PHARMACEUTICAL GUIDELINES: BASIC PRINCIPLES AND STATUTES

1. PHARMACEUTICAL GUIDELINES: BASIC PRINCIPLES AND STATUTES

2. DRUGS Consumers have two routes of access to therapeutic drugs. One route is by prescription or order froma 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.

3. Drug Laws and Standards Their main goal is to protect the public by ensuring thatdrugs marketed for therapeutic purposes, whether prescriptionor OTC, are safe and effective. With prescriptiondrugs, 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, theclient must make these decisions, with or without consultationwith a health care provider.

4. Questions to be answered • 1. Can consumers accurately self-diagnose the conditionfor which a drug is indicated? • 2. Can consumers read and understand the label wellenough to determine the dosage, interpret warnings andcontraindications and determine whether they apply,and recognize drugs already being taken that might interactadversely with the drug being considered? • 3. Is the drug effective when used as recommended? • 4. Is the drug safe when used as instructed?

5. Available OTC, advantages for consumers • Greaterautonomy; • faster and more convenient access to effectivetreatment; • possibly earlier resumption of usual activities ofdaily living; • fewer visits to a health care provider; • possiblyincreased efforts by consumers to learn about theirsymptoms/conditions and recommended treatments.

6. Available OTC,disadvantages for consumers • Inaccurate self-diagnoses and potentialrisks of choosing a wrong or contraindicated drug, • Delayingtreatment by a health care professional, • developing adversedrug reactions and interactions

7. OTC products 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.

8. COMPLIANCE • 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.

9. COMPLIANCE (cont’d) • (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.

10. COMPLIANCE (cont’d) • 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.

11. COMPLIANCE (cont’d) • 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.

12. 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 drug-related 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.