What should a drug monograph include?

What should a drug monograph include?

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 is monograph drug used for?

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.

What is the difference between a drug monograph and a package insert?

However, a major difference was acknowledged: unlike package inserts or medication guides that are reviewed and approved by the FDA, a pharmacy monograph patient information sheet is not reviewed or regulated by the FDA.

What is EDS in pharmacy?

Justification – Diagnosis and/or Indications for Use. NOTES REGARDING THE EXCEPTION DRUG STATUS (EDS) PROGRAM: Duly licensed practitioners prescribing within their scope of practice may apply for EDS. Requests can be submitted by mail or by fax.

Where can I get a drug monograph?

Prescription and Non-prescription Monographs

• RxList. The Internet Drug Index – part of the WebMD network.
• Drugs.com. Data sources include the Physicians’ Desk Reference (PDR), Cerner Multum, Thomson Reuters Micromedex and Wolters Kluwer Health.
• Medscape Drugs & Diseases. Free registration required – from WebMD.
• RxFiles.

What is a monograph example?

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 piece of writing of essay or book length on a specific, often limited subject.

What type of drug is monograph?

A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain.

What is an example of a monograph?

How do you read a USP monograph?

USP NF Online Tutorial Video S – YouTube

What medications should be avoided with EDS?

Official answer. With Ehlers-Danlos syndrome (EDS), experts recommend avoiding drugs that increase your risk of bleeding—such as anticoagulants and antiplatelet agents—because those affected with EDS are at higher risk for bruising and injury.

What is a common medication for EDS?

Medications. Your doctor may prescribe drugs to help you control: Pain. Over-the-counter pain relievers — such as acetaminophen (Tylenol, others) ibuprofen (Advil, Motrin IB, others) and naproxen sodium (Aleve) — are the mainstay of treatment.

What is the OTC monograph?

Simply stated, an OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients, uses (indications), doses, route of administration, labeling, and testing under which an OTC drug is generally recognized as safe and effective (GRASE).

What is an OTC monograph order request?

An OTC monograph drug sponsor may file a requestor-initiated order request (also called an OTC monograph order request, or OMOR) to establish or change conditions for an OTC drug. After a filing determination, FDA will proceed under the ordinary administrative order process.

How can I find a monograph?

Scholarly monographs are typically purchased by academic and research libraries for use by scholars, including students. You won’t usually find them on bookstore shelves.

How do you read a monograph?

1. Start with a BOOK REVIEW. Professional historians do all the time.
2. Read the INTRODUCTION very carefully. Ask yourself the following questions:
3. Review the TABLE OF CONTENTS. How are the chapters arranged?
4. Read the INDIVIDUAL CHAPTERS.
5. Read the CONCLUSION.

How do you find drug monographs?

Prescription and Non-prescription Monographs

1. RxList. The Internet Drug Index – part of the WebMD network.
2. Drugs.com. Data sources include the Physicians’ Desk Reference (PDR), Cerner Multum, Thomson Reuters Micromedex and Wolters Kluwer Health.
3. Medscape Drugs & Diseases. Free registration required – from WebMD.
4. RxFiles.

What is a monograph format?

Monograph is a straightforward and concise form of writing a research paper with less details on a specific subject or addressing a single identified research problem.

What is a general monograph?

A treatise on a particular subject or specific aspect of a subject. [mono- + G. graphē, a writing]

Does vitamin C help with Ehlers Danlos?

Supplementation with vitamin C has also been shown to improve collagen synthesis/clinical status in some patients with Ehlers–Danlos syndrome [7] Based on the above data, a dose of 1500 mg/ day of vitamin C is proposed.

Why is Ehlers Danlos painful?

Patients with EDS lose some of the sense of where their joints shouldbe, which causes misalignment. And this is a large factor in their pain.

Why is EDS so painful?

Causes and contributors to pain in EDS can include joints coming out of position, previous surgery (often done to treat pain), muscle weakness, improper movement in the neck and back, or issues with sense of joint position.

What is required on an OTC label?

The product’s active ingredients, including the amount in each dosage unit. The purpose of the product. The uses (indications) for the product. Specific warnings, including when the product should not be used under any circumstances, and when it is appropriate to consult with a doctor or pharmacist.

What is monograph antibiotic?

Monodox (doxycycline monohydrate) is a tetracycline antibiotic used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, and chlamydia, periodontitis (gum disease), and others.

Do OTC drugs go through clinical trials?

Unlike the NDA process, the OTC drug monograph process does not require a manufacturer to submit clinical trial data demonstrating safety and effectiveness of an individual drug product, nor does it require an OTC drug product to be approved by FDA before marketing.

Is a monograph the same as a book?

In library cataloging, monograph has a broader meaning—that of a nonserial publication complete in one volume (book) or a definite number of volumes. Thus it differs from a serial or periodical publication such as a magazine, academic journal, or newspaper.