• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail

What ARE The Risks Involved With Using Medical Products?

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Goals are to Maximize Benefit, Minimize Risk

In general, the sources of medical product risks can be thought of as falling into the following four categories: (1) product defects, (2) known side effects, both avoidable and unavoidable, (3) medication or device errors, and (4) remaining uncertainties. When using a medical product results in a patient's serious injury or death, the patient is said to experience a serious adverse event.


Product defects

Historically, product defects have been an important source of medical product-associated injuries. A significant portion of FDA's resources are currently devoted to regulating product quality. Although additional resources are needed to maintain and enhance current oversight activities, the risks associated with defective medical products are relatively well managed. FDA research, surveillance, and inspections form the cornerstone of FDA efforts to keep product defects to a minimum. The risks associated with poor product quality are not the subject of this report.

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 have been identified and are indicated as possible risks in a product's labeling. Known side effects are the source of the majority of injuries and deaths resulting from product use.

During product development and the premarketing review process, manufacturers and the FDA focus on identifying and understanding this very large category of risks. The risks must be identified, described, and measured before a sound overall risk-benefit decision can be made on the product's approval. After approval, product labels describe how to select patients, how to select and modify the dose schedule, how to avoid interacting treatments, how to monitor for toxicity, and what measures to use to avoid or mitigate toxicity. If additional side effects are identified during the postmarketing phase, the manufacturer changes the product's labeling information to reflect these possible side effects.

Avoidable side effects

Some known side effects are predictable and avoidable. To avoid them, the healthcare practitioner must select the best treatment and plan appropriate measures to manage the risks, for example, patient hydration for products that are toxic to the kidneys, or dose adjustments for patients with impaired kidney function. 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 side effects caused by prescribing an inappropriate dosage in the elderly. Communicating the potential for these types of risks to healthcare practitioners and explaining how to minimize them are major goals of product labeling. Occasionally, to further reduce such risks, additional restrictions are placed on the use of a product, its availability, or its promotion. But, generally, existing regulatory controls are intended to provide the necessary information to the product users and rely on them to use the product safely.

Problems resulting from poor product selection by a practitioner can be reduced by interventions such as targeted medical education, but are largely not amenable to FDA action. Reducing the risks related to poor product use requires collaboration by the manufacturer, the FDA, healthcare professionals, the various components of the healthcare delivery system, and patients.

Unavoidable side effects

In many cases, known side effects are unavoidable, even with the best medical practice because they can occur even when a product is used appropriately. Although estimates vary, the overall human and economic costs of unavoidable side effects are high. The risk of experiencing such side effects is the inevitable price for gaining the benefits of treatment. Superinfection following antimicrobial chemotherapy, fatigue and depression from interferon use, and bone marrow suppression from chemotherapy are common, predictable, and usually unavoidable side effects. Successfully managing these risks centers on ensuring that both the practitioner and patient are fully aware of the risks involved in treatment and that the patient is carefully monitored.

Medication or device errors

Medication or device errors involve the incorrect administration of the prescribed product or incorrect operation or placement of a medical device. Errors also can involve the unintended substitution of the wrong product for the prescribed product. Errors arise, 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 from medication or device errors. In general, these errors are believed by experts to result from systemic problems, rather than from a single individual's mistake. Such errors are not totally preventable, but can be minimized through interventions to the system.

Many outside organizations are involved with identifying and reducing medication errors. In its final report, The President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry called on interested parties to jointly develop a healthcare error reporting system to identify errors and prevent their recurrence. As a result, the Quality Interagency Coordination (QuIC) committee was formed on March 13, 1998. In addition, The Institute of Medicine within the National Academy of Sciences is expected to issue a report in 1999 on preventing medication errors.

In light of a series of highly publicized major adverse events in hospitals during 1995, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) reexamined existing processes for evaluating and monitoring such events and established a more consistent approach to reducing the likelihood of medication errors in all types of healthcare organizations. By 1996, JCAHO had established a sentinel event reporting policy that would provide for (1) a safe harbor context to encourage the self-reporting of sentinel events, (2) the establishment of a database of such serious events to determine their demographics and epidemiology, (3) the sharing of this aggregate information among healthcare organizations, (4) the continuous development and dissemination of information about the sentinel event causality through root cause analysis, and (5) an emphasis on the concept of prospective systems analysis to minimize errors and protect against the effects of errors through improved design and redesign of healthcare processes and systems.

In 1995, a National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) was formed. The NCC MERP is a collaborative effort to (1) increase awareness of medication errors and methods of prevention; (2) stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and prevent medication errors; (3) stimulate the development and use of a medication error reporting and evaluation system; (4) to examine and evaluate the causes of medication errors; and (5) to develop strategies relative to system modifications.

In 1997, the American Medical Association (AMA) announced the formation of the National Patient Safety Foundation (NPSF). The NPSF is a collaborative effort in pursuit of three goals: (1) serve as an educational forum for building awareness among providers and the public about patient safety, errors in healthcare, and preventive strategies; (2) support new research designed to analyze risk factors in healthcare to develop practical tools and solutions; and (3) serve as a clearinghouse for research information, best practices protocols, and preventive tools regarding patient safety risk factors.

In December of 1997, the Health Care Financing Administration (HCFA) proposed "Conditions of Participation in Medicare and Medicaid" that would require hospitals to routinely monitor for adverse drug events and medication errors.

The Institute for Safe Medication Practices and the United States Pharmacopeia (USP), operate a voluntary medication error reporting system (MERS). In addition, the USP has recently introduced MedMARx, an Internet-accessible database software program designed to anonymously report, track, and benchmark medication error data in a standardized format for hospitals nationwide.

During the premarketing review process, FDA works to reduce the risk of medication and device errors by evaluating product design and packaging, reviewing product names, and reviewing product labeling, dose, and dose modification instructions. In the postmarketing period, FDA is taking a more active role in attempting to identify common use errors and in developing strategies to reduce those errors. Examples of these efforts include the publication of Safety Alerts, Public Health Advisories, guidances, brochures, and other educational information. (See Appendix F.)

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 (e.g., digoxin) often becomes available as a result of further scientific study or new technologies. Therefore, a degree of uncertainty always exists about both benefits and risks from medical products. Several types of uncertainties exist.

Unexpected side effects

Unexpected side effects are those that were not identified as potential risks prior to product marketing. The contribution of serious adverse events resulting from unexpected side effects to the overall rate of serious adverse events is relatively small. Working together, manufacturers, clinicians, and the FDA have created an elaborate product development and premarketing review system to identify risks prior to marketing and thus minimize the occurrence of unexpected side effects. This system enables most of these types of risks to be identified.

There are risks, however, that are difficult to identify before a product goes on the market. Some very rare, serious or life-threatening side effects may be recognized only after marketing. These rare side effects are not usually identified during medical product development because they happen so infrequently.

As is the case with a medication or device error that results in injury or death, serious adverse events resulting from unknown side effects often gain widespread media attention because they are less acceptable to the public than injury resulting from known side effects. When these kinds of serious adverse events happen, they lead to questions about the quality of FDA's premarketing review process.

Long-term effects

Another type of uncertainty relates to the long-term outcomes of many medical interventions, including pharmaceutical or device interventions. Because long-term studies to assess these types of risks are not required prior to product approval or for continued marketing, considerable uncertainty exists about long-term side effects (particularly in the chronic disease setting). Pharmaceuticals, in particular, may provide short-term benefits, but may be associated with increased mortality or other serious long-term injuries.

Effects of off-label uses

Marketed products frequently are used to treat conditions that were not studied during clinical development (i.e., off-label uses). When products are used off label, there is usually greater uncertainty about both the benefits and risks because less information on safety and effectiveness is available. Unexpected adverse events may occur in this context.

Effects in populations not studied

Some groups (children, pregnant women) may not be studied before marketing. Additional uncertainties about risks (and benefits) occur with use in unstudied populations.

Next Section : What is FDA's role in Minimizing Risk?