Self Care & Nonprescription Medications: Overview

Question 1

What is self-care?

Answer 1

Individuals looking after their own health using the knowledge and information available to them

Question 2

What is the safety criteria that must be met for a nonprescription medication?

Answer 2

1. Any medication that is available without a prescription
2. Judged by FDA to be safe and effective without directions, oversight or access to a prescriber
3. Low abuse/misuse potential
4. used for self-diagnosed conditions
5. Adequately labeled (DRUG FACTS label, every OTC must have a drug facts label)

Question 3

What is Pharmacist-assisted Self Care?

Answer 3

A pharmacist helping a patient improve a condition by recommending the best **nonprescription product **and/or nonpharmacologic measure (diet, lifestyle changes, etc)

Question 4

What is patient-centered care?

Answer 4

Providing care that is respectful of and responsive to individual patient** preferences, needs, and values**, and ensuring that patient values guide all clinical decisions

Question 5

What are some common self-care conditions?

Answer 5

1. Pain
2. Cough, cold, flu or sore throat
3. Allergy or sinus problems
4. Heartburn, indigestion and other stomach problems
5. Constipation, diarrhea, and gas
6. Minor skin problems

Question 6

What are the risks and benefits of consumer suse of nonprescription/OTC medications?

Answer 6

1. Risk of safety and efficacy: side effects, drug interactions, delays in medical care because they are taking an OTC could have a serious injury or infection
2. Benefits of convenience and signifcant cost savings:

Question 7

Are OTC products always cheaper than prescriptions?

Answer 7

No, sometimes because it could available as a prescription and non-prescription product the prescription could be less expense or have lower out-of-pocket costs

Question 8

What are ways to decreaase OTC costs?

Answer 8

1. suggest the generic over brand name drug
2. suggest cheaper dosage form or dosage formulation (they are the exact same product)
3. look for active ingredients (if they have the same active ingredient, choose less expensive one)

Question 9

Consumers use OTC medications for many common self-care conditions. True or False?

Answer 9

True

Question 10

Are OTC medication risk free?

Answer 10

NO, can still have side effects, maximum doses, and drug interactions

Question 11

The generic version of an OTC medication is less effective than the brand name product. True or False

Answer 11

False

Question 12

What are the organizations that oversee OTCs?

Answer 12

1. FDA
2. FTC (oversees marketing)

Question 13

Which organization oversees marketing for OTCs?

Answer 13

Federal Trade Commission (FTC)

Question 14

1906 Pure Food and Drug Act

Answer 14

Prohibited adulteration and misbranding

Question 15

1914 Harrison Narcotic Act

Answer 15

Required prescription for opium and other narcotics

Question 16

1938 Federal Food, Drug, and Cosmetic Act (FDCA)

Answer 16

Mandated safety standards

Question 17

Which 2 products have both Rx and OTC medications?

Answer 17

1. Ibuprofen
2. Meclizine (Rx is antivert and otc is bonine)

Question 18

1962 Kefauver-Harris Amendment to FDCA

Answer 18

Mandated efficacy as well as safety of medications
Resulted in OTC Drug Review process

Question 19

Which OTC regulation resulted in OTC Drug Review process?

Answer 19

1962 Kefauver-Harris Amendment to FDCA

Question 20

1972 OTC Review

Answer 20

Led to development of OTC drug monographs

Question 21

1997 Food and Drug Modernization Act

Answer 21

Established inactive ingredient labeling requirements for nonprescription drugs

Question 22

2020 Coronovirus Aid, Relief and Economic Security Act (CARES Act)

Answer 22

Section 505G amends the FDCA – modernizes nonprescription drug development and review
Modifies the process for issuing, revising, and amending nonprescription (OTC) monographs
Categorizes nonprescription drugs that are generally recognized as safe and effective (GRASE) as OTC or as new drugs

Question 23

In the nonprescription drug review process, OTCs can be categorized as

Answer 23

1. GRASE (category I): can be at the store, generally recognized as safe and effective
2. Not GRASE (Category II): kind of safe and effective, not available in store but on the internet; required to reformulate or remove products from the market
3. Insufficient evidence to show safety and efficacy: not harmful per say but not much evidence to suppor their use (given more than 15 years to reformulate with Category I ingredients. Some just removed product due to cost of studies)

Question 24

What are the 2 main OTC approval pathways?

Answer 24

1. Monograph
2. New Drug Application (NDA): products that do not meet the condition of the monograph

Question 25

Which OTC approval pathway does Rx to OTC switch have to follow?

Answer 25

New Drug Application (NDA)

Question 26

What is a monograph?

Answer 26

Approved regulatory standards for products/ingredients with GRASE status Must follow all specifications (“recipe book”) Categories include analgesics, cough and cold products, antacids, antidiarrheal products, sleep aids, etc.

Question 27

What are the most recent Rx to OTC Switches (2020-2023)?

Answer 27

2023 – Opill (norgestrel) 2023 – Narcan (naloxone hydrochloride) nasal spray 2022 – Nasonex 24HR Allergy (mometasone furoate) 2021 – Lastacaft (alcaftadine) 2021 – Astepro (azelastine) nasal spray 2020 – Sklice (ivermectin) lotion 2020 – Pataday (olopatadine) 2020 – Voltaren Arthritis Pain (diclofenac)

Question 28

What are all components of drug facts label?

Answer 28

1. Active ingredient – knowing what is in a product helps to prevent duplicate therapy 2. Uses – What is this medication approved to treat 3. Warnings – when should a patient use caution or avoid this medication 4. Directions – how should this medication be taken 5. Storage information 6. Inactive ingredients