Investigational Use of Drugs in Hospital

Investigational Use of Drugs

Unless FDA approve a drugs then it can,t be distributed in to the wards.  Remember even in the phase 3 conditional approval can be given by FDA.  Investigational drug bear the statement:

Caution: New Drug- Limited by Federal Law to investigational use.

Investigational Use of drug:  are usually in phase 3 and Phase 4. It is applicable on new drug and quit possible it is done for already exist drugs (when some drug appear with new side effect). In 1900-60ties and 7ties drugs were on short clinical trials. Just like a drug thalidomide births effect without its proper clinical trials.  Then agencies came to the conclusion to have proper clinical trials.

They are released only to physicians who sign the proper federal food and drug release form for the manufacturer.   

Hospitals And Investigational use of drugs:

Why patient goes on trails?

•       Money
•        Terminally ill patient having no option just to treat.
•        Humanity involvement.

US Public Health Service policy Regarding Investigational use of the Drugs

The US public health service now require that the health, privacy, right and welfare must be protected before using the humans in a research and  their inform consent must be obtained.

Each hospital conducting investigational studies must have a pre-established committee on human Use in research.  Committee on human use in research is charge with responsibility to check all the aspect of human use in clinical and biomedical research including psychological research.  The processes and protocols that will be used in investigation must be checked for their safety, risk to benefit ratio when alternate is not available and appropriateness.  Appropriate written records should be maintained.

Committee have the authority to change the procedure and sensing any danger and thus concerning the chief or principle investigator.  

Guidelines for Pharmacist Regarding Investigational used of drugs :

•       A copy of the IRB –Approved research protocol should be kept in the pharmacy.
•        Using the protocol and additional information regarding the use of investigational drug must be prepared so which contain following information for nursing and medical staff. A) drug designation and some synonyms. B) dosage form(s). C ) usual dosage range. D) indications. E) expected therapeutic effect. F) Expected ADR or toxic effect. G) Expected contraindications. H) Storage requirements. I) Instructions for disposition of unused drugs. J) names and telephones numbers of principle authorities.
•       Investigational Drug are not allowed in wards storage and they should be only kept in pharmacy.
•       Drug for investigational use should be integrated with the rest of the drugs distribution system with respect to packaging, labeling, storage and other aspects except prescription and labels must be distinguishable by legend word investigational use only or investigational drugs.
•       Same like regular use of drugs patient must be educated and monitored for therapy.
•       At the conclusion or adjourning of the study pharmacy department must return all the drugs to principle investigator.
•       Statistical summary for investigational drug must be prepared. Including the number of drugs studied and related information.
•        Drug costs and other expenses associate with investigational drug studies and all expenses must be added for reimbursement.
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• ASHP Guidelines for the use of Investigational Drugs in Institutions
•      All the hospitals or clinical setups doing investigational studies must have a committee on Human use in clinical studies. And  it must be fully operative on it functions and obligations.
•        Investigational drug must be used only under the supervision of the principle investigator or authorized co-investigator who is from the staff of the hospital or institute.
•         Principle investigator is responsible for obtaining the written informed consent on the patient to participate in the study. And this consent must be approved by IRB.
•        Principle investigator is responsible for the maintenance of proper case reports.
•       Institution must have a strict and strong control regarding the various factors related with the investigational drugs.

Basic Principles Regarding the Investigational Use of the drugs

•       Institution running the investigational use of the drugs must assure the adequate safeguards for itself, its staff and scientific integrity of the study and to all the patient safety. For all of this institutions must have written policies and procedures.
•        All the Investigational studies must have ethical, legal and scientific standards.
•       A written informed consent must be taken form the patient or individuals taking part in the study or from their representatives. They must be informed about the objectives and the risks and benefits associated with the study drugs.

Some ethics from department doing trails?

Those hospitals who are performing trails should have a proper committee for smooth running of the trail

Ethics also involve to have proper protocol and consent form. Including Many more used in Biological and Medical Research.