependence information, overdosage discussion, dosage and administration, formulations, and appropriate references

The first thing listed is usually the brand name and generic name of the product. The other sections are as follows:

• Clinical pharmacology - tells how the medicine works in the body, how it is absorbed and eliminated, and what its effects are likely to be at various concentrations. May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.).
• Indications and usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure). Physicians legally can and often do prescribe medicines for purposes not listed in this section (so-called "off-label uses").
• Contraindications - lists situations in which the medication should not be used, for example in patients with other medical conditions such as kidney problems or allergies
• Warnings - covers possible serious side effects that may occur
• Precautions - explains how to use the medication safely including physical impairments and drug interactions; for example "Do not drink alcohol while taking this medication" or "Do not take this medication if you are currently taking MAOI inhibitors"
• Adverse reactions - lists all side effects observed in all studies of the drug (as opposed to just the dangerous side effects which are separately listed in "Warnings" section)
• Drug abuse and dependence - provides information regarding whether prolonged use of the medication can cause physical dependence (only included if applicable)
• Overdosage - gives the results of an overdose and provides recommended action in such cases
• Dosage and administration - gives recommended dosage(s); may list more than one for different conditions or different patients (e.g., lower dosages for children)
• How supplied - explains in detail the physical characteristics of the medication including color, shape, markings, etc., and storage information (e.g., "Do not store above 95°")