1 the name of the ingredient or preparation 2 Structural formula, empirical formula, MW, chemical names, Chemical Abstracts Service (CAS) registry number 3 the definition; packaging, storage, 4 labeling requirements; 5 specifications

HPUS

Homeopathic Pharmacopeia of the US

Informally known as the Hatch-Waxman Act, is a 1984 US federal law which encourages the manufacture of generic drugs by the pharmaceutical industry. The Act provides some protection for drug innovators while facilitating and providing incentives for companies to file ANDAs. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)

Homeopathy is based on the law of similar; “like cures like” by who?

Samuel Hahnemann

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)

International Pharmacopeia/ Pharmacopeia Internationalis (1951)

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)

Provides additional guidelines for drug quality required by certain practitioners and agencies

International Pharmacopeia

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)

EP or Ph Eur

European Pharmacopeia

The Mexican pharmacopeia

Farmacopea de los Estados Unidos Mexicanos

Five Schedules for classification and control of drug substances that are subject for abuse:

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)

Part of the MERCOSUR Pharmacopoeia, comprising Argentina, Brazil, Paraguay, and Uruguay.

Brazilian Pharmacopeia (Farmacopeia Brasilieira)

Five Schedules for classification and control of drug substances that are subject for abuse:

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)

ISO

International Standardization Organization

Five Schedules for classification and control of drug substances that are subject for abuse:

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)

It is an international consortium of representative bodies constituted to develop and promote uniform or harmonized international standards.

ISO

Five Schedules for classification and control of drug substances that are subject for abuse:

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)

ISO standards used in the pharmaceutical industry are those in the series __ to __

ISO 9000 to ISO 9004. Standardization includes: QA, QC, QM

Five Schedules for classification and control of drug substances that are subject for abuse:

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)

First federal law in the United States designed to regulate drug products manufactured domestically

Food and Drug Act of 1906 drugs marketed interstate to comply with their claimed standards for strength, purity, and quality.

Prohibited false claims of therapeutic effects, declaring such products misbranded.

1912 Sherley Amendment

Sulfanilamide tragedy Additional Drug Standardization Agency Prohibits the distribution and use of any new drug or drug product without the prior filing of a New Drug Application (NDA) and approval of the FDA.

Federal FD&C Act of 1938

Established a legal distinction between prescription and over-the-counter (OTC) or nonprescription drugs. Prescription drugs must bear the symbol “Rx Only” or the legend “Caution: Federal Law Prohibits Dispensing Without Prescription.”

Durham-Humphrey Amendment of 1951

Ensure a greater degree of safety for approved drugs, and manufacturers were now required to prove a drug both safe and effective before it would be granted FDA approval for marketing

Kefauver-Harris Amendments of 1962

Five Schedules for classification and control of drug substances that are subject for abuse:

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA-Controlled Substances Act)

It is the strictest warning put in the labeling of prescription drugs or drug products by the FDA when there is reasonable evidence of an association of a serious hazard with the drug.

Black Box Warnings

Gives the FDA the authority to compile a list of currently marketed drugs. ___ each drug is assigned a unique and permanent drug code called ___

1 Drug Listing Act of 1972 2 National Drug Code (NDC)

Ten Characters that identify manufacturer or distributor, drug formulation, size and type of packaging

National Drug Code (NDC)

A law passed in the US to facilitate development of orphan drug. - “rare diseases and conditions”

Orphan Drug Act of 1983

Orphan Diseases

1 Huntington's disease, 2 myoclonus, 3 ALS, 4 Tourette syndrome and 5 muscular dystrophy which affect small numbers of individuals residing in the United States.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)

Most potential for abuse and dependence No medical qualities

Schedule I

High potential for abuse and dependence Some medicinal qualities

Schedule II

Moderate potential for abuse / dependence Acceptable medicinal qualities Doctor's prescription required

Schedule III

Low potential for abuse and dependence Acceptable medicinal qualities Prescription required - fewer refill regulations

Schedule IV

Lowest potential for abuse / dependence Acceptable medicinal qualities Prescription required - fewer refill regulations

Schedule V

Schedule I drugs

1 Heroin 2 LSD 3 Marijuana 4 Ecstasy 5 Peyote

Schedule II drugs

1 Vicodin 2 Cocaine 3 Meth 4 Oxycontin 5 Adderall

Schedule III drugs

1 Tylenol with Codeine 2 Ketamine 3 Steroids 4 Testosterone

Schedule IV drugs

1 Xanax 2 Darvon 3 Valium 4 Ativan 5 Ambien 6 Tramadol

Schedule V drugs

1 Robitussin AC 2 Lomotil 3 Motofen 4 Lyrica

Controlled studies demonstrate no risk

Category A

No evidence of risks in humans

Category B

Risk cannot be ruled out

Category C

Potential evidence of risk

Category D

Contraindicated in pregnancy

Category X

Use of various herbs and dietary supplements and addressed the need to regulate the labeling claims made for these product a disclaimer must appear on the product: “This product is not intended to diagnose, treat, cure, or prevent any disease.”

Dietary Supplement Health and Education Act of 1994 and the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006

It is a voluntary action taken by a company at any time to remove a defective drug product from the market.

Drug Product Recall

Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions

MedWatch (Drug Product Recall)

Contemporary Role of Pharmacists

1 Community pharmacies 2 Patient care institutions 3 Managed care 4 Home health care 5 Military and government services 6 Academic settings 7 Professional associations 8 Pharmaceutical research 9 Manufacturing industry

A component of pharmacy practice which entails the direct interaction of the pharmacist with the patient for the purpose of caring for that patient’s drug-related needs. It is the direct responsible provision of medication-related care for the purpose of achieving definite outcomes that improve a patient’s quality of life. -ASHP

Pharmaceutical Care

A patient-centered, outcomes-oriented pharmacy practice that requires the pharmacist to work in concert with the patient and the patient's other healthcare providers to promote health, to prevent disease, and to assess, monitor, initiate, and modify medication use to assure that drug therapy regimens are safe and effective.

Pharmaceutical Care- APhA, 1996

Pharmacy Practice Standards

1 General management and administration of pharmacy 2 Processing the prescription 3 Patient care functions 4 Education of health care professionals and patients

Pharmacist Code of Ethics

I. A pharmacist respects the covenantal relationship between the patient and pharmacist II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner III. A pharmacist respects the autonomy and dignity of each patient IV. A pharmacist acts with honesty and integrity in professional relationships. V. A pharmacist maintains professional compétence VI. A pharmacist respects the values and abilities of colleagues and other health professionals. VII. A pharmacist serves individual, community, and societal needs VIII. A pharmacist seeks justice in the distribution of health resources.

Methods of Drug Discovery

1 Random Screening 2 Molecular manipulation 3 Molecular designing 4 Drug metabolites 5 Serendipity

Testing of synthetic organic compounds for biologic activity

Random Screening

Chemical alteration of previously characterized organic compound to enhance its usefulness.

Molecular manipulation

To design a drug that interferes specifically with known or suspected biochemical pathway or mechanism of disease process.

Molecular designing

For Prodrugs

Drug metabolites ex. Enalaprilat as metabolite of enalapril

By good chance

Serendipity