An excellent place to begin. It contains the most relevant drug information related to the drug.
Although it is not a complete listing, most of the FDA-approved prescription medications are listed.
Manufacturers offer useful information as well.
Primary literature plays a critical role in your research. Start by conducting a literature search and retrieve any pertinent articles related to your drug.
New Drug Application (NDA)
NDA's can be a very helpful in identifying limitations or pitfalls in the data that was submitted to the FDA.
Guidelines and Position Statements
Depending on the therapeutic area, professional associations, societies and organizations may have published statements that may help define the role of the medication for a given condition.
Criteria for Use
Healthcare organizations' criteria for use can be extremely helpful insight and support for or against a specific recommendation you are considering.
Evidence Based Medicine Resources
Evidence-Based Medicine Tools and databases promote evidence-informed health decision-making. Also, they point you to primary care literature.
Drug Information Databases
Drug information databases are structured in a similar format to the drug monograph and therefore may help simplify the information gathering
A variety of books can help you get the details you need for a complete monograph
Resources for Researching a Formulary Request
The following information resources serve as a guide to anyone interested in preparing a comprehensive drug monograph. References can be categorized into primary, secondary and tertiary drug information resources. Keep in mind that the information provided in these resources can change over time so it is important to indicate the date when the resource was used to access the information.
Not all of these resources are required for each drug monograph so it is important to individualize each review based on the medication and the indication. There is no right or wrong order to gathering information about the drug in question. However, the prescribing information is a good place to start.
The prescribing information is an excellent place to begin as you prepare a drug monograph as it contains the most relevant drug information related to the drug. The prescribing information is also known by several other names including the package insert, licensing information, or the approved labeling from the Food and Drug Administration (FDA). There are various sources for accessing the prescribing information for the drug in question including the drug manufacturer's website and the FDA Access Data site. Additionally, the prescribing information may be attached to or provided with the original manufacturer's packaging of the medication and in many online drug information databases.
The website DailyMed contains drug listings as submitted to the FDA for approved prescription medicines. Although it is not a complete listing, most of the FDA-approved prescription medications are listed. It provides information on medication content and labeling found in medication prescribing information. It may be used in place of the prescribing information as the information contained in both is the same.
Manufacturer's Medication Dossier
The medication dossier prepared by the pharmaceutical manufacturer can provide helpful information that can be used to complete the drug monograph. The dossier follows the Academy of Managed Care Pharmacy format. The dossier is only available after an unsolicited request is made to the manufacturer and the medication is FDA-approved and labeling has been finalized. Often, medication dossiers may not be immediately available following a medication's approval by the FDA. Useful components within the dossier can include pre-clinical trials, dose-finding studies, safety studies, a summary of posters/ abstracts presented at medical conferences, pharmacoeconomic modeling such as estimates on cost-effectiveness, budget impact models, and comparative effectiveness research.
Manufacturer's Press Release/Investor Relations
Reviewing manufacturer press releases or other investor-related information may help provide valuable information related to the marketing strategy for the medication. This can be helpful when evaluating a very expensive or targeted therapy as it can help distinguish the role of the drug relative to its comparators in the marketplace.
PubMed [Medline] or other similar indexing/abstracting services (EMBASE, CINAHL, IPA, etc.) are a critical step in reviewing the literature on the subject you are researching. You should conduct a literature search and retrieve any pertinent articles related to your drug. The results of this search can be compared to the studies reviewed in the manufacturer's medication dossier. Keep track of your literature search terms and always search using generic drug names. The number of available articles retrieved can vary based on the drug being researched.
Identifying a review article or a systematic review can help provide a summary of the published literature and may guide you to studies that you may not have identified through your initial literature search. Importantly, review articles may identify therapeutic areas where there are gaps in the literature or unmet clinical need and where further studies are needed.
New Drug Application (NDA) and Amended New Drug Applications (ANDA)
Searching for the New Drug Application and the Amended New Drug Application that the manufacturer submitted to the FDA for approval can be a very helpful document to review. The NDA/ANDA may include comments that the expert review committee provided to the manufacturer and may highlight limitations or pitfalls in the data that was submitted to the FDA. The New Drug Application and the Amended New Drug Application databases are both searchable and available on the FDA's web page.
Depending on the therapeutic area, professional associations, professional societies and organizations may have published statements that may help define the role of the medication for a given condition. To locate this information, search the Agency for Healthcare Research and Quality, National Guideline Clearinghouse. Not all therapeutic areas have guideline-driven care. Also, many of the guidelines take time to update, so it is common that new therapies may not appear in guidelines right away. One exception is in oncology where the practice is highly guideline-driven, National Comprehensive Cancer Network Guidelines. Always look for guidelines even if the guidelines are published by other countries as they can provide context regarding the drug's place in therapy. Reviewing international guidelines is important as the medication may have been marketed already in other countries and post-marketing experience would be very important to include in the drug monograph. Examples of guidelines include the National Institute for Health and Care Excellence (NICE) from the National Health Service in England only. In some instances you may find NICE guidelines that extend to Wales, Scotland and Northern Ireland depending on unique agreements between countries. Another helpful resource is the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) which also publishes medication-related guidelines. The Society of Nuclear Medicine and Molecular Imaging is another excellent resource for guidelines involving radiopharmaceuticals and contrast agents.
Criteria for Use from Other Healthcare Organizations
Accessing other healthcare organizations criteria for use can be extremely helpful in identifying a specific role in therapy for a given medication. The US Department of Veterans Affairs publishes clinical guidance on medications including drug monographs through their Pharmacy Benefits Management Services as well as drug class reviews. These documents can help provide additional insight and support for or against a specific recommendation you are considering.
Importantly, commercial health plans and managed care organizations may publish their prior-authorization criteria for the specific medication in question. This information can help guide recommendations that may include guidance on step-therapy (trying one or two therapies first before starting on the therapy in question), tier design (preference for a less expensive generic over a more expensive brand name medication), and restrictions for use (e.g., approved for a limited duration, in combination with other therapies, prescribed by a specialist, disease severity).
Cochrane is a global independent network of healthcare providers, researchers, and others, that aims to make sense of the vast amounts of evidence generated through research. Previously known as The Cochrane Collaboration, it is a not-for-profit organization where collaborators aim to produce credible, accessible health information that is free from commercial sponsorship and other conflicts of interest. Cochrane's mission is to promote evidence-informed health decision-making by producing high quality, relevant, accessible, systematic reviews, and other synthesized research evidence.
The published systematic reviews attempt to collate all empirical evidence that fits pre-specified eligibility criteria to answer a specific research question. It uses explicit, systematic methods that are selected to minimizing bias, thus providing more reliable findings from which conclusions can be drawn and decisions made. Searching the Cochrane library can help summarize the literature for areas where there is a significant amount of published studies.
Point of Care Evidence-Based Medicine Tools such as UpToDate and DynaMed Plus can help provide an overview of the standard of care for a given diagnosis. These resources are referenced which directs you to the primary literature supporting the approach to care. These tools can help provide you with an understanding of the general approach to the condition in which the medication is used.
Check with your institution to determine whether your institution subscribes to these tools otherwise the cost may be prohibitive to access as an individual user.
Clinical Trials in Development
A critical step in preparing a drug monograph is to consider other uses that are under investigation or may serve as unapproved indications. This information can help provide context for future uses for the medication and possibly new indications that the manufacturer may be pursuing. This can also help formulary managers forecast future expanded uses for a new or existing medication on the formulary and can assist with budgeting. An excellent resource for this information is Clinical Trials.gov. This resource provides information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). For each clinical trial, the site summarizes the stage of each clinical trial (e.g., recruiting, enrolling, completed, etc.).
Drug Information Databases
A comprehensive source for drug information is AHFS Clinical Drug Information. Lexicomp, Clinical Pharmacology and Micromedex are three drug information databases that may be used to prepare a drug monograph. Each of these databases requires a subscription; check with your institution to determine which of these resources are available. These databases are structured in a similar format to the drug monograph and therefore may help simplify the information gathering about the drug in question. In addition, institutional access to specific sub-databases and content may vary depending on the subscription, so it is important to know what your institution subscribes to, e.g. information non-FDA approved uses, ongoing clinical trials, etc.
The publications listed below provide very specific information that is not generally found elsewhere. This is not comprehenisive list of publications on these topics, but a good place to start.
The Orange Book is also known as the Approved Drug Products with Therapeutic Equivalence Evaluations. This reference contains medications that contain pharmaceutical equivalents that are expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
This Purple Book contains information on biological products specifically biosimilar medications and whether the medications are interchangeable with a reference biological product (an already-licensed FDA biological product) under the FDA, Public Health Service Act.
The Yellow Book
The Yellow Book is also known as the CDC Health Information for International Travel. The resource is published every two years with the latest health recommendations for international travel. It is written primarily for health care providers, including doctors, nurses, and pharmacists, who help travelers prepare for upcoming trips. The resource offers information on travel-related health risks, prevention strategies and offers advice for people with special travel health needs.
Drug Topics Red Book
Each institution's drug acquisition costs are individualized and can vary greatly depending on the organization's contracts, patients served, rebates and other purchasing-related financial incentives. The Average Wholesale Price (AWP) is one benchmark that may be used to summarize the medications cost. AWP information is available through the Drug Topics Red Book. The AWP is solely focused on the drug itself and does not include other medication-related costs (e.g., opportunity costs, ancillary costs, healthcare quality of life, etc.). A more detailed discussed on the pharmacoeconomic considerations for medications is provided in the Pharmacoeconomics section.
Training Videos/Conference Proceedings
The availability of medication-related video and audio recordings has grown significantly over the years. Accessing a manufacturer's training video can be a very helpful strategy when reviewing a therapy that has complex preparation, dilution or administration instructions. The information contained in the video can be included in the monograph and can aid in explaining the workflow required in the specific practice setting of the health system. Additionally, videos that contain subject matter experts or key opinion leaders discussing the disease state or medication during conference proceedings may be extremely helpful as they may summarize a treatment approach that may not be found in printed materials (e.g. clinical trials, review articles, etc.).
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