How to Build a Product Monograph

A product monograph is a factual, scientific document produced for pharmaceuticals that describes the properties of a drug and information necessary for safe dispensation and use. A product monograph is developed for doctors who prescribe the drug and consumers. The document does not contain promotional media, so it is regarded as an objective source of information about the properties of a drug. In the United States, the Food and Drug Administration (FDA) regulates monographs.

Instructions

• 1

  Describe the pharmacology of the drug. This includes all aspects of the effect of the drug on the body. Extent and rate of absorption, distribution, metabolism and excretion in the body are listed, which describe how the body processes a drug. Pharmacology also includes what the drug does to the body, including biochemical and physiological effects and how they relate to concentration of the drug.

• 2

  Review clinical trials. This includes a brief explanation of the methods used in the trials and the results that were produced. This also includes a clinical significance of the results.

• 3

  List indications and clinical uses. This is often phrased as, "Drug X is indicated for the treatment of symptoms A, B and C." These should be listed as bulleted points for clarity. This is usually accompanied by a notice that the drug should only be used for the clinical uses specified.

• 4

  List contraindications in bullet points. These are conditions under which the drug should not be used. A common contraindication specifies that women who are pregnant or breastfeeding should not take Drug X, for example. This also includes warnings and precautions about the effects of the drug on these conditions.

• 5

  Include a description of adverse reactions. List common and rare side effects, and the frequency of adverse reactions observed in clinical trials.

• 6

  List drug interactions and toxicology. Any drugs that alter the effectiveness or cause an adverse reaction should be listed, as well as drugs whose effectiveness is altered by the drug. Other substances that interact with the drug, such as alcohol, should also be described.

• 7

  Indicate dosage and administration for the prescribing doctor and the patient. These are detailed instructions for use. This should also include information about symptoms and treatment of overdosage. Also list special handling instructions.

• 8

  Include a glossary of terms. Also list the ingredients and their indications. Many product monographs also list the structural formula of the drug as a diagram and its molecular formula.

• 9

  Include a section for consumers with important information in laymen's terms. This can be a summary of the above information a consumer can easily understand.

• 10

  Organize the above information in a logical way that separates doctor's instructions from consumer information for easy readability. Bullet points improve clarity and readability. Strong headings and subheadings also improve comprehensibility. Style choices like bolding and boxes give salience to important points, particularly contraindications, adverse reactions and drug interactions.