University of Colorado Hospital Policy and Procedure. Administration of Inhaled Iloprost and Inhaled Treprostinil in the Inpatient Setting

Transcription

1 University of Colorado Hospital Policy and Procedure Administration of Inhaled Iloprost and Inhaled Treprostinil in the Inpatient Setting Table of Contents: Related Policies and Procedures Approved By Stakeholders Description Definitions Accountability Policy and Procedures A. Considerations for inpatient administration of inhaled iloprost (Ventavis) B. Using the I- Neb AAD device to administer inhaled iloprost (Ventavis) C. Considerations for the inpatient administration of inhaled treprostinil (Tyvaso) D. Using the Optineb apparatus to administer inhaled treprostinil (Tyvaso) E. Documentation Additional Resources References Related Policies and Procedures: Aerosol Therapy Use of Patient s Own Medications and Dietary Supplements Approved by: Professional Practice Policy and Procedure Committee, Critical Care Committee, Pharmacy and Therapeutics Committee Stakeholders: Pulmonary Hypertension Team, Pulmonary Unit Nurse Manager, Pulmonary Unit Nurse Educator, Tyvaso Taskforce, Respiratory Therapy, Inpatient Pharmacy Description: This policy/procedure describes how to safely administer the inhaled prostacylins, iloprost (Ventavis ) and treprostinil (Tyvaso ), in Pulmonary Arterial Hypertension patients. Definitions: Pulmonary Arterial Hypertension: Pulmonary Arterial Hypertension (PAH) is a rare disorder characterized by elevation of the mean pulmonary artery pressure greater than 25 mm Hg and a Pulmonary Capillary Wedge Pressures (PCWP) < 15 mmhg and Pulmonary Vascular Resistance < 3 WU. 1

2 Inhaled iloprost: Inhaled iloprost (Ventavis ) is a stable prostacyclin analogue approved in December of 2004 by the FDA for treatment of Pulmonary Arterial Hypertension. It is delivered through a specialized delivery system, the I-Neb AAD device. Inhaled treprostinil : Inhaled treprostinil (Tyvaso ) is a stable prostacyclin analogue approved in July of 2009 by the FDA for treatment of Pulmonary Arterial Hypertension. Inhaled treprostinil is delivered through the Optineb TYVASO Inhalation System. Accountability: The Pulmonary Hypertension Attending Physician is responsible for writing orders for inhaled prostacyclins in the inpatient setting. The on-call Pulmonary Hypertension Registered Nurse will be the designated resource for any questions that may arise regarding administration. The patient will be responsible for supplying all equipment and accessories, including back-up equipment. The patient will be responsible for inhalation through their own device. If for any reason, the patient is unable to perform these tasks, or if there is an equipment malfunction, the on-call Pulmonary Hypertension Attending Physician or Pulmonary Hypertension Registered Nurse will be contacted immediately to make recommendations. While the patient is hospitalized, inhalation will occur under the direct oversight of the Respiratory Therapist. Collaboratively, the Respiratory Therapist and the Registered Nurse will be responsible for monitoring side effects of treatment. Finally, the medication will be supplied and dispensed by Central Pharmacy while the patient is admitted to the inpatient setting. Central Pharmacy will not be responsible for supplying any other supplies or accessories. Policy and Procedures: A. Considerations for administration of inhaled iloprost in the inpatient setting 1. Inhaled iloprost is a long-term therapy and should not be interrupted unless specifically recommended by the Pulmonary Hypertension Attending. 2. The dose of inhaled iloprost is determined by the Pulmonary Hypertension Attending and should not be adjusted unless by the Pulmonary Hypertension Attending. 3. Patients on inhaled iloprost should be targeted for bed assignment on the Pulmonary Unit whenever floor status appropriate. 4. All patients on inhaled iloprost will have active telemetry monitoring orders. 5. Inhaled iloprost is delivered as an aerosolized liquid through a device specific dosing disk (2.5mcg or 5.0 mcg) via an I-Neb AAD device (a nebulizer device specifically designed for this medication). When a patient on inhaled iloprost is admitted to the hospital, it is their responsibility to bring with their own I-Neb AAD device and all accessories. 6. The patient should also supply a back-up I-Neb AAD device in case of equipment malfunction. 7. The medication itself is supplied in individual 2 ml ampules, in a concentration of 10 mcg per ml and 20 mcg per ml. The entire contents of one ampule are used for each inhalation, regardless of the dose. (The size of the dosing disk filter within the I-Neb AAD device will regulate dosage). 2

3 8. Central Pharmacy will only be responsible for supplying the ampules of inhaled iloprost. Central Pharmacy will not be responsible for supplying dosing disk filters or any other equipment or accessories. 9. The patient will inhale 6 to 9 evenly spaced aerosolized treatments during the waking hours every day, under the direct observation of the Respiratory Therapist. 10. It is not intended, but may in some cases be necessary for the patient to perform an inhalation during the night. The Pulmonary Hypertension Attending will determine when this is clinically necessary. 11. Treatments should be taken every 2-3 hours (no more frequently than every two hours). 12. Inhaled iloprost has a half-life of minutes after inhalation. Inhaled iloprost was generally not detected in the plasma 30 minutes to 1 hour after treatment. 13. Common side effects are vasodilation (flushing), increased cough, headache, jaw pain, nausea, and hypotension. 14. Adverse events that are to be reported to the Pulmonary Hypertension Attending or Pulmonary Hypertension NP immediately are: a. Systolic BP falls greater than 20 mm Hg from baseline or registers at or below 80 mm Hg b. Severe nausea, dizziness, lightheadedness c. Shortness of breath d. Chest pain e. Increase in heart rate by greater than 20 beats per minute from baseline or heart rate reaches 120 beats per minute f. Hemoptysis g. Hypoxia (Sa02 < 90%) h. Syncope B. Using the I-Neb AAD device to administer inhaled iloprost (Ventavis) 1. The following sequence of steps describes how to set up the I-Neb AAD device a. Wash hands. b. Remove the rechargeable battery from the AC wall plug charger. c. Place device on a flat surface. d. Attach the medication chamber to the rechargeable battery. e. Remove a clean, dry mesh filter dosing disc from the case. Place the dosing disc on top of the medication chamber. f. Withdraw entire contents of iloprost from ampule using pipette. g. Using pipette, drop medication onto the dosing disk. h. Close latch, and attach mouthpiece. i. Turn device on and wait for screen to display the face icon indicating that the device is ready for administration. 2. The following sequence of steps describes how the patient is to self- administer the medication a. Hold the device horizontally to the ground with the display pointing down. b. Close the lips around the mouthpiece c. Inhale and exhale normally through the mouth 3

4 d. Each treatment should take between 4 and 10 minutes, depending on the patient's breathing pattern e. The treatment is complete after the device emits a tone and the display shows smiley face icon. Older models may display a numeric countdown, which will disappear when the treatment is complete. f. The I-Neb AAD will automatically switch off after a few moments 3. The following sequence of steps describes how to clean the device: a. The device should be fully cleansed once per day b. Wipe off any spilled or medication from the external device using a clean, dry cloth. c. Dissemble device. d. Remove used dosing disk from medication chamber and place in red case for disposal. e. Place mouthpiece and medication chamber inside white washing basket. f. Close the lid of washing basket. g. Submerge entire washing basket in distilled water and a few drops of dishwashing soap. Swish basket around gently. h. Remove the basket from the washing water. Rinse basket by submerging in distilled water and gently swishing. i. Allow parts to air-dry within washing basket. 4. These instructions for operation, administration, and cleaning of the device will also be found on the Iloprost (Ventavis ) Inhaled Patient Care Orders in the patient s Medication Administration Record (MAR) in Epic. C. Considerations for the administration of inhaled treprostinil in the inpatient setting 1. Inhaled treprostinil is a long-term therapy and should not be interrupted unless specifically recommended by the Pulmonary Hypertension Attending. 2. The dose of inhaled treprostinil is determined by the Pulmonary Hypertension Attending and should not be titrated without an order from the Pulmonary Hypertension Attending. 3. Patients on inhaled treprostinil should be targeted for bed assignment on the Pulmonary Unit when floor status appropriate. 4. All patients on inhaled treprostinil will have active telemetry monitoring orders. 5. Inhaled treprostinil is delivered as an aerosolized liquid through a nebulizer device Opitineb TYVASO Inhalation System (specifically designed for this medication). It is the patient's responsibility to bring their own device and all accessories. 6. The patient should also supply a back-up Opitineb TYVASO Inhalation System in case of equipment malfunction. 7. Central pharmacy will supply and dispense the medication while the patient is in the hospital. Each foil packet of Tyvaso contains four ampules. Each ampule contains enough medication for one full day of treatment. Due to the high cost of the medication, only one ampule should be dispensed at a time. 8. The patient will self administer four evenly spaced aerosolized treatments during the waking hours every day, under the direct observation of the Respiratory Therapist. 9. Each treatment will consist of a prescribed number of three breath cycles. 4

5 10. Inhaled treprostinil reaches maximum plasma concentration within 15 minutes. Inhaled treprostinil remains detectable in the plasma for up to 3.5 hours after treatment. 11. Common side effects are vasodilation (flushing), increased cough, headache, jaw pain, nausea, and hypotension. 12. Adverse events that are to be reported to the Pulmonary Hypertension Attending or Pulmonary Hypertension NP immediately are: a. Systolic BP falls greater than 20 mm Hg from baseline or registers at or below 80 mm Hg b. Severe nausea, dizziness, lightheadedness c. Shortness of breath d. Chest pain. e. Increase in heart rate by greater than 20 beats per minute from baseline or reaches 120 beats per minute. f. Syncope. g. Hemoptysis h. Hypoxia (Sa02 < 90%) D. Using the Optineb TYVASO inhalation system to administer inhaled treprostinil (Tyvaso) 1. The following sequence of steps describes how to operate and clean the Optineb TYVASO inhalation system a. Wash hands b. Make sure the device is not connected to a power source. c. Make sure device is on a flat surface. d. Fill the chamber of the device with 45 ml of distilled water. There is a silver sensor on the inside wall of the chamber which must be completely covered with distilled water. Do not overfill or the medication cup will not fit correctly. Use only distilled water. e. Obtain a new, cone-shaped medicine cup and inspect it for holes, cracks, or dents. Do not use the medicine cup if it is damaged. f. Insert the medicine cup into the chamber of the device pointing upwards like a bowl, making sure that the bottom tip of the cup is resting in the distilled water. g. Carefully tear or cut open the top of the foil pouch, making sure not to cut the ampules. h. Remove one ampule of treprostinil from the foil pouch. Gently hold the ampule and twist off the top. i. Point ampule straight down towards the medicine cup center to avoid spills. Gently squeeze contents into medicine cup. Squeeze repeatedly until ampule is empty. j. Align and screw the clear plastic assembly onto the device. The assembly attaches in such a fashion that the medication cup will lock into the bottom of the assembly. k. Attach the inhalation piece and mouthpiece to the plastic assembly. l. Insert a clean filter into each filter shell. To install a new filter: Open the filter shell by unscrewing the two halves. Place a new filter in one of the filter shell halves. 5

6 Screw the two halves together until you can twist no further. m. Insert one of the assembled filter shells into the filter shell port on the side of the dome assembly and insert the other filter shell into the port on the bottom of the inhalation piece. The two filter shells are identical and can be used in either opening. Make sure to insert the filter shells straight into their ports, rather than at an angle. If necessary, rotate the inhalation piece. Do not force pieces together. n. Turn the device on by pressing the start/on button. A number will appear on the screen and the power light will be yellow. 2. The following sequence of steps explains how to administer the medication a. Press the START/STOP button to begin treatment. b. The power light turns green, the number of prescribed breaths is displayed, and the device emits two short beeps. c. While the device emits one long beep, exhale completely. d. After the device emits a short beep and while the inhalation indicator light is flashing green, close lips securely around the mouthpiece and inhale deeply. e. Repeat steps a through d to complete a treatment. The screen should count down and display 00 when all breaths of a treatment are complete. f. Note: some older models of the Optineb device will only allow for three breaths to be given at a time. If this is the case, administer breaths in series of three breaths. For instance, if the patient is prescribed nine breaths, the patient will first complete three breaths. The machine must be turned on and off and back on again. The patient then completes another three breaths, until the prescribed amount of breaths have been administered. 3. The following sequence of steps explains how to clean the device a. The device should be cleaned once a day after all treatments have been completed b. Disconnect the device from the power source c. Remove both filter shells d. Twist open both filter shells e. Discard used filters f. Remove the inhalation piece, mouthpiece and dome assembly piece g. The medication cup will stay attached to the dome assembly piece. Remove it by gently squeezing the sides. Discard the used medication cup. h. Remove the baffle plate by inserting a gloved finger into the top of the dome assembly and gently pushing the baffle plate through the bottom of the dome assembly. i. Clean plastic parts including dome assembly, inhalation piece, mouthpiece, both filter shells, and baffle plate by hand in mild, soapy warm water, preferably dish soap. Allow pieces to air dry. j. Dump out any distilled water still present in the medication chamber into the sink. Allow the device to dry upside down. k. Once the accessories are dry, reinsert the baffle plate by gently pressing it into the bottom opening of the dome assembly. This will protect it until the next day's use. 6

7 4. Step by step administration instructions will also be found on the Treprostinil (Tyvaso ) Inhaled Patient Care Order Set in the MAR. E. Procedure for the Initial Start of Inhaled Prostacyclin therapy in the inpatient setting 1. When possible, a representative from the specialty pharmacy will be present for a patient instruction session prior to the initiation of therapy. 2. The Pulmonary Hypertension Attending Physician and Pulmonary Hypertension Nurse on call will be immediately available by telephone. 3. The patient will be placed on telemetry monitoring prior to the initiation of therapy. 4. The Respiratory therapist will directly oversee the patient's self-administration. The patient s vital signs will be checked immediately before the administration of medication, and 5 minutes, 15 minutes and 30 minutes post administration. 5. Initial monitoring will be a collaborative responsibility between the Respiratory Therapist and the Registered Nurse. The Respiratory Therapist will be responsible for communicating to the Registered Nurse the time at which therapy was initiated. 6. The Pulmonary Hypertension Attending will be notified immediately for : a. Systolic BP falls greater than 20 mm Hg or decreases to less than 80 mm Hg systolic. b. Dizziness, lightheadedness c. Increased shortness of breath d. Chest pain e. Increased heart rate greater than 20 beats per minute or reaches 120 beats per minute. f. Syncope. g. Hemoptysis h. Hypoxia (Sa02 < 90%) 7. The second treatment dose will be administered in the same fashion. Vital signs will be taken immediately before the second dose, and 5 minutes, 15 minutes and 30 minutes post administration. 8. After each of the first two doses, the Pulmonary Hypertension Attending will be contacted to report the patient's tolerance and response. At this point the Pulmonary Hypertension Attending will decide whether to titrate dosage. 9. Each time dosage is increased, vital signs will be taken immediately before, and 5 minutes, 15 minutes and 30 minutes post administration. 10. After the patient has tolerated two consecutive treatments at a given dosage, it will not be necessary to check frequent vitals each treatment unless otherwise indicated. Documentation: A. The Respiratory Therapist will scan the medication and document the time of treatment on the scheduled Medical Administration Record (MAR). B. The Respiratory Therapist and/or the Registered Nurse will document vital signs as outlined above. C. Communication between nursing, respiratory, and pharmacy departments and the Pulmonary Hypertension Team shall be recorded under "Clinician Communication" 7

8 tab in Epic. Communication is also encouraged to be documented using a MAR note and/or a sticky note in Epic. Additional Resources: A. Manufacturer instructions and patient resources available online at: References: 1. Archer-Chicko, Christine (2011). Nursing care of patients with pulmonary arterial hypertension. Textbook of Pulmonary Vascular Disease, pp LOE: 8 2. Badesch, D.B., McLaughlin, V.V., Delcroix, M., Vizza, C.D. Olschewski, H., Sitbon O, Barst R., (2004) Prostanoid therapy for pulmonary arterial hypertension. Journal for the American College of Cardiology. 43 (12) LOE:2 3. Baggs, J. G., et al. (1992) "The association between interdisciplinary collaboration and patient outcomes." Heart and Lung LOE: 1 4. Benedict, N, Seybert, A, & Mathier, M. (2007). Evidenced-based pharmacologic management of pulmonary arterial hypertension. Clinical Therapeutics, 29(10), LOE:1 5. Channick, Richard N., Robert Voswinckel, and Lewis J. Rubin. (2012) "Inhaled treprostinil: a therapeutic review." Drug Des Devel Ther 6: LOE: 2 6. Ewert, R, Schaper, C, Halank, M, Glaser, S, & Bollmann, T. (2011). Inhaled iloprost for therapy in pulmonary arterial hypertension. Expert Review of Respiratory Medicine, 5(2), LOE: 1 7. Nadler, S.T. and Edelman, J.D. Inhaled treprostinil and pulmonary arterial hypertension. (2010). Vascular Health Risk Management 2010 (96) LOE: 1 8. Olschewski, H. (2009). Inhaled iloprost for the treatment of pulmonary hypertension. European Respiratory Review, 18(111), LOE: 1 9. Rodehorst, T. Kim, Susan L. Wilhelm, and Linda Jensen. "Use of interdisciplinary communication to understand perceptions of team members' roles." Journal of Professional Nursing 21.3 (2005): LOE: 4 8

9 10. Self TH, Brooks JB, Lieberman P, Ryan MR. (1999) The value of demonstration and role of the pharmacist in teaching the correct use of pressurized bronchodilators. Can Med Assoc J. 128(2): LOE: 4 c