Chapter 2 - Drug Monograph PDF

Lebanese International University School of Pharmacy Pharmacy Practice Department PHAR200 – Introduction to Drug Information Spring Semester, 2023 - 2024  Chapters: 1. Medical Terminologies 2. Drug Evaluation Monograph 3. Pharmacist Patient Care Process (PPCP) 4....

Lebanese International University School of Pharmacy Pharmacy Practice Department PHAR200 – Introduction to Drug Information Spring Semester, 2023 - 2024  Chapters: 1. Medical Terminologies 2. Drug Evaluation Monograph 3. Pharmacist Patient Care Process (PPCP) 4. Drug Information Resources 5. Drug Consult 6. Referencing 7. Drug Information Center (DIC) 8. Introduction to Biostatistics 9. Evaluation of Literature 10. Evaluation of Journal Club 11. Evidence-based Clinical Practice Guidelines 2  School of Pharmacy Lebanese International University PHAR200 – Introduction to Drug Information Chapter 2: Drug Evaluation Monograph 3  Drug Evaluation Monograph A drug monograph is a comprehensive document that provides detailed information about a specific drug It typically includes details about the drug's composition, indications for use, dosage forms, dosage recommendations, contraindications, precautions, adverse reactions, and other essential information Mainly automatically authorized by the Food and Drug Administration (FDA) Drug manufacturers are required to develop a detailed drug monograph o Considered as modified drug manufacturer packages insert 4  Purpose of Drug Evaluation Monograph When completing an evaluation, special consideration should be given to how a drug, if added to formulary, will safely be implemented at the institution All drug evaluations will have many similar components, but the emphasis and impact of those components may be different for each type of institution o Hospital, outpatient surgery center, long-term care facility, pharmacy… 5  4 Physician Drug Reference The Physician Drug Reference (PDR) is a compellation of drug monographs Updated yearly Used by physicians, pharmacist and nurses 6  5 Contents of the Drug Monograph Generic name Adopted common name/ non-proprietary name/ active ingredient Brand name Trade names (manufacturer-specific names) Synonyms Other names or accepted abbreviations of the generic drug Pharmacologic Unique systematic classification of medications category Indications / uses FDA approved uses of the drug (labeled use of the drug) Unlabeled of investigational use of the drug: non-FDA approved indication 7  10 Drug Monograph Format (Cont’d) Pharmacoeconomics The product being reviewed is compared in price to other similar products Detailed abstracts of pharmacoeconomic studies should be prepared Pharmacodynamics/ Pharmacodynamics is the effect that drugs have on the body pharmacokinetics (MOA) Pharmacokinetics: the effect of the body on the drug It is expressed in terms of ADME 8  11 Drug Monograph Format (Cont’d) Dosage Includes the amount of the drug to be used in pediatrics, adults, and geriatrics Also includes any dosing adjustments to be made in cases of renal impairment or hepatic impairment Dietary Includes information on how the drug should considerations be taken relative to meals or food Administration It includes instructions on how to properly administer the drug. Also, related to Frequency, how often the medication should be taken or administered within a specific time frame Monitoring Laboratory tests and patient physical parameters that should be monitored for parameters safety and efficacy of drug therapy Dosage forms Information with regard to form, strength, and availability of the drug 9  6 Drug Monograph Format (Cont’d) Pregnancy risk The estimated background risk for major birth defects and factor miscarriage Lactation Information regarding the use of the drug while breastfeeding Contraindications Includes situations where the drug should not be used because it may harm the patient Warnings/ Includes situations where the drug can be administered to the precautions patient, but with certain monitoring required (ex. BP, BG, LFTs…) Adverse Possible undesirable side effects that may be reactions encountered at recommended doses 10  7 Drug Monograph Format (Cont’d) Overdose / Overdose: exceeding the recommended dose of the drug leads to Toxicology toxicity Acute toxicity: are the effects that may arise after acute (short term) ingestion of the drug. Ex: overdose leading to liver damage Chronic toxicity: usually results after prolonged use of the drug This part may also include information about signs & symptoms of toxicity and suggested management of the patient 11  Drug Monograph Format (Cont’d) Ethanol Information regarding possible interactions / herbal interactions Between the drug and ethanol, or herbal products Storage/ Stability Information regarding storage of the product or steps for reconstitution. Provides the time and conditions for which the solution or mixture will maintain the full potency For example, some solutions may require refrigeration after reconstitution, while stored at room temperature before preparation 12  8 Drug Monograph Format (Cont’d) Drug interactions A list of common and/or severe drug interactions must be provided It is done with a brief explanation of the interaction and, perhaps, what to do about it Cytochrome P450 (CYP450): describes which CYP450 enzymes are responsible for metabolizing the drug and/or which enzymes might be induced or inhibited by the drug Increased effect/ toxicity: drug combinations that result in an increased or toxic therapeutic effect between the drug listed in the monograph and other drugs or drug classes Decreased effect: drug combinations that result in a decreased therapeutic effect between the drug listed in the monograph and other drug or drug classes 13  Drug Interactions in Drug Monograph 1. Example: Enzyme induction – Drug A is taken by the patient and is metabolized by CYP450 and then eliminated from the body – The patient is now also started on Drug B which induces CYP450 o Enzyme Inducer Increases CYP450 enzyme activity Drug A ↑↑ Elimination of Drug A ↓↓ Therapeutic effect of Drug A CYP450 Drug B 14  Drug Interactions in Drug Monograph 2. Example: Enzyme inhibition – Drug C is taken by the patient and is metabolized by CYP450 and then eliminated from the body – The patient is now also started on Drug D which inhibits CYP450 o Enzyme Inhibitor Decreases CYP450 enzyme activity Drug C ↓↓ Elimination of Drug C ↑↑ Therapeutic effect/toxicity of CYP450 Drug C Drug D 15  Drug Interactions in Drug Monograph Enzyme Induction o The process by which the rate of synthesis of an enzyme is increased Enzyme Inhibition o The process by which the expression of an enzyme is decreased 16  Pregnancy & Lactation in Drug Monograph The use of medications in pregnancy and lactation presents a challenge to all health care providers Making a risk–benefit ratio assessment is difficult The pregnancy risk of a pharmaceutical product is an assessment of the risk of fetal injury due to the product, if it is used as directed by the mother during pregnancy The Pregnancy/Lactation section of a drug monograph includes clinical details on risks during pregnancy and breastfeeding When relevant, information about impact on contraception and fertility, pregnancy testing, and contact details for pregnancy registries may also be found 17 in this section  Pregnancy and Monographs The use of medications in pregnancy and lactation presents a challenge to all health care providers – This is especially true with the long-standing pregnancy risk categories A, B, C, D, and X – Make risk–benefit ratio assessment difficult To address the need for updated risk categories, the FDA published – Pregnancy and Lactation Labeling Rule” (PLLR), in December 2014 – In June 2020 all drugs in the market started following this rule 18  Pregnancy & Lactation in Drug Monograph The FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule) The PLLR format assists health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication Allows them to make informed and educated decisions for themselves and their children The PLLR removes pregnancy letter categories – A, B, C, D and X FDA believes that a narrative structure for pregnancy labeling, rather than a category system, is best able to capture and convey the potential risks of drug exposure based on animal or 19  Examples of Pregnancy & Lactation Sections Ciprofloxacin (CIPROBAY®, Bayer) – Approved on March 25, 2004 – Available animal and human pregnancy & lactation data Administration: – CIPROBAY with food and drink: CIPROBAY can be taken independently of meal times. Do not eat or drink any dairy products (such as milk, yoghurt or cheese) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance and CIPROBAY may not work properly 20  Examples of Pregnancy & Lactation Sections Doxycycline (VIBRAMYCIN®, Pfizer) – Approved on June 01, 1967 – Available long-term animal and short-term human pregnancy & lactation data Section Lactation Section Pregnancy – VIBRAMYCIN® is excreted in – Pregnancy category D breast milk – Animal studies indicate that VIBRAMYCIN®: – It should be avoided in nursing Cross the placenta mothers Is found in fetal tissues Can cause problems with the color and 21  Examples of Pregnancy & Lactation Sections Amoxicillin (AMOXIL®, GSK) – Approved on July 18, 1980 – Available animal and human pregnancy & lactation data Storage: − How to store Amoxicillin Capsules: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. Store in the original pack below 30°C. 22