Good Clinical PracticesRegulatory Guidelines for the Conduct of Clinical research

Introduction to

Research Pharmacy Services

Javier Palacios, R.Ph.

Sponsored by the Research Committeeof the Medical Dental Staff at UHS

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Learning Objectives

Define Good Clinical Practice and

Explain GCP guidelines in handling of drugs.

Understand role and services of UHS Research Pharmacy Department.

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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.

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Drug HandlingMust 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

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Investigational DrugHandling Policy at UH

Studies at UH Investigational drugs will be managed by the

Research Pharmacy DepartmentStudies 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.

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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

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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

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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.

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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

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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