What is a pharmacy monograph?

What is a pharmacy monograph?

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.

How do you write a drug monograph?

Patient Information:

  1. Name and description of the medication.
  2. Dosage form.
  3. Route of administration.
  4. Duration of therapy.
  5. Special directions and precautions.
  6. Side effects.
  7. Techniques for self-monitoring.
  8. Proper storage.

What should a drug monograph include?

The information within these monographs is presented in a standardized format to provide the following information:

  1. Description/Classification.
  2. Mechanism of Action.
  3. Pharmacokinetics.
  4. Administration.
  5. Indications/Dosage.
  6. Interactions.
  7. Contraindications/Precautions.
  8. Adverse Reactions.

What information can be found in a monograph?

Furthermore, a monograph contains detailed instructions for identification, purity tests and other specific tests to limit the amount of undesirable impurities, all of which may be used to verify common requirements by manufacturers and formulators concerned with the quality of their ingredients and products.

What is an example of a monograph?

The definition of a monograph is a long, detailed scholarly piece of writing on a specific subject. An example of a monograph is a book on how the human body uses Vitamin D. A scholarly book or a treatise on a single subject or a group of related subjects, usually written by one person.

What is the medicine monograph used for?

An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market …

What is the medication monograph used for?

What is monograph in technical writing?

A monograph is a specialist work of writing (in contrast to reference works) or exhibition on a single subject or an aspect of a subject, often by a single author or artist, and usually on a scholarly subject. …

What is monograph medication used for?

Monographs are utilized to help ensure patient safety USP’s publicly available monographs are used by regulators, public health authorities, and others to confirm that the medicines provided to patients meet quality expectations for safety and effectiveness.

Does monograph treat UTI?

Has been used (single dose or multiple doses†) for treatment of UTIs caused by multidrug-resistant bacteria and some clinicians suggest it may be a viable option for treatment of such infections; however, additional study needed.

What are the different types of drug monographs?

Azacitidine. Azelaic Acid (FINACEA) Foam Monograph. Azilsartan, Drug Monograph. Bedaquiline Drug Monograph; restricted to ID or local designee. Belatacpet (Nulojix) Drug Monograph. Belimumab Drug Monograph. Bendamustine Monograph.

Why are technical writing skills important in the pharmaceutical industry?

Technical writing skills are extremely important for any industry, but even more so when manufacturing pharmaceutical drugs. In this industry, if a batch record step is unclear or contains a mistake, it could have several types of negative consequences.

What is a Drug Evaluation monograph?

The drug evaluation monograph provides a structured method to review the major features of a drug product.

What is a PharmD monograph?

Monographs are an innovative and useful method of integrating learning concepts in the PharmD curriculum. Incorporating monographs increased PharmD students’ understanding of the relevance of a pharmacoeconomics course.