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Geri Foster, DPh Compounding & Investigational Drug Pharmacist . July 20, 2001, Friday Johns Hopkins Death Brings Halt To U.S.- Financed Human Studies . Warning letter to Johns Hopkins. No IND submission Didn’t mention all risks in consent Failed to report adverse reactions

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slide1

Geri Foster, DPh

Compounding & Investigational Drug Pharmacist

slide2
July 20, 2001, Friday

Johns Hopkins Death Brings Halt To U.S.- Financed Human Studies

warning letter to johns hopkins
Warning letter to Johns Hopkins
  • No IND submission
  • Didn’t mention all risks in consent
  • Failed to report adverse reactions
  • Failed to update consents following adverse reactions.
warning letter to johns hopkins4
Warning letter to Johns Hopkins
  • Failed to disclose experimental use of drug.
  • Represented product as a medication and failed to disclose it as chemical grade intended only as lab use.
  • Failed to submit technical information, such as, source and purity of the drug substance.
warning letter to johns hopkins5
Warning letter to Johns Hopkins
  • Poor documentation
    • Undetermined amount of Sodium Bicarb added to second solution, no records
  • Changed the dosing conditions in protocol
    • delivery system
    • pH, osmolarity
    • rate of administration
  • Changed pre-medication
slide6

DEPARTMENT: INSTITUTIONAL REVIEW BOARD POLICY NUMBER: XI.A SECTION: Investigational Drugs, Biologics & Device REVIEW RESPONSIBILITIES:IRB Policy & Procedure Committee ORIGINAL CREATION DATE: February 04, 2002 REVISION DATES October 17, 2003

Subject: Storage, Handling, and Dispensing of Investigational Drugs, Agents, and/or Biologics in Clinical Trials

slide7
Definitions:1. Investigational Agents: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes products with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, products used for an unapproved indication, or products used to gain further information about an approved use.
slide8
2. Definitions:Investigational Drugs/Investigational Biologics (Test Articles):A new drug/agent or biologic that is used in a clinical investigation. The term investigational biologic also includes a biological product that is used in vitro for diagnostic purposes. Investigational drugs or biologics may include:
  • Products that are not generally recognized as being safe and effective for any use under the conditions prescribed, recommended, or suggested by the FDA; or
  • Products already approved by the FDA as safe and effective for specific indications that are being studied for new indications (or doses, strengths, or frequency).
slide9
3 Definitions:Investigational Drug Service (IDS): A division of the VUMC Pharmacy Department that provides support for clinical drug studies including Institutional Review Board consultation and dispensing services for investigational drugs, agents, or biologics. This division actively supports all Departments and Investigators involved in research.
slide10
4. Definitions:Joint Commission on Accreditation of Healthcare Organizations (JCAHO): A national accrediting body for hospitals and other health care delivery organizations.
policy
Policy

It is the policy of the Vanderbilt University Institutional Review Board that all investigational drugs, agents and/or biologics used in human subjects research be stored, handled, and dispensed in accordance with governing regulations and Institutional policy.

policy storage of investigational drugs agents or biologics
Policy: Storage of Investigational Drugs, Agents, or Biologics.

I.A. It is the responsibility of the Investigator to comply with all Institutional, State and Federal regulations in regards to storage of investigational drugs, agents, or biologics.

slide13
Policy:

1. B. Investigational drugs, agents, or biologics used in the context of research, may be stored in areas other than the IDS under the direct supervision of the Investigator and is in accordance with the sponsor, if applicable.

slide14
Policy:

I. C. Controlled substances may not be stored outside of the pharmacy department.

slide15
Policy:

I. D. Investigational agent storage facilities outside of the IDS must be in compliance with Institutional, State, Federal [Food and Drug Administration (FDA)], and Joint Commission on Accreditation of Hospital Organizations (JCAHO) requirements. Pharmacy monitoring may be incorporated into the IRB auditing process as needed to assure compliance.

ii dispensing of investigational drugs agents or biologics
II. Dispensing of Investigational Drugs, Agents, or Biologics.

II. A. All investigational drugs, agents, or biologics administered to inpatients should be dispensed through the IDS pharmacy. This includes all inpatient beds in the

Vanderbilt University Medical Center,

Clinical Research Center,

Stallworth Rehabilitation Hospital,

Psychiatric Hospital at Vanderbilt

slide17
II. B. If IDS is not utilized for the dispensing of investigational drugs, agents, or biologics, it is the responsibility of the Investigator to assure that dispensing is in accordance with all Institutional, State, Federal, and JCAHO requirements.
slide18
II. C. The Pharmacy must prepare and dispense controlled substances for all inpatients and outpatients.
slide19
II. D. Compounding of oral and intravenous drugs must be handled by the Pharmacy. The Pharmacy must prepare and dispense such medications for all inpatients and outpatients.
slide20
III. Investigations of issues related to the potential mishandling of investigational drugs, agents, or biologics will be conducted by the IDS and promptly reported to the IRB.
pharmacy irb ex offico members
Pharmacy IRB Ex-Offico Members
  • Phil Johnston: Asst. Director of Pharmacy
  • David DiPersio: Clinical Pharmacist

Critical Care Pharmacy

  • Debbie Harrell: Geriatric Pharmacist Specialist
vanderbilt university institutional review board pharmacy reviewer s comment form
Vanderbilt University Institutional Review BoardPharmacy Reviewer’s Comment Form
  • Name of Drug
  • Is it FDA Approved?
  • Is it being used for its approved indication?
  • IND# for this protocol
slide23
Are the doses within acceptable dosing limits?
  • Is the route of administration noted in the protocol?
  • Are the side effects of all agents listed adequately in the protocol?
  • Are other clinical considerations (pregnancy, dietary restrictions, or drug interaction potential) clearly addressed in the consent document?
  • Are the Investigator’s descriptions of handling, storage and dispensing adequate, if not using the IDS?
what regulations govern investigational drug policies
What regulations govern investigational drug policies?
  • Hospital policy (IRB)
  • ASHP (residency site)
  • JCAHO standards (Investigational agents)
  • Department of Health and Human Services through OHRP and FDA
  • USP/NF 795 & 797 (FDA enforced)
jcaho standards
JCAHO Standards

MM.7.40 Investigational medications are safely controlled and administered.

Specifying that when pharmacy services are provided, the pharmacy controls the storage, dispensing, labeling, and distribution of the investigational medication

why follow the usp nf chapter 797 standards
Why follow the USP/NF Chapter 797standards:
  • They may be adopted and enforced by State Boards
  • Surveyed by accreditation organizations (JCAHO).
  • Enforceable by the FDA
slide27
USP/NF Chapter 797
  • Sterile Products
  • Training and Competence
  • Compounding Environment
  • Labeling and Expiration Dating
  • Aseptic Technique
  • Product and Environmental Testing
  • QC procedures
  • What to do after the products are made and distributed
who must follow 797
Who must follow 797
  • The standards are applicable to health care institutions, pharmacies, physician practices and other facilities in which compounded sterile products (CSP) are prepared and stored.
    • Not applicable to sterile products prepared for immediate use.
slide29
Immediate Use means there is no intermediary step such as laying it down and waiting to give later- Daryl Rich Pharm.D JCAHO Surveyor
  • Practices that will fall under <797> using this definition:
    • Drawing up flu vaccine or immunizations into multiple syringes for later use
    • Anesthesiologists’ practice of drawing up all drugs into syringes at the beginning of the day
is this going to be your office attire
Is this going to be your office attire?
  • Booties or shoe covers
  • Occlusive hair cover
  • Mask
  • Gown
  • Gloves
investigational drug service personnel

Investigational Drug Service Personnel

Phil Johnston, Pharm.D.

Assistant Director of Pharmacy

Hope Campbell, Pharm.D., BCPS, Coordinator of IDS

Geri Foster, D.Ph.

Compounding Coordinator

Lori Choate, Certified Pharmacy Technician

Deborah Allen, Certified Pharmacy Technician

advantages of the ids
Advantages of the IDS
  • Investigators able to accommodate more protocols
  • Ensure use is limited to authorized prescribers
  • Ensures patient consent is obtained
  • Verification of protocol compliance
  • Available for monitoring visits and FDA audits
  • Guaranteed compliance with all applicable state, & federal regulations
advantages of the ids34
Advantages of the IDS
  • Patient specific labeling
  • Consistency in labeling
  • Randomization and blinding available
  • Patient counseling (if needed)
  • Complete and maintain drug related case report forms
  • Serve as the un-blinded participant
  • Order drugs and maintain proper storage
  • Secured drug storage/space
slide35

Advantages of the IDS

  • Placebos identical in appearance to product
  • Approved sources of products (C of A)
  • Formulas with sources/documentation/logs
  • Drug accountability documentation
  • Quality service
  • Timely delivery
inpatient studies the ids
Inpatient Studies & The IDS
  • Study medication is printed on patient MAR (medication administration record)
  • Drug interaction check specific to protocol
  • Drug exclusion check, specific to protocol
  • Protocol synopsis and nursing sheets on the chart
slide37
Pharmacy

Supported

Study

items needed from principal investigator to setup protocol
Items needed from Principal Investigator to setup Protocol
  • Protocol
  • Amendments
  • FDA 1572
  • IRB approval letter
  • Consent form copy
  • Drug Accountability forms (if sponsor provided)
  • Drug Label Pages (if sponsor provided)
  • Pharmacy Binder (if sponsor provided)
  • Investigator’s brochure (if sponsor provided)
  • Nursing Information Sheet
pharmacy commitments
Pharmacy Commitments
  • Budget
  • Drug
  • Horizon Expert Orders (Wiz)
  • HMM (Horizon Meds Manager)
  • Outpatient Prescription
  • Maintain Protocol Specific Binder
pharmacy binder
Pharmacy Binder
  • Enrollment Log/Randomization Log
  • Drug Accountability Record
  • Patient Worksheet
  • RX How-to
  • Mixing Instructions
  • Copy of Current Consent
  • Copy of Protocol
  • Correspondence
  • Current IRB Approval Letter
documentation and inventory control requirements
Documentation and Inventory Control Requirements
  • Date of dispensing
  • Patients name and or study number
  • Manufacturer’s lot number
  • Balance on hand
  • Retest or expiration date
pharmaceutical dispensing
Pharmaceutical dispensing
  • Dispensing Pharmacy
  • The physician’s name, telephone, and address
  • The words “CAUTION: New Drug Limited by Federal Law to Investigational Use”
  • Study title
  • Patient’s name or Study ID
  • Date
  • Drug name and strength & quantity dispensed
  • Complete directions for use
  • Storage Conditions/Expiration/Auxiliary Labels
storage facilities
Storage facilities
  • Locked
  • Restricted access
  • Investigational agents are kept separate from non study medications
  • Appropriate temperature monitoring
  • Maintain temperature logs
  • Alarms notify of malfunctions 24/7
slide53

Investigational Drug Service Department of Pharmaceutical Services

1161 21st Avenue South, VUH RM B-101 Nashville, TN 37232-7610

Phone: (615) 343-6537 Fax: (615) 322-6643

Investigational Drug Prescription

Ketamine Nasal Spray versus placebo to decrease narcotic usage

Principal Investigator: Pretend, MD

Co-Investigators: Geri Foster, DPh

Patient name:___________________ Date:________________

Rx :

Ketamine 25 mg/mL or Placebo

Treatment one: Date: ____/____/____

Treatment two: Date: ____/____/____

Deliver to GCRC S-3100 or E-507

____________________________________________________, M.D.

Patient meets study criteria and copy of informed consent signature page is attached.

slide56

Can either

  • Enroll Patient
  • View Information Sheet
slide63

Order for Investigational Agent

Study Authorization Order

why compound at vumc
Why compound at VUMC?
  • Quality patient care
  • Serve needs of specialty patients
    • Burn
    • Pediatrics
    • Trauma
    • Investigational Drug Service (30%)
  • Part of solution to healthcare problem
  • Compliance with regulations
    • USP 795 & 797
plan ahead for compounding
Plan Ahead for Compounding
  • Determine compounding costs
  • 21 day lead time minimum
  • Customize product for protocol
  • Plan one dose unit per patient visit
  • Project needs for 6 months
compounding team
Compounding Team
  • Geri Foster, Compounding Pharmacist
  • Deborah Allen, Lead Compounding Technician
  • Teresa Vo, Compounding Pharmacist
  • Josephine Guirguis, Eileen Cooper,Van Nguyen, Linda Phaneuf, Technicians
slide68
“Compounding means the preparation, mixing, assembling, packaging, or labeling of a drug or device (i) as the result of a practioner’s prescription drug order or initiative based on the pharmacist/patient/prescriber relationship in the course of professional practice, or (ii) for the purpose of, as an incident to research, teaching, or chemical analysis and not for sale or dispensing.  Compounding also includes the preparation of drugs and devices in anticipation of prescription drug orders based on routine, regularly observed patients.”
compounding
Compounding
  • Pharmaceutical compounding is subject to standards listed in United States Pharmacopoeia (USP) or National Formulary (NF), monograph if such monograph exists
  • If monographs do not exist then drug substance should be a component of drugs approved by the Secretary or are manufactured by an establishment registered to do so and certificates of analysis are available for each bulk component
types of compounding
Oral liquids

Capsules

Topicals

Ophthalmics

Otics

Inhalations

Injections

Types of Compounding
compounding attire
Compounding Attire

Compounding Attire

  • Gown
  • Gloves

Quality Assurance

  • Print Weights
  • Log sheets
  • Calibration
  • Double Checks
  • Weight Variance
sterile compounding
Sterile Compounding
  • Compounding attire
    • Hair cover
    • gloves
    • mask
    • gown
  • Quality assurance measures
    • Endotoxin testing
    • Sterility testing
    • Record keeping
    • Balance calibration
chemo prep area
Chemo Prep Area
  • Morphine
  • Bupivacaine
  • Brilliant Green
  • Terbutaline
  • Cocaine Eye Drops
  • Clonidine
  • Hydromorphone HCl
  • Tyramine
  • Yohimbine
  • Methacholine
  • Bradykinin
sterilization techniques
Sterilization Techniques
  • Dry heat oven
  • Filtration
  • Gas
  • Steam Autoclave
  • Sterrad

Future - Radiation

examples of errors to avoid
Examples of Errors to Avoid
  • Order sent before consent received
  • Consenting volunteer to more than one study
  • Wrong consent form signed – out of date, or wrong study
  • Administering meds not on consent form
  • Change practice before amendment approved
  • Dispense without appropriate labeling/container
  • Exceeding approved number of patients
  • Consent obtained by non-approved personnel
  • Inappropriate surrogate consent
  • Inappropriate destruction of study medications
ids pharmacy
VUH Room B101- 7610

Main Phone # 3-6537

Hope Campbell

Beeper 835-9066

Geri Foster

Beeper 835-1797

Lori Choate

Beeper 835-9067

Deborah Allen

Beeper 835-9068

IDS Pharmacy