(IV) Medications - Compounded Sterile Preparations - UNM Cancer ...

Title: Intravenous (IV) Medications - Compounded SterilePreparations (CSPs)Applies To: All HSC Hospitals & UNMCCComponent(s):Responsible Department: PharmacyRevised: (New 6/2009)ProcedurePatient Age Group: ( ) N/A ( ) All Ages ( ) Newborns ( ) Pediatric ( ) AdultDESCRIPTION/OVERVIEWThe preparation, dispensing and administration of IV medications are some of the most criticalfunctions undertaken by hospital staff. The purpose of this procedure is to delineateresponsibility for non-pharmacy personnel regarding compounded sterile preparations and toprovide guidelines in the preparation of a compounded sterile preparation in an emergent/urgentsituation.REFERENCES USP Pharmaceutical Compounding, Sterile Preparations (CSPs) The Joint Commission (TJC): Medication ManagementAREAS OF RESPONSIBILITYThis document as set forth by Pharmacy applies to appropriately licensed health care providersbased on their scope of practice as determined by licensure and education.PROCEDURE1. Preparing Compounded Sterile Preparationsa. PharmacyThe Pharmacy will prepare, label and dispense all hospital CSPs with the exception ofimmediate-use CSPs. Pharmacy can also provide drug information and compatibilityinformation for safe and effective IV medication use.b. Non-Pharmacy PersonnelNon- Pharmacy personnel (nurses, respiratory therapists) are authorized to prepare animmediate-use CSP only in urgent/emergent situations or when the product stabilityprecludes pharmacy preparation. They must have successfully completed the OnlineCompetency of Compounded Sterile Preparations for Non-pharmacy Personnel.2. Physician’s ResponsibilityA physician shall prescribe the drug, dose, route and frequency3. Physician’s OrdersOrders for all IV admixtures and medications are sent directly to the pharmacy from the nursingunit via the scanner, pneumatic tube system, fax or may be hand delivered.4. Patient Special Precautions or RequirementsNursing staff shall advise the Pharmacy of special precautions or requirements regarding patients(i.e. sodium or fluid restriction)5. Labeled Directions and Precautions/Pharmacy NotificationHospital staff shall be responsible for abiding by the labeled directions and precautions as notedon each component of the admixture. Pharmacy shall be a resource for of contraindications,appropriate route of administration, or other medication questions.CSPs Preparation:_________________________________________________________________________________________________________________Title: Intravenous (IV) Medications - Compounded Sterile Preparations (CSPs)Owner: Director, PharmacyEffective Date: 7/21/2009Doc. #2524Page 1 of 4

1. Documented CompetencyAll personnel who prepare sterile preparations must have documented annual competency to doso.2. Ensure Proper aseptic technique3. Designated AreasEating, drinking and the storage of food are prohibited in the area designated for sterile productpreparation.4. InspectionAll bottles are inspected for particulate matter, cracks and the manufacturer’s expiration date. AIV bag is inspected for leaks and particulate matter before and after admixture is made. Anyquestionable product is discarded.5. Additive Ports and Vial TopsAdditive ports and vials tops and IV containers are wiped with sterile 70% isopropyl alcohol(IPA) sponges (swabs) prior to performing admixtures. Swab must be wet and not overused.Minimally, a new swab is used on each additive container (bags or vials).6. Touch ContaminationTouch contamination of syringe tips, needles, stopper and injection ports is avoided.7. Medication Vials and Containers The person preparing the medication is responsible for labeling the medication. All medications drawn up or prepared, including those prepared from multi-dose vials, will beappropriately labeled before being taken to the patient. Medication or solution labels will include the patient’s name, medical record number, medicationname, strength, amount (if not apparent from container), initials of person preparing admixture,and the exact one-hour beyond use date.Single-dose containers shall be used within one hour after opening or needle-punctured andremaining contents properly discarded. Multi-dose vials contain an antimicrobial preservativewhich may be used for 28 days and should be initialed and dated when opened.Preparation Procedure:Non-pharmacy personnel are authorized to prepare immediate-use CSP’s only inurgent/emergent situations or when the product stability precludes pharmacy preparation. Theymust have successfully completed the Online Competency of compounded sterile preparationsfor non-pharmacy personnel.A. Pre-Procedure Steps1. Check the physician orders.2. Assemble all equipment and supplies needed in a designated work area, free of traffic,preferably an isolated area3. Assure that the designated area is clean4. Complete the appropriate label to include:a. Patient’s name, location, and medical record numberb. Name of drug, amount of drug, name of basic parenteral solution and solution volumec. Date and time of the addition5. If there are any questions of compatibility of medications check with resources availableand/or call PharmacyB. Drawing up of a single entity medication into a syringe1. Swab the diaphragm or stopper of the vial with sterile IPA and allow drying.2. Draw up correct amount of medication.3. Label syringe and administer.C. Admixture Reconstitution Procedure_________________________________________________________________________________________________________________Title: Intravenous (IV) Medications - Compounded Sterile Preparations (CSPs)Owner: Director, PharmacyEffective Date: 7/21/2009Doc. #2524Page 2 of 4

1. Read the medication dilution instruction carefully.2. Select the correct diluent.3. Remove the protective cap from the diluent container.4. Swab the diaphragm or stopper of the vial with alcohol and allow drying.5. Draw up the recommended amount of diluent6. Inject the diluent into the drug vial7. Mix the drug and diluent as directed by manufacturer. Use when particles can no longer beseen in the solution8. Swab the stopper or port of entry of the IV bag with sterile IPA and allow drying.9. Pull up the required amount of medication and inject into the bag.D. Procedure for Ampules1. Swab the neck of the ampule with sterile IPA and allow drying.2. Using sterile gauze, break the ampule carefully, use a filter needle to draw up the requireddose, remove filter needle and replace with new sterile needle.3. Swab the port of entry on the IV bag with sterile IPA and allow drying.4. Inject the required dose into the IV bag.E. Procedure for Vials1. Swab the diaphragm or stopper on the vial and the IV bag port of entry with sterile IPA andallow drying.2. Pull up the correct amount of medication and inject into the bag.F. Post-Preparation1. Complete and affix the Medication additive label to the mixture (refer to labeling section)Double check against physician orders before administeringDEFINITIONSCompounded sterile preparations (CSPs): Per USP the following are CSPs“compounded biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals, including butnot limited to the following dosage forms that must be sterile when they are administered topatients: aqueous bronchial and nasal inhalations, baths and soaks for live organs and tissues,injections (e.g., colloidal dispersions, emulsions, solutions, suspensions), irrigations for woundsand body cavities, ophthalmic drops and ointments, and tissue implants.Immediate-use CSP: intended only when there is an emergency or immediate patientadministration. The immediate-use CSP is compounded from not more than three (3) sterile,commercially, manufactured, non-hazardous products and not more than two (2) entries into anycontainer.Beyond-Use Date (BUD): the date and time after which a CSP shall not be stored or transported.Immediate-use CSP shall initiate within one hour from the start of compounding the preparation.Compounding: The preparation, mixing, assembling, packaging and labeling of drug or devicein accordance with a licensed practitioner’s prescription.Reconstitution: The process of adding a diluent to a drug vial to create a liquid medication atthe required strength that can be administered to the patient with a syringe.SUMMARY OF CHANGESNew DocumentRESOURCES/TRAININGAnnual Competency in Learning Central_________________________________________________________________________________________________________________Title: Intravenous (IV) Medications - Compounded Sterile Preparations (CSPs)Owner: Director, PharmacyEffective Date: 7/21/2009Doc. #2524Page 3 of 4

Resource/DeptLearning CentralInternet/Linkhttps://learningcentral.health.unm.edu/plateau/user/login.jspDOCUMENT APPROVAL & TRACKINGItem Contact Date ApprovalOwnerDirector, PharmacyConsultant(s)Dierdre Kearney, Director, Neuroscience Line ServicesCommittee(s)Clinical Operations PP&G CommitteeNursing Practice PP&G CommitteeYNursing Officer Sheena Ferguson, Chief Nursing Officer YOfficial Approver Erin Doles, Administrator, Professional & Support Services YOfficial Signature Date: 7/21/2009Effective Date 7/21/2009Origination Date 6/2009Issue Date Clinical Operations Policy Coordinator 7/24/2009ATTACHMENTSNone_________________________________________________________________________________________________________________Title: Intravenous (IV) Medications - Compounded Sterile Preparations (CSPs)Owner: Director, PharmacyEffective Date: 7/21/2009Doc. #2524Page 4 of 4