Improving Patient Safety
Patti Cornish, Sandra Knowles, and Dr. Ed Etchells, Patient Safety Service
Opioids, also known as narcotic analgesics, (e.g., morphine, HYDROmorphone, oxycodone, fentanyl) are high-alert drugs, because there is an increased risk of harm when they are used in error. Errors are not necessarily more common with high-alert drugs than other drugs, but when they occur, the consequences are potentially more devastating.
The pharmacists with the Patient Safety Service review all e-Safety reports involving medication and look for trends. Information from Sunnybrook’s e-Safety Reporting system from the past 9 months indicates that medication incidents involving opioid analgesics are commonly reported. Opioid analgesics constitute the largest single category of drugs involved (i.e., 15% of all reports).
Fortunately, the vast majority of opioid errors at Sunnybrook from Jan-Sep 2008 were not associated with any significant harm; in only 7% of the incidents was the harm listed as moderate or severe at the time of the report. In terms of specific opioids mentioned in the e-Safety reports, the breakdown was as follows: hydromorphone – 31%; morphine – 26%; oxycodone/OxyCONTIN® - 23%; fentanyl – 7%; and others – 13%.
This newsletter is intended to highlight three commonly reported errors with opioids and provide some suggestions for safety improvements.
Confusion between HYDROmorphone and Morphine
Case: A 93-year-old female patient was ordered morphine 2 mg subcutaneously q4h prn post-operatively. Both HYDROmorphone 2 mg/1 mL vials and morphine 2 mg/1 mL ampoules were stocked in the narcotic drawer on the patient care unit. On one occasion, HYDROmorphone 2 mg was inadvertently selected from the narcotic drawer and administered to the patient instead of morphine 2 mg. Shortly thereafter, the patient seemed unusually groggy and the error was identified. The physician was informed and the patient was closely monitored for several hours – vital signs remained stable and the patient recovered completely.
Mix ups between HYDROmorphone and morphine are common and potentially serious errors. Although in this situation the patient recovered, confusion between these two drugs can be fatal. A high-profile error occurred several years ago at an emergency department of a hospital in Alberta where a 69-year-old patient received HYDROmorphone 10 mg intramuscularly instead of 10 mg of morphine. The patient was discharged from the emergency department shortly after the drug had been administered, deteriorated on the drive home, arrested and died at another rural Alberta hospital.
HYDROmorphone is a very potent opioid – it is generally considered to be at least five times more potent than morphine, meaning that a dose of 10 mg of HYDROmorphone is equivalent to at least 50 mg of morphine. Over the past decade, the role of HYDROmorphone in acute and chronic pain management has been increasing. HYDROmorphone is often used when patients are unable to tolerate the adverse effects of morphine. As well, HYDROmorphone is becoming increasingly preferred for use in elderly patients or those with renal or hepatic impairment. As a result of this more extensive usage, the availability of HYDROmorphone in patient care areas has been necessarily increased, enhancing the potential for errors and confusion with morphine.
There are several important factors that contribute to the risk of substitution errors with HYDROmorphone and morphine:
The drug names both look-alike and sound-alike.
Both HYDROmorphone and morphine injections are available in the same strengths – i.e., 2 mg/1 mL and 10 mg/1 mL. For the oral dosage forms of these drugs, the strengths are different; however, substitution errors are also reported with the oral products.
Lack of familiarity with HYDROmorphone (some of the reported mix-ups have been due to the mistaken belief that HYDROmorphone is a generic or chemical name for morphine).
Over the past few years, several strategies have been implemented at Sunnybrook to safeguard the use of HYDROmorphone. First and foremost, the high concentration injectable formats of HYDROmorphone (i.e., ≥ 10 mg/1 mL) have been eliminated as much as possible from patient care areas (exceptions include palliative care, oncology, intensive care). Our Sunnybrook "in-house" drug labels and narcotic documentation records use TALLman lettering to emphasize the "HYDRO" portion of HYDROmorphone, to help distinguish it better from morphine. Despite these strategies, there is still an ongoing risk of substitution errors with HYDROmorphone and morphine and further attention to this problem is required. Referring to HYDROmorphone by its traditional brand name "Dilaudid®" to reduce name confusion with morphine has been considered. However, the availability of several generic HYDROmorphone products makes this strategy problematic to implement.
The following safety tips are simple improvements that can be employed in any patient care area to further minimize the risk of errors with these opioids.
Safety Tips to Reduce the Risk of Errors with HYDROmorphone and Morphine
1. Ensure that staff is familiar with the difference between HYDROmorphone and morphine – i.e., HYDROmorphone is five times more potent than morphine. [a pocket card on equianalgesic doses of opioids is available from Pharmacy and also on SunnyNet: http://sunnynet/data/pharmacy/htdocs/misc/Opioid_Dose_Equiv_Card.pdf]
2. In narcotic storage areas, segregate HYDROmorphone from morphine injection (e.g., place in separate compartments of the narcotic drawer, store on different shelves in the narcotic cupboard).
Outer Packaging
Morphine Ampoule and HYDROmorphone Vial
3. If high concentration HYDROmorphone injection (10 mg/1 mL) is issued to a patient care area to meet the needs of a specific patient, ensure that it is returned to pharmacy as soon as the patient is discharged or no longer requires it.
4. Always read back telephone or verbal orders to the prescriber to ensure that you have heard the correct drug name. If needed, ask for clarification by using HYDROmorphone’s brand name (e.g., Do you mean Dilaudid®?).
5. Consider the role of an independent double-check before administration of injectable opioids. [see link to Sunnybrook’s procedure for independent double-checks: http://sunnynet/Default.aspx?cid=100865&lang=1]
6. When implemented, Computerized Provider Order Entry (CPOE) will help to reduce the risk of errors at the time of ordering by including TALLman lettering for all HYDROmorphone entries, accompanied by the brand name "Dilaudid®".
Confusion between Short- and Long-Acting Oral Opioid Analgesics
Sustained release (long-acting) oral formulations of opioid analgesics are designed to deliver the medication gradually over an 8- or 12-hour period. This compares to immediate-release (short-acting) opioid analgesics that require doses to be administered every 2 to 4 hours. When properly used, long-acting opioid analgesics provide a decrease in frequency of administration, longer periods of consistent pain control and may lower the incidence of adverse effects. Short-acting opioid analgesics are often used in conjunction with long-acting opioids to help manage breakthrough pain. Unfortunately, confusion may occur between the long- and short-acting formulations of opioid analgesics, especially when they contain the same drug in the same dose. Although most medication error reports document confusion with short- and long-acting formulations of oxycodone (i.e., oxycodone and OxyCONTIN®), there have also been reports with HYDROmorphone (HYDROmorphone and Hydromorph CONTIN®) and morphine (Statex® and MS CONTIN®, M-Eslon®).
When a long-acting opioid analgesic is inadvertently substituted for a short-acting preparation, this can potentially result in accumulation of the opioid analgesic leading to toxicity. For example, a patient was ordered short-acting oxycodone 10 mg orally every 2 hours when needed. The long-acting product (OxyCONTIN® 10 mg) was selected in error and several doses were administered every 2 hours because the patient was not experiencing adequate pain relief. This is explained by the fact that OxyCONTIN® slowly releases the drug for absorption and peak blood levels are not achieved for several hours. After 8 to 12 hours, the patient became excessively sedated due to the cumulative effect of repeated doses of OxyCONTIN®. The error was recognized and the patient recovered completely.
Conversely, when a short-acting opioid analgesic is accidentally substituted for a long-acting preparation, this may result in excessive opioid effects initially, followed by lack of pain control later in the dosing interval. For example, a patient was scheduled to receive a long-acting product, Hydromorph CONTIN®, 12 mg orally every 12 hours. Inadvertently, immediate-release HYDROmorphone 12 mg was given. Since the immediate-release preparation is formulated to release HYDROmorphone rapidly and provide analgesia over a 3 to 4 hour period, the patient experienced excessive sedation within one hour of administration, followed by the need for breakthrough medication in the last half of the dosing interval due to inadequate pain control.
Confusion between the short- and long-acting formulations of opioid analgesics may be the result of several contributing factors including:
Lack of awareness of the differences between the immediate- and sustained-release formulations of opioid analgesics. At Sunnybrook, a Table outlining the characteristics of commonly used oral narcotic preparations (the "pink sheet") is available in every narcotic binder.
Similarity between the names of the various preparations (e.g., oxycodone and OxyCONTIN®; HYDROmorphone and Hydromorph CONTIN®). At Sunnybrook, all long-acting opioid formulations that are packaged "in-house" have fluorescent pink labels and auxiliary stickers ("long-acting") attached to the package. (see photos in Figure 2)
Figure 2: Oxycodone Immediate-Release and Sustained-Release (OxyCONTIN®) Packaging
Safety Tips:
1. Physically separate short- and long-acting preparations of opioid analgesics in the narcotic storage area (e.g., place in different compartments of the drawer or store on separate shelves in a cupboard).
2. Understand the differences between short- and long-acting products; short-acting formulations are typically administered every 2 to 6 hours and long-acting products are administered no more frequently than every 8 to 12 hours. [see link to document on oral opioid products: http://sunnynet/data/pharmacy/htdocs/misc/Opioid_Oral_Products_Table.pdf]
3. Never crush or allow patients to chew long-acting products – this will destroy the sustained-release properties of the product.
4. When implemented, Computerized Provider Order Entry (CPOE) will help to reduce the risk of ambiguous orders by using full drug names and clearly designating which products are sustained-release. As well, CPOE will include default dosing options to ensure that immediate- and sustained-release products are ordered at appropriate intervals.
Fentanyl Patches: Caution Needed
There have been several patient deaths linked to inappropriate prescribing of the fentanyl patch in opioid-naïve patients despite warnings from Health Canada, the US Food and Drug Administration and the pharmaceutical manufacturer. Luckily we have not had a reported serious adverse event at Sunnybrook, although numerous medication incident reports highlight issues surrounding the use of the fentanyl patch.
Case: A 65-year-old woman with a history of osteoarthritis of the right knee underwent a right total knee replacement. Prior to surgery, she was on NO regular opioid pain medication. Post-op, her pain was well managed with oxycodone, gabapentin and acetaminophen, although she experienced severe nausea and vomiting in addition to extreme drowsiness. Her gabapentin was discontinued and her long-acting oxycodone (OxyCONTIN®) dose was reduced from 20 mg every 8 hours to 5 mg every 8 hours over a three-day period, supplemented with short-acting oxycodone for breakthrough pain.. Despite these changes, the nausea and vomiting continued and the patient refused further OxyCONTIN® doses. On the weekend, the patient was started on fentanyl patch 50 mcg to be applied every 3 days in order to maintain pain control and to possibly reduce her nausea and vomiting. Concern was raised by an RN due to:
Inappropriate use of the fentanyl patch: the fentanyl patch is not recommended for relief of post-op pain
Inappropriate dose: on the previous day, the patient had received a total oxycodone dose of 45 mg (equivalent to 75 mg of morphine) which translates to a 25 mcg fentanyl patch (not 50 mcg as prescribed)
The fentanyl patch was discontinued two days later. Luckily, the patient did not develop any adverse effects from this event.
Fentanyl patches contain a very strong opioid and it is imperative that the following best safety practices be followed in the prescribing and use of this product:
• Fentanyl patches should NOT be used for the management of short-term, acute or post-op pain. Non-tolerant patients may develop respiratory depression, potentially leading to death.
• Fentanyl patches can be used for the management of persistent, chronic moderate to severe pain. They should ONLY be considered for use in adults who have already been receiving opioid therapy for a minimum of one week at a total dose of at least 60 mg/day oral morphine or equivalent. (A fentanyl patch of 25 mcg/hour is equivalent to approximately 60 to 130 mg of oral morphine per day).
• Fentanyl patches are intended for use in patients who require continuous (around the clock) opioid administration for an extended period of time.
• Fentanyl patches are generally administered every 3 days. It is important that the previous patch be removed at the time of application of a new patch since there is enough residual drug remaining in the old patch to potentially cause harm.
• A heat source should NOT be applied to the patch (e.g., heating pad, hot water bottle) as this can result in increased and/or faster release of fentanyl from the patch.
• Used patches contain residual drug and most be disposed of safely.
Correct disposal of used patches in hospital: fold the sticky sides together and dispose of in the sharps containers.
Correct disposal of used patches in the community: fold the sticky sides together and flush the used patch down the toilet.
• Fentanyl patches are available as 12, 25, 50, 75 and 100 mcg/hour patches. Cutting of the patch to accommodate unusual doses must NOT be done as this can result in leakage and uncontrolled release of the medication.
Safety Tips:
1. Fentanyl patches should only be used in patients who have been on a stable dose of an opioid analgesic (e.g., morphine, oxycodone, hydromorphone) for a minimum of one week.
2. Never cut fentanyl patches.
3. Always remove the previous fentanyl patch before applying a new one.
4. Dispose of used fentanyl patches in the sharps container (NOT the regular garbage).
The Patient Safety Service would like to thank Mona Sawhney of the Acute Pain Service at the Holland Centre for reviewing this newsletter.
No comments:
Post a Comment