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Guaranteeing High Quality Outsourcing Pharmacy Services
Christopher Fortier, PharmD Manager, Pharmacy Support & OR Services Medical University of South Carolina Adjunct Assistant Professor South Carolina College of Pharmacy
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LEARNING OBJECTIVES Identify the areas of influence that contribute to outsourcing of pharmacy compounding services as a viable option. Compare and contrast regulatory, liability, and safety considerations related to providing outsourced services versus in-house compounding services. Explain the various measures to evaluate and document an outsourcer’s level of performance and analyze compliance related to safety, quality, and performance standards.
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Poll: Which category best describes your organ...
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Poll: Who currently has a relationship with an...
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CURRENT STATE State of Pharmacy Compounding. Pharmacy Purchasing & Products. 2012
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OUTSOURCING VENDORS PharMEDium
CAPS® – Central Admixture Pharmacy Services Cantrell Drug Company Unique Pharmaceuticals Ameridose™ New England Compounding Center AnazaoHealth®
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OUTSOURCING SERVICES Pain management OR/Anesthesia PCA IV push
Epidural Continuous pain management Nerve block Intrathecal OR/Anesthesia Propofol Ephedrine Morphine Succinylcholine Epinephrine Fentanyl Glycopyrrolate Phenylephrine
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OUTSOURCING SERVICES Intensive care unit Labor & delivery Cardiac
Sedation Analgesic Antiemetics Antibiotics Electrolytes Diuretics Anticoagulants Labor & delivery Oxytocin Magnesium sulfate
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CURRENT STATE State of Pharmacy Compounding. Pharmacy Purchasing & Products. 2012
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Poll: How many compounded sterile products do ...
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REASONS TO CONSIDER Operational Safety Quality Assurance Staffing
Extended BUD Drug shortage High/low volume Hood time Ability to standardize Safety Enhanced labeling Ready to use product Complex products Quality Assurance USP 797 requirements Regulatory compliance Staffing Possible labor reduction Reallocate duties Lack of staff/limited training Financial Reduced waste Facility renovation Cost of product testing
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FUTURE STATE State of Pharmacy Compounding. Pharmacy Purchasing & Products. 2012
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MEDICAL UNIV. OF SOUTH CAROLINA
Located in Charleston, SC 709-bed academic medical center Consists of: University Medical University Hospital Authority University Medical Associates Inpatient admissions: 34,033 Outpatient admissions: 36,780 Number of employees: ~10,000
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MUSC PRODUCTS Cardioplegia Oxytocin Phenylephrine 20 mg bags
Epinephrine 1 mg bags Epinephrine 4 mg bags Fentanyl epidural Hydromorphone PCA Fentanyl PCA Morphine PCA Cefazolin PFS Vecuronium PFS Atropine PFS Glycoyrrolate PFS Esmolol PFS Succinylcholine PFS Ephedrine PFS Phenylephrine PFS Lidocaine PFS Magnesium 40 gram bags Midazolam 1 mg/mL bag Lorazepam 1 mg/mL bag Morphine 1 mg/mL PFS
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STRATEGIC ROADMAP
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Poll: Which item below will or has MOST influe...
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- Lou Diorio and Dave Thomas
“Outsourcing CSPs does not release you from your responsibilities under USP and state board of pharmacy statutes, rules, or regulations” - Lou Diorio and Dave Thomas Diorio L, Thomas D. Maximizing Outsourcing Options for Compounded Preparations. Pharmacy Purchasing & Products. July 2009
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INITIAL ASSESSMENT Who are the market vendors? How long in business?
Does outsourcer supply CSP at your current concentration and volume? Provide CSP to address current trends/needs in market? What other hospitals serviced? Location of facilties, delivery options, turnaround
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STRATEGIC APPROACH Strategic plan Request for proposal Site visit
Outsourced vendor contract Ongoing performance
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Poll: Have you ever conducted a site visit of ...
Don’t forget: You can copy-paste this slide into other presentations, and move or resize the poll. Poll: Have you ever conducted a site visit of ... In an emergency during your presentation, if the poll isn't showing, navigate to this link in your web browser: If you like, you can use this slide as a template for your own voting slides. You might use a slide like this if you feel your audience would benefit from the picture showing a text message on a phone. Poll: Have you ever conducted a site visit of ... 23
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PRE-SITE VISIT Knowledge of USP 797 and cGMP
Multiple production facilities Request/review documents prior to visit 1 day visit Use comprehensive assessment tool
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SITE VISIT AGENDA 5. Quality control record review 1. Introductions
Beyond use dating Environmental monitoring records 6. Labeling/packaging 7. Customer complaint review 8. Tour 1. Introductions 2. Licensure and certification review Training files and competency State, DEA, FDA inspection 3. Standard operating procedure review Compliance with USP 797 Revisions of SOP and management approvals 4. Stability, sterility, pyrogenicity testing procedure review McAteer F, Churchill W. Develop an Approved Vendor Program for Outsourced Compounding. Pharmacy Purchasing & Products. May 2009
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CONTRACTOR ASSESSMENT TOOL
ASHP Research and Education Foundation The assessment tool helps you evaluate: Regulatory compliance Quality and patient safety measures Medication administration safety features Service excellence
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SITE VISIT OBSERVATIONS
Compliance with SOPs Pharmacist role Double-checks Aseptic technique Documentation process Inspect equipment, calibration Medication safety technology Inventory, quarantine areas Control substance
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PRODUCT TRACER AUDIT Completeness of documentation
Validation of quality control results Beyond use dating proof Drug recall documentation Staff train/competency files McAteer F, Churchill W. Develop an Approved Vendor Program for Outsourced Compounding. Pharmacy Purchasing & Products. May 2009
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QUALITY REPORTS Media fill Sterility test Stability tests
Hood surface sampling Air sampling Customer complaints Internal service issue Delivery issues
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CONSIDERATIONS
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REGULATORY COMPLIANCE
Accreditation/licensing USP/NF ingredients Liability insurance FDA registered suppliers Hazardous product preparation Legal/punitive action Transparent reporting
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QUALITY AND PATIENT SAFETY
Staff training/competency Full USP 797 compliance Extended BUD process Environmental monitoring Equipment calibration, maintenance Shipping temperature
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MEDICATION ADMIN SAFETY
Labeling Tall man lettering Route of administration Drug amount/concentration Color coding Tamper evident Bar code Type of barcode Information contained w/in barcode Packaging
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SERVICE EXCELLENCE New services Product portfolio Ordering
CSOS Tracking Turnaround time After-hours/emergency Shortages and allocation Recalls Control substances 24/7 customer service Labeling, packaging, bar code
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FINANCIAL CONSIDERATIONS
Could you make these products internally? Staff training Facilities Labeling Are costs competitive? Associated costs Material costs Labor costs Overhead costs Safety costs Compliance costs Apfelbaum J, et al. Special Report: Outsourcing Anesthesia. Anesthesiology News. January 2010.
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CONTRACTING CONSIDERATIONS
Quality monitoring criteria required by USP 797 Ongoing quality reporting Drug shortages/Allocation Turn around time requirements Recall process Corrective action program
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Poll: Are you receiving and reviewing monthly ...
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CONTINUOUS FOLLOW-UP Annual site visit Monthly report format
Visit other production sites Monthly report format Sterility/batch results/certification Competency of staff Environmental reports Equipment validation Drug recalls FDA or BOP action reports
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VENDOR COMPARISONS Exceed accreditation, regulatory compliance
Quality control records New request validation process Environmental monitoring records Staff training Extended BUD USP/NP ingredients Sterile or Non-sterile powders Use FDA registered suppliers FDA licensing
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