Overall, the clinicians interviewed felt that fentanyl ITS was easy to use for their patients. The patients in this case series consistently reported to their clinician that the product was easy to use. Nurses expressed relief at not having to program PCA settings or manage an additional IV line (or any IV line). One site also indicated that the use of fentanyl ITS with its fixed dosing is an asset as it eliminated unnecessary programming and variability in postoperative pain management. In addition, the physical therapists (physiotherapists) managing the prostate surgery patients noted that mobilizing patients was much easier without an IV line. Fentanyl ITS also reduced issues with IV access and workload associated with IV PCA devices.
The sites emphasized the importance of staff training on how to manage the system. For example, at the site where the bariatric surgeries are conducted, all clinical team members (not limited to the physicians and nurses) who see these patients are trained on fentanyl ITS which allows them to reinforce the training when they see the patient. Also, the center now places a sign above each patient’s bed that says “IONSYS in place” as a reminder for the clinical staff to reinforce the key training points with the patients.
The fentanyl ITS development program enrolled a broad range of surgery types. The labeled indication includes patients with moderate-to-severe postoperative pain without specification as to surgery type. However, when the phase 3 clinical studies were conducted, bariatric surgery was relatively uncommon. In this case series, three patients had bariatric surgical procedures with BMI ranging from 37 to 58 kg/m2. Fentanyl ITS was safe and effective for all three, supporting previous data  that higher BMI patients with postoperative pain can be appropriately treated with the system. Moreover, consistent with the characteristics of this patient population, all three bariatric patients had a history of sleep apnea and none developed signs of clinically relevant respiratory depression while fentanyl ITS was administered. Clinicians must routinely balance the benefit-risk of opioid postoperative pain management with the potential for respiratory depression.
Several of the patients in these case series had significant medical histories and co-morbidities. Two of the patients had a complicated hospital course prior to fentanyl ITS treatment: renal failure and silent MI. These experiences build upon the phase 3 study results and further show that fentanyl ITS can be used for pain management in more complex postoperative patients, within the parameters of the Prescribing Information.
Six of the seven cases were elective or semi-elective surgeries; the perirectal abscess case was an emergent case performed at night. This case was also managed successfully with fentanyl ITS and showed that training the staff in advance can enable appropriate use of the device in surgeries that are not pre-planned.
Titration to Comfort before Initiating Fentanyl ITS
It was repeatedly noted that patients responded better to fentanyl ITS if they were titrated to comfort prior to initiation, which is consistent with the Prescribing Information for fentanyl ITS. These clinicians initiated fentanyl ITS on the medical-surgical unit because they found that patients in the PACU may be too sedated to understand or operate the system, although the system can be applied in the PACU or on the patient floor.
In this series, most patients did not require additional analgesic medication during fentanyl ITS administration; however, the sites reported that it is worthwhile to have PRN orders of opioids and/or NSAIDs to assist with breakthrough pain in case it is required. However, it is important to remember that the concomitant use of fentanyl ITS with other central nervous system depressants can increase the risk of respiratory depression and therefore the clinicians must monitor patients even more closely if using a concomitant opioid.
Medication after Fentanyl ITS
Once patients were able to progress beyond parenteral opioids, they were easily transitioned from fentanyl ITS to the clinician’s standard pre-discharge oral analgesia regimen. Most were switched to the combination of hydrocodone and acetaminophen. This allowed fentanyl ITS to be readily incorporated into each center’s standard-of-care pain management regimen.
When applying fentanyl ITS, it is important to press and hold the system firmly in place, with the sticky side down, onto the patient’s skin for at least 15 s. However, occasionally, the system may loosen from the skin and if this occurs, it should be secured to the patient’s skin by pressing the edges with fingers or securing with a non-allergenic tape to make sure that all edges have complete contact with the skin. It is important to remember not to place tape over the button, light, or digital display.
Application Site Skin Reactions
Consistent with the fentanyl ITS Prescribing Information, some patients experienced redness at the application site. In this case series, none of the site reactions were severe; none required intervention or discontinuation of the product. It is important to train and alert the clinical staff that this can be an adverse event associated with fentanyl ITS use; however, it is typically self-limited.