Challenges to Effective Drug Therapy

Glossary of Key Terms

 alternative therapy: includes herbs and other “natural” products as often found in ancient
records; these products are not controlled or tested by the U.S. Food and Drug
Administration and are considered to be dietary supplements; however, they are often the
basis for discovery of an active ingredient that is later developed into a regulated medication
 biological weapons: so-called germ warfare; the use of bacteria, viruses, and parasites on a
large scale to incapacitate or destroy a population
 cost comparison: a comparison of the relative cost of the same drug provided by different
manufacturers to determine the costs to the consumer
 Internet: the worldwide digital information system accessed through computer systems
 off -label uses: uses of a drug that are not part of the stated therapeutic indications for
which the drug was approved by the FDA; off -label uses may lead to new indications for a
drug
 self-care: tendency for patients to self-diagnose and determine their own treatment needs
 street drugs: nonprescription drugs with no known therapeutic use; used to enhance mood
or increase pleasure

CONSUMER AWARENESS

A. Media Influence
If a drug advertisement states what the drug is used for, it must also state contraindications,
adverse effects, and precautions. Because in many cases listing the possible adverse effects
is not a good selling point, many advertisements are pure business ploys intended to interest
consumers in the drug and to have them request it from their health care providers (even if
it is unclear what the drug is used for).

B. The Internet
The Internet, the worldwide digital information
system accessed through computer systems, and
World Wide Web are now readily accessible to most
consumers. A person can spend hours looking up
information on a drug—including pharmaceutical
company information sites, chat rooms with other
people who are taking the drug, online pharmacies,
lists of government regulations, and research reports
about the drug and its effectiveness.
OVER-THE-COUNTER DRUGS

- OTC medications allow people to take care of simple medical problems without seeking
advice from their health care providers.
- Although OTC drugs have been deemed to be safe when used as directed, many of these
medications were “grandfathered in” as drugs when stringent testing and evaluation
systems became law and have not been tested or evaluated to the extent that new drugs are
today.
- Aspirin, one of the nonprescription standbys for many years, falls into this category. Slowly,
the FDA is looking at all of these drugs to determine their effectiveness and safety.
- Ipecac, a former standard OTC drug, was used for many years by parents to induce vomiting
in children in cases of suspected poisoning or suspected drug overdose. The drug was finally
tested, and in 2003, the FDA announced that it was not found to be effective for its intended
use. New guidelines have since been established for parents regarding possible poisoning,
and parents were advised to dispose of any ipecac that they had at home.
- Some well-known approved OTC drugs are cimetidine (Tagamet) for decreasing gastric
upset and heartburn; various vaginal antifungal medications for treating yeast infections
(Mycelex, GyneLotrimin); and omeprazole (Prilosec) and famotidine (Pepcid), two other
drugs for dealing with heartburn.

ALTERNATIVE THERAPIES AND HERBAL MEDICINE

- Herbal medicines and alternative therapies are found in ancient records and have often
been the basis for the discovery of an active ingredient that is later developed into a
regulated medication.
- Today, alternative therapies can also include nondrug measures, such as imaging and
relaxation.
- There is an element of the placebo effect in using some of these therapies. The power of
believing that something will work and that there is some control over the problem is often
very benefi cial in achieving relief from pain and suffering.
- The challenge for the health care provider is to balance the therapies that the patient wishes
to use with the medical regimen that is prescribed. This may involve altering doses or timing
of various drugs
OFF-LABEL USES

- When a drug is approved by the FDA, the therapeutic indications for which the drug is
approved are stated.
- Off-label use refers to uses of a drug that are not part of the stated therapeutic indications
for which the drug was approved by the FDA. Once a drug becomes available for use, it may
be found to be effective in a situation not on the approved list. Using it for this indication
may eventually lead to a new approval of the drug for that new indication.
- Off-label use is commonly done for groups of patients for which there is little premarketing
testing, particularly pediatric and geriatric groups. With the ethical issues involved in testing
drugs on children, the use of particular drugs in children often occurs by trial and error when
the drug is released with adult indications.
- Off-label use of drugs is widespread and often leads to discovery of a new use for a drug. The
nurse needs to be cognizant of off-label uses, and know when to question the use of a drug
before administering it. Liability issues surrounding many of these uses are very fuzzy, and
the nurse should be clear about the intended use, why the drug is being tried, and its
potential for problems.

COSTS OF HEALTH CARE AND THE IMPORTANCE OF PATIENT TEACHING

- To save costs, patients are being discharged from hospitals far earlier than ever before, and
many are not even admitted to hospitals for surgical or invasive procedures that used to
require several days of hospitalization and monitoring. As a result, there is less monitoring of
the patient, and more responsibility for care falls on the patient or the patient’s signifi cant
others. Teaching the patient about self-care, drug therapies, and what to expect is even
more crucial now. The nurse is the one who most often is responsible for this teaching.

A. Health Maintenance Organizations and Regulations

 HMOs maintain a centralized control system to provide patient medical care
within a budget.
 The HMO may regulate access to emergency facilities, types and timing of tests
allowed, and procedures covered. Accessibility to prescription drugs is also
controlled.
 The formulary for each HMO differs. Sometimes only generic products are
covered, and newer drugs must be paid for by the patient; in other instances, a
tier system exists, and the patient may urge the provider to choose a drug from
a lower tier, at a lower cost.

B. Home Care
 Patients go home directly from surgery with the responsibility for changing
dressings, assessing wounds, and monitoring their recovery.
 Patients need to know exactly what medications they are taking (generic and
brand names), the dose of each medication, and what each is supposed to do.
Patients also need to know what they can do to alleviate some of the adverse
effects that are expected with each drug (e.g., small meals if gastrointestinal
upset is common, use of a humidifier if secretions will be dried and make
 breathing difficult); which OTC drugs or alternative therapies they need to avoid
while taking their prescribed drugs; and what to watch for that would indicate a
need to call the health care provider.

C. Cost Considerations
 Patients may be forced into a situation where they have to decide whether to
“treat or eat.” Sometimes patients do not tell the health care provider that they
are not filling a prescription because of cost and lose the therapeutic benefit
that the drug could offer.
 Sometimes this may mean not selecting a first-choice drug but settling for a drug
that should be effective. Patients who take antibiotics must be reminded to take
the full course and not to stop the drug when they feel better.

EMERGENCY PREPAREDNESS

- One of the potential threats that is being addressed by the Centers for Disease Control and
Prevention (CDC) and the Office of Homeland Security is the risk of exposure to biological
and chemical weapons.

DRUG ABUSE

- Illicit drug use in this

country is a growing
problem. Professional
athletes are cited
regularly for abusing
anabolic steroids.
Hollywood stars are
often part of the drug
scene, using street
drugs—nonprescription
drugs with no known
therapeutic use—to
enhance their moods
and increase pleasure.
- Alcohol and nicotine
are two commonly
abused drugs that
cause serious problems
for the abuser or can
interact with various
drugs and alter a
patient’s response to a prescribed drug
but that are often not seen as drug
addiction issues.

PROTECTING THE ENVIRONMENT

- Many people store these extra pills and end up with a medicine cabinet full of prescription
drugs. In the past, people would often just flush these extras down the toilet, where they
would enter the water system. Some people just threw them out, where they would
eventually enter the ground of various landfills or would be diverted for illicit use by drug
seekers going through garbage sites.
- With these things in mind and the push to protect the environment, the Office of National
Drug Control Policy has released specific guidelines for the proper disposal of prescription
drugs.