When investigating a claim for injury related to a pharmaceutical product there are many resources available via the Internet. A general search engine such as Google (www.google.com) will provide general information concerning litigation involving these products. By selecting the advanced Google search option for news services you can find information provided by popular newswire services. When performing a general search for the drug or product by name you can find lawfirm websites, medical information and a variety of resources that are valuable in researching your client’s claim. Some of the professional and peer reviewed resources available online are discussed below.
International and National Pharmacopoeias
In the so-called pharmacopoeias the respective governments of a state issue obligatory regulations for the quality of the active ingredients and also the excipients of a medicine. Consequently pharmacopoeias represent important prescriptions for a chemist in his pharmacy and the researching pharmaceutical industry, but also for universities and regulatory authorities all over the world.
Caused by the rapidly increasing globalization we see ourselves again and again confronted with the need for pharmaceutical regulations of other countries and other parts of the world. However, once in this situation we often do not know where we can obtain these information. One place found on the web is at http://www.pharmacopoeia.org.uk/ where information on purchasing pharmacopeias from European, middle eastern, and oriental countries is found.
The United States Pharmacopeia
What is the U.S. Pharmacopeia?
The United States Pharmacopeia (USP) is a non-government organization that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. These standards are developed by a unique process of public involvement and are accepted worldwide. In addition to standards development, USP’s other public health programs focus on promoting optimal health care delivery and are listed below. USP is a not-for-profit organization that achieves its goals through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, the U.S. government, the pharmaceutical industry, and consumer organizations.
USP works closely with the Food and Drug Administration (FDA), the pharmaceutical industry, and the health professions, to establish authoritative drug standards. These standards are enforceable by the FDA and the governments of other countries, and are recognized worldwide as the hallmark of quality. More than 3,800 standards monographs are published in the U.S. Pharmacopeia (USP) and the National Formulary (NF), the official drug standards compendia. USP also provides about 1,300 premier chemical Reference Standards to carry out the tests specified in USPBNF.
USP believes that the sharing of field experiences and concerns among health care professionals is important to reducing medication errors and providing safer, better quality health care. It therefore operates programs for health care professionals to report problems encountered during clinical practice. Reports received are used to build comprehensive information databases, improve USP’s drug standards, and provide feedback to reporting professionals, product manufacturers, and regulatory agencies. By sharing these experiences, pharmacists, nurses, physicians, and students can contribute to improved patient safety and to the development of valuable educational services for the prevention of future errors.
USP reviews each report for health hazards and forwards all information to the FDA and the product manufacturer. USP will act as your liaison with the FDA and the manufacturer should you wish to submit a report anonymously. The MER Program is presented in cooperation with the Institute for Safe Medication Practices.
What does USP do?
USP’s activities and initiatives revolve around four public health programs:
* Standards Establishing standards is a core USP activity. Currently, USP provides standards for more than 3,400 prescription and non-prescription drugs, nutritional and dietary supplements, veterinary drug standards, and health care products. These standards are published in the United States Pharmacopeia and the National Formulary (USP-NF), which are officially recognized in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. ‘ 321 et seq.). USP also produces Reference Standards, which are an integral part of USP’s standards program. In addition, USP offers a Pharmacopeial Education program that provides continuing educational courses for professionals working in the pharmaceutical industryChelping those who use the USP-NF better understand pharmacopeial processes, standards, and tests and methods.
* Dietary Supplement Verification Program (DSVP). USP has developed this program in response to the increasing concerns expressed about the quality of dietary supplements in the marketplace. Through compliance testing and document review, adherence to good manufacturing principles, and post-marketing surveillance, DSVP is designed to help assure that dietary supplement products contain the declared ingredients in the declared quantities. Further information about DSVP is at www.usp-dsvp.org.
* Health Care Information. In association with MICROMEDEX (a division of Thomson Publishing), USP provides oversight and approval of drug information content in the USP DI7 database, which covers nearly all medicines in the U.S. and Canada. USP contributes “value-added” information about new and off-label uses of drugs. USP’s Health Care Information program also consists of several global initiatives. USP was awarded several grants by the United States Agency for International Development’s (USAID) Center for Population, Health and Nutrition (PHN). Currently, USAID is supporting the USP Drug Quality and Information (USPDQI) program, which funds programs in Nepal, Russia, Mozambique, and the Mekong Delta region.
* Patient Safety. USP operates two medication error reporting, tracking, and analysis programs: the Medication Errors Reporting (MER) Program (operated in collaboration with the Institute for Safe Medication Practices) and the MedMARxSMProgram. MedMARx is an Internet-accessible database for hospitals to report and track medication errors anonymously (www.medmarx.com)
Drugs Facts and Comparisons
Published by Lippincott Williams & Wilkins
The most up-to-date, comprehensive drug information source available. Drug Facts and Comparisons contains more than 22,000 Rx and almost 6,000 OTC drugs, grouped by therapeutic category for ease of comparison. Orphan and investigational drugs are included. Drug Facts and Comparisons also contains thousands of charts and tables. Drug Facts and Comparisons is updated monthly and is ideal to keep current on all changes in the drug industry.
Stanford SKOLAR MD
Stanford SKOLAR MD is a Web-based medical knowledge service for physicians. SKOLAR was developed and is used at the Stanford University School of Medicine for the purpose of bringing up-to-date medical information to the clinician. Content is continuously updated, reviewed and approved by a content committee of respected Stanford and community physicians. Physicians can use AMA-approved SKOLAR MD to research a patient problem or condition and earn Category 1 CME credit for the time spent improving your patient’s care. SKOLAR is the first AMA-approved system that allows physicians to earn CME credit for independently directed learning.
Enter a key word or phrase and SKOLAR searches across multiple resources that you can select: textbooks, drug databases, bibliographies, guidelines, full text journals, evidence based medicine and patient education material. You can even do a ICDM Code look up with your search. Drug database information is displayed in a format that highlights the most commonly sought after information and simplifies navigation within the material. For a demonstration of all the features you can go to: http://www.skolar.com/demonstrations.html To sign up for a free 10 trial period go to: http://www.skolar.com/index.html
Institute for Safe Medication Practice
The Institute for Safe Medication Practices (ISMP) is a nonprofit organization that works closely with healthcare practitioners and institutions, regulatory agencies, professional organizations and the pharmaceutical industry to provide education about adverse drug events and their prevention. The Institute provides an independent review of medication errors that have been voluntarily submitted by practitioners to a national Medication Errors Reporting Program (MERP) operated by the United States Pharmacopeia (USP) in the USA. Information from the reports may be used by USP to impact on drug standards. All information derived from the MERP is shared with the U.S. Food and Drug Administration ( FDA) and pharmaceutical companies whose products are mentioned in reports.
Lawfirm Websites/Class Actions/Document Vaults
The lawfirm of Feldman & Rifkin, LLP has put together a good site of resources related to class actions and pharmaceutical related litigation resources. Also another site link www.badproducts.com has a wealth of litigation resources including pleadings and exhibits.
Formulary is a monthly clinical journal for members of Pharmacy and Therapeutic (P & T) Committees (and others charged with drug management responsibilities) at hospitals, hmo’s and other managed care settings, PBM companies, and within the VA system.. This publication contains peer-reviewed clinical articles plus drug-related clinical news, drug-related regulatory news, meeting “pearl” reports, formulary trends, and clinical experience briefs.
The American Society of Health-System Pharmacists
Founded in 1942, this is the premier professional association for hospital and other health-system pharmacists. The Association publishes the IPA database, the American Hospital Formulary Service (the “Red Book”) and the American Journal of Health-System Pharmacy, as well as a number of books and continuing education publications. The site offers timely alerts on medications which have been recalled by the FDA or had warnings issued. The site also offers free MEDLINE access, as well as a directory of headquarters staff and the Association’s publications catalog. Information on purchasing publications is found at this website.
American Association of Pharmaceutical Scientists
The American Association of Pharmaceutical Scientists consists of more than 9,300 pharmaceutical scientists employed in academia, industry, government, and other research institutions worldwide. “Founded in 1986, the goal of AAPS is to improve human health through the development of better pharmaceuticals.” This site provides information about the pharmaceutical science profession, information for members, publications, and links to additional health and pharmaceutical sites.
The American Pharmaceutical Association
The American Pharmaceutical Association (APhA), the national professional society of pharmacists, was founded in 1852 and is the first established and largest professional association of pharmacists in the United States. The more than 50,000 members of APhA include practicing pharmacists, pharmaceutical scientists, pharmacy students, pharmacy technicians, and others interested in advancing the profession. The Association is a leader in providing professional information and education for pharmacists and an advocate for improved health of the American public through the provision of comprehensive pharmaceutical care.
International Society for Pharmaceutical Engineering
ISPE is the Society of choice for more than 13,000 healthcare technology professionals in more than 60 countries… ISPE [is] the leading global source of information, educational services, and forums providing knowledge and practical experience for technical professionals who develop, manufacture, regulate, and support healthcare products. This site includes a calendar of upcoming educational programs; information on ISPE publications; career development and student areas; contact information for affiliates and chapters; and Shared Interest Groups (SIGs) Bulletin Boards, plus information on Good Automated Manufacturing Practices (GAMP), Baseline Pharmaceutical Engineering Guides, and Clinical Trial Materials training tools.
Parenteral Drug Association
PDA is a non-profit professional/technical association whose mission is to support the advancement of pharmaceutical technology by promoting scientifically sound and practical technical information and education for industry and regulatory agencies. PDA is the recognized authoritative voice and leading technical organization in the field of parenteral science and technology. Through the development of technical reports, bulletins and responses to regulatory initiatives. Membership consists of over 9,000 individual and 250 corporate members worldwide. Conferences, meetings and open forums bring together pharmaceutical manufacturers, suppliers, users, academics and regulatory officials to discuss issues of mutual interest.
FDA-Electronic Orange Book-Approved Drug Products with Therapeutic Equivalence Evaluations (For information on this publication go to http://www.fda.gov/cder/ob/docs/preface/ecpreface.htm)
At this site you can search for drug information by active ingredient, drug applicant holder, proprietary name, or application number. If you have the trade name, search the Electronic Orange Book Rx or OTC section using the Proprietary Name search. This determines the ingredient(s). Then use the Ingredient Search for all approved products that contain the ingredient(s). The resulting list will provide approved products by dosage form and route. For each dosage form; route grouping, there will be a Reference Listed Drug (RLD) that is the innovator product. One or more strengths will have a Yes RLD. If there are approved generic products of another firm, the RLD will be No and all the products within the dosage form; route grouping will have a therapeutic Equivalence Code (TE Code). Products that have been discontinued are in the Discontinued Section and do not RLD or TE Codes. The OTC Section products are not evaluated for therapeutic Equivalence.
Information not found here can be requested from the FDA by going to CDER Freedom of Information Office website at http://www.fda.gov/cder/foi/index.htm
Pharmaceutical Research and Manufacturers of America
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading research-based pharmaceutical and biotechnology companies. You can search medication/pharmaceuticals in development by disease, drug name, or company name.
Biotechnology Information Directory
This directory contains well over 1500 URLs of companies, research institutes, universities, sources of information and other directories specific to biotechnology, pharmaceutical development and related fields. It places emphasis on product development and the delivery of products and services. It includes a listing of pharmaceutical companies and their associated websites, as well as a link to the European mirror site.
Hardin Meta Directory of Internet Health Sources: Pharmacy and Pharmacology
As a “metadirectory” this site provides a “directory of directories” on a variety of medical topics. The section on pharmacy and pharmacology provides links to 20 different directories on the World Wide Web.
Virtual Library: Pharmacy
This general site also includes links to information on pharmacokinetics and pharmaceutical chemistry. Included are links to schools of pharmacy throughout the world, community pharmacy webpages, and job information for pharmacists. Maintained by the University of Oklahoma College of Pharmacy.
This site is maintained at the University of Manchester (England), and is “mirrored” by over a half-dozen sites throughout the world. It includes extensive links to Internet resources of interest to pharmacists and maintains numerous discussion groups.
University of Sydney Department of Pharmacy – Pharmacy Internet Guide
This site includes a thorough and logically organized guide with links to pharmacy resources on the Internet. The guide includes an extensive list of email discussion groups and electronic journals of interest to pharmacists.
FDA Bulletin Board/World Wide Web Site
Includes FDA Federal Register Notices, Drug & Device Approvals, agency press releases, FDA Consumer Magazine. A search form is available for searching the FDA web site for information on a specific topic or drug.
U.S. Department of Health & Human Services
The DHHS is the parent agency of the Health Care Financing Administration MedicareMedicaid), Food & Drug Administration, Centers for Disease Control, Agency for Health Care Policy & Research, Agency for Toxic Substances & Disease Registry and others. Links to the agency web sites, as well as grant, research and policy information are available from this central site.
National Institutes of Health
Links to CancerNet PDQ Drug Information, the full-text of Clinical Practice Guidelines, grant information, and NIH sponsored research in progress.
National Library of Medicine
The National Library of Medicine (NLM) provides no-cost access to MEDLINE, a database which provides citations to the primary biomedical literature. MEDLINE can be searched via the World Wide Web from this website using either NLM’s “Internet Grateful Med” search engine, or the “Pub Med” search engine. Pub Med also includes links to a small number of full-text articles available on the World Wide Web.