Over-The-Counter Drugs

Siti Nurul Afiqah binti Johari 10-6-95

Over-the-counter drugs also known as OTC or nonprescription

drugs, and defined as drugs that are safe and effective to use by the general public without a doctor’s prescription.

Play an increasingly vital role in our healthcare system and are the most prevalent means of treating the majority of common health problems in the United States

Regulation by countries

In US, the manufacture and sale is regulated by Food and Drug Administration (FDA)

In UK, medication is governed by Medicines Regulations 2012

What does FDA do with regard OTC drugs?

Review OTC products for safety and effectiveness

Responsible for establishment of regulations of OTC drugs labeling

Responsible for reclassifying process of OTC drugs from prescription status

OutlineTwo regulatory pathways which exist for the legal marketing of such products:

1. Marketing in compliance with an OTC drug monograph

2. Marketing under the authority of an approved product-specific new drug application (NDA) or an abbreviated new drug application (ANDA)

The reasons for a drug to become OTC: Overall risk and potential abuse or dependency

low Availability for a larger population early in a

disease The company's way of extending the life of their

drug and reduced price product Rx drug cost has increase by 15% per year -

financial relief to consumer Increased consumer awareness – increase

reliance on self medication as public awareness on common ailments goes up

What are requirements for all OTC drug products?

Standards for safety and efficacy

Good manufacturing practices (inspections)

Labeling under 21 CFR 201.66

Safety and Effectiveness Standards for OTC Products

Same standards as prescription drugs. Also, consumers must be able to: Self- diagnose Self-treat Self-manage

Which can be assessed through: Label comprehension studies Actual use studies

Label According to the law, OTC drug labeling must include “all of the information that an ordinary consumer needs for safe and effective use”.

OTC drugs : the labeling regulated by FDA but advertising by Federal Trade Commission (FTC)

Prescription drugs advertising is strictly regulated only by FDA

OTC Labeling “Drug facts”

Standardized labeling format Similar to “Nutrition facts” &

“Supplement Facts”

21 CFR 201.66

Required as of May 2005

• Over 300,000 marketed OTC drug products

• The active ingredients and labeling of over 80 therapeutic classes of drugs are reviewed by FDA

• For each category, OTC drug monograph is developed and published in Federal Register

• Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval

• New products that conform to a final monograph may be marketed without further FDA review

• Those that do not conform must be reviewed by the New Drug Application process

OTC MonographsRepresent regulatory standards for marketing of nonprescription drugs not covered by NDA “Recipe book” for marketing an OTC drug, a list

and explanation of GRASE conditions -active ingredients, doses, formulation, labeling and testing , continually updated

New Drug Application (NDA) New ingredients , Rx-OTC switch, generic (ANDA)

What is included in an OTC Drug Monograph?

GRASE active ingredients Dosage strength Dosage form

Labeling requirements Indications Warning and directions for use

Final formulation testing

NDA Process OTC Monograph Process

Pre-market approval NoConfidential filing Public processDrug product-specific Active ingredient-specific

• OTC drug category

May require a user fees No user feesPotential for marketing exclusivity

No marketing exclusivity

Mandated FDA review timelines

No mandated timelines

May require clinical studies• Label comprehension• Actual use

May require clinical studies• Label comprehension

and actual use studies not required

OTC Drug Review Established to evaluate the safety and

effectiveness of OTC drug products marketed in US before May 11th, 1972

It is a three-phase public rulemaking process (each phase requiring Federal Register publication) resulting in establishment of standards (monographs or non-monographs) for an OTC therapeutic drug category

1. First phase was accomplished by advisory review panels

Role of advisory review panels

Reviewing the ingredients in nonprescription drugs to determine whether these ingredients could be generally recognized as safe and effective for use in self-treatment

Charged with reviewing claims and recommending appropriate labeling (tx indications, dosage instructions, warnings about side effects and preventing misuse)

The panels classified ingredients in three categories as follows:

Category I: GRASE for the claimed tx indication

Category II: not GRASE or unacceptable indications

Category III: cannot determine if safe and effective as insufficient data available to permit final classification

2. Second phase was the agency’s review of ingredients in each class of drugs based on panel’s findings, public comments and new data that may have become available

The agency, in turn, publishes its conclusions in the Federal Register in form of a tentative final monograph

After publication, a period of time is given for objections to the agency’s proposal or for requests to be submitted for a hearing before the Commissioner of FDA

3. Third phase was the publication of final regulations in form of drug monographs

The monographs establish conditions under which certain OTC drug products are generally recognized as safe and effective

Characteristics of Eligibility for OTC Approval

OTC drugs generally have these characteristics: their benefits outweigh their risks the potential for misuse and abuse is

low consumer can use them for self-

diagnosed conditions, self treat and self manage

they can be adequately labeled health practitioners are not needed for

the safe and effective use of the product

Disadvantages

Reduced opportunities to receive counseling about possible lifestyle therapies (e.g. diet, exercise)

Poorer compliance Misdiagnosis, patients won’t

benefit from the drug but will be exposed to its risks

More difficult to study a drug’s effects

OTC Drug Labeling (cont.)

Comprehensibility

Readability

Comprehensiveness

Comprehensibility:

FDA regulations require that OTC drug labeling contain terms likely to be read and understood by the average consumers

Counseling consumers on how to interpret product labels properly

Readability:

Provision of essential information in the same orders and area

Uniformity in print size, pictogram, icons, colours, numbering, margins and etc.

Special population: a threshold print size of 4.5 has been suggested as minimum, while not optimum

Limitations of package labeling

A package label can never address the infinite management issues associated with drug use, particularly in the comorbidity or polypharmacy.

Thus, packaging should acknowledge and encourage dialogue with health professionals.

Expiration date on labeling

Expiration date: is the date beyond which product should not be used because the stability, potency, strength or quality may have been affected over time

FDA regulations govern how this date is determined and tested

Most OTC drugs are required to include an expiration date on the labeling

Checklist for choosing OTC drugs

OTC DRUGS-Pregnancy-Abuse of OTCDHAMIRAH SAKINAH MAKMON10-6-75

OTC drugs for pregnancy

OTC drugs for pregnancy Constipation – Colace , Metamucil Heart burn - Gaviscon® (aluminum hydroxide,

magnesium carbonate Sleep problems- Unisom® SleepTabs® (doxylamine

succinate) Sinus congestion and cold- loratidine Vomiting - Emetrol® Syrup (phosphorated [phosphoric

acid] carbohydrates [dextrose, fructose] syrup), vitamin B6

OTC that should be avoided

Abuse of the OTC drug Dextrometrophan

BRAND/COMMERCIAL NAMES:Any Cold Medicine with “DM” or “TUSS” in the title such as: Dimetapp DM®, Nyquil®, Robitussin®, Theraflu®, Vick’s Formula 44®SIGNS OF ABUSE:Nausea, loss of coordination, headache, vomiting, slurred speech, disassociation

Pain reliever-Acetaminophen/ibuprofen Diet Pills - phenylpropanolamine, ephedrine,

and ephedra

Dimenhydrinate (Dramamine) or diphenhydramine (Benadryl) Motion sickness pill taken in large doses can cause one to feel high and have hallucinations similar to street drugs

Pseudoephedrine: This nasal decongestant and stimulant is found in many cold medicines. Its similarity to amphetamines has made it sought out to make the illegal drug methamphetamine. The medicine has also been taken as a stimulant to cause an excitable, hyperactive feeling

Herbal- nutmeg, salvia