Monograph Methodology

From Pubdrug

Contents 1 Pubdrug.org Monograph Template Methodology 1.1 I. Choose Principal References 1.2 II. Research Web-based Resources 1.3 III. Research for Generic Drugs 1.4 IV. Review References 1.5 V. Constructing the Main Monograph Body 1.6 VI. Fine Tuning

Pubdrug.org Monograph Template Methodology

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I. Choose Principal References

• Package insert
• Drug handbook
• Clinical pharmacology text
• Drug interactions text

When choosing references to cite, remember that all factual or qualitative data must be substantiated by at least one primary source (journal article) or two or more secondary or tertiary resources. The only exception to this rule is the package insert, which may be cited as a primary source.

II. Research Web-based Resources

• Product Webpage (i.e. Lipitor.com)
• Manufacturer Webpage (i.e. Pfizer.com)
• Drug Treating Disease Webpage (i.e. National Cholesterol Education Webpage)
• Electronic Site for Clinical Guidelines for the Disease

III. Research for Generic Drugs

• Information on generic drugs requires tedious searching and the utilization of numerous search engines to locate appropriate information. Leads to articles can be found though PubMed, Medline and Embase searches using key words to narrow the number of studies to a specific topic. Google scholar and baseline searches are also useful. Often literature citations or excerpts may be found, which can then be used to access the full journal article through U.B. libraries.
• Generic drugs have often been on the market for an extended time, thus trials may not be found in recent journals. These can usually be accessed through Bison or Iliad.
• Clinical Pharmacology is worth looking at for direction to cited information. Using a cited journal article in a PubMed search will often bring up multiple similar trails. Additionally citations used in pertinent articles are often useful in finding additional articles with desirable information
• HubNet is another valuable resource with books and search engines, such as StatRef. These are useful for basic drug information with linked citations.
• The Drug Bank: http://redpoll.pharmacy.ualberta.ca/drugbank/index.html is a distinctive resource with approximately 4300 drug entries. It is supported by the Canadian federal government as a comprehensive source of genomic, pharmacologic, chemoinfomatic and bioinformatics information. Drug card entries contain greater than 80 data fields. The suggested citation is: Wishart DS et al., DrugBank: a comprehensive resource for in silico drug discovery and exploration. Nucleic Acids Res. 2006 1;34.
• Drug package inserts may be available online and provide a good starting resource for basic drug information, though may not be available for older drugs. Drug information for healthcare professionals can be found on the FDA site: http://www.fda.gov/cder/.

IV. Review References

• Read through all chosen references and decide which source will provide the most accurate and complete information for each section of the monograph.
• It is often necessary to use multiple references to construct most of the sections of the monograph.

V. Constructing the Main Monograph Body

• It is recommended that the text is typed directly into the edit field on the pubdrug.org site instead of compiling in another word processor such as Microsoft Word. The format of word and some of the characters in Word are not reciprocal for WikiMedia. Furthermore, compiling directly in the edit field will facilitate your learning of WikiMedia code, which will help down the road when you are fine tuning the page and creating tables, inserting images, etc.
• Suggested order for inserting information into each section:

1. Insert external website resources (from Section II): This will help to navigate to these pages when you are referring to them while compiling the rest of the text. Also, it is a check mechanism to see if your links are working properly.
2. Complete sections which contain purely factual information such as: Product Availability, NDC codes, Administration & Dosage Information.
3. Next insert the Adverse Reactions/Side Effects. Be sure to include the relative incidence range for each side effect (i.e. headache (5-10%). This information is most likely not readily available in the package insert and this is where a current drug information handbook such as Lexi-comp’s Drug Information Handbook is valuable.
4. Next insert the FDA-Approved and Non-FDA Approved Indications. This section should have the primary clinical trials which led to the indication approval or validation of the non-approved indication cited. These studies are generally discussed heavily in the current package inserts.
5. Next insert the Pharmacokinetic data as separated into Absorption, Distribution, Metabolism, & Excretion. This section requires focus because the information must be in your own words and will likely come from multiple sources. Package inserts, the primary phase I and phase II trials (if available), and PK review articles will have this information available. Make sure to be as complete as possible. We want to have the most complete source for clinical reference in one place.
6. Next insert the Mechanism of Action (MOA) section. This data will come from mainly a reputable, current pharmacology text, as well as the package insert. Try to be as complete and descriptive as possible. To often drug references are scarce on the MOA, which leads to an incomplete understanding of the drugs mechanism. And if the pharmacist completely understands a drugs mechanism it will truly help in predicting drug/drug or drug/food interactions, adverse reactions, and side effect without having to refer back to the drug information source.
7. Now that you have a good understanding of the drug, it is time to insert the drugs description. This section showcases the drugs utility as a member of a class of drugs and it is also the time to distinguish it from other members of a class (either positively or negatively). Remember, this is a non-biases drug information source. If you find that one drug in a class is proven superior to the others for whatever reason, this is the place to state that information. Generally, this section is 2 paragraphs, the first will discuss some disease background for the disease the drug treats and the benefit(s) the drug brings treatment. Also, product history should be included in the first paragraph (i.e. digoxin come from the Digitalis purpurea plant, etc). The second paragraph is reserved for specific efficacy information. Here you would include the primary outcome or what the drug is supposed to do (i.e. it is supposed to lower blood pressure) and how efficacious it is at completing that task (i.e. it will lower the blood pressure on average of 15 mmHg at 100 mg daily). This is where you would compare the drug’s efficacy with others in its class or drugs in other classes.
8. Next you should insert your references in the respective places throughout the text.
9. Next you should find the most relevant primary literature for your drug and insert the link to the PubMed abstracts and a free text copy if available.
10. Construct the Quick Reference Table for your drug (See separate document for instructions).

VI. Fine Tuning

• Check or recheck all links to make sure they are functional.
• Internally link all drugs on your monograph so they will be linked when the respective monograph is created.