Investigational use drugs

Definition Research or investigational use drugs are those compounds, which have not been released by the federal food and drug administration for general distribution and use

Caution New drug limited by federal law to investigational use Released to those physician, who sign proper federal food and drug release form for the manufacturer

Us public health service policy Each hospital establish a committee on human use in research Risk and potential medical benefits of the investigation Rights and welfare of individuals involved Informed consent

 FDA amendments of 1966 BASIC PRINCIPLE ASHP guidelines for the use of

investigational drugs Policies and procedure for the safe use of drugs

 Institution must assure studies contain

proper safeguard for itself, its staff and specialty for patient Written policies and procedures for approval Management and control of investigational drug studies

 Staff informed about these policies and

procedure Ethical ,legal and scientific standards, conducted by qualified investigators Patient who participate in investigational drug studies must freely consent in writing ,treatment with drug

Guidelines for institution

Committee on human investigations Clinical research committee Investigational drugs must be used under
supervision of principal investigators Principal investigators responsible for written, informed consent of patient to participate in study Proper maintained of case report form

 Institute drug control systems must

contain the following elements Packed with applicable standards Completely and correctly labeled Written information about their pharmacology, storage requirement, method of dose preparation, precautions

 Bulk supplies of drug must be properly

stored Records of amount of drug received from sponsor Institution records on investigation drug studies should be designed

Guidelines for pharmacist

Pharmacist , institution and principal
investigator, responsible for control of investigational drug Copy of research protocol should be kept in pharmacy

 Investigational drug data sheet provide

information Drug designation dosage form strength Strength Dosage schedule Route of administration indication

storage requirement Instruction for dosage preparation Instructions for disposition of unused dose Name and cell num of investigators Investigational drug kept in pharmacy Patient education and monitoring of therapy At conclusion of study ,pharmacy should return and unused drugs to principal investigator

Classification of drugs
Establish drug classification Centralize information about concerning

drugs Availability of such drug to staff members stocking and dispensing unit within the hospital

 PTC responsible for establish drug

classification system Classification divide into four classes Class A CLASS A contain all investigational use drug that are in preliminary experimental stage Two school of thought

 Stocked and dispensed by principal investigator Stored and dispensed through pharmacy by

pharmacist Class B Consist of investigational drug which passed through preliminary research stage, drug supply to pharmacy by principal investigator

 Class C Limited to drug approved by Usp, NF, or

FDA for commercial distribution CLASS D Drug are prepared which have been accepted for use in hospital and listed in hospital formulary

Control of investigational use drug

Registered with PTC Information about New drug number Generic name Manufacturer General chemistry Toxicology pharmacology

Dose range Method of administration Therapeutic uses Above data are usually found in brochure prepared by manufacturer and supplied to each investigator Pharmacist develop form information about investigational drug to doctors and nurses

 Form title, physician data sheet on

investigational drugs, nurses data sheet, pharmacist data sheet on investigational drug New drug report form provide all data required for proper handing of investigational use drug by physician, pharmacist, and nurses This form placed on each pavilion, for any investigator

Role of pharmacist in clinical evaluation of drug

Pharmacologist Animal test Clinical trials proceed into two step Preliminary Extended Drug efficacy

New dosage form Potency Clinical evaluation of new drug product Biopharmaceutics Pharmacokinetics Dosage adjustment