Registered Pharmacist - Investigational Drug Service

IDS Pharmacist

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About the Job

Reporting to the IDS Pharmacy Supervisor, the IDS Pharmacist is responsible for the daily operation and quality of IDS pharmacy services which include ensuring safe and effective use of investigational products by research patients, developing and implementing internal workflows for research trials involving investigational products, and enforcing relevant standard operating procedures to maintain compliance with applicable regulations. The incumbent must demonstrate the knowledge and skills necessary to provide care appropriate to this unique patient population and support the mission and vision of CHOP and CHOP's Research Institute.

What You Will Do

1. Provides technical and operational support of clinical trial protocols and conforms to the IDS Policy and Procedures for the appropriate and efficient preparation and utilization of investigational products at CHOP.

• Creates and implements investigational drug data sheets for pharmacy and nursing staff
• Prepares and distributes investigational product and other necessary medications and supplies according to the protocol, accurately, in the appropriate quantity and at the time the product is needed
• Responds to inquiries from internal staff (i.e., pharmacy staff and study coordinators) and external personnel (i.e., monitors and auditors)
• Coordinates with the hospital information systems (HIS) teams to allow for research drug activities to occur seamlessly

2. Reviews and process medication orders using the hospital information system (HIS) and the pharmacy computer system to ensure that the medication is appropriate in terms of dose, dosage form, route of administration, frequency, duration of therapy, and patient's disease state.

• Ensures medication order is appropriate for age, weight and disease state 100% of all medication orders.
• Reviews medication orders for potential allergic reactions, drug interactions, therapeutic duplication, and potential drug incompatibilities 100% of all medication orders.
• Ensure PRN medication orders contain indications and documented 100% of time.
• For medication orders that are outside the normal range, ensure reason and rationale for use is appropriate and documented in pharmacy intervention record.
• Provides drug information and/or presents educational programs to healthcare professionals and patients.
• Consults with physicians, nurses and other healthcare professionals concerning the dose, dosage form, availability, proper administration, side effects, and possible incompatibilities of currently available drugs.
• Advises patients and family on the use of various medications as per OBRA: name, description, route, dosage form, duration of therapy, directions for preparation, administration, use, common side effects, interactions, contraindications, self monitoring, storage, refill information and action to be taken if dose is missed.
• Provides training to new pharmacy staff, as assigned, in compliance with training goals/objectives.
• Ensures compliance to CHOP Formulary System.
• When Non-formulary medications are ordered, pharmacist ensures order is reviewed for appropriateness or approved by the clinical pharmacist.
• IDS Pharmacist who can approve non formulary medication orders must ensure use is appropriate and reasonable/rationale. Appropriateness and rationale must be documented in the Pharmacy Intervention Record.
• IDS Pharmacist who has order approval rights for non formulary medication orders must ensure use is appropriate/rationale. Appropriateness and rationale must be documented in the Pharmacy Intervention Record.
• IDS Pharmacist who has order approval rights or receives clinical pharmacist approval for non formulary medication orders must ensure there is adequate inventory for completion of therapy.

3. Supervises pharmacy technicians and interns to ensure that pharmacy products are prepared and distributed accurately, with the appropriate quantity and at the time the product is needed.

• Ensures that each unit dose medications (PO, SVP, LVP, TPN, Chemotherapy) are correctly and accurately prepared and labeled. Verification process is appropriately documented as per policy and procedure.
• Compounded Sterile Preparations (CSPs) are prepared aseptically, accurately, and safely in accordance to USP 797, USP 800 and CHOP Pharmacy Standard Operating Procedures (SOP).
• Responsible for compliance to all federal, state, and department standards and regulations for sterile product compounding- USP797, USP800, CMS Conditions of Participation, FDA Compounding Guidance and TJC standards.
• Prepare accurately and safely Compounded Non-Sterile Products (CNSPs) in accordance with USP795 and CHOP Pharmacy Standard Operating Procedures (SOP).
• Responsible for compliance to all federal, state, and department standards and regulations for non-sterile product compounding- USP795, USP800, CMS Conditions of Participation, FDA Compounding Guidance and JCAHO standards.
• Ensures medication is prepared and stored in a manner that ensure the medication remains compatible and stable within the anticipated time of use.
• Ensures replacement of approved floor stock medications as per policy and procedure.
• Ensures the proper repackaging of doses of medication and completion of required quality control records.
• Verification process is appropriately documented as per policy and procedure.
• Verifies content of individual patient cassette bins to ensure that the correct medication and quantity are available for administration to the patient.
• Enables the proper retrieval of all medications that are discontinued or expired from nursing units by using standardized communication procedures (eg. label messages).
• Ensures the appropriate medication and quantity of medication is available to the patient, when there is a frequency or dosage form change, by using standardized communication procedures (eg. label messages).
• The turnaround time for an uncomplicated medication order does not exceed 1 hour.
• The turnaround time for a stat medication order does not exceed 15 minutes.
• Ensures errors identified are immediately corrected, and retrieved from patient care unit. Errors are reported to prescriber, nursing, and pharmacy administration. Error is documented on incident report and forwarded to pharmacy administration.

4. When necessary, the pharmacist prepares and distributes pharmacy product accurately, in the appropriate quantity and at the time the product is needed.

• Unit dose medications (PO, SVP, LVP, TPN, Chemotherapy) are correctly and accurately prepared and labeled.
• Preparation is appropriately documented as per policy and procedure.Sterile product (SVP, LVP, TPN and chemotherapeutic solutions ) prepared in compliance with USP 797.
• Medication is prepared and stored in a manner that is compatible and stable within the anticipated time of use.
• Proper repackaging of doses of medication and completion of required quality control records.
• Preparation process is appropriately documented as per policy and procedure.

5. Ensures the proper documentation and secure storage of controlled substances and investigational products.

• Document every transaction completely and accurately
• No generation of discrepancies in the C2 Safe, Pyxis Medstation, or Inventory Logs
• Ensure the destruction of returned controlled substance continuous medication infusions

6. Participates in hospital and departmental Continuous Quality Improvement (CQI) activities.

• Utilizes the Lean Principals of to analyze, and resolve problems in a systematic manner.
• All improvements must be made in accordance with the scientific method
• Participate in departmental LEAN Projects (RPI / 5S)Work OT to allow co-workers to participate in department RPI
• Provide pre- and post- project feedback and support sustain measures to ensure successful outcomes.
• Achieve patient safety and satisfaction through the use of lean principles:5SElimination of WasteJITStand WorkQualityPromote and Comply with Standardized Procedures.
• Promote and Comply with Standard Work..Identify "waste" in

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