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Drug Approval Process: A Comprehensive Guide with Questions and Answers, Exams of Nursing

Oklahoma State University (OSU) - Oklahoma City Nursing

A comprehensive overview of the drug approval process, covering pre-clinical testing, clinical trial phases, post-marketing surveillance, and regulatory requirements. It includes detailed explanations of key concepts such as ind, nda, bla, and otc monograph approval process. The document also features a series of questions and answers, designed to test understanding and reinforce learning.

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Pre-clinical (Is it safe?) - CORRECT ANSWERS ✔✔- Drug safety testing on

animal

(Manufacturer can only file an *investigational new drug (IND)* to FDA for

permission to begin clinical studies phase I if the pre-clinical animal research

appears to indicate a relatively safe drug with a potential therapeutic use.)

Phase I Clinical Trial (Is it safe for human?) - CORRECT ANSWERS ✔✔-

Study on small number of healthy subjects (20-80) to determine if drug is safe.

- The safety of drug is studied on:

+ Side effects, Adverse event

+ Pharmacokinetics

+ Pharmacodynamics

Phase II Clinical Trial (Is it safe and effective for human?) - CORRECT

ANSWERS ✔✔- Study about the safety and effectiveness of drug on a little bit

bigger population of real pateints (35-100)

- This study includes: safety and efficacy, dosing range.

Phase III Clinical Trial (How effective is the drug?) - CORRECT ANSWERS

✔✔- Larger population of real patients from 300 - 3000

- Study to determine if the drug is better, safer, or more effective than a standard

drug treatment (gold-standard treatment) or placebo.

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Pre-clinical (Is it safe?) - CORRECT ANSWERS ✔✔- Drug safety testing on animal (Manufacturer can only file an investigational new drug (IND) to FDA for permission to begin clinical studies phase I if the pre-clinical animal research appears to indicate a relatively safe drug with a potential therapeutic use.) Phase I Clinical Trial (Is it safe for human?) - CORRECT ANSWERS ✔✔- Study on small number of healthy subjects (20-80) to determine if drug is safe.

The safety of drug is studied on:

Side effects, Adverse event
Pharmacokinetics
Pharmacodynamics Phase II Clinical Trial (Is it safe and effective for human?) - CORRECT ANSWERS ✔✔- Study about the safety and effectiveness of drug on a little bit bigger population of real pateints (35-100)

This study includes: safety and efficacy, dosing range. Phase III Clinical Trial (How effective is the drug?) - CORRECT ANSWERS ✔✔- Larger population of real patients from 300 - 3000
Study to determine if the drug is better, safer, or more effective than a standard drug treatment (gold-standard treatment) or placebo.

What does the manufacturer have to do before Phase IV clinical study after the Phase III study showed promising result? - CORRECT ANSWERS ✔✔- They need to submit New Drug Application (NDA) for drug OR Biologics License Application (BLA) for biologics to FDA.

The NDA or BLA will include all:

Collected animal data and human data
Pharmacokinetic & Pharmacodynamic analysis.
Drug interaction studies
Complete review of the manufacturing process. Who will review NDA and BLA? - CORRECT ANSWERS ✔✔- The Center for Drug Evaluation and Research (CDER) of the FDA.

The CDER is expected to review 90% of applications:

Within 10 months for standard drugs
Within 6 months for priority drugs Phase IV Clinical Studies - CORRECT ANSWERS ✔✔- Post-marketing surveillance studies that may be conducted after the drug is approved and released for use.

The FDA might request this study to examine the risks and benefits in different population
The manufacturer may also conduct this study to assess such issues as the long- term effects of drug exposure.
The company requires to send the collected A/E reports to MedWatch at quarterly intervals for the first 3 years after the drug approval. Supplemental New Drug Application (sNDA) - CORRECT ANSWERS ✔✔- An application is submitted to FDA for:

OTC monograph approval process - CORRECT ANSWERS ✔✔- It has three steps which the FDA calls a "three-phase public rulemaking process"

Each phase requires a publication in:

The Federal Register
The Federal government's daily 'newspaper' What happens during the first phase of OTC monograph approval process? - CORRECT ANSWERS ✔✔- FDA advisory review panels review the active ingredients and determine whether they are "generally recognized as safe and effective" for use in self-treatment.

The conclusions are published in teh Federal Register in the form of an advanced notice of proposed rulemaking (ANPR)
After publication of the ANPR, a period of time is given for any interested parties to submit comments or data in response to the proposal. What is the labeling recommends from FDA advisory review panels during the first phase of OTC monograph? - CORRECT ANSWERS ✔✔- Therapeutic indications
Dosage instructions
Warnings about side effects
How to prevent misuse. Second Phase of OTC monograph - CORRECT ANSWERS ✔✔- Agency reviews the active ingredients in each class of drugs, the public comments, and any new data that has become available.
The FDA publishes its conclusion in the Federal Register in the form of a tentative final monograph (TFM)

Third Phase of OTC monograph (Final Phase) - CORRECT ANSWERS ✔✔- The publication of the final OTC drug monograph.

The monograph will establish the conditions under which OTC drug has been recognized as safe and effective. Abbreviated New Drug Application (ANDA) - CORRECT ANSWERS ✔✔- The Generic Drug approval process that requires a review of:

Generic product's chemistry
Manufacturing controls
The labeling.

The review is abbreviated (shorter) because it does NOT require pre-clinical animal studies and clinical studies with human subjects. Where can the healthcare professional and patients report A/E to? - CORRECT ANSWERS ✔✔- MedWatch (by FDA) OR
Drug Manufacturer Grandfathered Drugs - CORRECT ANSWERS ✔✔- Unapproved drugs that are not required to go through the same approval process as new drugs because they are available before the FDA approval process was established in year 1938.
An unapproved drug will have an NDC number but will NOT be listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (Over time, the FDA has been bringing these older drugs into the approval process, starting with those medications that pose the greatest health risk to the public)

Quality is filthy, putrid, or decomposed.
Producing under unsanitary conditions where it may have become contaminated
Strength is different from official standards
Purity or quality is lower than the official standards
Strength, purity, or quality are lower than listed on the label. Misbranding - CORRECT ANSWERS ✔✔- The label is false or misleading such as:
Lack of required information on the package and in the labeling.
False or misleading product information
Lack of special precautions needed to prevent decomposition
Contain information that is illegible
Package doesn't contain the proprietary (branded) or established common name
Doesn't contain the manufacturer and business location
Improper packaging
Improper or incomplete labeling of additives
There is deficiency in packaging. Durham-Humphrey Amendment of 1951 - CORRECT ANSWERS ✔✔- Create a clear distinction between OTC and Prescription Drugs.

The amendment classified the three conditions that would make a drug available only by prescription.

Drugs that are habit-forming
Drugs considered unsafe for use except under expert supervision d/t toxicity

Drugs limited to prescription use only under a manufacturer's new drug application

OTC drugs were required to contain adequate directions for use in the "Drug Facts Label"
Another term for prescription drug is "legend" drugs. Kefauver-Harris Amendment of 1962 - CORRECT ANSWERS ✔✔- Also known as the Drug Efficacy Amendment
Manufacturers must prove that a drug is both safe and effective before it can be FDA-approved.
After the drug is on the market, manufacturers must continue to report serious side effects to FDA Controlled Substances Act of 1970 - CORRECT ANSWERS ✔✔- A.K.A: the Comprehensive Drug Abuse Prevention and Control Act.
Established the regulations surrounding controlled substances which all manufacturers, importers, exporters, distributors, researchers, hospitals, pharmacies, prescribers, and pharmacists must follow.
Established a closed system of the manufacturing, distribution, and dispensing of drugs with the purpose of reducing drug diversion. Poison Prevention and Packaging Act of 1970 (PPPA) - CORRECT ANSWERS ✔✔- Enforced by the Consumer Product Safety Commission.
Requires a number of household substances and drugs to be packaged in child- resistant (C-R) packaging.
The packaging must be significantly difficult for children under 5 years of age to open within a reasonable time.

Hatch-Waxman Act of 1984 (Drug Price Competition and Patent Term Restoration Act) - CORRECT ANSWERS ✔✔- Purpose: Increase the availability of generics and cut costs for the patient and the healthcare system.

Generic drug companies can file one of two abbreviated applications for generic drug approval: the Abbreviated New Drug Application (ANDA), or the 505(b)(2) application (also referred to as paper NDA).
This Act also provided patent protection to the company that created the brand name drug by granting up to 5 years of patent exclusivity to make up for the effort the company spent conducting clinical trials to establish safety and efficacy (No generic versions can be approved during this period) Requirements for ANDA - CORRECT ANSWERS ✔✔- A generic drug company must provide study data to establish that the generic drug has the SAME following things as branded drug:

Active ingredient
Route of administration
Dosage form
Strength

The generic drugs is also bioequivalent to the branded drug. Paper NDA [505(b) application] - CORRECT ANSWERS ✔✔- Allows the generic drug manufacturer to submit evidence of previously published reports of investigations of safety and effectiveness. Prescription Drug Marketing Act of 1987 (PDMA) - CORRECT ANSWERS ✔✔- Prohibits reimportation of prescription drugs products manufactured in the U.S. and subsequently exported to a foreign country cannot be reimported back into the U.S, except by the product's manufacturer.

The sale of drug samples was prohibited.
The sale of drug coupons was prohibited
Patients cannot buy drugs in other countries and bring them into the U.S., except under either of these conditions:

The quantity is for a <= 90-day supply, and is for the patient (Cannot be resold)
An effective treatment is not available in the U.S., the condition is serious, and the drug being imported has no unreasonable risk.

PDMA requires wholesalers to be state-licensed and meet uniform standards.
Blocked hospitals from reselling drugs as a normal part of business by placing strict limits on the percentage of drugs that hospital pharmacies can resell.
Selling drugs to another hospital (that is not a part of the same hospital group) is only permitted in order to help the other hospital manage a drug shortage. Omnibus Budget Reconciliation Act of 1990 (OBRA) (D/t concerns about improper medication use and inefficient use of federal dollars spent on healthcare) - CORRECT ANSWERS ✔✔- OBRA requires the pharmacist to perform a prospective drug utilization review and counseling for all Medicaid beneficiaries before dispensing the prescription to the patient.
States were also required to perform a retrospective drug utilization review. Dietary Supplement Health and Education Act of 1994 (DSHEA) (Prior to this act, dietary supplements were regulated in the same manner as drugs) - CORRECT ANSWERS ✔✔- Company does not need to provide the FDA with safety and efficacy data and FDA approval is not needed prior to the release of product and nay related marketing material.
Product must include a disclaimer that the FDA has not evaluated the claim

Permitting fast-track approval which is developed to accelerate approval for high-priority medications. (have 4 programs for this) Under FDAMA, what are 4 programs for helping speed the development and review of new drugs? - CORRECT ANSWERS ✔✔1) Fast track designation

Breakthrough therapy designation
Accelerated approval
Priority review designation. The Drug addiction Treatment Act of 2000 (DATA) (Prior to this act, Methadone was the only primary treatment through DEA- registered opioid treatment program) - CORRECT ANSWERS ✔✔- Permits physicians to prescribe and dispense controlled substances in a off-based setting to treat opioid dependence. FDA Amendments Act of 2007 - CORRECT ANSWERS ✔✔- Gave a new authority to the FDA to enhance drug safety

The Risk Evaluation and Mitigation Strategy (REMS) program was part of this legislation.
A REMS program drug will require more involvement from the manufacturer, distributor, prescriber, pharmacist, and/or patient to ensure that the benefits of the drug or biologic outweight the risks. The biologics price competition and innovation Act of 2010 - CORRECT ANSWERS ✔✔- Was passed as part of the Affordable Care Act and created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological products.
The biosimilar must have the same MOA, route of administration, dosage form and strength as the reference product.

The biosimilar will only be approved for the indications of the reference biologic. Drug Quality and Security Act of 2013 (DQSA) - CORRECT ANSWERS ✔✔- Consist of the Compounding Quality Act and the Drug Quality and Security Act.
The Compounding Act gave the FDA increased authority to regulate compounding
The law makes a distinction between traditional compounders and "outsourcing facilities".
If a facility compounds sterile drugs for human, they can register as an outsourcing facility under 503B
Drugs compounded by an outsourcing facility are exempt from FDA new drug approval process and certain labeling requirements
Need to comply with CGMP requirements, report A/E, and provide the FDA with certain information about the products they compound Drug Supply Chain Security Act (part of DQSA) - CORRECT ANSWERS ✔✔- To prevent counterfeit drugs from entering the market, the Drug supply chain security act establishes requirements to document the transactions of prescription drugs products through the pharmaceutical supply distribution train.
Document must include: transaction information, transaction history, and transaction statements. Pregnancy and Nursing Labeling Final Rule 2014 - CORRECT ANSWERS ✔✔- The previous Pregnancy Categories (A, B, C, D & X) will no longer be used and the information will be placed into new categories.
The new requirements will be in package inserts by 2020.
The new information is placed into 3 categories:

Pregnancy: Labor & Delivery guidelines now fall this category.

All preceptors shall successfully complete an examination, prepared by the board, related to pharmacy laws and rule in 535: 10-5-8 subchapter OK law book for Preceptor.
Preceptor certification is renew at each renewal date of their pharmacy license. Preceptor to intern ratio in Oklahoma - CORRECT ANSWERS ✔✔- One intern per one preceptor at a time for most situation.
In experiential rotation, one preceptor can go with up to 2 interns at a time T/F: No pharmacist shall be approved or continue as a preceptor, who is under probation or suspension by the board, or who has been convicted of a felony which was drug related. - CORRECT ANSWERS ✔✔TRUE Oklahoma Intern Application Requirement - CORRECT ANSWERS ✔✔- Completed at least 1,500 (fifteen hundred) hours of pharmacy practice training, under the supervision of a preceptor, in a licensed pharmacy or other professional practice site that has been approved as training area by a board. Oklahoma Intern Identification Requirements - CORRECT ANSWERS ✔✔- Pharmacy intern shall wear a designation tag (name tag) and be distinctly identifiable from a practicing pharmacist.
All interns shall identify themselves as interns on any phone calls initiated or received.
No person shall wear or use an intern designation unless currently licensed as an intern by the board. T/F: Interns will be held accountable to the rules and violations of professional conduct. - CORRECT ANSWERS ✔✔True

T/F: All licensed pharmacy interns shall notify the Board of Pharmacy, in writing, of the place of their non-experimental employment within ten (10) days of going to work and/or termination of this practice location. - CORRECT ANSWERS ✔✔True T/F: Pharmacists are responsible for the work of the intern and thus there are ratios restricting the number of interns (and tech) that he pharmacist can supervise. - CORRECT ANSWERS ✔✔TRUE Oklahoma definition of licensed intern - CORRECT ANSWERS ✔✔- A licensed intern shall be defined as a student having completed fifty (50) college hours of credit, with an overall average of not less than "C", currently enrolled and attending classes and in good standing in an accredited college of pharmacy in a Doctor of Pharmacy program, or a graduate of an accredited college of pharmacy. In Oklahoma, When do the pharmacy colleges notify the board about their students? - CORRECT ANSWERS ✔✔- When a student is not continuously enrolled in a college of pharmacy in an accredited Pharmacy program.

When a pharmacy student is not in good standing
When a pharmacy student's overall grade point is less than "C" (Students who are reported, their licenses automatically void and the intern shall return such license to the Board) How long does an Oklahoma intern license last? - CORRECT ANSWERS ✔✔- 5 years after the date of issuance

Reinstated - CORRECT ANSWERS ✔✔- License that was taken away is given back, in active status Surrendered - CORRECT ANSWERS ✔✔- Individual agrees to voluntarily gives up licensure, often with compulsion in order to avoid penalties and/or criminal charges. The most common causes of disciplinary action - CORRECT ANSWERS ✔✔- Impairment

Drug theft
Drug diversion FDA defines repackaging as - CORRECT ANSWERS ✔✔- an act of taking a finished drug product from the container in which it was distributed by the original manufacturer and placing it into a different container without further manipulation of the drug. Class I Recall - CORRECT ANSWERS ✔✔- A situation in which there is a reasonable probability that the use or exposure will cause serious adverse health consequences or death. (Example: a morphine tablet manufactured with 10 times the amount of active ingredient) Class II Recall - CORRECT ANSWERS ✔✔- A situation in which use or exposure can cause temporary or reversible adverse health consequences or where the probability of harm is remote. (Example: Ketorolac injections were recalled in 2010 and 2015 due to the possibility of particles in the vials)

Class III Recall - CORRECT ANSWERS ✔✔- A situation in which use of or exposure is not likely to cause adverse health consequences. (Example: the coloring on tablets may have been applied inconsistently) Imminent Danger Suspension - CORRECT ANSWERS ✔✔- If the Director finds that there is imminent danger to the public health or safety, he may immediately suspend any registration simultaneously with the scheduling of a Board hearing. Order of Procedure - CORRECT ANSWERS ✔✔- Hearings shall be conducted in an orderly manner by the President of the Board, or his designee. The order of procedure and rules of evidence shall be those specified by the Oklahoma Administrative Procedures Act. Admissibility - CORRECT ANSWERS ✔✔- The president of the Board, or his designee, shall rule upon the admissibility of evidence and objections thereto, and shall rule upon other motions or objections arising in the course of the hearing. Standard of Proof - CORRECT ANSWERS ✔✔- Clear and convincing evidence Failure to appear or failure to comply - CORRECT ANSWERS ✔✔- Fails to appear as directed may be determined to have waived his right to present a defense to the charges alleged in the complaint.

If the violation alleged did in fact occur, suspension, revocation or other disciplinary action may be ordered by the Board
Failure to comply with the Board's order may result in additional sanctions by the Board.

Drug Approval Process: A Comprehensive Guide with Questions and Answers, Exams of Nursing

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