PHARMACY LAW, ETHICS, AND REGULATORY AGENCIES

THESE ARE THE IMPORTANT PARTS THAT WILL BE TESTED ON.

HISTORY OF THE FDA

FDA is under the direction of the Department of Health and Human Services.

• FDA’S Main Function - Enforces guidelines for manufacturers

• Ensures safety and effectiveness of medications

1906 - PURE FOOD AND DRUG ACT

Enacted to stop the sale of inaccurately labeled drugs.

Manufacturers were required to:

• Provide truthful information on the label before a drug is sold

• Prove the drug’s effectiveness

1914 - HARRISON NARCOTICS ACT

Enacted to curb recreational use of opium.

• No longer available without a prescription

• Records required for prescriptions

• Importation and distribution is illegal

1938 - FOOD, DRUG, AND COSMETIC ACT

Enacted because the Pure Drug and Food Act was not

worded strictly enough and did not include cosmetics.

Required drug companies to include directions to the consumer

regarding use of the drug and package inserts.

All addictive substances also have to be

labeled: “Warning: May be habit forming.”

It also defined the exact labeling for products and defined

misbranding and adulteration (making something poorer

quality by the addition of another substance) as illegal.

Requires the following:

• Mandatory Food Labeling

• Standards to Identity

• Information on imitation foods

• Nutritional information for special dietary foods

This provided the legal status for the FDA.

1951 - DURHAM-HUMPHREY AMENDMENT

Required label on prescription drugs. Also required a

doctor’s order and supervision for certain drugs.

Made a distinction between:

• Legend Drugs (by prescription)

• Over the Counter (OTC) (does not require a

  doctor’s order, or non-prescription drugs)

1962 - KEFAUVER-HARRIS AMENDMENTS

Enacted in an attempt to ensure the safety and effectiveness

of all new drugs on the market. The burden was put on manufacturers

to ensure “good manufacturing practices” (GMP).

Prevented the sale of Thalidomide in the USA; children in Europe were

born with birth defects after mothers used the drug during pregnancy.

1970 - COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT

Established the Drug Enforcement Administration (DEA) to enforce

the laws covering controlled substances and their distribution. The

DEA issues physicians a DEA license number enabling them to write

Rx for controlled substances. They also issue licenses to pharmacies,

enabling them to order controlled substances from a wholesaler.

Also created the controlled substances classes (Schedules I-IV).

1970 - POISON PREVENTION PACKAGING ACT

Required all medications to be placed in containers with childproof

caps or packaging. This includes both OTC and Legend drugs.

Exception includes:

• Physician request for non-childproof cap

• Certain legend medications

• Emergency medications such as sublingual nitroglycerin

• Patient or physician request

• Hospitalized or patients or patient request

1972 - DRUG LISTING ACT: NATIONAL DRUG CODE (NDC)

A 10 digit number composed of 3 segments that completely unique

in identifying label, product, and package size/type.

• 1st Segment: labeler code, assigned by FDA. A labeler is any firm

  that manufactures or distributes the drug

• 2nd Segment: product code, identifies a specific strength, dosage

  form, and formulation of a particular firm

• 3rd Segment: package code, identifies package sizes and types

1983 - ORPHAN DRUG ACT

Eased restrictions for development of new drugs for those with

rare diseases (affecting 1 in 200,000 people).

1987 - PRESCRIPTION DRUG MARKETING ACT

This helped prevent counterfeit drugs and ingredients from entering

the supply chain. It also limited the diversion of pharmaceutical samples

and prescription drugs.

1990 - OMNIBUS BUDGET RECONCILIATION ACT (OBRA ‘90)

Deals specifically with practicing pharmacists. it was enacted because

of reimbursement regulations for people who are covered by Medicaid

or Medicare. It requires pharmacists to counsel all patients who receive

new prescriptions at the time of the purchase. Pharmacy Technicians

cannot council most individuals.

OBRA ‘90 DRUG UTILIZATION EVALUATION (DUE)

Requires review of healthcare provider prescribing, pharmacist dispensing,

and patient use of medication for appropriateness. This can include, but not

limited to, review of possible drug interactions, appropriateness of dosage

and duration of therapy, and contraindications.

Three Provisions:

• Evaluation of drug therapy

• Review of drug therapy

• DUE board review

Although it was specific to Medicaid coverage, most pharmacies now

offer counseling for all patients on medications that have been prescribed.

1996 - HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)

Deals with a patient’s rights to the continuance of health insurance even

when changing employers. HIPAA limits the type of information that can be

released and to whom. A family member is not considered a HIPAA covered entity.

Pharmacists and technicians have direct knowledge of a patient’s medical information.

The patient must sign a consent form to grant others access to this information.

PATIENT CONFIDENTIALITY

This prevents privileged information about a customer from being

disclosed without their consent.

• All individually identifiable health information is protected

• Pertains to information in any form or media

• Technicians play a crucial role in protecting patients’ records

PUBLIC HEALTH ACTIVITIES

**$Protected Health Information (PHI)$**may be disclosed to:

• Public health authorities

• Entities subject to FDA regulation

• Those who have been exposed to a communicative disease

• Employers regarding work related illness/injury and safety

  to comply with OSHA

LAW ENFORCEMENT PURPOSES

PHI may be enclosed to law enforcement officials:

• As required by law

• To identify or locate a suspect, fugitive, material witness, or missing person

• To provide information about a victim

• If criminal activity caused a victim’s death

2000 - DRUG ADDICTION TREATMENT ACT (DATA 2000)

Physicians can prescribe controlled substances to a person

suffering from opioid addiction.

• Only for maintenance or detoxification treatments

• The first letter in the DEA number begins with an X

2003 - MEDICARE MODERNIZATION ACT

Government insurance for seniors and those with long term disabilities

under the age of 65. June 1, 2004, Medicare began paying for some

medications through discount cards. Medicare also pays for medical

devices such as walkers, breathing machines, some diabetic supplies,

and besides commodes.

2005 - COMBAT METH ACT

Addresses all areas of the manufacture and sale of pseudoephedrine

(an ingredient used to make methamphetamine), as well as law enforcement.

Strict guidelines include:

• Only a licensed pharmacist or technician may dispense, sell, or distribute

  this drug and is limited to 3.6 g per calendar day, 9 g per 30 days from a

  retailer, have 7.5 g on same line per 30 days by mail order

• Must be kept behind the pharmacy counter or in a locked cabinet. You must

  also be 18 with a valid ID to purchase it.

2010 - ACA AND 2013 - DRUG QUALITY AND SECURITY ACT

The Patient Protection and Affordable Care Act (ACA). Two

important technician-related components:

• Electronic health records (EHR)

• Medication therapy management (MTM)

Drug Quality and Security Act (DOSA):

• FDA tracking system for bulk compounding supplies

Functions of the FDA

The FDA enforces guidelines for manufacturers to ensure

safety and effectiveness of medications.

• Anything that contains any avoidable, poisonous, or harmful

  substance that is considered unsafe

• Under the authority of Health and Human Services

• Prevents illegal distribution and misuse of controlled substances

• Issues licenses and enforces the nation’s drug laws

FDA REPORTING PROCESS AND ADVERSE REACTIONS

1-800-FDA-1088 is the toll-free number for reporting any defects in

OTC medications and any other drug problems. Any medication that

might cause disability, hospitalization, or death should be reported.

The patient’s identity must be kept confidential.

• MedWatch: FDA program that allows consumers and healthcare

  professionals to report any discrepancies, drug errors or adverse

  reactions to medications.

FLASHCARDS HERE.