Prescription Drugs and the Elderly: Many Still Receive Potentially
Harmful Drugs Despite Recent Improvements (Letter Report, 07/24/95,
GAO/HEHS-95-152).

Pursuant to a congressional request, GAO examined the elderly's
inappropriate use of prescription drugs, focusing on: (1) whether the
inappropriate use of prescription drugs by the elderly is widely viewed
as a serious health problem; (2) the ways prescription drugs are used
inappropriately and why these situations occur; (3) how public knowledge
of prescription drugs can be improved; and (4) how emerging trends in
health care delivery affect drug prescribing for the elderly.

GAO found that: (1) the inappropriate prescription drug use is a serious
health risk for the elderly, since they take more prescription drugs
than other age groups, they often take several drugs at once, resulting
in adverse drug reactions, and they do not efficiently eliminate drugs
from their systems due to decreased body function; (2) the percentage of
Medicare recipients over 65 using unsuitable prescription drugs dropped
from 25 percent in 1987 to 17.5 percent in 1992; (3) inappropriate
prescription drug use results from physicians using outdated prescribing
practices, pharmacists not performing drug utilization reviews, and
patients not informing their physician and pharmacist of all the drugs
they are taking; (4) to address the problem of inappropriate
prescription drug use, the government is working to disseminate
information on the effect of prescription drugs on the elderly, the
medical community is working to increase physicians' knowledge of
geriatrics, and patients are increasingly seeking information about
their drug therapies; and (5) enrollment in managed care plans has grown
rapidly, particularly among senior citizens, allowing for the potential
to improve the coordination of drug therapies for newly enrolled elderly
patients.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  HEHS-95-152
     TITLE:  Prescription Drugs and the Elderly: Many Still Receive 
             Potentially Harmful Drugs Despite Recent Improvements
      DATE:  07/24/95
   SUBJECT:  Elderly persons
             Health maintenance organizations
             Physicians
             Pharmacological research
             Pharmaceutical industry
             Drugs
             Information dissemination operations
             Health hazards
             Health surveys
IDENTIFIER:  Medicare Program
             Medicaid Program
             National Medical Expenditures Survey
             Santa Monica (CA)
             New York
             Massachusetts
             
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Cover
================================================================ COVER


Report to the Honorable
Ron Wyden, House of Representatives

July 1995

PRESCRIPTION DRUGS AND THE ELDERLY
- MANY STILL RECEIVE POTENTIALLY
HARMFUL DRUGS DESPITE RECENT
IMPROVEMENTS

GAO/HEHS-95-152

Prescription Drugs and the Elderly


Abbreviations
=============================================================== ABBREV

  AARP - American Association of Retired Persons
  FDA - Food and Drug Administration
  HCFA - Health Care Financing Administration
  HMO - health maintenance organization

Letter
=============================================================== LETTER


B-259603

July 24, 1995

The Honorable Ron Wyden
House of Representatives

Dear Mr.  Wyden: 

A recent study concluded that, in 1987, nearly one of four
noninstitutionalized elderly patients were taking prescription drugs
that many experts regard as generally unsuitable for their age group
because alternative drugs provide the same therapeutic benefit with
fewer side effects.\1 According to gerontology experts, the
percentage of elderly patients affected by the inappropriate use of
prescription drugs would be even greater if other situations, such as
potentially dangerous drug interactions or incorrect dosages, were
taken into account.  The inappropriate use of prescription drugs may
cause unnecessary adverse drug reactions that may lead to subtle
deterioration of function or precipitate medical crises resulting in
hospitalization or death.  They also contribute to higher medical
costs borne in part by either Medicare or Medicaid.  The Food and
Drug Administration (FDA) estimates that the annual cost of
hospitalizations due to inappropriate prescription drug use is $20
billion. 

Concerned that the inappropriate use of prescription drugs harms the
health and quality of life of the elderly, you asked us to

  determine if the inappropriate use of prescription drugs among the
     elderly is widely viewed as a serious health problem;

  identify the ways prescription drugs are inappropriately used and
     why these situations occur;

  identify how physicians, pharmacists, and patients receive
     information on prescription drugs and how their knowledge of
     prescription drugs and drug therapies could be improved; and

  provide information on how emerging trends in health care delivery
     affect drug prescribing for the elderly. 

To address these issues, we conducted a literature review and
obtained documents from leading researchers in the fields of
gerontology and elderly clinical pharmacology.  We interviewed these
individuals as well as representatives of FDA, the Health Care
Financing Administration (HCFA), state Medicaid programs, industry
trade associations, senior citizen and consumer advocacy groups, and
medical associations who are knowledgeable in the use of prescription
drugs for the elderly.  We analyzed data on prescription drug use
from HCFA's 1992 Medicare Current Beneficiary Survey.\2 We conducted
our study from October 1994 to May 1995 in accordance with generally
accepted government auditing standards.  (See app.  I for details on
our scope and methodology.)


--------------------
\1 Sharon M.  Wilcox, David U.  Himmelstein, and Steffie Woolhandler,
"Inappropriate Drug Prescribing for the Community-Dwelling Elderly,"
Journal of the American Medical Association, Vol.  272, No.  4 (July
27, 1994), pp.  292-96. 

\2 For a complete explanation of the Medicare Current Beneficiary
Survey, see appendix II. 


   RESULTS IN BRIEF
------------------------------------------------------------ Letter :1

The inappropriate use of prescription drugs is a potential health
problem that is particularly acute for the elderly.  Not only do the
elderly use more prescription drugs than any other age group, they
are more likely to be taking several drugs at once, increasing the
probability of adverse drug reactions.  Furthermore, the elderly do
not eliminate drugs from their systems as efficiently as younger
patients because of decreased liver and kidney function. 

Our analysis of 1992 data from the Medicare Current Beneficiary
Survey found that about 17.5 percent of almost 30 million
noninstitutionalized Medicare recipients 65 or older used at least
one drug identified as generally unsuitable for elderly patients
since safer alternative drugs exist.  While still significant, this
is an improvement over the almost 25 percent reported for 1987 data. 

Inappropriate prescription drug use can result from the behavior not
only of the physician but also of the pharmacist and patient.  Such
behavior includes physicians using outdated prescribing practices,
particularly for elderly patients; pharmacists not performing drug
utilization reviews; and patients not informing their physician and
pharmacist about all the drugs they are taking.  Any of these factors
can increase the likelihood that an elderly person will use a drug
that may impair his or her health. 

Although the experts we interviewed agreed that the inappropriate use
of prescription drugs remains a significant health problem, they
identified several recent efforts that are helping to address this
problem.  Federal and state initiatives have encouraged the
development and dissemination of detailed information on the effect
of prescription drugs on the elderly.  At the same time, the medical
community has begun to emphasize the need to increase physicians'
knowledge of geriatrics and elderly clinical pharmacology.  The
development of drug utilization review systems now permits
prescriptions to be screened before they are filled to identify
potential problems, such as adverse drug interactions or
inappropriate dosage levels.  Finally, patients increasingly have
been seeking information about their drug therapies from several
sources, including consumer advocacy groups, state agencies, and
pharmaceutical companies. 

Changes in the health care delivery system also have the potential to
reduce the inappropriate use of prescription drugs.  Managed care
plans, whose enrollment has grown from 10 million in 1980 to almost
90 million in 1992, are now actively enrolling senior citizens. 
Through utilization controls such as a "gatekeeper," managed care
plans have the potential to improve the coordination of drug
therapies for newly enrolled elderly patients.  Furthermore, a
growing number of employers and health plans now use pharmacy benefit
management firms to administer their prescription drug benefit
programs.  From 1989 to 1993, the number of individuals covered by
pharmacy benefit management firms increased from fewer than 60
million to 100 million.  Through increased oversight and review,
these firms have the potential to further reduce inappropriate
prescription drug use. 


   INAPPROPRIATE USE OF
   PRESCRIPTION DRUGS IS A MAJOR
   HEALTH PROBLEM FOR THE ELDERLY
------------------------------------------------------------ Letter :2

The inappropriate use of prescription drugs is a problem that is
particularly acute for the elderly.  The elderly use more
prescription drugs than any other age group and are more likely to be
taking multiple prescription drugs, which increases the probability
of adverse drug reactions.  Furthermore, the elderly are more
susceptible to adverse drug reactions because of the aging process. 
As a result, many experts believe that some drugs are generally
inappropriate for the elderly because equally effective and safer
alternative drugs exist.  Additionally, other drugs though
appropriate should be used at reduced dosage levels to accommodate
elderly physiology. 


      INAPPROPRIATE PRESCRIPTION
      DRUG USE IS WIDESPREAD AMONG
      THE ELDERLY
---------------------------------------------------------- Letter :2.1

Based on 1987 data from the National Medical Expenditure Survey, a
research study published in July 1994 concluded that almost 25
percent of the noninstitutionalized elderly 65 or older used
prescription drugs at least once during the year that are generally
considered unsuitable for their age group.\3 The study used a list of
20 drugs, based on criteria published in 1991, that generally should
not be used by elderly patients.\4

A second study published in October 1994 reinforced the findings of
the earlier study.\5 In this study, the researchers interviewed a
sample of community residents, 75 or older living in Santa Monica,
California, during 1989 and 1990 about their use of prescription
drugs, over-the-counter medications, and home remedies within the 4
weeks prior to the interview.  The researchers used primarily the
same criteria as the July 1994 study, but only looked at drug usage
over a 1-month period rather than the entire year.  This study
concluded that 14 percent of those interviewed used at least one of
the drugs generally identified as not suitable for elderly patients. 

Several experts we interviewed expressed reservations about the
appropriateness of using 1991 criteria to evaluate prescription drug
use in years before the criteria were developed.  However, these
experts did not disagree with the criteria themselves.  To determine
if there was much change in prescribing patterns after 1991, we
analyzed data from the Medicare Current Beneficiary Survey conducted
by HCFA's Office of the Actuary to see what percentage of
noninstitutionalized Medicare beneficiaries in 1992 used any of the
20 drugs.\6 Our analysis showed that an estimated 17.5 percent of the
almost 30 million senior citizens in the survey used at least one of
these drugs in 1992.\7 Although this represented an improvement over
the 1987 data, more than one out of six elderly patients were still
using prescription drugs generally considered unsuitable for their
age group. 

Many health care practitioners questioned whether the use of these
drugs should always be characterized as inappropriate.  They
maintained that, under certain circumstances, their use would be
perfectly acceptable.  For example, if a patient was already using a
particular drug and doing well, there would be little medical
justification for switching to another drug.  Still, none of these
practitioners said that this rationale would account for the high
percentage of elderly patients using drugs deemed inappropriate.  All
the experts we interviewed agreed that the inappropriate use of
prescription drugs continues to be a significant health problem. 

Several experts also pointed out that these research studies only
looked at one type of the inappropriate use of prescription drugs. 
In their opinion, when other examples are considered such as
potentially dangerous drug interactions or incorrect dosages, the
percentage of senior citizens affected by the inappropriate use of
prescription drugs would be even greater than the estimates provided
in those studies. 


--------------------
\3 Wilcox, Himmelstein, and Woolhandler, pp.  292-96. 

\4 Mark Beers, Joseph G.  Ouslander, Irving Rollingher, and others,
"Explicit Criteria for Determining Inappropriate Medication Use in
Nursing Home Residents," Archives of Internal Medicine, Vol.  151
(Sept.  1991), pp.  1825-32.  A list of these 20 drugs is in appendix
III. 

\5 Andreas E.  Stuck, Mark Beers, Andrea Steiner, and others,
"Inappropriate Medication Use in Community-Residing Older Persons,"
Archives of Internal Medicine, Vol.  154 (Oct.  10, 1994), pp. 
2195-2200. 

\6 According to HCFA, this survey is representative of the Medicare
population as a whole. 

\7 For the details of this analysis and a discussion of the three
studies, see appendix IV. 


      THE ELDERLY ARE PARTICULARLY
      VULNERABLE TO INAPPROPRIATE
      PRESCRIPTION DRUG USE
---------------------------------------------------------- Letter :2.2

The elderly are more likely than other segments of the population to
be affected by the inappropriate use of prescription drugs.  As a
group, the elderly are more likely to suffer from more than one
disease or chronic condition concurrently, which means that they may
take several different drugs at one time.  As the number of
prescriptions increases, so does the potential for adverse drug
reactions caused by drug interactions or drug-disease
contraindications.  The physiological changes of aging are a major
reason drugs have the potential to cause problems in the elderly. 
Elderly patients often lack the ability to eliminate drugs from their
systems as efficiently as younger patients do because of decreased
liver and kidney function.  In addition, they are more sensitive to
the effects of drugs.  Thus, they are not able to accommodate the
normal adult dosage. 

The inappropriate use of prescription drugs is a major cause of
adverse drug reactions that, if severe enough, can result in
hospitalization or death.  Since the elderly are more vulnerable to
the effects of the inappropriate prescription drug use, they are at
greater risk from adverse drug reactions than other segments of the
population.  Studies indicate that about 3 percent of all hospital
admissions are caused by adverse drug reactions.\8

However, the percentage is much higher for the elderly.  One study
estimated the percentage of hospitalizations of elderly patients due
to adverse drug reactions to be 17 percent, almost 6 times greater
than for the general population.\9 Applying an average unit cost to
the proportion of hospital admissions that are drug-related, FDA
estimates that hospitalizations due to inappropriate prescription
drug use cost about $20 billion annually. 

Less severe adverse drug reactions may go unnoticed or be discounted
by both health practitioners and the elderly as the normal effects of
the aging process.  However, these side effects, such as drowsiness,
loss of coordination, and confusion, can result in falls or car
accidents.  A study estimated that 32,000 senior citizens annually
suffer hip fractures as a result of falls caused by adverse drug
reactions.\10 Another study concluded that about 16,000 car accidents
resulting in injuries each year can be attributed to adverse drug
reactions experienced by elderly drivers.\11 Even if no serious
bodily injury occurs, adverse drug reactions decrease the general
quality of life for patients because of drug-induced mental
impairment, loss of coordination, or addiction. 


--------------------
\8 Keith Beard, "Adverse Reactions as a Cause of Hospital Admission
in the Aged," Drugs & Aging, Vol.  2, No.  4 (July/Aug.  1992), pp. 
356-67. 

\9 Nananda Col, James E.  Fanale, and Penelope Kronholm, "The Role of
Medication Noncompliance and Adverse Drug Reactions in
Hospitalizations of the Elderly," Archives of Internal Medicine, Vol. 
150, No.  4 (Apr.  1990), pp.  841-45. 

\10 Wayne A.  Ray, Marie R.  Griffin, William Schaffner, and others,
"Psychotropic Drug Use and the Risk of Hip Fracture," New England
Journal of Medicine, Vol.  316, No.  7 (Feb.  12, 1987), pp.  363-69. 

\11 Wayne A.  Ray, Randy L.  Fought, Michael D.  Decker,
"Psychoactive Drugs and the Risk of Injurious Motor Vehicle Crashes
in Elderly Drivers," American Journal of Epidemiology, Vol.  136, No. 
7 (Oct.  1, 1992), pp.  873-83. 


   MANY FACTORS CONTRIBUTE TO THE
   INAPPROPRIATE USE OF
   PRESCRIPTION DRUGS
------------------------------------------------------------ Letter :3

The factors leading to the inappropriate use of prescription drugs
are multifaceted and interconnected, according to experts we
interviewed.  These factors reflect the behavior of the physician,
pharmacist, and patient, either collectively or individually.  From
the time a drug is prescribed to the point where the drug is taken,
many possible events, often interconnected with each other, can lead
to an adverse drug reaction or other serious results. 

The inappropriate use of prescription drugs can take several
different forms, ranging from potentially life- threatening drug-drug
interactions to therapeutic duplication (using two or more similar
drugs to treat the same problem), which yields little benefit at
increased cost.  Other examples of the inappropriate use of
prescription drugs include

  drug-age contraindication,

  drug-allergy contraindication,

  drug-disease contraindication,

  incorrect drug dosage,

  incorrect duration of drug therapy, and

  less effective drug therapy.\12

A physician, a pharmacist, or a patient may take or omit actions that
can produce an adverse drug reaction.  For example, a drug-drug
interaction could be due to a physician not recognizing that a
prescribed drug interacts badly with another prescribed medication or
over-the-counter drug used by the patient.  (See fig.  1.) The
pharmacist may contribute to the situation by not detecting the
negative interaction or by failing to determine which drugs the
elderly patient is taking.  The elderly patient may not give the
doctor and pharmacist a complete list of all the medications,
including over-the-counter drugs, that he or she is taking.  Thus,
all three parties may contribute to a drug-drug interaction, with
potentially serious consequences to the patient. 

   Figure 1:  Possible Causes and
   Outcomes of Adverse Drug
   Reactions

   (See figure in printed
   edition.)

Health care professionals noted that the overuse and underuse of drug
therapies may also contribute to the inappropriate use of
prescription drugs.\13 Drug overuse occurs when a medication is
prescribed but either no medication was needed or an alternative
treatment approach existed.  For example, changes in diet and
lifestyle may be more appropriate than drug therapy.  More
controversial is the selection of drug therapy over counseling to
treat psychological conditions such as anxiety or depression.  Drug
underuse occurs when an appropriate medication either is not
prescribed or is underprescribed.  For example, one study reported
that patients with advanced cancer were at risk of receiving less
than adequate pain medication.\14


--------------------
\12 Definitions of these terms are in the glossary. 

\13 Jerry H.  Gurwitz, "Suboptimal Medication Use in the Elderly: 
The Tip of the Iceberg," Journal of the American Medical Association,
Vol.  272, No.  4 (July 27, 1994), pp.  316-17. 

\14 Charles Cleeland, Rene Gonin, Alan K.  Hatfield, and others,
"Pain and Its Treatment in Outpatients With Metastatic Cancer," New
England Journal of Medicine, Vol.  330, No.  9 (Mar.  3, 1994), pp. 
592-96. 


   BETTER INFORMATION AND
   COMMUNICATION CAN HELP PREVENT
   INAPPROPRIATE DRUG USE
------------------------------------------------------------ Letter :4

According to several experts we interviewed, lowering the elderly's
risk of adverse drug reactions requires that more detailed
information on the impact of drug therapies on the elderly be
developed and disseminated to health practitioners.  Furthermore,
many health practitioners agreed that physicians, pharmacists, and
patients should all participate in the drug therapy decision-making
process.  Increased communication between and among physicians,
pharmacists, and patients is vital to ensuring that this process is
effective. 


      FDA HAS IMPROVED DRUG
      GUIDELINES FOR THE ELDERLY
---------------------------------------------------------- Letter :4.1

One difficulty in prescribing drugs for the elderly has been the lack
of specific information on dosage levels established for the elderly
through clinical tests.  Recognizing the need for additional
information on the effects of drugs on the elderly, FDA issued
voluntary guidelines in 1989 governing the testing of new drugs
intended for elderly patients.  These guidelines call for the
inclusion of elderly patients during the drug's testing process.  The
intent of these guidelines is to develop better information for both
physicians and pharmacists on dosage standards for new drugs intended
for elderly patients as well as to identify side effects that are
more pronounced in the elderly than in the general population.  FDA's
Director of Drug Policy and Evaluation stated that he believed that
pharmaceutical manufacturers have complied with these guidelines. 
However, several experts said that clinical trials performed under
these guidelines are not representative of the elderly population as
a whole.  For example, they believe that elderly patients over 75 are
underrepresented.\15


--------------------
\15 Jerry Avorn, "Grant Watch--Medication Use and the Elderly: 
Current Status and Opportunities," Health Affairs (Spring 1995), pp. 
276-86. 


      BETTER PHYSICIAN EDUCATION
      CAN IMPROVE POOR PRESCRIBING
      PRACTICES
---------------------------------------------------------- Letter :4.2

The medical community has only recently started to emphasize the
study of geriatrics and elderly clinical pharmacology.  For example,
board certification in geriatrics was offered for the first time in
1988.  Recognizing the aging of the population, most medical schools
now offer courses in geriatrics, though only 12 schools require
courses devoted solely to geriatrics.  Experts we interviewed agreed
that medical schools could improve how they train doctors in
geriatrics.  Moreover, several experts stressed the need to improve
the quality of continuing education in geriatrics, because a large
portion of the education doctors receive in medical school becomes
outdated during their careers.  Since medical schools have only
recently introduced geriatric training in their curricula, many
doctors in practice today have had little formal training in that
area.  Two experts also pointed out a similar need for an emphasis on
geriatrics in the training of pharmacists, both in pharmacy school
and through continuing education. 

While preclinical training in pharmacology is routinely provided in
medical school, several experts said that improvements are needed in
the teaching of clinical pharmacology, which trains doctors in the
use of drug therapies to treat disease.  Doctors obtain their
clinical pharmacology training during their residencies.  Physicians'
clinical knowledge of the unique aspects of elderly pharmacology
depends on their exposure to elderly patients.  Several experts
believe that the real expertise in pharmacology rests with the
pharmacists and that doctors need to use this expertise in deciding
the most appropriate drug therapy to prescribe. 


      DRUG UTILIZATION REVIEW
      PROGRAMS OFFER SAFEGUARDS
      AGAINST INAPPROPRIATE USE OF
      PRESCRIPTION DRUGS
---------------------------------------------------------- Letter :4.3

One strategy that is increasingly used to identify and minimize the
inappropriate use of prescription drugs involves drug utilization
reviews.  Drug utilization reviews are intended to screen drug
therapies for potential problems, such as drug-drug interactions,
drug-disease contraindications, incorrect dosages, or improper
duration of treatment.  These reviews can be done either
prospectively or retrospectively.  Prospective drug utilization
reviews are designed to detect potential problems before a
prescription is filled by the pharmacist.  Retrospective drug
utilization reviews occur after the prescription is filled and are
intended to detect prescribing patterns that indicate inappropriate
or unnecessary medical treatment as well as fraud or abuse.  The
Omnibus Budget Reconciliation Act of 1990 requires all states to
conduct ongoing retrospective reviews of Medicaid prescription drug
claims and prospective reviews before each prescription is filled. 
Most states have expanded that requirement to mandate drug
utilization review of all prescriptions.  While several experts
acknowledged the potential benefits of drug utilization review
systems, two experts cautioned that these benefits have not been
thoroughly documented to date. 

A prospective drug utilization review system allows point-of-sale
vendors such as pharmacies to check a prescription and a patient's
history against a central database.  This database can alert a
pharmacist to possible drug-drug interactions or a drug-disease
contraindication.  Our study of prospective Medicaid drug utilization
review systems in five states during fiscal year 1993 found that
pharmacies' use of automated drug utilization review systems linked
to statewide Medicaid databases provided a more thorough prospective
review than a manual or localized system.\16

This type of automated review can reduce the risk of inappropriate
drug therapy and increase patient safety, though we recognized the
need for these benefits to be demonstrated conclusively and
recommended that HCFA take steps to do so.  We also recommended that
HCFA develop guidance for the development of these systems to ensure
standard implementation of effective drug utilization review systems. 

New York State's Elderly Pharmaceutical Insurance Coverage program
provides prescription drug insurance coverage for low-income senior
citizens not eligible for Medicaid.  This program uses a
retrospective drug utilization review system for its therapeutic drug
monitoring program.  This review system monitors each client's
prescriptions, using data from prescription claims submitted for
payment by pharmacies, to detect potential problems such as
overutilization of a drug or a drug-drug interaction.  Once a
potential problem is detected, a program official notifies the
prescribing physician.  The alert is informational only and provides
the doctor with a history of the patient's prescription drug usage,
the suspected problem, its effect and severity, and recommendations
for resolving the problem.  No action is required, but the doctor is
asked to respond.  In one analysis conducted by program staff, 38.4
percent of the patients whose doctors received letters alerting them
to a potential problem subsequently had their drug therapy changed. 

The Massachusetts Medicaid program also uses its retrospective drug
utilization review system to detect questionable prescribing
practices affecting any of its recipients.  For example, if a patient
is prescribed a nonsteroidal anti-inflammatory drug commonly used to
relieve the symptoms of arthritis, the system will monitor that
patient for potential side effects of this type of medication, such
as stomach or intestinal bleeding.  If the patient later begins to
take antiulcer medications, the system will issue an alert to the
prescribing doctor that the usage of the first drug may be the cause
of the ulcers.  This allows the doctor to evaluate the situation and,
if warranted, alter the patient's drug therapy. 

A retrospective drug utilization review system can also monitor
patient compliance with a prescribed drug therapy.  For example, a
patient may discontinue his or her blood pressure medication when the
symptoms disappear.  Despite the lack of symptoms, the causes remain,
leaving the patient still at risk.  A retrospective drug utilization
review can detect the patient's failure to refill a prescription and
alert the patient's doctor to the situation for further action. 


--------------------
\16 Prescription Drugs:  Automated Prospective Review Systems Offer
Potential Benefits for Medicaid (GAO/AIMD-94-130, Aug.  5, 1994). 


      IMPROVED PATIENT COUNSELING
      CAN REDUCE THE RISK OF
      ADVERSE DRUG REACTIONS
---------------------------------------------------------- Letter :4.4

One way to lower the potential of adverse drug reactions is to ensure
that patients are counseled by either their doctor or pharmacist on
the usage and characteristics of a prescription drug.  Often, subtle
side effects of drugs are ignored by patients and not reported back
to the doctor or pharmacist.  Unless alerted that the patient is
experiencing side effects, a doctor would not be likely to change
drug therapies.  Counseling not only improves the information
received by the patient but also that obtained from the patient. 
This improved communication between doctor or pharmacist and the
patient may prompt a question that leads to the discovery of a
drug-drug interaction or drug-allergy interaction. 

Although effective counseling by doctors and pharmacists can help
reduce the likelihood of an adverse drug reaction, two studies have
found that many patients do not receive this counseling.  A Consumer
Reports study of 70,000 people published in 1995 found that about 26
percent had not been counseled by a physician about their drug
therapies.\17 A 1989 study by the American Association of Retired
Persons (AARP) found that more than one out of three patients
reported that they were not counseled by their doctors on their drug
therapies.\18 Time pressures on both doctors and pharmacists may also
be an obstacle to effective counseling. 

Recognizing the importance of counseling, the Omnibus Budget
Reconciliation Act of 1990 mandated that pharmacists counsel Medicaid
patients when they receive prescription drugs.  A majority of states
have expanded this requirement to include all patients.  Officials of
the American Pharmaceutical Association and the American Society of
Consultant Pharmacists, two professional associations that represent
pharmacists, stressed the importance of counseling but noted that the
current system of compensation for pharmacists is based on dispensing
drugs and lacks meaningful incentives for counseling.  For example, a
pharmacist may detect a potential problem with a prescription and,
after consultation with the doctor and patient, cancel the
prescription.  If another drug is not substituted and no drug is
dispensed, the pharmacist receives no reimbursement for the
professional services rendered. 


--------------------
\17 "How Is Your Doctor Treating You?," Consumer Reports (Feb. 
1995), pp.  81-88. 

\18 Mismedication and Its Impact on Older Americans, a statement of
the American Association of Retired Persons presented by John Lione,
M.D., before the U.S.  House of Representatives, Committee on Ways
and Means, Subcommittee on Health (Sept.  20, 1994). 


      PATIENTS CAN PROTECT
      THEMSELVES FROM ADVERSE DRUG
      REACTIONS
---------------------------------------------------------- Letter :4.5

Patients who seek information about their drug therapies can reduce
their likelihood of experiencing adverse drug reactions.  Besides
requesting counseling from both the doctor and pharmacist, public
advocacy groups urge individuals to develop their own knowledge of
drugs.  To achieve this objective, AARP encourages the development of
package product inserts in large type that are easy for the elderly
to read and understand.  Public Citizen Health Research Group, a
public advocacy group, has also published a consumer guidebook for
prescription drugs.  Moreover, pharmaceutical manufacturers have
begun to make information available directly to consumers.  Increased
understanding of their drugs, dosage requirements, and possible side
effects makes patients more likely to avoid the inappropriate use of
drugs. 

State and local agencies have developed several initiatives to alert
consumers to the dangers of inappropriately using prescription drugs. 
For example, the Massachusetts Department of Public Health sponsors
brown bag seminars at senior citizen or community centers.  At these
seminars, elderly patients are encouraged to bring in all their
medicines for review by pharmacists.  The goal is to inventory all
the medications a senior citizen has and eliminate those that are for
conditions no longer being treated or which have expired.  The
remaining drugs are cataloged in what is called a "medicine passport"
that can be shown to doctors and pharmacists as new or additional
drugs are prescribed.  This record allows health practitioners to
quickly review what other medications the person is taking and why. 


   MANAGED CARE HAS THE POTENTIAL
   TO REDUCE THE INAPPROPRIATE USE
   OF PRESCRIPTION DRUGS
------------------------------------------------------------ Letter :5

Recent changes in the health care delivery system have implications
for the use of prescription drugs.  The growing emphasis on
controlling health care costs creates a strong incentive to reduce
the inappropriate use of prescription drugs and the physical and
financial costs associated with adverse drug reactions.  Likewise,
the increasing importance of cost containment has helped spur the
emergence of managed care as a major form of health care delivery. 
The number of people covered by managed care plans has increased
dramatically from 10 million in 1980 to almost 90 million in 1992. 
Moreover, many managed care plans have recently initiated major
marketing efforts to enroll elderly patients.  Similarly, the number
of people whose prescriptions are filled by pharmacy benefit
management companies has also increased.  While it is too early to
understand the full impact these changes may have on reducing
inappropriate drug use--in general, and among the elderly in
particular--several experts we interviewed stated that these changes
have the potential to improve the coordination of care and to
increase the ability to detect inappropriate use of drugs.  However,
one expert cautioned that the achievement of these goals might be
adversely affected by pressures to contain costs or increase profits. 


      IMPROVED COORDINATION OF
      CARE IS A GOAL OF MANAGED
      CARE
---------------------------------------------------------- Letter :5.1

Many elderly patients are under the care of several specialists as
well as their primary care physician.  At times, these doctors may
prescribe several drugs to treat various ailments.  Unless these
various drug therapies are coordinated, adverse drug reactions pose a
serious risk.  Experts in gerontology and elderly clinical
pharmacology that we spoke to stated that the most effective way to
deal with the inappropriate use of prescription drugs was to improve
the coordination of care.  Ideally, this role should fall to the
patient's primary physician. 

Proponents of managed care have stressed improved coordination of
care as a major goal.  Though there are several variations of managed
care such as health maintenance organizations (HMO) or preferred
provider organizations, a basic characteristic of managed care is
control over utilization.  Often, this is done through a gatekeeper. 
A gatekeeper is usually the patient's designated primary doctor who
oversees the individual's care, referring the patient to specialists
as needed.  This allows one doctor to coordinate various treatments,
including drug regimens.  Several experts agreed that such
coordination could help lower the risk of adverse drug reactions
posed by inappropriate drug therapy or a patient receiving multiple
prescriptions from different doctors.  However, they cautioned that
the improved coordination of care is dependent on the quality of
patient care, which varies widely among managed care plans. 

Managed care plans also have the potential to use formularies to
reduce the inappropriate use of prescription drugs.  A formulary
lists the preferred drugs used to treat certain diseases or
conditions.  Typically, the formulary is developed by a committee of
doctors and pharmacists associated with the managed care plan, who
seek to identify the most effective drug therapies at the lowest cost
to the plan.  For example, if two drug therapies are deemed equally
effective, then the plan will recommend the less costly of the two as
the preferred treatment.  However, several experts expressed the
concern that cost concerns rather than effectiveness may be the
primary driving force in selecting which drugs to place on a managed
care plan's formulary. 

A managed care plan can change its formulary to reflect new drug
therapies.  This has an impact on the prescribing behavior of a
plan's doctors who may have to seek an exception if they wish to
prescribe a drug not designated by the plan's formulary.  However,
two experts said that few managed care plans have used their
formularies to improve prescribing practices for elderly patients
though the experts acknowledged this potential exists. 

Another potential advantage of managed care is the data collected on
patients.  This gives managed care plans the information needed to
monitor both the drug therapies patients receive and the prescribing
patterns of physicians.  One HMO we visited provided its doctors with
periodic analyses of their drug-prescribing habits as compared with
standards developed by the HMO.  This comparison allows the HMO to
identify doctors who may need additional training or counseling in
prescribing drugs for their patients, particularly the elderly. 


      INCREASING NUMBER OF PEOPLE
      OBTAIN PRESCRIPTIONS FROM
      PHARMACY BENEFIT MANAGEMENT
      FIRMS
---------------------------------------------------------- Letter :5.2

Over the past few years, the number of people who receive their
prescription drugs through pharmacy benefit management firms has
increased dramatically from fewer than 60 million in 1989 to 100
million in 1993.  Pharmacy benefit management firms manage
prescription drug benefits on behalf of health plan sponsors,
including self-insured employers, insurance companies, and managed
care plans. 

The initial attraction of pharmacy benefit management firms is their
ability to reduce administrative costs and obtain discounts on
prescriptions drugs through volume buying.  However, these firms can
also provide formulary management and drug utilization review
services with the potential to reduce inappropriate drug use.  For
example, the drug utilization review done by one pharmacy benefit
management firm, PCS Health Systems, generated almost 25 million
alerts in 1994.  Of these alerts, 25 percent dealt with drug-age
contraindications and excessive daily dosages, two types of
inappropriate drug use prevalent among the elderly.  Likewise, by
monitoring patient prescription drug use, pharmacy benefit management
firms can detect a patient's failure to refill a prescription for a
persistent medical condition such as high blood pressure.  The firm
can then alert the patient's doctor to this situation for further
action if required. 

Pharmacy benefit management firms can also develop initiatives to
address the inappropriate use of drugs among the elderly.  For
example, Medco has instituted an educational program called "Partners
for Healthy Aging." This program provides specialized information to
doctors, pharmacists, and patients to alert them to potential
concerns in the use of prescription drugs among the elderly. 

As the number of patients served by these firms has increased so has
the information gathered on patients.  With the accumulation of data
on patient characteristics, medical conditions, and drug therapies,
pharmacy benefit management firms are developing the necessary
database for engaging in outcomes research.  Such research allows
companies to demonstrate the effectiveness of different courses of
treatment for a disease from both a therapeutic and cost perspective. 
This would permit doctors, patients, and payers to make both
financially and clinically informed health care decisions. 


---------------------------------------------------------- Letter :5.3

A draft of this report was reviewed and commented on by five leading
experts in the field of elderly clinical pharmacology.  Where
appropriate, the report was changed to reflect their comments. 

As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days
after its issue date.  At that time, we will make copies available
upon request. 

This report was prepared by John C.  Hansen, Assistant Director,
Frank Putallaz, and Tom Taydus.  Please call Mr.  Hansen at (202)
512-7105 if you or your staff have any questions about this report. 

Sincerely yours,

Jonathan Ratner
Associate Director
Health Financing Issues


SCOPE AND METHODOLOGY
=========================================================== Appendix I

To determine the significance of the inappropriate use of
prescription drugs among the elderly, we conducted a literature
review and obtained documents and testimonial evidence from leading
researchers in the fields of gerontology and elderly clinical
pharmacology.  Additionally, we interviewed other knowledgeable
professionals concerning the issues related to the use of
prescription drugs by the elderly.  Included among these
professionals were representatives of FDA, HCFA, senior citizen and
consumer advocacy groups, the American Pharmaceutical Association,
the Pharmaceutical Research and Manufacturers of America, the
American Medical Association, the American Society of Consultant
Pharmacists, and the American Association of Medical Colleges. 

We interviewed state officials in Massachusetts, New York, and
Vermont to see how state and federal health programs deal with the
inappropriate use of prescription drugs among the elderly. 
Massachusetts was selected because of the number of prominent
researchers in the areas of elderly clinical pharmacology located
there.  New York was selected because the state administers the
Elderly Pharmaceutical Insurance Coverage program, which provides
prescription drug coverage to low-income senior citizens.  Vermont, a
rural state in contrast to Massachusetts and New York, was selected
because it was one of only eight states that had implemented a
statewide automated prospective drug utilization review system for
Medicaid prior to 1994.  In each state, we obtained information on
the operation of Medicaid drug utilization review systems as well as
various state initiatives to help senior citizens avoid adverse drug
reactions. 

To update the results from earlier research studies, we analyzed data
from HCFA's 1992 Medicare Current Beneficiary Survey, the most
recently available data.  According to HCFA, this survey is designed
to provide reliable baseline data to project Medicare costs and is
representative of the Medicare population as a whole. 

To determine what causes the inappropriate use of prescription drugs,
we reviewed the literature and interviewed the leading experts
previously cited.  We also obtained information on physician
gerontology education and questioned state officials about the
implementation of drug utilization review programs and their effect
on the causes of the inappropriate use of prescription drugs. 

To determine how physicians, pharmacists, and patients receive
information on drug therapies, we identified actions that drug
manufacturers and FDA have taken to provide better dosage information
for elderly patients as well as changes in how drug manufacturers
disseminate information to physicians, pharmacists, and patients.  We
also obtained information on efforts by state agencies, senior
citizen advocacy groups, pharmacy groups, and medical organizations
to improve communication between and among physicians, pharmacists,
and patients. 

To identify emerging trends in the health care delivery system and
their potential effects on the inappropriate use of prescription
drugs, we obtained information on how managed care plans develop
formularies, train their staff on new drug therapies, and track both
patient and physician use of prescription drugs.  To assess the
effect of the growth of pharmacy benefit management firms, we
obtained information on how these plans coordinate and monitor drug
therapies. 


MEDICARE CURRENT BENEFICIARY
SURVEY
========================================================== Appendix II

The Medicare Current Beneficiary Survey is a continuous, multipurpose
survey of a representative sample of the Medicare population.  It is
administered by HCFA's Office of the Actuary and began gathering data
in 1991.  The survey generates data on issues of prime importance to
the management of the Medicare program and the development of health
care policy.  Focusing on health care use and expenditures, the
survey generates data to (1) allow HCFA to monitor the financial
effects of changes in the Medicare program; (2) develop reliable and
current information on the use and cost of services not covered by
Medicare such as prescription drugs and long-term care; and (3)
obtain information on the sources of payments for costs of covered
services not assumed by Medicare.  Although its focus is on the
financing of health care, the survey collects a variety of
information about the Medicare population, including demographic
characteristics, health status, insurance coverage, financial
resources, and family support. 

The survey is based on a sample of Medicare recipients drawn from the
Medicare enrollment file.  The sample is representative of the
Medicare population as a whole.  Since the survey is a longitudinal
study, those selected for participation are interviewed three times a
year for several years to form a continuous profile of their health
care.  Initial participants who completed the first round of
interviews numbered 12,677.  Of these, 942 resided in an
institutional setting and 11,735 were community-based.  The sample is
adjusted annually for attrition and for newly eligible persons. 

The initial interview gathers baseline data on demographic
characteristics, health status, insurance coverage, financial
resources, and family support.  Subsequent interviews gather details
of the participants' health care use since the last interview
emphasizing the type of health care used and the source for paying
for it.  This includes information on the prescription drugs a
participant is using even though Medicare does not provide
reimbursement for their cost. 

Information collected is edited for consistency, documented, and
organized into files.  Later, these files are merged with HCFA claims
payment records.  Also, administrative data such as Medicaid buy-in
status and capitated plan membership are added to the file.  All
personal identifying information is removed. 


20 DRUGS GENERALLY CONSIDERED
INAPPROPRIATE FOR THE ELDERLY
========================================================= Appendix III

Table III.1 lists the 20 drugs deemed generally inappropriate for
elderly patients by a panel of experts.  The reasons given by this
panel for judging a drug inappropriate are also provided as is the
purpose of these drugs.  The panel's results and methodology were
published in 1991.\19 Though the goal of this panel was to identify
drugs inappropriate for the elderly living in a nursing home setting,
a later examination of these drugs by another panel of experts also
judged these drugs as generally inappropriate for elderly patients
living in a community-based setting.\20 Several of the experts we
interviewed agreed that these drugs should normally not be used with
elderly patients though they stressed that there would be some
medical situations where the use of these drugs would be appropriate. 
One expert noted the need for research studies based on
patient-related outcomes data to confirm the views of the expert
panelists. 



                         Table III.1
           
           Drugs Considered Generally Inappropriate
                 for Elderly Patients and Why

Prescription drug   Use                 Comment
------------------  ------------------  --------------------
Diazepam            As a tranquilizer   Shorter-acting
                    or antianxiety      benzodiazepines are
                    medication          safer alternatives.

Chlordiazepoxide    As a tranquilizer   Shorter-acting
                    or antianxiety      benzodiazepines are
                    medication          safer alternatives.

Flurazepam          As a sleeping pill  Shorter-acting
                                        benzodiazepines are
                                        safer alternatives.

Meprobamate         As a tranquilizer   Shorter-acting
                                        benzodiazepines are
                                        safer alternatives.

Pentobarbital       As a sleeping pill  Safer sedative-
                    and to reduce       hypnotics are
                    anxiety             available.

Secobarbital        As a sleeping pill  Safer sedative-
                    and to reduce       hypnotics are
                    anxiety             available.

Amitriptyline       To treat            Other antidepressant
                    depression          medications cause
                                        fewer side effects.

Indomethacin        To relieve the      Other nonsteroidal
                    pain and            anti-inflammatory
                    inflammation of     agents cause less
                    rheumatoid          toxic reactions.
                    arthritis

Phenylbutazone      To relieve the      Other nonsteroidal
                    pain and            anti-inflammatory
                    inflammation of     agents cause less
                    rheumatoid          toxic reactions.
                    arthritis

Chlorpropamide      To treat diabetes   Other oral
                                        hypoglycemic
                                        medications have
                                        shorter half-lives
                                        and do not cause
                                        inappropriate
                                        antidiuretic hormone
                                        secretion.

Propoxyphene        To relieve mild to  Other analgesic
                    moderate pain       medications are more
                                        effective and safer.

Pentazocine         To relieve          Other narcotic
                    moderate to severe  medications are
                    pain                safer and more
                                        effective.

Isoxsuprine         To improve blood    Effectiveness is in
                    circulation         doubt.

Cyclandelate        To improve blood    Effectiveness is in
                    circulation         doubt. This drug is
                                        no longer available
                                        in the U.S.

Dipyridamole        To reduce blood-    Effectiveness at low
                    clot formation      dosage is in doubt.
                                        Toxic reaction is
                                        high at higher
                                        dosages. Safer
                                        alternatives exist.

Cyclobenzaprine     To relieve severe   Minimally effective
                    pain caused by      while causing
                    sprains and back    toxicity. Potential
                    pain                for toxic reaction
                                        is greater than
                                        potential benefit.

Methocarbamol       To relieve severe   Minimally effective
                    pain caused by      while causing
                    sprains and back    toxicity. Potential
                    pain                for toxic reaction
                                        is greater than
                                        potential benefit.

Carisoprodol        To relieve severe   Minimally effective
                    pain caused by      while causing
                    sprains and back    toxicity. Potential
                    pain                for toxic reaction
                                        is greater than
                                        potential benefit.

Orphenadrine        To relieve severe   Minimally effective
                    pain caused by      while causing
                    sprains and back    toxicity. Potential
                    pain                for toxic reaction
                                        is greater than
                                        potential benefit.

Trimethobenzamide   To relieve nausea   Least effective of
                    and vomiting        available
                                        antiemetics.
------------------------------------------------------------
Note:  While these drugs are generally considered inappropriate for
elderly patients, individuals should always consult with their
physicians before making any changes in their prescription drugs. 


--------------------
\19 Beers, Ouslander, Rollingher, and others, pp.  1825-32. 

\20 Stuck, Beers, Steiner, and others, pp.  2195-2200. 


USE OF DRUGS CONSIDERED GENERALLY
INAPPROPRIATE FOR THE ELDERLY
========================================================== Appendix IV

At our request, HCFA's Office of the Actuary used data from the
Medicare Current Beneficiary Survey to determine the percentage of
community-based elderly who used at least 1 of the 20 drugs
identified in appendix III as generally inappropriate for their age
group.\21 The most current compiled data are for 1992.  The first
step was to identify survey participants who were 65 or older and who
were noninstitutionalized.  Of their survey population, 9,182
participants met these criteria.  This group represented 29,862,854
Medicare beneficiaries nationwide according to HCFA's Office of the
Actuary.  The next step was to determine which of these participants
used at least 1 of the 20 drugs sometime during 1992 and project that
use to the national population.  The results indicated that an
estimated 17.5 percent or 5,219,811 noninstitutionalized Medicare
beneficiaries 65 or older used at least 1 of those drugs during 1992. 

These results are displayed in table IV.1.  Specifically, the table
lists the percentages of noninstitutionalized elderly found to be
using each of the 20 drugs.  The middle column details the results
based on research using data from the 1987 National Medical
Expenditure Survey covering noninstitutionalized residents 65 or
older.\22 The right-hand column presents the results of the analysis
described above.  We did not include the research results based on
interviews conducted during 1989 and 1990 of a sample of
noninstitutionalized elderly 75 or older residing in Santa Monica,
California.\23 This was because the participants in this study
represented one community rather than a national sample and belonged
to a different age group than the other two studies.  In addition,
their use of the 20 drugs was measured during a period of 1 month
versus 1 year in the other 2 analyses. 



                          Table IV.1
           
              Percentage of Noninstitutionalized
                Elderly Using Drugs Generally
              Inappropriate for Their Age Group

                                                1987    1992
                                              result  result
Prescription drug                                  s       s
--------------------------------------------  ------  ------
Diazepam                                        2.82    2.13
Chlordiazepoxide                                1.95    0.60
Flurazepam                                      1.25    0.77
Meprobamate                                     0.82    0.32
Pentobarbital                                   0.12    0.02
Secobarbital                                    0.03    0.01
Amitriptyline                                   3.13    2.63
Indomethacin                                    2.64    1.72
Phenylbutazone                                  0.28    0.11
Chlorpropamide                                  2.08    0.87
Propoxyphene                                    4.83    5.63
Pentazocine                                     0.30    0.14
Isoxsuprine                                     0.31    0.06
Cyclandelate                                    0.25    0.05
Dipyridamole                                    6.44    4.09
Cyclobenzaprine                                 0.70    0.59
Methocarbamol                                   0.42    0.40
Carisoprodol                                    0.38    0.68
Orphenadrine                                    0.33    0.30
Trimethobenzamide                               0.27      No
                                                        data
                                                      availa
                                                         ble
Percentage of elderly using 1 or more of the   23.50   17.50
 20 drugs
------------------------------------------------------------

--------------------
\21 For a complete explanation of the Medicare Current Beneficiary
Survey, see appendix II. 

\22 Wilcox, Himmelstein, and Woolhandler, pp.  292-96. 

\23 Stuck, Beers, Steiner, and others, pp.  2195-2200. 


GLOSSARY
============================================================ Chapter 0


      DRUG-AGE CONTRAINDICATION
-------------------------------------------------------- Chapter 0:0.1

Use of a drug not recommended for the age group of a patient. 


      DRUG-DRUG INTERACTION
-------------------------------------------------------- Chapter 0:0.2

The potential for, or the occurrence of, an adverse drug reaction as
a result of the use of two or more drugs together. 


      DRUG-ALLERGY INTERACTION
-------------------------------------------------------- Chapter 0:0.3

The potential for, or the occurrence of, an allergic reaction as a
result of drug therapy. 


      DRUG-DISEASE
      CONTRAINDICATION
-------------------------------------------------------- Chapter 0:0.4

The potential for, or occurrence of, an undesirable alteration of the
therapeutic effect of a given prescription because of the presence,
in the patient for whom it is prescribed, of an additional disease
condition.  Also, the potential for, or the occurrence of, an adverse
effect of the drug on the patient's disease condition. 


      INCORRECT DRUG DOSAGE
-------------------------------------------------------- Chapter 0:0.5

A dosage that lies outside the daily recommended dosage range as
specified in predetermined standards as necessary to achieve
therapeutic benefit. 


      INCORRECT DURATION OF DRUG
      THERAPY
-------------------------------------------------------- Chapter 0:0.6

The number of days of prescribed therapy exceeds or falls short of
the recommendations contained in the predetermined standards. 


      THERAPEUTIC DUPLICATION
-------------------------------------------------------- Chapter 0:0.7

The prescribing and dispensing of two or more drugs from the same
therapeutic class such that the combined daily dose puts the patient
at risk of an adverse drug reaction or yields no additional
therapeutic benefit. 


      LESS EFFECTIVE DRUG THERAPY
-------------------------------------------------------- Chapter 0:0.8

Use of a drug therapy that is less desirable than other alternatives
because of factors such as therapeutic effectiveness, presence of
side effects, ease of use, or cost. 


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============================================================ Chapter 1

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