Health Care Laws

Pure Food and Drug Act

1906; stopped the sale of incorrectly labeled drugs or food. Manufacturers must provide truthful information on the label and prove the drug's effectiveness.

International Opium Convention

1912; exchange views on the problem of opium trade and consumption. Agreed to gradually suppress opium smoking, to limit its use to medical purposes, to control its exports and to control its harmful derivatives.

Harrison Narcotics Act

1914; created to reduce recreational use of opium. No longer avaliable via prescription, records required for prescriptions, and importation and distribution was limited.

Federal Food and Drug, and Cosmetics Act

1938; required drugs to include directions to consumers on how to use the drug and required package inserts. All addictive substances must be labeled "Warning: May be habit forming". Defined misbranding and adulteration as illegal. Mandatory food labeling, Standards of identity, Information on imitation foods, and nutritional information for special dietary foods. Provided legal status for FDA.

Durham-Humphrey Amendment

1951; Prohibits dispensing without a prescription. Made Legend drugs (by prescription only) and over-the-counter (OTC) distinction.

Kefauver-Harris Amendments

1962; Attemped to ensure the safety and effectiveness of all new drugs on the market. Put burden on manufacturers to ensure "good manufacturing practice" (GMP)

Fair Packaging and Labeling Act

1967; Requires medications to make sure that the quantity and also the trade and generic name should be on the bottle.

Comprehensive Drug Absue Prevention and Control Act

1970; Established Drug Enforcement Administration (DEA) to enforce laws regarding controlled substances. Created schedules of drugs (1-5)

Poison Prevention Packaging Act

1970; All medications needed to be placed with childproof caps or packaging.

Drug Listing Act: The National Drug Code

1972; Unique 10-digit number divided into 3 segments. First- set of #s assigned by the FDA. Second- set of #s identifies product specifics. Third- set of #s identifies the specifics of the package size and types.

Orphan Drug Act

1983; Eased restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people).

Prescription Drug and Marketing Act

1987; Helps prevent counterfeit drugs and ingredients from entering the supply chain and limits diversion of pharmaceutical samples and prescription drugs.

Omnibus Budget Reconciliation Act (OBRA)

1990; requires pharmacists to counsel all patients with a new prescription. 3 important provisions: Evaluation of drug therapy, review of drug therapy, and drug utilization evaluation (DUE) board review. This is for MEDICAID (people with low income)

The Humanitarian Device Exemption-Safe Medical Devices Act.

1990; A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD).

Anabolic Steroids Act

1990; Established steroids as a schedule 3 drug and created penalties for use of steroids.

Dietary Supplement Health and Education Act

1994; Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.

Health Insurance Portability and Accountability Act (HIPAA)

1996; patients must sign a consent form to grant others access to their medical records. Protected PHI.

Food and Drug Modernization Act

1997; Allows pharmacists to compound specialized drugs and make sure that any drugs that they individualize are compounded, not manufactured. Updated FDA.

Drug Addiction Treatment Act (DATA)

2000; physicians can prescribe controlled substances to people suffering from opioid addiction
Schedule X

Medicare Modernization Act

2003; Provides a drug discount card to those who are older than 65 who require assistance from a pharmacy company to obtain medications.

Combat Methamphetamine Epidemic Act

2005; Addresses all areas of the manufacture and sale of pseudoephedrine (an ingredient used to make methamphetamine), as well as law enforcement
Strict guidelines
Only a licensed pharmacist or technician may dispense, sell, or distribute this drug

Dietary Supplement and Nonprescription Drug Act

2006; Created a mandatory reporting system for serious adverse events for nonprescription drugs and dietary supplements and contains proper instructions for labeling.

Patient Protection and Affordable Care

2010; "Obama Care" Made sure that insurances cover preexisting conditions and made preventative care more accessible and affordable. Two important technician-related components:
Electronic health records (EHRs)
Medication therapy management (MTM)

Drug Quality and Security Act

2013; FDA tracking system for bulk compounding supplies.

3 classes of recalled drugs

Class 1: Products that could cause serious harm or prove fatal
Class 2: Products found to cause a temporary health problem or pose a slight threat of serious harm
Class 3: Products that may have a minor defect or other condition that would not harm the patient

Drug schedules

C-I: Strongest potential for abuse; no medicinal use in the United States (for example, LSD, heroin)
C-II, C-III, C-IV, C-V: All medicinal narcotic drugs
C-V: Kept OTC in some states because of low potential abuse
C-II: Must be locked up because of high potential abuse
U.S. Attorney General assigns the schedule for a drug

Form 224

Needed by pharmacy to dispense controlled substances

Form 225

To manufacture or distribute controlled substances

Form 363

To run a narcotic treatment program or compound narcotics

Form 41

Returns to reverse distributor

Form 222

Needed in order to order narcotics.

C-III-C-IV refill amount

Can be refilled a max of 5 times and cannot be refilled after 6 months of the original order.

How long are controlled substance (C-II) forms and invoices held for?

7 years

How long are C-III, C-IV, and C-V forms and invoices held for?

2 years

Partial filling of C-II

C-II: Must have remainder dispensed within 72 hours

Prescription labels must include

Name, address, and phone number of the pharmacy; name of prescriber and date prescription was filled; prescription number and cautions

How to make sure a DEA # is valid

1st letter: A/B/F/X for a physician or an M for a PA or NP
2nd letter: Last initial of physician's last name
7-last digits:
Add 1st, 3rd, and 5th digit
Add 2nd, 4th, and 6th digit and multiply by 2
Then add those 2 numbers and the last digit should be the 7th digit of the DEA number.

Ex: Is the DEA number for Dr. John Green AG3489764 valid?

He is a doctor, so the A matches and the G matches his last name
(3+8+7) + 2(4+9+6)=54
The 4 in 54 matches the last number in his code, so it's valid!!

Where can you locate monographs of drugs?

The Physicians' Desk Reference (PDR)

Who can prescribe?

Not up to DEA or FDA, based on state's individual licensing requirements

The Joint Commission Area of concern

How look-alike, sound-alike (LASA) drugs are identified
How communication, allergy notification, conflicting prescriptions, verbal orders, and other areas that may create an avenue for errors are handled
Do Not Use List