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103.19a Organization Policy on Drug Use and Control in Clinical Investigations

August 2010

Definitions:

Dispensing Drugs:  Drug dispensing occurs when a supply of drug that is not patient-specific or that requires manipulation (counting, mixing, preparing, lyophilizing, etc.) is given to a specific patient.  By law, dispensing may only be done by a pharmacist, physician, nurse practitioner, podiatrist, or dentist.  Examples of dispensing drugs include:

(a)    selecting a quantity of drug from a general bulk supply and placing it in another container for a patient; and

(b)   reconstituting a drug with a quantity of water before giving it to the patient.

Distributing Drugs:  A drug is distributed when it is given to the patient in a pre-labeled container with specific patient identification (patient's name or patient- specific identification code), and does not require manipulation (counting, mixing, preparing, etc.) before giving it to the patient. Drugs may only be distributed upon the order of an authorized prescriber and should be distributed only by a nurse, physician assistant or other personnel trained to do so by the Principal Investigator (PI).

DUCI (Drug Used in a Clinical Investigation):  Any drug, biological, botanical, or other substance used specifically for a clinical investigation as described in the investigational protocol.  Such drugs shall be either commercially available or not commercially available and used according to, or outside of, the FDA-approved indications.

IDS pharmacist:  Refers to a pharmacist in Investigational Drug Services (IDS) at JHM.

Investigational Drug:  Any drug, or biological product for which the FDA accepts an Investigational New Drug (IND) application and is used in a clinical investigation.  It also includes a biological product that is used in vitro for diagnostic purposes.  The terms “investigational drug” and “investigational new drug” are deemed synonymous.

Pharmacy:  Refers to a pharmacy controlled by Johns Hopkins Medicine (JHM).

General:

All clinical research conducted by full-time faculty members of The Johns Hopkins University (JHU) shall be reviewed by an IRB as specified by the reciprocity agreement dated July 12, 2002.  Clinical research conducted by part-time faculty members of JHU School of Medicine (SOM) are obliged to obtain JHM IRB approval of all human subjects activities conducted under the auspices of their Hopkins' appointment, by which is meant use of Hopkins' personnel or space or the use of the faculty appointment in correspondence, agreements with sponsors, etc.  JHU School of Medicine part-time faculty should consult the "Blue Book" for further clarification. This requirement applies also to faculty from non-JHU SOM and hospital campuses (such as JHU School of Nursing, JHU Homewood campus, and JH Applied Physics Lab).

The Pharmacy and Therapeutics Committee Members of the JHM and Bloomberg School of Public Health (BSPH) Institutional Review Boards (IRB):

  1. The membership of all JHM and BSPH IRBs reviewing research applications involving a DUCI will include at least one member who serves jointly on the IRB and either the site-specific P&T Committee or Investigational Drug Service (IDS) [“P&T/IDS IRB member’].
  2. All applications reviewed by a JHM or BSPH IRB involving the clinical use of DUCIs require approval by an IRB.  The P&T/IDS IRB member shall review the DUCI associated drug issues either:

(a) prior to the IRB meeting and have the review incorporated into the IRB review process; or
(b) at the convened IRB meeting.  

The review process conducted by the P&T/IDS IRB member must include specific IRB issues related to the following:

(a) drug safety;
(b) drug management;
(c) study design;
(d) IND status;
(e) IDDS review for INDs;
(f) informed consent documents; and
(g) any other relevant material.

3.    The IRB will be responsible for reviewing in accord with the Organization policy 103.6(b), unanticipated problems involves risk, which may include adverse drug events that occur during a clinical investigation.

Selection Process and Qualifications of the P&T/IDS IRB member on a JHM IRB

P&T Committee members, or IDS members, selected to serve as the P&T/IDS member shall be appointed by the Institutional Official in accord with Organization Policy No. 107.1.  The Institutional Official shall consult with the Chair of the site-specific P&T Committee/IDS to identify individuals who may be appointed as an IRB member, but IO has the final appointment authority.

Selection of candidates for P&T/IDS members shall include in the evaluation:

  1. expertise in the concepts of pharmacology and study design (as may be indicated by the attainment of relevant academic degrees or by specific training); or clinical investigation experience; or at least two years of IDS activity:
  2. commitment to attendance at 80% or more of convened IRB meetings; and
  3. demonstrated ability to effectively communicate and to think clearly regarding medication-related issues.

P&T/IDS IRB Member Approval of Studies Involving Devices

Device studies that do not contain a DUCI do not require review and approval by the P&T/IDS IRB member.

In cases where a device study includes a DUCI, the study must be approved per paragraph 2 above. In such cases of review of a device study that includes a DUCI, the P&T/IDS IRB member will base approval on the appropriateness of use involving the drug(s) and not on the use of the device per se.

Appointment Process for P&T/IDS Member on the Bloomberg School of Public Health IRB

IRBs of Bloomberg School of Public Health (BSPH) that review research involving a DUCI should have a P&T/IDS member appointed in accord with BSPH policy and in consultation with the Chair of the JHH P&T Committee. BSPH policy will determine  requirements for P&T/IDS IRB member review

Reports of the P&T/IDS IRB Member to the P&T Committee

The P&T/IDS IRB members are fully accountable and responsible to their respective organization P&T Committees. An appropriate mechanism for reporting liaison activities to the P&T Committee must be established by each P&T Committee.

Storage, Control, Preparation and Dispensing of Drugs Used in Clinical Trials

Inpatient Studies:

  1. INDs:  The pharmacy shall store, control, prepare, and dispense all investigational drugs and all study specific drug inventory supplied by a study sponsor.  Exceptions may be granted by the P&T/IDS IRB member (see below).
  1. Non-INDs:  For DUCIs that are not investigational drugs or study specific inventory supplied by a sponsor, the pharmacy may be required to control and dispense the medication if the P&T/IDS IRB member believes this to be appropriate.

Outpatient Studies:

All outpatient DUCIs requiring manipulation (e.g., mixing, formulating, counting, compounding, etc.) shall be stored, controlled, prepared and dispensed by the pharmacy unless an exception is granted by the P&T/IDS IRB member (see below).

In situations where the investigator wishes to store, control, or dispense their own DUCI the investigator must describe, at the time of application submission, their procedures for performing these functions. In situations where the investigator may want to control dispensing of a DUCI, such as when a medication needs to be dispensed urgently or the study is conducted at a distant geographic site, both the P&T/IDS IRB member and the IRB must approve this arrangement.

The Investigational Drug Data Sheet (IDDS)

An Investigational Drug Data Sheet shall be completed for all investigational new drugs and for any study specific drugs that the pharmacy may be required to control and dispense.  The purpose of the IDDS is to provide sufficient information to allow the investigational drug to be dispensed and administered safely. 

Completed IDDS shall be reviewed by a P&T/IDS IRB member as part of the application review process. 

Clinicians administering an investigational new drug shall be familiar with the contents of the IDDS prior to drug administration.  The IDDS shall be placed into every study patient's paper medical record.  It is not possible to upload a document into the EPR system and this requirement does not apply to EPR.  It is the responsibility of the PI to assure that the most current version of the IDDS is placed into the inpatient paper chart of study subjects.

Authorization to Prescribe an Investigational Drug

PIs shall identify those individuals authorized to prescribe investigational drugs used in their study. For each investigational drug, a IDDS shall be completed and shall indicate those authorized to prescribe the investigational drug or indicate the location of a current list of those authorized to prescribe. 

Anyone who dispenses or administers an investigational drug shall verify that the prescriber is authorized to do so prior to dispensing or administering the drug.

Principal Investigator Auditing

In situations where an investigator has been approved to control a DUCI at a JHH, JHBMC, Howard County General Hospital, or JHU SOM facility, an IDS pharmacist shall audit the storage, control, preparation and dispensing of the investigational drug to assure that all regulatory and hospital requirements are met. 

For studies based at a JHH, JHBMC, Howard County General Hospital, or JHU SOM facility where DUCIs are controlled by the PI, audits of studies shall be conducted (a) prior to the study beginning, (b) within 1 month of the beginning of patient accrual, (c) within one month of each yearly renewal, and (d) upon termination of the study. If unsatisfactory audit findings are discovered which cannot be resolved during the audit, additional audits shall be scheduled until the identified problem(s) is resolved. Audit results should be forwarded to the IRB. 

When a PI receives a study audit report from a regulatory agency or from a study sponsor (or agent of the sponsor), the PI must provide a copy of the report to the IRB within 5 working days. 

 When a PI receives a notice that the FDA wishes to audit/inspect study records, the IRB must be notified before the inspection visit occurs.

Pharmacy Quality Control

In situations where Hopkins pharmacy controls a DUCI, an IDS pharmacist will perform monthly quality control of the procedures use by the pharmacy. A pharmacist, who is not directly involved with dispensing the DUCI(s) in question, will perform quality control. These audits will use criteria defined in Appendix B.

Communication of Audit Findings

Audit findings shall be reported at least quarterly to the IRB Chairs, to P&T Committee chairs, and to P&T/IDS IRB members.

Funding

The PI has fundamental responsibility to secure funding for clinical investigation. Resource assessment and indemnification issues affecting the viability of each clinical investigation involving DUCIs will not be the responsibility of the P&T/IDS IRB member.


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