Drug Regulation and Control

Drug Regulation and Control

Chapter 3

Chapter 3 Objectives Understand the importance and role of drug regulation. Knowledge of the history of drug regulation. Understanding of the drug development and approval

process. Become familiar with the Behind-the Counter OTC

Medications and regulations for dispensing them. Knowledge of label and labeling requirements. Knowledge of controlled substance schedules and

requirements for handling controlled substances. Understand the recall process. Understand health care provider’s responsibilities under

HIPAA.

Food and Drug Administration

The leading enforcement agency at the federal level for regulations concerning drug products.

Drug Enforcement Administration

The agency which controls the distribution of drugs that may be easily abused.

Drug Regulation – A Timeline

Food and Drug Act of 1906: Prohibited interstate commerce in foods and drugs

that have added inferior materials and misbranded drinks and drugs.

1914 Harrison Tax Act: In response to growing addiction to opiates and

cocaine-containing medicines, the Harrison Tax Act established that manufacturers, pharmacists, importers, and physicians prescribing narcotics should be licensed and required to pay a tax.

Timeline begins on page 30


1938 Food, Drug and Cosmetic Act: In response to the fatal poisoning of 107

people, primarily children, by an untested sulfanilamide concoction, this law requires new drugs to be safe before marketing.

1951 Durham-Humphrey Amendment October 26, 1951:

The Durham-Humphrey Amendment is passed. The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without prescription."

Defines what drugs require a prescription

The Thalidomide Lesson Sleeping pill developed in

1962 that was found to cause severe birth defects when used by pregnant women.

1962 Kefauver-Harris Amendment Requires drug

manufacturers to provide proof of both safety and effectiveness before marketing a drug.

Now used as a safe and effective treatment for multiple myeloma, prostate cancer, and leprosy. User must under stand risks of taking this Rx.


1970 Poison Prevention Packaging Act: Requires child-proof packaging on all controlled

and most prescription drugs dispensed by pharmacies.

1970 Controlled Substances Act: Classifies drugs that may be easily abused and

restricts their distribution. Enforced by the DEA. This law established that the DEA is part of the

US Justice Department

Drug Regulation – A Timeline 1983 Orphan Drug Act:

Provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases

1984 Drug Price Competition And Patent Term Restoration Act (Hatch-Waxman):Extension of drug patent terms and quicker

introduction of lower cost generic drugs 1990 Anabolic Steroid Control Act:

Passed to address abuse of steroids in children


1990 Omnibus Budget Reconciliation Act (OBRA): Act Requires pharmacists counsel Medicaid

patients regarding medication. 1996 Health Insurance Portability and

Accountability Act (HIPAA): Provided broad and stringent regulations to

protect patients’ privacy.

Bell Work 1/19, 1/20

Which act provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases? Orphan Drug Act of 1983

Which act requires drug manufacturers to provide proof of both safety and effectiveness before marketing a drug? 1962 Kefauver-Harris Amendment

New Drug Approval

All new drugs, whether made domestically or imported, require FDA approval before they can be marketed in the United States.

Before it will be approved, a new drug must be shown to be both safe and effective by the manufacturer and that its benefits outweighs the risks.

Page 32, 33

Clinical Trials

Extensive testing begins in the laboratory doing chemical analysis, animal testing and then clinical trials with people. Trial participants must give their informed consent. Children are only part of the trial after the drug has been fully tested on adults.

Proof that the drug is both safe and effective is based on results of clinical trials.

Testing Phases in Humans Phase 1

20-100 patientsTime: several monthsPurpose: mainly safety

Phase 2Up to several hundred patientsTime: several months to two yearsPurpose: short-term safety but mainly

effectivenessPhase 3

Several hundred to several thousand patientsTime: one to four yearsPurpose: safety, dosage, and effectiveness

Only about 25% of drugs tested in phase 1 successfully complete phase 3 and are approved for marketing.

Clinical Trial Phase

The proposed new drug is called an investigational new drug (IND).

Drug is only available to those in the trial, but sometimes it will be given to groups outside the trial who are critically ill.

Placebo drugs are often used. A placebo is an inactive substance given in place of a medication.

Trials are always “blind.” Patients are not told which group they are in.

Marketed Drugs

A patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under a brand name. A drug patent is in effect for 17 years from the date of the drug’s discovery.

Once a patent expires, other manufacturers may copy the drug and release it under its pharmaceutical or “generic” name.

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Marketed Drugs

Generic drugs must be pharmaceutically equivalent to the patented drug – it must have the same active ingredients, same dosage form, same route of administration, and same strength. And it must be therapeutically equivalent – that the body’s use of the drug is the same.

Bell 1/25

What is Med Watch?

Why is generic ibuprofen the same as Motrin?

OTC Labels

Over-The-Counter (OTC) are drugs that do not require a prescription.

OTC medications are not without risks. Package inserts and labels are designed so the consumer can take them without medical advice.

The label should include: The product name Name & address of the manufacturer List of all active and other ingredients Amount of contents Adequate warnings Adequate directions for use

Behind-The-Counter OTC Meds While most OTC medications are not kept

behind the pharmacy counter, some are, even if a prescription is not required.Combat Methamphetamine Epidemic Act

(CMEA) Federal law that sets daily and monthly limits on OTC sale of pseudoephedrine and ephedrine.

Records of sales must be kept for 2 years

Exempt narcotics. (pg 37)Emergency contraception

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Bell Work 1/24, 25

Limits on the sale of pseudoephedrine are monitored _______ and _________.Daily and monthly

Name two Behind the Counter OTC medications.Plan B and pseudoephedrine

Prescription Drug Labels Manufacturer Stock Label includes:

Generic and brand name NDC number – National Drug Code Manufacturer's name and address Drug form Package quantity Warnings Lot number and expiration date Storage requirements Dispensing container required Active ingredients and strength

Page 38, 39

Sample Labels

Bell Work 1/25, 1/26

What is the generic name of this drug?

What is the dosage form?

What is the package quantity?

Controlled Substances

Controlled Substances Act of 1970 (CSA) established by US Congress, identifies 5 groups or schedules of drugs as controlled substances and put strict guidelines on their distribution. This act also requires dispensers of these

substances register with the DEA.Page 40, 41

The Five Schedules Are: Schedule I – High potential for abuse and no accepted

medical use in the US. Heroin, some opium derivatives, and hallucinogenic substances

Schedule II – High potential for abuse and may lead to physical or psychological dependence, but also has a currently accepted medical use in the US. Amphetamines, cocaine, methadone, and various opiates

Schedule III – Potential for abuse is less than those in Schedules I and II and there is a currently accepted medical use in the US, but abuse may lead to moderate or low physical dependence or high psychological dependence. Anabolic steroids , compounds that contain codeine

The Five Schedules con’t Schedule IV – Low potential for abuse relative to

Schedule III and current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. Phenobarbital, sedative chloral hydrate, and some anesthetics

Schedule V – Low potential for abuse relative to Schedule IV and current accepted medical use in the US, but abuse may lead to limited physical dependence or psychological dependence. Limited amounts of codeine included in this group Exempt narcotics are in this group

In case you were wondering?

Opiates and Opioids are drugs that are most commonly used for their euphoric and/or analgesic effects.

Opiates are drugs that are derived from the Opium poppy plant.

The term 'Opioid' is used to describe a compound that binds opioid receptors in the brain, and produces effects characteristic of naturally occurring opiates.

Opiate drug names.

Some of the more well known semi-synthetics opiates, that is to say narcotic drugs, created from morphine, codeine and thebaine are heroin, hydrocodone, hydromorphone, oxycodone, oxymorphone, and there are many others.

Medical Marijuana Debate

Medical marijuana is not approved by the FDA Federal law does not recognize the difference

between medical and recreational use of the drug

MM is treated like cocaine or heroin by the federal government and users can be imprisoned by federal drug enforcement agents

Public Safety

The FDA process is thorough but it is impossible to fully prove that a drug is safe for use.

To monitor this the FDA has a monitoring system called MedWatch.

Prescribers are encouraged to voluntarily report any adverse effects by approved drugs.

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Recalls Action to remove a drug from the market

and are voluntary on the part of manufacturer Class I – strong likelihood that the product will

cause serious adverse effects or death Class II – product may cause temporary but

reversible adverse effects, little likelihood of serious adverse effect

Class III– the product is not likely to cause adverse effects

Law and the Technician

Federal law provides a foundation for state laws that govern pharmacy practice. These laws guarantee patient rights including

rights to privacy, confidentiality, right to file complaints, right for informed consent and the right to refuse treatment.

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Law and the Technician State Law is responsible for licensing all

prescribers and dispensers. Many states have stricter regulations than

federal law. A few states allow pharmacists to prescribe

under limited conditions.States regulate pharmacy technician by

holding the pharmacist responsible for the technicians performance.

Liability

Legal liability means you can be prosecuted for misconduct.

You can be guilty of misconduct by simply failing to do something you should have done.

You are liable even if you are directed to do something by your supervisor.Misconduct is called negligence

Liability

Ways the pharmacy tech can be negligent: Incorrectly labeling the prescriptionBreaking confidentialityFailing to recognize expired drugsCalculation errorsDispensing the wrong medication Incorrect handling of a controlled substance Inaccurate record keeping

Other standards

ASHP – American Society of Health- System Pharmacists

USP – United States Pharmacopeia JCAHO – Joint Commission on

Accreditation of Health Care Organizations ASCP – The American Society for

Consultant Pharmacists.

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Drug Regulation and Control