Dr. Gustin's Blog

Dr. Gustin's Blog

Narcan Nasal Spray approved by FDA

An intranasal form of naloxone hydrochloride (Narcan, Adapt Pharma, Inc), a drug that stops or reverses opioid overdose, has been approved by the US Food and Drug Administration (FDA) under a fast-track approval process.

Naloxone hydrochloride has long been given by intramuscular injection to stop or reverse the effects of opioid overdose, in particular respiratory depression. It usually works within 2 minutes but must be given quickly to prevent death.

The nasal form will be easier for first responders and others to deliver, and will eliminate the threat of contaminated needle sticks. Until now, unapproved naloxone kits have combined the injectable form of naloxone with an atomizer to administer the drug nasally.

No assembly is required for the approved nasal product, and anyone can administer it, even those without medical training. The product can be given to adults and children. It is sprayed into one nostril while the patient lies on his or her back, and can be repeated if needed. The FDA cautions that the person administering the drug should still seek immediate medical attention for the patient.

Drug overdose deaths have risen steadily for the past decade and now surpass motor vehicle crashes as the leading cause of injury death in the United States. The increase is due in large part to prescription drug overdoses, as well as a rise in heroin use.

"Combating the opioid abuse epidemic is a top priority for the FDA," Stephen Ostroff, MD, acting FDA commissioner, said in an FDA news release. "We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of the opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose."

The approval follows an expedited review of data from clinical trials in which nasal administration achieved the same or higher levels of naloxone as those obtained with intramuscular injection, and in about the same amount of time.

The FDA's priority review program facilitates approval of drugs that are expected to significantly improve the safety or effectiveness of the prevention, treatment, or diagnosis of a serious medical condition. The FDA approved the nasal spray in less than 4 months.

Narcan Nasal Spray to Counter Opiate Overdose Approved by FDA

"We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication — a critical attribute for this emergency life-saving drug," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in the FDA news release.

The National Institute on Drug Abuse (NIDA) designed and conducted clinical trials to determine that the intranasal formulation worked as quickly and effectively as the injectable form. NIDA then worked with its partners in the private sector to obtain approval from the FDA.

"This easy-to-use intranasal formulation will no doubt save many lives," Nora Volkow, MD, director, National Institute on Drug Abuse at the National Institutes of Health, explained in the news release. "While prevention is the ultimate goal, the drug's successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis right now."

Health and Human Services Secretary Sylvia M. Burwell proposed a targeted strategy for addressing the opioid epidemic that includes increasing access to and use of naloxone in March. In July the FDA sponsored a public workshop at which addiction and advocacy groups demanded expanded availability of the lifesaving drug.

Naloxone nasal spray can cause severe opioid withdrawal in patients who are opioid dependent.

Fentanyl Overdose

The Centers for Disease Control and Prevention (CDC) has issued a warning regarding increases in fentanyl drug confiscations and a potential increased risk for fentanyl-related overdose fatalities.

According to the CDC, reports from the National Forensic Laboratory Information System, a program of the Drug Enforcement Administration's (DEA's) Office of Diversion Control, indicate there has been a significant increase in the confiscation of illicit fentanyl by authorities from 2012 to 2014, raising concerns that these drug seizures may be a proxy for increased overdose risk.

The reports show there were 618 such drug seizures in 2012, 945 in 2013, and 4585 in 2014. More than 80% of drug seizures in 2014 (3790) were concentrated in 10 states. Ohio had by far the highest number (1245), which was almost twice as many as occurred in Massachusetts (630). Pennsylvania was next with 419 seizures. Maryland, New Jersey, Kentucky, Virginia, Florida, New Hampshire, and Indiana were also on the "top 10" list.

The number of states reporting 20 or more fentanyl seizures every 6 months is also increasing, according to the CDC's Health Alert Network advisory. From July to December 2014, 18 states reported 20 or more fentanyl drug seizures. In contrast, six states reported 20 or more illicit fentanyl drug seizures during the same period in 2013.

In addition, recent data suggest that fentanyl-related fatalities have increased in states reporting large increases in fentanyl seizures. Two of the top five seizure states, Ohio and Maryland, reported sharp increases in fentanyl-related deaths in 2014.

The CDC notes that, similar to previous fentanyl overdose outbreaks, most of the more than 700 fentanyl-related overdose deaths reported during this period were attributable to illicitly manufactured fentanyl — not diverted pharmaceutical fentanyl — that was mixed with either heroin or other diluents and sold as a highly potent substance, sometimes under the street name "China White."

However, the true number of fentanyl-related overdose deaths is likely higher because many coroners' offices and state crime laboratories do not test for fentanyl or its analogues unless given a specific reason to do so, the DEA noted.

Nonpharmaceutical fentanyl (NPF) is sold illicitly for its heroinlike effect and is often mixed with heroin and/or cocaine ― sometimes without the user's knowledge ― to increase its euphoric effects. Although NPF-related overdoses can be reversed with naloxone (multiple brands), a higher dose or multiple doses may be required to revive a patient, owing to the high potency of NPF.

CDC Recommendations

In addition to alerting healthcare providers, public health departments, first responders, and others to possible additional fentanyl-related seizures and overdoses, the CDC advisory makes recommendations for improving detection of fentanyl-related overdose outbreaks.

For example, the CDC suggests that public health departments explore methods for more rapidly detecting outbreaks and that they use existing surveillance systems, such as medical examiner data, emergency medical services data, or near-real-time emergency department data.

It also suggests that in situations of dramatically increased opioid overdoses, consideration be given to asking emergency departments to report fatal and nonfatal opioid overdose cases to them within 48 hours and to engaging local poison control centers to help track and treat patients.

The CDC suggests that medical examiners and coroners screen for fentanyl in suspected opioid overdose cases in regions reporting increases in fentanyl seizures, fentanyl-related overdose fatalities, or unusually high spikes in heroin or unspecified drug overdose fatalities.

It also recommends that these experts screen specimens from fatal drug overdose deaths using an enzyme-linked immunosorbent assay (ELISA) with the capacity to detect fentanyl.

The CDC noted that law enforcement personnel can play an important role in identifying and responding to increases in the distribution and use of illicitly manufactured fentanyl.

It also advised that investigating officers consider their potential exposure to fentanyl through skin and/or inhalation of aerosolized drug and to use appropriate safety precautions and personal protective equipment.

The CDC also recommends that law enforcement agencies share data on fentanyl and acetyl-fentanyl drug seizures with local health departments, coroners, and medical examiners.

Dangerous Prescribing Errors

Dangerous prescribing errors afflicts all areas of medicine, and is more common that most appreciate.  There are several types of prescribing errors.  The following report appeared recently in Medscape and I attached it here verbatim..

Poor penmanship was once the bane of prescribing, and the cause of many prescribing errors. Even as electronic prescribing (eRx) has markedly reduced some types of errors,[1] others have cropped up to take their place,[2] and the benefits of eRx are at risk of being overshadowed by unintended consequences.[3]

Recent reports of prescribing errors vary widely, from 5% to 81% of prescriptions.[3,4] A significant proportion of errors are believed to be caused not by system design features or software glitches, but by human factors, such as fatigue, selecting the wrong option, or entering the wrong patient information into an often cumbersome system. And although most prescribing errors are detected and resolved by pharmacists in both the inpatient and community settings,[5-7] some still slip through the entire medication use chain, making it all the way to the patient.

The five main categories of traditional prescribing errors are wrong patient; wrong drug; wrong dose, strength, or frequency; wrong drug formulation; and wrong quantity. In a recent study,[3] the four most common errors observed were wrong drug quantity (40%), wrong duration of therapy (21%), wrong dosing directions (19%), and wrong dosage formulation (11%).

The following serious prescribing errors are consistent with these traditional categories, although with various twists introduced by eRx. These errors, collated from the literature, patient safety experts, and the Institution for Safe Medication Practices (ISMP), are not ranked in any way, but simply represent a sample of potentially serious errors in contemporary drug prescribing.

Prescribing the Wrong Drug

At an outpatient clinic, a clinician used an eRx system to order an antibiotic for a child whose throat culture was positive for group A streptococci. She intended to prescribe penicillin, but accidentally selected penicillamine (a chelating agent used to treat Wilson disease) on the drop-down drug list. The prescription was dispensed by a community pharmacist, and the child received penicillamine 250 mg by mouth twice a day for 2 days. His father noticed that his son appeared pale and sleepy, and his strep throat did not seem to be improving. He showed the medication bottle to the pharmacist, and the error was discovered. The child was treated at the local emergency department.[8]

Some eRx systems autopopulate or present a drop-down menu after the first few letters of the desired drug are typed into a search field, at which point a prescriber might inadvertently select the wrong medication.[1] It is believed that this was one cause of recent prescription and dispensing errors reported to the US Food and Drug Administration involving Brintellix® (vortioxetine, a serotonergic agonist/antagonist) and Brilinta® (ticagrelor, a platelet inhibitor).

The prescriber knows what drug he or she wishes to prescribe. The error comes in trying to convey this to another healthcare provider, such as a pharmacist or nurse. This can occur when the prescriber's handwriting is less than crystal-clear, as in the photo above. The pharmacist or nurse misreads the prescriber's handwritten prescription, the mind substituting a similar-looking drug, and a wrong drug medication error is born. In the illustration here, the intended drug PreNexa® was misread as Ranexa®, and the latter was dispensed. Illegibility continues to be a significant source of prescribing error in ambulatory settings.[10]

The 21st-century equivalent of poor penmanship is the long list of look-alike, sound-alike (LASA) drugs on a drop-down screen. The prescriber opens a menu of drugs (many of which have similar or identical stems) and inadvertently selects the wrong drug, frequency, or quantity; this order is then transmitted to the pharmacy. If the system does not require the prescriber to enter an indication for the drug, it is difficult for a pharmacist to know that the wrong drug has been ordered.

ISMP recommends "Tall Man lettering" (mixed case or capitalized letters within drug names to highlight primary dissimilarities with look-alike drug names, such as hydrOXYzine and hydrALAZINE) as a means of reducing the risk for drug selection errors.[10] It also helps to include both the brand name and generic name on prescriptions. Most LASA drugs also have different indications, so indication prompts can be useful to intercept drug selection errors.[11] Where possible, practices should consider limiting the number of drugs that show up on drug selection menus to those that are most commonly prescribed in that practice.

Formulation Blunders

Drug modifiers for different drug formulations are common,such as the once-daily formulation Wellbutrin XL® (bupropion extended-release) and Wellbutrin SR® (bupropion sustained-release), which is indicated for twice-daily dosing. Wellbutrin mix-ups are especially likely because both the SR and XL formulations are available in 150-mg tablet strengths, and it's not unusual for the SR formulation to be prescribed once daily.

The anticonvulsant agent Depakote® is another drug with multiple modifiers. It is available as delayed-release capsules (Depakote Sprinkles), delayed-release tablets (Depakote), and extended-release tablets (Depakote ER).

A clinician intended to prescribe 1500 mg of Depakote ER to a patient with a seizure disorder. However, several formulations of Depakote (delayed release, extended release, tablets, and capsules) were listed on the drop-down menu, and the clinician selected delayed-release instead of extended-release. Nine hours later, the patient received the full 1500-mg dose of Depakote at once, because the full dose of delayed-release Depakote enters the circulation more rapidly than the extended-release formulation. The patient developed significant hypotension and sedation but eventually recovered.

Many prescribers and pharmacists have noticed the high potential for confusion among the various formulations of drugs, and errors of formulation selection are common.[13,14] The modifiers for short-acting, intermediate-acting, and long-acting formulations are not standardized in the industry. ER (extended-release) may mean a 24-hour formulation for one drug and a 12-hour formulation for another drug. The United States Pharmacopeia defines delayed-release tablets as enteric-coated, intended to delay the release of the medication until the tablet has passed through the stomach to prevent the drug from being inactivated by gastric secretions or to prevent gastric mucosa irritation. Extended-release tablets are formulated to make the drug available over an extended period after ingestion. The delayed-release formulation of Depakote is enteric-coated, whereas Depakote ER is not enteric-coated. They are not bioequivalent or interchangeable.[12] Another agent that is often involved in serious formulation prescribing errors is insulin.[15]

As more drug product lines expand to offer different formulations, this type of error could become more common. The best way to prevent such errors is to become familiar with the different modifiers on prescribed medications. Be explicit in the dosing directions for the frequency that you want the medication taken, and tell the patient exactly how it should be taken. Most often, if a mistake is made, the pharmacist will contact the prescriber because the frequency is not consistent with the formulation.

Alert Madness

A 33-year-old woman with refractory epilepsy was admitted to the hospital with increasing frequency of seizures. Her seizures were controlled with fosphenytoin, and she was discharged 2 days later with a prescription for phenytoin, 500 mg once daily. However, the clinician inadvertently failed to change the default frequency (three times daily) to the desired frequency of once daily, and ignored an overdose alert triggered by the excessive daily dose. In this case, the pharmacist also missed the high-dose alert, and dispensed the phenytoin with instructions to take three times daily. The patient took the phenytoin as instructed for a few days, but when she began having trouble walking, the error was discovered. The patient experienced transient phenytoin toxicity.[

presented during the order entry process also can interfere with the prescriber's concentration, increasing the likelihood of error.[17]

Most alerts (even those warning of high-severity drug interactions) are rejected or ignored by clinicians.[18,19] In one recent study,[19] 93% of drug/drug interaction and drug-allergy alerts were overridden. Too many alerts with low credibility can induce prescribers to override important alerts along with false-positives,[18] a phenomenon known as "alert fatigue."[20]

Perhaps nowhere is the human/computer interaction as important as in the prescriber's response to alerts. This case demonstrates that prescribers can become desensitized to alerts. To minimize this, alerts in the eRx system must be both sensitive and specific, and only alerts that warn of potential errors should be presented, not irrelevant or redundant messages.[16] The threat of missing a rare event must be balanced with the dangers of burdening clinicians with unnecessary and interruptive electronic alerts.[21] The credibility of prescribing alerts can be improved by reducing alerts that contradict broadly accepted clinical practices.[17] It is also recommended that alerts be tiered according to severity, and that they be presented to prescribers at an appropriate place in the workflow to improve prescribing efficiency.[19,22]

And what, if anything, would prescribers like to see more alerts for? Lab values, and a list of drugs prescribed for the patient by other providers.[17]

Failure to Adjust

A 71-year-old woman receiving palliative chemotherapy for lung cancer developed methicillin-resistant Staphylococcus aureus bacteremia. Vancomycin 1.25 g was given, and she was transferred to a referral hospital. Her serum creatinine level at the community hospital was 0.4 mg/dL, and at the referral hospital, it had doubled to 0.8 mg/dL (although this was still within the normal range). Vancomycin was continued. By the next day, she was in acute renal failure with an elevated creatinine level. A vancomycin trough level was obtained, and reported as 64 mg/L. Her renal failure worsened; she became anuric and required urgent dialysis.[23]

Vancomycin is renally eliminated and has a narrow therapeutic index with a high potential for nephrotoxicity. The admitting clinician neither recognized the doubling of this patient's serum creatinine level nor ordered a vancomycin trough level.

Chronic kidney disease (CKD) is an increasing concern in elderly persons.[24] Senile pharmacokinetic changes in the kidney include dysautonomia; glomerular filtration rate reduction; tubular back-filtration; sodium, calcium, and magnesium loss; potassium retention; altered dilution-concentration capability; and tubular frailty.[25] Furthermore, elderly patients are frequently on multiple medications to manage their many comorbid conditions. The early stages of CKD are often unrecognized, placing the elderly person at high risk for serious, yet largely preventable, drug-related safety events.[26,27] Indeed, inappropriate prescribing of renally cleared drugs is common in adults.[28,29] A recent study identified perindopril, fenofibrate, glibenclamide, gliptins, metformin, olmesartan, bisphosphonates, and strontium as drugs frequently prescribed to elderly adults without evaluation of renal function.[29]

It is essential to consider renal function when prescribing renally cleared drugs in this population and make appropriate dosage adjustments.[30] Either the Cockcroft-Gault equation or the Modification of Diet in Renal Disease (MDRD) study equation can be used for routine estimation of glomerular filtration rate (GFR), although the MDRD is considered superior in patients with low GFR (< 60 mL/min/1.73 m2).[31,32] The Beers Criteria for Potentially Inappropriate Medication Use in Older Adults,[33] issued by the American Geriatric Society (AGS), is also an important resource when prescribing for older adults. AGS released updated criteria in 2015.

Phoning It In

A 56-year-old man was hospitalized for replacement of a percutaneous endoscopic gastrostomy tube. He was on warfarin owing to a history of intracardiac mural thrombus, but his international normalized ratio (INR) was low. His medical team decided to increase his warfarin from 5 mg/day to 10 mg/day for 3 days to raise his INR. Later that day, on review of his case, it was decided to stop warfarin altogether until an echocardiogram could be obtained to evaluate whether he still had intracardiac thrombus. The resident started to enter the order into his smartphone but was interrupted by a personal text. After answering the text, he forgot to complete the order to discontinue warfarin. As a result, the patient continued to receive 10 mg daily. On the fourth day, he experienced shortness of breath, tachycardia, and hypotension. An echocardiogram showed hemipericardium and tamponade, requiring emergency open heart surgery.[34]

As of 2014, smartphones were being used by one third of physicians to prescribe.[35] The use of such mobile devices as smartphones and tablets can increase the convenience of prescribing, but not without a cost to patient safety. Having clinical information and decision support at one's fingertips could improve the timeliness of care, but mobile technologies also pose such risks as transmission of infection; interference from electromagnetic radiation; breach of confidentiality; multitasking, and as shown in the case, interruption and distraction.

Institutions are challenged to develop policies and technologies for mitigating the risks associated with mobile prescribing, to capture their benefits while reducing their harm.[34] However, the safe use of mobile devices falls heavily on the shoulders of individual prescribers, to ensure that personal communications or interruptions do not pose risks to patient safety.

Errors In, Errors Out

A 17-month-old toddler was brought in to the emergency department for evaluation of an eye infection. The nurse weighed the toddler and recorded the weight in the chart. However, the nurse entered "25 kg" instead of "25 lb" (11.3 kg). The physician prescribed clindamycin 225 mg orally three times daily, calculated using the weight of 25 kg, and the first dose was given before discharge. The child's mother noticed the incorrect weight on the discharge paperwork, and the dose was corrected. The child suffered only diarrhea from the incident.[36]

Wrong, outdated, or missing information can result in myriad prescribing errors. Patient information that is critical to prescribing includes allergies, medical history, current medication list, body weight, and laboratory data. Body weights should always be recorded using the metric system, because that is how drugs are dosed. When such information is missing or out of date, errors in prescribing may follow. In one incident, staff failed to record in the chart that a woman with chronic asthma was pregnant, and she was given bronchodilators, corticosteroids, and intravenous levofloxacin (a pregnancy category C drug).

Ambiguous Abbreviations

To save time, prescribers often will use abbreviations, especially in handwritten prescriptions. Prescribers may abbreviate a long drug name, use an often misunderstood symbol, or use abbreviations for dosing or administration instructions. This category of error also includes misuse of decimals (leading and trailing zeros) and other symbols. These shortcuts might save the prescriber a few seconds of writing, but can spell confusion for other healthcare professionals downstream and potential harm for the patient. Abramson and colleagues[37] found a very high rate of abbreviation errors in their study of outpatient prescribing errors.

In the cases illustrated in this slide, the first prescriber (top) intended for the order to read "Dilaudid 0.6 mg Q 10′ PRN (every 10 minutes as needed)," but it was read as "Dilaudid 0.6 mg QID PRN (4 times daily as needed)." The second prescriber (middle) intended to prescribe potassium chloride QD (daily), but the prescription was misread as QID (4 times daily). The use of "Pot" as an abbreviation for potassium is also error-prone and is not recommended. The order for vincristine (bottom) was intended to be a dose of 0.4 mg, but the decimal point was misplaced and barely visible. It was read as "4 mg vincristine." This type of error can be prevented by using a leading zero for doses less than one.

eRx is not immune to confusion from error-prone abbreviations. In some electronic systems, decimal points are difficult to visualize, making wrong dose selections more likely.

Drug name abbreviations are often confused (eg, MgSO4 for morphine). The simplest way to avoid misinterpretation of drug name abbreviations is to fully spell out drug names and directions. If abbreviations must be used, use only standard abbreviations approved by the acute care institution and avoid abbreviations completely for outpatient prescriptions. ISMP provides a list of error-prone abbreviations, symbols, and dose designations, and the Joint Commission has a "Do Not Use" list. These include the commonly used abbreviations µg, OU, and D/C, which should instead be written as "mcg," "both eyes," and "discharge" (or "discontinue"), respectively.

More Errors

Wrong patient. An emergency medicine physician inadvertently switched medication orders on two patients. One was in the emergency department for intravenous hydration, and the other had been in a motor vehicle accident and was going to be intubated and transferred to a trauma center. Because of the switch, the hydration patient received midazolam and vecuronium, went into respiratory arrest, and died.[38]

Wrong patient errors are being reported more frequently with eRx. In the pre-electronic era, unless it was a telephone order, the prescriber had to be physically present on the unit, because that is where the chart was located. With computerized charting, it is possible to have several patient files open at the same time and inadvertently click on the wrong chart to enter the order. Alternatively, the prescriber is on a different unit, and enters a remote order on the wrong patient because of similarity in patient names.

Some wrong patient errors can be prevented by limiting the number of charts or files that can be open at one time.[38] Many electronic health records (although not all) have this feature built in. An exception is often made for the emergency department.

Wrong dose or frequency selection. Like picking the wrong drug, clicking on the wrong dose or frequency from the numerous choices typically displayed on drop-down menus can easily occur. Sometimes, prescribers have entered the wrong frequency, or left the default frequency and used a comment field to communicate the correct information through free text. These instructions may be ambiguous or confusing and, furthermore, often appear several screens after the main screen and are easily overlooked by the pharmacist. The drug is then dispensed with the wrong or the default frequency.

Errors in dose calculation. A potentially serious prescribing error is miscalculating a dose, especially with weight-based dosing. Historically, "decimal point errors" made during calculations have been responsible for serious prescribing overdoses in neonates and children.[39]

Failure to Deprescribe

An 86-year-old woman is seeing a new healthcare provider because her previous provider has retired, and she is experiencing pain, insomnia, and diarrhea. She is being treated for mild heart failure secondary to valve disease, hypertension, hyperlipidemia, glaucoma, depression, chronic kidney disease, and diabetes. She reports an increase in dizziness as of late; she is having trouble getting into and out of the bathtub. She knows that she takes a handful of pills daily but is not sure what they are for. Her healthcare provider looks at her current medication list, and although he realizes that this list represents polypharmacy, he is reluctant to change anything at this time because he is not familiar with her history and why she is taking these medications. Instead, he refills several of her medications. Two days later, the woman gets up during the night because she can't sleep, intending to make some tea. She is dizzy, and falls and breaks her hip and her humerus, requiring surgery.

Some experts distinguish between prescribing errors and prescribing faults. Prescribing errors are those made in the act of writing or entering a prescription, whereas prescribing faults include irrational prescribing, inappropriate prescribing, underprescribing, overprescribing, and ineffective prescribing, as a result of erroneous medical judgement, treatment decisions, or treatment monitoring.[40]

Deprescribing is the act of tapering, reducing, or stopping a medication.[41] The failure to deprescribe ("prescribing inertia") is a prescribing fault that is especially dangerous in the elderly population, who might already be taking a handful of pills every day. When a new drug is prescribed, the risk for drug/drug interactions and adverse events rises.[42] Polypharmacy in older adults is associated with, at the very least, falls, cognitive impairment, and increased mortality.[43-45]

Barriers to deprescribing include ambivalence about stopping medications, reticence to stop medications prescribed by others, limited knowledge about best practice for stopping medications, and concern about potential withdrawal.[41] However, deprescribing has a major benefit for eRx because it can reduce the number of pesky alerts about potential drug interactions.

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  31. Poggio ED, Wang X, Greene T, Van Lente F, Hall PM. Performance of the modification of diet in renal disease and Cockcroft-Gault equations in the estimation of GFR in health and in chronic kidney disease. J Am Soc Nephrol. 2005;16:459-466.
  32. Erler A, Beyer M, Petersen JJ, et al. How to improve drug dosing for patients with renal impairment in primary care—a cluster-randomized controlled trial. BMC Fam Pract. 2012;13:91.
  33. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;60:616-631. http://www.medscape.com/viewarticle/762283 Accessed September 9, 2015.
  34. Halamaka J. Order interrupted by text; multitasking mishap. AHRQ Patient Safety Network. WebM&M. December 2011. http://webmm.ahrq.gov/case.aspx?caseID=257 Accessed September 7, 2015.
  35. Alvarez A. What tasks are physicians performing on their smartphones? Kantar Media. October 22, 2014. http://www.kantarmedia-healthcare.com/what-tasks-are-physicians-performing-on-their-smartphones Accessed September 8, 2015.
  36. Bokser SJ. A weighty mistake. Morbidity and Mortality Rounds on the Web. March, 2013. http://webmm.ahrq.gov/case.aspx?caseID=293. Accessed September 7, 2015.
  37. Abramson EL, Bates DW, Jenter C, et al. Ambulatory prescribing errors among community-based providers in two states. J Am Med Inform Assoc. 2012;19:644-648.
  38. Institute for Safe Medication Practices. Oops sorry, wrong patient. ISMP Medication Safety Alert. 2011;16. https://www.ismp.org/newsletters/acutecare/articles/20110310.asp Accessed September 7, 2015.
  39. Lesar TS. Tenfold medication dose prescribing errors. Ann Pharmacother. 2002;36:1833-1839.
  40. Velo GP, Minuz P. Medication errors: prescribing faults and prescription errors. Br J Clin Pharmacol. 2009;67:624-628.
  41. Anthierens S, Tansens A, Petrovic M, Christiaens T. Qualitative insights into general practitioners views on polypharmacy. BMC Fam Pract. 2010;11:65.
  42. Farrell B, Tsang C, Raman-Wilms L, Irving H, Conklin J, Pottie K. What are priorities for deprescribing for elderly patients? Capturing the voice of practitioners: a modified delphi process. PLoS One. 2015;10:e0122246.
  43. Hajjar ER, Cafiero AC, Hanlon JT. Polypharmacy in elderly patients. Am J Geriatr Pharmacother. 2007;5:345-351.
  44. Huang AR, Mallet L, Rochefort CM, Eguale T, Buckeridge DL, Tamblyn R. Medication-related falls in the elderly: causative factors and preventive strategies. Drugs Aging. 2012;29:359-376.
  45. Jyrkka J, Enlund H, Korhonen MJ, Sulkava R, Hartikainen S. Polypharmacy status as an indicator of mortality in an elderly population. Drugs Aging. 2009;26:1039-1048.

Published on Medscape:  October 22,2015  Authors: Graham, LR, Scudder L, Stokowski L

 

Tort Review: Medical and Toxicology

Here are a few ideas how the tort system can be reformed.

 

5 Ways to Improve Our Medical Liability System

Brian S. Kern, JD

|January 14, 2015

Some Steps Toward Tort Reform

As healthcare delivery evolves, the medical professional liability tort system largely remains static. Judges and trial attorneys are forced to navigate endlessly complex rules and legal theories to achieve a simple end: compensating injured patients. Assuming that the United States is not going to move to a "no-fault" system anytime soon, it can still take several steps to streamline our current fault-based system and improve the situation for physicians and many others involved.

1. Recognize Healthcare Entities

Most state laws hold individual physicians accountable if they are found to be negligent—typically defined as breaching a duty owed to a patient, if that breach causes an injury. Over the past decade, many healthcare systems have set up self-insurance models (mainly a captive or risk-retention group) that cover themselves and affiliated providers against all professional liability claims. To comply with the various state laws, the insurance program must then issue distinct limits and policies to each physician. Given that the healthcare system ultimately assumes all liability anyway, these requirements defy logic.

Instead, hospitals or healthcare systems should be permitted to adopt an enterprise approach to manage its liability.

2. Embrace Wholly, or Eliminate, Vicarious Liability

"Vicarious liability" is a theory that permits a plaintiff to hold a company accountable for the acts of its employees. This theory is critical in virtually every industry, to insulate individuals from personal liability and allow a company to respond to claims of negligence. Not so in healthcare.

Most state laws hold physicians personally liable for their acts, preventing them from creating a legal entity to serve as a corporate shield. For this reason, these same states often require physicians to carry individual limits of insurance. But they also permit vicarious liability claims, which undermines the intent of the theory in the first place.

States should not try to have it both ways. States ought to either permit vicarious liability and eliminate the requirement for physicians to carry their own insurance limits, or abandon altogether the vicarious liability framework in medical professional liability claims.

3. Immunize New Healthcare System Guidelines

Under the accountable care organization regulations, participating healthcare systems are required to develop a host of internal policies, procedures and clinical guidelines related to patient care. This concept has also been embraced by managed care organizations that enter into shared-savings agreements with providers across the United States.

By developing such guidelines, which are often ideal in nature, physicians worry that they will become their own standard of care that, if not followed, opens them up to tremendous liability.

The American Congress of Obstetricians and Gynecologists (ACOG) has attempted to claim that its widely respected guidelines are not to serve as a standard of care in professional liability litigation, but stating something does not make it so; indeed, many plaintiffs are successful in using ACOG guidelines as the standard in medical malpractice lawsuits.

Healthcare entities and systems should enjoy legislative immunity when creating best practice guidelines. Simply preventing the discoverability of such internal guidelines (perhaps even allowing them to be incorporated under a patient safety organization protection) would probably suffice, and encourage systems to strive to be idealistic when developing guidelines for optimal patient care.

Reducing Waste and Compensating Injured Patients

4. Consolidate Claims

 

Increasingly, plaintiff attorneys are using bodies of law outside of the negligence framework to hold physicians accountable to patients. Presumably, this tactic of adding certain counts to a negligence complaint is used to gain leverage, because they know that professional liability insurance policies rarely cover such claims—including violations of laws or regulations (eg, laws against discrimination, nursing home bill of rights), international infliction of emotional distress, breach of privacy, and negligent billing practices.

What this means is that if a physician is sued for negligence, he or she may have another—uninsurable—issue also added to the lawsuit. The courts should step in and prevent plaintiffs from using this tactic. If a patient is suing a physician for negligence, superfluous counts serve only to frustrate matters, and should be dismissed.

5. Reward Positive Innovation

Successful programs exist to eliminate waste of a system's or physician's resources when dealing with a potential malpractice lawsuit; these include early apology and disclosure programs, binding arbitration, and even early settlement programs. The goal is not only to reduce the massive expenses associated with entering the legal system, but also to ensure that the patients (not the attorneys and experts) get a larger share of the recovery, and in a far shorter period.

These types of programs should be supported so that they blossom—not stifled in a maze of outdated regulations.

What Can Physicians Do to Help Make This Happen?

Physician organizations have spent significant resources to defend caps on noneconomic damages and fight for other important tort reform measures. By fighting for simple changes, such as the ones outlined above, healthcare systems and physicians will be in a position to tailor professional liability programs in a way that will reduce waste and best compensate injured patients.

It is time that the US healthcare professional liability system adapts to the US healthcare system.

 

Bupropion Use is Increasing!

Bupropion, otherwise known as Wellbutrin is commonly prescribed for major depression, and for smoking cessation.  It's major adverse side effects are seizures.  But in high enough doses it also increases sexual desire, and a high that has been compared to that of cocaine. The following report describes the data of increasing use, and some of the problems associated with the drug.

 

The proportion of bupropion prescriptions that were refilled under circumstances that suggest misuse or diversion increased roughly 10-fold in Ontario, Canada, during a 13-year period, according to a study published in the July/August issue of the Annals of Family Medicine.

In the final study year, such questionable prescriptions totaled an estimated 48,000 pills of the drug, which is clinically used to treat depression and to support smoking cessation efforts. People who abuse the drug say it provides a cocaine-like high.

"These findings suggest a troubling phenomenon that bupropion prescriptions are being used recreationally at an increasing rate," write the investigators, led by Leah S. Steele, MD, PhD, from the Institute for Clinical Evaluative Sciences; St. Michael's Hospital; and the University of Toronto in Ontario, Canada.

"Physicians and pharmacists should be aware of the potential for bupropion misuse, particularly in patients prone to substance use disorders or those who display unusual drug-seeking behaviors," they write. "Adding questions about misuse of bupropion to population-based drug use surveys could help determine the extent of the problem."

The serial cross-sectional study included data from Ontarians younger than 65 years and not residing in long-term care facilities who received prescriptions under the province's public drug program from April 1, 2000, to March 31, 2013.

The investigators ascertained the quarterly number of bupropion prescriptions that were potentially inappropriate, defined as early refills dispensed within half of the duration of the preceding prescription, and that were potentially duplicitous, defined as such early refills originating from a different prescriber and different pharmacy. They conducted the same analyses for citalopram and sertraline, which are antidepressants not known to be prone to abuse.

Overall, the authors identified 1,780,802 prescriptions for bupropion, 3,402,462 for citalopram, and 1,775,285 for sertraline.

There was a sharp rise in potentially duplicitous prescriptions for bupropion during the study period, going from less than 0.05% of all prescriptions to 0.47%, with greatest increase seen after 2008. In the final study quarter, this 0.47% rate was significantly higher than that for both citalopram (0.11%) and sertraline (0.12%).

However, the rate of early refills for bupropion fell during the study period, from 4.8% to 3.1%, as did the rate for the other two drugs. In the final quarter, the 3.1% rate of early refills for bupropion was significantly higher than that for citalopram (2.2%), but not that for sertraline (2.9%).

The investigators note that the public drug program from which the study data were derived accounts for less than half of all prescription drug expenditures in Ontario. "Consequently, although we identified a large proportion of anomalous bupropion prescriptions in the province, the total number is necessarily higher," they point out.

Ann Fam Med. 2015;13:343-346. Full text

Emergency Management of Marijuana Psychosis

Marijuana is a commonly used drug.  In some states it is legal.  The following article appeared in the Western Journal of Emergency Medicine, and it describes the correct approach and standard of practice in the treatment of marijuana overdose resulting in psychosis in the emergency department.  The citation is noted at the bottom of the article.

 

Abstract and Introduction

Abstract

We use a case report to describe the acute psychiatric and medical management of marijuana intoxication in the emergency setting. A 34-year-old woman presented with erratic, disruptive behavior and psychotic symptoms after recreational ingestion of edible cannabis. She was also found to have mild hypokalemia and QT interval prolongation. Psychiatric management of cannabis psychosis involves symptomatic treatment and maintenance of safety during detoxification. Acute medical complications of marijuana use are primarily cardiovascular and respiratory in nature; electrolyte and electrocardiogram monitoring is indicated. This patient's psychosis, hypokalemia and prolonged QTc interval resolved over two days with supportive treatment and minimal intervention in the emergency department. Patients with cannabis psychosis are at risk for further psychotic sequelae. Emergency providers may reduce this risk through appropriate diagnosis, acute treatment, and referral for outpatient care.

Introduction

Already the most commonly used illicit drug in the United States, marijuana (or cannabis) is becoming more widely used and more potent with expanded legalization.[1–3] Legalization has also popularized "edible" forms of marijuana, including teas and food products. Although often portrayed as a harmless drug with potential therapeutic uses, marijuana has detrimental effects on brain development, psychiatric health (eg, psychosis, schizophrenia, depression and anxiety), lungs (eg, chronic bronchitis and lung cancer) and heart (eg, myocardial infarction and arrhythmias).[2] Public perception of these risks decreases with legalization, and no guidelines exist to help patients gauge the personal safety of use.[4,5] As emergency providers treat more patients with cannabis use disorders, they must educate patients about these chronic health risks and also manage the acute medical and psychiatric complications of marijuana intoxication.

To illustrate the management of acute complex marijuana intoxication and psychosis, we present a case of a woman requiring prolonged emergency department management after ingestion of edible tetrahydrocannabinol (THC), the active ingredient in marijuana.

Case Report

A 34-year-old woman with no significant psychiatric history presented to the emergency department (ED) with erratic and disruptive behavior. She broke into a neighbor's home, requesting to "go to heaven." She feared people were stealing from her and that "something bad" was going to happen. She reported insomnia, racing thoughts, and euphoria for the past week.

Upon arrival to the ED, her vital signs were temperature of 36.4°C, heart rate of 96bpm, blood pressure 148/111mmHg, and respiratory rate of 11. She was difficult to redirect and her mental status revealed a thin, "nervous," well-groomed woman with a labile affect and pressured speech. The patient's thought process was loose and disorganized with thought blocking. She was paranoid, grandiose, hyper-religious, and endorsed auditory hallucinations. She denied suicidal or homicidal ideation. Her attention and memory were considered impaired though not formally tested.

The patient admitted to using cannabis lip balm and consuming edible cannabis chocolate bars daily over the past week, most recently the day of presentation. She could not quantify her consumption. She believed her paranoia and insomnia onset coincided with her THC ingestion last week. The patient denied other recent substance or alcohol use. She denied any falls or history of traumatic brain injuries. A friend of the patient confirmed this history. Her other medications included propranolol 20mg twice a day for hypertension and infrequent sumatriptan as needed for migraines. Family history of mental illness was unknown since the patient was adopted.

For this presentation of acute psychosis, emergency medical providers conducted a comprehensive work-up to exclude organic etiologies of psychosis or concurrent medical morbidity. A basic metabolic panel was significant for a potassium level of 3.2mg/dL (reference range: 3.5–5.0); her electrocardiogram (EKG) demonstrated a prolonged QTc of 508ms, a pulse of 86, and no U waves or T wave changes. A 9-carboxy-THC level was over 500ng/mL; her urine toxicology screen was negative for cocaine, amphetamines, benzodiazepines, and opioids. A B12 level was elevated at 1186pg/mL. Her complete blood count and a noncontrast head computerized tomography (CT) study were unremarkable.

The patient refused supplemental potassium, and it was thought that her EKG findings did not warrant emergent, forcible repletion. She also removed her intravenous line while agitated. She was placed in two-point soft restraints for her safety. After consultation with psychiatry, the patient was deemed medically appropriate for transfer to the ED's psychiatric emergency service (PES) for further evaluation and treatment.

In the PES, the patient was hypersexual, hyperactive, and intrusive, entering other patients' rooms and touching them. As she could not be safely re-directed, physical restraints were again ordered for the patient's and others' safety. Risperidone 0.5mg PO q6hr and lorazepam 1mg PO q6hr were ordered as needed for management of psychosis and anxiety; the patient required one dose of each during her PES stay.

Twenty-four hours after presentation, her psychotic symptoms and anxiety persisted: she suggested that her food was poisoned and asked whether she was African-American (though she was Caucasian). The patient claimed to have forgotten her father's name, did not know where she was currently living, and was oriented only to person and place. She received her scheduled propranolol for hypertension and 40meq of oral potassium chloride (which she had earlier refused). Her consciousness and attention were intact.

Forty-eight hours after presentation, the patient's paranoia and hallucinations improved dramatically. The patient was able to reflect on the unreality of her paranoia and "odd thoughts" of being African-American. With improved insight, she confirmed heavy use of multiple edible THC products in addition to frequent coffee and energy drink consumption, which she had difficulty quantifying. The patient was diagnosed with cannabis-induced psychotic disorder and severe marijuana use disorder; she was instructed to follow up with outpatient mental health to ensure resolution of her psychosis and begin substance abuse treatment.

Discussion

New-onset psychosis is a medical emergency with a broad differential.[6] Signs and symptoms concerning for a medical etiology of psychiatric symptoms include abnormal vital signs, altered consciousness, or lack of prior psychiatric history in a patient over 40 years old.[7] The acute onset of symptoms with marijuana use, high serum marijuana metabolite levels, and symptomatic resolution with detoxification suggest these symptoms were secondary to marijuana use.

Cannabis-induced psychotic disorder ("cannabis psychosis") is diagnosed when psychotic symptoms persist beyond acute intoxication and may require clinical management.[8] Psychiatric symptoms include paranoia, derealization, disorganized thinking, persecutory and grandiose delusions, hallucinations, and cognitive impairment. Patients pose a danger to others and themselves due to their altered sense of reality. Safe cannabis detoxification typically requires 24 hours, but sometimes longer for patients with unstable vital signs and persistent psychosis. Benzodiazepines are recommended for agitation related to stimulant intoxication – unless psychosis is present, in which case oral atypical antipsychotics are considered first-line.[9]

Cannabis blood levels reflect the extent and chronicity of marijuana use. A free THC level below 3ng/mL (μg/L) suggests occasional consumption (≤1 joint/week) while a concentration higher than 40ng/mL corresponds to heavy use (≥10 joints/month).[10] Levels above 10ng/mL impair motor function, leading two states with legal recreational marijuana to establish the legal limit for driving at 5ng/mL. In clinical practice, measuring an inactive metabolite of THC, 9-carboxy THC, is preferred due to the rapid decrease in free serum THC levels.[11] In a prior case report, oral cannabis-induced psychosis resolved within 24 hours after recorded serum THC levels below 20ng/mL, or 9-carboxy-THC levels below 50ng/mL; the authors suggested that oral administration may not achieve high serum THC levels.[12] Our patient's 9-carboxy-THC level over 500ng/mL demonstrates that oral administration can achieve high serum THC levels and suggests a dose-response relationship between serum metabolite levels and the severity of psychosis. Moreover, serum drug levels may anticipate a patient's clinical course.

The medical risks of acute cannabis use are primarily cardiovascular in nature. THC enhances sympathetic tone, thereby increasing heart rate and blood pressure.[13] Marijuana increases the risk of myocardial infarction within one hour of use, and cardiovascular events have been reported in otherwise healthy patients.[5,14,15] A Norwegian autopsy study suspected THC-induced arrhythmias (including ventricular tachycardia and fibrillation) as the culprit in six patients who died suddenly.[15,16] Electrocardiograms should be obtained for patients with severe cannabis intoxication; telemetry monitoring may be considered for patients with known cardiac pathology.

Electrolyte abnormalities reported in marijuana users contribute to this cardiac pathology. Chronic marijuana users have lower serum sodium and potassium than non-users.[17] The heavy consumption of carbohydrates while intoxicated leads to an increase in serum insulin levels, driving potassium into cells and causing serum hypokalemia.[18] This hypokalemia can produce reentrant arrhythmias by decreasing conductivity and increasing the resting membrane potential, duration of the action potential, and duration of the refractory period.[19] EKG changes include the decrease in T-wave amplitude, presence of U waves and a prolonged QTc. This patient's very high THC metabolite level, prolonged QTc, and hypokalemia increased her risk for an arrhythmia. The hypokalemia observed in this case was likely related to acute intracellular potassium shifts superimposed on chronic hypokalemia.

Clinicians must manage other, non-vascular risks of acute marijuana use. Respiratory symptoms include shortness of breath, wheezing, and even respiratory failure when marijuana has been smoked "wet" with phenylcyclidine or embalming fluid.[20,21] Patients with pre-disposing genetic vulnerabilities may develop hypokalemic periodic paralysis.[18] And, marijuana use correlates with fatal motor vehicle collisions – clinicians should educate patients and ensure a safe transportation plan on discharge.[22]

Patients with toxic ingestion must be screened for co-ingestion. The persistence and intensity of the patient's symptoms warranted consideration of multiple involved substances. Co-ingestion may also be signaled by an abnormal osmolar or anion gap, positive urine toxicology screen, or QTc or QRS prolongation (Only QTc prolongation was present here).[23,24] However, in many cases, the presence of co-ingestion may only be detected once the patient is able to provide a reliable history. In this case, an elevated B12 level was found on work up of the patient's psychiatric symptoms and suspected to have been caused by energy drink consumption; only later did the patient confirm this suspicion. By its effects on mesolimbic dopamine activity, caffeine may precipitate psychosis, exacerbate chronic psychosis, or worsen affective lability and mood states.[25–28] This patient's high THC metabolite level and medical course are consistent with cannabis psychosis; however, we cannot exclude excessive caffeine use as a contributor to this presentation.

What is this patient's prognosis? Marijuana correlates with the onset of psychosis in patients with schizophrenia and perhaps bipolar disorder as well.[29–32] About half of patients with cannabis psychosis will later be diagnosed with a primary psychotic disorder.[8,33] This high rate may reflect high rates of marijuana use among patients with schizophrenia. Younger age, greater frequency of marijuana use, family history of psychosis, trauma history, and schizotypal personality correlate with higher risk of a later diagnosis of primary psychosis.[8] ED providers can mitigate the risk of psychopathology by addressing the patient's substance use disorder. Safe detoxification is a primary goal and was accomplished here; brief interventions like motivational interviewing and referral for treatment in the ED may reduce use on discharge.[34,35]

References

  1. Choo EK, Benz M, Zaller N, et al. The impact of state medical marijuana legislation on adolescent marijuana use. J Adolescent Health. 2014;55(2):160–166.
  2. Volkow ND, Baler RD, Compton WM, et al. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227.
  3. Sevigny EL, Pacula RL, Heaton P, et al. The effects of medical marijuana laws on potency. Int J Drug Policy. 2014;25(2):308–319.
  4. Schuermeyer J, Salomonsen-Sautel S, Price RK, et al. Temporal trends in marijuana attitudes, availability and use in Colorado compared to non-medical marijuana states: 2003–11. Drug Alcohol Depend. 2014;140:145–155.
  5. Rezkalla SH, Sharma P, Kloner RA. Coronary no-flow and ventricular tachycardia associated with habitual marijuana use. Ann Emerg Med. 2003;42:365–369.
  6. Nordstrom K, Zun LS, Wilson MP, et al. Medical evaluation and triage of the agitated patient: consensus statement of the American association for emergency psychiatry project BETA medical evaluation workgroup. Western J Emerg Med. 2012;13(1):3–10.
  7. Sood, TR, McStay CM. Evaluation of the psychiatric patient. Emerg Med Clin North Am. 2009;27(4):669–683.
  8. Radhakrishnan R, Wilkinson ST, D'Souza DC. Gone to pot - a review of the association between cannabis and psychosis. Front Psychiatry. 2014;5:1–24.
  9. Wilson MP, Pepper D, Currier GW, et al. The psychopharmacology of agitation: consensus statement of the american association for emergency psychiatry project BETA psychopharmacology workgroup. Western J Emerg Med. 2012;13(1):26–34.
  10. Fabritius M, Favrat B, Chtioui H, et. al. THCCOOH concentrations in whole blood: are they useful in discriminating from heavy smokers? Drug Test Anal. 2014;6(1–2):155–63.
  11. Sharma, P, Murthy P, Bharath MM. Chemistry, metabolism, and toxicology of cannabis: clinical implications. Iran J Psychiatry. 2012;7(4):149–156.
  12. Favrat B, Menetrey A, Augsburger M, et al. Two cases of "cannabis acute psychosis" following the administration of oral cannabis. BMC Psychiatry. 2005;5:17.
  13. Aryana A, Williams MA. Marijuana as a trigger of cardiovascular events: Speculation or scientific certainty? Int J Cardiol. 2007;118(2):141–144.
  14. Mittleman MA, Lewis RA, Maclure M, et al. Triggering myocardial infarction by marijuana. Circulation. 2001;103:2805–2809.
  15. Charles R, Holt S, Kirkham N. Myocardial infarction and marijuana. Clin Toxicol. 1979;14(4):433–438.
  16. Bachs L, Morland H. Acute cardiovascular fatalities following cannabis use. Forensic Sci Int. 2001;124:200–203.
  17. Osadolor HB, Emokpae AM. Effects of marijuana on sodium and potassium ions homeostasis among smokers in benin city - a metropolitan city in nigeria. International Journal of Pharma and Bio Sciences. 2010;1(3):1–3.
  18. Feldman ML, Hadfield S. Pot paresis: marijuana and a case of hypokalemic periodic paralysis. J Emerg Med. 2009;36(3):236–238.
  19. Helfant, RH. hypokalemia and arrhythmias. Am J Med. 1986;80(4):13–22.
  20. Lutchmansingh D, Pawar L, Savici D. Legalizing cannabis: a physician's primer on the pulmonary effects of marijuana. Curr Respir Care Rep. 2014;3(4):200–205.
  21. Gilbert CR, Baram M, Cavarpocchi NC. "Smoking west": respiratory failure related to smoking tainted marijuana cigarettes. Tex Heart Inst J. 2013;40(1):64–67.
  22. Asbridge M, Hayden JA, Cartwright JL. Acute cannabis consumption and motor vehicle collision risk: systematic review of observational studies and meta-analysis. BMJ. 2012;344.
  23. Holstege C, Borek H. Toxidromes. Crit Care Clin. 2012;28:479–498.
  24. Mokhlesi B, Leiken JB, Murray P, et al. Adult toxicology in critical care – part I: general approach to the intoxicated patient. CHEST. 2003;123:577–592.
  25. Nehlig A, Daval JL, Debry G. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Res Brain Res Rev. 1992;17(2):139–169.
  26. Hedges DW, Woon FL, Hoopes SP. Caffeine-induced psychosis. CNS Spectrum. 2009;14(3):127–129.
  27. Shaul PW, Farrell MK, Maloney MJ. Caffeine toxicity as a cause of acute psychosis in anorexia nervosa. J Pediatr. 1984;105(3):493–495.
  28. Szpak A, Allen D. A case of acute suicidality following excessive caffeine intake. J Psychopharmacol. 2012;26(11):1502–1510.
  29. Moore THM, Zammit S, Lingford-Hughes A, et al. Cannabis use and risk of psychotic or affective mental health outcomes: a systematic review. Lancet. 2007;370(9584):319–328.
  30. Large M, Sharma S, Compton MT, et al. Cannabis use and earlier onset of psychosis: a systematic meta-analysis. Arch Gen Psychiatry. 2011;68(6):555–561.
  31. Gibbs M, Winsper C, Marwaha S, et al. Cannabis use and mania symptoms: a systematic review and meta-analysis. J Affect Disord. 2014;171C:39–47.
  32. Bally N, Zullino D, Aubry JM. Cannabis use and first manic episode. J Affect Disord. 2014;165:103–108.
  33. Arendt M, Rosenberg R, Foldager L, et al. Cannabis-induced psychosis and subsequent schizophrenia-spectrum disorders: followup study of 535 incident cases. Br J Psychiatry. 2005;187:510–515.
  34. Woodruff SI, Eisenberg K, McCabe CT, et al. Evaluation of california's alcohol and drug screening and brief intervention project for emergency department patients. West J Emerg Med. 2013;14(3):263–270.
  35. Magill M, Barnett NP, Apodaca TR, et al. The role of marijuana use in brief motivational intervention with young adult drinkers treated in an emergency department. J Stud Alcohol Drugs. 2009;70(30):409–413.

Western J Emerg Med. 2015;16(3):414-417. © 2015  Western Journal of Emergency Medicine

Emergency Treatment of Marijuana Psychosis

Marijuana is a commonly used drug.  In some states it is legal.  The following article appeared in the Western Journal of Emergency Medicine, and it describes the correct approach and standard of practice in the treatment of marijuana overdose resulting in psychosis in the emergency department.  The citation is noted at the bottom of the article.

Abstract and Introduction

Abstract

We use a case report to describe the acute psychiatric and medical management of marijuana intoxication in the emergency setting. A 34-year-old woman presented with erratic, disruptive behavior and psychotic symptoms after recreational ingestion of edible cannabis. She was also found to have mild hypokalemia and QT interval prolongation. Psychiatric management of cannabis psychosis involves symptomatic treatment and maintenance of safety during detoxification. Acute medical complications of marijuana use are primarily cardiovascular and respiratory in nature; electrolyte and electrocardiogram monitoring is indicated. This patient's psychosis, hypokalemia and prolonged QTc interval resolved over two days with supportive treatment and minimal intervention in the emergency department. Patients with cannabis psychosis are at risk for further psychotic sequelae. Emergency providers may reduce this risk through appropriate diagnosis, acute treatment, and referral for outpatient care.

Introduction

Already the most commonly used illicit drug in the United States, marijuana (or cannabis) is becoming more widely used and more potent with expanded legalization.[1–3] Legalization has also popularized "edible" forms of marijuana, including teas and food products. Although often portrayed as a harmless drug with potential therapeutic uses, marijuana has detrimental effects on brain development, psychiatric health (eg, psychosis, schizophrenia, depression and anxiety), lungs (eg, chronic bronchitis and lung cancer) and heart (eg, myocardial infarction and arrhythmias).[2] Public perception of these risks decreases with legalization, and no guidelines exist to help patients gauge the personal safety of use.[4,5] As emergency providers treat more patients with cannabis use disorders, they must educate patients about these chronic health risks and also manage the acute medical and psychiatric complications of marijuana intoxication.

To illustrate the management of acute complex marijuana intoxication and psychosis, we present a case of a woman requiring prolonged emergency department management after ingestion of edible tetrahydrocannabinol (THC), the active ingredient in marijuana.

Case Report

A 34-year-old woman with no significant psychiatric history presented to the emergency department (ED) with erratic and disruptive behavior. She broke into a neighbor's home, requesting to "go to heaven." She feared people were stealing from her and that "something bad" was going to happen. She reported insomnia, racing thoughts, and euphoria for the past week.

Upon arrival to the ED, her vital signs were temperature of 36.4°C, heart rate of 96bpm, blood pressure 148/111mmHg, and respiratory rate of 11. She was difficult to redirect and her mental status revealed a thin, "nervous," well-groomed woman with a labile affect and pressured speech. The patient's thought process was loose and disorganized with thought blocking. She was paranoid, grandiose, hyper-religious, and endorsed auditory hallucinations. She denied suicidal or homicidal ideation. Her attention and memory were considered impaired though not formally tested.

The patient admitted to using cannabis lip balm and consuming edible cannabis chocolate bars daily over the past week, most recently the day of presentation. She could not quantify her consumption. She believed her paranoia and insomnia onset coincided with her THC ingestion last week. The patient denied other recent substance or alcohol use. She denied any falls or history of traumatic brain injuries. A friend of the patient confirmed this history. Her other medications included propranolol 20mg twice a day for hypertension and infrequent sumatriptan as needed for migraines. Family history of mental illness was unknown since the patient was adopted.

For this presentation of acute psychosis, emergency medical providers conducted a comprehensive work-up to exclude organic etiologies of psychosis or concurrent medical morbidity. A basic metabolic panel was significant for a potassium level of 3.2mg/dL (reference range: 3.5–5.0); her electrocardiogram (EKG) demonstrated a prolonged QTc of 508ms, a pulse of 86, and no U waves or T wave changes. A 9-carboxy-THC level was over 500ng/mL; her urine toxicology screen was negative for cocaine, amphetamines, benzodiazepines, and opioids. A B12 level was elevated at 1186pg/mL. Her complete blood count and a noncontrast head computerized tomography (CT) study were unremarkable.

The patient refused supplemental potassium, and it was thought that her EKG findings did not warrant emergent, forcible repletion. She also removed her intravenous line while agitated. She was placed in two-point soft restraints for her safety. After consultation with psychiatry, the patient was deemed medically appropriate for transfer to the ED's psychiatric emergency service (PES) for further evaluation and treatment.

In the PES, the patient was hypersexual, hyperactive, and intrusive, entering other patients' rooms and touching them. As she could not be safely re-directed, physical restraints were again ordered for the patient's and others' safety. Risperidone 0.5mg PO q6hr and lorazepam 1mg PO q6hr were ordered as needed for management of psychosis and anxiety; the patient required one dose of each during her PES stay.

Twenty-four hours after presentation, her psychotic symptoms and anxiety persisted: she suggested that her food was poisoned and asked whether she was African-American (though she was Caucasian). The patient claimed to have forgotten her father's name, did not know where she was currently living, and was oriented only to person and place. She received her scheduled propranolol for hypertension and 40meq of oral potassium chloride (which she had earlier refused). Her consciousness and attention were intact.

Forty-eight hours after presentation, the patient's paranoia and hallucinations improved dramatically. The patient was able to reflect on the unreality of her paranoia and "odd thoughts" of being African-American. With improved insight, she confirmed heavy use of multiple edible THC products in addition to frequent coffee and energy drink consumption, which she had difficulty quantifying. The patient was diagnosed with cannabis-induced psychotic disorder and severe marijuana use disorder; she was instructed to follow up with outpatient mental health to ensure resolution of her psychosis and begin substance abuse treatment.

Discussion

New-onset psychosis is a medical emergency with a broad differential.[6] Signs and symptoms concerning for a medical etiology of psychiatric symptoms include abnormal vital signs, altered consciousness, or lack of prior psychiatric history in a patient over 40 years old.[7] The acute onset of symptoms with marijuana use, high serum marijuana metabolite levels, and symptomatic resolution with detoxification suggest these symptoms were secondary to marijuana use.

Cannabis-induced psychotic disorder ("cannabis psychosis") is diagnosed when psychotic symptoms persist beyond acute intoxication and may require clinical management.[8] Psychiatric symptoms include paranoia, derealization, disorganized thinking, persecutory and grandiose delusions, hallucinations, and cognitive impairment. Patients pose a danger to others and themselves due to their altered sense of reality. Safe cannabis detoxification typically requires 24 hours, but sometimes longer for patients with unstable vital signs and persistent psychosis. Benzodiazepines are recommended for agitation related to stimulant intoxication – unless psychosis is present, in which case oral atypical antipsychotics are considered first-line.[9]

Cannabis blood levels reflect the extent and chronicity of marijuana use. A free THC level below 3ng/mL (μg/L) suggests occasional consumption (≤1 joint/week) while a concentration higher than 40ng/mL corresponds to heavy use (≥10 joints/month).[10] Levels above 10ng/mL impair motor function, leading two states with legal recreational marijuana to establish the legal limit for driving at 5ng/mL. In clinical practice, measuring an inactive metabolite of THC, 9-carboxy THC, is preferred due to the rapid decrease in free serum THC levels.[11] In a prior case report, oral cannabis-induced psychosis resolved within 24 hours after recorded serum THC levels below 20ng/mL, or 9-carboxy-THC levels below 50ng/mL; the authors suggested that oral administration may not achieve high serum THC levels.[12] Our patient's 9-carboxy-THC level over 500ng/mL demonstrates that oral administration can achieve high serum THC levels and suggests a dose-response relationship between serum metabolite levels and the severity of psychosis. Moreover, serum drug levels may anticipate a patient's clinical course.

The medical risks of acute cannabis use are primarily cardiovascular in nature. THC enhances sympathetic tone, thereby increasing heart rate and blood pressure.[13] Marijuana increases the risk of myocardial infarction within one hour of use, and cardiovascular events have been reported in otherwise healthy patients.[5,14,15] A Norwegian autopsy study suspected THC-induced arrhythmias (including ventricular tachycardia and fibrillation) as the culprit in six patients who died suddenly.[15,16] Electrocardiograms should be obtained for patients with severe cannabis intoxication; telemetry monitoring may be considered for patients with known cardiac pathology.

Electrolyte abnormalities reported in marijuana users contribute to this cardiac pathology. Chronic marijuana users have lower serum sodium and potassium than non-users.[17] The heavy consumption of carbohydrates while intoxicated leads to an increase in serum insulin levels, driving potassium into cells and causing serum hypokalemia.[18] This hypokalemia can produce reentrant arrhythmias by decreasing conductivity and increasing the resting membrane potential, duration of the action potential, and duration of the refractory period.[19] EKG changes include the decrease in T-wave amplitude, presence of U waves and a prolonged QTc. This patient's very high THC metabolite level, prolonged QTc, and hypokalemia increased her risk for an arrhythmia. The hypokalemia observed in this case was likely related to acute intracellular potassium shifts superimposed on chronic hypokalemia.

Clinicians must manage other, non-vascular risks of acute marijuana use. Respiratory symptoms include shortness of breath, wheezing, and even respiratory failure when marijuana has been smoked "wet" with phenylcyclidine or embalming fluid.[20,21] Patients with pre-disposing genetic vulnerabilities may develop hypokalemic periodic paralysis.[18] And, marijuana use correlates with fatal motor vehicle collisions – clinicians should educate patients and ensure a safe transportation plan on discharge.[22]

Patients with toxic ingestion must be screened for co-ingestion. The persistence and intensity of the patient's symptoms warranted consideration of multiple involved substances. Co-ingestion may also be signaled by an abnormal osmolar or anion gap, positive urine toxicology screen, or QTc or QRS prolongation (Only QTc prolongation was present here).[23,24] However, in many cases, the presence of co-ingestion may only be detected once the patient is able to provide a reliable history. In this case, an elevated B12 level was found on work up of the patient's psychiatric symptoms and suspected to have been caused by energy drink consumption; only later did the patient confirm this suspicion. By its effects on mesolimbic dopamine activity, caffeine may precipitate psychosis, exacerbate chronic psychosis, or worsen affective lability and mood states.[25–28] This patient's high THC metabolite level and medical course are consistent with cannabis psychosis; however, we cannot exclude excessive caffeine use as a contributor to this presentation.

What is this patient's prognosis? Marijuana correlates with the onset of psychosis in patients with schizophrenia and perhaps bipolar disorder as well.[29–32] About half of patients with cannabis psychosis will later be diagnosed with a primary psychotic disorder.[8,33] This high rate may reflect high rates of marijuana use among patients with schizophrenia. Younger age, greater frequency of marijuana use, family history of psychosis, trauma history, and schizotypal personality correlate with higher risk of a later diagnosis of primary psychosis.[8] ED providers can mitigate the risk of psychopathology by addressing the patient's substance use disorder. Safe detoxification is a primary goal and was accomplished here; brief interventions like motivational interviewing and referral for treatment in the ED may reduce use on discharge.[34,35]

References

  1. Choo EK, Benz M, Zaller N, et al. The impact of state medical marijuana legislation on adolescent marijuana use. J Adolescent Health. 2014;55(2):160–166.
  2. Volkow ND, Baler RD, Compton WM, et al. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227.
  3. Sevigny EL, Pacula RL, Heaton P, et al. The effects of medical marijuana laws on potency. Int J Drug Policy. 2014;25(2):308–319.
  4. Schuermeyer J, Salomonsen-Sautel S, Price RK, et al. Temporal trends in marijuana attitudes, availability and use in Colorado compared to non-medical marijuana states: 2003–11. Drug Alcohol Depend. 2014;140:145–155.
  5. Rezkalla SH, Sharma P, Kloner RA. Coronary no-flow and ventricular tachycardia associated with habitual marijuana use. Ann Emerg Med. 2003;42:365–369.
  6. Nordstrom K, Zun LS, Wilson MP, et al. Medical evaluation and triage of the agitated patient: consensus statement of the American association for emergency psychiatry project BETA medical evaluation workgroup. Western J Emerg Med. 2012;13(1):3–10.
  7. Sood, TR, McStay CM. Evaluation of the psychiatric patient. Emerg Med Clin North Am. 2009;27(4):669–683.
  8. Radhakrishnan R, Wilkinson ST, D'Souza DC. Gone to pot - a review of the association between cannabis and psychosis. Front Psychiatry. 2014;5:1–24.
  9. Wilson MP, Pepper D, Currier GW, et al. The psychopharmacology of agitation: consensus statement of the american association for emergency psychiatry project BETA psychopharmacology workgroup. Western J Emerg Med. 2012;13(1):26–34.
  10. Fabritius M, Favrat B, Chtioui H, et. al. THCCOOH concentrations in whole blood: are they useful in discriminating from heavy smokers? Drug Test Anal. 2014;6(1–2):155–63.
  11. Sharma, P, Murthy P, Bharath MM. Chemistry, metabolism, and toxicology of cannabis: clinical implications. Iran J Psychiatry. 2012;7(4):149–156.
  12. Favrat B, Menetrey A, Augsburger M, et al. Two cases of "cannabis acute psychosis" following the administration of oral cannabis. BMC Psychiatry. 2005;5:17.
  13. Aryana A, Williams MA. Marijuana as a trigger of cardiovascular events: Speculation or scientific certainty? Int J Cardiol. 2007;118(2):141–144.
  14. Mittleman MA, Lewis RA, Maclure M, et al. Triggering myocardial infarction by marijuana. Circulation. 2001;103:2805–2809.
  15. Charles R, Holt S, Kirkham N. Myocardial infarction and marijuana. Clin Toxicol. 1979;14(4):433–438.
  16. Bachs L, Morland H. Acute cardiovascular fatalities following cannabis use. Forensic Sci Int. 2001;124:200–203.
  17. Osadolor HB, Emokpae AM. Effects of marijuana on sodium and potassium ions homeostasis among smokers in benin city - a metropolitan city in nigeria. International Journal of Pharma and Bio Sciences. 2010;1(3):1–3.
  18. Feldman ML, Hadfield S. Pot paresis: marijuana and a case of hypokalemic periodic paralysis. J Emerg Med. 2009;36(3):236–238.
  19. Helfant, RH. hypokalemia and arrhythmias. Am J Med. 1986;80(4):13–22.
  20. Lutchmansingh D, Pawar L, Savici D. Legalizing cannabis: a physician's primer on the pulmonary effects of marijuana. Curr Respir Care Rep. 2014;3(4):200–205.
  21. Gilbert CR, Baram M, Cavarpocchi NC. "Smoking west": respiratory failure related to smoking tainted marijuana cigarettes. Tex Heart Inst J. 2013;40(1):64–67.
  22. Asbridge M, Hayden JA, Cartwright JL. Acute cannabis consumption and motor vehicle collision risk: systematic review of observational studies and meta-analysis. BMJ. 2012;344.
  23. Holstege C, Borek H. Toxidromes. Crit Care Clin. 2012;28:479–498.
  24. Mokhlesi B, Leiken JB, Murray P, et al. Adult toxicology in critical care – part I: general approach to the intoxicated patient. CHEST. 2003;123:577–592.
  25. Nehlig A, Daval JL, Debry G. Caffeine and the central nervous system: mechanisms of action, biochemical, metabolic and psychostimulant effects. Brain Res Brain Res Rev. 1992;17(2):139–169.
  26. Hedges DW, Woon FL, Hoopes SP. Caffeine-induced psychosis. CNS Spectrum. 2009;14(3):127–129.
  27. Shaul PW, Farrell MK, Maloney MJ. Caffeine toxicity as a cause of acute psychosis in anorexia nervosa. J Pediatr. 1984;105(3):493–495.
  28. Szpak A, Allen D. A case of acute suicidality following excessive caffeine intake. J Psychopharmacol. 2012;26(11):1502–1510.
  29. Moore THM, Zammit S, Lingford-Hughes A, et al. Cannabis use and risk of psychotic or affective mental health outcomes: a systematic review. Lancet. 2007;370(9584):319–328.
  30. Large M, Sharma S, Compton MT, et al. Cannabis use and earlier onset of psychosis: a systematic meta-analysis. Arch Gen Psychiatry. 2011;68(6):555–561.
  31. Gibbs M, Winsper C, Marwaha S, et al. Cannabis use and mania symptoms: a systematic review and meta-analysis. J Affect Disord. 2014;171C:39–47.
  32. Bally N, Zullino D, Aubry JM. Cannabis use and first manic episode. J Affect Disord. 2014;165:103–108.
  33. Arendt M, Rosenberg R, Foldager L, et al. Cannabis-induced psychosis and subsequent schizophrenia-spectrum disorders: followup study of 535 incident cases. Br J Psychiatry. 2005;187:510–515.
  34. Woodruff SI, Eisenberg K, McCabe CT, et al. Evaluation of california's alcohol and drug screening and brief intervention project for emergency department patients. West J Emerg Med. 2013;14(3):263–270.
  35. Magill M, Barnett NP, Apodaca TR, et al. The role of marijuana use in brief motivational intervention with young adult drinkers treated in an emergency department. J Stud Alcohol Drugs. 2009;70(30):409–413.

Western J Emerg Med. 2015;16(3):414-417. © 2015  Western Journal of Emergency Medicine

Surprising Verdicts In Med-Legal Cases

A recent article by Dr. Segal in Medscape discusses two defensible cases that resulted in surprising horrific outcomes for the two doctors who were sued.  There is a take home message and lesson to be learned embedded in these two cases.

 

How Would You Have Handled Patients Like These?

Being sued for malpractice is a traumatic experience. The odds of being sued at least once over one's career are high.[1] Doctors typically have sufficient professional liability coverage to prevent financial loss. But not all cases get resolved as expected, and doctors may end up with unforeseeable financial loss.

In addition, disciplinary action by a state medical board can also result in onerous remediation, the cost of which can also be surprisingly steep.

It's one thing when a physician clearly did something wrong and as a result suffers the consequences. But what if the wrongdoing isn't clear-cut—yet the financial hit to the doctor is still severe? Consider two unusual cases in point.

Did This Doctor Instruct His Patient?

In 2012, a Georgia jury awarded $3 million dollars to the estate of William Martinez.[1] Martinez was 31 years old when he entered his cardiologist's office. He complained of chest pain radiating into his arm. His cardiologist noted that Martinez was at "high risk" of having coronary disease and ordered a nuclear stress test. The test was scheduled to take place 8 days later.

The day before his test, however, Martinez apparently engaged in some "exertional activity."[2] He participated in a threesome with a woman who was not his wife and a male friend. While in the midst of this three-way sexual experience, Martinez died. Naturally, his family then sued the cardiologist, arguing that no instruction to avoid exertional activity had been given. The family's rationale was that had Martinez been properly instructed to avoid high-risk activities, he would have complied.

During the trial, the cardiologist alleged that Martinez was instructed to avoid exertional activity until after the test was completed.[2]

The family initially claimed $5 million in damages, but this claim was reduced by a finding that Martinez was 40% liable for his own death.[2] So the patient was 40% liable; the liability of the doctor was 60%. If the cardiologist's malpractice policy coverage was for the typical $1 million, it probably leaves him $2 million short.

In states that have implemented substantive tort reform, the sizeable award might have been reduced as a matter of law—if a large portion of that award was attributable to "pain and suffering." In 2010, however, the Georgia Supreme Court overturned that state's law, which set a $350,000 limit on damages paid out for pain and suffering in medical malpractice cases.[1] It ruled that the 5-year-old Georgia law violated a person's constitutional right to trial by jury and a plaintiff's right to allow a jury to calculate noneconomic damages as it sees fit.

That prior decision has concrete implications for physicians—particularly given that most doctors carry only $1 million in malpractice coverage. As such, understand what your policy limits are if you are sued; assess the likelihood that a judgment will exceed those limits in a particular case if you lose; and see whether limiting your downside risk while still allowing you to have your day in court would be helpful, an option discussed next.

Hedging Your Risk if You Go to Court

The patient died young, with decades of unrealized earning capacity. For the physician being sued, this means that if the plaintiff wins, there is a sizable chance of a multimillion-dollar award. Juries are unpredictable. How can a doctor protect himself against a financially crippling judgment when the alternative is to give the carrier permission to pay an amount up to and including the policy limits?

The answer is a high/low agreement. A high/low agreement allows the doctor to both have his day in court and potentially be vindicated with a verdict of "not liable," without having his carrier simply pay the plaintiff an amount up to and including his policy limits (a tacit admission of liability) and not risking his entire nest egg should he lose the judgment.

In a high/low agreement, the each side agrees that there is risk to their case. A doctor may be concerned that an injured patient (such as someone in a wheelchair) will elicit a strong emotional reaction from a jury when testifying about an expensive life-care plan. Or a young widow with little earning capacity may likewise generate sympathy with a jury when they learn that her children will not be able to afford college. Such judgments could be as high as $10 million and bankrupt a doctor.

On the other hand, a plaintiff may be concerned that although the injury was great, the doctor did not violate the standard of care—and even if he did, the doctor's actions did not cause the injury. If the jury agrees, the plaintiff may get nothing.

A contractual high/low agreement between both parties can create settlement "bookends" of, say, $100,000 and $1 million. The doctor gets his day in court. The jury renders its verdict. But each side hedges its risk. If the jury says the doctor is liable for $10 million, the doctor only has to pay the "high" value—or $1 million, typically his policy limit. If the jury finds the doctor not liable, the plaintiff still gets something—in this example, $100,000. In addition, because the jury finds the doctor not liable, there's no report to the National Practitioner Data Bank.

Because there was no way to prove whether the cardiologist had properly advised his patient—because the advice was not documented, it was the doctor's word against that of the family of the deceased—the jury could just as easily have found for 100% for the plaintiff or 100% for the defendant. Given this possibility, a high/low strategy might have helped mitigate risk for the cardiologist.

If you are in a situation with a potentially catastrophic payout, consider bringing up the possibility of this arrangement with your carrier.

Was This Surgeon "Grossly Negligent"?

On December 4, 2010, at 11:47 AM, a patient was admitted to the emergency department (ED) of a hospital in California's Bay Area with a self-reported history of having inserted a bottle into his rectum 2 days earlier.[4] He was in pain and had gone 2 days without a bowel movement. A physician assistant documented distention and diffuse tenderness. A plain abdominal radiograph showed a glass bottle in the mid-pelvis. There was no free air, although the patient was in the supine position.

The surgeon arrived at 2:11 PM and ordered 25 μg of fentanyl for pain.[4]

What happened next resulted in a complaint to the California Board of Medicine. An interview with the surgeon by a board investigator provided the details.[4] The surgeon explained that she had given the patient two options: He could have the bottle removed surgically, or it could be extracted manually in the ED. The surgeon stated that the patient chose the ED route because he did not want to lose his new job. (It is unclear whether this decision was related to a longer perceived recovery time if he had surgery, a higher bill for a surgical procedure, or something else.)

During the interview, the surgeon said that she could feel the bottom of the bottle with one finger but could not move it at all.[4] However, the history and physical documented something else: The surgeon "was able to palpate the bottle and was able to manipulate the bottle and move the foreign body around but was unable to rectally extract it."

During the first part of her interview, the surgeon stated that she placed her hand into the rectum to remove the bottle while the patient pushed.[4]

Nursing notes indicated that the surgeon placed her arm into the rectum up to her bicep, and the patient was screaming in pain.[4] This same nurse said the surgeon did not want the patient to receive any additional pain medication, because she needed the patient conscious for him to help push the bottle out.

The surgeon then performed a rigid sigmoidoscopy, which showed the sigmoid colon to be dusky and swollen. A new abdominal radiograph suggested perforation. The patient was taken to an operating room (OR) for a laparotomy.[4]

The board of medicine detailed its parade of horribles[4]:

  • Gross negligence: Excessive force while attempting to remove the bottle demonstrated disregard for patient safety and departure from standard of care or incompetence.
  • Gross negligence: The decision to continue with the procedure in the ED without securing appropriate assistance from nursing staff demonstrated disregard for patient safety and constituted extreme departure from the standard of care.
  • Repeated negligent acts: Inadequate sedation during attempts to manually extract the bottle constituted departure from the standard of practice.
  • No informed consent and substandard documentation of procedure note.
  • No "timeout" was performed before starting the procedure. [Author's note: It's unclear whether the timeout would have been used to verify that the correct patient was about to undergo a procedure, or to confirm that the procedure addressed the correct side of the rectum.]
  • Dishonesty: There are multiple story lines—was a finger, hand, or arm involved? Was the bottle mobile, or not mobile?

The penalty the board imposed[4]:

  • 25 hours a year (for each year of probation) of education addressing the deficiencies outlined in the complaint.
  • Complete an approved course on professionalism—at the surgeon's expense, and in addition to other continuing medical education (CME) requirements.
  • Complete an approved course on medical record-keeping—at the surgeon's expense, and in addition to other CME requirements.
  • License revoked, but revocation temporarily suspended and surgeon's license placed on probation for 3 years as long as she has no further infractions.
  • The surgeon will pay the costs of monitoring her probation—currently set at $3999 per year—for each year of probation.

The surgeon was licensed to practice in Ohio as well as California. The Ohio Medical Board learned of the California board's imposed discipline. The Ohio Board wrote to the surgeon stating that it was investigating whether to impose discipline in Ohio as well.[4] The board gave her 30 days from the date of mailing to request a hearing. That deadline was May 12, 2014.

The board received the surgeon's letter on May 15, 2014, and that letter did not include a request for a hearing.[4] (The record is silent on what information the letter did contain. Presumably, it was an explanation of the surgeon's treatment of the case, or why she failed to respond to the Ohio board in a timely manner.)

The board revoked her license.[4]

Ignore a State Licensing Board at Your Peril

Many doctors have licenses in more than one state. Discipline in one state often triggers discipline in another state. Most, if not all, licensing boards mandate that the licensee has an affirmative obligation to notify them of discipline in any other venue (for example, another state, the Centers for Medicare & Medicaid Services, or the US Drug Enforcement Administration) within a couple of weeks of the disciplinary action.

Most disciplinary actions are reportable to the National Practitioner Data Bank, which means that the boards of the state or states in which you are licensed will eventually learn about these actions. If you address such an action proactively, it's considered an "explanation." If you address it after it's discovered by a board, without prior notification by you first, it's considered an "excuse."

As such, if you hear from a licensing board, don't ignore it. Most of the time, they are just looking for your side of the story. Statistically, you are likely to prevail. But if you miss a deadline to respond, you will have wasted an opportunity. Make sure that you respond in a timely manner and document that you sent your response by certified mail with return receipt requested, or by FedEx or UPS with a tracking number. Not all boards will impose the same penalty as the first board. Some boards may rule the opposite of the first board.

There are times and reasons for doing a procedure in the ED instead of the OR: timeliness, OR availability, cost, and patient preference. Whatever the rationale, make sure the record supports your thinking. In this case, the surgeon was on the defensive from the beginning because the record was sparsely documented.

Next, it's okay to stop a procedure if you're not succeeding. The patient may tolerate some amount of pain if the anticipated outcome is a near-term success. At some point, however, that strategy may change—and then it's time to go to the OR. A common manifestation of that strategy is a trial of labor that turns into cesarean section.

The attending nurse's story was dramatically different from the surgeon's story. The nurse documented her story. It's hard to believe that the surgeon was able to place her arm (up to the bicep) into the patient's rectum. But there was no competing narrative in the chart.

Finally, the penalty seems steep both in cost and time. The question is how and why this matter evolved into a board complaint. Perhaps it was a dispute over a residual bill, poor communication, or verbal sparring with the nurse that escalated into score-evening retribution. The record of the case doesn't address these issues.

The Moral: Take Steps to Limit Your Risk

Even when doctors diligently care for their patients, they may be exposed to unexpected liability. If a patient's outcome is poor, judgment at trial may well exceed policy limits.  Proper documentation of the medical record and timely responses to board complaints are the best ways to prevent a gray-zone set of facts from evolving into formal discipline by a medical board.

Published in Medscape: 2015, Dr. Segal

 

Sunscreen Dangers

The US Food and Drug Administration (FDA) is proposing to prevent two sunscreen ingredients from entering the US market unless the manufacturers can provide new data proving safety and effectiveness.

The agency published its proposal on February 25 in the Federal Register . The two ingredients — ecamsule and enzacamene — were among eight ingredients that the agency has been reviewing for years.

In early January, the FDA said that the other six were not safe or effective. Ecamsule and enzacamene are the last two in the backlog that it was required to address as part of the Sunscreen Innovation Act, which was signed into law in December.

The organization that was most active in getting that law passed — Public Access to SunScreens (PASS) Coalition — expressed dismay at the agency's proposal.

"Today's action taken by the FDA regarding ecamsule and enzacamene means that Americans will not have access to innovative products that have been used safely all over the world — in some cases for more than a decade," said Michael Werner, policy advisor to the PASS Coalition, in a statement.

"Last fall, the U.S. Surgeon General issued a Call to Action on skin cancer urging the federal government to work with the private sector and take necessary steps to respond to this public health crisis," added Werner. "FDA's latest action is inconsistent with this approach."

Need More Data

Ecamsule has been approved for use in the US since 2006, but only at a specific concentration and only in a few products manufactured by L'Oreal.

L'Oreal got approval for those products through a new drug application process. The FDA's latest proposal applies to a different process in which L'Oreal is seeking a blanket approval for ecamsule at various concentrations and in various formulations.

Enzacamene has been under review at the agency since 2002. The application was submitted by a division of the German pharmaceutical company Merck KGaA.

According to the FDA, neither of the companies had sufficient data to prove that the ingredients were safe or effective.

L'Oreal (which is a member of the PASS Coalition) was seeking to market various products with concentrations of up to 10% ecamsule. The trials only looked at concentrations of 0.33% to 3.96%, and in the end did not support "human dermal safety of ecamsule at any concentration," according to the FDA.

The agency also said that the company needed to submit more animal data to determine potential effects from systemic exposure, and that it wanted carcinogenicity studies, in addition to other data.

L'Oreal also needs to prove effectiveness, said the FDA, which is requesting two such trials.

The FDA is also seeking more data on enzacamene, including on bioavailability, dermal safety, and toxicity. Some published studies have also indicated that the ingredient has the potential to be an endocrine disruptor, so the FDA has requested more data on hormonal changes.

In addition, the agency said that the manufacturer needed to conduct two, and possibly three, efficacy studies.

The FDA proposal is open for public comment until April 13. Manufacturers will also have a chance to meet with the FDA and submit more data.

Eventually, the agency will publish a final determination

Powdered Alcohol: Is it harmful?

Powdered alcohol is now here.  This marks the beginning of an entirely new problem for toxicologists. The key question is:  Powdered Alcohol--Is is harmful?  Several experts have weighed in on this and have offered up their opinions.  Below is a sampling of these opinions.

Substance abuse experts are concerned about the imminent availability of powdered alcohol because of its health risks and abuse potential.

The flavored, freeze-dried alcohol, which looks like powdered Jell-O, can be thrown into a back pocket and taken almost anywhere, according to Harris Stratyner, PhD, regional clinical vice president, Caron Treatment Center's New York Recovery Services, and associate professor of psychiatry, Mount Sinai School of Medicine, New York City.

"You don't have to carry around a bottle of alcohol if you're going camping or for a bike ride. And when you get to your destination, you just add water or mixer to reconstitute the alcohol ― and voilá, you've got an instant alcoholic beverage," he said.

The powdered alcohol ― known as Palcohol ― was approved for sale earlier this month by the US Alcohol and Tobacco Tax and Trade Bureau.

The product, which comes in single-serving packages, each the equivalent of one shot of alcohol and weighing about an ounce, will reportedly hit retail stores and be available online by the summer.

There are five versions: vodka, rum, and three cocktails – Cosmopolitan, Lemon Drop, and Powderita, which tastes just like a Margarita. The mixed drink cocktails have natural flavorings and use Sucralose as a sweetener.

Because it is concentrated, the product would be easier than liquid alcohol to sneak into concerts and other places where alcohol is banned, said addiction specialist Petros Levounis, MD, chair, Department of Psychiatry, Rutgers New Jersey Medical School, Newark.

Disaster Waiting to Happen?

The powdered substance makes it easy to snort the alcohol, which is "worrisome" and "dangerous," according to Dr Stratyner. He is also concerned about combining it with other drugs, such as cocaine and marijuana.

"Say you sprinkle it on a brownie made with marijuana, which is an antiemetic. Then suddenly you're going to have something that's inhibiting your ability to fight off alcohol poisoning."

Because the water has been removed, the percentage of alcohol by volume depends on how much liquid is added. When you add 6 ounces of liquid, it is equal to a standard mixed drink.

Dr Levounis is concerned about a product that "we don't know much about" bringing unanticipated problems. "We've been burned before" when products that appeared to be different formulations of a seemingly benign substance were approved and became a "completely new beast."

He used the example of Four Loko, a combination of alcohol and four shots of espresso. Alcohol has a "built-in protection" in that when you drink too much, you fall asleep. "But if you add four shots of espresso, you prolong your ability to continue to drink," he said.

Another concern is the misconception that products subject to abuse are safer when legal.

"The biggest disaster in addiction has come from cigarettes, not from marijuana," said Dr Levounis.

In addition, the novelty of the product might draw young people to try the powdered alcohol to impress their peers or seem cool, and to use it to excess, added Dr Levounis. He has seen first hand the fallout from such "crazy" behavior among kids.

Although approved at the federal level, the product is still subject to state regulations.

The powdered alcohol was approved before by the Alcohol and Tobacco Tax and Trade Bureau, but the approval was "rescinded," said Dr Stratyner. He and his colleagues at Caron Treatment Centers hope that "something can be done to take a closer look at it" again.

Sources: Interviews with Dr Stratyner and Dr Levounis, Palcohol website.

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