How to Write a Product Monograph

chillibreeze writer — Dr. Queenita Fernandes

In the medical, or more precisely, pharmaceutical community a ‘Product Monograph’ stands for a factual, scientific document that describes the properties, claims, indications and conditions of use for a drug. Developed by the drug manufacturer, it may or may not be according to certain guidelines. Mostly prepared for new drugs, a product monograph needs to meet the informative needs of a community or consumers. Some health communities may have a standard format, however it is widely disseminated.

A Product Monograph should contain material that communicates well with the major three sections of society,

Health Professional
Scientific Information
Patient Information

Health professionals, patients and the general public require accurate, objective and complete information on drugs approved for use in any country all over the world, to ensure safe and effective use.

Health Professional

The Information for the ‘Health Professional’ section contains essential prescribing information, including dosage and strength, indications and clinical uses, warnings and precautions, adverse reactions and drug interactions.

Scientific Information

The Scientific Information section contains more detailed scientific information including toxicology and data from animal studies, clinical trials, pharmaceutical information and pharmacology.

Patient Information

Such a section may or may not be included. It is informative about how to use the medicine safely and most effectively.

How to begin a product monograph

Summary:

The Product Monograph may begin with an executive summary highlighting the most relevant points of the drug or class review. It may extend to 2 pages. For instance when was the drug approved, who gave the approval, what class the drug belongs to, what are its combinations etc.

Let’s take the example of Emtricitabine:

Emtricitabine was approved on July 2, 2003 for use in combination with other antiretrovirals (ARVs) to treat HIV-1 infection in adults. This indication was based upon virologic (HIV viral load) and immunologic (CD4 lymphocyte count) responses during controlled clinical trials in ARV-naïve and ARV-experienced patients. To date, only one of these clinical trials has been published in a peer-reviewed journal while the others have been presented at scientific meetings in oral presentations and poster formats. Information presented in this monograph includes much of this information as well as data filed with the FDA for the new drug application (NDA).

Emtricitabine belongs to the nucleoside reverse transcriptase inhibitor (nRTI) class of anti-HIV agents. There are currently 9 products from the nRTI class of anti-HIV agents on the VA National Formulary. Each has a unique profile that permits its use in a specific patient relative to co-administered medications, existing resistance mutations and co-morbid conditions. For this review, all drugs in the nRTI class will be included to permit comparisons where data are available. The medications are:

Single Agent	Co-formulated Product
abacavir (ZIAGEN®, ABC)	lamivudine/zidovudine (Combivir®, CBV)
didanosine (VIDEX®, VIDEX® EC, ddI)	abacavir/lamivudine/zidovudine (Trizivir®, TZV)
lamivudine (EPIVIR®, 3TC)
stavudine (ZERIT®, ZERIT® XR, d4T)
tenofovir (VIREAD®, TFV)
zalcitabine (HIVID®, ddC)
zidovudine (RETROVIR®, ZDV)
emtricitabine (EmtrivaTM, FTC)*

Current drug development trials only study a single agent as monotherapy for a short period of time (2 weeks) to limit the possible development of resistance in that study cohort. As a result, there is practically no information on the long-term effect (clinical outcome or toxicity related) of any single agent approved since 1996. Also, ARVs are to be prescribed as a multidrug regimen making assessment of toxicities difficult especially when agents share common side effect profiles (e.g. rash).

(Source: http://www.pbm.va.gov/monograph/9857emtricitabine.pdf; www.vapbm.org or http://vaww.pbm.med.va.gov )

Contents of a product monograph

1. Pharmacology of the drug
2. Clinical Trials
3. Indications and Clinical Uses
4. Contraindications
5. Warnings and Precautions
6. Adverse Reactions
7. Toxicology and Drug Interactions
8. Dosage and Administration
9. Special Handling Instructions
10. Glossary

Pharmacology of the drug:

"Pharmacon" meaning drug and "kinetikos" meaning putting in motion, is a branch of pharmacology dedicated to the determination of the fate of substances administered externally. Pharmacokinetics is often divided into several areas including, but not limited to, the extent and rate of Absorption, Distribution, Metabolism and Excretion. This sometimes is referred to as the ‘ADME’ scheme.

Pharmacokinetics is often studied in conjunction with pharmacodynamics. Pharmacodynamics is the study of the biochemical and physiological effects of drugs and the mechanisms of drug action and the relationship between drug concentration and effect. Pharmacodynamics is often summarized as the study of what a drug does to the body, whereas pharmacokinetics is the study of what the body does to a drug. Pharmacodynamics is sometimes abbreviated as "PD", and when referred to in conjunction with pharmacokinetics can be referred to as "PKPD".

Clinical Trials

Clinical trials vary greatly in size: from a single researcher in one hospital/clinic to an international multicenter study with several hundred participating researchers on several continents. Data pertaining to such trials are added under this heading in a systematic manner. This is considered relevant information.

Some examples of what a clinical trial may be designed to do:

assess the safety and effectiveness of a new medication or device on a specific kind of patient (e.g., patients who have been diagnosed with Alzheimer's disease for less than one year)
assess the safety and effectiveness of a different dose of a medication than is commonly used (e.g., 10 mg dose instead of 5 mg dose)
assess the safety and effectiveness of an already marketed medication or device on a new kind of patient (who is not yet approved by regulatory authorities to be given the medication or device)
assess whether the new medication or device is more effective for the patient's condition than the already used, standard medication or device ("the gold standard" or "standard therapy")
compare the effectiveness in patients with a specific disease of two or more already approved or common interventions for that disease (e.g., Device A vs. Device B, Therapy A vs. Therapy B)

Other points:

Clinical trials included in the Clinical Trials section should be properly referenced (e.g. published reference, data on file).
There should be explanations of differences between statistical findings in a trial compared with clinical findings. That is, there should be an explanation of the clinical significance of a statistical finding.
ADRs from clinical trials should be in this section.
There should be a clear description of the patient enrollment criteria, the duration of the trial, drop-out statistics (including reasons for drop-outs) and the characteristics of the patient population, including age, sex, and pregnancy and lactation. Results should be stratified by patient group.
The information in the clinical trials section should be expanded to include information about clinical experience.
Level of evidence needs to be described (e.g. randomised trial, multicentre study).
May be presented in the format of a tabulated summary.

Adverse Drug Reactions

This section should clearly indicate the frequency (percentage of time reaction occurs) of the particular adverse reaction and the probability of it occurring. Adverse drug reactions should be graded according to severity.

For serious adverse reactions, there should be information about how to recognize it and what the patient should do about it.
There should be information that explains to the consumer how to report adverse drug reactions.
The type of adverse reactions and the risk of those reactions should be included in any advertising for the drug.
The information about adverse drug reactions needs to be presented in a user-friendly format and updated regularly.
Both consumers as well as health professionals should be able to report adverse drug reactions.
Some monographs may have a feedback mechanism on adverse drug reaction reporting for both the patient and the reporter of the reaction.
Global data on adverse drug reactions should be reported.
Need information oriented to parents when dealing with children.
Need more information in pregnancy and lactation. Not sufficient to state not safe in pregnancy. Patients may need to continue medication and may be put at risk.

Certain points to remember:

Sections like indications, contraindications, and adverse reactions should be presented in bullet form for easier retrieval. They need to be precise and accurate leaving no room for doubt. Tabular formats may capture the important details of results; hence may also be used wherever suitable for instance in toxicology and drug interactions.

Glossary

A glossary of terms presented in the end may be in two languages such as English and French. Mostly meant for patients and students they should include words such as "sensitivity" and "adverse reaction" to allow the consumer/ health professional to understand the information better. There should be standardized terminology for drug information

Updating product monographs:

Information needs to be updated regularly since knowledge base is limited at initial marketing and grows later.

How to end a product monograph

The product monograph may be ended in any of the following manner:

Reader’s notes
Product / company advertisements
Product catch line
List of the various marketed products
Product pipeline in tablular format that names the product, phase and indication
Pharmaceutical name, address and website

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—About our writer:

Dr. Queenita,

A classical homeopath by profession. Friendly and family - oriented person. Always strives to be a perfectionist!

How to Write a Product Monograph

chillibreeze writer — Dr. Queenita Fernandes

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