**** + the back of the handout

Tell whether the following statement is true or false:

Groups of similar drugs all of which are derived from an original prototype are available today because of technological
advances that make a particular drug more desirable in a specific situation.

Answer: true

(Technological advances have led to the development of groups of similar drugs all of which are derived from an original
prototype but each of which has slightly different properties making a particular drug more desirable in a specific
situation.)

*** As part of the standards for testing and safety, the FDA requires that each new drug be assigned to a pregnancy
category. The categories indicate a drug's potential or actual teratogenic effects. Thus, offering guidelines for use of that
particular drug in pregnancy.

THE CONTROLLED SUBSTANCES ACT OF 1970

- Control over the coding of drugs and the enforcement of these codes to the FDA and the Drug Enforcement
Agency (DEA), a part of the U.S. Department of Justice,
- Prescription, distribution, storage, and use of these drugs are closely monitored.
- Local policies and procedures might be even more rigorous.

*** The Controlled Substances Act of 1970, established categories for ranking of the abuse potential of various drugs.
This same act gave control over the coding of drugs and the enforcement of these codes to the FDA and the drug
enforcement agency (DEA), a part of the US Department of Justice.

*** In the Philippines, Republic Act 9165, also known as the Comprehensive Dangerous Drugs Act of 2002, aims to
safeguard the integrity of its territory and the well-being of its citizenry ,particularly the youth from the harmful effects of
dangerous drugs on their physical and mental well-being and to defend the same against acts or omissions detrimental to
their development and preservation. In view of the foregoing the state needs to enhance further the efficacy of the law
against dangerous drugs. It being one of today's more serious social ills.

GENERIC DRUGS
- Chemicals that are produced by companies involved solely in the manufacturing of drugs
- Bioavailability of the drug
- “Dispensed as written”
 Important in drugs that have narrow safety margins

*** Generic drugs are chemicals that are produced by companies involved solely in the manufacturing of drugs.

ORPHAN DRUGS
- Drugs that have have been discovered but are not financially viable and therefore have not been “adopted” by any
drug company
- The Orphan Drug Act of 1983

*** Orphan drugs are drugs that have been discovered but are not financially viable and therefore have not been adopted
by any drug company. Orphan drugs may be useful in treating a rare disease or they may have potentially dangerous
adverse effects.

OVER-THE-COUNTER DRUGS
- Products that are available without prescription for self-treatment of a variety of complaints
 Some of these agents were approved as prescription drugs
 Later were found to be very safe and useful for patients (Example: loratadine)
 Many of these drugs were “grandfathered”
- Nurses should consider several problems related to OTC drug use:
 Taking these drugs could mask the signs and symptoms of underlying disease, making diagnosis difficult
 Taking these drugs with prescription medications could result in drug interactions and interfere with drug
therapy
 Not taking these drugs as directed could result in serious overdoses

***Over-the-counter (OTC) drugs are products that are available without prescription for self-treatment of a variety of
complaints some of these agents were approved as prescription drugs but later were found to be very safe and useful for
patients without the need of a prescription.

SOURCES OF DRUG INFORMATION

- DRUG LABEL
 Drug labels have specific information that identifies a specific drug
 Understanding how to read a drug label is essential
- Package Insert
 Prepared by the manufacturer
 Contains all of the chemical and study information that led to the drug’s approval
 Difficult to understand and read

*** Drug labels have specific information that identifies a specific drug. For example, a drug label identifies the brand and
generic names for the drug. The drug dosage, the expiration date, and special drug warnings. Some labels also indicate
the root and dose for administration. All drugs come with the package insert prepared by the manufacturer according to
strict FDA regulations. The package insert contains all of the chemical and study information that led to the drug's
approval. A wide variety of reference books are available for drug information. The physician's desk reference (PDR) is a
compilation of the package insert information from drugs used in this country, along with some drug advertising drug
labels are a source of information.

What information might a drug label provide?

a) the manufactured date
b) the expiration date
c) when the patent expires
d) the binding properties of the drug

ANSWER: B (expiration date)

Drug labels have specific information that identifies a specific drug. For example, a drug label identifies the brand and
generic names for the drug, the drug dosage, expiration date, and special drug warnings. Some labels also indicate the
route and dosage for administration.