Medical Product Safety
Ensure the safe use of medical products.
The Medical Product Safety objectives for 2020 focus on overall improvement of patient treatment and appropriate use of medical products. Medical products include drugs, biological products, and medical devices. These objectives reflect strong scientific support for safe use of medical products, which promotes better health among Americans.
Why Is Medical Product Safety Important?
Increasing appropriate use and monitoring adverse effects of medical products will:
- Decrease adverse events and harmful reactions by focusing safety efforts.
- Improve the overall effectiveness of treatment by reducing harm from medical products.
- Further personalize medical treatment.
Understanding Medical Product Safety
Many factors influence the safety of medical products and their effects on patients. These factors include:
- A patient’s genetic make-up and physiological condition
- Drug composition (ingredients), manufacturing, and labeling
- Appropriate use
- Monitoring for adverse effects
Incorrect use and inadequate monitoring of many medical products can cause adverse effects. For this reason, greater focus and emphasis on the safe use of such products is critical. Successfully reducing adverse events that result from medical products will improve overall treatment and increase the number of patients who benefit from medical products.
Emerging Issues in Medical Product Safety
An important focus for the improvement of medical product safety is the expanded use of health information technology. The U.S. Department of Health and Human Services is coordinating efforts to develop a national health information technology infrastructure that would include electronic medical records, digital prescribing programs, and electronic decision-support programs.* The system is intended to improve health care quality and patient safety by:
- Improving communication to better inform and empower consumers.
- Enhancing the capacity of postmarket surveillance to promptly and efficiently detect previously unknown problems with medical products.
Continued and innovative efforts are necessary to improve medical product safety and to meet the objectives for 2020.
*US Department of Health and Human Services (HHS), Office of the National Coodinator for Health Information Technology (ONC). The ONC-coordinated Federal health IT strategic plan: 2008–2012. Washington: HHS. Available from: http://www.uspreventiveservicestaskforce.org/Page/Topic/recommendation-s...
Agency for Healthcare Research and Quality (AHRQ). Health service technology assessment text: HSTATS. Evidence Reports from AHRQ [Internet]. Rockville, MD: AHRQ. Available from: http://www.ncbi.nlm.nih.gov/books/NBK16710/
Aspden P, Wolcott JA. Bootman L, et al., editors. Washington: National Academies Press; 2007 [cited 2010 Feb]. Available from: http://books.nap.edu/catalog/11623.html
Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. JAMA. 1995 Jul 5;274(1):29-34.
Battles JB, Stevens DP. Adverse event reporting systems and safer healthcare [editorial]. Qual Saf Health Care. 2009 Feb;18(1):2.
Bronstein A, Spyker DA, Cantilena LR Jr, et al. 2007 annual report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 25th Annual report. Clin Toxicol. 2008 Dec;469(10):927-1057.
Budnitz DS, Pollock DA, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA. 2006;296:1858-66.
Budnitz DS, Shehab N, Kegler SR, et al. Medication use leading to emergency department visits for adverse drug events in older adults. Ann Intern Med. 2007;147(11):755-65.
Centers for Disease Control and Prevention (CDC). Diseases, genetics, and family history [Internet]. Atlanta: CDC; 2010. Available from: http://www.cdc.gov/genomics/resources/diseases
Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. Bridged-race population estimates, United States (vintage 2008) request: Resident population by state, county, age, sex, bridged-race, and Hispanic origin, compiled from 1990–1999; Bridged-race intercensal population estimates; and 2000–2008 bridged-race postcensal population estimates. [cited 2010 Mar 22]. Available from: http://wonder.cdc.gov/bridged-race-v2008.html
Cohen AL, Budnitz DS, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. J Pediatr. 2008 Mar;152(3):416-21.
Farley DO, Haviland A, Champagne S, et al.; RAND Corporation. Adverse-event-reporting practices by US hospitals: Results of a national survey. Qual Saf Health Care. 2008;17:416-23.
Institute of Medicine (IOM), Committee on Identifying and Preventing Medication Errors, Board on Health Care Services. Preventing medication errors: Quality chasm series. 2007.
International Marketing Services (IMS) Health Inc. 2008 US sales and prescription information [Internet]. Norwalk, CT: IMS Health; 2010. Available from: http://imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=85f4a56216a10210VgnVCM100000ed152ca2RCRD&cpsextcurrchannel=1
Jhung MA, Budnitz DS, Mendelsohn AB, et al. Evaluation and overview of the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES). Med Care. 2007;45(suppl 2):S96-S102.
Kass-Bartelmes BL, Bosco L; Agency for Healthcare Research and Quality (AHRQ). Prescription drug therapies: Reducing costs and improving outcomes [Internet]. Research in Action, Issue 8, 2002 Sept. Available from: http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/factsheets/pharmaceutical/rxtherapies/rxria.pdf
Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. JAMA. 995;274(1):35-43.
Lucero C, Shehab N, Budnitz D. Emergency department visits for adverse drug events from diabetes medications, United States. American Diabetes Association 68th Scientific Session, 2008 June 6–10; San Francisco, CA.
McCaig LF, Besser RE, Hughes JM. Trends in antimicrobial prescribing rates for children. JAMA. 2002:287;3096-102.
National Council on Patient Information and Education (NCPIE). Talk about prescriptions month [Internet]. Rockville, MD: NCPIE; 2010 [cited 2010 Feb]. Available from: http://www.talkaboutrx.org
Pedersen CA, Schneider PJ, Scheckelhoff DJ. American Society of Health-System Pharmacists national survey of pharmacy practice in hospital settings: Monitoring and patient education—2006. Am J Health-Syst Pharm. 2007 Mar;64(5):507-20.
Schillie SF, Shehab N, Thomas KE, et al. Medication overdoses leading to emergency department visits among children. Am J Prev Med. 2009 Sept;37(3):181-7.
Taylor AT, Gostin L, Pagonis K. Ensuring effective pain treatment. JAMA. 2008 Jan;299(1):89-91.
US Department of Health and Human Services. US system of oversight of genetic testing: A response to the charge of the Secretary of Health and Human Services: Report of the Secretary’s Advisory Committee on Genetics, Health, and Society [Internet]. April 2008. 276 p. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873211/ [PDF - 48 KB]
US Food and Drug Administration (FDA). Approvals of FDA-regulated products [Internet]. Silver Spring, MD: FDA; 2009 [cited 2008 Oct 6]. Available from: http://www.fda.gov/NewsEvents/ProductsApprovals/default.htm
US Food and Drug Administration (FDA). FDA enforcement report index [Internet]. Silver Spring, MD: FDA; 2010. Available from: http://www.fda.gov/opacom/Enforce.html
US Food and Drug Administration (FDA). Is it really FDA approved? [Internet]. Silver Spring, MD: FDA; 2008 Sept 30 [cited 2008 Oct 6]. Available from: http://www.fda.gov/consumer/updates/approvals093008.html
US Food and Drug Administration (FDA). Marketed unapproved drugs: Compliance policy guide center for drug evaluation and research [Internet]. Silver Spring, MD: FDA; 2006 Jun. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf [PDF - 164 KB]
US Food and Drug Administration (FDA). Medical devices: How to report a problem [Internet]. Silver Spring, MD: FDA; 2009. Available from: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm
US Food and Drug Administration (FDA). MedWatch: The FDA Safety Information and Adverse Event Reporting Program [Internet]; 2010 [cited 2010 Feb]. Available from: http://www.fda.gov/medwatch
US Food and Drug Administration (FDA). MedWatchPlus/FAERS (FDA Adverse Event Reporting System) [Internet]. Silver Spring, MD, 2009 May. Available from: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/SpotlightonCPIProjects/ucm083295.htm
US Food and Drug Administration (FDA). National drug code directory [Internet]. Silver Spring, MD: FDA; 2010. Available from: http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm
US Food and Drug Administration (FDA). Recalls, market withdrawals, and safety alerts [Internet]. Silver Spring, MD: FDA; 2010. Available from: http://www.fda.gov/opacom/7alerts.html