September 20, 2005

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Research PharmacyQuality Assurance

• By Karen Helms, PharmD
• September 20, 2005

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Pharmacy ResponsibilitiesM-2, Pt VII, CH 6

• Proper approval prior to order, receipt, storage,
  use
• Receipt, custody, storage, dispensing, and
  disposition of unused stock of all drugs used
  under investigational protocols
• Maintain a file of protocols, correspondences,
  investigators, and signed informed consents
• Maintain a dispensing log

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Pharmacy ResponsibilitiesM-2, Pt VII, CH 6
continued

• With PI, prepare and distribute study drug
  information to hospital staff
• Receive allergy information, toxicities and
  adverse drug reactions from PI
• Be represented on the local RD Committee

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Receipt, Control, Custody, Dispensing

• All investigational drugs will be delivered to
  the pharmacy for receipt, storage, and
  distribution
• VA form 10-9012 provided to pharmacy by the PI
  prior to initial drug shipment
• Investigational drugs stored separate from other
  drugs
• Orders should be written by authorized
  prescribers only

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Maintaining a File M-2 Pt VII, CH 6.02 (c and e)

• Approved protocol
• Form 10-1223 (VHA handbook 1200.5)
• Signed informed consents
• VA form 10-9012 (investigational drug information
  record)

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Maintaining a Dispensing Log

• Name of drug
• Manufacturer or other source
• Date drug received
• Quantity received
• Expiration/re-test date
• Control number
• Date protocol approved

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Maintaining a Dispensing Logcontinued

• Authorized practitioner
• Patient name
• Prescription serial number
• Quantity dispensed
• Remaining balance
• Dispensing pharmacist

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Pharmacy Quality Assurance Programs

• Investigational medication accountability
• Authorized prescriber audit
• New study subject audit
• Protocol re-approval process
• Investigational drug service interventions
• Adverse drug reaction monitoring
• CPRS documentation
  
  
  
  
  

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Investigational Medication Accountability

• Ensure completeness of written record of
  investigational medication dispensing

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Investigational Medication Accountability Audit

• Review medication dispensing log for missing
  documentation

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Investigational Medication Accountability Log
Results 1 error rate
1
99
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Authorized Prescribers

• Authorized prescribers must be approved by the
  IRB to prescribe investigational drugs for each
  protocol this can include MDs and PAs, ARNPs,
  and PharmDs with a scope of practice
• Must be listed on VA form 10-9012

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Authorized Prescriber Audit

• Check IRB documentation related to additions and
  deletions of investigators against the names
  written on the 10-9012
• Ensure prescriptions are written by authorized
  practitioners only

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New Study Subjects

• The pharmacist ensures an allergy assessment is
  completed
• The pharmacist reviews each new subject consent
  and maintains a signed copy in the pharmacy
• The pharmacist assists in distributing drug
  information to the hospital staff

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Protocol Re-approval Process

• Protocol should have current IRB approval in
  order for pharmacy to dispense investigational
  medications

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Protocol Re-approval Audit

• Research Pharmacy receives copy of renewal letter
  
• Renewal dates are checked against dispensing
  records
• A reminder letter is sent to the investigator 60
  days before protocol expires
• Must evaluate subject safety risk prior to
  stopping medications if protocol expires

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Investigational Drug Interventions

• Categories of interventions made by the pharmacy
  are tracked and include
• No Informed consent
• No allergy assessment
• Missing or incorrect prescription directions
• Wrong subject SSN or name

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Investigational Drug Interventionscontinued.

• Wrong medication kit
• Incorrect dispensing quantity
• Unscheduled administration
• Medication interaction
• Subject allergy to study drug
• Study not approved
• Incorrect storage of study med
• Incomplete consent
• Prescription not dated or signed
• Unauthorized prescriber

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Interventions Results
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Adverse Drug Reaction Monitoring

• Research pharmacy receives copies of all
  Significant Adverse Events (SAEs) occurring with
  investigational drugs
• Pharmacist tracks SAEs that are related or
  possibly related to investigational drug use
• Identify trends
• Ensure appropriate follow up
• Reports to PT Committee and SCI

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CPRS Documentation

• Informed consents
• Initial progress note
• VA form 10-9012 (drug information record)

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Audit Results Prior to CPRS

• Manual Charts per study
• Consent forms 50 - 100
• Initial progress note 0 - 100
• Drug information record 20 - 100

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Results after staff education
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Audit Results after documentation in CPRS
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.Other Monitoring Areas

• Inventory checks
• Temperature log
• Controlled substances
• Inventory every 72 hours in vault
• Inventory once weekly in pyxis
• Inventory once per shift in satellites

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Other Monitoring Areas continued.

• Documentation of staff education
• in-servicing of non-research staff involved in
  dispensing, and administration of study drugs
• Documentation of Investigational Drug Destruction
• VA Form 2237 or other

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Other Monitoring Areas continued.

• Limited access to research medications
• Adequate code break procedure
• Medication errors
• Pharmacy compliance with local policies

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A Successful Research Pharmacy Program

• RCO and research pharmacist communication
• Detailed record keeping and organization
• Adequate pharmacy staff
• Research pharmacist and investigator
  communication
• Continuity of pharmacy staff

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A Successful Research Pharmacy Program continued.

• Local research pharmacy policies
• Pharmacy review of new investigational drug
  studies
• Pharmacy quality assurance programs
• Education