NHA PharmTech Exam

Pure Food and Drug Act 1906

Prohibited the interstate transportation or sale of adultered or misbranded medications and food.

Food and Drug Administration

Federal agency that supervises the development, testing, purity, safety, and effectiveness of prescription and OTC medications. Provides information on all approved medications in the U.S. They must approve medications before they can be sold in the U.S.

Food, Drug, and Cosmetic Act of 1938

Created the FDA and meant to ensure all medications are pure and safe.

Durham-Humphrey Amendment of 1951

Amendment to the Food, Drug, and Cosmetic Act. Requires all products to have adequate directions for use unless they contain the federal legend “Caution: Federal law prohibits dispensing without a prescription.”

Comprehensive Drug Abuse Prevention and Control Act of 1970

Commonly known as Controlled Substances Act. Regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration.

Poison Prevention Packaging Act of 1970

Requires most prescriptions for oral use to be dispensed in child-restraint containers unless patients or prescribers request otherwise.

Drug Listing Act of 1972

All medications are assigned a specific 10-digit identification number. Known as a National Drug Code Number.

National Drug Code Number (NDC)

First 5 digits identify manufacturer, next 4 identify medication product, last 2 represent package size.

Orphan Drug Act of 1983

Incentive for drug manufacturers to develop medications for treatment, diagnosis, or prevention of rare diseases. Orphan drugs treat a condition of which there are fewer than 200,000 cases in the U.S.

Omnibus Budget Reconciliation Act of 1990

OBRA ‘90. Federal law that increases pharmacists’ professional responsibility in two ways. Requires them to keep records of all medications used by Medicaid patients. Requires them to counsel all Medicaid patients about the proper use of their medications. Now interpreted to include all patients. Requires pharmacy tech’s to enter a new patient’s profile into the pharmacy’s computer system upon receiving a prescription.

Professional standard

A requirement or set of requirements which do not have the force of law.

Statute

Passed by legislatures and approved by the chief executive

Regulation

Adopted by executive agencies (such as the state board of pharmacy) and given authority by the legislature

Drug Supply Chain Security Act

Outlines critical steps to build a system to identify and trace prescription medications as they are distributed through the U.S.

Combat Methamphetamine Epidemic Act

Creates a new category of products called scheduled listed chemical product (SLCP) and includes any nonprescription product that contains ephedrine, pseudoephedrine, or phenylpropanolamine

National Association of Boards of Pharmacy

Representation from each state board of pharmacy in U.S territories. Implemented CPE Monitor which tracks continuing education documentation for pharmacists.

United States Pharmacopeia

Establishes standards for identity, strength, quality, and purity of medicines, foods, ingredients, and dietary supplements. Responsible for USP-National Formulary (USP-NF) which contains standards for chemical and biological drug substances and dosage forms. 1st book of medication standards accepted by the entire nation.

Joint Commission

Sets forth standards for organizations like hospitals, home care, and laboratories. Facilities that meet these standards becomes accredited which helps them improve patient care and make them eligible for reimbursement by Medicare and Medicaid.

Centers for Medicare and Medicaid Services (CMS)

Known as Health Care Financing Administration. Regulates and administers Medicare, Medicaid, the State Children’s Health Insurance Program, HIPAA and other health programs. Issues a pharmacy’s National Provider Identifier.

USP <797>

Addresses sterile compounding

USP <795>

Addresses non-sterile compounding

USP <800>

Provides information on handling hazardous medications

Orange Book

Approved Drug Products with Therapeutic Equivalence Evaluations provided by FDA. All FDA-approved prescription and OTC medications products that are rated for safety, effectiveness, and bioequivalence. Determines whether a generic medication is the same as a brand-name medication.

Physician’s Desk Reference (PDR)

Listing of more than 4,000 current brand-name and generic medications with descriptions and information on their usage, warnings, medications interactions, category, and more than 2,000 life-size color photos.

Package insert

Complete labeling and dispensing information provided by the product manufacturer that includes product description, indications for use, contraindications, warnings, precautions, adverse reactions, dosage, and administrations, contents, storage, and handling.

Red Book

Contains average wholesale price information for brand-name and generic medications. Online reference.

USP-Drug Information (USP-DI)

Patient version contains easy to understand information about prescription medications and what they are, what they do, and how to take them. Professional is similar but more detailed. Similar to DFC..

Drug Facts and Comparisons

Encyclopedia of medications that contains facts about product groups and individual products and makes comparisons among them. Contains dispensing and prescribing info, interactions, allergies, warnings, whether they are prescription or nonprescription, controlled substance or not, and schedule.

Handbook of Nonprescription Drugs

Provides information on OTC medications

Kefauver-Harris Amendment of 1962

Amendment to the Food, Drug, and Cosmetic Act. Enacted to ensure all medications are pure, safe, and effective. Gave FDA authority to require proof of efficacy.

American Hospital Formulary Services Drug Information

Information is submitted by members of the National Institutes of Health, the Centers for Disease Control and Prevention, and other health care organizations.

Institute for Safe Medication Practices

Operates two error-reporting programs: the National Medication Errors Reporting Program and the National Vaccine Errors Reporting Program. Nonprofit organization to prevent medication errors.

Clean room

Controlled environment for compounding sterile products (infusion)

Compounding counter

Compounding of nonsterile products like creams and lotions

Dispensing area

Where a technician counts, pours, and packages medications

Lot number

A code that identifies one batch of a product that is made at the same time. Best used to identify a medication that has been recalled.

National Institute for Occupational Safety and Health (NIOSH)

Publishes the official list of hazardous drugs in the health care setting

Class I recall

Recall by FDA. Strong chance of serious adverse effects or death.

Class ll recall

Temporary but reversible chance of adverse effect or little chance of serious adverse effect

Class lll recall

Problem not likely to cause adverse effects

P-listed medications

Acutely hazardous medications. Empty containers of these are hazardous. Nicotine, warfarin, epinephrine.

D-listed medications

Toxic, ignitable, corrosive, or reactive. They have the potential to get into drinking water. Toxic materials contain mercury or heavy metals. Benzoyl alcohol, albuterol inhalers, silver sulfadiazine.

U-listed medications

Toxic and usually are chemotherapy. Mercury, mitomycin.

DEA Form 41

Used to request permission to destroy expired controlled substances.

DEA Form 106

Used to document the loss or theft of controlled substances

DEA Form 224

Used to apply for new registration to dispense controlled substances

DEA Form 222

Used to order Schedule l and ll controlled substances. 20 different types can be ordered.

FDA MedWatch

System used for reporting side effects or medication errors with pharmaceutical products.

Handbook on Injectable Drugs

Reference guide to solution compatability

The Merck Index

Lists the chemical attributes of chemicals, medications, and biologicals

Enteric-coated tablets

Coated to prevent them from dissolving in the stomach, where they may be neutralized or rendered inactive by stomach acids. They dissolve in the intestine instead.

Nitroglycerin

Dispensed in easy-open closures for patients with heart conditions. Easy-open enables quick access for a patient who is experiencing a heart attack. Sublingual that must be dispensed in the original, unopened container so it doesn’t lose its potency.

Dispense as written (DAW)

Request by a prescriber that a pharmacist dispense the brand-name medication rather than a generic equivalent.

Pharmaceutical equivalents

Medications that have the same active ingredients, dosage form, route of administration, and strength. May differ in shape, color, packaging, and inactive ingredients.

Pharmaceutical alternatives

Same therapeutic function but may differ with regard to the particular chemical complex, dosage form, or strength. Tylenol tablets and Tylenol capsules are an example of products that are alternatives but not equivalents.

Therapeutic equivalents

Pharmaceutical equivalents and have the same clinical effect and safety profile. Generic equivalents. A-rated in Orange Book.

Therapeutic alternatives

Do not have the same active ingredients but have similar clinical effects.

Bioequivalents

Medications that release their active ingredients at the same rate as the original medication. Must produce virtually the same medication levels in the blood over time.

Stock bottle label requirements

Medication name, strength, legend statement, storage requirements, quantity, dosage form, manufacturer’s name, controlled substance mark, lot/control number, expiration date, NDC number

Legend statement

Medications that can be dispensed only be prescription must have Rx-only symbol or “Caution: Federal law prohibits dispensing without a prescription.”

Tall Man Lettering

Technique used to differentiate between look-alike, sound-alike drug names. (HYDROcodone and OxyCODONE)

Sublingual tablets

Dissolve rapidly under the tongue and are absorbed directly into the bloodstream without passing through the digestive tract.

Troches and lozenges

Held in the mouth while they dissolve. Keep the medication in contact with the mouth and throat for an extended period of time.

Prescription information

Patient’s name, address, DOB, date prescriber wrote the prescription,

Reverse distributor

A business registered with the state and federal government to manage the removal and disposal of controlled substances. Requires a pharmacy to complete DEA Form 222.

What is included on the DEA Form 106

Name and address of pharmacy, DEA registration number, date of theft, name and nu

Deductible

The amount that must be paid by the patient during a specified time period before benefits are paid by the insure company.

Coinsurance

The set percentage of the cost of a prescription that must be paid by the patient.

Maximum allowable cost

The maximum price per dispensing unit an insurer will pay

Dispensing fee

Intended to reimburse pharmacies for the cost of dispensing a prescription. Component of the reimbursement formula.