NEWTON-WELLESLEY HOSPITAL
NEWTON, MASSACHUSETTS
EFFECTIVE DATE: POLICY TYPE: ADMIN
01/08/15 CLINICAL X
DEPARTMENTAL
INVESTIGATIONAL DRUG POLICY
PURPOSE: The purpose of this policy is to assist in protecting patients from potential harm and ensuring the rights of patients undergoing clinical trials with Investigational Drugs. The Pharmacy adheres to established professional codes for ethical behavior as required by the FDA and other regulatory agencies.
SCOPE: This policy applies to all Newton-Wellesley Hospital Clinical staff.
POLICY & PROCEDURE STATEMENT: Newton-Wellesley Hospital assures that the
Pharmacy is the designated place for the storage, control, labeling, and distribution of all investigational drugs. Any investigational drug brought into the hospital and not dispensed by Pharmacy is not to be used.
DEFINITIONS:
Clinical investigation: any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
Investigational Drug: a new drug or biological drug that is used in a Clinical Investigation [(21 CFR 312.3(b)].
Investigator: an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
PROCESS:
I. Study approval must be obtained from the Human Research & Investigational Committee, the Partners Human Research Committee, the Dana-Farber Institutional Review Board, or the National Cancer Institute Institutional Review Board prior to initiation of the study, except when the investigational drug is being used in an emergency use situation. (See Human Research Policy).
II. The Pharmacist will complete an "Investigational Drug Summary Form" supplied by the Pharmacy. (See Attachment 1.)
III. The Investigator is responsible for securing a signed informed consent form from the patient. This consent form must be a current stamped consent form that has been approved by the Human Research and Investigation Committee, the Partners Human Research Committee, the Dana Farber Institutional Review Board, or the National Cancer Institute Institutional Review Board.
IV. The investigational drug as well as a copy of the protocol for the use of the drug are to be stored in the Pharmacy.
V. These drugs will be properly labeled and dispensed from the Pharmacy only on receipt of an order written by the Investigator or his/her agent.
VI. A brief summary of important side effects, dosage and administration information will be dispensed with the drug. (See Investigational Drug Summary Form, a hard copy is in the Protocol Manual in the Pharmacy.)
VII. The Pharmacist will check to be sure that the order was written by the Investigator and/or his/her agent.
VIII. Pharmacy will dispense the medication only when the orders have been verified as being written by the Investigator or his/her agent.
IX. The following information is to appear on the label
A. The name and location of the patient
B. The number, name and dose of the drug
C. The name of the Investigator
D. A statement of the fact that the drug is an investigational agent: “Caution: New Drug – Limited by Federal (or United States) law to investigational use.”
X. Proper records are to be maintained for the study on the Investigational Report form (See hard copy sample attached in Protocol Manual in Pharmacy). For studies sponsored by the National Cancer Institute, the NCI Drug Accountability Form (DARF) will be used to record the receipt and disposition of all drugs.
A. Name, unit number and location of the patient
B. Name of the drug
C. Lot number(s) of the drug
D. Remaining inventories
E. Prescription/orders are to be placed in the "Investigational Order" file in the drug storage area
XI. Investigational drugs that are unusable (e.g., outdated, damaged) are returned or destroyed according to protocol-specific instructions. At the end of the study investigational drugs are returned or destroyed according to protocol-specific instructions.
XII. The Investigational Report form will be retained in the pharmacy for 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. At the time of termination of the study, all remaining investigational drug, shall be returned to the Sponsor.
XIII. In cases involving double blind studies, if directed by the study, the Pharmacy will maintain all codes and keys necessary.
XIV. For outpatient prescriptions a Pharmacist will affix a label to the drug container with the following information:
A. Prescription number
B. Patient name
C. Date
D. Quantity, name and strength of the drug
E. Complete and concise directions for use
F. Physician name
G. Auxiliary labels when necessary
H. A statement of the fact that the drug is an investigational agent: “Caution: New Drug – Limited by Federal (or United States) law to investigational use.”
I. Pharmacists initials
XV. Procedures for purposes of record keeping are the same as those outlined above.
XVI. The Physician must complete the “Use of Investigational Product when a Patient Enters a Second Institution” Form when a patient under his/her care is a subject in a research protocol at another institution and the physician plans to supervise the administration of the study drug(s) while the subject is a patient at Newton-Wellesley Hospital. Storage, Distribution, Labeling and Record Keeping for these Investigational Drugs are the same as those outlined above. (See Attachment 2.)
REFERENCE(S): American Society of Health-System Pharmacists. ASHP Guidelines for the use of Drugs in Clinical Research. Am J Health-Syst Pharm. 1998; 55:369-76
American Society of Hospital Pharmacists, ASHP Guidelines for Pharmaceutical Research in organized Healthcare Settings. Am J Hosp Pharm. 1991; 48:1781
Current Joint Commission Standards
21 CFR 312
ORIGINATOR(S): Pharmacy
ORIGINATION DATE: 08/95
SPONSOR: Director of Pharmacy
COLLABORATOR(S): Pharmacy; Nursing Education; Pharmacy and Therapeutics Committee; and Office of Research
REVIEWED: 12/06 REVISED: 05/16/00
04/04
02/05
12/06
02/10
11/11
11/14
CROSS-REFERENCES:
NWH/Admin: Human Research Policy
APPROVED BY:
Patient Services Executive Committee: 05/16/00, 02/28/05, 01/10/07, 03/10/10, 11/09/11
Clinical Policy and Procedure Committee: 12/04/14
Executive Committee of the Medical Staff: 03/01/05, 01/16/07, 03/16/10, 11/15/11, 12/16/14
CANCELLATION: This policy supersedes Pharmacy Policy III.40
KEY SEARCH WORDS: investigational, drug
ATTACHMENTS:
1. Investigational Drug Summary Form
2. Use of Investigational Product when Patient Enters a Second Institution Form
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