# ![](media/image1.wmf){width="2.3986111111111112in" height="2.2930555555555556in"} {#section .Chapter-#}

# 17 {#section-1 .Chapter-#}

# Medical Product Safety

Lead Agency: Food and Drug Administration

### Contents {#contents .Heading-Special}

[Goal Page 17-3](#goal)

[Overview Page 17-3](#overview)

[Issues and Trends Page 17-3](#issues-and-trends)

[Disparities Page 17-7](#disparities)

[Opportunities Page 17-8](#opportunities)

[Interim Progress Toward Year 2000 Objectives Page
17-10](#interim-progress-toward-year-2000-objectives)

[Healthy People 2010---Summary of Objectives Page
17-11](#healthy-people-2010summary-of-objectives)

[Healthy People 2010 Objectives Page
17-12](#healthy-people-2010-objectives)

[Related Objectives From Other Focus Areas Page
17-16](#related-objectives-from-other-focus-areas)

[Terminology Page 17-17](#terminology)

[References Page 17-18](#references)

## Goal

**Ensure the safe and effective use of medical products.**

## Overview

### Issues and Trends

Medical productswhich include drugs, biological products, and medical
devicesprovide 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
decisionmaking in medicine and health care.

The United States has an elaborate system to maintain this benefit-risk
balance by making sure that products are developed, tested,
manufactured, labeled, prescribed, dispensed, and used in a way that
maximizes benefit and minimizes risk. This complex system involves
several key players: manufacturers that develop and test medical
products and submit applications for marketing approval to the Food and
Drug Administration (FDA); FDA, which has an extensive premarketing
review and approval process and uses a series of postmarketing programs
to gather data on and assess risks; the health care delivery system; and
patients, who rely on the health care system and providers for needed
interventions and protection from injury. Regrettably, however, this
elaborate benefit-risk system and its subsystems lack the integration
needed to ensure optimal public health and safety.

**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]{.smallcaps}, 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]{.smallcaps} also
accepts reports of medication errors or potential errors.
[MedWatch]{.smallcaps} 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]{.smallcaps} partners rapidly disseminate new FDA-related
product safety information back to their membership.

The growing complexity of medical technology, coupled with economic
pressures and organizational changes within health care institutions,
increases the potential for unanticipated and unintended consequences in
using medical devices. These developments demand that postmarket
surveillance move from passive surveillance to a proactive strategy that
includes understanding how organizations encounter medical devices, how
problems are perceived and reported, and which characteristics of the
health care system contribute to a given event. A safer patient
environment can be created if increased efforts are made to identify
product failures and errors before patients are injured.

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.

Efforts to manage risk at the community, national, and global levels
present the most difficult public health challenges. The introduction of
hepatitis B surface antigen screening and the change to an all-volunteer
blood donor population in the mid-1970s resulted in substantial
reductions in transfusion-transmitted viral hepatitis.[^3] This success,
however, was overshadowed by the unexpected emergence of a new
blood-borne pathogen, human immunodeficiency virus (HIV). Since its
initial recognition in the early 1980s, more than 8,000 persons have
been diagnosed with transfusion-associated acquired immunodeficiency
syndrome (AIDS), and approximately half of the U.S. hemophiliac
population has been infected with HIV.[^4] The HIV epidemic remains a
potent reminder of the Nation's vulnerability to emerging agents and the
tragic repercussions they can exact on those who depend on life-saving
blood and blood products.

FDA has primary responsibility for ensuring blood safety. Improvements
in donor screening, serologic testing, and viral inactivation procedures
have made the U.S. blood supply one of the safest in the world.
Nevertheless, many additional steps can be implemented by FDA, industry,
consumers, and blood donor volunteers to go further. Since 1998, the
U.S. Department of Health and Human Services (HHS) has coordinated the
efforts of the Centers for Disease Control and Prevention (CDC), the
National Institutes of Health (NIH), and FDA, with cooperation from
other government agencies, in a Blood Action Plan. Consumer and donor
confidence are important factors in maintaining a safe blood supply, and
Healthy People 2010 objectives reflect those concerns and incorporate a
science-based approach to expanding the blood supply and enhancing its
safety.

**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.[^5] 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.[^6] 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.[^7] 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.

Because national data systems will not be available in the first half of
the decade for tracking progress, three subjects of interest are not
addressed in the Healthy People 2010 Medical Product Safety objectives.
Representing a research and data collection agenda for the coming
decade, the topics are related to record practices of health care
professionals, plasma manufacturing, and data analysis. The first topic
covers health care professionals who record their patient's use of
botanicals, dietary supplements, and other alternative products to
identify the risks of using these products in combination with
conventional drugs and biologics. The second topic addresses the
development and application of effective methods for complete
inactivation or removal of pathogens from plasma, blood, and blood
products. The third involves the proportion of new medical products that
have had pre- and postmarketing clinical data analyzed for gender
differences.

### 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.[^8] Of elderly patients taking three or more
prescription drugs for chronic conditions, more than one-third are
rehospitalized within 6 months of discharge from a hospital, with 20
percent of those re-admissions due to drug problems.[^9] Twenty-eight
percent of hospitalizations of older people are due to noncompliance
with drug therapy and adverse events.[^10] 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.[^11] 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.[^12] 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.

Data collection systems do not exist that would allow analysis of
disparities in adverse events among different population groups. Because
there is a need to look at select populations, which are diverse in
race, ethnicity, socioeconomic status, and area of residence, it is
likely that data will be needed from many provider organizations.

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.[^13] 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 Focus Area 7.\
Educational and Community-Based Programs and Focus Area 11. Health
Communication.)

### Opportunities

Although medical products provide benefits, they also can cause injury
and harm. FDA and other participants (for example, pharmaceutical
manufacturers, health care providers, consumers, and patients) act in
ways to maximize the benefits and minimize the risks associated with
using medical products.Error: Reference source not found Often, these
actions are insufficiently integrated. A common goal of maximizing
benefits and minimizing risks could be greatly advanced if the
participants work together within an integrated framework. An integrated
benefit-risk management framework, if adopted, would contribute to
improving risk communication and risk confrontation.

**Risk communication.** The health care industry has experienced
tremendous growth and demand in building an infrastructure driven by
technology. For example, elaborate information technology (IT) software
programs, which link to huge databases, allow access to a vast amount of
valuable information for pharmacists and other health care
professionals, health care organizations, and consumers. The information
in these systems is used to improve patient care, design better health
care methods, improve operations, and enhance organizational planning.
Many groups benefit from sharing information between different
components of health care, including patients, providers, insurance
companies, medical equipment companies, pharmaceutical companies,
hospitals, and data processing and health research corporations.
Technology is available to integrate the different components of health
care, but its use today is minimal except in select health care
settings. Therefore, it would be advantageous to encourage upgrades to
present technology systems and links to other integrated technology
systems to improve patient care, always keeping in mind, of course,
patient confidentiality.

Evolving automation offers the possibility of placing the entire patient
record into an electronic format. Electronic formats offer the
possibility of automatically and instantaneously checking any new
therapy for incompatibilities with the products, appropriate indications
and dosing range, and the patient's current therapies and
contraindications (for example, allergies or reduced hepatic or renal
function). Electronic formats also offer the possibility of looking at
diagnoses and seeing whether patients (or in cases of children, their
parents) have been exposed to existing therapies in the past.

Further, as IT systems become more advanced and sophisticated, there is
a growing need to ensure and protect patient confidentiality. Health
plans, providers, and pharmacy benefit managers have long recognized the
importance of maintaining the confidentiality of patient-identifiable
medical information. There is a vast potential for information sharing
between different components of health care if the confidentiality
issues can be overcome. Legislation to protect patients from the
inappropriate disclosure of their medical information will be essential
to the development of systems that are designed to protect their health
and welfare.

One final consideration for effective risk communication is to provide
information about medical products that is useful for patients,
consumers, and practitioners. (See Focus Area 11. Health Communication.)
Effective risk communication requires information presented in words and
formats readily understood by practitioners, caregivers, and patients.
This information must be disseminated in a timely fashion and
incorporated into clinical practice that is aimed at altering behaviors.
Since March 1999, Federal regulations have required over-the-counter
(OTC) drug manufacturers to follow a specific format for the labeling of
OTC drugs.[^14] The format is intended to assist consumers in reading
and understanding OTC drug product labeling so that they can use these
products safely and effectively.

**Risk confrontation.** Determining the acceptable level of risk should
occur in a larger context.[^15] This activity is characterized as risk
confrontation, defined as community-based problem solving that actively
involves stakeholders in the decisionmaking process.[^16] This
definition implies that social and community values are at least as
important as the technical judgments of professionals and should be
included in the determination of acceptable risk.

Science provides only a statistical assessment of risk; it cannot
determine its acceptability. Affected communities may differ from
regulatory agencies in how they value either risks or benefits. They
also may judge differently the amount of uncertainty that is tolerable.
Advocacy groups for patients with various diseases, most notably AIDS
and cancer, have shown over the past several years that it is impossible
to assess accurately the acceptability of risks in light of the
potential benefits without the input of the affected community. Although
some advocates for patients with life-threatening illnesses are willing
to accept a high degree of risk to gain the benefits of new products,
other advocacy groups, such as those against mandatory vaccination, feel
that no risk is acceptable.

To obtain community input, FDA has engaged in multiple outreach efforts
with external stakeholders, soliciting their ideas, opinions, and
concerns regarding the safe use of medical products. In the context of
determining risk, for example, fostering open public discussions is
critical to enhancing participants' practical understanding and
illuminating practice choices in the risk decision process. A carefully
prepared summary of scientific information will not give participants in
the risk decision the understanding they need if that information is not
relevant to the decision to be made. It is not sufficient to get the
science right; an informed decision also requires getting the right
science, that is, directing the scientific effort to the issues most
pertinent to the decision.

## Interim Progress Toward Year 2000 Objectives

The Healthy People 2000 objective on linked computer systems has been
met. In 1995, 98 percent of pharmacies were using computers. Data for
providers who review medications for older patients and for the
proportion of patients who\
receive verbal and written information for new prescriptions from
prescribers and dispensers show progress. The proportion of adverse
event drug reports voluntarily sent to FDA that are regarded as serious
has declined slightly and is moving away from the target.

Note: Unless otherwise noted, data are from the Centers for Disease
Control and\
Prevention, National Center for Health Statistics, *Healthy People 2000
Review, 1998--99*.

## Healthy People 2010---Summary of Objectives

### Medical Product Safety {#medical-product-safety-1 .Heading-Special-Sub}

**Goal:** Ensure the safe and effective use of medical products.

  ------------ -------------------------------------------------------------
  **Number**   **Objective Short Title**

  17-1         Monitoring of adverse medical events

  17-2         Linked, automated information systems

  17-3         Provider review of medications taken by patients

  17-4         Receipt of useful information about prescriptions from
               pharmacies

  17-5         Receipt of oral counseling about medications from prescribers
               and\
               dispensers

  17-6         Blood donations
  ------------ -------------------------------------------------------------

## Healthy People 2010 Objectives

1.  **(Developmental) Increase the proportion of health care\
    organizations that are linked in an integrated system that monitors
    and reports adverse events.**

**17-1a.** Health care organizations that are linked in an integrated
system that monitors and reports adverse events associated with medical
therapies.

**17-1b.** Health care organizations that are linked in an integrated
system that monitors and reports adverse events associated with medical
devices.

**Potential data sources:** Office of Postmarketing Drug Risk Assessment
(OPDRA), [MedWatch]{.smallcaps}, and Manufacturer and User Device
Experience (MAUDE) Database, FDA.

Collaboration between Federal authorities and researchers with
pharmacoepidemiologic databases can be helpful in monitoring suspected
associations between specific drug exposures and specific adverse events
and in estimating such risk. Linked databases could provide immediate
access to existing data sources with the capability of providing
assessments of study feasibility, responding to specific drug safety
questions within a few weeks, and providing a complete analysis of those
questions deemed feasible within a few months. Databases should be able
to provide exposure data on new molecular entities (those approved
within the past 5 years in the United States), to perform feasibility
studies of multiple drugs or multiple outcomes, to identify adverse drug
events that occur infrequently (that is, at rates lower than can be
detected in clinical trials), and to provide data and preliminary
analyses within a very short time frame (2 to 4 weeks, depending on the
problem).

To identify unknown events more rapidly, there must be an enhanced
program of communication for health professionals nationwide that builds
on the work of [MedWatch]{.smallcaps}, encouraging the recognition of
unique and rare events. To evaluate and quantify newly identified
events, there must be a significant population base under close
electronic surveillance for indicators of adverse reactions. A
relatively large number of persons (estimated around 20 million) is
necessary because so many persons are lost to followup when they move
from one provider organization to another. If medical records are
ultimately transferred from one provider to another, a number smaller
than 20 million may suffice to allow outcomes to be linked with earlier
therapies. A system must be available for accessing the original patient
record while maintaining confidentiality.

Staff-model health maintenance organizations (HMOs) are providing health
care services to a greater proportion of patients and, therefore, would
be a good target for linked data systems capable of picking up rare
adverse events and signals in patient populations. HMOs and other health
care providers capable of producing complete patient records should be
particularly targeted to participate in this development. At present,
there is no standard format for these records. HMOs may have different
systems at each site, or, where organizations have come together to form
a single large organization, each remnant of the original organizations
may have preserved its own medical record system. HMOs might be
encouraged to see safety surveillance data as a product, which could be
purchased by the Federal Government and industry after appropriate
protection of patient privacy. Alternatively, large employers or
government agencies might use their purchasing power to demand safety
surveillance as a deliverable under managed care contracts.

The Safe Medical Device Acts of 1990 and 1992 mandate reporting of
device-related deaths to FDA and device-related deaths and serious
injuries to manufacturers. The program has shown only limited success.
Research on the program indicates that the quantity and quality of data
received could be enhanced through training and education for end users
of medical devices regarding how to report device-related deaths and
serious injuries to manufacturers, additional assurance of the
protection of data submitted, and regular, timely feedback. The research
also suggested that a medical surveillance network could improve the
protection of patients and device users by reducing the likelihood of
medical device-related adverse events. The system should collect
high-quality data on adverse medical events, analyze the data to
identify newly emerging device problems and changes in device use,
disseminate data on such problems in a timely manner to concerned
parties, and apply the knowledge gained from the reported data to the
device approval process and to prevention and control programs.

17-2. (Developmental) Increase the use of linked, automated\
systems to share information.

**17-2a**. By health care professionals in hospitals and comprehensive,\
integrated health care systems.

**17-2b**. By pharmacists and other dispensers.

**Potential data sources:** National Survey of Pharmacy Practice in
Acute Care and Survey of Managed Care and Ambulatory Care Pharmacy
Practice in\
Integrated Health Systems, American Society of Hospital Pharmacists
(ASHP).

Automated information systems enable pharmacists in hospitals, HMOs, and
U.S. Department of Veterans Affairs (VA) settings to review a patient's
medical record, pharmaceutical history, allergies and contraindications
to medications, blood chemistries and microbiological drug
sensitivities, and treatment schedule files. These systems help
administrative personnel in various work settings to process
prescription claims and payments, measure the quality of health care,
perform cost analyses, provide drug information, perform
pharmacoeconomic analyses, and purchase pharmaceutical products.

Dispensers of prescription medications use linked systems to provide
warnings about dosing errors and potential adverse events among
medications dispensed by different sources to individual patients. In
1993, 95 percent of pharmacies used computer systems.[^17] Advances in
computer technology should facilitate information sharing in a way that
helps health care professionals and researchers link drug products and
outcomes in order to benefit individual patients and to discover
previously unknown adverse reactions.

Computerization of the medication use process can help prevent
prescribing, dispensing, and administration errors. The documented value
of direct order entry continues to be confirmed.[^18] A recent study
demonstrated that replacing handwritten medication orders with a
computerized physician order entry system led to a 54 percent reduction
in serious medication errors.[^19] In addition, the National Patient
Safety Foundation at the American Medical Association (AMA) has
identified direct computerized order entry as one of the best practices
for preventing adverse drug events.Error: Reference source not found

17-3. (Developmental) Increase the proportion of primary care providers,
pharmacists, and other health care professionals who routinely review
with their patients aged 65 years and older and patients with chronic
illnesses or disabilities all new prescribed and over-the-counter
medicines.

**Potential data sources:** Survey on Prescription Drug Issues and
Usage, AARP; Physician Survey Under the Medication Error Reduction
Initiative.

Adults aged 65 years and older account for less than 15 percent of the
population, but they use about one-third of all retail
prescriptions.Error: Reference source not found This population also
purchases at least 40 percent of all nonprescription medicines.Error:
Reference source not found Further, older adults are more likely to
suffer from multiple chronic diseases and, as a result, may routinely
visit multiple physicians, each of whom may be unaware of other
medicines that have been prescribed.

In 1998, an AMA House of Delegates report urged physicians to
incorporate medication reviews as part of routine office-based practice.
The report also encouraged physicians to discuss compliance with the
drug regimen with their patients and to inquire about the beneficial or
adverse effects of drug therapy during followup office visits. AMA's
House of Delegates report suggests that physician medication reviews are
critically important in long-term therapy.[^20]

17-4. (Developmental) Increase the proportion of patients\
receiving information that meets guidelines for usefulness when their
new prescriptions are dispensed.

**Potential data source:** Patient/Consumer Medication Information
Survey, FDA.

A 1992 survey conducted by FDA of the amount of information received by
consumers found that 14 percent of people received information about
prescription drugs from prescribers and 32 percent from
pharmacists.[^21] These percentages do not reflect the usefulness of the
information received because no content analyses were performed on the
informational materials reported in the survey. Congress enacted
legislation in 1996 that called on the private sector to develop a plan
whereby 95 percent of persons would receive useful written information
with their prescriptions by 2006. HHS approved guidelines in the Action
Plan for the Provision of Useful Prescription Medicine Information in
January 1997. In accordance with the plan, patient information materials
were to be evaluated in 1999 and 2000. (See Focus Area 28. Vision and
Hearing.)

5.  Increase the proportion of patients who receive verbal counseling
    from prescribers and pharmacists on the\
    appropriate use and potential risks of medications.

Target and baseline:

+---------+---------------------------+---------------+---------------+
| Ob      | Increase in Patients      | 1998\         | 2010\         |
| jective | Receiving Oral Counseling | Baseline      | Target        |
|         | From:                     |               |               |
+---------+---------------------------+---------------+---------------+
|         |                           | ##            |               |
|         |                           | ##### Percent |               |
+---------+---------------------------+---------------+---------------+
| **1     | Prescribers               | 24            | 95            |
| 7-5a.** |                           |               |               |
+---------+---------------------------+---------------+---------------+
| **1     | Pharmacists               | 14            | 95            |
| 7-5b.** |                           |               |               |
+---------+---------------------------+---------------+---------------+

**Target setting method:** 296 percent improvement for prescribers and
579\
percent improvement for pharmacists. (Better than the best will be used
when data are available.)

**Data source:** National Survey of Prescription Drug Information
Provided to\
Patients, FDA.

> **Data for population groups currently are not analyzed.**

Patients and their caregivers should be fully informed about the
appropriate use and the risks of newly prescribed prescription
medicines. The physician (or other prescribing health care professional)
should initially discuss this information with the patient. The next
opportunity for verbal counseling arises at the pharmacy. In both
settings, written information about the medicine may be conveyed but is
most effective when supplemental to verbal counseling. Elements of
verbal counseling should include not only how much and how often to take
the medication but also appropriate risk information, including
precautions to take and the relevant side effects of the medication.

Participants in a 1997 national symposium on verbal counseling,
sponsored by national pharmacy and pharmacist organizations, gave the
highest rankings to the following reasons for such low counseling
levels: patients do not understand what and why they need to know about
their medicines, patients do not demand or expect counseling services
from the pharmacists, and patients and payors do not see the value of
counseling.Error: Reference source not found These findings suggest that
a high number of pharmacists believe that patients do not understand
what and why they need to know about their medications and, therefore,
do not provide needed counseling. Since 1997, the American
Pharmaceutical Association has maintained a policy stating that
pharmacists should provide drug-related information to their patients in
face-to-face oral consultations, supplemented by written or printed
material or any other means best suited to an individual patient's
needs.[^22]

The National Council on Patient Information and Education (NCPIE)
advocates that health care professionals anticipate consumers' desire
for medication information but also recognize their possible reluctance
to ask questions. NCPIE has developed several educational campaigns to
facilitate question-asking behaviors by consumers and support
information-giving behaviors by health care professionals.

17-6. Increase the proportion of persons who donate blood, and in so
doing ensure an adequate supply of safe blood.

**Target:** 8 percent.

**Baseline:** 5 percent of the total population donated blood in 1994.

**Target setting method:** 60 percent improvement.

**Data source:** American Association of Blood Banks.

> **Data for population groups currently are not collected.**

FDA assumes primary responsibility for the safety of the Nation's blood
supply. Blood availability, however, is restricted by, among other
factors, the number of donors who qualify to give blood. Approximately 5
percent of the population in the United States donates blood once or
twice a year. Recruitment of a larger percentage of the population would
increase the availability of blood and blood products. Public awareness
of the benefits that blood and blood products provide to cancer patients
and others in need could serve to elicit a more generous response.
Educational campaigns that address underlying public fears regarding the
safety of blood donation procedures could also help. Increasing the
donor pool would benefit the overall health of the Nation and remove
donor incentives that border on remuneration.

## Related Objectives From Other Focus Areas

1\. Access to Quality Health Care

1-3. Counseling about health behaviors

3\. Cancer

3-10. Provider counseling about cancer prevention

3-12. Colorectal cancer screening

4\. Chronic Kidney Disease

4-8. Medical therapy for persons with diabetes and proteinuria

5\. Diabetes

5-17. Self-blood-glucose-monitoring

7\. Educational and Community-Based Programs

7-7. Patient and family education

7-8. Satisfaction with patient education

7-9. Health care organization sponsorship of community health\
promotion activities

7-11. Culturally appropriate and linguistically competent community
health\
promotion programs

9\. Family Planning

9-3. Contraceptive use

9-4. Contraceptive failure

9-5. Emergency contraception

11\. Health Communication

11-1. Households with Internet access

11-2. Health literacy

11-3. Research and evaluation of communication programs

11-4. Quality of Internet health information sources

11-5. Centers for excellence

11-6. Satisfaction with health care providers' communication skills

12\. Heart Disease and Stroke

12-10. High blood pressure control

12-12. Blood pressure monitoring

13\. HIV

13-6. Condom use

13-7. Knowledge of serostatus

15\. Injury and Violence Prevention

15-10. Emergency department surveillance systems

15-13. Deaths from unintentional injuries

23\. Public Health Infrastructure

23-1. Public health employee access to the Internet

23-2. Public access to information and surveillance data

23-13. Use of geocoding in health data systems

23-14. Access to epidemiology services

24\. Respiratory Diseases

24-6. Patient education

24-8. Surveillance systems

## Terminology

(A listing of abbreviations and acronyms used in this publication
appears in Appendix H.)

**Adverse drug experience (ADE):** Any adverse event (defined below)
associated with the use of a drug in humans, whether or not considered
drug related. ADEs include the following: an adverse event occurring in
the course of the use of a drug product in professional practice; an
adverse event occurring as a result of a drug overdose, whether
accidental or intentional; an adverse event occurring as a result of
abusing a drug; an adverse event occurring from drug withdrawal; and any
failure of a drug's expected pharmacological action.

**Adverse event:** Undesirable result from the use of a medical product.
Terms used to describe such an event include adverse drug reaction
(ADR), adverse experience, and adverse effect. For the purposes of
Healthy People 2010, the term *adverse event* is used in most cases to
avoid confusion.

**Consumer:** An individual who consumes or acquires medical products,
such as nonprescription (over-the-counter) medicines or nonprescription
medical devices, and prescription medicines.

**Medical device:** An instrument, apparatus, implement, machine,
implant, or other similar or related article intended for use in the
diagnosis of disease or other conditions or in the cure, mitigation,
treatment, or prevention of disease.

**Medical product:** Any prescription and nonprescription drug, device,
or biological product intended for use in the diagnosis of disease or
other conditions or in the cure, mitigation, treatment, or prevention of
the disease.

**Medication or device error:** A preventable event that may cause a
medication or device to be used inappropriately and thus may harm a
patient. Harm can occur while the medical product is being used by a
health care professional, patient, or consumer.

**Off-label use:** Uses other than those for which the product is
approved.

**Patient:** An individual who is under medical care or treatment.

**Pharmacoepidemiologic database:** A computerized database for
capturing and manipulating data associated with the collection,
analysis, and communication of drug or other therapeutic product risk
information.

**Risk assessment:** Estimation and evaluation of risk.

**Risk communication:** Interactive process of exchanging risk
information.

**Superinfection:** A new infection complicating the course of
antimicrobial therapy by an organism different from that which caused
the initial infection. The new infection results from invasion by
bacteria or fungi resistant to the antimicrobial in use.

**U.S. Pharmacopeia (USP):** Organization that promotes the public
health by establishing and disseminating officially recognized standards
of quality and authoritative information for the use of medicines and
other health care technologies.

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