PTCE General Practice

Pure Food and Drug Act

Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs, poisoned or contaminated drugs

Adultered drugs

Any drug that is not pure

misbranded drug

Not labeled correctly

FDCA (Federal Food, Drug, and Cosmetic act)

drugs must comply with standards of safety and efficacy, more modern act than Pure Food and Drug Act. Oversees safety of food, drugs and cosmetics

FDA (Food and Drug Administration)

a division of USDHHS responsible for regulating food and drug products sold to the public. Handles drug approvals, sold, and recalls of drugs

3 types of Drug Recalls

1. Most severe: permanent health hazard or death

2. Medium severity: temporary or reversible damage

3. Least severe: mislabeling or misbranded drugs, low damage from drugs

MedWatch Program

Reports to FDA side effects or adverse effects of any drugs

(FAERS) FDA Adverse Event Reporting System

Database that contains information on adverse event and medication error reports submitted to the FDA; designed to support the FDA's post-marketing safety surveillance program.

VAERS (Vaccine Adverse Event Reporting System)

keeps track of all adverse effects associated with vaccines

IND (Investigational New Drug)

A drug not yet approved for marketing by the FDA but available for use in experiments to determine its safety and efficacy.

FDA drug approval process

1. Hypothesis: comes up with the drug and reports findings (dosage, research and findings) to FDA

2. Pre-phase: consists of animal testing then human testing to small population (reports correct dosing and side effects)

3. Large Human Trial: tests on wider population with longer procedure

4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent

tall man lettering

medication names that have mixed case lettering in the description name, which helps reduce errors between medication names that either look or sound alike

FAERS and VAERS

Reports to the CDC (centers of disease control) as well

Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs". • Legend Drugs can only be dispensed with a valid Prescription.. • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs". • The emphasis on this act was to insure safety thru qualified medical supervision.

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . • Required drug advertising to be more closely regulated and disclose accurate information about side effects

Harrison Narcotic Act

a 1914 congressional act that criminalized the sale and use of narcotics

Comprehensive Drug Abuse Prevention and Control Act of 1970

established schedules of controlled substances and moved enforcement to the Justice Department (C-1 to C-5) Established the DEA

DEA

Enforces the controlled substance act under the DOJ. Makes sure all controlled substances are manufactured, distributed, and stored properly.

Control 1 (C-1) drugs

High abuse. Considered not medical use or street drugs. (Marijuana, ecstasy, heroin, LSD)

Control 2 (C-II) drugs

Consists of narcotics, pain killers, ADHD drugs. Highly addicting (Percocet, Endocet, Norco, Fentanyl, Morphine)

Control 3 (C-III) drugs

Mild pain killers, anabolic steroids and caffeine pills, can be moderately abused (Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)

Control 4 (C-IV) drugs

Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite suppressants, Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax, Carisoprodol/soma, clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)

Control 5 (C-V) Drugs

Low Codeine amounts in cough suppressants. Considered the least abusive (phenergan w/Codeine, guaifenesin w/codeine)

Biennial Inventory

exact count for schedule II and an estimated count for III-V drugs must be performed every 2 years

C-II Supply

Only for 30 days. No partial filling or given for 90 day supply

Does C-II must have a prescription hard copy?

Yes, and there are exceptions: for patients in community care or in long term IV care

Expiration date for C-II?

No expiration date but just be filled in 1 month or in a 10 day period

Can doctor make a phone prescription for C-II?

Only for extreme emergencies. A hard copy must be sent to the pharmacy in 7 days or pharmacy can report the doctor to DEA

DEA Form 222

must be used whenever Sch II drugs are bought, sold or transferred between pharmacies or qualified distributors, can only order 10 medications at a time

Form 222 triplicate forms?

1. Seller

2. DEA

3. Pharmacy

How long must form 222 be kept in file?

For 2 years

Can you make mistakes on form 222?

No, must be mistake free. If a mistake is made, it is kept on file

Can you loan Form 222 to other pharmacies?

No, each form is different for each pharmacy. Can loan medication to other pharmacies when ordering.

DEA Form 41

to destroy controlled substances

DEA Form 106

report of theft or loss of controlled substances

DEA form 224

New registration for Retail / Hospital / Clinic / Practitioner / Mid level practitioner / teaching institution

When do you need to renew DEA Form 224?

Every 3 years, and when ownership of pharmacy changes

Perpetual Inventory Method

keeps track of inventory levels on a daily basis

POS system

A system in which the item is deducted from inventory as it is sold or dispensed.

Initial Inventory

is a complete and accurate inventory of all controlled substances before the opening of the first day of business for a pharmacy or when pharmacist in charge (PIC) is changed. You must also count all control 2 drugs

OSHA (Occupational Safety and Health Administration)

The main federal agency charged with regulating safety and health in the workplace. Offers workers compensation and in charge of safety data sheets (SDS), which addresses how to clean up medications.

The Joint Commission (TJC)

An organization that accredits health care organizations and programs

Are retail pharmacies to be certified by TJC?

No, TJC is in charge of pharmacies that have direct contact with patients (hospitals, compounding facilities, health day care centers)

Do not use list

the Joint Commission issued a minimum list of dangerous abbreviations, symbols, and acronyms that must be included on a this list by every organization it accredits. JACHO also issued a list of additional abbreviations, acronyms, and symbols for possible future inclusion in the DO NOT USE list.

HIPPA (Health Insurance Portability and Accountability Act)

a federal law that sets standards for protecting the privacy of patients' health information

HIPPA Security Rule

law requiring covered entities to establish safeguards to protect health information

HIPPA Privacy Rule

Law that regulates the use and disclosure of patients' protected health information (PHI).

PPPA (Poison Prevention Packaging Act)

required the use of Child-resistant packaging for prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous materials that could be considered dangerous for children.

What drugs are exempt from PPPA?

Nitroglycerin

DAW (Dispense as Written)

0: substitution is allowed 1: doctor wants brand 2: patient wants brand

OBRA (Omnibus Budget Reconciliation Act) of 1987

Federal Law, enacted by Congress, in 1987, to improve quality of life of residents living in a nursing home environment. Also, made sure that a pharmacist is available 24/7

OBRA 90

Made sure drug counseling was available for Medicaid and Medicare patients. Patient profiling was necessary (demographics, emergency contacts, address, etc.).

DUE (Drug Utilization Evaluation)

Determines how efficient a drug works

Prior Authorization (PA)

A special approval needed before an insurance company will cover a specific medication for a patient, generally an expensive brand name drug that is not present on the formulary

TAR (treatment authorization request)

This document is a request that an insurance company or health maintenance organization (HMO) make payment for the tests, procedures, or other care identified by the health-care provider.

COBRA (Consolidated Omnibus Budget Reconciliation Act)

A landmark federal law passed by Congress in 1986 that provides continuing coverage of group health benefits to employees and their families upon the occurrence of certain qualifying events where such coverage would otherwise be terminated.

Drug Listing Act of 1972

Required -NDC-National Drug Code numbers to be assigned to every marketed drug

NDC number

a unique number identifying a drug product; it indicates the manufacturer's name (first set), drug strength/dosage form (second set) and package size (last set).

I-Pledge (Isotretinion)

Medication that doctor, pharmacy and patient must register if dispensed. Drug is treated as C-II and a hard copy must be needed. Rx is valid for 7 days and causes birth defects.

Combat Methamphetamine Epidemic Act of 2005

Placed Pseudoephedrine, ephedrine, and phenylpropanolamine to the category "schedule listed chemical products" product must be sold behind RX counter Requires: Picture ID/ must be 18 yoa/ provide personal information. Patients allowed only 3.6 g per Day & 9g in a 30 day period.

Orphan Drug Act of 1983

Provided incentives by the government for the development of orphan drugs for treatment of rare diseases

Rx Drug Marketing Act

Manufacturers are only allowed to import drugs into the United States. Also enforces sample drugs to be given out only by doctors

FDA Safe Medical Devices Act of 1990

All medical devices are to be tracked and records maintained for durable medical equipment (DME)

Center for Medicare and Medicaid Services (CMS)

Approves whether the person is eligible for Medicare/Medicaid

Medicare

A federal program of health insurance for persons 65 years of age and older. Nationally funded

Medicaid

A federal and state assistance program that pays for health care services for people who cannot afford them. In California, it is known as Medi-Cal. Yearly renewal is required for patients with Medi-Cal

Medicare Part A

The part of the Medicare program that pays for hospitalization, care in a skilled nursing facility, home health care, and hospice care.

Medicare Part B

The part of the Medicare program that pays for physician services, outpatient hospital services, durable medical equipment, and other services and supplies.

Medicare Part C (Medicare Advantage)

managed care health plans under the Medicare program. Allows patients to apply for HMO or PPO insurance

HMO (Health Maintenance Organization)

A managed care organization that provides comprehensive medical services for a predetermined annual fee per enrollee.

PPO (Preferred Provider Organization)

A type of health plan that contracts with medical providers, such as hospitals and doctors, to create a network of participating providers. You pay less if you use providers that belong to the plan's network.

Medicare Part D

Prescription drug coverage. Covers insulin, vaccines, certain supplies (i.e. needles, syringes, etc) and medicine

Premium

Amount you pay monthly, quarterly, semiannually or annually to purchase different types of insurance

Deductible

Amount you must pay before you begin receiving any benefits from your insurance company

Co-insurance

the percentage of the bill for services that the policy holder must pay

Co-pay

the amount of money the patient has to pay that the insurance company will not pay

Medicare Modernization Act of 2003 (MMA)

legislation passed in 2003 designed to expand healthcare services for seniors with major focus on prescription drug benefits

Health Savings Account (HSA)

Tax-sheltered savings account similar to an IRA but created primarily to pay for medical expenses. Low premium = high deductible. High premium = low deductible

AWP (Average Wholesale Price)

The average price at which drugs are purchased at the wholesale level. It is mainly used to determine third-party reimbursement.

AAC (Actual Acquisition Cost)

Final amount of money the pharmacy pays for the drug from wholesaler (acquisition cost + markup price)

MAC (Maximum Allowable Cost)

the maximum price per tablet (or other dispensing unit) an insurer will pay for a given product

GPO (group purchasing organization)

Negotiates better pricing when ordering drugs

Prime Vendor Agreement

formed when a pharmacy agrees to purchase a majority of its goods from a wholesaler. Can only stay with one wholesaler

Benefits of Prime Vendor Agreements

For drug shortages (pharmacy gets priority) and discounts

Formulary

a list of medications approved for use by state board of pharmacy

Open Formulary

a system that allows a pharmacy to use an prescribed medications (mainly retail pharmacies)

Closed Formulary

a limited list of approved medications (specialty clinics)

Restricted Formulary

A selective, limited, partially closed formulary in which some nonformulary medications are available; an exception process does occur. (Mainly in Hospitals)

How long does a Formulary change?

Every 12-16 months

P&T Committee (Pharmacy & Therapeutic)

group that develops drug policies, educates professionals on med use, develops & revises list of approved drugs in a hospital

State Board of Pharmacy (BOP)

Provides licensing (for techs and pharmacists), certifications (to open a pharmacy), and discipline of pharmacies.

Who selects the formulary?

BOP for states

United States Pharmacopeia (USP)

authoritative list of drugs, formulas, and preparations that sets a standard for drug manufacturing and dispensing

USP

Sterile compounding (IV compounding, TPN, etc.)

USP

Non-sterile compounding (creams, tinctures, solutions, etc.)

Laminar Flow Hoods

reduce the risk of contaminating when preparing IV admixtures

Horizontal Flow Hood

a laminar flow hood where the air crosses the work area in a horizontal direction. Any IV is prepared in this (TPN, antibiotics, etc.)

Vertical Flow Hood

a laminar flow hood where the air crosses the work area in a vertical direction (mainly for chemo medications)

Biological Safety Cabinet

a vertical laminar flow hood used to provide protection for the worker, the work environment, and the drug. Only your hands goes in

How many months does a HEPA filter must be certified?

Every 6 months