Geri Foster, DPh Compounding & Investigational Drug Pharmacist

Geri Foster, DPhGeri Foster, DPh

Compounding &Compounding & Investigational Drug Pharmacist Investigational Drug Pharmacist

July 20, 2001, Friday July 20, 2001, Friday

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

http://www.nytimes.com/

Warning letter to Johns HopkinsWarning letter to Johns Hopkins

No INDNo IND submission submission

Didn’t Didn’t mentionmention all risks in consent all risks in consent

Failed to Failed to reportreport adverse reactions adverse reactions

Failed to Failed to updateupdate consents following consents following adverse reactions.adverse reactions.


Failed to discloseFailed to disclose experimental use of experimental use of drug.drug.

Represented product as a medication and Represented product as a medication and failed to disclosefailed to disclose it as chemical grade it as chemical grade intended only as lab use.intended only as lab use.

Failed to submitFailed to submit technical information, technical information, such as, source and purity of the drug such as, source and purity of the drug substance.substance.


Poor documentation Poor documentation Undetermined amount of Sodium Bicarb Undetermined amount of Sodium Bicarb

added to second solution, no records added to second solution, no records

Changed the dosing conditions in protocolChanged the dosing conditions in protocol delivery system delivery system pH, osmolaritypH, osmolarity rate of administration rate of administration

Changed pre-medicationChanged pre-medication

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

Definitions:Definitions:1. 1. Investigational AgentsInvestigational Agents:: A A pharmaceutical form of an pharmaceutical form of an active active ingredient or placeboingredient or placebo being tested or used being tested or used as a reference in a clinical trial. This as a reference in a clinical trial. This includes products with includes products with a marketing a marketing authorizationauthorization when when used or assembledused or assembled (formulated or packaged) in a way (formulated or packaged) in a way different from the approved formdifferent from the approved form, products , products used for an used for an unapproved indicationunapproved indication, or , or products used to products used to gain further informationgain further information about an approved use.about an approved use.

2. 2. Definitions:Definitions:Investigational Drugs/Investigational Investigational Drugs/Investigational Biologics (Test Articles)Biologics (Test Articles):: A A new drug/agent or new drug/agent or biologicbiologic that is used in a clinical investigation. that is used in a clinical investigation. The term investigational biologic also includes a The term investigational biologic also includes a biological product that is used biological product that is used in vitroin vitro for for diagnostic purposes. Investigational drugs or diagnostic purposes. Investigational drugs or biologics may include: biologics may include:

a.a. Products that are Products that are not generally recognized as not generally recognized as being safe and effective for any usebeing safe and effective for any use under the under the conditions prescribed, recommended, or conditions prescribed, recommended, or suggested by the FDA; or suggested by the FDA; or

b.b. Products Products already approved by the FDAalready approved by the FDA as safe as safe and effective for specific indications that are and effective for specific indications that are being studied for new indications (or doses, being studied for new indications (or doses, strengths, or frequency). strengths, or frequency).

3 3 Definitions:Definitions:Investigational Drug Service (IDSInvestigational Drug Service (IDS)):: A division of the VUMC Pharmacy A division of the VUMC Pharmacy Department that provides support for Department that provides support for clinical drug studies including clinical drug studies including Institutional Review Board Institutional Review Board consultation and dispensing services consultation and dispensing services for investigational drugs, agents, or for investigational drugs, agents, or biologics. This division actively biologics. This division actively supports all Departments and supports all Departments and Investigators involved in research. Investigators involved in research.

4. 4. Definitions:Definitions:Joint Commission on Accreditation of Joint Commission on Accreditation of Healthcare Organizations (JCAHO)Healthcare Organizations (JCAHO):: A A national accrediting body for hospitals and national accrediting body for hospitals and other health care delivery organizations. other health care delivery organizations.

PolicyPolicyIt is the policy of the Vanderbilt It is the policy of the Vanderbilt

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

Policy:Policy: Storage of Investigational Storage of Investigational Drugs, Agents, or Biologics.Drugs, Agents, or Biologics.

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

Policy:Policy: 11. B. Investigational drugs, agents, . B. Investigational drugs, agents,

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

Policy:Policy:

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

pharmacy departmentpharmacy department. .

Policy:Policy: I. D. I. D. Investigational agent storage facilities Investigational agent storage facilities

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

II. Dispensing of Investigational II. Dispensing of Investigational Drugs, Agents, or Biologics.Drugs, Agents, or Biologics.

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

Vanderbilt University Medical Center, Vanderbilt University Medical Center, Clinical Research Center, Clinical Research Center, Stallworth Rehabilitation Hospital, Stallworth Rehabilitation Hospital, Psychiatric Hospital at VanderbiltPsychiatric Hospital at Vanderbilt

II. B. II. B. If IDS is not utilized for the If IDS is not utilized for the dispensing of investigational dispensing of investigational drugs, agents, or biologics, it is drugs, agents, or biologics, it is the responsibility of the the responsibility of the Investigator to assure that Investigator to assure that dispensing is in accordance dispensing is in accordance with all Institutional, State, with all Institutional, State, Federal, and JCAHO Federal, and JCAHO requirements. requirements.

II. C. II. C. The Pharmacy must The Pharmacy must prepare and dispense prepare and dispense controlled substances for all controlled substances for all

inpatients and outpatients.inpatients and outpatients.

II. D. II. D. Compounding of oral and Compounding of oral and intravenous drugs must be intravenous drugs must be handled by the Pharmacy. The handled by the Pharmacy. The Pharmacy must prepare and Pharmacy must prepare and dispense such medications for dispense such medications for

all inpatients and outpatients.all inpatients and outpatients.

III. III. Investigations of issues Investigations of issues related to the potential related to the potential mishandling of investigational mishandling of investigational drugs, agents, or biologics will drugs, agents, or biologics will be conducted by the IDS and be conducted by the IDS and promptly reported to the IRB.promptly reported to the IRB.

Pharmacy IRB Ex-Offico MembersPharmacy IRB Ex-Offico Members

Phil Johnston: Asst. Director of Phil Johnston: Asst. Director of PharmacyPharmacy

David DiPersio: Clinical PharmacistDavid DiPersio: Clinical Pharmacist

Critical Care PharmacyCritical Care Pharmacy

Debbie Harrell: Geriatric Pharmacist Debbie Harrell: Geriatric Pharmacist SpecialistSpecialist

Vanderbilt University Institutional Vanderbilt University Institutional Review BoardReview Board

Pharmacy Reviewer’s Comment FormPharmacy Reviewer’s Comment Form

Name of DrugName of Drug

Is it FDA Approved?Is it FDA Approved?

Is it being used for its approved Is it being used for its approved indication?indication?

IND# for this protocolIND# for this protocol

Are the Are the dosesdoses within acceptable dosing limits? within acceptable dosing limits?

Is the Is the route of administrationroute of administration noted in the noted in the protocol? protocol?

Are the Are the side effectsside effects of all agents listed of all agents listed adequately in the protocol? adequately in the protocol?

Are other Are other clinical considerationsclinical considerations (pregnancy, (pregnancy, dietary restrictions, or drug interaction potential) dietary restrictions, or drug interaction potential) clearly addressed in the consent document? clearly addressed in the consent document?

Are the Investigator’s descriptions of Are the Investigator’s descriptions of handling, handling, storage and dispensingstorage and dispensing adequate, if not using adequate, if not using the IDS? the IDS?

What regulations govern What regulations govern investigational drug policies?investigational drug policies?

Hospital policy (IRB) Hospital policy (IRB)

ASHP (residency site)ASHP (residency site)

JCAHO standards (Investigational JCAHO standards (Investigational agents)agents)

Department of Health and Human Department of Health and Human Services through OHRP and FDAServices through OHRP and FDA

USP/NF 795 & 797 (FDA enforced)USP/NF 795 & 797 (FDA enforced)

JCAHO StandardsJCAHO Standards

MM.7.40 MM.7.40 Investigational medications are Investigational medications are safely controlled and administered.safely controlled and administered.

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

Why follow the USP/NF Why follow the USP/NF Chapter 797Chapter 797 standardsstandards::

They may be adopted and They may be adopted and enforced by State Boards enforced by State Boards

Surveyed by accreditation Surveyed by accreditation organizations (JCAHO).organizations (JCAHO).

Enforceable by the FDAEnforceable by the FDA

USP/NF Chapter 797USP/NF Chapter 797 Sterile ProductsSterile Products Training and CompetenceTraining and Competence Compounding EnvironmentCompounding Environment Labeling and Expiration Dating Labeling and Expiration Dating Aseptic TechniqueAseptic Technique Product and Environmental Product and Environmental

TestingTesting QC proceduresQC procedures What to do after the products What to do after the products

are made and distributedare made and distributed

Who must follow 797Who must follow 797

The standards are applicable to health The standards are applicable to health care institutions, pharmacies, physician care institutions, pharmacies, physician practices and other facilities in which practices and other facilities in which compounded sterile products (CSP) compounded sterile products (CSP) are prepared are prepared and storedand stored. . Not applicable to sterile products Not applicable to sterile products

prepared for immediate use.prepared for immediate use.

Immediate Use means there is no Immediate Use means there is no intermediary step such as laying it intermediary step such as laying it

down and waiting to give later- down and waiting to give later- Daryl Rich Daryl Rich

Pharm.D JCAHO SurveyorPharm.D JCAHO Surveyor

Practices that will fall under <797> using Practices that will fall under <797> using this definition:this definition:

Drawing up flu vaccine or Drawing up flu vaccine or immunizations into multiple syringes immunizations into multiple syringes for later use for later use

Anesthesiologists’ practice of drawing Anesthesiologists’ practice of drawing up all drugs into syringes at the up all drugs into syringes at the beginning of the day beginning of the day

Is this going to be your Is this going to be your office attire?office attire?

Booties orBooties or s shhoe coversoe covers

Occlusive hair Occlusive hair covercover

MaskMask GownGown GlovesGloves

Why use the Why use the Investigational Drug Service ?Investigational Drug Service ?

Investigational Drug Investigational Drug Service PersonnelService Personnel

Phil Johnston, Pharm.D.Phil Johnston, Pharm.D.

Assistant Director of PharmacyAssistant Director of Pharmacy

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

Geri Foster, D.Ph.Geri Foster, D.Ph.

Compounding CoordinatorCompounding Coordinator

Lori Choate, Certified Pharmacy TechnicianLori Choate, Certified Pharmacy Technician

Deborah Allen, Certified Pharmacy TechnicianDeborah Allen, Certified Pharmacy Technician

Advantages of the IDSAdvantages of the IDSInvestigators able to accommodate Investigators able to accommodate more protocolsmore protocolsEnsure use is limited to authorized Ensure use is limited to authorized prescribersprescribersEnsures patient consent is obtained Ensures patient consent is obtained Verification of protocol compliance Verification of protocol compliance Available for monitoring visits and FDA Available for monitoring visits and FDA auditsauditsGuaranteed compliance with all Guaranteed compliance with all applicable state, & federal regulationsapplicable state, & federal regulations

Advantages of the IDSAdvantages of the IDS

Patient specific labelingPatient specific labeling Consistency in labelingConsistency in labeling Randomization and blinding availableRandomization and blinding available Patient counseling (if needed) Patient counseling (if needed) Complete and maintain drug related Complete and maintain drug related case report formscase report formsServe as the un-blinded participantServe as the un-blinded participantOrder drugs and maintain proper Order drugs and maintain proper storage storage Secured drug storage/spaceSecured drug storage/space

Placebos identical in appearance to Placebos identical in appearance to productproduct

Approved sources of products (C of A)Approved sources of products (C of A)

Formulas with Formulas with sources/documentation/logssources/documentation/logs

Drug accountability documentationDrug accountability documentation

Quality service Quality service

Timely deliveryTimely delivery

Advantages of the IDSAdvantages of the IDS

Inpatient Studies & The IDSInpatient Studies & The IDS

Study medication is printed on patient Study medication is printed on patient MAR (medication administration record)MAR (medication administration record)

Drug interaction check specific to protocolDrug interaction check specific to protocol

Drug exclusion check, specific to protocolDrug exclusion check, specific to protocol

Protocol synopsis and nursing sheets on Protocol synopsis and nursing sheets on the chart the chart

PharmacyPharmacySupportedSupported

StudyStudy

Obtain a budgetObtain a budget

Principal Investigator: Pretend, MD Date: 5/25/2006

Sponsor Procter & Gamble

Protocol Number 555999

Yearly Cost $1,500.00

Yearly Fees

Investigator Initiated $ 500.00

Yearly Fees Score 6-10 $ 750.00

Yearly Fees Score 11-

15 $1,000.00

Yearly Fees Score 16-

20 $1,500.00

Estimated Number of Years 1

Yearly Cost Calculator

When will enrollment occur? Scale

Study Estimation

M-F, 7-5 1 1

M-Su, 7a-11p 2

365/24/7 3

Drug Storage Requirements?

Room Temperature 1

Refrigerated 2-8°C 2 2

Frozen -20°C 3

Frozen -70°C 4

Combination of

temperature ranges 5

How many drug products will be provided by sponsor to be stored?

1-2 drugs 1

3-4 drugs 2

Patient specific Kit 3 3

DEA Scheduled Drug 4

How will randomization occur?

Blinded Envelopes/Sequential

Enrollment 2

IVRS database or automated 4 4

Open Label 1

schedule created by pharmacy 3

Research occurs where?

Inpatient 4 4

Outpatient 2

Both 4

Sponsored or Nonsponsored Research?

Sponsor 2 2

Investigator Initiated 1

Total Poin

ts 16

Additional services provided under yearly fee cost

Protocol Review

Computer Files Creation

Pharmacy Procedure Establishment

Site Initiation Meeting

Site Startup Meeting

Monitoring Visits

Drug Storage

Continous Temperature Monitoring

Drug Disposal

Long Distance fax/phone charges

Dispensing Fee $ 50.00

Estimated Number of Dispenses per patient 1

Gene Therapy Preparations $ 100.00

Oral Medication outpatient dispensing/per medication $ 15.00

Compounded Prescription Dispensing fees $ 10.00

Oral Medication inpatient dispensing/dose $ 10.00

Preparation of Infusion single bag/day $ 50.00

Preparation of Infusion multiple bag/day $ 25.00

Preparation of HIV/Smallpox Vaccine $ 75.00

Preparation of SC or IM injections for outpatient use/dispense $ 30.00

Compounding Fees Quantity

Required

Placebo Capsule Compounding Fee $ 0.15 0

$ -

Active Drug Capsule Compounding Fee (0.15 + Cost of drug) $ 0.15 0

$ -

Compounded Sterile IV preparation per vial (15.00 + Cost of drug)

$ 15.00 0

$ -

Endotoxin (LAL) & Sterility Testing per IV batch compounded

$ 250.00 0

$ -

Total Compounding Costs

Number of estimated patients 25

Estimated Service Charges $1,500.00

Estimated Dispensing Fees $1,250.00

Estimated Compounding Fees $ -

Estimated Total Charge for study $2,750.00

Items needed from Principal Items needed from Principal Investigator to setup ProtocolInvestigator to setup Protocol

ProtocolProtocol

AmendmentsAmendments

FDA 1572FDA 1572

IRB approval letterIRB approval letter

Consent form copyConsent form copy

Drug Accountability forms (if sponsor provided)Drug Accountability forms (if sponsor provided)

Drug Label Pages (if sponsor provided)Drug Label Pages (if sponsor provided)

Pharmacy Binder (if sponsor provided)Pharmacy Binder (if sponsor provided)

Investigator’s brochure (if sponsor provided)Investigator’s brochure (if sponsor provided)

Nursing Information SheetNursing Information Sheet

Pharmacy CommitmentsPharmacy Commitments

BudgetBudget

DrugDrug

Horizon Expert Orders (Wiz)Horizon Expert Orders (Wiz)

HMM (Horizon Meds Manager)HMM (Horizon Meds Manager)

Outpatient PrescriptionOutpatient Prescription

Maintain Protocol Specific BinderMaintain Protocol Specific Binder

Pharmacy BinderPharmacy BinderEnrollment Log/Randomization LogEnrollment Log/Randomization Log

Drug Accountability RecordDrug Accountability Record

Patient WorksheetPatient Worksheet

RX How-toRX How-to

Mixing InstructionsMixing Instructions

Copy of Current Consent Copy of Current Consent

Copy of ProtocolCopy of Protocol

CorrespondenceCorrespondence

Current IRB Approval LetterCurrent IRB Approval Letter

Documentation and Inventory Documentation and Inventory Control RequirementsControl Requirements

Date of dispensingDate of dispensing Patients name and or study Patients name and or study

numbernumber Manufacturer’s lot numberManufacturer’s lot number Balance on handBalance on hand Retest or expiration dateRetest or expiration date

Pharmaceutical dispensingPharmaceutical dispensing Dispensing Pharmacy Dispensing Pharmacy The physician’s name, telephone, and addressThe physician’s name, telephone, and address The words “CAUTION: New Drug Limited by Federal The words “CAUTION: New Drug Limited by Federal

Law to Investigational Use”Law to Investigational Use” Study titleStudy title Patient’s name or Study IDPatient’s name or Study ID DateDate Drug name and strength & quantity dispensedDrug name and strength & quantity dispensed Complete directions for use Complete directions for use Storage Conditions/Expiration/Auxiliary LabelsStorage Conditions/Expiration/Auxiliary Labels

Storage facilitiesStorage facilities

Locked Locked

Restricted accessRestricted access

Investigational agents are kept Investigational agents are kept separate from non study medicationsseparate from non study medications

Appropriate temperature monitoringAppropriate temperature monitoring

Maintain temperature logsMaintain temperature logs

Alarms notify of malfunctions 24/7Alarms notify of malfunctions 24/7

Investigational Drug Service Department of Pharmaceutical Services

1161 21st Avenue South, VUH RM B-101 Nashville, TN 37232-7610Phone: (615) 343-6537 Fax: (615) 322-6643

Investigational Drug PrescriptionKetamine Nasal Spray versus placebo to decrease narcotic usage

Principal Investigator: Pretend, MDCo-Investigators: Geri Foster, DPhPatient 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.

Department of Pharmaceutical Services Investigational Drug Service

1161 21st Avenue South, VUH Rm B-101, Nashville, Tn 37232-7610 Phone: (615) 343-6537 Fax: (615) 322-6643

Investigational Drug Accountability Record

Name of Institution

Investigator of Record Sponsor:

Vanderbilt University Medical Center Pretend, MD Pfizer

IRB # Drug Name/Strength/Dosage Form: Storage Location:

049996 Ketamine Nasal Spray 25 mg/ml IDS Ref Shelf

Package Size: Storage Temp/Form Lot Number Expiration Date:

30 ml vial 2-8C

Quantity

Line Date Patient Patient Dispensed BalanceDispens

ed Comments

# mm/dd/yy Initials Number or 6 x 30 mL by:

Received Balance

1

2

Department of Pharmaceutical Services Investigational Drug Service

1161 21st Avenue South, VUH Rm B-101, Nashville, Tn 37232-7610

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

Pharmacy Enrollment Log

Sponsor Protocol # Investigator

GCRC IRB # 032229 Pretend, MD

Patient Patient Name Date Received

Number Enrolled Consent Orderby:

Ketamine

Placebo

Can either1. Enroll Patient2. View Information Sheet

Can Print Document

Return To Previous Screen

Prompted for Weight if not already in WizOrder

Known Values can be automatically loaded on page

Web Page enforces that all relevant fields be completed

Web Page evaluates information entered

Order for Investigational Agent

Study Authorization Order

Compounding ServiceCompounding Service

Why compound at VUMC?Why compound at VUMC?

Quality patient careQuality patient careServe needs of specialty patientsServe needs of specialty patients BurnBurn PediatricsPediatrics TraumaTrauma Investigational Drug Service (30%)Investigational Drug Service (30%)

Part of solution to healthcare problemPart of solution to healthcare problemCompliance with regulations Compliance with regulations USP 795 & 797USP 795 & 797

Plan Ahead for CompoundingPlan Ahead for Compounding

Determine compounding costsDetermine compounding costs

21 day lead time minimum21 day lead time minimum

Customize product for protocolCustomize product for protocol

Plan one dose unit per patient visitPlan one dose unit per patient visit

Project needs for 6 monthsProject needs for 6 months

Compounding TeamCompounding Team

Geri Foster, Compounding PharmacistGeri Foster, Compounding Pharmacist

Deborah Allen, Deborah Allen, Lead Compounding TechnicianLead Compounding Technician

Teresa Vo, Compounding PharmacistTeresa Vo, Compounding Pharmacist

Josephine Guirguis, Eileen Cooper,Josephine Guirguis, Eileen Cooper,Van Nguyen, Linda Van Nguyen, Linda PhaneufPhaneuf, Technicians, Technicians

““Compounding means the Compounding means the preparation, mixing, preparation, mixing, assembling, packaging, or labeling of a drug or assembling, packaging, or labeling of a drug or devicedevice (i) as the result of a practioner’s (i) as the result of a practioner’s prescription drug order or initiative based on the prescription drug order or initiative based on the pharmacist/patient/prescriber relationship in the pharmacist/patient/prescriber relationship in the course of professional practice, or (ii) for the course of professional practice, or (ii) for the purpose of, as an incident to research, teaching, purpose of, as an incident to research, teaching, or chemical analysis and not for sale or or chemical analysis and not for sale or dispensing. Compounding also includes the dispensing. Compounding also includes the preparation of drugs and devices in anticipation preparation of drugs and devices in anticipation of prescription drug orders based on routine, of prescription drug orders based on routine, regularly observed patients.”regularly observed patients.”

CompoundingCompoundingPharmaceutical compounding is subject to Pharmaceutical compounding is subject to standards listed in United States standards listed in United States Pharmacopoeia (USP) or National Pharmacopoeia (USP) or National Formulary (NF), monograph if such Formulary (NF), monograph if such monograph existsmonograph existsIf monographs do not exist then drug If monographs do not exist then drug substance should be a component of substance should be a component of drugs approved by the Secretary or are drugs approved by the Secretary or are manufactured by an establishment manufactured by an establishment registered to do so and certificates of registered to do so and certificates of analysis are available for each bulk analysis are available for each bulk componentcomponent

Types of CompoundingTypes of Compounding

Oral liquidsOral liquids

CapsulesCapsules

TopicalsTopicals

OphthalmicsOphthalmics

OticsOtics

InhalationsInhalations

InjectionsInjections

Compounding AttireCompounding Attire

Compounding AttireCompounding Attire

GownGown

GlovesGloves

Quality AssuranceQuality Assurance

Print WeightsPrint Weights

Log sheetsLog sheets

CalibrationCalibration

Double ChecksDouble Checks

Weight Variance Weight Variance

LEVAMISOLE 150 MG CAPSULES SIZE #3 BLUE

#100 #25 Ingredients: Levamisole Hydrochloride USP 17.7 gm 4.425gm Red Dye, FD&C # 40 0.025 gm 0.013 gm Lactose monohydrate, NF 3.825 gm 0.956 gm Levamisole 1 mg = Levamisole Hydrochloride USP 1.18 mg Yield 100 capsules or 25 capsules Starting Materials: Capsule machine Electronic balance with printer mortar and pestle capsule cleaning towels large plastic bag and powder roller Size #3 blue Compounding: 1. Don appropriate attire for compounding. 2. Weigh powders and print weights. Add levamisole and red dye to mortar and triturate with pestle. 3. Add lactose to mortar and mix well. Transfer to plastic bag and mix powders together using powder roller until consistent color is achieved. 4. Fill capsules, clean capsules, perform QA and label appropriately. . References : VUMC Pharmacy experience, Charlie Armstrong, RPh , PCCA consultant 2/24/06 Expiration Date: 3 months Storage: Room Temperature Auxiliary Labels: Investigational Use Only Sample Labels: Vanderbilt Hospital Compounding Pharmacy Levamisole 150 mg capsules # 100 or #25 (in Lactose, with red dye # 40) NDC# Lot# 022406M1 Exp:4 8/24/06 Prep by da/gef

Sterile CompoundingSterile Compounding

Compounding attireCompounding attire Hair coverHair cover glovesgloves maskmask gowngown

Quality assurance Quality assurance measuresmeasures Endotoxin testingEndotoxin testing Sterility testingSterility testing Record keepingRecord keeping Balance calibrationBalance calibration

Chemo Prep AreaChemo Prep AreaMorphineMorphineBupivacaineBupivacaineBrilliant GreenBrilliant GreenTerbutalineTerbutalineCocaine Eye DropsCocaine Eye DropsClonidineClonidineHydromorphone HClHydromorphone HClTyramineTyramineYohimbineYohimbineMethacholineMethacholineBradykininBradykinin

Sterilization TechniquesSterilization Techniques

Dry heat ovenDry heat oven

FiltrationFiltration

GasGas

Steam AutoclaveSteam Autoclave

SterradSterrad

Future - RadiationFuture - Radiation

Examples of Errors to AvoidExamples of Errors to Avoid

Order sent before consent receivedOrder sent before consent receivedConsenting volunteer to more than one studyConsenting volunteer to more than one studyWrong consent form signed – out of date, or wrong Wrong consent form signed – out of date, or wrong studystudyAdministering meds not on consent formAdministering meds not on consent formChange practice before amendment approvedChange practice before amendment approvedDispense without appropriate labeling/containerDispense without appropriate labeling/containerExceeding approved number of patientsExceeding approved number of patientsConsent obtained by non-approved personnelConsent obtained by non-approved personnelInappropriate surrogate consentInappropriate surrogate consentInappropriate destruction of study medicationsInappropriate destruction of study medications

IDS PharmacyIDS Pharmacy

VUH Room B101- 7610VUH Room B101- 7610

Main Phone # 3-6537Main Phone # 3-6537

Hope CampbellHope Campbell

Beeper 835-9066Beeper 835-9066

Geri FosterGeri Foster


Lori ChoateLori Choate


Deborah AllenDeborah Allen


Documents

Geri Foster, DPh Compounding & Investigational Drug Pharmacist