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Onboarding Advanced Practice Clinicians

Medication management

Record keeping - medication orders, prescriptions and refills

One of the Joint Commission’s National Patient Safety Goals is to “maintain and communicate accurate patient information.”1 Communication errors and issues related to medications are highly associated with adverse events and medical liability claims. According to data from the Physician Insurer’s Association of America, in 2012, medication errors ranked among the top five most prevalent chief medical factors in closed claims.2

Safe medication practices call for accurate record keeping. Safe prescribing is difficult to accomplish without a complete medication record. It is recommended that providers maintain an up-to-date prescription refill list and display it in a prominent or easy-to-find location. When providing refills, document the drug name, strength, frequency, quantity given, and date to discontinue use with initials. Document the reason for discontinuing a certain medication for future reference. Guidance from ECRI (2013) states,

Maintaining the accuracy of medical records regarding each patient’s medication regimen has become the focus of intense efforts across the continuum of care to ensure that the drugs the patient is taking are reviewed at all transitions in care—a process known as medication reconciliation. The purpose is to avoid errors of omission, duplication of therapy, and drug to drug and drug to disease interactions.3

In office-based settings where there is more than one physician or provider, errors can occur when important information is not documented or not readily available in the medical record. It is important that medication information be documented in a consistent location and in a manner that is understood by all providers involved in the care of the patient. Communicating about the medication list, making sure it is accurate, and reconciling any discrepancies whenever new medications are ordered or current medications are adjusted, are essential to reducing the risk of transition-related adverse drug events.

Authorization for prescription renewals

It is recommended that providers establish reliable office policies for how prescription requests from patients will be handled. When staff members are authorized to provide refills pursuant to a written protocol, it is suggested that physicians sign off on all protocols before they are implemented. It is prudent to periodically review the protocols and maintain copies of any that are revised or discontinued.

Although the need for patients to obtain prescription refills is an inevitable part of any medical practice, it must be emphasized that clinical reviews are essential for safe medication prescribing. The decision to utilize written protocols should be weighed against the risks of a delay in a full medical assessment. The disadvantage is that this process may bypass opportunities to provide preventive care and can jeopardize patient safety.

Some issues to consider when establishing safe medication refill guidelines:

  • Establish a timeframe for addressing all refill requests (i.e. 24, 48 hours)
  • Establish the manner in which urgent requests will be handled (for example, they may be directed to the physician immediately)
  • Identify the medications that are considered “urgent” medications, such as those for hypertension, asthma, seizures, diabetes.
  • Identify non-urgent medications such as those prescribed for acne, allergy, and contraceptives.
  • Identify the medications that require provider approval, e.g. controlled substances, oral steroids, and antibiotics.
  • Establish restrictions for the number of times a refill may be issued and time frames when patients are expected to have monitoring visits before being given more refills.

Example:

Request #Supply may RxRefillsComments1st30 days Make appointment2nd15 days Make appointment;3rd7 days Make appointment4thnone Make appointment

You may also specify any laboratory information needed prior to refilling certain medications. See example below.

Medication;Labs/Information NeededRefills approvedDiabetic (Metformin, Insulin, Glipizide, Actos)BMP, Normal Cr, AIC90 days + 1 refill

It may be helpful to establish documentation requirements for the office staff for prescription refills. For example:

  • The next scheduled appointment date and time
  • The date of the last office visit and date of last prescription written for requested medication
  • The date of the last well women exam for HRT or OCP requests

Other suggestions include:

  • Provide sufficient drug quantities and refills to last beyond the next appointment.
  • Update all prescriptions at every patient visit.
  • Use EHR software to prompt sufficient refills and coverage verifications during the prescribing moment.
  • Preload prescriptions with instructions to allow substitute dosage forms.
  • If patients run out of medication before their next planned visit, investigate whether appointment-scheduling strategies are insufficient or drugs are being diverted.
  • Avoid automatically writing a new prescription when a patient changes pharmacies. Pharmacists may transfer a prescription's remaining refills between pharmacies.1

Keep in mind that prescribing laws may vary from state to state and can change over time. Physicians are advised to check with their state board of pharmacy or health licensing board to determine the rules in their particular area.

Post-discharge medication reconciliation

Patient safety initiatives have recently placed a greater focus on the need for improved communication and care coordination, particularly at transitional points. Communication among the healthcare team and coordination of care is critical to improving patient outcomes and reducing professional liability claims. Medication reconciliation is an important patient safety initiative to identify changes in prescribed medications, particularly in elderly patients.

A transitional point in care, such as a recent hospitalization, can be a vulnerable time for an adverse medication event or a change in status to occur. One observational study showed that 1.5 new medications were initiated per patient during hospitalization, and 28% of chronic medications were canceled by the time of hospital discharge. Another observational study showed that at one week post-discharge, 72% of elderly patients were taking incorrectly at least one medication started in the inpatient setting, and 32% of medications were not being taken at all.1

Estimates suggest that 46% of medication errors occur on admission or discharge from a hospital.2 Therefore, medication reconciliation is a critical piece of care coordination post-discharge for all individuals who use prescription medications.

Underscoring the significance of medication reconciliation, measures are included in the Physician Quality Reporting System (PQRS). PQRS is a reporting program that uses a combination of incentive payments and negative payment adjustments to promote reporting of quality information by eligible professionals (EPs). Beginning in 2015, the program also applies a negative payment adjustment to EPs who do not satisfactorily report data on quality measures for covered professional services.

The measure pertaining to medication reconciliation is #46; percentage of patients aged 18 years and older discharged from any inpatient facility (eg, hospital, skilled nursing facility, or rehabilitation facility) and seen within 30 days following discharge in the office by the physician, prescribing practitioner, registered nurse, or clinical pharmacist providing on-going care who had a reconciliation of the discharge medications with the current medication list in the outpatient medical record documented.3

The PQRS offers the following guidance related to medication reconciliation in the ambulatory setting:

  • First, a medication list must be collected. It is important to know what medications the patient has been taking or receiving prior to the outpatient visit in order to provide quality care. This applies regardless of the setting from which the patient came — home, long-term care, assisted living, etc. The medication list should include all medications (prescriptions, over-the-counter, herbals, supplements, etc.) with dose, frequency, route and reason for taking it. It is also important to verify whether the patient is actually taking the medication as prescribed or instructed, as sometimes this is not the case.

    At the end of the outpatient visit, a clinician needs to verify three questions:

    1. Based on what occurred in the visit, should any medication that the patient was taking or receiving prior to the visit be discontinued or altered?
    2. Based on what occurred in the visit, should any prior medication be suspended pending consultation with the prescriber?
    3. Have any new prescriptions been added today?4

Providers are encouraged to improve the accuracy of medication lists by providing performance feedback and training to the healthcare team and increasing patient participation in the medication reconciliation process.5

Maintaining a medication list in the medical record

Accurate medication records are central to delivering safe, effective clinical care. Drug-drug interactions, drug-disease interactions, incorrect doses, omissions and duplications are often attributed to outdated and incomplete medication lists. In emergency situations, medical records may serve as the only source of information on a patient’s medications, thereby performing a critical function in that person’s care.

Furthermore, medication lists represent one of the most important components of an electronic health record (EHR) since they are used for filling refill requests, assessing quality, performing research, and for informing computerized clinical decision support.

Maintaining accurate medication records is a challenge. A multitude of factors such as patients’ lack of knowledge of their medications, physician and nurse workflows, and lack of integration of patient health records across the continuum of care — all contribute to a lack of complete medication reconciliation. In addition, patients change their medications frequently, often visit more than one physician and may use undocumented over-the-counter medications. Both patient and provider interventions are necessary to facilitate a collaborative approach to medication management.

Medication Reconciliation

The process recommended for providers to maintain the most complete and accurate list possible of a patient’s current medications is known as “medication reconciliation”.

Medication reconciliation is a formal, standardized process that includes the following steps:

  • Develop a medication form or format most workable for your group.
  • Engage the patient in the process
  • At each patient visit obtain a complete, accurate list of the medications the patient is taking, and compare this list to the list documented in the medical record.
  • Ask the patient about medications he/she may be taking from other providers and add these to your list.
  • Ask the patient about medications he/she may no longer be taking and delete these from your list.

A comprehensive list of medications should include all prescription medications, herbals, vitamins, nutritional supplements, over-the-counter drugs, vaccines, diagnostic and contrast agents, radioactive medications, parenteral nutrition, blood derivatives, and intravenous solutions (hereafter referred to collectively as medications). Over-the-counter drugs and dietary supplements are not currently considered by many clinicians to be medications and thus are often not included in the medication record. As interactions can occur between prescribed medication, over-the-counter medications or dietary supplements, all medications and supplements should be part of a patient’s medication history and included in the reconciliation process, which in turn creates the potential for error.

Commonly overlooked medications include birth control pills, inhalers, eye drops, patches, herbal medicines and medications prescribed by other physicians. As you gather this information, ensure that each drug’s brand name, generic name, strength and frequency are documented with the current date.

  • Provide the patient with an updated copy of his/her medication list after performing medication reconciliation at each visit.
  • Look for opportunities to provide the patient with additional education about their medications.

With consistent and proper use, a simple medication list can become a very powerful part of the chart providing countless benefits, such as the following:

Efficient charting: Because the medication list can be updated via a few check marks, it makes documentation quicker and easier. Reviewing it at each visit requires less time than documenting each medication in the progress note. The physician can simply refer to the medication list in the note (“the medication list is reviewed today with the patient”), thus saving time and money in dictation costs.

Safer refills: When patients require prescription refills, the medication list makes it easy to check that the patient is receiving the correct prescription. Physicians and nurses do not have to search through pages of progress notes as the information is clearly displayed at the front of the chart.

Improved Communication with other physicians: The medication list can easily be photocopied and sent to other doctors involved in the patient’s care so they can see the patient’s medication history. This improved information-sharing between physicians can prevent dangerous medication errors.

Information recall: A patient’s medication list is often a snapshot of his or her medical history. Reviewing the medication list with the patient helps the physician recall past treatments. This is particularly helpful when a patient presents with a recurring problem.

Allergy documentation: Ideally, allergies should be documented in one place in the chart. What better place than the medication list? The allergy list should describe the type of reaction and include the date by each allergen.

Summary

An effectively maintained medication list through the process of medication reconciliation makes practicing medicine easier, may help facilitate improvements in the quality of patient care, and may also help reduce medication errors. While a perfectly accurate medication list cannot be attributed to a single intervention or tool, a collaborative approach involving education, accountability, and technology can go a long way in helping patients and their providers tackle the challenge of medication safety together.

Patient monitoring/medication management

The Facts

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.

Patient death blamed on negligent opioid prescribing, $875,000 awarded

A California physician will pay almost $875,000 to the family of a patient who died from respiratory suppression that allegedly resulted from negligent overprescription of opioids for managing back pain, states the November 2012 Medical Malpractice Verdicts, Settlements, and Experts. The 34-year-old patient had been treated with opioids by her primary care physician for two years to manage chronic pain that followed a work-related injury in 2003. The physician prescribed, changed, and increased the prescriptions of painkillers from June 2008 to February 2009. Although the physician made referrals for pain management three different times, the patient was unable to attend the sessions because she could not get transportation to the pain management clinic 30 miles from her home. The patient informed her physician that she was dropping out from the pain management program because she could not get to the appointments. Days later, she was seen by her physician for back pain. The physician did not find any signs of abnormality at this appointment or when the patient returned a month later with the same complaints. During this time, the patient was taking two tablets of a slow release opiate twice a day and another narcotic pain reliever every four hours as needed. The plaintiff claimed that the instructions for the slow-release opiate included “as needed,” meaning that the patient could take two doses in less than twelve hours, provided that no more than two doses were taken every 24 hours. The plaintiff claimed that the opioids caused respiratory suppression and cardiac arrest. The patient’s husband called 911 when he found his wife not breathing, but she could not be resuscitated. According to the coroner, the death was from acute opioid toxicity. The plaintiff claimed that the amount of opiate found in the patient’s system at autopsy meant she had taken two doses of the drug in less than twelve hours consistent with the prescribing instructions. The plaintiff alleged negligent prescription of increasingly higher doses of opiates, which reportedly led to respiratory suppression and death. The plaintiff contended that the physician should have weaned the patient from the high dose of painkillers. In his defense, the physician claimed that the patient knew how to take the slow-release tablets and that she had been properly referred to the pain management clinic three times.

Documentation and referral issues snag pulmonologist in prostate cancer case

The Case

The patient's physicians described him as being very noncompliant with his treatment plan. He suffered from multiple sclerosis (MS), obstructive sleep apnea, morbid obesity, spinal stenosis and coronary artery disease. Despite numerous warnings, the physicians documented that the patient continued to smoke and drink heavily.

When he developed urinary incontinence, the patient's urologist performed a cystoscopy that showed bilateral prostate enlargement with partial obstruction, but no evidence of stones, tumor, orifice abnormalities or any other bladder pathology. The patient's symptoms did not improve with Detrol. The urologist concluded that the voiding problem was due to developing neurological problems, perhaps related to the patient's MS. The patient had no further visits to the urologist, nor was he under the care of a primary care physician. At the same time, the patient was being treated by our insured pulmonologist (pulmonologist #1) for sleep apnea. Pulmonologist #1 worked in a pulmonology group with two other pulmonologists, #2 and #3. In addition to related tests, the pulmonologist ordered routine labs, including a PSA, as a courtesy, since the patient didn't have a primary care physician. The labs returned a PSA result of 3.5.

The patient returned to the pulmonologist six months later. It was noted that he had gained 20 lbs since the last visit, and was not using his BiPAP. Additional labs were requisitioned, including another PSA. The labs returned a PSA value of 4.1. The group's medical assistant placed a sticky note with the word "call" written on it on the lab sheet. She testified at trial that it was her usual and customary practice to place the note, and then call these patients to advise them that their lab results had returned, and that the physician would review them at the follow-up visit. However, she did not document that the call was made anywhere in the medical record. At trial, the patient and his wife denied receiving the medical assistant's call.

Shortly afterward, the patient developed a sore throat with inability to swallow.

Pulmonologist #1 admitted him to the hospital to rule out/treat supraglottic edema, abscess and/or infection. While in the hospital, the patient came under the care of pulmonologist #2. He improved with antibiotics and steroids. A week after discharge, the patient followed up with pulmonologist #2. His sore throat had improved and he had no dysphasia. While not documented, pulmonologist #2 was adamant that he also reviewed the hospital labs and the labs from pulmonologist #1. He stated that he advised the patient to follow up with his ENT, cardiologist and urologist. Pulmonologist #1 stated that he had called the patient after discharge, also emphasizing the importance of following his PSA values with the urologist, and stating his approval that the patient continue to follow up with his partner, pulmonologist #2. Seven days after his first follow-up visit, the patient called pulmonologist #2 advising him that he was feeling much better, and did not wish to keep his second appointment. Pulmonologist #2 documented that he discussed the (pulmonary) plan of care with the patient in detail and that the patient agreed with it. Pulmonologist #2 maintained that during the telephone conversation, he once again advised the patient of the need to follow up with his ENT and urologist. The patient stated that he would.

Within the next two years the patient was seen by several physicians, including pulmonologist #2, for multiple complaints leading up to difficulty in ambulating. He was admitted to the hospital where studies and bone scans were performed. After a markedly elevated PSA, the patient underwent a prostate biopsy, which revealed cancer in various portions of his prostate. Thereafter, the patient underwent surgical removal of spinal metastasis as well as chemotherapy and Lupron injections. He was given a very poor prognosis.

Allegation

The plaintiff alleges that pulmonologists #1 and #2 knowingly concealed the patient's PSA results causing him to fail to seek treatment, and also that they were negligent in failing to inform the patient about his abnormal PSA results.

Disposition

The jury found pulmonologist #2 negligent, and awarded the plaintiff a very large amount.

Risk Management Commentary

Two experts were both of the opinion that the patient had metastatic prostate cancer at the time his PSA was 4.1. Expert #1 opined that if the patient had been referred to a urologist at that time, there was a 50% chance that a rectal exam and biopsy would have been performed, that the biopsy would have been positive for metastatic disease, and most likely assigned a Gleason score of 9. He did point out that a questionably abnormal PSA does not mandate performing a biopsy, and a rise in PSA from 3.5 to 4.1 over the course of six months was not indicative of a rapid rise. Expert #2 was unable to support the standard of care in this matter because of the lack of documentation/evidence that the PSA of 4.1 had been discussed with the patient, and that a referral to the urologist had been made.

This expert opined that once the PSA was ordered, the physicians were charged with following up on the results and discussing them with the patient. He went further to say that the standard of care requires a biopsy or digital rectal exam be performed if the PSA rises following a negative PSA.

Although we recognized the difficulty the lack of chart documentation would present to a jury, we wanted to give our policyholders an opportunity to persuade a jury that they did notify the patient of the PSA results. From the verdict, it appears that the jury simply did not believe pulmonologist #2 when he testified that he had advised the patient at each of his seven consecutive visits of the 4.1 PSA, and instructing him each time to go to his urologist. Both the lack of documentation of any of these conversations, lack of documentation that any urology referral had been made, and the testimony from the patient's wife that she attended each and every one of those office visits and no such conversations took place, appears to have had greater weight with the jury.

The patient presented a sympathetic figure confined to a wheelchair with an oxygen tank, and given less than six months to live.

Summary

The limitations of brief specialty consultations with a chronically ill patient who had multiple needs are obvious, but classic risk management caveats still apply:

  1. If it isn't documented, it wasn't done.
  2. If you ordered it, you own it.
  3. If referrals are suggested or made, they should be tracked to completion.
  4. Sustained follow up ensures early detection of adverse effects, problems in compliance, failure to respond to treatment, and recurrence of symptoms. It affords opportunities to solve problems and demonstrate the concern of the care team. Telephone follow up by nurses or other staff in chronic illness care may also be effective, but these consultations should be documented in the medical record with date, time and person.
  5. Pulmonologists #1 and #2 were partners in practice and, therefore, shared the same medical records. Thus, pulmonologist #2 was responsible for knowing his partner's care and treatment plan. Communication clarity dictates that each medical record have a problem list with corresponding problem status. If such a problem list had existed in this patient's chart, it is conceivable that pulmonologist #2 would have seen the rising PSA value on the list, and understood the expanded role pulmonologist #1 had assumed for the pulmonology group to formally make the urology referral.
  6. Lastly, labeling a patient as noncompliant may fail to recognize the patient as a competent partner in his or her own care, and also may be punitive, jeopardizing the patient's ability to seek out other care providers. Despite the patient's decisions, juries often will side with a patient when there is no evidence of follow-up on behalf of the physician(s) or practice.

Editor's note: This Claims Lesson is not an attempt to answer the question of whether men should be screened for prostate cancer, or to interpret the US Preventative Task Force (USPSTF) latest draft recommendation. See Reference: Stratifying Risk-The U.S. Preventive Services Task Force and Prostate-Cancer Screening,http://www.nejm.org/doi/full/10.1056/NEJMp1112140.

Amiodarone prescription and physician credentialing issues hamper the defense

Abstract

This case involves a patient who developed bilateral ischemic optic neuropathy, secondary to taking Amiodarone for atrial flutter. The patient developed a severe impairment of visual acuity, and visual field deficits, consistent with legal blindness. In addition to the alleged inappropriate Amiodarone use, the cardiac electrophysiologist’s credentials were questioned.

The Case

This patient had been established with the cardiology practice for a number of years. His medical history included ischemic heart disease, morbid obesity, Type 2 Diabetes Mellitus, hypercholesterolemia, and hypertension. When he began experiencing episodes of atrial flutter, the patient’s cardiologist recommended evaluation by an electrophysiologist, a physician who was in the same practice. The electrophysiologist recommended the patient begin treatment with Coumadin and undergo an elective radiofrequency ablation.

During the radiofrequency ablation, the electrophysiologist experienced technical difficulties due to the rotation of the patient’s heart, an enlarged right atrium, and difficulty accessing the coronary sinus.  The ablation attempt was incomplete, but the electrophysiologist performed a successful cardioversion. The patient converted to NSR, and was placed on Amiodarone 200 mg BID and magnesium to help him maintain a normal rhythm.

Three months later the patient complained of problems with his eyesight. He was seen by an ophthalmologist who diagnosed optic neuritis, thought to be due to the Amiodarone. The patient was instructed to discontinue the Amiodarone immediately. Neuro-ophthalmology testing showed severe diffuse visual field impairment in both eyes. The neuro-ophthalmologist opined that the most likely etiology for the bilateral ischemic optic neuropathies was secondary to the Amiodarone therapy. He recommended treatment with corticosteroids to decrease any optic disc swelling. In addition the ophthalmologist suggested the patient have a temporal artery biopsy to fully rule out giant cell arteritis. The patient decided against both of these recommendations. Several months later, the patient’s eye examination remained unchanged; the neuro-ophthalmologist informed him that he was legally blind.

Allegations: The plaintiffs alleged there was no indication for treatment with Amiodarone. In addition, once this medication was prescribed, the patient should have been closely monitored. No information with regard to potential side effects was provided to the patient.  The plaintiffs also alleged the other doctors in the practice were vicariously liable for the electrophysiologist because they had failed to properly credential him to practice the subspecialty of cardiac electrophysiology.

Disposition: the case was settled for a large amount of money.

Risk Management Commentary

Several clinical experts reviewed the cardiac- electrophysiologist’s medical records and expressed concerns about his care.

  • Each reviewer individually opined that the physician could have considered a more conservative approach. Amiodarone has the highest risk for side effects compared to other medications that could have been prescribed. One expert criticized the decision-making process that led the physician to prescribe Amiodarone.
  •  From a medical record review, it could not be determined whether the patient had been advised of the risks and alternatives of taking Amiodarone
  • The physician had not completed all ACGME Program Requirements for Graduate Medical Education in Clinical Cardiac Electrophysiology, as required by his contract with his cardiology group.
  • Most importantly, the electrophysiologist not truthful in his discovery responses about his actual credentials. This fact created a credibility issue for the physician, and added to problems for his defense.

About Amiodarone

Amiodarone is a complex antiarrhythmic agent with multiple electrophysiological effects, unusual pharmacokinetics, and numerous potentially harmful drug interactions and adverse effects. Although the U.S. Food and Drug Administration (FDA) has labeled Amiodarone only for the treatment of life-threatening ventricular arrhythmias, the drug also is used to treat atrial fibrillation. Because of the complexity and widespread use of this agent, other treatment decisions often are affected.[1]

According to the literature [2] patients treated with Amiodarone should be followed regularly to assess ongoing need for Amiodarone, efficacy of the drug, appropriateness of dosage, adverse effects, and potential drug interactions.

Consensus follow-up recommendations from the North American Society of Pacing and Electrophysiology (NASPE) have been summarized by the Practice Guidelines Subcommittee of the NASPE. [3]

In the article [4]Amiodarone: Guidelines for Use and Monitoring, Dr. Lyle Siddoway shares a form to help guide the monitoring of adult patients taking Amiodarone. A downloadable checklist is available online at:http://www.aafp.org/afp.

 

[1] American Family Physician, Amiodarone: Guidelines for Use and Monitoring  LYLE A. SIDDOWAY, M.D., York Hospital, York, PennsylvaniaAm Fam Physician.2003 Dec; 68(11):2189-2197. dol: http://www.aafp.org/afp/2003/1201/p2189.html

[2] IBID

[3] Goldschlager N, Epstein AE, Naccarelli G, Olshansky B, Singh B. Practical guidelines for clinicians who treat patients with Amiodarone. Practice Guidelines Subcommittee, North American Society of Pacing and Electrophysiology. Arch Intern Med. 2000;160:1741–8.

[4] American Family Physician, Amiodarone: Guidelines for Use and Monitoring

Prescribing opioids for adult patients in the emergency department

Parallel to the public health concerns over the prevalence and cost of pain-related conditions, prescription drug diversion, abuse, and overdose have reached alarming levels in the United States. According to the Centers for Disease Control and Prevention:

  • 100 people die from drug overdoses every day in the United States.
  • Prescription drug overdose death rates in the United States have more than tripled since 1990.
  • Prescription drugs were involved in more overdose deaths in 2008 than cocaine and heroin overdose deaths combined.1
  • The misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years.2
  • Prescription opioid drugs were involved with nearly 75% of the 22,000 plus prescription drug overdose deaths reported in 2010.3
  • Americans represent 4.6% of the world’s population and consume 80% of the global opioid supply, 99% of all the hydrocodone, and two-thirds of the world’s illegal drugs overall.4

The CDC reports that nearly three out of four prescription drug overdoses are caused by opioid pain relievers.5 This alarming epidemic has prompted many state medical boards to develop guidelines and rules related to managing patients with chronic pain.

Some state medical boards require mandatory education for DEA registration and other initiatives to place tighter regulations for opioid use.

In most states, all practitioners with the authority to prescribe or order controlled substances are allowed to register and have access to the state prescription monitoring program. According to the Alliance of States with Prescription Monitoring Programs, as of October 16, 2011, 37 states had operational prescription drug monitoring programs that have the capacity to receive and distribute controlled substance prescription information to authorized users. The use of these monitoring programs, while beneficial, can create challenges considering the volume of patients treated in the emergency department (ED) and the number of patients with clear indications for the use of opioid analgesics.

In June 2012, the American College of Emergency Physicians (ACEP) developed its “Clinical Policy: Critical Issues in the Prescribing of Opioids for Adult Patients in the Emergency Department.”

The ACEP policy committee addressed four critical questions:

  1. In the adult ED patient with noncancerous pain for whom opioid prescriptions are considered, what is the utility of state prescription drug monitoring programs in identifying patients who are at high risk for opioid abuse?
  2. In the adult ED patient with acute low back pain, are prescriptions for opioids more effective during the acute phase than other medications?
  3. In the adult ED patient for whom opioid prescription is considered appropriate for treatment of new-onset acute pain, are short-acting schedule II opioids more effective than short-acting schedule III opioids?
  4. In the adult ED patient with an acute exacerbation of noncancerous chronic pain, do the benefits of prescribing opioids on discharge from the ED outweigh the potential harms?

The following recommendations were adopted:

State Prescription Drug Monitoring Programs

  • The use of a state prescription monitoring program may help identify patients who are at high risk for prescription opioid diversion or doctor shopping.

Acute Low Back Pain

  • For the patient being discharged from the ED with acute low back pain, the emergency physician should ascertain whether nonopioid analgesics and nonpharmacologic therapies will be adequate for initial pain management.
  • Given a lack of demonstrated evidence of superior efficacy of either opioid or nonopioid analgesics and the individual and community risks associated with opioid use, misuse, and abuse, opioids should be reserved for more severe pain or pain refractory to other analgesics rather than routinely prescribed.
  • If opioids are indicated, the prescription should be for the lowest practical dose for a limited duration (e.g.,
  • For the short-term relief of acute musculoskeletal pain, emergency physicians may prescribe short-acting opioids such as oxycodone or hydrocodone products while considering the benefits and risks for the individual patient.

Short-acting Schedule II versus Schedule III

  • Research evidence to support superior pain relief for short-acting schedule II over schedule III opioids is inadequate.

Prescribing Opioids on Discharge from the ED - Risks vs. Benefits

  • Avoid routinely prescribing opioids for an outpatient who has an acute exacerbation of chronic noncancerous pain.
  • If opioids are prescribed on discharge, provide the lowest practical dose and for a limited duration (e.g.,
  • When practicable, honor existing patient-physician pain contracts/treatment agreements, and consider past prescription patterns from information sources such as prescription drug monitoring programs.6

To view the entire policy, visit the ACEP website at www.acep.org

Prescribing opioids for adult patients in the emergency department

Parallel to the public health concerns over the prevalence and cost of pain-related conditions, prescription drug diversion, abuse, and overdose have reached alarming levels in the United States. According to the Centers for Disease Control and Prevention:

  • 100 people die from drug overdoses every day in the United States.
  • Prescription drug overdose death rates in the United States have more than tripled since 1990.
  • Prescription drugs were involved in more overdose deaths in 2008 than cocaine and heroin overdose deaths combined.1
  • The misuse and abuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years.2
  • Prescription opioid drugs were involved with nearly 75% of the 22,000 plus prescription drug overdose deaths reported in 2010.3
  • Americans represent 4.6% of the world’s population and consume 80% of the global opioid supply, 99% of all the hydrocodone, and two-thirds of the world’s illegal drugs overall.4

The CDC reports that nearly three out of four prescription drug overdoses are caused by opioid pain relievers.5 This alarming epidemic has prompted many state medical boards to develop guidelines and rules related to managing patients with chronic pain.

Some state medical boards require mandatory education for DEA registration and other initiatives to place tighter regulations for opioid use.

In most states, all practitioners with the authority to prescribe or order controlled substances are allowed to register and have access to the state prescription monitoring program. According to the Alliance of States with Prescription Monitoring Programs, as of October 16, 2011, 37 states had operational prescription drug monitoring programs that have the capacity to receive and distribute controlled substance prescription information to authorized users. The use of these monitoring programs, while beneficial, can create challenges considering the volume of patients treated in the emergency department (ED) and the number of patients with clear indications for the use of opioid analgesics.

In June 2012, the American College of Emergency Physicians (ACEP) developed its “Clinical Policy: Critical Issues in the Prescribing of Opioids for Adult Patients in the Emergency Department.”

The ACEP policy committee addressed four critical questions:

  1. In the adult ED patient with noncancerous pain for whom opioid prescriptions are considered, what is the utility of state prescription drug monitoring programs in identifying patients who are at high risk for opioid abuse?
  2. In the adult ED patient with acute low back pain, are prescriptions for opioids more effective during the acute phase than other medications?
  3. In the adult ED patient for whom opioid prescription is considered appropriate for treatment of new-onset acute pain, are short-acting schedule II opioids more effective than short-acting schedule III opioids?
  4. In the adult ED patient with an acute exacerbation of noncancerous chronic pain, do the benefits of prescribing opioids on discharge from the ED outweigh the potential harms?

The following recommendations were adopted:

State Prescription Drug Monitoring Programs

  • The use of a state prescription monitoring program may help identify patients who are at high risk for prescription opioid diversion or doctor shopping.

Acute Low Back Pain

  • For the patient being discharged from the ED with acute low back pain, the emergency physician should ascertain whether nonopioid analgesics and nonpharmacologic therapies will be adequate for initial pain management.
  • Given a lack of demonstrated evidence of superior efficacy of either opioid or nonopioid analgesics and the individual and community risks associated with opioid use, misuse, and abuse, opioids should be reserved for more severe pain or pain refractory to other analgesics rather than routinely prescribed.
  • If opioids are indicated, the prescription should be for the lowest practical dose for a limited duration (e.g.,
  • For the short-term relief of acute musculoskeletal pain, emergency physicians may prescribe short-acting opioids such as oxycodone or hydrocodone products while considering the benefits and risks for the individual patient.

Short-acting Schedule II versus Schedule III

  • Research evidence to support superior pain relief for short-acting schedule II over schedule III opioids is inadequate.

Prescribing Opioids on Discharge from the ED - Risks vs. Benefits

  • Avoid routinely prescribing opioids for an outpatient who has an acute exacerbation of chronic noncancerous pain.
  • If opioids are prescribed on discharge, provide the lowest practical dose and for a limited duration (e.g.,
  • When practicable, honor existing patient-physician pain contracts/treatment agreements, and consider past prescription patterns from information sources such as prescription drug monitoring programs.6

To view the entire policy, visit the ACEP website at www.acep.org

Pain management plan of care

During the past decade, the United States has witnessed an alarming increase in the use of opioids. According to the U.S. Centers for Disease Control and Prevention, deaths from an overdose of opioid pain relievers now exceed the number of deaths linked to heroin and cocaine, combined.iDuring this “abuse epidemic”, physicians are challenged with the issue of managing pain appropriately while giving adequate attention both to the over treatment and under treatment of pain.

The goals of pain treatment include reasonably attainable improvement in pain and function; improvement in pain associated symptoms such as deep sleep disturbance, depression, and anxiety; and avoidance of unnecessary or excessive use of medications. Most state medical boards have developed guidelines for pain management.

The Federation of State Medical Boards established guidelines recommend establishing a treatment plan and goals as early as possible in the treatment process. Reviewing the treatment plan with each patient encounter will enable individualized objectives to guide the choice of therapies and a clear direction for the plan of care.

Monitoring the effects of opioid therapy may best be objectively assessed utilizing the “5As” of chronic pain management: Analgesia (reduction in pain), Activity (level of function), Adverse effect, Aberrant substance-related behaviors, and Affect (mood).ii Periodic drug testing may be beneficial to monitor adherence to the treatment plan and to detect the use of any non-prescribed drugs.

Other actions to take when developing and managing a treatment plan may include, but are not limited to, the following:

  • Seek consultation or refer patients to a pain, psychiatry, addiction, or mental health specialist as needed.
  • Explore other pain management modalities such as physical therapy, massage, and other alternative therapies.
  • Regularly weigh the potential benefits and risks to determine whether the treatment remains appropriate.
  • If your state has a prescription monitoring data base, check it for controlled prescription information relevant to your patients.
  • Complete and maintain medical records to include patient history, reassessment, changes in medical condition and response to treatment. Comprehensive record keeping demonstrates the care provided was medically necessary and enhances communication with others involved in the patient’s care.

As pain management guidelines vary from state to state, it is advisable to contact your state medical board for state-specific guidance. Should you hold licenses in more than one state, reviewing and developing knowledge of the policies in each state for which you maintain active licensure is recommended.

MagMutual Risk Management and Patient Safety Consultants invite our policyholders' questions. If you wish to discuss issues related to this article, or have other questiones please call us at 1-800-282-4882, and ask for Risk Management.

Resource Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain located at www.fsmb.org

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.