Drug Evaluation Monograph Overview

Drug Evaluation Monograph

• A comprehensive document providing detailed information about a specific drug.
• Includes information about composition, indications, dosage forms, dosage recommendations, contraindications, precautions, adverse reactions, and other essential information.
• Usually authorized by the Food and Drug Administration (FDA).
• Drug manufacturers are required to develop a detailed drug monograph.
• Essentially a modified drug manufacturer package insert.

Purpose of Drug Evaluation Monograph

• Aims to evaluate how a drug, if added to the formulary, can be safely implemented at an institution.
• Components vary depending on the type of institution (hospital, outpatient surgery center, long-term care facility, pharmacy etc.).

Physician Drug Reference (PDR)

• A compilation of drug monographs updated annually.
• Used by physicians, pharmacists, and nurses.

Contents of the Drug Monograph

• Generic name: The adopted common name, non-proprietary name, or active ingredient.
• Brand name: Trade names specific to the manufacturer.
• Synonyms: Other names or abbreviations for the generic drug.
• Pharmacologic category: A unique systematic classification of medications.
• Indications/uses: FDA-approved uses of the drug (labeled use).
• Unlabeled or investigational use: Non-FDA approved indication for drug use.

Drug Monograph Format (Continued)

• Pharmacoeconomics: Compares the drug's price to similar products with detailed abstracts of pharmacoeconomic studies.
• Pharmacodynamics/Pharmacokinetics: Pharmacodynamics describes the drug's effects on the body (MOA). Pharmacokinetics describes the body's effect on the drug (ADME).
• Dosage: Includes dosage amounts for pediatrics, adults, and geriatrics, as well as dosage adjustments for renal or hepatic impairment.
• Dietary considerations: Explains how to take the drug relative to meals or food.
• Administration: Provides instructions on proper administration of the drug, including frequency and time frame.
• Monitoring parameters: Lists laboratory tests and patient physical parameters to be monitored for safety and efficacy.
• Dosage Forms: Details about the form, strength, and availability of the drug.

Drug Monograph Format (Continued)

• Pregnancy risk factor: The estimated risk of fetal injuries due to the drug, as directed by the mother during pregnancy.
• Lactation: Information related to drug use while breastfeeding.
• Contraindications: Situations where the drug should not be used due to potential harm.
• Warnings/precautions: Situations where the drug can be administered but require specific monitoring (BP, BG, LFTs etc.).
• Adverse reactions: Possible undesirable side effects encountered at recommended doses.

Drug Monograph Format (Continued)

• Overdose/Toxicology: Information about exceeding the recommended drug dose leading to toxicity.
  • Acute toxicity: Short-term effects after drug ingestion.
  • Chronic toxicity: Effects after prolonged drug use.
  • Offers guidance on handling signs and symptoms of toxicity and patient management.
• Ethanol/herbal interactions: Information regarding possible interactions with ethanol or herbal products.
• Storage/Stability: Explains storage, stability, and reconstitution instructions for the product, including time and conditions necessary to maintain full potency.

Drug Monograph Format (Continued)

• Drug interactions: Provides a list of common and severe drug interactions with explanations and potential management strategies.
  • Cytochrome P450 (CYP450): Details CYP450 enzymes responsible for metabolizing the drug and/or enzymes affected by the drug.
  • Increased effect/toxicity: Drug combinations that result in increased therapeutic effect or toxicity.
  • Decreased effect: Drug combinations that result in a decreased therapeutic effect.

Drug Interactions in Drug Monograph (Examples)

• Enzyme induction: An increase in the rate of enzyme synthesis.
• Enzyme inhibition: A decrease in the expression of an enzyme.

Pregnancy & Lactation in Drug Monograph

• The use of medications during pregnancy and lactation is challenging for healthcare providers, requiring careful risk-benefit assessment.
• The Pregnancy/Lactation section in a drug monograph includes clinical details on risks during pregnancy and breastfeeding.
• May also include information on contraception, fertility, pregnancy testing, and pregnancy registries.

Pregnancy and Monographs

• The Pregnancy and Lactation Labeling Rule (PLLR) has replaced the previous pregnancy letter categories (A, B, C, D, and X).
• PLLR provides a narrative structure for pregnancy labeling, allowing healthcare providers to make informed decisions based on specific risks.

Examples of Pregnancy & Lactation Sections

• Ciprofloxacin (CIPROBAY®, Bayer): Available animal and human pregnancy & lactation data.
• Doxycycline (VIBRAMYCIN®, Pfizer): Available long-term animal and short-term human pregnancy & lactation data.
• Amoxicillin (AMOXIL®, GSK): Available animal and human pregnancy & lactation data.