About Risk

 

From:  Healthy People 2010 / Focus Area 17 - Medical Product Safety

See: http://www.healthypeople.gov/Publications/

Medical products¾which include drugs, biological products, and medical devices¾provide great public benefit. Although marketed medical products are required to be safe, this safety requirement does not mean they have zero risk. A safe product has reasonable risks, given the magnitude of the benefit expected from the product and the alternatives to its use. Thus the choice to use a medical product involves balancing its benefits with the potential risks of using it. The comparative evaluation—which involves weighing the benefits (positive effects) and risks (potential harm) of various medical options for treatment, prophylaxis, prevention, or diagnosis—is an essential part of determining product safety. Evaluation is done during research and development on new medical products or procedures (such as surgery) or by a regulatory authority deliberating the approval or withdrawal of a product or some intermediate action, by a physician on behalf of a patient, or by the patient. Such weighing, whether implicit or explicit, is at the heart of decision-making in medicine and health care.

Sources of risk.  It is widely accepted that enormous benefits can be gained from using medical products. Yet while most are well tolerated, producing only minimal side effects or a low rate of adverse events, some products can be very toxic, producing a high rate of complications from side effects.1 It is estimated that millions of adverse events associated with the use of medical products occur each year; many of these are serious and may result in death.2 Federal oversight of a medical product’s benefits versus risks continues well beyond the initial marketing of a product. Once a medical product is approved for marketing, the safety of the product continues to be monitored by FDA, which collects and analyzes reports of product experience. As more products are approved for marketing, postmarketing surveillance becomes increasingly important.

 

Through a program called MedWatch, FDA’s Medical Products Reporting and Safety Information Program, health care professionals, patients, and consumers can report serious adverse events and problems associated with medical products to FDA, the manufacturer, or both. MedWatch also accepts reports of medication errors or potential errors. MedWatch partners include health professionals, consumers, and other appropriate health-related organizations or commercial interests that actively disseminate information on the critical importance of monitoring and reporting serious adverse events and product problems, along with information on how to report directly to FDA. These partners also provide a multiplier effect, by which MedWatch partners rapidly disseminate new FDA-related product safety information back to their membership.

 

Beyond the individual level of risk management (for example, patients and health care providers), managing risk must be targeted at the organization level. For example, user facilities such as hospitals, long-term care facilities, ambulatory surgical, outpatient treatment, and outpatient diagnostic centers are required to report errors related to medical devices. By law, these facilities are required to report any death to FDA and to the manufacturer of the device within 10 working days. Any serious illness or injury also must be reported by the user facility to the manufacturer within 10 working days, or, if the manufacturer is unknown, the report should be sent to FDA.  Further, FDA encourages user facilities to report product or device malfunctions (for example, intravenous catheter defects) that do not result in death or serious injury directly to the manufacturer.

 

Management of medical product risk. In general, the sources of medical product risks can be thought of as falling into four categories: (1) product defects, (2) known side effects, both avoidable and unavoidable, (3) medication or device errors, and (4) remaining uncertainties.3 Because each type of risk has a different source, effective management of each is likely to be different:

 

Product defects. Historically, product defects have been an important source of medical product-associated injuries. In the case of pharmaceuticals, product defects usually include the lack of potency and the lack of purity of drugs. A significant portion of resources currently is devoted to regulating product quality. Research, surveillance, quality systems also called current good manufacturing practices, and inspections form the cornerstone of FDA efforts to minimize product defects.

 

Known side effects. When using a drug or other medical product, a patient runs the risk of experiencing reactions resulting from the product’s interaction with the body. For pharmaceuticals, these reactions are commonly termed side effects. They usually are identified in a product’s package insert as possible risks. Known side effects are the source of the majority of injuries and deaths resulting from product use.

 

Some known side effects often are predictable and avoidable. To avoid them, the health care practitioner must select the best treatment and plan appropriate measures to manage the risks to the patient. For example, when prescribing certain prescription medications that are renal toxic (toxic to the kidneys), practitioners need to ensure that their patients are well hydrated or calculate dose adjustments to reduce the risk of toxicity or kidney failure. A medical practitioner can choose the wrong therapy for a specific condition (for example, using antibiotics for viral infections). Alternatively, a practitioner may prescribe the appropriate therapy but fail to individualize the therapy or monitor the patient for signs of toxicity. Examples of avoidable side effects include the consequences of known drug-drug interactions or prescribing an inappropriate dosage for elderly persons.

 

In many cases, known side effects are unavoidable because they can occur even if a product is used appropriately. Although estimates vary, the overall human and economic costs of unavoidable side effects are high.4 The risk of experiencing such side effects is the inevitable price of the benefits of treatment. Examples of common, predictable, usually unavoidable side effects include superinfection following antimicrobial chemotherapy, fatigue and depression from interferon use, and bone marrow suppression from chemotherapy. For the successful management of these risks, both the practitioner and patient must be fully aware of the risks involved in treatment, agree to the treatment, and provide careful patient monitoring to detect early symptoms of known side effects.

 

Medication or device errors. A medication or device error involves the incorrect use of a prescribed product or incorrect operation or placement of a medical device. Errors also involve unintended substitution of the wrong product for the prescribed product. Errors can occur, for example, when a confusing product name results in the wrong product being dispensed or when inattention results in an overdose of an intended drug. Substantial numbers of injuries and deaths occur annually because of medication or device errors.5  In general, medication and device errors are believed to result from problems intrinsic to the health care system. That is, these errors often are the result of a sequence of errors within the health care system. For example, a physician’s poor handwriting on the prescription pad and unclear or confusing prescription drug labeling result in pharmacists’ misreading prescriptions and labeling and filling prescriptions with the wrong medications. Such errors are not totally preventable, but they can be minimized through enhancements aimed at integrating the overall health care system.

 

Remaining uncertainties. Given current scientific and medical knowledge, it is not possible to learn everything about the effects of a medical product. For example, new information about long-marketed products may become available. Therefore, a degree of uncertainty always exists about both the benefits and risks of medical products, including unexpected side effects, long-term effects, effects of off-label use, and effects in populations not studied before marketing.

 

Managing risk and medical product safety is a matter of continuously developing information. A comprehensive risk management system requires risk communication. Thus, effective risk communication demands that risk information be translated into words and formats that are readily understood by practitioners, caregivers, and patients.

 

For example, U.S. Pharmacopeia (USP) and FDA have adopted the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Taxonomy for Medication Errors in order to report, track, and benchmark medication error data in a standardized format for hospitals nationwide. In this risk communication strategy, FDA and USP are expected to provide a nationally projected measure of errors grouped according to categories established by the NCC MERP.

 

Disparities

 

Certain groups are particularly vulnerable to poor health outcomes because they are exposed to both socioeconomic and age-related physiological stress factors that interact synergistically. People aged 65 years and older, for example, take the greatest number and quantity of medications.6  Of elderly patients taking three or more prescription drugs for chronic conditions, more than one-third are re-hospitalized within 6 months of discharge from a hospital, with 20 percent of those re-admissions due to drug problems.7 Twenty-eight percent of hospitalizations of older people are due to noncompliance with drug therapy and adverse events.8  Adverse drug events rank fifth among the top preventable threats to the health of older people in the United States, after congestive heart failure, breast cancer, hypertension, and pneumonia.9 Moreover, 32,000 adults aged 65 years and older suffer hip fractures each year as a result of falls associated with the use of psychotropic drugs, which are used to treat the patients’ underlying medical condition.10 A growth in these numbers is expected, given the increasing number and potency of drug products being marketed and the increasing percentage of the population that are elderly.

 

Another example of a common variable that predisposes individuals to vulnerability and poor health outcomes is literacy. Literacy disparities are of concern because low-literacy patients cannot be “empowered” consumers.11 Further, patients who do not understand health professionals’ instructions will not receive good-quality care. Finally, because health literacy problems are concentrated in populations that depend on public programs for their medical care, an education effort may be required to inform public assistance patients about how to understand the proper use of their medicines. To reach all people effectively, information must be provided in a variety of formats and reading levels. (See Healthy People 2010, Focus Area 7. Educational and Community-Based Programs, and Focus Area 11. Health Communication).

 

Footnotes:

 

1. Lazarou, J.H; Pomeranz, B.; and Corey, P.N. Incidence of adverse drug reactions in hospitalized patients. A meta-analysis of prospective studies. Journal of the American Medical Association 279(15):1200-1205, 1998.

2. Institute of Medicine. To Err Is Human: Building a Safer Health System. Kohn, L.T., ed. Washington, DC: National Academy Press, 1999.

 

3. Food and Drug Administration (FDA) Task Force on Risk Management. Managing the Risks from Medical Product Use: Creating a Risk Management Framework. Rockville, MD: FDA, May 1999.

 

4. Johnson, J.A., and Bootan, L.J. Drug-related morbidity and mortality: A cost-of-illness model. Archives of Internal Medicine 155:1949-1956, 1995.

 

5. Bates, D.W.; Cullen, D.J.; Laird, N.; et al. Incidence of adverse drug events and potential adverse drug events: Implications for prevention. Journal of the American Medical Association 274:29-34,1995.

 

6. U.S. General Accounting Office (GAO). Prescription Drugs and the Elderly. AO/HEHS-95-152. Washington, DC: GAO, 1995.

 

7. Bero, L.A.; Lipton, H.L.; and Bird, J.A. Characterization of geriatric drug-related hospital readmissions. Medical Care 29(10):989-1003, 1991.

 

8. Col, N.; Fanale, J.E.; and Kronholm, P. The role of medication noncompliance and adverse drug reactions in hospitalizations of the elderly. Archives of Internal Medicine 150(4):841-845, 1990.

 

9. Fink, A.; Siu, A.L.; Brook, R.H.; et al. Assuring the quality of health care for older persons. An expert panel’s priorities. Journal of the American Medical Association 258(14):1905-1908, 1987.

 

10. Ray, W.A.; Griffin, M.R.; Schaffner, W.; et al. Psychotropic drug use and the risk of hip fracture. New England Journal of Medicine 316(7):363-369, 1987.

 

11. Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs, American Medical Association. Health literacy: Report of the Council on Scientific Affairs. Journal of the American Medical Association 281(6):552-557, 1999.