Hosp Pharm 2015;50(11):985–993 2015 © Thomas Land Publishers, Inc. www.hospital-pharmacy.com doi: 10.1310/hpj5011-985
Original Article
US Food and Drug Administration Web Site: A Primer for Pharmacists James Leonard* and Danial E. Baker, PharmD, FASCP, FASHP†
ABSTRACT The US Food and Drug Administration (FDA) Web site includes a vast amount of information, but it can be difficult to navigate. Despite frequently asked question (FAQ)–type pages within the Web site, it may not be easy for first-time users to find drug information. This article presents some examples of common questions, provides the locations of the answers on the FDA Web site, and gives a brief description of some of the many resources the FDA provides for health care professionals. Additionally, a newer project being undertaken by the FDA, Snapshot, is introduced. Key Words—drug information, FDA, Food and Drug Administration, online resource, pharmacists Hosp Pharm—2015;50:985–993
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here are multiple resources available to pharmacists for drug information. Online sources include paid subscriptions (eg, Lexicomp, Micromedex, Clinical Pharmacology, Facts & Comparisons eAnswers, UpToDate),1,2 free sources (National Library of Medicine’s Drug Information Portal, Lactmed, Toxnet, Livertox, Medline Plus, PubMed Central, MEDLINE),3 and mixed free/paid (PubMed journal subscriptions, Merck Medicus).2 Unfortunately, updates to these resources can be delayed, and they rely upon the US Food and Drug Administration (FDA) as their source of information. Updated drug information is released on an almost daily basis in various sections of the FDA’s Web site. The ability to quickly navigate the site and find specific information can improve utility of the site for pharmacists. Multiple online drug information sources have been introduced by other authors, who have provided overviews of paid and free resources without in-depth descriptions.1-3 Marchand et al4 published an in-depth description of the FDA approval process and how it applies to formulary decisions. Grossman and Zerilli1 provided succinct descriptions of the Approved Drug Products with Therapeutic Equivalence Evaluations
(Orange Book), MedWatch, and the drug information database (Drugs@FDA). The FDA provides frequently asked questions (FAQ) within some sections (Drugs@FDA, Advisory Committee), but not for the whole Web site. The intent of this primer is to provide a more thorough description of available resources on the FDA Web site that are useful for hospital pharmacists, discuss some resources that have been omitted from other articles, and highlight some newer resources within the FDA (Table 1). FDA RESOURCES Homepage The FDA homepage5 provides a brief overview of the contents of the entire site. This includes abbreviated versions of other portions (eg, news, public health, initiatives) of the Web site along with a search function. For answers to some common types of questions and a guide to the location of the answers, see Table 1. The homepage has tabs to broad divisions (eg, Food, Drugs, Medical Devices, Vaccines, Blood & Biologics) that have more specific and directed information. The search function yields broad results that can be filtered by topics and formats or sorted by relevance or date.
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Doctor of Pharmacy student, College of Pharmacy, Washington State University, Spokane; †Professor of Pharmacotherapy, Director, Drug Information Center, College of Pharmacy, Washington State University, Spokane. Corresponding author: James Leonard, College of Pharmacy, Washington State University, PO Box 1495, Spokane, WA 99210-1495; phone: 509-358-7662; fax: 509-358-7744; e-mail: [email protected]
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Table 1. Fingertip guide to select questions Questions
Answer location
How can I sign up for email notifications from the FDA?
Subscribe to FDA e-mail alerts https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_ id=USFDA_221https://public.govdelivery.com/accounts/USFDA/subscriber/ new?topic_id=USFDA_221
Where can I report an ADR from a drug?
MedWatch: The FDA Safety Information and Adverse Event Reporting Program http://www.fda.gov/Safety/MedWatch/default.htm
Is buprenorphine injection still in shortage?
FDA Drug Shortages http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Is my lot of 0.9% NaCl recalled?
Drug Recalls http://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm
Is my wholesaler licensed in my state?
Know Your Source: Protecting Patient from Unsafe Drugs http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ ucm389121.htm
When was ramucirumab approved?
Drugs@FDA search http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
For what indication(s) is ramucirumab FDA approved?
Drugs@FDA search http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Does tocilizumab have a REMS program?
Postmarket Drug Safety Information for Patients and Providers http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm
Is Hospira’s acetylcysteine 20% solution generically equivalent to Acetadote?
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Is there a generic equivalent for ReoPro (abciximab)?
Purple Book: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ucm411418.htm
What did the FDA advisory committee say about serelaxin during the committee meeting?
Advisory Committee http://www.fda.gov/AdvisoryCommittees/default.htm
What information was provided to the advisory committee regarding the use of serelaxin?
Advisory Committee http://www.fda.gov/AdvisoryCommittees/default.htm
What are the most common ADRs seen in the studies used to approve vedolizumab?
Drug Trials Snapshot http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm
In what population was dalbavancin primarily studied?
Drug Trials Snapshot http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm
Note: ADR = adverse drug reaction; FDA = US Food and Drug Administration.
Drug Information The Drug Information page6 (FDA Home > Drug Databases > Drugs@FDA) of the FDA Web site is one of the most inclusive divisions. It has a search engine that can locate information for individual drugs based on at least 3 letters of a drug
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name, an A to Z index, or approval month. The site includes both small molecule and biologic medications. Once a medication is selected, links to the prescribing information, original and updated approval letters, risk evaluation and mitigation strategies (REMS) programs, and the FDA review
FDA Web Site Primer of Resources for Pharmacists
are available (Figure 1). The FDA review includes an extensive review of the pharmacology, clinical efficacy, and naming process, any action letters taken toward the company, and a summary review. The medical review includes descriptions of each study performed during the approval process. It is useful for finding data that may not have been published in peer-reviewed literature. Utilization of the
FDA Web site to guide formulary decisions has been discussed at length by other authors.4 Information for Healthcare Professionals (Drugs) The Information for Healthcare Professionals (Drugs) page7 [Home > Drugs > Resources for You > Information for Healthcare Professionals (Drugs)] provides a central link to all sites within the FDA
Figure 1. Drugs@FDA Information. Figure shows an example of a biological medication selected through Drugs@FDA. Links to the (1) prescribing information (label), (2) approval letter, (3) review, (4) summary review, and (5) REMS program are all available on this page.
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Web site that a health care professional may want to access regarding medications. The page only has links, but it is a convenient shortcut for providers to most of the sections discussed in this article.
warnings from the FDA regarding specific products that may contain undeclared ingredients or are no longer generically equivalent. Information is limited to hyperlink titles and dates of publication.
Drug Information Rounds The Drug Information Rounds page8 [Home > Drugs > Resources for You > Information for Healthcare Professionals (Drugs); left panel] contains videos describing multiple initiatives in process by the FDA regarding medications. Videos are available from May 2010 and are added infrequently (1 to 5 videos per year since 2010). Topics include new safety information (long-acting beta-agonists, 2010; proton pump inhibitors, 2011), patents (2012), communicating benefit and risk information (2013), managing drug shortages (2014), and disposal of unused medicines (2015). This material can be used by pharmacists to educate patients (benefit and risk information; traveling with prescription medications) or to develop policies for management of medicine in the hospital (disposal of unused medicines).
Drug Shortages The FDA Drug Shortages page12 (Home > Drugs > Drug Safety and Availability > Drug Shortages) spotlights recent updates and provides links to updates discussing how the FDA is working to prevent and mitigate drug shortages. Information is limited and is focused mostly on providing links. The Drug Shortages database is available as a link from the FDA Drug Shortages page.13 This database has a search engine with multiple features. Users can search by at least 3 characters of a generic name, view the products indexed by letter, search by class, or search new and updated shortages. Discontinued medications are listed and include the estimated time current supplies will last. Subscribers to e-mail updates will be notified when there are changes to shortages. As noted by other authors, the American Society of Health-System Pharmacists (ASHP) provides a similar list that includes therapeutic alternatives.1
Drug Safety and Availability The Drug Safety and Availability page9 (Home > Drugs > Drug Safety and Availability) links to the following 3 primary sections: drug safety communications, current drug recalls, and shortages. It is similar to the Information for Healthcare Professionals (Drugs) page, but it includes links to recent communications and recalls, whereas Information for Healthcare Professionals (Drugs) does not include descriptors for any of the links. Drug Safety Communications The Drug Safety Communications section10 (Home > Drugs > Drug Safety and Availability) of the FDA Web site provides brief descriptions of safety announcements throughout the year. These are often related to new warnings, rare adverse reactions, and changes to drug labels. Each individual link provides a short summary of the medication, information for patients and providers, and a clinical summary of the reason for the alert (eg, 6 patients experienced an infection). Although the page does not include a search engine, there are a limited number of Drug Safety Communications posted (between 30 and 50 per year), and the “Find” function works within browsers. Similar to the Drug Safety Communications are Drug Alerts and Statements.11 This source includes
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Drug Recalls Drug Recalls14 (Home > Drugs > Drug Safety and Availability > Drug Recalls) is a repository of press releases from manufacturers announcing recalls. Recalls are listed in chronological order, and each link is a title. The titles are often formatted as company name, type of recall, number of lots, geographic location, product, and then reason for recall. Recall notifications are sent via e-mail alerts. Know Your Source: Protecting Patients from Unsafe Drugs When shortages occur, buyers will often look to new suppliers for medications. The FDA warns of “stolen, counterfeit, substandard, or unapproved” medications from rogue wholesalers.15,16 They have provided links to verify that a supplier is licensed in your state on their Know Your Source: Protecting Patients from Unsafe Drugs page (Home > Drugs > Resources for You > Information for Healthcare Professionals (Drugs); left panel).17 The FDA also recommends that professionals pay attention to patients’ reports that their medication is not effective or causing new adverse events, especially if there are m ultiple reports or there has been a recent change in supplier.18
FDA Web Site Primer of Resources for Pharmacists
MedWatch: The FDA Safety Information and Adverse Event Reporting Program MedWatch19 (Home > Safety > MedWatch: The FDA Safety Information and Adverse Event Reporting Program) or FAERS is a reporting system and database for potential medication issues. Because medications are approved in trials involving hundreds to a few thousand patients, not all potentially serious, but rare, adverse events are identified prior to marketing. This postmarketing surveillance program is made up of voluntary submissions from consumers and health care professionals. Updates to the prescribing information are made if the FDA determines that there is a significant risk potential. One example of this was the additional warning of severe skin reactions (acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that was added to acetaminophen-containing products in October 2013.20 After review, the FDA posts their findings and any recommendations on the MedWatch page. Users can report problems to the FDA through the MedWatch site via the “Report a Problem” link. Reports are narrative and can include patient demographics, a description of the problem, the product, and any concomitant factors that may contribute to the problem. The MedWatch page lists updates in chronological order. It offers titles of topics along with a short blurb about the post. Each topic title is a hyperlink that leads a user to the full post. These posts outline the issue in discussion and provide some background on the issue, official recommendations (eg, do not purchase/use, warn patients to watch for adverse events, increase monitoring frequency), a link to the “Dear Healthcare Provider” letter, and previous releases that are related to the topic at hand. Along with these documents, the page cross-references to DailyMed, medication guides, a reporting system, and postmarket safety evaluations. MedWatch safety alerts are included in e-mail subscription, through Twitter, and an RSS feed. Medication Errors The Medication Errors page21 (Home > Drugs > Drug Safety and Availability > Medication Errors) has a very short list of potentially problematic drugs. Problems include similar packaging (heparin and insulin), similar drug names (Keppra and Kaletra), poor labeling (Anzemet), and others. The list is not nearly as inclusive as the Institute of Safe Medication Practice’s (ISMP) look-alike and sound-alike (LASA)
list or error-prone abbreviations, symbols, and dose designations lists, but the FDA provides extensive recommendations to prevent reoccurrence of the error.22,23 Additionally, it does not appear as if the site is updated consistently; the last communication was published in 2012. The site links externally to ISMP’s lists. Postmarketing Safety Index to Drug-Specific Information Similar to the Drug Safety Communications page, the Postmarketing Safety Index to Drug-Specific Information page24 (Home > Drugs > Drug Safety and Availability > Postmarket Drug Safety Information for Patients and Providers) informs the reader of cumulative changes in the prescribing information and other potential safety issues regarding specific drugs. Each link is updated as changes happen, and the user can find the history of safety updates for a drug. The page is alphabetically indexed and lists medications by both proprietary and generic names. Each link provides updates to the prescribing information, including changes in precautions, boxed warnings, updates due to manufacturing issues, and others. The FDA also does postmarketing safety reviews and evaluations 18 months post approval or after 10,000 patients have used the drug of biologic product.19 Reports include the major indication(s), a summary of findings, and actions taken by the agency, if any.25 REMS programs are included in postmarket drug safety information.26 The approved REMS programs, along with a brief summary of what is required, are supplied by the FDA. The agency also provides a list of drugs no longer included in REMS programs.27 Requirements of REMS include education, medication guides, elements to ensure safe use, and an implementation plan. A more in-depth discussion of specific REMS programs is available elsewhere.28 Vaccines, Blood & Biologics Therapeutic biologics including monoclonal antibodies, cytokines, growth factors, enzymes, immunomodulators, and thrombolytics are listed in Drugs@FDA (Home > Vaccines, Blood & Biologics).29 The Center for Biologics Evaluation and Research (CBER) evaluates other biologic “drug” products not included in Drugs@FDA. These include fractionated plasma products, infectious disease tests, and blood grouping and phenotyping reagents.30 Searching on the home page for a specific biologic yields a product-specific page that includes
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supporting documents, press releases, and prescribing information, similar to Drugs@FDA results as shown in Figures 1 and 2.31,32 Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)33 (FDA Home > Drug Databases > Orange Book) is the FDA’s generic equivalency resource. The page has a search engine that can locate information based on proprietary, generic, patent, applicant, or application number. Search results include whether or not the item is the Reference Listed Drug (RLD) and the dosage form, strength, and manufacturer. Additional search options include over-the-counter or discontinued drug products. The preface of the Orange Book defines the terms found within the book, requirements for equivalence, and definitions of codes and abbreviations. In brief, the RLD is the original prod-
uct (usually the brand name) to which other agents are compared: “A” coded drugs (eg, AB, AC, AN) are approved therapeutic equivalents; “B” coded drugs (eg, BB, BC, BN) are products with actual or potential equivalence issues that have not been resolved. “B” coded drugs should not be interchanged for the RLD. The Orange Book has been presented and reviewed by other authors.1 Purple Book The Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity of Interchangeability Evaluations34 [Home > Drugs > Development & Approval Process (Drugs) > How Drugs are Developed and Approved > Types of Applications > Therapeutic Biologic Applications (BLA) > Biosimilars] is the FDA’s biologic interchangeability (biosimilar) equivalency resource. Biosimilars may be approved based on analytical
Figure 2. Kcentra information. An example of a biologic medication available through the Vaccines, Blood & Biologics site. Links to the (1) prescribing information (product label), (2) approval letter, (3) summary review, and (4) press release are all available on this page.
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studies, animal (toxicity) studies, and human studies for immunogenicity, pharmacokinetic, and pharmacodynamic properties. These products will be considered interchangeable with the RLD and will be approved as substitutes without prescriber consent.35 The Purple Book is separated into 2 lists — one from the Center for Drug Evaluation and Research (CDER) and one from CBER. A description of what constitutes a biologic product being evaluated by CDER or CBER has been previously provided. Although the Purple Book does not currently include therapeutically interchangeable medications, anticipated biosimilars include adalimumab, etanercept, infliximab, and rituximab, among others. A checklist for hospital pharmacy formulary inclusion has been proposed and published in Hospital Pharmacy.36 Advisory Committees For some new medications, the FDA enlists advisory committees to discuss and decide on specific questions. The Advisory Committees page37 (Home > Advisory Committee) includes a search bar along with links to upcoming meetings. Medications that undergo advisory panel review often have complex risk-benefit profiles or are first-in-class treatments.4 FDA advisory committees are made up of experts in their respective field, with limited conflicts of interest [18 U.S.C. 208(a)]. Even though the FDA is not required to follow the advice of the FDA Advisory Committee, they often do. Announcements for specific meetings are on the main advisory committee page. Materials related to the meeting (eg, briefing documents, draft questions) are supplied ideally 2 days prior to the meeting.37 The utility of advisory committee decisions and reports for formulary decisions has been discussed elsewhere.4 NEW FDA PROGRAM Drug Trials Snapshot One of the new programs initiated by the FDA is the Snapshot program (Home > Drugs > Drug Approvals and Databases; left panel).38 The program is currently limited to a few recently approved drugs, with anticipated additions starting January 2015. The Snapshot program provides a breakdown of pivotal trials of new medications. It provides graphical summaries of subgroups by age, gender, and race, presenting differences in efficacy and adverse events experienced in clinical trials for each group. This Web page is designed for patients and is written in plain language, but it is also useful for providers to refer patients for
more information. Pharmacists in the hospital could provide either a link or a handout to patients requesting information about a new drug. There is also a link to the full medical review of the drug. MOST CURRENT INFORMATION Keeping up with daily changes is best facilitated by 2 main pages on the FDA site: the What’s New Related to Drugs and e-mail alerts. The What’s New Related to Drugs page39 (Home > Drugs > News & Events) provides a brief overview of news for the day. This includes links to shortages, Drug Safety Communications, new presentations, medication guides, drug approvals, public notifications, and other. Information on this Web page is limited, but a convenient overview is provided and each link connects to separate departments with in-depth explanations. The list of topics for e-mail subscription40 (Home> About FDA > Contact FDA > Stay Informed > Get Email Updates) is too long to include in full, but some of the more useful topics of interest to pharmacists include Drug Information, Drug Shortages, Consumer Health Information, BadAd, and Drug Safety news. Users can set their preferences to receive e-mails immediately, daily, or weekly (some alerts are e-mailed immediately regardless of your preferences). Individuals can find a link on the FDA homepage to “Follow FDA.” Links to e-mail subscription, social media, blogs, videos, and podcasts are available. DISCUSSION The FDA Web site provides a lot of information, but many pharmacists may find that only a small portion of the site is useful for their practice. A director of pharmacy in charge of purchasing may either frequently check the shortages database or rely upon their e-mail subscription to see updates regarding shortages. If they see that a medication has an anticipated shortage or has been recalled, they may want to look at new suppliers; they could then refer to the Know Your Source Web page to verify that wholesalers in the area are licensed. To verify generic equivalency, the purchasing pharmacist could reference the Orange Book prior to purchasing a new product. A Pharmacy and Therapeutics Committee looking to evaluate a new drug may wait a few months for the full medical review to be published on Drugs@FDA or Vaccines, Blood & Biologics.4 The reviewing committee would be able to see every trial submitted to the FDA along
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with commentary as to why a drug may or may not be approved in a specific population or for a specific use. Alternatively, if the medication underwent review by an advisory panel, unpublished studies may be available in the briefing document prior to the publication of the full FDA review. The Pharmacy and Therapeutics team may use the briefing document to aid in formulary decisions. Prior to formulary addition of a biosimilar product, the reviewing committee should evaluate any information contained in the Purple Book to verify therapeutic interchangeability with an RLD. If patients report severe adverse events to a pharmacist, it is the obligation of that pharmacist to file a report with MedWatch. The Snapshot program provides a brief overview of pivotal trials for patient handouts or patient information requests. Checking the What’s New Related to Drugs Web page on a regular basis provides a brief overview of the FDA’s daily actions. Although descriptions are limited, the page does provide links to stories, press releases, and other departments of the FDA. Drug Information Rounds provides a useful overview of different projects and descriptions of various aspects of the FDA. These videos could be used for educational sessions for new students and new pharmacists. The FDA Web site is by no means all-inclusive. Medications that have been approved as generics are rarely updated with efficacy data, although safety data is updated. If clinicians are searching for offlabel uses of a medication (eg, gabapentin for diabetic neuropathy), they will not find information on the FDA Web site. Shortage management information is limited to anticipated market return date, rather than therapeutic interchange information that is provided by ASHP.1 The Snapshot program is new and is limited to a few medications approved during 2014; although starting in 2015, all newly approved biologic and small molecule medications will be included. CONCLUSION The FDA Web site contains medical information pertinent to patients, prescribers, and pharmacists. It can be difficult to navigate for some individuals, but by subscribing to select e-mail topics and frequently checking the most commonly updated portions of the site, practitioners stay current with crucial topics related to medication safety, information, and approvals. 992
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ACKNOWLEDGMENTS Conflicts of interest: The authors state no known conflicts of interest. Additional contributions: The authors would like to acknowledge Drs. Anne Kim, Colleen Terriff, Ross Bindler, and Shannon Panther for feedback and insights from pharmacists in various fields. REFERENCES 1. Grossman S, Zerilli T. Health and medication information resources on the World Wide Web. J Pharm Pract. 2013;26(2):85-94. 2. Martin CM, Counts SL. Get the information you need: Top clinical web sites. Consult Pharm. 2010;25(9):544-553. 3. Knoben JE, Phillips SJ. New drug information resources for pharmacists at the National Library of Medicine. J Am Pharm Assoc. 2014;54:49-55. 4. Marchand HC, Rose BJ, Fine AM, Kremzner ME. The U.S. Food and Drug Administration: Drug information resource for formulary recommendations. J Manage Care Pharm. 2012;18(9):713-718. 5. US Food and Drug Administration. Homepage. http:// www.fda.gov/default.htm. Accessed February 17, 2015. 6. Drugs@FDA. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm. Accessed February 17, 2015. 7. Information for Healthcare Professionals (Drugs). US Food and Drug Administration Web site. http://www.fda.gov/ Drugs/ResourcesForYou/HealthProfessionals/default.htm. Accessed February 17, 2015. 8. FDA Drug Info Rounds Video. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/ResourcesFor You/HealthProfessionals/ucm211957.htm. Accessed February 17, 2015. 9. Drug Safety and Availability. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ default.htm. Accessed February 17, 2015. 10. Drug Safety Communications. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ ucm199082.htm. Accessed February 17, 2015. 11. Drug Alerts and Statements. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ ucm215175.htm. Accessed February 17, 2015. 12. Drug Shortages. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm. Accessed February 17, 2015. 13. FDA Drug Shortages. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/drugshortages/ default.cfm. Accessed February 17, 2015. 14. Drug Recalls. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default. htm. Accessed February 17, 2015.
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15. Beware of Offers. US Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396537.pdf. Accessed February 17, 2015.
28. Nelson LS, Loh M, Perrone J. Assuring safety of inherently unsafe medications: The FDA risk evaluation and mitigation strategies. J Med Toxicol. 2014;10(2):165-172.
16. Caution! Check Signs. US Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396536.pdf. Accessed February 17, 2015.
29. Vaccines, Blood & Biologics. US Food and Drug Administration Web site. http://www.fda.gov/BiologicsBloodVaccines/ default.htm. Accessed December 17, 2014.
17. Know Your Source: Protecting Patients from Unsafe Drugs. US Food and Drug Administration Web site. http:// www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ ucm389121.htm. Accessed February 17, 2015. 18. Pay Close Attention. US Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/ResourcesFor You/HealthProfessionals/UCM396544.pdf. Accessed February 17, 2015. 19. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. US Food and Drug Administration Web site. http://www.fda.gov/Safety/MedWatch/default.htm. Accessed February 17, 2015. 20. FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ucm363041.htm. Published August 1, 2013. Accessed February 17, 2015. 21. Medication Errors. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ default.htm. Accessed February 17, 2015. 22. ISMP’s List of Confused Drug Names. Institute for Safe Medication Practices Web site. http://www.ismp.org/tools/ confuseddrugnames.pdf. Updated April 2014. Accessed December 17, 2014. 23. ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations. Institute for Safe Medication Practices Web site. http://www.ismp.org/tools/errorproneabbreviations. pdf. Updated 2013. Accessed December 17, 2014. 24. Index to Drug-Specific Information. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/ DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm. Accessed February 17, 2015. 25. Postmarket Drug and Biologic Safety Evaluations. US Food and Drug Administration Web site. http://www.fda. gov/Drugs/GuidanceComplianceRegulatoryInformation/ Surveillance/ucm204091.htm. Accessed December 17, 2014. 26. Approved Risk Evaluation and Mitigation Strategies (RE MS). US Food and Drug Administration Web site. http://www. fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm. Accessed December 17, 2014. 27. Released REMS. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm393231.htm. Accessed December 17, 2014.
30. Vaccines, Blood & Biologics. Licensed Products (BLAs). US Food and Drug Administration Web site. http://www.fda.gov/ BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/default.htm. Accessed December 17, 2014. 31. Vaccines, Blood & Biologics. Kcentra (Prothrombin Complex Concentrate, Human). US Food and Drug Administration Web site. http://www.fda.gov/biologicsbloodvaccines/ bloodbloodproducts/approvedproducts/licensedproductsblas/ fractionatedplasmaproducts/ucm350130.htm. Accessed December 17, 2014. 32. Drugs@FDA. Label and Approval History. Myalept. US Food and Drug Administration Web site. http://www.accessdata. fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search. Label_ApprovalHistory#apphist. Accessed December 17, 2014. 33. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/ob/ default.cfm. Accessed December 17, 2014. 34. Purple Book: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ ucm411418.htm. Accessed December 17, 2014. 35. Biologics Price Competition and Innovation Act of 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf. Accessed February 17, 2015. 36. Griffith N, McBride A, Stevenson JG, Green L. Formulary selection criteria for biosimilars: Considerations for US healthsystem pharmacists. Hosp Pharm. 2014;49(9):813-825. 37. Advisory Committees. US Food and Drug Administration Web site. http://www.fda.gov/AdvisoryCommittees/default. htm. Accessed December 17, 2014. 38. Drug Trials Snapshot. US Food and Drug Administration Website. http://www.fda.gov/Drugs/InformationOnDrugs/ ucm412998.htm. Accessed February 17, 2015. 39. What’s New Related to Drugs. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/News Events/ucm130958.htm. Accessed February 17, 2015. 40. Email Updates. US Food and Drug Administration Web site. https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_221. Accessed February 17, 2015.
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Original Article
US Food and Drug Administration Web Site: A Primer for Pharmacists James Leonard* and Danial E. Baker, PharmD, FASCP, FASHP†
ABSTRACT The US Food and Drug Administration (FDA) Web site includes a vast amount of information, but it can be difficult to navigate. Despite frequently asked question (FAQ)–type pages within the Web site, it may not be easy for first-time users to find drug information. This article presents some examples of common questions, provides the locations of the answers on the FDA Web site, and gives a brief description of some of the many resources the FDA provides for health care professionals. Additionally, a newer project being undertaken by the FDA, Snapshot, is introduced. Key Words—drug information, FDA, Food and Drug Administration, online resource, pharmacists Hosp Pharm—2015;50:985–993
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here are multiple resources available to pharmacists for drug information. Online sources include paid subscriptions (eg, Lexicomp, Micromedex, Clinical Pharmacology, Facts & Comparisons eAnswers, UpToDate),1,2 free sources (National Library of Medicine’s Drug Information Portal, Lactmed, Toxnet, Livertox, Medline Plus, PubMed Central, MEDLINE),3 and mixed free/paid (PubMed journal subscriptions, Merck Medicus).2 Unfortunately, updates to these resources can be delayed, and they rely upon the US Food and Drug Administration (FDA) as their source of information. Updated drug information is released on an almost daily basis in various sections of the FDA’s Web site. The ability to quickly navigate the site and find specific information can improve utility of the site for pharmacists. Multiple online drug information sources have been introduced by other authors, who have provided overviews of paid and free resources without in-depth descriptions.1-3 Marchand et al4 published an in-depth description of the FDA approval process and how it applies to formulary decisions. Grossman and Zerilli1 provided succinct descriptions of the Approved Drug Products with Therapeutic Equivalence Evaluations
(Orange Book), MedWatch, and the drug information database (Drugs@FDA). The FDA provides frequently asked questions (FAQ) within some sections (Drugs@FDA, Advisory Committee), but not for the whole Web site. The intent of this primer is to provide a more thorough description of available resources on the FDA Web site that are useful for hospital pharmacists, discuss some resources that have been omitted from other articles, and highlight some newer resources within the FDA (Table 1). FDA RESOURCES Homepage The FDA homepage5 provides a brief overview of the contents of the entire site. This includes abbreviated versions of other portions (eg, news, public health, initiatives) of the Web site along with a search function. For answers to some common types of questions and a guide to the location of the answers, see Table 1. The homepage has tabs to broad divisions (eg, Food, Drugs, Medical Devices, Vaccines, Blood & Biologics) that have more specific and directed information. The search function yields broad results that can be filtered by topics and formats or sorted by relevance or date.
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Doctor of Pharmacy student, College of Pharmacy, Washington State University, Spokane; †Professor of Pharmacotherapy, Director, Drug Information Center, College of Pharmacy, Washington State University, Spokane. Corresponding author: James Leonard, College of Pharmacy, Washington State University, PO Box 1495, Spokane, WA 99210-1495; phone: 509-358-7662; fax: 509-358-7744; e-mail: [email protected]
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Table 1. Fingertip guide to select questions Questions
Answer location
How can I sign up for email notifications from the FDA?
Subscribe to FDA e-mail alerts https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_ id=USFDA_221https://public.govdelivery.com/accounts/USFDA/subscriber/ new?topic_id=USFDA_221
Where can I report an ADR from a drug?
MedWatch: The FDA Safety Information and Adverse Event Reporting Program http://www.fda.gov/Safety/MedWatch/default.htm
Is buprenorphine injection still in shortage?
FDA Drug Shortages http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
Is my lot of 0.9% NaCl recalled?
Drug Recalls http://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm
Is my wholesaler licensed in my state?
Know Your Source: Protecting Patient from Unsafe Drugs http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ ucm389121.htm
When was ramucirumab approved?
Drugs@FDA search http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
For what indication(s) is ramucirumab FDA approved?
Drugs@FDA search http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Does tocilizumab have a REMS program?
Postmarket Drug Safety Information for Patients and Providers http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.htm
Is Hospira’s acetylcysteine 20% solution generically equivalent to Acetadote?
Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Is there a generic equivalent for ReoPro (abciximab)?
Purple Book: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ TherapeuticBiologicApplications/Biosimilars/ucm411418.htm
What did the FDA advisory committee say about serelaxin during the committee meeting?
Advisory Committee http://www.fda.gov/AdvisoryCommittees/default.htm
What information was provided to the advisory committee regarding the use of serelaxin?
Advisory Committee http://www.fda.gov/AdvisoryCommittees/default.htm
What are the most common ADRs seen in the studies used to approve vedolizumab?
Drug Trials Snapshot http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm
In what population was dalbavancin primarily studied?
Drug Trials Snapshot http://www.fda.gov/Drugs/InformationOnDrugs/ucm412998.htm
Note: ADR = adverse drug reaction; FDA = US Food and Drug Administration.
Drug Information The Drug Information page6 (FDA Home > Drug Databases > Drugs@FDA) of the FDA Web site is one of the most inclusive divisions. It has a search engine that can locate information for individual drugs based on at least 3 letters of a drug
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name, an A to Z index, or approval month. The site includes both small molecule and biologic medications. Once a medication is selected, links to the prescribing information, original and updated approval letters, risk evaluation and mitigation strategies (REMS) programs, and the FDA review
FDA Web Site Primer of Resources for Pharmacists
are available (Figure 1). The FDA review includes an extensive review of the pharmacology, clinical efficacy, and naming process, any action letters taken toward the company, and a summary review. The medical review includes descriptions of each study performed during the approval process. It is useful for finding data that may not have been published in peer-reviewed literature. Utilization of the
FDA Web site to guide formulary decisions has been discussed at length by other authors.4 Information for Healthcare Professionals (Drugs) The Information for Healthcare Professionals (Drugs) page7 [Home > Drugs > Resources for You > Information for Healthcare Professionals (Drugs)] provides a central link to all sites within the FDA
Figure 1. Drugs@FDA Information. Figure shows an example of a biological medication selected through Drugs@FDA. Links to the (1) prescribing information (label), (2) approval letter, (3) review, (4) summary review, and (5) REMS program are all available on this page.
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Web site that a health care professional may want to access regarding medications. The page only has links, but it is a convenient shortcut for providers to most of the sections discussed in this article.
warnings from the FDA regarding specific products that may contain undeclared ingredients or are no longer generically equivalent. Information is limited to hyperlink titles and dates of publication.
Drug Information Rounds The Drug Information Rounds page8 [Home > Drugs > Resources for You > Information for Healthcare Professionals (Drugs); left panel] contains videos describing multiple initiatives in process by the FDA regarding medications. Videos are available from May 2010 and are added infrequently (1 to 5 videos per year since 2010). Topics include new safety information (long-acting beta-agonists, 2010; proton pump inhibitors, 2011), patents (2012), communicating benefit and risk information (2013), managing drug shortages (2014), and disposal of unused medicines (2015). This material can be used by pharmacists to educate patients (benefit and risk information; traveling with prescription medications) or to develop policies for management of medicine in the hospital (disposal of unused medicines).
Drug Shortages The FDA Drug Shortages page12 (Home > Drugs > Drug Safety and Availability > Drug Shortages) spotlights recent updates and provides links to updates discussing how the FDA is working to prevent and mitigate drug shortages. Information is limited and is focused mostly on providing links. The Drug Shortages database is available as a link from the FDA Drug Shortages page.13 This database has a search engine with multiple features. Users can search by at least 3 characters of a generic name, view the products indexed by letter, search by class, or search new and updated shortages. Discontinued medications are listed and include the estimated time current supplies will last. Subscribers to e-mail updates will be notified when there are changes to shortages. As noted by other authors, the American Society of Health-System Pharmacists (ASHP) provides a similar list that includes therapeutic alternatives.1
Drug Safety and Availability The Drug Safety and Availability page9 (Home > Drugs > Drug Safety and Availability) links to the following 3 primary sections: drug safety communications, current drug recalls, and shortages. It is similar to the Information for Healthcare Professionals (Drugs) page, but it includes links to recent communications and recalls, whereas Information for Healthcare Professionals (Drugs) does not include descriptors for any of the links. Drug Safety Communications The Drug Safety Communications section10 (Home > Drugs > Drug Safety and Availability) of the FDA Web site provides brief descriptions of safety announcements throughout the year. These are often related to new warnings, rare adverse reactions, and changes to drug labels. Each individual link provides a short summary of the medication, information for patients and providers, and a clinical summary of the reason for the alert (eg, 6 patients experienced an infection). Although the page does not include a search engine, there are a limited number of Drug Safety Communications posted (between 30 and 50 per year), and the “Find” function works within browsers. Similar to the Drug Safety Communications are Drug Alerts and Statements.11 This source includes
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Drug Recalls Drug Recalls14 (Home > Drugs > Drug Safety and Availability > Drug Recalls) is a repository of press releases from manufacturers announcing recalls. Recalls are listed in chronological order, and each link is a title. The titles are often formatted as company name, type of recall, number of lots, geographic location, product, and then reason for recall. Recall notifications are sent via e-mail alerts. Know Your Source: Protecting Patients from Unsafe Drugs When shortages occur, buyers will often look to new suppliers for medications. The FDA warns of “stolen, counterfeit, substandard, or unapproved” medications from rogue wholesalers.15,16 They have provided links to verify that a supplier is licensed in your state on their Know Your Source: Protecting Patients from Unsafe Drugs page (Home > Drugs > Resources for You > Information for Healthcare Professionals (Drugs); left panel).17 The FDA also recommends that professionals pay attention to patients’ reports that their medication is not effective or causing new adverse events, especially if there are m ultiple reports or there has been a recent change in supplier.18
FDA Web Site Primer of Resources for Pharmacists
MedWatch: The FDA Safety Information and Adverse Event Reporting Program MedWatch19 (Home > Safety > MedWatch: The FDA Safety Information and Adverse Event Reporting Program) or FAERS is a reporting system and database for potential medication issues. Because medications are approved in trials involving hundreds to a few thousand patients, not all potentially serious, but rare, adverse events are identified prior to marketing. This postmarketing surveillance program is made up of voluntary submissions from consumers and health care professionals. Updates to the prescribing information are made if the FDA determines that there is a significant risk potential. One example of this was the additional warning of severe skin reactions (acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that was added to acetaminophen-containing products in October 2013.20 After review, the FDA posts their findings and any recommendations on the MedWatch page. Users can report problems to the FDA through the MedWatch site via the “Report a Problem” link. Reports are narrative and can include patient demographics, a description of the problem, the product, and any concomitant factors that may contribute to the problem. The MedWatch page lists updates in chronological order. It offers titles of topics along with a short blurb about the post. Each topic title is a hyperlink that leads a user to the full post. These posts outline the issue in discussion and provide some background on the issue, official recommendations (eg, do not purchase/use, warn patients to watch for adverse events, increase monitoring frequency), a link to the “Dear Healthcare Provider” letter, and previous releases that are related to the topic at hand. Along with these documents, the page cross-references to DailyMed, medication guides, a reporting system, and postmarket safety evaluations. MedWatch safety alerts are included in e-mail subscription, through Twitter, and an RSS feed. Medication Errors The Medication Errors page21 (Home > Drugs > Drug Safety and Availability > Medication Errors) has a very short list of potentially problematic drugs. Problems include similar packaging (heparin and insulin), similar drug names (Keppra and Kaletra), poor labeling (Anzemet), and others. The list is not nearly as inclusive as the Institute of Safe Medication Practice’s (ISMP) look-alike and sound-alike (LASA)
list or error-prone abbreviations, symbols, and dose designations lists, but the FDA provides extensive recommendations to prevent reoccurrence of the error.22,23 Additionally, it does not appear as if the site is updated consistently; the last communication was published in 2012. The site links externally to ISMP’s lists. Postmarketing Safety Index to Drug-Specific Information Similar to the Drug Safety Communications page, the Postmarketing Safety Index to Drug-Specific Information page24 (Home > Drugs > Drug Safety and Availability > Postmarket Drug Safety Information for Patients and Providers) informs the reader of cumulative changes in the prescribing information and other potential safety issues regarding specific drugs. Each link is updated as changes happen, and the user can find the history of safety updates for a drug. The page is alphabetically indexed and lists medications by both proprietary and generic names. Each link provides updates to the prescribing information, including changes in precautions, boxed warnings, updates due to manufacturing issues, and others. The FDA also does postmarketing safety reviews and evaluations 18 months post approval or after 10,000 patients have used the drug of biologic product.19 Reports include the major indication(s), a summary of findings, and actions taken by the agency, if any.25 REMS programs are included in postmarket drug safety information.26 The approved REMS programs, along with a brief summary of what is required, are supplied by the FDA. The agency also provides a list of drugs no longer included in REMS programs.27 Requirements of REMS include education, medication guides, elements to ensure safe use, and an implementation plan. A more in-depth discussion of specific REMS programs is available elsewhere.28 Vaccines, Blood & Biologics Therapeutic biologics including monoclonal antibodies, cytokines, growth factors, enzymes, immunomodulators, and thrombolytics are listed in Drugs@FDA (Home > Vaccines, Blood & Biologics).29 The Center for Biologics Evaluation and Research (CBER) evaluates other biologic “drug” products not included in Drugs@FDA. These include fractionated plasma products, infectious disease tests, and blood grouping and phenotyping reagents.30 Searching on the home page for a specific biologic yields a product-specific page that includes
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supporting documents, press releases, and prescribing information, similar to Drugs@FDA results as shown in Figures 1 and 2.31,32 Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)33 (FDA Home > Drug Databases > Orange Book) is the FDA’s generic equivalency resource. The page has a search engine that can locate information based on proprietary, generic, patent, applicant, or application number. Search results include whether or not the item is the Reference Listed Drug (RLD) and the dosage form, strength, and manufacturer. Additional search options include over-the-counter or discontinued drug products. The preface of the Orange Book defines the terms found within the book, requirements for equivalence, and definitions of codes and abbreviations. In brief, the RLD is the original prod-
uct (usually the brand name) to which other agents are compared: “A” coded drugs (eg, AB, AC, AN) are approved therapeutic equivalents; “B” coded drugs (eg, BB, BC, BN) are products with actual or potential equivalence issues that have not been resolved. “B” coded drugs should not be interchanged for the RLD. The Orange Book has been presented and reviewed by other authors.1 Purple Book The Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity of Interchangeability Evaluations34 [Home > Drugs > Development & Approval Process (Drugs) > How Drugs are Developed and Approved > Types of Applications > Therapeutic Biologic Applications (BLA) > Biosimilars] is the FDA’s biologic interchangeability (biosimilar) equivalency resource. Biosimilars may be approved based on analytical
Figure 2. Kcentra information. An example of a biologic medication available through the Vaccines, Blood & Biologics site. Links to the (1) prescribing information (product label), (2) approval letter, (3) summary review, and (4) press release are all available on this page.
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studies, animal (toxicity) studies, and human studies for immunogenicity, pharmacokinetic, and pharmacodynamic properties. These products will be considered interchangeable with the RLD and will be approved as substitutes without prescriber consent.35 The Purple Book is separated into 2 lists — one from the Center for Drug Evaluation and Research (CDER) and one from CBER. A description of what constitutes a biologic product being evaluated by CDER or CBER has been previously provided. Although the Purple Book does not currently include therapeutically interchangeable medications, anticipated biosimilars include adalimumab, etanercept, infliximab, and rituximab, among others. A checklist for hospital pharmacy formulary inclusion has been proposed and published in Hospital Pharmacy.36 Advisory Committees For some new medications, the FDA enlists advisory committees to discuss and decide on specific questions. The Advisory Committees page37 (Home > Advisory Committee) includes a search bar along with links to upcoming meetings. Medications that undergo advisory panel review often have complex risk-benefit profiles or are first-in-class treatments.4 FDA advisory committees are made up of experts in their respective field, with limited conflicts of interest [18 U.S.C. 208(a)]. Even though the FDA is not required to follow the advice of the FDA Advisory Committee, they often do. Announcements for specific meetings are on the main advisory committee page. Materials related to the meeting (eg, briefing documents, draft questions) are supplied ideally 2 days prior to the meeting.37 The utility of advisory committee decisions and reports for formulary decisions has been discussed elsewhere.4 NEW FDA PROGRAM Drug Trials Snapshot One of the new programs initiated by the FDA is the Snapshot program (Home > Drugs > Drug Approvals and Databases; left panel).38 The program is currently limited to a few recently approved drugs, with anticipated additions starting January 2015. The Snapshot program provides a breakdown of pivotal trials of new medications. It provides graphical summaries of subgroups by age, gender, and race, presenting differences in efficacy and adverse events experienced in clinical trials for each group. This Web page is designed for patients and is written in plain language, but it is also useful for providers to refer patients for
more information. Pharmacists in the hospital could provide either a link or a handout to patients requesting information about a new drug. There is also a link to the full medical review of the drug. MOST CURRENT INFORMATION Keeping up with daily changes is best facilitated by 2 main pages on the FDA site: the What’s New Related to Drugs and e-mail alerts. The What’s New Related to Drugs page39 (Home > Drugs > News & Events) provides a brief overview of news for the day. This includes links to shortages, Drug Safety Communications, new presentations, medication guides, drug approvals, public notifications, and other. Information on this Web page is limited, but a convenient overview is provided and each link connects to separate departments with in-depth explanations. The list of topics for e-mail subscription40 (Home> About FDA > Contact FDA > Stay Informed > Get Email Updates) is too long to include in full, but some of the more useful topics of interest to pharmacists include Drug Information, Drug Shortages, Consumer Health Information, BadAd, and Drug Safety news. Users can set their preferences to receive e-mails immediately, daily, or weekly (some alerts are e-mailed immediately regardless of your preferences). Individuals can find a link on the FDA homepage to “Follow FDA.” Links to e-mail subscription, social media, blogs, videos, and podcasts are available. DISCUSSION The FDA Web site provides a lot of information, but many pharmacists may find that only a small portion of the site is useful for their practice. A director of pharmacy in charge of purchasing may either frequently check the shortages database or rely upon their e-mail subscription to see updates regarding shortages. If they see that a medication has an anticipated shortage or has been recalled, they may want to look at new suppliers; they could then refer to the Know Your Source Web page to verify that wholesalers in the area are licensed. To verify generic equivalency, the purchasing pharmacist could reference the Orange Book prior to purchasing a new product. A Pharmacy and Therapeutics Committee looking to evaluate a new drug may wait a few months for the full medical review to be published on Drugs@FDA or Vaccines, Blood & Biologics.4 The reviewing committee would be able to see every trial submitted to the FDA along
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with commentary as to why a drug may or may not be approved in a specific population or for a specific use. Alternatively, if the medication underwent review by an advisory panel, unpublished studies may be available in the briefing document prior to the publication of the full FDA review. The Pharmacy and Therapeutics team may use the briefing document to aid in formulary decisions. Prior to formulary addition of a biosimilar product, the reviewing committee should evaluate any information contained in the Purple Book to verify therapeutic interchangeability with an RLD. If patients report severe adverse events to a pharmacist, it is the obligation of that pharmacist to file a report with MedWatch. The Snapshot program provides a brief overview of pivotal trials for patient handouts or patient information requests. Checking the What’s New Related to Drugs Web page on a regular basis provides a brief overview of the FDA’s daily actions. Although descriptions are limited, the page does provide links to stories, press releases, and other departments of the FDA. Drug Information Rounds provides a useful overview of different projects and descriptions of various aspects of the FDA. These videos could be used for educational sessions for new students and new pharmacists. The FDA Web site is by no means all-inclusive. Medications that have been approved as generics are rarely updated with efficacy data, although safety data is updated. If clinicians are searching for offlabel uses of a medication (eg, gabapentin for diabetic neuropathy), they will not find information on the FDA Web site. Shortage management information is limited to anticipated market return date, rather than therapeutic interchange information that is provided by ASHP.1 The Snapshot program is new and is limited to a few medications approved during 2014; although starting in 2015, all newly approved biologic and small molecule medications will be included. CONCLUSION The FDA Web site contains medical information pertinent to patients, prescribers, and pharmacists. It can be difficult to navigate for some individuals, but by subscribing to select e-mail topics and frequently checking the most commonly updated portions of the site, practitioners stay current with crucial topics related to medication safety, information, and approvals. 992
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ACKNOWLEDGMENTS Conflicts of interest: The authors state no known conflicts of interest. Additional contributions: The authors would like to acknowledge Drs. Anne Kim, Colleen Terriff, Ross Bindler, and Shannon Panther for feedback and insights from pharmacists in various fields. REFERENCES 1. Grossman S, Zerilli T. Health and medication information resources on the World Wide Web. J Pharm Pract. 2013;26(2):85-94. 2. Martin CM, Counts SL. Get the information you need: Top clinical web sites. Consult Pharm. 2010;25(9):544-553. 3. Knoben JE, Phillips SJ. New drug information resources for pharmacists at the National Library of Medicine. J Am Pharm Assoc. 2014;54:49-55. 4. Marchand HC, Rose BJ, Fine AM, Kremzner ME. The U.S. Food and Drug Administration: Drug information resource for formulary recommendations. J Manage Care Pharm. 2012;18(9):713-718. 5. US Food and Drug Administration. Homepage. http:// www.fda.gov/default.htm. Accessed February 17, 2015. 6. Drugs@FDA. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index. cfm. Accessed February 17, 2015. 7. Information for Healthcare Professionals (Drugs). US Food and Drug Administration Web site. http://www.fda.gov/ Drugs/ResourcesForYou/HealthProfessionals/default.htm. Accessed February 17, 2015. 8. FDA Drug Info Rounds Video. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/ResourcesFor You/HealthProfessionals/ucm211957.htm. Accessed February 17, 2015. 9. Drug Safety and Availability. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ default.htm. Accessed February 17, 2015. 10. Drug Safety Communications. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ ucm199082.htm. Accessed February 17, 2015. 11. Drug Alerts and Statements. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/ ucm215175.htm. Accessed February 17, 2015. 12. Drug Shortages. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm. Accessed February 17, 2015. 13. FDA Drug Shortages. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/drugshortages/ default.cfm. Accessed February 17, 2015. 14. Drug Recalls. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default. htm. Accessed February 17, 2015.
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15. Beware of Offers. US Food and Drug Administration Web site. http://www.fda.gov/downloads/Drugs/ResourcesForYou/HealthProfessionals/UCM396537.pdf. Accessed February 17, 2015.
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30. Vaccines, Blood & Biologics. Licensed Products (BLAs). US Food and Drug Administration Web site. http://www.fda.gov/ BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/default.htm. Accessed December 17, 2014. 31. Vaccines, Blood & Biologics. Kcentra (Prothrombin Complex Concentrate, Human). US Food and Drug Administration Web site. http://www.fda.gov/biologicsbloodvaccines/ bloodbloodproducts/approvedproducts/licensedproductsblas/ fractionatedplasmaproducts/ucm350130.htm. Accessed December 17, 2014. 32. Drugs@FDA. Label and Approval History. Myalept. US Food and Drug Administration Web site. http://www.accessdata. fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search. Label_ApprovalHistory#apphist. Accessed December 17, 2014. 33. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration Web site. http://www.accessdata.fda.gov/scripts/cder/ob/ default.cfm. Accessed December 17, 2014. 34. Purple Book: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ ucm411418.htm. Accessed December 17, 2014. 35. Biologics Price Competition and Innovation Act of 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf. Accessed February 17, 2015. 36. Griffith N, McBride A, Stevenson JG, Green L. Formulary selection criteria for biosimilars: Considerations for US healthsystem pharmacists. Hosp Pharm. 2014;49(9):813-825. 37. Advisory Committees. US Food and Drug Administration Web site. http://www.fda.gov/AdvisoryCommittees/default. htm. Accessed December 17, 2014. 38. Drug Trials Snapshot. US Food and Drug Administration Website. http://www.fda.gov/Drugs/InformationOnDrugs/ ucm412998.htm. Accessed February 17, 2015. 39. What’s New Related to Drugs. US Food and Drug Administration Web site. http://www.fda.gov/Drugs/News Events/ucm130958.htm. Accessed February 17, 2015. 40. Email Updates. US Food and Drug Administration Web site. https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_221. Accessed February 17, 2015.
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