Transcript Good Clinical Practices Regulatory Guidelines for the

Good Clinical Practices
Regulatory Guidelines for the Conduct of
Clinical research
Introduction to
Research Pharmacy Services
Javier Palacios, R.Ph.
Sponsored by the Research Committee
of the Medical Dental Staff at UHS
Learning Objectives

Define Good Clinical Practice and

Explain GCP guidelines in handling of drugs.

Understand role and services of UHS
Research Pharmacy Department.
2
Good Clinical Practice


GCP international ethical and scientific
quality standard for designing, conducting,
recording, and reporting trials that involve
human subjects
Compliance with GCP assures that the rights,
safety, and well-being of trial subjects are
protected and that the clinical trial data are
credible.
3
Drug Handling
Must comply with GCP


Secure, locked storage limited access.
Dispensing and product labeling



Compliant with State and Federal requirements
Storage temperature monitoring with proper
record keeping
Accountability

proper records
4
Investigational Drug
Handling Policy at UH

Studies at UH


Investigational drugs will be managed by the
Research Pharmacy Department
Studies outside of UH

Managed by Investigator


If patients are admitted into UH the Study medications
will be brought to the Research Pharmacy for proper
labeling.
A Patient Consent Form and Drug Information Sheet
will be provided by the investigator or research
coordinator and placed in the patient’s chart.
5
Research Pharmacy:
Services






7 day, 24 hour coverage
Receive, ship, pack
Dispense to patients, Investigators, Research
coordinators and nursing staff.
Deliver drugs to inpatients
Inventory, destroy, handle patient drug returns,
interact with monitors, regulators, sponsors,
investigators, coordinators
Provide Drug Information
6
UH Research Pharmacy:
Services

Services




Inpatient and outpatient dispensing of research medication
(IV and oral)
Formulation work, preparation of novel sterile IV products,
capsules and tablets.
Drug distribution center for multi-center drug studies.
(Start Center and VA Hospital)
Clients



All hospital divisions and departments
Drug companies
University Health Science Center
7
UH Research Pharmacy:
Dispensing Location

UH Inpatient Pharmacy, 1st floor,
across A service elevators
Javier V. Palacios, R.Ph;
Michael J. Andersen, R.Ph; Bryan Davis, RPh.
8
Routine FDA Inspection Findings

Most Common Deficiencies


Consent form problems
Protocol non-adherence




Infusion time incorrect
Administration time not within dosing window
Drug accountability problems
No drug administration records to document
9
UH Research Pharmacy:
Final Comments



Contact the Research Pharmacy when
looking for a study medication dose.
Use only medications which are labeled for
study. Do not use medications from other
sources such as the Pyxis
Contact the Research Pharmacy with any
questions concerning the investigational drug
and its handling
10