Pharmaceutical Regulations: Durham-Humphrey Amendment

Questions and Answers

What does the Durham-Humphrey Amendment establish?

Both A and B

Different labeling requirements for drugs (correct)

OTC drugs have no labeling requirements

Only prescription drugs can be sold

How was the Durham-Humphrey Amendment established?

It was established to address the issue of drug manufacturers labeling products as either OTC or prescription.

How are prescription drugs categorized?

Prescription drugs are categorized based on safety, method of use, and compliance with the new drug application indicating it is prescription only.

What are three things that the FDA must prove to change a drug's status from OTC to prescription?

<ol> <li>Toxicity, 2) Prove harm from unsupervised use, 3) Drug requires collateral measures.</li> </ol> Signup and view all the answers

What does it mean that collateral measures necessary to use the drug require supervision?

It means that if a drug cannot cure the patient, the delay in doctor visit required for its use is harmful. Signup and view all the answers

The DHA allows for which two forms of prescription?

Oral prescription Signup and view all the answers

Where should refills be specified?

In the original prescription. Signup and view all the answers

How would pharmacists label dispensed prescription drugs without the DHA?

They would have to follow the same labeling requirements as drug manufacturers. Signup and view all the answers

What items must pharmacists place on the label, as required by federal law?

<ol> <li>Name and address of the dispenser, 2) Serial number and date of prescription, 3) Name of the prescriber and patient, 4) Directions for use and cautionary statements.</li> </ol> Signup and view all the answers

What is the expiration date for most dispensed drugs?

It shall not be later than the expiration date on the manufacturer's container, or one year from the date when the drug is dispensed, whichever is earlier. Signup and view all the answers

What is the expiration date for insulin products?

24 months from their date of manufacture. Signup and view all the answers

What are the OTC products that are exempt from expiration dating?

They must be stable for at least 3 years, have no dosing limitations, and be safe and suitable for frequent and prolonged use. Signup and view all the answers

What is the Kefauver-Harris Amendment?

An amendment requiring an evaluation of all marketed drugs, both OTC and prescription, for efficacy. Signup and view all the answers

How did the FDA evaluate OTC drugs that are already in the market in response to the Kefauver-Harris Amendment?

They evaluated OTC products based on therapeutic categories rather than individually. Signup and view all the answers

What can manufacturers do if a product does not contain the approved active ingredients or labeling?

Manufacturers must remove, reformulate, and relabel or withdraw the product and follow NDA procedures. Signup and view all the answers

During OTC drug review, the final monograph on a reviewed ingredient specifies in which of the three categories the ingredient is placed:

Category I = Ingredients generally recognized as safe and effective and not misbranding. Category II = Ingredients that are not generally recognized as safe and effective or that are misbranded. Category III = Ingredients for which data available are insufficient to permit classification. Signup and view all the answers

What are three mechanisms that prescription drugs can switch to OTC?

<ol> <li>Manufacturer may request switch by a supplemental application to its approved NDA, 2) Manufacturer may petition the FDA, 3) Drug may switch during the OTC review process.</li> </ol> Signup and view all the answers

Why may the same drug by different manufacturers be OTC or prescription, and what will pharmacists do?

Because some manufacturers changed to OTC status by submitting a supplemental application while others did not; pharmacists should follow the label. Signup and view all the answers

What are drugs that are available only in pharmacies and require pharmacist counseling?

Third class drugs (behind-the-counter) include insulin, syringes, pseudoephedrine, plan B. Signup and view all the answers

Who can authorize prescription refills?

Only the physician. Signup and view all the answers

Which law gives prescriptive authority to different health care practitioners?

State law. Signup and view all the answers

What is a collaborative practice agreement?

Legislation allowing pharmacists to initiate or adjust drug therapies in collaboration with a physician. Signup and view all the answers

Do physicians have the authority to dispense prescription drugs?

Yes, by the same standard (DHA) as pharmacists. Signup and view all the answers

What drugs must accompany patient package inserts?

Oral contraceptive drugs, estrogen containing drugs, diethylstilbestrol (DES), IUD contraceptive device. Signup and view all the answers

When should patient package inserts be shown to ambulatory patients?

Before the first dose and 30 days thereafter. Signup and view all the answers

What are medication guides (medguides)?

Patient labeling for products posing serious concerns which help prevent adverse effects and ensure adherence. Signup and view all the answers

What are examples of drugs that require medication guides?

Motrin, Abilify, SSRIs (Prozac), Ambien, Accutane, Lotronex, Lariam, and Lindane. Signup and view all the answers

What are two reasons why unlabeled indications are common?

<ol> <li>Practitioners find new uses for drugs faster than regulatory processes, 2) Manufacturers seek NDA approvals for a minimal number of indications to speed the process.</li> </ol> Signup and view all the answers

What is a pharmacist's duty to patients regarding unlabeled indications?

If the risk is unreasonable, the pharmacist has a duty to call the prescriber and document the call. Signup and view all the answers

Who decides whether to use a brand or generic drug in Massachusetts?

The prescriber. Signup and view all the answers

What is bioequivalence?

A term defined as the products display comparable bioavailability under similar conditions. Signup and view all the answers

What is a pharmaceutical equivalent?

Products that contain the same active ingredients, are identical in strength, and are in the same dosage form. Signup and view all the answers

What is therapeutic equivalence?

Pharmaceutical equivalents that are expected to have the same clinical effect and safety. Signup and view all the answers

What are two sources of drugs that may be therapeutically equivalent but not listed in the Orange Book?

<ol> <li>Drugs marketed before 1938, 2) Certain generics that demonstrate bioavailability but not bioequivalence.</li> </ol> Signup and view all the answers

What are examples of Narrow Therapeutic Index drugs?

Carbamazepine, Clonidine, Levothyroxine, Lithium, Phenytoin, Warfarin, Theophylline. Signup and view all the answers

What is the FDA's bioequivalence standard range?

80-125%. Signup and view all the answers

What are the steps to determine if a prescription written for a brand name drug is interchangeable in Massachusetts?

<ol> <li>Look up the drug product. 2) Find the same dosage form and strength in the Orange Book. 3) Check if it's classified as 'A' and not on the Exception List. 4) If it's 'B', refer to additional lists. 5) If listed in additional lists, it is interchangeable.</li> </ol> Signup and view all the answers

For what purposes is tax-free alcohol used?

For medicinal and research purposes. Signup and view all the answers

Which type of alcohol do retail pharmacies usually use for compounding prescriptions?

Tax-paid ethyl alcohol, usually 190 proof grain alcohol purchased from authorized outlets. Signup and view all the answers

How should tax-free alcohol be stored and handled in a pharmacy?

Must be stored in a securely locked storeroom with intact labels; labels must be obliterated before discarding empty containers. Signup and view all the answers

What substances are defined under PPPA as customarily produced for use in households?

<ol> <li>Hazardous substances under the federal Hazardous Substance Act, 2) Economic poisons under the federal Insecticide Act, 3) Foods, drugs, or cosmetics under the FDA, 4) Household fuels stored in portable containers.</li> </ol> Signup and view all the answers

According to the PPPA, what percentage of children under 5 years of age must be unable to open containers?

80%, and 90% of adults must be able to open them. Signup and view all the answers

Can plastic bottles be reused? What about glass bottles?

Plastic bottles cannot be reused; glass bottles can, but the plastic cap needs to be replaced. Signup and view all the answers

What are four exemptions to the child-resistant container rule?

<ol> <li>Non-compliant container requested by physician or patient, 2) OTC products with labels stating no child-resistant packaging, 3) Dispensed to institutionalized patients, 4) Certain prescription drugs requiring immediate use.</li> </ol> Signup and view all the answers

What is the list of prescription drugs that are exempt from child-resistant containers?

<ol> <li>SL nitroglycerin, 2) SL and chewable forms of isosorbide dinitrate, 3) Sodium fluoride, 4) Anhydrous cholestyramine, 5) Methylprednisolone, 6) Erythromycin ethylsuccinate granules.</li> </ol> Signup and view all the answers

Study Notes

Durham-Humphrey Amendment

Establishes distinct labeling requirements for prescription drugs and over-the-counter (OTC) drugs within Section 502 of the FDCA.
Prior to the amendment, manufacturers could label the same drug as OTC or prescription, leading to inconsistencies.

Classification of Prescription Drugs

A drug is categorized as prescription if:
- It is unsafe without practitioner supervision due to potential harm or necessary collateral measures.
- The new drug application explicitly indicates it is prescription only.

FDA's Role in Drug Status Change

The FDA must prove the following to reclassify a drug from OTC to prescription:
- The drug demonstrates harmful pharmacological or toxic effects without physician oversight.
- Evidence that unsupervised use has caused harm.
- Collateral measures are needed to ensure safe drug usage.

Collateral Measures

If a drug cannot cure a condition, a delay in seeing a doctor could result in further harm.

Prescription Forms

Allows for written or oral prescriptions, with electronic prescriptions recognized after 2000.

Labeling Requirements for Pharmacists

Prescription refills must be specified in the original prescription.

Pharmacists' Labeling Obligations

Pharmacists must include on labels:
- Name and address of the dispenser.
- Serial number and date of prescription filling.
- Name of the prescriber and patient.
- Directions for use and cautionary statements.

Drug Expiration Guidelines

Most dispensed drugs expire no later than the manufacturer’s expiration date or one year post-dispensing, whichever comes first.
Insulin products have an expiration of 24 months from the date of manufacture.

OTC Products and Expiration

OTC products exempt from expiration dating are stable for at least three years, without dosing limitations, suitable for regular use, e.g., toothpaste.

Kefauver-Harris Amendment

Required all marketed drugs, both OTC and prescription, to undergo efficacy evaluations.

Evaluating OTC Products

The FDA assesses OTC products based on therapeutic categories instead of individual review.

Manufacturer Actions for Non-compliance

Products lacking approved ingredients must either be reformulated, relabeled, or withdrawn.

OTC Drug Categories

Category I: Recognized as safe and effective.
Category II: Not recognized as safe or effective.
Category III: Insufficient data for classification.

Prescription to OTC Transition

Mechanisms include:
- Manufacturer's request via supplemental application.
- Petitioning the FDA.
- Transition during the OTC review process.

Brand vs. Generic Drug Decisions

The same drug may have different statuses (OTC or prescription) depending on the manufacturer; pharmacists must adhere to the label.

Behind-the-Counter Drugs

Certain drugs, such as insulin and pseudoephedrine, are classified as behind-the-counter, available only in pharmacies with required counseling.

Prescription Refills Authorization

Only the prescriber can authorize prescription refills, and pharmacists must verify authorization.

Prescriptive Authority

Varies by state law, granting different health care practitioners the ability to prescribe.

Collaborative Practice Agreement

Legislation in many states permits pharmacists to initiate or adjust therapies collaboratively with physicians.

Authority to Dispense Prescription Drugs

Physicians follow the same standards (DHA) as pharmacists when dispensing drugs.

Patient Package Inserts

Required for specific drugs, including oral contraceptives and IUDs, to ensure patients receive vital information.

Timing for Patient Package Inserts

Must be provided before the first dose and within 30 days after.

Medication Guides

Labeling for drugs posing significant risks, ensuring patients understand potential adverse effects and proper adherence.

Examples of Drugs Requiring Medication Guides

Includes medications like Accutane, Lotronex, and Ambien.

Unlabeled Indications in Medicine

Common due to practitioners’ quick adaptation to new uses and manufacturers’ limited NDA approvals.

Pharmacists' Duty Regarding Unlabeled Indications

Must contact prescribers if risk appears unreasonable concerning unlabeled drug uses.

Brand vs. Generic Decision Authority

The prescriber ultimately decides whether to use a brand or generic drug in Massachusetts.

Definitions and Equivalence

Bioequivalence: Similar bioavailability under identical conditions.
Pharmaceutical equivalence: Same active ingredients, identical strength and form.
Therapeutic equivalence: Expected to have the same clinical effects and safety profile.

Exceptions from Orange Book

Drugs marketed before 1938 and certain generics may be therapeutically equivalent but not listed.

Narrow Therapeutic Index Drugs

Examples include carbamazepine, lithium, and warfarin, requiring careful monitoring.

FDA Bioequivalence Standards

Allow a 80-125% range in bioavailability.

Steps for Drug Interchangeability in MA

Identify drug product and verify its equivalence in the Orange Book based on dosage and strength.

Tax-Free Alcohol Uses

Utilized for medicinal and research purposes.

Alcohol Used in Retail Pharmacies

Typically involves tax-paid ethyl alcohol from authorized outlets.

Storage and Handling of Tax-Free Alcohol

Must be securely locked and properly labeled, with requirements for obliterating labels before discarding containers.

Definition of Hazards under PPPA

Substances that are customarily used in households and defined under several federal acts.

Child-Resistant Container Standards

Containers must be designed to be opened by 80% of adults and not by 90% of children under five.

Reuse of Bottles

Glass containers can be reused; plastic containers can be reused if caps are replaced.

Exemptions from Child-Resistant Container Rule

Include requests by prescribers, certain OTC products, dispensed items to institutionalized patients, and immediate use prescription drugs.

Prescription Drugs Exempt from Child-Resistant Containers

Includes SL nitroglycerin and sodium fluoride among others.

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Description

Explore the key aspects of the Durham-Humphrey Amendment which established labeling requirements for prescription and OTC drugs. Understand the criteria for classifying drugs and the FDA's role in reclassification. This quiz will enhance your knowledge of pharmaceutical regulations and drug safety measures.