PROCESS FOR HANDLING ELASTOMERIC PAIN RELIEF BALLS (ON-Q PAINBUSTER AND OTHERS)

PROCESS FOR HANDLING ELASTOMERIC PAIN RELIEF BALLS (ON-Q PAINBUSTER AND OTHERS) REQUIRES SAFETY IMPROVEMENTS From the July 16, 2009 issue Problem: In our May 21, 2009, newsletter we noted an association between the ON-Q PainBuster elastomeric pump and chondrolysis (destruction of cartilage), particularly if the local anesthetic intended to reduce pain after surgery is infused directly into a joint rather than the tissue around it. Since then, we have received numerous reports of potential problems with using ON-Q pumps. Most of these problems can be addressed by hospitals so the pumps can be used safely to provide surgical wound analgesia and/or peripheral nerve block. The ON-Q PainBuster Post-Op Pain Relief System (see Figure 1 in the PDF version of the newsletter) provides continuous infusion of a local anesthetic directly into the patient s surgical site for effective, non-narcotic postoperative pain relief for up to 5 days. Four pump models are available: one with a fixed flow rate that cannot be changed; one that delivers a basal infusion and also allows delivery of on-demand boluses; one that allows the user to adjust the flow rate within a predetermined range; and one with an adjustable rate controller and a bolus device. Various sizes and types of catheters are available to deliver the medication. According to the company, about 700 hospitals are using ON-Q pumps after cardiovascular, cardiothoracic, urologic, gynecological, obstetrical, orthopedic, and general surgical procedures. While the ON-Q pump may provide effective pain relief, numerous hospitals and outpatient surgical centers have reported potentially harmful management issues associated with use of the device. Recently, a hospital reported a serious event that may have been linked to premature emptying of the reservoir ball that holds the medication. A patient had been sent home with an ON-Q pump filled with a local anesthetic. The surgeon asked the patient to come back in 5 days to refill the pump for another 5 days. Two days after the pump had been refilled, the patient was brought to the emergency department (ED) in cardiac arrest. The ED staff noticed that the medication reservoir ball of the ON-Q pump was empty. Initially, they did not know what medication had been delivered to the patient or how fast it had been delivered because the device was unlabeled. (In its simplicity, the ON-Q pump does not record the infusion history, so there was no record of how fast the drug was delivered.) When the ED staff learned that the pump contained a local anesthetic, a drug level was drawn. How-ever, this lab test had to be performed by an external lab, so the results were not readily available to help guide the treatment of the patient or determine the cause of his cardiac arrest. Later, a local anesthetic drug level was found to be elevated, but not alarming. Unfortunately, rescue efforts were unsuccessful and the patient died, although his death was probably not related to the incident. To date, hospital staff can only speculate regarding the cause of the premature

emptying of the medication reservoir perhaps patient tampering and whether drug toxicity played any role in the patient s death. Other potential process problems with ON-Q pump use have been reported and are described below. Used without staff education. We have received reports of patients appearing on postoperative units with an ON-Q pump where staff had never seen the pumps or been educated about their use. Used without pharmacy involvement. In many reported instances, the pumps were piloted in the operating room (OR), and/or used regularly without pharmacy knowledge. Pharmacy s first encounter with the device often occurred when nurses called the pharmacy because the reservoir ball was empty and they didn t know what to do, or when pharmacy staff was informed that a pain ball trial would begin the next day. One hospital reported that the only way pharmacy knew about ON-Q pump use was through unit-based pharmacists who happened to learn about them from nurses. No pharmacy profiling of orders. Even when pharmacy has knowledge regarding use of the devices, orders for the medications are rarely profiled or screened. In many cases, the pumps are started in the OR, and the order is part of the intra-operative documentation. Thus, an order is not sent to the pharmacy for drugs being delivered by the pump. Some pharmacists told us they now utilize a standard order form for ON-Q pumps. One pharmacist told us she had to build special order templates for the pumps. Pharmacists also may have to remember to screen for drug interactions and allergies if such screening does not occur automatically. Medication preparation outside of pharmacy. Many ON-Q pumps are not filled in the pharmacy; they are filled in the OR where there is seldom a system of independent double-checks, and where labeling and hand-off communication may not be sufficient. We recently learned about an error in which the pumps for two patients were filled using a local anesthetic that contained EPINEPHrine, rather than the local anesthetic alone. (Vasoconstrictors such as EPINEPHrine are not recommended for continuous infusion via ON-Q pumps.) In one case, the nurse noticed the error and corrected it after the patient received just 1 ml of the wrong drug. In the other case, the patient developed severe tissue damage and required follow- up care. Pharmacy preparation of the medication has sometimes been met with resistance because surgeons claim they don t know until the end of the case whether they want to use the pump. The product may also be marketed in a way that promotes physician autonomy and touts filling of the pumps by the surgeon or anesthesiologist in the OR as an advantage (a marketing strategy we discourage). One hospital pharmacist reported that she thought the pharmacy was preparing all medications for the ON-Q pumps only to learn that surgeons were also preparing pumps in the OR.

Use with medications other than local anesthetics. The ON-Q pump is designed to deliver local anesthetics to surgical sites for non-narcotic pain relief. The company s product information suggests using ropivacaine, bupivacaine, or lidocaine. However, I-Flow, the company that markets ON-Q, also provides information regarding stability when various local anesthetics are mixed with dexamethasone, ketorolac, morphine sulfate and ketorolac, ceftriaxone, or cefazolin implying that mixing the local anesthetics with other drugs is safe and perhaps even effective. However, the company does not supply data to support this and does not make any specific recommendations regarding use of these products with ON-Q. We have also received reports that surgeons have added vancomycin, and even fentanyl, to the local anesthetic. With a simplistic pump that promises a delivery accuracy of ±15% of the labeled infusion rate (± 20% for models with adjustable flow rates), use with antibiotics and drugs such as ketorolac, morphine, and fentanyl may not be advisable. Varying infusion rates. The accuracy of the pump s rate of delivering medication is dependent on filling the reservoir ball with an exact amount of medication. The proper fill volume is variable based on the type of pump and duration of therapy. Over- or under-filling the ball results in variable rates of infusion. The flow restrictor part of the pump must also be in contact with the patient s skin and be kept away from any cold therapy (e.g., ice packs) or else the medication will infuse more slowly than expected. Taping over the filter may affect the flow rate. Flow rate is also unpredictable if the dial is not clicked into place at the proper numerical setting. Confusion has also been reported when determining the correct rate of infusion for pumps with dual catheters, with each port infusing half of the total volume of medication. If patients receive too much bupivacaine, ropivacaine, or lidocaine the drugs most commonly used with ON-Q pumps cardiotoxicity is possible. Varying concentrations. We heard from a pharmacist who viewed a hospital protocol for ON-Q pumps with more than 17 concentrations available for bupivacaine, ropivacaine, and lidocaine because the staff changed the concentration when they needed to change the dose (similar to the rule of 6). The use of nonstandard concentrations has contributed to preparation and dosing errors. Unlabeled medication. The drug reservoir ball (or ON-Q pump tubing) has been found unlabeled, particularly when the ball has been filled in the OR. In cases where there is no order for the drug or pump, the medication being administered may be unknown by those providing care to the patient. Drug administration documentation. If the pharmacy profiles orders for ON-Q pumps, the drug therapy may appear on the nurses computer-generated medication administration record (MAR). But several hospital staff told us that the ON-Q pump does not appear on their MARs,

and they do not monitor or document the type and amount of drug administered via this delivery method. Extended duration of use. As in the event initially described in this article, some physicians are refilling the ON-Q pump after 5 days of use. However, the manufacturer states that the pump should not be refilled and is only intended for a single use (up to 5 days), after which the pump should be removed and disposed. Longer use may present an infection control concern. Concomitant analgesics. As with other forms of analgesia delivery, unclear maximum doses of the local anesthetics delivered by the ON-Q pump and possible concomitant use of analgesics by other routes of administration are of concern. For example, many long-standing order sets already include intermittent and/or continuous pain medications, which may still be enacted despite use of the ON-Q pump. Since pharmacy may not be aware of the pump s use or be profiling related orders, unnecessary and potentially dangerous duplicate therapy may not be identified. For example, one of our consultants was recently at a hospital where he reviewed a patient s chart with concurrent orders for an ON-Q pump, patient-controlled analgesia, and ketorolac every 8 hours. Safe Practice Recommendations: See Table 1 below for a list of suggested strategies to improve safety when using ON-Q pumps. Please also note: While this article features problems associated with the management of ON-Q pumps, there are other elastomeric pumps manufactured by other companies that may have similar issues. Please take steps to reduce the risk of errors and adverse events with these pumps and, thus, maximize the potential benefits of this form of pain control. In fact, a failure mode and effects analysis (FMEA) should be considered in hospitals that are using these devices or are considering their use. Table 1. Strategies for Safe Use of ON-Q Pumps Before Using the Pumps Grant privileges to surgeons through the credentialing process before they can insert the catheters and prescribe ON-Q pumps. Establish protocols for use of ON-Q pumps which include: indications; models and tubing to be used for each indication; process steps for prescribing, preparing, and dispensing the device and associated medications; required testing of knowledge and skills; handoff communication between providers; patient/family education; and patient monitoring. Have the Pharmacy and Therapeutics Committee approve the drugs that can be administered through the ON-Q pump, taking into consideration the accuracy of the infusion rate (± 15-20% of desired rate) and conditions that could influence the rate (e.g., heat and cold).

Ensure clinical staff education before use even trial use of the pumps. (The manufacturer may provide orientation materials and some of the staff education if requested.) Include the signs of bupivacaine, ropivacaine, and lidocaine cardiotoxicity and the risks associated with pump use, as outlined in this article. Prescribing the Pumps Establish standard order sets for prescribing the pumps and specific medications. Specify any concomitant analgesics that are acceptable or should be avoided. Require activation of the appropriate order set before the patient is transferred from the OR. Use the device for a maximum of 5 days without refills, according to the manufacturer s recommendations. Placing the Catheters and Setting Up the Pumps Ensure proper insertion of the catheter(s) in the tissue and/or adjacent nerves surrounding a wound. Do not insert the catheter directly into a joint. Label the pump with the name of the drug, the concentration, infusion rate (in ml/hour and dose/hour), and start date. Ensure that the adjustable rate controller (available on some models) is clicked into place under the specified rate of infusion. Apply an occlusive dressing over the catheter insertion site. Tape the flow restrictor to the patient s skin. Do not tape over the filter. Dispensing the Pumps and Medication Establish standard concentrations for the local anesthetics (and other drugs, if appropriate) used in the pumps. Also establish pharmacy compounding procedures for preparing any mixtures of drugs. Establish order sets in the pharmacy computer that will facilitate automated screening of the drug(s) being used for appropriate dose, drug interactions, allergies, and duplicate therapy. Require pharmacy preparation of the medication reservoir balls following a protocol that specifies the exact amount of solution to instill based on the duration of therapy and expected rate of infusion. Outsourced compounding can also be utilized. Require an independent double-check in the pharmacy of the drug, strength, and total volume added to the reservoir ball by comparison to the prescriber s order and the protocol. Providing Nursing Care to Patients with Pumps

Ensure that any medications administered via the pump are listed as an entry on the nursing medication administration record. Ensure the occlusive dressing over the catheter site is intact. Regularly check that the flow restrictor is taped to patient s skin for accurate flow rates. Keep the pump at room temperature, and instruct the patient to keep the pump in the carrying case on the outside of clothing. Keep the flow restrictor away from cold therapies (e.g. ice packs). Monitor the patient s level of pain and response to medication while using this device. Remove the rate-changing key from the dial if the patient is discharged home with an ON-Q pump. Keep the rate-changing key with the healthcare provider in case the patient s pump requires adjustment. Secure the plastic cover over the dial with a standard tie wrap. Educating Patients about Pumps Educate patients and caregivers about how the pump works and items to periodically check (e.g., flow restrictor is taped to the skin, medication ball appears to be getting smaller each day, patient s pain is under control). Educate patients about the signs of cardiotoxicity, when to call the physician, and how to clamp the tubing to prevent further drug administration, if necessary. Provide patients with the Patient Guidelinesprovided by the manufacturer of ON-Q pumps (www.iflo.com/prod_onq_classic.php). PROCESS FOR HANDLING ELASTOMERIC PAIN RELIEF BALLS (ON-Q PAINBUSTER AND OTHERS) REQUIRES SAFETY IMPROVEMENTS From the July 16, 2009 issue Problem: In our May 21, 2009, newsletter we noted an association between the ON-Q PainBuster elastomeric pump and chondrolysis (destruction of cartilage), particularly if the local anesthetic intended to reduce pain after surgery is infused directly into a joint rather than the tissue around it. Since then, we have received numerous reports of potential problems with using ON-Q pumps. Most of these problems can be addressed by hospitals so the pumps can be used safely to provide surgical wound analgesia and/or peripheral nerve block.

The ON-Q PainBuster Post-Op Pain Relief System (see Figure 1 in the PDF version of the newsletter) provides continuous infusion of a local anesthetic directly into the patient s surgical site for effective, non-narcotic postoperative pain relief for up to 5 days. Four pump models are available: one with a fixed flow rate that cannot be changed; one that delivers a basal infusion and also allows delivery of on-demand boluses; one that allows the user to adjust the flow rate within a predetermined range; and one with an adjustable rate controller and a bolus device. Various sizes and types of catheters are available to deliver the medication. According to the company, about 700 hospitals are using ON-Q pumps after cardiovascular, cardiothoracic, urologic, gynecological, obstetrical, orthopedic, and general surgical procedures. While the ON-Q pump may provide effective pain relief, numerous hospitals and outpatient surgical centers have reported potentially harmful management issues associated with use of the device. Recently, a hospital reported a serious event that may have been linked to premature emptying of the reservoir ball that holds the medication. A patient had been sent home with an ON-Q pump filled with a local anesthetic. The surgeon asked the patient to come back in 5 days to refill the pump for another 5 days. Two days after the pump had been refilled, the patient was brought to the emergency department (ED) in cardiac arrest. The ED staff noticed that the medication reservoir ball of the ON-Q pump was empty. Initially, they did not know what medication had been delivered to the patient or how fast it had been delivered because the device was unlabeled. (In its simplicity, the ON-Q pump does not record the infusion history, so there was no record of how fast the drug was delivered.) When the ED staff learned that the pump contained a local anesthetic, a drug level was drawn. How-ever, this lab test had to be performed by an external lab, so the results were not readily available to help guide the treatment of the patient or determine the cause of his cardiac arrest. Later, a local anesthetic drug level was found to be elevated, but not alarming. Unfortunately, rescue efforts were unsuccessful and the patient died, although his death was probably not related to the incident. To date, hospital staff can only speculate regarding the cause of the premature emptying of the medication reservoir perhaps patient tampering and whether drug toxicity played any role in the patient s death. Other potential process problems with ON-Q pump use have been reported and are described below. Used without staff education. We have received reports of patients appearing on postoperative units with an ON-Q pump where staff had never seen the pumps or been educated about their use. Used without pharmacy involvement. In many reported instances, the pumps were piloted in the operating room (OR), and/or used regularly without pharmacy knowledge. Pharmacy s first encounter with the device often occurred when nurses called the pharmacy because the

reservoir ball was empty and they didn t know what to do, or when pharmacy staff was informed that a pain ball trial would begin the next day. One hospital reported that the only way pharmacy knew about ON-Q pump use was through unit-based pharmacists who happened to learn about them from nurses. No pharmacy profiling of orders. Even when pharmacy has knowledge regarding use of the devices, orders for the medications are rarely profiled or screened. In many cases, the pumps are started in the OR, and the order is part of the intra-operative documentation. Thus, an order is not sent to the pharmacy for drugs being delivered by the pump. Some pharmacists told us they now utilize a standard order form for ON-Q pumps. One pharmacist told us she had to build special order templates for the pumps. Pharmacists also may have to remember to screen for drug interactions and allergies if such screening does not occur automatically. Medication preparation outside of pharmacy. Many ON-Q pumps are not filled in the pharmacy; they are filled in the OR where there is seldom a system of independent double-checks, and where labeling and hand-off communication may not be sufficient. We recently learned about an error in which the pumps for two patients were filled using a local anesthetic that contained EPINEPHrine, rather than the local anesthetic alone. (Vasoconstrictors such as EPINEPHrine are not recommended for continuous infusion via ON-Q pumps.) In one case, the nurse noticed the error and corrected it after the patient received just 1 ml of the wrong drug. In the other case, the patient developed severe tissue damage and required follow- up care. Pharmacy preparation of the medication has sometimes been met with resistance because surgeons claim they don t know until the end of the case whether they want to use the pump. The product may also be marketed in a way that promotes physician autonomy and touts filling of the pumps by the surgeon or anesthesiologist in the OR as an advantage (a marketing strategy we discourage). One hospital pharmacist reported that she thought the pharmacy was preparing all medications for the ON-Q pumps only to learn that surgeons were also preparing pumps in the OR. Use with medications other than local anesthetics. The ON-Q pump is designed to deliver local anesthetics to surgical sites for non-narcotic pain relief. The company s product information suggests using ropivacaine, bupivacaine, or lidocaine. However, I-Flow, the company that markets ON-Q, also provides information regarding stability when various local anesthetics are mixed with dexamethasone, ketorolac, morphine sulfate and ketorolac, ceftriaxone, or cefazolin implying that mixing the local anesthetics with other drugs is safe and perhaps even effective. However, the company does not supply data to support this and does not make any specific recommendations regarding use of these products with ON-Q. We have also received reports that surgeons have added vancomycin, and even fentanyl, to the local anesthetic. With a simplistic pump that promises a delivery accuracy of ±15% of the

labeled infusion rate (± 20% for models with adjustable flow rates), use with antibiotics and drugs such as ketorolac, morphine, and fentanyl may not be advisable. Varying infusion rates. The accuracy of the pump s rate of delivering medication is dependent on filling the reservoir ball with an exact amount of medication. The proper fill volume is variable based on the type of pump and duration of therapy. Over- or under-filling the ball results in variable rates of infusion. The flow restrictor part of the pump must also be in contact with the patient s skin and be kept away from any cold therapy (e.g., ice packs) or else the medication will infuse more slowly than expected. Taping over the filter may affect the flow rate. Flow rate is also unpredictable if the dial is not clicked into place at the proper numerical setting. Confusion has also been reported when determining the correct rate of infusion for pumps with dual catheters, with each port infusing half of the total volume of medication. If patients receive too much bupivacaine, ropivacaine, or lidocaine the drugs most commonly used with ON-Q pumps cardiotoxicity is possible. Varying concentrations. We heard from a pharmacist who viewed a hospital protocol for ON-Q pumps with more than 17 concentrations available for bupivacaine, ropivacaine, and lidocaine because the staff changed the concentration when they needed to change the dose (similar to the rule of 6). The use of nonstandard concentrations has contributed to preparation and dosing errors. Unlabeled medication. The drug reservoir ball (or ON-Q pump tubing) has been found unlabeled, particularly when the ball has been filled in the OR. In cases where there is no order for the drug or pump, the medication being administered may be unknown by those providing care to the patient. Drug administration documentation. If the pharmacy profiles orders for ON-Q pumps, the drug therapy may appear on the nurses computer-generated medication administration record (MAR). But several hospital staff told us that the ON-Q pump does not appear on their MARs, and they do not monitor or document the type and amount of drug administered via this delivery method. Extended duration of use. As in the event initially described in this article, some physicians are refilling the ON-Q pump after 5 days of use. However, the manufacturer states that the pump should not be refilled and is only intended for a single use (up to 5 days), after which the pump should be removed and disposed. Longer use may present an infection control concern. Concomitant analgesics. As with other forms of analgesia delivery, unclear maximum doses of the local anesthetics delivered by the ON-Q pump and possible concomitant use of analgesics by other routes of administration are of concern. For example, many long-standing order sets already include intermittent and/or continuous pain medications, which may still be enacted

despite use of the ON-Q pump. Since pharmacy may not be aware of the pump s use or be profiling related orders, unnecessary and potentially dangerous duplicate therapy may not be identified. For example, one of our consultants was recently at a hospital where he reviewed a patient s chart with concurrent orders for an ON-Q pump, patient-controlled analgesia, and ketorolac every 8 hours. Safe Practice Recommendations: See Table 1 below for a list of suggested strategies to improve safety when using ON-Q pumps. Please also note: While this article features problems associated with the management of ON-Q pumps, there are other elastomeric pumps manufactured by other companies that may have similar issues. Please take steps to reduce the risk of errors and adverse events with these pumps and, thus, maximize the potential benefits of this form of pain control. In fact, a failure mode and effects analysis (FMEA) should be considered in hospitals that are using these devices or are considering their use. Table 1. Strategies for Safe Use of ON-Q Pumps Before Using the Pumps Grant privileges to surgeons through the credentialing process before they can insert the catheters and prescribe ON-Q pumps. Establish protocols for use of ON-Q pumps which include: indications; models and tubing to be used for each indication; process steps for prescribing, preparing, and dispensing the device and associated medications; required testing of knowledge and skills; handoff communication between providers; patient/family education; and patient monitoring. Have the Pharmacy and Therapeutics Committee approve the drugs that can be administered through the ON-Q pump, taking into consideration the accuracy of the infusion rate (± 15-20% of desired rate) and conditions that could influence the rate (e.g., heat and cold). Ensure clinical staff education before use even trial use of the pumps. (The manufacturer may provide orientation materials and some of the staff education if requested.) Include the signs of bupivacaine, ropivacaine, and lidocaine cardiotoxicity and the risks associated with pump use, as outlined in this article. Prescribing the Pumps Establish standard order sets for prescribing the pumps and specific medications. Specify any concomitant analgesics that are acceptable or should be avoided. Require activation of the appropriate order set before the patient is transferred from the OR. Use the device for a maximum of 5 days without refills, according to the manufacturer s recommendations. Placing the Catheters and Setting Up the Pumps

Ensure proper insertion of the catheter(s) in the tissue and/or adjacent nerves surrounding a wound. Do not insert the catheter directly into a joint. Label the pump with the name of the drug, the concentration, infusion rate (in ml/hour and dose/hour), and start date. Ensure that the adjustable rate controller (available on some models) is clicked into place under the specified rate of infusion. Apply an occlusive dressing over the catheter insertion site. Tape the flow restrictor to the patient s skin. Do not tape over the filter. Dispensing the Pumps and Medication Establish standard concentrations for the local anesthetics (and other drugs, if appropriate) used in the pumps. Also establish pharmacy compounding procedures for preparing any mixtures of drugs. Establish order sets in the pharmacy computer that will facilitate automated screening of the drug(s) being used for appropriate dose, drug interactions, allergies, and duplicate therapy. Require pharmacy preparation of the medication reservoir balls following a protocol that specifies the exact amount of solution to instill based on the duration of therapy and expected rate of infusion. Outsourced compounding can also be utilized. Require an independent double-check in the pharmacy of the drug, strength, and total volume added to the reservoir ball by comparison to the prescriber s order and the protocol. Providing Nursing Care to Patients with Pumps Ensure that any medications administered via the pump are listed as an entry on the nursing medication administration record. Ensure the occlusive dressing over the catheter site is intact. Regularly check that the flow restrictor is taped to patient s skin for accurate flow rates. Keep the pump at room temperature, and instruct the patient to keep the pump in the carrying case on the outside of clothing. Keep the flow restrictor away from cold therapies (e.g. ice packs). Monitor the patient s level of pain and response to medication while using this device. Remove the rate-changing key from the dial if the patient is discharged home with an ON-Q pump. Keep the rate-changing key with the healthcare provider in case the

patient s pump requires adjustment. Secure the plastic cover over the dial with a standard tie wrap. Educating Patients about Pumps Educate patients and caregivers about how the pump works and items to periodically check (e.g., flow restrictor is taped to the skin, medication ball appears to be getting smaller each day, patient s pain is under control). Educate patients about the signs of cardiotoxicity, when to call the physician, and how to clamp the tubing to prevent further drug administration, if necessary. Provide patients with the Patient Guidelinesprovided by the manufacturer of ON-Q pumps (www.iflo.com/prod_onq_classic.php). USP 797 requires elastomerics to be prepared in Clean Rooms. ISO class 5 sterile area or USNFS class 100