Transcript pharmaceutical guidelines: basic principles and statutes

PHARMACEUTICAL
GUIDELINES: BASIC
PRINCIPLES AND STATUTES
DRUGS
Consumers have two routes of access to
therapeutic drugs.
One route is by prescription or order from a
licensed health care provider.
The other route is by over-the-counter
(OTC) purchase of drugs that do not require
a prescription.
Both of these routes are regulated by
various drug laws.
Drug Laws and Standards
Their main goal is to protect the public by ensuring
that drugs marketed for therapeutic purposes,
whether prescription or OTC, are safe and
effective.
With prescription drugs, a health care professional
diagnoses the condition, often with the help of
laboratory and other diagnostic tests, and
determines a need for the drug.
With OTC drugs, the client must make these
decisions, with or without consultation with a
health care provider.
Questions to be answered
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1. Can consumers accurately self-diagnose the
condition for which a drug is indicated?
2. Can consumers read and understand the label
well enough to determine the dosage, interpret
warnings and contraindications and determine
whether they apply, and recognize drugs already
being taken that might interact adversely with
the drug being considered?
3. Is the drug effective when used as
recommended?
4. Is the drug safe when used as instructed?
Available OTC, advantages for
consumers
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Greater autonomy;
faster and more convenient access to effective
treatment;
possibly earlier resumption of usual activities of
daily living;
fewer visits to a health care provider;
possibly increased efforts by consumers to learn
about their symptoms/conditions and
recommended treatments.
Available OTC, disadvantages for
consumers
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Inaccurate self-diagnoses and potential
risks of choosing a wrong or
contraindicated drug,
Delaying treatment by a health care
professional,
developing adverse drug reactions and
interactions
OTC products
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To use OTC products safely, it is
important to understand
their side effects,
their effects on other underlying medical
conditions such as diabetes mellitus,
high blood pressure, asthma, and other
conditions,
their interactions with other prescribed
medications such as antidepressants,
blood thinners, and high blood pressure
medicines,
the product's limitations.
COMPLIANCE
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Compliance (sometimes called adherence) is the
extent to which patients follow treatment instructions.
There are four types of noncompliance leading to
medication errors.
(1) The patient fails to obtain the medication.
Some studies suggest that one third of patients
never have their prescriptions filled. Some
patients leave the hospital without obtaining
their discharge medications, whereas others
leave the hospital without having their
prehospitalization medications resumed. Some
patients cannot afford the medications
prescribed.
COMPLIANCE (cont’d)
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(2) The patient fails to take the medication as prescribed.
Examples include wrong dosage, wrong frequency of
administration, improper timing or sequencing of
administration, wrong route or technique of administration,
or taking medication for the wrong purpose. This usually
results from inadequate communication between the
patient and the prescriber and the pharmacist.
(3) The patient prematurely discontinues the medication.
This can occur, for instance, if the patient incorrectly
assumes that the medication is no longer needed because
the bottle is empty or symptomatic improvement has
occurred.
(4) The patient (or another person) takes medication
inappropriately. For example, the patient may share a
medication with others for any of several reasons.
COMPLIANCE (cont’d)
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Several factors encourage noncompliance.
Some diseases cause no symptoms (eg,
hypertension); patients with these
diseases therefore have no symptoms to
remind them to take their medications.
Patients with painful conditions, such as
arthritis, may continually change
medications in the hope of finding a better
one.
COMPLIANCE (cont’d)
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Characteristics of the therapy itself can limit the
degree of compliance; patients taking a drug
once a day are much more likely to be compliant
than those taking a drug four times a day.
Various patient factors also play a role in
compliance. Patients living alone are much less
likely to be compliant than married patients of
the same age. Packaging may also be a
deterrent to compliance¾elderly arthritic
patients often have difficulty opening their
medication containers. Lack of transportation as
well as various social or personal beliefs about
medications are likewise barriers to compliance.
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Strategies for improving
compliance
include enhanced communication between the patient
and health care team members;
assessment of personal, social, and economic conditions
(often reflected in the patient's lifestyle);
development of a routine for taking medications (eg, at
mealtimes if the patient has regular meals);
provision of systems to assist taking medications (ie,
containers that separate drug doses by day of the week,
or medication alarm clocks that remind patients to take
their medications);
mailing of refill reminders by the pharmacist to patients
taking drugs chronically. The patient who is likely to
discontinue a medication because of a perceived drugrelated problem should receive instruction about how to
monitor and understand the effects of the medication.
Compliance can often be improved by enlisting the
patient's active participation in the treatment.