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Balancing Medication Safety with Door to Needle Time Melissa S Baxter, Pharm.D., BCPS Kaleida Health Buffalo General Medical Center/ Gates Vascular Institute Buffalo, NY Presenter Disclosure Information Melissa S Baxter, Pharm.D., BCPS Balancing Medication Safety with Door to Needle Time Financial Disclosure: No relevant financial relationship exists Unlabeled/Unapproved Uses Disclosure: Use of alteplase in acute ischemic stroke in the 3 – 4.5 hour window Objectives Understand the importance of establishing a set flow for a stroke patient including the use of a time-out and procedure record for nursing/pharmacy to ensure proper preparation and administration of alteplase Establish best practice through a systematic review of your procedure and equipment to identify the barriers in administering an accurate dose of alteplase. When dosing alteplase, which weight does your institution most frequently use? 1. 2. 3. 4. 5. 6. Estimated weight from family or patient Actual weight using a standing scale Actual weight using a weight cart when patient just arrives and is fully clothed Actual weight after patient has had most heavy pieces of clothing removed Old weight from record Other/I don’t know 17% 1 17% 2 17% 17% 3 4 17% 5 17% 6 Flow of Stroke Patient Ambulance/Walk-ins/Helicopter meet at Triage ESI (Name/Height/Weight/allergies) is completed Patient moves to stroke alcove ED MD: Completes initial exam and NIHSS and pages stroke team with name and NIHSS Orders diagnostics and imaging ED NURSES: Two large bore IV’s are established, patient is placed on cardiac monitor, and pulse ox monitor Blood work is sent CBC, CMP, PT/INR/aPTT, troponin-I, CK Patient is rolled to CT on EMS cart or wheelchair Flow of Stroke Patient STROKE team is activated by the ED MD stroke page Non-contrast CT of head is completed first to r/o bleed CT perfusion study and CTA is completed next Patient is moved from CT scanner to a zeroed weight cart Team meets in CT area Most heavy items have been removed from patient Weight is written on bed sheet Where is alteplase prepared at your institution? 1. 2. 3. 4. 5. 6. ED Pharmacy Satellite Pharmacy, located in close proximity to ED Pharmacy, located > 4 floors or in another building from ED Bedside with active pharmacy participation Bedside by nursing Sent by pharmacy in pneumatic tube system 17% 1 17% 2 17% 17% 3 4 17% 5 17% 6 HIGH ALERT MEDICATIONS Alteplase is defined as a high-alert medication by the Institute for Safe Medication Practices (ISMP) High alert meds bears a heightened risk of causing significant patient harm when they are used in error High-alert medications require special safeguards to be put in place to reduce the risk of errors Current State of Practice: In many institutions the pharmacy prepares and dispenses alteplase given its high-alert status. This can lead to significant delays in administration of alteplase. ISMP DTN Flow of Stroke Patient Call is made to partner nurse that patient is an alteplase candidate Alteplase is pulled from locked medicine cabinet in the ED by ED pharmacist or ED nurse Patient is rolled to ED BEST PRACTICE STRATEGY: The AHA/ASA through Target: Stroke has published 10 best practice strategies to help achieve a door to needle (DTN) time of 60 minutes or less in at least 50% of all alteplase eligible patients. Best practice strategy #8 is: Rapid Access to alteplase. Under this point they advise that alteplase "should be readily available in the emergency department or CT scanner area (if CT scanner is not located in the ED).” At your institution how is the bolus prepared/given? 1. Drawn up in a syringe and given by MD 2. Drawn up in a syringe and given by RN 3. Delivered by pump 4. Other 5. I don’t know 20% 1 20% 20% 2 3 20% 4 20% 5 At your institution how is the 60 minute alteplase infusion prepared/given? 1. 2. 3. 4. 5. The discard quantity is removed from the 100 mg vial, then the vial is spiked with an infusion set and hung The discard quantity is not removed from the 100 mg vial, then the vial is spiked with an infusion set and hung The infusion is drawn up and put in an empty PVC bag, we use 100 mg vials The infusion is drawn up and put in an empty PVC bag, we use 50 mg vials 20% 20% 20% 2 3 20% 20% I don’t know 1 4 5 BASIC SAFEGUARDS Remove Unused Quantity/Discard Volume to avoid an overdose Or draw up quantity to be infused and place in an empty PVC bag Prime primary set of tubing with alteplase so that infusion starts immediately Delay in therapy has been shown to have worse outcomes Use pump library software with guardrails To avoid administering a medication too quickly or too slowly To avoid an overdose or an under dose Flushing/Clearing of the Line Dilemma If using a standard infusion pump Primary infusion set tubing priming volumes vary May be ~10-25 ml, every pump/site has different volumes This volume must be given slowly avoiding a quick “re-bolus” during the clearing of the line Total volume of 60 minute infusion is not a fixed volume and varies based upon the patients weight ~ 30 to 81 ml In smaller patients the majority of the infusion may be in the primed tubing There is not another medication like this given in the adult ED Overfill Volume Dilemma 100 mg vials contain up to 10% overfill per manufacturers allowances 100 ml vials dose prepared at bedside Bolus removed by syringe Infusion measured with syringe(s) and infusion placed in 100 ml empty PVC bag Unused quantity remains in vial We measured 30 “unused quantities” after alteplase was administered to verify overfill volumes Range of overfill 2.4 – 8.4 ml Mean 5.6 ml NOTE: During preparation, some product was lost due to the large hole made by the piercing pin. Addressing The Problems Goal is to Stop the infusion when the alteplase dose to be administered has completely emptied into the tubing Don’t be tempted to get every last drop from the 100 mg vial If discard volume is not removed this step will catch that To avoid administering overfill But the tubing is full Alteplase is still in drip chamber This prevents air from getting into the cassette At this point switch the near empty 100 mg vial with a 50 ml bag of NS and resume infusion at the previous rate of the alteplase infusion The Solution: 2 Step Pump Programming This can be safely and reliably accomplished by altering the volume to be infused Pump Step 1: Enter your rate in mg/hour i.e. 81 mg/hour Alter the volume to be infused Subtract the priming volume of tubing from your 60 min infusion volume i.e. 81 ml – 20 ml = 61 ml This will call the nurse back to the pump to make the switch to NS prior to air getting into the cassette. Pump Step 2: Resume at previous rate in mg/hour i.e. 81 mg/hour Set volume to be infused at a minimum to clear the lines i.e. 25 ml Flushing/Clearing of the Line Dilemma Syringe pumps Utilize microbore tubing and have minimal volumes to flush at the end of the infusion (~1-2 ml max) Allow for infusion of up to 60 ml at a time 1 – 2 syringes can be used to infuse total volume OK to flush 1 – 2 ml We currently do not have syringe pumps… TIME OUT RECORD PROCEDURE RECORD PROCEDURE RECORD PUMP STEP 1 Directions PUMP STEP 2 Directions ADVERSE REACTION RESUMING INFUSION Recommendations to Overcome Barriers Obtain patients actual weight when heavy items have been removed Include pharmacy in the stroke team notification system so they can mobilize to the ED to prepare the alteplase Store alteplase in the ED in a locked medicine cabinet or prepare in the ED pharmacy satellite pharmacy Consider drawing up bolus and infusion to ensure delivering precise doses, avoiding opportunities for overdose Develop a detailed procedure record with your institutions process for alteplase preparation and administration Utilizing a 2 step pump process or use of syringe pumps Educate, Educate, Educate… QUESTIONS ??? 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