Investigational Use Drugs

Investigational Use Drugs: Investigational (research) use drugs are those compounds or mixtures which have not been released by the Federal Food and Drug Administration for general distribution and use. These drugs usually bear a caution: New drug-limited by Federal Law to investigational use.

You may read this related article:  Difference between Drug and Medicine

Principle Involved in Investigational Use of Drugs

The “Guidelines for the use of Investigational Drugs in Hospitals” was approved by the board of directors of the American Hospitals Association.

ASHP guidelines for the Investigational Use of Drugs in Institution:

  1) An institution that is the setting for investigational drug studies must assure that such studies contain adequate safeguards for itself, its staff, the scientific integrity of the study & specially the patient. In doing so they must have written policies and procedure.

 (2) All investigational drug studies must meet accepted ethical, legal & scientific standards and be conducted by appropriately qualified investigators and co-investigators.

(3) All patients participating in the investigation must freely consent, in writing to treatment with the drugs. This consent must be obtained by the authorized representative before treatment.

(4) The principal investigator is responsible for the proper maintenance of the case report forms & all other records required in the study by the drug sponsor, institution or FDA.

5) The institution’s drug control system must assure

     a) Proper packaging of the drug product.

     b) Proper labeling of the drug product.

     c) Sufficient supplies of the drugs

     d) Nurses must have sufficient information about their pharmacology

     e) Records of the amount of drug received from the sponsor & its disposition.

     f) Proper arrangement of patient’s drug administration should be prepared.

     d) Various statistical analysis method should available for the smooth investigation and   for reference.

Guidelines for Pharmacists

The pharmacist is the principal investigator and is responsible to the institution for control of the investigational use of drugs.

(1)   A copy of the IRB-approved research protocol should be kept in the pharmacy.

(2) Using protocol and information the pharmacy should prepare a data sheet which contain at the minimum--

      a)  Drug designation and synonyms

      b) Dosages form

      c) Strengths

      d) Dosage range

       e) Indications

      f) Expected T/U

      g) Untoward effect

      h) Contraindications

      i) Storage requirements

      j) Instructions for dosage preparation and administration

      k) Names and telephone no. of principal   investigator.

(3) The pharmacy should maintain an investigational Drug Inventory Record & drug supplies must be kept in the pharmacy.

(4) The dispensing of investigational drugs should be integrated with the rest of the drug distribution system.

(5) Patient education & monitoring of therapy are two important clinical functions.

(6) At the conclusion of the study the pharmacy should return all unused drugs to the principal investigator or sponsor.

(7) Pharmacy should prepare the annual or semiannual statistical summary of investigational drug use.

(8) Drug costs & other expenses associated with investigational drug studies should be properly allocated & reimbursed.

Classification of Investigational Use Drugs

Investigational used drugs are usually classified as the simple forms as follows—

Class A: it should contain investigational drugs that are in preliminary investigational stage. The use of these drugs are usually restricted to the principal investigator. Although there are two opinion; first is these drugs must be stocked and dispensed by the principal investigator. The second thought is it should be dispensed and stocked by the pharmacists in pharmacy. The latter opinion is more advantageous.

Class B: It should contains investigational use drugs that have passed preliminary research stage. Drugs of these groups are usually send by the principal investigator to the department of pharmacy with written prescription for further study under supervision of co-investigator.

Class C is limited to the drugs approved by USP, NF or passed by the FDA for commercial distribution. These drugs may be used in the hospitals or clinics if the physician complies. In that case the physician must take the written consent of the patients.

Class D drugs are preparations which have been accepted for use in the hospital & are listed in the hospital formulary.

Another simple classification of drugs into three categories

1)General: An FDA approved drug, recommended as essential for good patient care with well-established usage, once accepted, may be prescribed by the medical stuff of the hospitals.

(2) Conditional: Certain drugs may be approved for a conditional period of trial. In this case FDA committee wishes to evaluate the drug for a given period before final consideration, may be prescribed by all attending medical staff.

3) Investigational: These drugs are not approved by the FDA for use other than under controlled clinical settings must be approved by the Research Advisory committees. A protocol of any study involving drugs must be submitted to the pharmacy.

Control of Investigational Use Drugs: All investigational use drugs should be registered with the PTC. This may be accomplished by the principal investigator which provides the following information’s —

1. New drug no.                       10.Method of administration
2. Generic Name                     11. Antidote (if any)
3. Manufacturer                       12. T/U
4. Proprietary Name (if any)
5. Chemical Name
6. General Chemistry
7. Pharmacology
8. Toxicology
9. Dose range

The above data are usually found in the brochure prepared by the manufacturer and supplier to each investigator. Therefore the brochure may be sent to PTC with a letter indicating investigator’s intent to use such a product.

The above informations are putted in to a suitable format. These forms are usually titled as “Physician Data Sheet on Investigational Drugs”, “Nurses Data Sheet on Investigational Drugs” & “Pharmacist’s Data Sheet on Investigational Drugs”.

Identification of Investigational Use Drugs

Whenever class A or B drugs are dispensed from the pharmacy, they should be labeled in such a manner as to differentiate them from routine prescription drugs. In some hospitals, investigational use drugs are printed in red ink on white paper stock.

In addition to the commonly required label information of patient’s name, data, prescription no., doctor’s name & direction for use & a space for the research drug no. is provided. The prescription no. & research drug no. is used for identification of the investigational use drugs.

Role of Pharmacist in Clinical Evaluation of Investigational Use Drugs

After the demonstration about the safety and efficacy of a new drug from a pharmacologist through animal tests, clinical trials (Preliminary & Extended) usually proceed. Preliminary trials are done by the principal Investigator with great caution to a limited no. of patients & closely monitor the outcomes. After that stage the functions of pharmacist started.

1)   The pharmacist prepare a protocol for drug administration & double blind study. Such tests are devised by having the experimental drug and the placebo. The pharmacist maintain the record of administⁿ .Neither the patient and nor the physician is informed about the administration.  Through the close monitoring & assessment the pharmacist provide exact information’s regarding the new drug.

(2) The pharmacists can provide a valuable service to the drug researchers by formulating new dosage forms from the pure chemical. The pharmacist should insist upon the time necessary to develop a scientifically sound formulation as well as for the performance of chemical & bacteriological tests for potency and sterility.

 3) College of Pharmacy train up more and more clinical pharmacist in bio pharmaceutics, pharmacokinetics & in the use of modern instrumentation techniques of analysis. These trained pharmacists can monitor the blood & tissue levels of the new drugs as well as their excretion rates & thereby advise the clinical pharmacologist relative to the need for dosage adjustment, mode of administration or product formulation.