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Orthopedic Surgery Toolkit

Medication lessons learned

Simple prescription mistake leads to tragic outcome

This case involves a wheelchair bound, legally blind gentleman. The patient had a history of diabetes with peripheral neuropathy, hypertension, osteoarthritis, degenerative joint disease, hyperlipidemia, and venous insufficiency, with a non-healing venous stasis ulcer to his left lower extremity. He was taking multiple medications, including Coumadin 1 mg each day for presumed peripheral vascular disease. The patient lived with his son who was a college student. The son described his Dad as being fairly independent taking care of his medications and preparing his own meals.

The patient presented to his primary care physician (PCP) for a follow up evaluation of his stasis ulcer. He also requested some prescription re-fills, including his Coumadin prescription. The PCP wrote refill prescriptions for these medications, including a refill for Coumadin 30 tablets at a dose of 10 mg per day, as opposed to Coumadin 1 mg, his maintenance dose for well over a year. The patient’s son picked up the refilled prescriptions from the pharmacy. Neither the PCP nor the pharmacist advised the patient of the change in Coumadin dose.

Three months later, the patient presented to the PCP’s office with complaints of blood in the urine, bleeding from his gums, and bruising.  The patient’s INR was 8.0. The patient reported that the bleeding stopped when he stopped taking Coumadin. The PCP instructed the patient to discontinue his use of Coumadin for one week and to return for a follow-up visit and INR. The PCP did not recognize that the original Coumadin prescription was for 1 mg, not 10 mg.

The patient returned to the PCP’s office within a month for a repeat INR. According to the PCP’s notes, the patient’s hematuria and Coumadin toxicity had resolved. He instructed the patient to resume the previous Coumadin prescription.

The following month, the patient presented to the Emergency Department with complaints of excessive fatigue, feeling faint, severe headache and loss of appetite. He was ecchymotic, with bruises all over his body. His labs were PTT > 290 (26 – 33.2 critical); PT > 140 (9.9 -11.7 critical); INR was unable to be calculated. The patient was diagnosed with Coumadin toxicity, and admitted to the hospital by a neurology consultant. In his deposition, the PCP stated that he had no recollection of being notified of his patient’s admission.

The next day, the hospital nurses found the patient unresponsive. A CT scan of his brain revealed an acute left-sided subdural hematoma with right brain shift. He was transferred emergently to the neurosurgery service at another hospital where he remained comatose until his death two months later.

The allegations against the PCP were that the patient’s Coumadin toxicity was due to this excessive and inappropriately prescribed dose; the PCP failed to recognize that he had prescribed 10x the dose of Coumadin, and the PCP failed to recognize the incorrect dosage at the next two follow up visits.

The plaintiffs also made a claim for punitive damages and attorney’s fees alleging that the PCP displayed a reckless disregard for the care he rendered. Certain facts, particularly with respect to the PCP’s treatment record were fodder for the plaintiff’s case.

There was no expert support for the PCP. The case was settled for a very large amount of money.

Risk Management Commentary:

One of the major issues in this case was that the PCP instructed the patient to return to his prior dosage schedule of Coumadin without checking his medication history. It’s probably reasonable to expect that the pharmacist who filled the 10 mg Coumadin prescription would have called the physician’s office to verify the change or have applied a warning to the prescription and counseled the patient of the change; neither occurred in this case.

Coumadin (warfarin sodium), one of the most commonly prescribed drugs in the United States, has also been identified as one of the top five drug types associated with medication errors. The appropriate use of Coumadin has been identified as an important indicator of high-quality health care and patient safety.

Some risk management considerations when prescribing anticoagulants:

  • Become familiar with anticoagulation guidelines and consider how following these guidelines will affect your patient.
  • Establish a process for tracking/monitoring patients on anticoagulation therapy. Tools may include tracking logs, computer appointment software, dedicated personnel, etc.
  • Determine and document who will manage the patient’s anticoagulation while the patient is in the hospital, and who will resume the management after discharge.
  • Ensure the patient knows who to contact to manage their anticoagulation therapy once they leave the hospital.
  • Provide initial and ongoing patient education
  • When indicated, include the patient’s family in your discussions.
  • Remind patients to ask questions if the pharmacy dispenses tablets of a different size or color. A legally blind patient such as the patient in this Claim Lesson may not be as attentive to a change in pill colors or shapes.

Some Published Guidelines for the Use of Anticoagulants

The American College of Chest Physicians’ guidelines are available at www.guideline.gov or in the June 2008 issue of Chest, available at www.chestjournal.org.

The American Heart Association/American College of Cardiology at: http://www.acc.org/qualityandscience/clinical/topic/topic.htm, search topic: anticoagulants

Several national specialty societies have also published guidelines related to anticoagulation in specific patient populations. These guidelines are available at www.guideline.gov.

Patient monitoring/medication management

This case involves a 32 y/o white, married male who was initially diagnosed with atopic dermatitis in year 2000. At that time his physician prescribed 40 mgs of prednisone for seven days, followed by 20 mgs for an additional seven days. Two years later the patient presented to a second physician with the same symptoms. At that time he stated, “I can’t go on living like this.” After a lengthy discussion of the risks and benefits, the patient agreed to proceed with a plan of care that included taking prednisone. This physician instructed the patient to “take 10 mgs daily until clear,” then to try to reduce the dose to 10mgs every other day. He scheduled the patient for a two month follow-up in March. The patient did not show up for his March appointment. A week later, the patient called the office requesting a prednisone refill. The physician was not in the office. His Physician’s Assistant gave the patient a prescription for 30 additional prednisone pills. Two months later the patient called again for another refill. The PA gave him 20 pills with no refill. Two weeks after that refill, the patient called for another. He had again missed his scheduled follow-up appointment. The PA gave him just enough pills until he could be seen. The patient did return to the office in mid-June and was seen by that PA. The PA provided a three month prescription of prednisone with no refill. The patient was a no-show for his September appointment, but called in October for a prescription refill. When the physician pulled the record, he wrote a note that the patient was to receive no more prednisone. That same month the patient began experiencing hip pain, and was diagnosed by MRI as having developed avascular necrosis in both of his hips. Subsequently, the patient underwent surgery on both hips and became a candidate for full bilateral hip replacements.

In summary, after having had one initial visit at the beginning of the year, this patient had been prescribed multiple 30 day courses of prednisone, 10 mg /day in February, March, April, May and June. He showed for one follow-up visit in June with the PA, who continued his prednisone prescriptions in July, August and September.

The Allegations

The lawsuit filed two years later alleged the physician failed to monitor prednisone therapy resulting in the patient’s development of avascular necrosis.

Defenses

Our primary defense in this case was that it was not definitive that prednisone in these low doses was the cause of the plaintiff’s avascular necrosis, as opposed to prednisone prescriptions provided by the patient’s first physician, and prior to seeing our physician. The patient did not voice complaints of hip pain in his June follow-up visit. The physician’s office notes clearly state he went over the risks associated with prednisone. Despite these risks, the patient insisted that prednisone was “the only thing that worked” for his condition. He would accept no alternative or more conservative forms of treatment. The patient was also non-compliant, and did not keep his office appointments. During the nine months of treatment the physician’s office continued to tell him that they were not going to continue the prednisone therapy unless he kept his appointments. Despite that warning, the PA continued to provide the telephone refills.

Risk Management Commentary & Advice

  • Our experts could not provide full support because it was concluded that the physician had not provided adequate supervision of the PA.
  • In addition to monitoring patients receiving certain medications, it is important to involve the patient in his/her care by providing the patient with practical and relevant information concerning the medications prescribed, and the overall goals of the management plan.
  • Physicians should emphasize to patients the importance of following up with scheduled appointments, and taking the medication(s) as prescribed. Patients should be made aware of serious, well-recognized risks, as well as the potential benefits of taking certain medications.
  • Physicians should consider referring patients to an appropriate specialist if the patient’s condition does not improve after a few months of following a medication treatment plan.
  • Offices should have refill monitoring policies in place, and supervise staff authorized to provide refills.

Disposition

With the physician’s consent, this case settled for a moderate amount.

Hospital employees implicated in patient’s death from fentanyl toxicity

The patient presented to the ED, reporting having been bitten on the middle finger of his right hand by his pet cat six days earlier.  He had a significant history of narcotic seeking behavior. The cat bite incident began a long, stormy course involving multiple hospitalizations, numerous long courses of various antibiotics, and multiple surgical procedures by an orthopaedic hand surgeon. Complete healing and resolution of infection was achieved six months after the patient’s initial presentation.

Three weeks later, the patient presented to the ED reporting that he had cut his right middle finger in the exact area of the previous wound. He was found to have a 4 cm gaping laceration with visible laceration to the tendon. The hand surgeon performed an incision and drainage and sent the patient home the same day.  Eleven days later, the patient again presented to the ED complaining of increased pain and swelling of his right middle finger. His right hand was noted to be swollen twice the size of his left hand, visibly red with drainage. The hand surgeon’s partner admitted the patient to the hospital, initiated pain management with a 50 ug Duragesic (Fentanyl) patch and an infectious disease (ID) consult.  ID began management of the patient, initiating therapy with four antibiotics, including Biaxin (clarithromycin).

On the fourteenth admission day, the hand surgeon took the patient to the operating room. The previous tendon repair had been completely disrupted, necessitating a tendon graft.  The surgeon found no obvious abscess pocket and all wound and blood cultures were negative for growth. He wrote orders to resume the antibiotics recommended by ID, the Duragesic patch initiated by his partner, morphine via PCA pump for breakthrough pain, and the patient’s other routine medications. The patient’s Duragesic patch was placed at approximately 3 pm, the patient’s wife arrived shortly afterwards to visit for several hours. Other than reporting her husband being drowsy, the wife recounted she noticed nothing unusual about her husband and left the hospital.  After dinner, a nurse found the patient face down on his bed and in cardiac arrest. Despite aggressive resuscitative measures, he was pronounced dead an hour later.

The Duragesic patch was missing from the patient at the time of the autopsy, leading to the question as to whether the patient may have ingested it. The patch was never located.  Upon investigation, it was discovered that hospital personnel dispensed and applied a 75 ug Duragesic patch as opposed to the 50 ug Duragesic patch ordered. Further, it was discovered that the manufacturer of the patch had issued a recall of the 75 ug patches due to rapid defective dissemination from a faulty seal on the patch. Lot numbers for the faulty patches were traced back to the hospital supplier.

An autopsy report stated, “Subject died as a result of Fentanyl toxicity (Fentanyl level 5.4 ug/L) with hypertensive heart disease, cardiomegaly, and pulmonary edema…surreptitious medications administered by third party…trace amounts of cocaine in his system.”

Allegations:

The following allegations were made against the defendant surgeon and his partner.

  • Fentanyl patches were contraindicated for use in the acute post-operative period
  • The macrolide antibiotic (Biaxin) exacerbated the metabolism of Fentanyl causing respiratory depression, arrest, and death.

Disposition: The claims against the hand surgeon and his partner were dismissed.  The Plaintiff settled cases with the Duragesic patch manufacturer, the hospital and its employees.

Risk/Patient Safety Commentary:

  • Experts opined the hospital employees failed to adhere to the standard of care by dispensing an incorrect dosage of Duragesic patch, and failing to notify the prescribing physician of the potentially fatal effects of co-administration of macrolide antibiotics and other opioids.

Experts rejected the theory that the patient ingested the patch, opining that his Fentanyl level would have been higher than 5.4 ug/L found at autopsy.  Experts also pointed out the patient tolerated the initial Fentanyl dose, demonstrating no overt signs of developing Fentanyl toxicity.  Although the toxic/lethal dose of Fentanyl ranges from 3.0-28.0 ug/Liter, this patient’s blood level of 5.4ug/L is difficult to interpret because he was a chronic opioid user.  Generally, the expected therapeutic blood range of Fentanyl is 1.1-2.6 ug/L.

  • Experts further opined that in the case, Biaxin did not exacerbate the Fentanyl level because the Biaxin dosages had been adjusted.

Patient Safety Suggestions:

In August 2012, the Joint Commission issued a sentinel event alert on the safe use of opioids in hospitals, noting that opioid analgesics rank among the drugs most frequently associated with adverse drug events.[1] As cited in the report, some of the causes for adverse events associated with opioid use are:

  • Lack of knowledge about potency differences among opioids;
  • Improper prescribing and administration of multiple opioids and modalities of opioid administration (i.e., oral, parenteral and transdermal patches); and
  • Inadequate monitoring of patients on opioids.

According to a special report on postoperative opioid-induced respiratory depression, “The addition of continuously displayed metrics that demonstrate adequate oxygenation and ventilation combined with smart analysis algorithms can help clinicians detect respiratory deterioration early on, in order to provide effective interventions while maintaining patient safety.”[2]

The Joint Commission suggests these actions, among others[3]:

  • Implement effective processes, policies and procedures for the ongoing clinical monitoring of patients receiving opioid therapy, including, but not limited to, performing serial assessments of the quality and adequacy of respiration and depth of sedation.
  • Utilize safe information technology to monitor opioid prescribing.
  • Conduct appropriate education and training.  Advise clinicians who prescribe pain medications to use both pharmacologic and non-pharmacologic alternatives, including multi-modal adjuvant therapies (e.g., physical therapy, acupuncture, manipulation or massage, ice, music therapy).
  • Provide standardized tools that can be used to screen patients for risk factors associated with over sedation and respiratory depression.  Among the available screening tools for patients in the acute care setting are the Pasero Opioid-Induced Sedation Scale (POSS) and the Richmond Agitation-Sedation Scale (RASS).

Please refer to the full Sentinel Event Alert for details regarding recommended actions.  The full Sentinel Event Alert is available online at The Joint Commission’s website:

http://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf

Drug-Drug Interactions

Determining whether a patient will experience drug-drug interactions usually requires the intervention of a clinical pharmacist.  In this particular case, experts did not believe Biaxin (clarithromycin) interacted significantly with Fentanyl.  However, clarithromycin will increase the level or effect of Fentanyl transdermal by affecting hepatic/intestinal enzyme CYP3A4 metabolism, causing possible serious or life-threatening interaction.  It is important to use alternatives, if available. If co-administration of CYP3A4 inhibitors with Fentanyl is necessary, monitor patients for respiratory depression and sedation at frequent intervals and consider Fentanyl dose adjustments until stable drug effects are achieved.[4]

References:

[1]The Joint Commission. "Safe use of opioids in hospitals." Oakbrook Terrace, IL, August 8, 2012.

[2]Overdyk, Frank, Michael A. DeVita, and Chris Pasero. "Special Report: Postoperative opioid-induced respiratory depression: Current challenges and new developments in patient monitoring." Anesthesiology News, October 2012: 1-8.  (Emphasis added.)

[3]Ibid

Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.