investigational use of drug by Mohd Rafiq.pptx

investigational use of drug by Mohd Rafiq.pptx

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  investigational use of drug. Name: Mohd Rafiq Class: B-Pharmacy 7th sem
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  Investigational use ofdrug • Introduction:- investigational drugs are those drugs or mixture or chemical which are not released and certified by the food and drug administration for the general use and sale for commercial concern. These drugs usually stand the statement on their labels as ‘caution: New Drug- limited by federal law to investigational use” they are released only to principle investigator who is the member of medical staff of hospital after obtaining consent by duly sign the food and drug release for the manufacture of respective investigational drugs. • Principle • Hospital are the primary centers for clinical investigational on drug. • Investigational drug should be used only under the direct supervision of the principle investigator who should be member of medical staff and who should assumed the burden of securing the necessary consent. • When nurses are called upon to administer investigational drug they should have available to them basic information concerning such drugs including dosage form strength available, action and uses, side effect and symptoms of toxicity etc.
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  Classification of investigationalnew drug Class A: • This class should contain all investigational use drugs which are under the preliminary experiment stage . • these drugs are restricted to use only by principle investigator. Class B: • This class of investigational drug has passed through preliminary experimental research stage. In this class the investigational drugs are supplied to pharmacy department by principle investigator and are only dispensed after obtaining of his written prescription which duly sign. Class C: • This class of investigational use of drug approved by the USP, NF, or passed by the federal FDA for use and sale as commercial concern. These drugs may be used only in hospital setup for their patient under the supervision of medical staff after fulfillment of specific procedure Class D: • These class of drug have been accepted for use in hospital and are listed in the hospital formulary.
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  Classification on thebasis of Pharmacy operation (a) General : An FDA approved drugs which as recommended as essential for good patient care with a well established usage once accepted may be prescribed by all members of attending and house staff. (b) Conditional: certain drugs may be approved for a conditional period of trail. A drug approved by FDA for general use but which the committee wishes to evaluate for given period before final consideration. May be prescribed by all member of the attending and house staff. (c) Investigational: Drug which are not approved by the FDA for use other then under controlled clinical setting must be approved by the Research advisory committee. A Protocol of any study involving drug must be submitted by the pharmacy.
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  Advisory committee andtheir responsibilities • In the view of drug which are used in the investigational purpose in the hospital are subjected to review by advisory committee which are nothing by the committee on the human use in research and pharmacy and therapeutic committee (PTC) in which the principle investigator should provide all the information related to investigational drug to the PTC and should letter for intention to use of investigational drug in patient. • It is the responsibilities of hospital and member of PTC to develop procedure and policies for holding of investigational drugs in the hospital for patient benefits.
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  Control of investigationaluse of drug • All investigational drug should be registered with the pharmacy and therapeutic committee. This may be accomplished bay a latter from the principle investigator, which provide the following information. 1. New drug name 2. Generic Name 3. Manufacturer 4. Chemical name 5. Proprietary Name 6. General chemistry 7. Pharmacology 8. Toxicology 9. Dose Range 10. Method of Administration 11. Antidote 12. Therapeutic uses
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  • In orderto control the use of investigational drugs many pharmacist have developed various forms which may be used to disseminate the above information on an investigational use drug to the various staff doctors and nurses. • The forms are usually titled. 1. Physician’s data sheet on investigational drug 2. Nurses data sheet on investigational drug 3. Pharmacist data sheet on investigational drug. 1.Physician’s data sheet 1) name of investigational drug 2) Manufacturer 3) Strength/ Dosage forms 4) Amount Received 5) Date received. 6) Control or Batch 7) Pharmacology and therapeutic properties, Dosage, Precaution. 8) Mode of Administration. 9) Signature of investigator
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  • Nurses Datasheet 1) Name of investigational drug 2) Manufacturer 3) Strength and form 4) Pharmacology and therapeutic properties, dosage, and precaution. 5) Mode of administration. 6) Signature of Nursing in charge. • Pharmacist data sheet.
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  • Authorization forTreatment with drug under clinical investigation. The law department of American medical association states that drug under clinical investigation should be administered only where. 1. The informed consent of the patient or his/her authorized representative has been obtained. 2. The Physician is convinced of the reasonable accessory of his diagnosis and, if necessary, has confirmed it by adequate consultation and 3. Existing method of treatment have proven unsatisfactory.
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  • Role ofPharmacist in clinical investigation of drug • During this stage the pharmacist can play an important role by assisting in the development of the protocol and the control of double blind test/study having the experimental drug or placebo prepared exactly the same dosage forms and presentation. Neither the present nor the doctor informed as to whether the placebo and the potent article . • Collecting, storing and distributing essential information concerning the drug being studied. • Packing and labeling investigational drug in multiple or unit dosage containers. • Preparing dosage forms • Dispensing of investigational drug to both inpatient or outpatient
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  • Advisory committeefor the investigational use of drug. 1. the pharmacy and therapeutic committee 2. FDA advisory committee system. 1) The pharmacy and therapeutic committee (PTC) • The PTC is a group of person which formulate policies regarding evaluation and therapeutic use of investigational drug. • The committee is composed of physician, Pharmacist and other health care professionals with the inclusion of medical staff. • It look after the safety in handling and administering the investigational drug. • It also play a vital role in monitoring adverse drug reaction. Every case of adverse drug reaction is first reported by the attending physician to the chairman of the PTC. • The PTC interact with the various government bodies like (DTAB) central drug institute (Lucknow) Drug controller central of India. AIMS (New Delhi) PGI Chandigarh for consultation of adverse drug reaction of investigational drug.
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  • FDA advisorycommittee system • FDA advisory committee provide technical assistance related to the development and evaluation of investigational drug. Biologics and medical device. • The primary role of FDA advisory committee is to provide independent expert scientific advice to the agency in its evaluation of investigational drug any stage of consideration by the agency. Thank you