Pip

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Generic name

Back 1

US adopted name

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Brand names

Back 2

Trade names found in a specific country or region: manufacturer-specific

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Synonyms

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Other names or accepted abbreviations of the generic drug

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Therapeutic category

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Unique systematic classification of medication

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Use

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•Information pertaining to appropriate indications of the drug

•May include both FDA approved and non-FDA approved indications

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Restrictions

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•Controlled substance classification for the Drug Enforcement Agency (DEA)

•US shedules are I to V; varies by country and sometimes by state

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Pregnancy risk factor

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Five categories established by the FDA to indicate the potential of a systematically absorbed drug for causing birth defects

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Pregnancy/ Breast-feeding implications

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Information pertinent to or associated with the use of of the drug it relates to clinical effects on fetus, breast-feeding or lactation, and clinical effects on infants

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Contraindications

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Information pertaining to inappropriate use of the drug

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Warnings/ Precautions

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Precautionary considerations, hazardous conditions related to use of the drug, and disease states or patient populations in which the drug should be cautiously used

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Adverse reactions

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Side effects of the drug; usually grouped by percentage of incidence and/or body system

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Overdosage/ Toxicology

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Comments and/or considerations offered when appropriate

- Includes signs and symptoms of excess drug and suggested management of the patient

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Drug interactions

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Indicates the capability of a drug to alter the effects of another drug once they are given together

- Identifies whether a drug is an inhibitor, an inducer or a substrate of a specific enzyme

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Stability

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Information regarding storage of product or steps for reconstitution

- Provides the time and conditions for which a solution or mixture will maintain full potency

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Mechanism of Action

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How the drug works to elicit a response

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Pharmacodynamics and Pharmacokinetics

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The magnitude of a drug’s effect depending on its concentration at the site of action

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Pharmacodynamics

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expressed in onset of action and duration of action

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Pharmacokinetics

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expressed in terms of absorption, distribution, metabolism and excretion

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Usual dosage

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- Amount of the drug to be typically given or taken during therapy for children and adults

Also includes dosing adjustment/comments for renal impairment or hepatic impairment and other suggested dosing requirements

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Dietary considerations

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Information offered, when appropriate regarding food, nutrition and/or alcohol

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Administration

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Information regarding the recommended final concentrations, rates of administration for parenteral drugs, or other guidelines when giving the medication

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Monitoring Parameters

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Laboratory tests and patient physical parameters that should be monitored for safety and efficacy of drug therapy

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Reference range

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Therapeutic and toxic serum concentrations listed including peak and trough levels

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Test interactions

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Listing of assay interferences, when relevant

- May indicate the alterations brought about by drug use on blood, serum and urine tests

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Patient information

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Specific information pertinent for the patient

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Nursing implications

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Includes additional instructions for the administration of the drug and monitoring tips from the nursing perspective

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Dosage forms

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Information with regard to form, strength, and availability of the drug

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Extemporaneous preparations

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Directions usually for preparing liquid formulations from solid drug products

- May include stability information and references

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Legal Classifications of Drugs

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1. Prescription Drugs

2. Over-the-Counter Medications

3. Pharmacist-Only Medications

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Prescription drugs

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Also known as ethical drugs

- Drugs which require a legal document – the prescription – prior dispensing

- May only be dispensed by a registered pharmacist

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Over-the-counter medications

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Drugs which do not require a prescription prior dispensing

- May be dispensed either in a drug store or in non-traditional outlets

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Pharmacist-only medications

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A new legal classification of drug introduced in RA 10918

- Medications which may be considered as OTC but may only be dispensed by a registered pharmacist

- Pharmacists are expected to provide essential drug information to the patient prior dispensing to enhance

drug efficacy

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Pregnancy risk categories

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1. Category A

2. Category B

3. Category C

4. Category D

5. Category X

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Category A

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Studies indicate no risk to the human fetus

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Category B

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Studies indicate no risk to animal fetus; information in humans is not available

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Category C

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Adverse effects reported in animal fetus; information in humans is not available

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Category D

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Possible fetal risk in humans reported; however, considering potential benefit vs risk may, in selected cases, warrant the use of these drugs in pregnant women

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Category X

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Fetal abnormalities reported and positive evidence of fetal risk in humans is available from animal and/or human studies; should not be used by pregnant women

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Lactation Safety Categories

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L1: Safest

L2: SaferL3: Moderately SafeL4: Possibly HazardousL5: Contraindicated

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L1: Safest

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Drug which has been taken by a large number of breastfeeding mothers without any observed increase in adverse effects in the infant. Controlled studies in breastfeeding women fail to demonstrate a risk to the infant and the possibility of harm to the breastfeeding infant is remote; or the product is not orally bioavailable in an infant.

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L2: Safer

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Drug which has been studied in a limited number of breastfeeding women without an increase in adverse effects in the infant.

- Evidence of a demonstrated risk which is likely to follow use of this medication in a breastfeeding woman is remote.

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L3: Moderately Safe

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--There are no controlled studies in breastfeeding women, however the risk of untoward effects to a breastfed infant is possible; or, controlled studies show only minimal non-threatening adverse effects. Drugs should be given only if the potential benefit justifies the potential risk to the infant.

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L4: Possibly hazardous

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There is positive evidence of risk to a breastfed infant or to breastmilk production, but the benefits of use in breastfeeding mothers may be acceptable despite the risk to the infant (e.g. if the drug is needed in a life- threatening situation of for a serious disease for which safer drugs cannot be used or are ineffective).

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L5: Contradicted

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Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. Risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. Drug is contraindicated in women who are breastfeeding an infant.

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Schedules of controlled substances

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Schedule I

Schedule II

Schedule III

Schedule IV

Schedule V

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Schedule I

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The drug has a high potential for abuse. The drug has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug under medical supervision.

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Schedule II

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The drug has a high potential for abuse. The drug has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug may lead to severe psychological or physical dependence.

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Schedule III

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The drug has a potential for abuse less than the drugs in schedules 1 and 2. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence.

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Schedule IV

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The drug has a low potential for abuse relative to the drugs in schedule 3. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in schedule 3.

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Schedule V

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The drug has a low potential for abuse relative to the drugs in schedule 4. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in schedule 4.

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L4: Possibly hazardous

Back 51

There is positive evidence of risk to a breastfed infant or to breastmilk production, but the benefits of use in breastfeeding mothers may be acceptable despite the risk to the infant (e.g. if the drug is needed in a life- threatening situation of for a serious disease for which safer drugs cannot be used or are ineffective).

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L5: Contradicted

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Studies in breastfeeding mothers have demonstrated that there is significant and documented risk to the infant based on human experience, or it is a medication that has a high risk of causing significant damage to an infant. Risk of using the drug in breastfeeding women clearly outweighs any possible benefit from breastfeeding. Drug is contraindicated in women who are breastfeeding an infant.

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Schedules of controlled substances

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Schedule I

Schedule II

Schedule III

Schedule IV

Schedule V

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Schedule I

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The drug has a high potential for abuse. The drug has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug under medical supervision.

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Schedule II

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The drug has a high potential for abuse. The drug has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug may lead to severe psychological or physical dependence.

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Schedule III

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The drug has a potential for abuse less than the drugs in schedules 1 and 2. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to moderate or low physical dependence or high psychological dependence.

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Schedule IV

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The drug has a low potential for abuse relative to the drugs in schedule 3. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in schedule 3.

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Schedule V

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The drug has a low potential for abuse relative to the drugs in schedule 4. The drug has a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in schedule 4.