LAWS AFFECTING PRESCRIPTION DISPENSING Flashcards
- Responsible for:
- Approval of Rx and OTC meds
- Drug labeling
- Drug manufacturing standards
Food and Drug Administration (FDA)
- regulations for infection control
- Publishes the requirements for vaccinations and immunizations
Centers for Disease Control and Prevention (CDC)
- enforce laws and regulation for controlled substances and illegal drugs
- Sets requirements for dispensing and refilling controlled substances
Drug Enforcement Administration (DEA)
- requires that manufacturers to prove a drug is safe before being sold
- Before selling manufacturers had to prove a drugs’: Purity, Strength, and Safety
Food, Drug, and Cosmetic Act of 1938
- Prohibits misbranding - false labeling, drugs that does not meet FDA standards
- Prohibits adulterations - contaminations, unknown/unsafe contents (contains ingredients not in the labels)
Pure Food and Drug Act of 1906
created 2 classes of medications: prescriptions and nonprescription
Durham-Humphrey Amendment of 1951
- Cannot be safely used w/o medical supervision
- Can be dispensed directly to the pt by the prescribers
- Products have “Rx Only” on the product label - tells you prescription is required before you dispense med to the pt
Prescription - Only Drugs (aka Legend drugs)
- Typically safe when used correctly
- Labeling is regulated by FDA (1999) and must include:
- Active ingredients
- Inactive ingredients
- Purpose/Uses
- Warnings
- Dosage instructions
- Labeling is regulated by FDA (1999) and must include:
Nonprescription Drugs - OTC drugs
standards for packaging meds to protect kids
Poison Prevention Packaging Act of 1970 (PPPA)
regularly agency responsible for creating standards for packaging to protect children from accidental poisonings w/ meds.
Consumer Product Safety Commission
Child-resistant containers: cannot be opened by __% of children under 5, can be opened by __% of adults
Child-resistant containers: cannot be opened by 80% of children under 5, can be opened by 90% of adults
- sublingual form only (sublingual nitroglycerin)
- oral contraceptives and hormonal treatments
- inhalers
- inpatient meds
Meds that are not required to be in a child-resistant containers.
What med requires Patient Package Inserts?
- Oral contraceptives (Ortho Tri-Cyclen, Yaz, etc)
- Estrogen-containing products (Premarin, Cenestin, Prempro, vagifem, etc)
NDC
National Drug Code
HOW MANY DIGITS DOES NDC HAVE?
10
(Labeler code): identifies the manufacturer or distributor of the product
First section of NDC
(Product code): name, strength, and dosage form
2nd section of NDC
(Package code) : size and type of packaging
3rd section of NDC
Unique and permanent code of each drug
Drug Listing Act of 1972
- Abbreviated new drugs application (ANDA) for generic meds
- Still must prove generis is : safe, effective, and performs like brand name drug
- Expedite bringing less costly generic drugs to market
- FDA approves ANDAs for generic meds.
Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984)
vitamins, minerals, herbs
Dietary Supplements
- requires products to be treated more like drugs than food
- must be safe
- labels can only say the intended effect on the body
- cannot say that it can treat, prevent, or cure any specific disease or condition
- loosely regulated by FDA who can intervene if proven to be harmful, unsafe, or mislabeled
Dietary Supplement Health and Education Act of 1994 (DSHEA)
a marking or imprint code on the face of the product for both prescriptions and OTC drugs.
Imprint Codes
- requires pharmacists to discuss info about meds w/ patients
Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)
governs pt’s privacy and sharing of pt’s info.
Health Insurance and Portability and Accountability Act of 1996 (HIPAA)
- 1st : Protect patient info
- 2nd : Use and disclose the minimum necessary amount of protected info
- 3rd : Establish the right of pts to approved who has access and use of their medical info
Three Principles of HIPAA privacy rules:
Handouts for drugs that pose the most significant and serious public health concerns
Medguides
Required to be dispensed w/ many common drugs such as NSAIDs, antidepressants
Medguides
WHEN DO I INCLUDE A MEDGUIDE?
- When pt ask: inpatients and outpatients
- New and Refill Rx - outpatients
- Part of REMS program - inpatient and outpatient
- Consider misbranding when you don’t dispense them when required.
inform pt about benefits and risks associated w/ certain drugs.
package insert
protect the health, safety, and welfare of pts.
-Set of laws specific to practice of pharmacy
Board of Pharmacy
can differ from federal laws, always follow stricter law
-Uusally state laws are more stricter.
State Laws
