Principles of Pharmacy Practice: Laws Affecting Prescription Dispensing

Question 1

Food and Drug Administration (FDA)

Answer 1

• 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

Question 2

Centers for Disease Control and Prevention (CDC)

Answer 2

• 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

Question 3

Drug Enforcement Administration (DEA)

Answer 3

• Enforces the laws and regulations surrounding controlled and illegal substances
• Sets requirements for dispensing and refilling controlled substances

Question 4

The Pure Food and Drug Act of 1906

Answer 4

• First law to regulate medications
• Prohibits falsely labeling pharmaceutical products (misbranding)
• Prohibits sale of contaminated products or those with unknown contents (adulteration)

Question 5

Food, Drug, and Cosmetic Act of 1938

Answer 5

• 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

Question 6

Durham‐Humphrey Amendment of 1951

Answer 6

• 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

Question 7

Poison Prevention Packaging Act of 1970 (PPPA)

Answer 7

• Authorized by the Consumer Product Safety Commission (CPSC)
• Standard for packaging to protect children from taking harmful medications

Question 8

Child-Resistant Packaging Definition

Answer 8

• Cannot be opened by 80% of children younger than 5 years of age
• Can be opened by 90% of adults

Question 9

Medications That Don’t Require Child-Resistant Packaging

Answer 9

• Sublingual nitroglycerin
• Oral contraceptives in memory-aid packaging
• Inhalers
• Inpatient meds
• Some OTC meds
• Some vitamins and supplements

Question 10

Child-Resistant Packaging Waiver

Answer 10

• Patients may opt out of child-resistant packaging for their meds.
• Patient must fill out form authorizing the pharmacy to use easy-open containers

Question 11

Patient Package Insert

Answer 11

• 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

Question 12

Medications that require a patient package insert

Answer 12

• Oral contraceptives

* Estrogen-containing medications

Question 13

Requirements for Outpatient Pharmacies

Answer 13

• Must be dispensed with every oral contraceptive or estrogen-containing prescription, including
refills

Question 14

Requirements for Inpatient Pharmacies

Answer 14

• 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

Question 15

National Drug Code (NDC)

Answer 15

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

Question 16

NDC continued

Answer 16

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

Question 17

Hatch-Waxman Act 1984 (aka Drug Price Competition and Patent Term Restoration Act of 1984)

Answer 17

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

Question 18

Omnibus Budget Reconciliation Act of 1990 (aka OBRA 90)

Answer 18

Requires pharmacist to discuss meds with patients

Counseling requirements vary by state, but no matter what, pharmacy techs cannot counsel

Question 19

Dietary Supplements

Answer 19

Most common: vitamins, minerals, herbs

Are not considered drug or food, but somewhere between

Question 20

Dietary Supplement Health and Education Act of 1994 (DSHEA)

Answer 20

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

Question 21

Imprint Codes

Answer 21

Required by the FDA on solid oral dosage forms

Advantages: identify loose tablets, mis-filled RXs, and counterfeit drugs

Question 22

Health Insurance Portability Accountability Act (HIPAA)

Answer 22

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

Question 23

Protected/Private Health Information (PHI)

Answer 23

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

Question 24

Minimum necessary rule

Answer 24

Good rule of thumb: only request what is needed, and only disclose what is required

Question 25

Incidental disclosure

Answer 25

Another patient overhearing discussion in a semi-private area

Question 26

Examples

Answer 26

Insurance asks you for the patient’s DOB. You CAN do this, as they need it to access the patient’s information. You CAN talk about the relevant med/condition, but not about any others.
Over the intercom, do not mention anything aside from “Mr./Ms. _, please return the pharmacy.”

Question 27

Who has access to PHI?

Answer 27

Another health care provider, as long as they are treating the patient and has informed the patient of their privacy policy
The minimum info necessary rule does not apply here, as more information might be beneficial to the patient’s health

Question 28

Who has access to PHI? (Continued)

Answer 28

Relatives, friends, caregivers; unless the patient explicitly says not to
Minimum necessary rule DOES apply

Question 29

Restricting access

Answer 29

Maneuver your computer screens to prevent others from seeing
Do not give out your password
Shred or otherwise destroy physical PHI
Electronic PHI (ePHI) will need to be wiped, or the hardware destroyed

Question 30

MedGuides

Answer 30

Medication Guides are handouts with info on a med’s significant risks
Required to be dispensed with many common drugs, such as NSAIDs and antidepressants

Question 31

MedGuide Requirements

Answer 31

May prevent serious adverse effects
Required when a med has serious risks and when a med’s use is critical for effectiveness
May influence whether a patient wants to use or continue to use a med

Question 32

MedGuide Standards

Answer 32

Required by the FDA
Must contain specific comprehensive, scientifically accurate information and be written in non-technical English
Must identify itself as a med guide, contain the name and phonetic spelling of the drug, and have certain headings with clear explanations

Question 33

Dispensing MedGuides

Answer 33

• Give when a patient or caretaker asks, for inpatient and outpatient
• Give with new and refills RXs for outpatient (applies to retail and hospital pharmacies)
• Give even when the medication will be administered by a healthcare provider, such as in a clinic (outpatient)
• Give when part of a REMS Program (that’s Risk Evaluation and Mitigation Strategies); most often with outpatient, but can be for inpatient too

Question 34

T/F: MedGuides are part of labeling, so it’s misbranding if you don’t dispense them when required

Answer 34

True

Question 35

Don’t confuse MedGuides with patient package inserts or patient information

Answer 35

They are for drugs that pose the most significant and serious public health concerns
None of these replace any of the others

Question 36

Board of Pharmacy

Answer 36

Every state has one; protects the health, safety, and welfare of patients
Has a set of laws specific to the practice of pharmacy
(These laws are more about the practice of pharmacy than the approval and manufacturing of drug products)

Question 37

State Laws

Answer 37

Can differ from federal laws

When there’s a difference, follow the stricter law (usually that’s the state law)