Principles of Pharmacy Practice: Laws Affecting Prescription Dispensing Flashcards
Food and Drug Administration (FDA)
- Governing body over medications sold in U.S.
- Branch of U.S. Department of Health and Human Services
- Responsible for approval of prescription and over‐the‐counter medications, drug labeling, and standards for drug manufacturing
Centers for Disease Control and Prevention (CDC)
- Provides regulation for infection control
- Publishes annual vaccination and immunization requirements for children, adolescents, and adults
- Involved with national health issues, like HIV and AIDS
Drug Enforcement Administration (DEA)
- Enforces the laws and regulations surrounding controlled and illegal substances
- Sets requirements for dispensing and refilling controlled substances
The Pure Food and Drug Act of 1906
- First law to regulate medications
- Prohibits falsely labeling pharmaceutical products (misbranding)
- Prohibits sale of contaminated products or those with unknown contents (adulteration)
Food, Drug, and Cosmetic Act of 1938
• Created amendments to Pure Food and Drug Act of 1906
• Expanded role of FDA (e.g., authority to approve or deny new drugs coming on the market)
• Requires pharmaceutical manufacturers to prove a drug’s purity, strength, and safety
before it can be sold
Durham‐Humphrey Amendment of 1951
• Created 2 classes of medications: prescription (legend) and nonprescription (OTC)
• Prescription-only medications will have “Rx Only” stated on the medication labeling
• OTC labeling must contain active and inactive ingredients, purpose or uses, warnings, and
dosage instructions
Poison Prevention Packaging Act of 1970 (PPPA)
- Authorized by the Consumer Product Safety Commission (CPSC)
- Standard for packaging to protect children from taking harmful medications
Child-Resistant Packaging Definition
- Cannot be opened by 80% of children younger than 5 years of age
- Can be opened by 90% of adults
Medications That Don’t Require Child-Resistant Packaging
- Sublingual nitroglycerin
- Oral contraceptives in memory-aid packaging
- Inhalers
- Inpatient meds
- Some OTC meds
- Some vitamins and supplements
Child-Resistant Packaging Waiver
- Patients may opt out of child-resistant packaging for their meds.
- Patient must fill out form authorizing the pharmacy to use easy-open containers
Patient Package Insert
- Contains information similar to a package insert
- Written in an abbreviated, easy-to-read format
- Designed specifically for patients
- Generally attached to the stock bottle or part of the product packaging
- Considered part of the product’s labeling
Medications that require a patient package insert
- Oral contraceptives
* Estrogen-containing medications
Requirements for Outpatient Pharmacies
• Must be dispensed with every oral contraceptive or estrogen-containing prescription, including
refills
Requirements for Inpatient Pharmacies
- Must be dispensed before the first dose of the oral contraceptive or estrogen-containing medication is administered
- Must be dispensed once every 30 days thereafter as long as the therapy continues
National Drug Code (NDC)
Drug Listing At of 1972
Unique and permanent code for each drug
10 digits, 3 sections: labeler code (the manufacturer/distributor), product code (name, strength, dosage form), and package code (size and type of packaging), in that order
NDC continued
11-digit NDCs just have a leading or placeholder 0; they are still technically 10-digit NDCs
Sometimes an asterisk can take the place of a leading 0
If the labeler code has 5 digits already, use a placeholder 0 with the package code
Hatch-Waxman Act 1984 (aka Drug Price Competition and Patent Term Restoration Act of 1984)
Defined and set up regulations for generic drugs
Set up rules that allowed manufacturers to set up ANDAs (abbreviated new drug applications)
Generic manufacturers do not need to go through all full steps to be approved; used to expedite the process to get to the patients more quickly (condensed FDA review)
Must prove that they are safe and do the same things that the brand name drug does
Omnibus Budget Reconciliation Act of 1990 (aka OBRA 90)
Requires pharmacist to discuss meds with patients
Counseling requirements vary by state, but no matter what, pharmacy techs cannot counsel
Dietary Supplements
Most common: vitamins, minerals, herbs
Are not considered drug or food, but somewhere between
Dietary Supplement Health and Education Act of 1994 (DSHEA)
More regulated than foods, but less than drugs
Generally treated closer to drugs
Must be safe and labels must NOT be misleading
Limits on health claims
Although regulation is limited, FDA can intervene if determined to be unsafe
Supplements used with some medications or in place of some medications can lead to harmful effects
USP mark for added security
Imprint Codes
Required by the FDA on solid oral dosage forms
Advantages: identify loose tablets, mis-filled RXs, and counterfeit drugs
Health Insurance Portability Accountability Act (HIPAA)
Governs patient privacy and the sharing of patient information
3 rules: protect patient information, use/disclose the minimum necessary amount of protected information, and establish that patients have the right to approve who can access and use their medical information
Protected/Private Health Information (PHI)
Any information that identifies the patient
Included is information related to any health condition
PHI is not restricted to written information, but also includes oral information
Minimum necessary rule
Good rule of thumb: only request what is needed, and only disclose what is required
