About Dr. Gustin
Dr. Gustin is residency-trained and board-certified in Emergency Medicine and Forensic Medicine and has been actively practicing in the fields of Emergency Medicine, Toxicology, and Forensic Medicine for more than 30 years. He has additional training and expertise in Medical, Occupational, and Environmental Toxicology and has Masters Degrees in Biochemistry, Metabolism and Nutrition, as well as Toxicology and Public Health. He is the primary founder of the American College of Forensic Medicine which currently has more than 2,000 members.
Dr. Gustin has reviewed thousands of medical malpractice, personal injury, criminal, and toxicology cases during his career. Dr. Gustin also has substantial testimony experience as an expert witness.
You can access Dr. Gustin's medical-legal experience by requesting a FREE phone or email consultation now. To review all the Services he offers, please click here.
Dr. Gustin's education, training, and experience qualifies him to evaluate and testify regarding a broad range of cases, in the following medical and toxicology specialty areas:
- Emergency Medicine, medical, surgical, pediatric
- Emergency Medical Ambulance Services (EMS)
- Trauma and Critical Care
- Forensic Toxicology
- Medical Toxicology and Poisoning (eg: accidental overdose, carbon monoxide poisoning, and all other product and drug exposures)
- Occupational and Environmental Toxicology
- Mechanisms and Forces of Injury in Criminal Cases
- Substance Abuse and Drug Addiction (Drug and Alcohol, including DUI)
- Electrical Injury
- Pharmaceutical Medicine (Drug-Drug interactions, Drug-Disease Interactions, Overdose, Unsafe poorly tested Drugs, Adverse Drug Reactions)
- Flight, Travel, and Wilderness Medicine
- Hospital Malpractice
- Public Health (eg: Legionnaire's Disease, Outbreak Diseases, Food Poisoning, and Waterborne Diseases)
- Legal Medicine (standard of care, evidence-based causation, medical ethics)
His primary areas of specialization are Emergency Medicine and Toxicology.
A partial list of cases Dr. Gustin has consulted on include: drugs of abuse including Methamphetamine, Cocaine, Opiates, Ambien,and Alcohol, occupational chemical poisonings including toluene, benzene, isocyanates, other solvents, heavy metals including lead, carbon monoxide, and cyanide, occupational and travel-related infectious illness including Legionnaire's disease, MRSA, skin infections, bacterial enteritis, misdiagnosis and delayed treatments in the ER, civil rights cases, environmental exposure cases including contaminated water and sewage exposure.
Dr. Gustin's expert opinions will comply with ACEP (American College of Emergency Physicians) guidelines for Expert Witness Testimony: See: http://www.acep.org/practres.aspx?id=29446 ; the ACT (American College of Toxicology); and ACFE (American College of Forensic Examiners) Creed of Ethics. See: http://www.acfei.com/about_acfei/creed/
Office: 2928 Derby Street, Berkeley, CA 94705
Email: Click here to email Dr. Gustin
The End of Medical Malpractice Lawsuits?
Is Legislation to End Malpractice Lawsuits Realistic?
A recent Medscape article contended that controversial legislation now wending its way through the Georgia and Florida legislatures would, if enacted, put an end to malpractice litigation in those states and could serve as a template for other states to follow suit, replacing the current medical tort system with an administrative system for redress. The patient, via a patient advocate, would appeal to the system to investigate an injury. The full record would be reviewed by a rotating panel of relevant medical experts. If the panel agreed that the injury was avoidable, the case would be referred to a compensation committee to make payment.
The patient would not need a lawyer, although he or she could have one to ensure that due process was followed. Physicians would not need malpractice insurance because they could not be sued. Instead, they would pay an annual contribution to administer to the program—rates, the article contended, that would be significantly below the current market rate for professional liability premiums. In response, Hal Dasinger, JD, Vice President of Government Relations at the Napa, California-based Doctors Company, the nation's largest physician-owned medical malpractice insurer, offers the following counterpoint.
An End to Malpractice Lawsuits?
In recent years, physicians, other health care providers, and lawmakers across the United States have been addressed by keynote speakers, pitched to, surveyed, and lobbied by people promoting a proposal that would replace civil litigation for claims of medical professional liability with an administrative process for compensating patients for avoidable injuries.
The proponents claim that their administrative system has several advantages over civil litigation. The most striking of these claims, and the source of much of the initial physician interest in the idea, is the promise that physicians will no longer be sued. Next, the proponents claim that payments to patients will not be reported to the National Practitioner Data Bank (NPDB). Finally, proponents say that far more claims would be paid to patients who have suffered genuine harm, but who aren't able obtain legal representation under the current tort system because their cases are too insignificant to be potentially profitable—yet system costs would not exceed current levels.
That last promise is the key to understanding this proposal, and also its most fundamental flaw. Proponents insist that because the process is nonadversarial, defensive medicine—treatment designed primarily to avoid liability rather than to improve the patient's health—would all but disappear, producing savings on overall healthcare spending.
Even if we accept these proponents' estimate of the cost of defensive medicine, which Gallup reports is 1 in 4 health care dollars, or about $650 billion annually—an estimate that has been widely criticized as excessive—there is no assurance that this cost will decrease.
Under the plan, a panel of experts would review each claim to determine whether an injury was avoidable. Plan administrators would have discretion in reporting providers to their state medical boards. This assignment of causation and culpability is not conceptually different from finding fault. There may be fewer depositions, and certainly fewer opportunities for physicians to defend their actions, but the likelihood is that defensive medicine will continue.
Will the Proposed System Actually Cost More?
Nor is the cost of defensive medicine the only problem with the promise to reduce costs. The proposal promises to compensate far more patients than currently receive settlements or jury awards through the courts, and to do so according to a payment schedule using NPDB data for typical payments for particular types of injuries. More payments at current average-per-claim values can only result in far more money paid out. This inevitable increase in costs is addressed in the versions of the bill introduced so far in a manner unlikely to satisfy anyone trying to calculate costs and benefits: The proposed statutes explicitly prohibit compensation from exceeding current medical professional liability costs.
To repeat: Simple math says the new system will cost more, but the proposed law says it won't.
You don't have to be an actuary to spot the problem with that legislative requirement. As it happens, actuaries consulted about the proposal agree that costs will inevitably rise. The proponents' own study estimated a 13% increase from the bill introduced in Georgia.Others put that figure from 35% to over 100%. Compensation for insignificant injuries would rise an estimated 1730%.
The most recent versions of the bills seeking to install this process rely on physician surcharges to pay for patient compensation, costs of handling the claims, and presumably a fee for the entity providing the administrative support. If any state enacts this proposal, when the actual costs exceed the stated estimates and swamp the available funds, some combination of undesirable effects will follow soon after: Physician surcharges will increase, payments to patients will decrease, or the criteria for compensation will tighten—or perhaps all of these will occur.
In short, the benefits promised will disappear, but the shortcomings of the administrative process will remain. The state will have to subsidize the fund or scrap the program altogether, and taxpayers, physicians, and patients will be left picking up the pieces.
Will You Avoid Being Reported to the NPDB?
The pronouncement that physicians in the system will not be reported to the NPDB is no more credible. No state has adopted this plan, so no definitive opinion is available. However, recent action by the Department of Health and Human Services (HHS) regarding new legislation in Oregon and Massachusetts is instructive.
Both states enacted alternative programs for dealing with medical injury, although neither went as far as the administrative model proposed in Georgia, Florida, and elsewhere. Both states sought rulings from HHS that payments under their alternative models be exempt from reporting to NPDB. Both were instructed that payments are reportable. And before any objection is raised that the situations aren't comparable, take a look at the first paragraph of the HHS decision:
Although the Massachusetts and Oregon medical malpractice reform models are the only two existing models of their type, based in legislation, other states (including Florida and Georgia) are examining similar models for future implementation.
Much of the momentum behind these proposals has been generated by promising physicians that they will never be sued. Unfortunately, this promise will prove as impossible to keep as the others. The right to jury trial for medical injury is a feature of common law; is guaranteed by many state constitutions; and has been clearly enunciated by the state supreme courts in Georgia, Illinois, Missouri, Oregon, and a multitude of other states. Substituting administrative review as an exclusive remedy for medical injury will not stand up to the criteria applied even to proven, effective reforms. The former Georgia attorney general wrote an opinion to that effect, and no credible counter has been offered by the proponents.
Too Good to Be True?
No one will argue that civil litigation is an efficient way to compensate legitimate claimants for their injuries. But the proposed substitute doesn't stand up to legal scrutiny, actuarial analysis, or logical examination. Legislation seeking to establish this administrative substitute has been introduced in a number of states, usually under the guise of tort reform. So far, none of these bills has been successful.
Advocates for patients and for physicians should be wary of any plan promising to both increase payments and decrease costs. If something seems too good to be true, it probably is. In the case of this particular proposal, both patients and providers stand to lose when the plan inevitably fails to keep the promises made by its proponents.
Scherz H, Oliver W. Defensive medicine: a cure worse than the disease. Forbes. August 27, 2013.http://www.forbes.com/sites/realspin/2013/08/27/defensive-medicine-a-cure-worse-than-the-disease Accessed July 20, 2013.
Larcher G. Georgia Senate Bill 141: Patients Compensation System. Aon Risk Solutions. October 22, 2013.
An evaluation of the impact to direct medical malpractice costs in the state of Georgia related to the implementation of a patients compensation system. Aon Risk Solutions.October 10, 2012.
Wakefield MK. Appropriate medical malpractice payment reporting to the National Practitioner Data Bank (NPDB) in light of recent medical malpractice Reforms in Massachusetts and Oregon—decision. Department of Health and Human Services. May 20, 2014. http://www.citizen.org/documents/2211%20Enclosure.pdf Accessed July 20, 2015.
Bowers MJ. The proposed Patient Injury Act would not meet the requirements of Ga. Const. Art. 1, Sec. 1, Par. XI (a). Balch & Bingham LLP. November 28, 2012.http://pdfserver.amlaw.com/dailyreport/Editorial/PDF/Bowers_letter_on_bad_faith.pdf Accessed July 20, 2015.
Medscape Business of Medicine © 2015 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this article: Hal Dasinger. Is Legislation to End Malpractice Lawsuits Realistic? Medscape. Jul 30, 2015.
Bupropion use is on the rise!
Bupropion, otherwise known as Wellbutrin, is commonly prescribed for major depression, and for smoking cessation. It's major adverse side effects are seizures; but there are additional adverse effects too. In high enough doses it also increases sexual desire in men and women, and produces a high that has been compared to that of cocaine. The following report describes the data of increasing use. A future blog entry will discuss the problems associated with bupropion abuse.
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 Room 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
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.
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). 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.
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.
New-onset psychosis is a medical emergency with a broad differential. 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. 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. 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.
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). 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. 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. 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. 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. The heavy consumption of carbohydrates while intoxicated leads to an increase in serum insulin levels, driving potassium into cells and causing serum hypokalemia. 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. 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. And, marijuana use correlates with fatal motor vehicle collisions – clinicians should educate patients and ensure a safe transportation plan on discharge.
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. 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]
- 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.
- Volkow ND, Baler RD, Compton WM, et al. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227.
- 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.
- 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.
- Rezkalla SH, Sharma P, Kloner RA. Coronary no-flow and ventricular tachycardia associated with habitual marijuana use. Ann Emerg Med. 2003;42:365–369.
- 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.
- Sood, TR, McStay CM. Evaluation of the psychiatric patient. Emerg Med Clin North Am. 2009;27(4):669–683.
- 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.
- 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.
- 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.
- Sharma, P, Murthy P, Bharath MM. Chemistry, metabolism, and toxicology of cannabis: clinical implications. Iran J Psychiatry. 2012;7(4):149–156.
- 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.
- Aryana A, Williams MA. Marijuana as a trigger of cardiovascular events: Speculation or scientific certainty? Int J Cardiol. 2007;118(2):141–144.
- Mittleman MA, Lewis RA, Maclure M, et al. Triggering myocardial infarction by marijuana. Circulation. 2001;103:2805–2809.
- Charles R, Holt S, Kirkham N. Myocardial infarction and marijuana. Clin Toxicol. 1979;14(4):433–438.
- Bachs L, Morland H. Acute cardiovascular fatalities following cannabis use. Forensic Sci Int. 2001;124:200–203.
- 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.
- Feldman ML, Hadfield S. Pot paresis: marijuana and a case of hypokalemic periodic paralysis. J Emerg Med. 2009;36(3):236–238.
- Helfant, RH. hypokalemia and arrhythmias. Am J Med. 1986;80(4):13–22.
- 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.
- 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.
- 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.
- Holstege C, Borek H. Toxidromes. Crit Care Clin. 2012;28:479–498.
- 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.
- 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.
- Hedges DW, Woon FL, Hoopes SP. Caffeine-induced psychosis. CNS Spectrum. 2009;14(3):127–129.
- Shaul PW, Farrell MK, Maloney MJ. Caffeine toxicity as a cause of acute psychosis in anorexia nervosa. J Pediatr. 1984;105(3):493–495.
- Szpak A, Allen D. A case of acute suicidality following excessive caffeine intake. J Psychopharmacol. 2012;26(11):1502–1510.
- 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.
- 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.
- 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.
- Bally N, Zullino D, Aubry JM. Cannabis use and first manic episode. J Affect Disord. 2014;165:103–108.
- 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.
- 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.
- 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 and Perplexing Med-Legal Verdicts
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. 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. 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." 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.
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. 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. 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. 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.
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. 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. 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.
Nursing notes indicated that the surgeon placed her arm into the rectum up to her bicep, and the patient was screaming in pain. 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.
The board of medicine detailed its parade of horribles:
- 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:
- 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. 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. (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.
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
Ending Medical Malpractice Litigation
A Sensible Alternative to Our Broken System?
As every physician knows, our tort system is broken. Various solutions have been suggested over the years, only to fade away. But now, a promising new system for patient compensation in cases of medical error is being proposed in two states: Georgia and Florida. It makes sense for doctors and patients alike, and for our healthcare system as a whole.
The bills would, if passed, transform the current medical tort system into an administrative system for redress. Georgia's—the Patient Compensation Act in Georgia, SB 86—opens with the following game-changing text:
"Effective January 1, 2016, the cause of action under Georgia law for medical malpractice against a provider as defined in Code Section 51-13-2 is hereby repealed in its entirety."
A patient who is injured would seek a potential remedy via the Patient Compensation Act, which calls for the establishment of a "Patients' Compensation System."
That patient, via a patient advocate, would appeal to the system to investigate his or her injury. The full record would be reviewed by a rotating collection of medical experts in the relevant field. If this panel agreed that the injury was avoidable, the case would be referred to a compensation committee to make payment.
To qualify for compensation, the panel would, in the Georgia law's verbiage, use the following criteria:
"Medical injury" means a personal injury or wrongful death due to medical treatment, including a missed diagnosis, where all of the following criteria exist:
- The provider performed a medical treatment on the applicant;
- The applicant suffered a medical injury with damages;
- The medical treatment was the proximate cause of the damages; and
- Based on the facts at the time of medical treatment, one or more of the following:
- An accepted method of medical services was not used for treatment;
- An accepted method of medical services was used for treatment, but executed in a substandard fashion.
The patient would not need a lawyer to propel his or her case forward; however, if desired, a lawyer could help the patient ensure that due process was followed.
The total pool of funds available for making payments would be less than the aggregate amount of funds doctors paid in professional liability premiums before enactment of the law. In other words, the system would not pay out more in the future than is currently being paid in by physicians. This term would keep costs stable for doctors—by statute—regardless of the number of claims.
The Patients' Compensation System would be a state-based entity and, similar to other state based entities—such as the Florida or Virginia Birth-Related Neurological Injury Compensation programs—payments would not be reportable to the National Practitioner Data Bank (NPDB).
Physicians would not need to purchase medical malpractice insurance, because they could not be sued. Instead, they would pay an annual contribution to administer the program. A family practitioner, for example, would pay $3900 per year; an orthopedic surgeon, $15,600 per year; and a spine surgeon, $17,500 per year. The specialists with the highest contribution rate, pediatric neurosurgeons, would pay $25,300 per year. These rates would be significantly below the current market rate for professional liability premiums—which typically cover only $1 million of liability.
How Physicians Would Benefit
In the Patients' Compensation System, there is no claim to defend. A doctor need only provide the patient's medical record. He or she may ignore any other procedural nuance, if desired. Alternatively, he or she may provide an explanation of care that was rendered.
And if the doctor wants to advocate for the patient, he or she may sit with the patient. If a doctor, for example, misses a critical diagnosis that could have easily be made, and that error cost the patient an extra month in the intensive care unit, the doctor could apologize to the patient and work with him or her in a nonadversarial setting to help the patient achieve reasonable compensation.
Furthermore, there would be no depositions, no cross-examinations, and no shutting down of a practice for 3 weeks to sit in a courtroom. Unlike the current system, there would be no reason to deny and defend.
In the Patients' Compensation System, the doctor incurs no personal financial liability for malpractice. In the current system, professional liability policies cover a limit for damages, usually $1 million. If a judgment exceeds this limit, the doctor is personally liable. This creates pressure on the doctor (and his or her insurer) to settle cases that might be defensible. Unlike in the current system, the doctor is fully "indemnified" for a patient's injury.
In the Patients' Compensation System, settlements and judgments reflecting payments to patients are not reportable to the NPDB. Because—unlike in the current system—payment would be made by the state-based system, such payment would not trigger reporting to the NPDB. As the statutory language states, "'Application' means a request for investigation by the Patients' Compensation System of an alleged occurrence of a medical injury and does not constitute a written demand for payment under any applicable state or federal law" (which might otherwise trigger reporting to the NPDB).
How Patients Would Benefit
In the Patients' Compensation System, all complaints would be reviewed. Currently, low-value claims are generally ignored by plaintiffs' attorneys because the cost of prosecuting such claims exceeds the estimated recovery. In contrast, because low-value claims would be heard under the Patients' Compensation System, more claims would be paid; in other words, more patients would have access to justice.
Payment would be made in months rather than years, as is common now. And the amount paid would be rational, reasonable, and predictable. Physicians would be able to speak openly and plainly about medical errors—enabling broad patient safety initiatives to be implemented.
The bill would allow a three-doctor panel to report any practitioner to the state licensing board who is an imminent danger to the public. A physician who poses such a risk would come to the attention of the board much sooner than under the status quo. Transparency is the starting point for fixing systemic safety problems related to those few physicians who are truly a danger to patients. A system cannot change what it cannot identify or measure.
How the Healthcare System Would Benefit
In the Patients' Compensation System, physicians would have no incentive to practice medicine defensively. Currently, if a doctor fails to order a particular test or imaging study and the patient has a bad outcome, that doctor is at risk for defending against a lawsuit that will last years and potentially bankrupt his or her life savings. Under this paradigm, defensive medicine is rational. As one emergency physician explained, "I will scan patients till they glow if it means avoiding even a day in court."
In the proposed system, doctors would be free to exercise their judgment. For example, if a person experiences a minor concussion, that individual will generally head to an emergency department. A minor concussion might be associated with brief loss of consciousness, nausea, headache, and other symptoms. On arrival in the emergency department, such a patient would ordinarily be neurologically intact. Best practices would include ordering an imaging study only for patients who either have or would be likely to develop an intracranial abnormality.
However, defensive medicine is often at odds with best practices—encouraging, in this hypothetical case, the ordering of an expensive scan and needlessly exposing the patient to radiation, whether or not the patient is deemed to be at risk.
In other words, resources could be saved without causing harm to patients. And patients who are unlikely to develop intracranial pathology would be spared radiation from an unnecessary imaging study.
The Patients' Compensation System would create an environment in which defensive medicine would not be needed. If this goal were achieved, the healthcare system would save a fortune.
Challenges to Passing the Bills
Those who benefit from the status quo will fight tooth and nail against change. This includes the trial bar, even though they will have a potential role to play in ensuring that patients' rights are preserved. Plaintiffs' lawyers will argue, for example, that state constitutions guarantee patients trial by jury, and the Patients' Compensation System removes that right.
Of course, old habits die hard. But trial lawyers would not have to risk their money going long on cases that might deliver zero payout. Plaintiffs' lawyers could assist patients without incurring any risk whatsoever, because they would be paid per transaction. Real estate attorneys, for example, have done quite well with such a model.
Whether the Patients' Compensation System is constitutional is beyond the scope of this article, but experts who have reviewed the proposed law firmly believe it passes constitutional muster.
What do patients say about a payment system as an alternative to litigation? A Georgia statewide survey by McLaughlin & Associates in August 2013 noted that 63% of participants support "reforming the current medical malpractice system" and 61% favor replacing the current medical malpractice system with a Patients' Compensation System.[4-6] There is an appetite on the part of the public to scrap what we currently have and try something new.
Long acting opioids and increased risk of overdose
Long-acting opioids were associated with a greater than 2-fold risk for unintentional overdose compared with short-acting formulations, according to a cohort study published online February 16 in JAMA Internal Medicine. Moreover, the risk was more than 5-fold greater in the first 2 weeks of using a long-acting opioid.
"If replicated in other cohorts, our findings suggest that clinicians weighing the benefits and risks of initiating different opioid regimens should consider not only the daily dose prescribed but also the duration of opioid action, favoring short-acting agents whenever possible, especially during the first 2 weeks of therapy," write Matthew Miller, MD, ScD, from the Department of Health Sciences and Epidemiology at Northeastern University in Boston, Massachusetts, and colleagues. The study population was made up of veterans who were largely men older than 50 years.
Previous studies had found that higher doses of opioids were associated with greater risk for overdose, but few studies have considered the duration of action in overdose risk, the authors note.
The current study involved 840,606 veterans with chronic pain diagnoses who began opioid therapy between January 1, 2000, and December 31, 2009, who had not taken opioids in the previous 6 months. The researchers reviewed diagnostic and procedural codes as well as pharmacy data from the Veterans Health Administration. They note that they were not able to track the actual amount of medication taken, but considered patients to be using the opioids on the basis of filled and refilled prescriptions.
Overall, 18,887 patients used long-acting opioids, which included orally administered sustained-release morphine sulfate, methadone hydrochloride (but not the liquid methadone used for treating addiction), controlled-release oxycodone hydrochloride, levorphanol tartrate, and fentanyl patches. Short-acting opioids, taken by the majority of patients in the study (801,729), included codeine phosphate, hydrocodone, and oxycodone that were orally administered either by themselves or in a formulation with acetaminophen or aspirin. The authors note that patients who were given prescriptions for long-acting opioids were more likely to be given higher doses and were more likely to also be taking antidepressants and benzodiazepines.
Three hundred nineteen patients experienced an unintentional, nonfatal overdose. After adjustment for age, sex, opioid dose, and other covariates, the hazard ratio for overdose was substantially higher for those receiving long-acting opioids (2.33; 95% confidence interval, 1.26 - 4.32). The risk for overdose during the first 2 weeks of treatment was more than 5 times higher for those taking long-acting opioids (hazard ratio, 5.25; 95% confidence interval, 1.88 - 14.72).
The authors note that the rate of overdose is likely to be an underestimate, as events may go unreported if patients die, do not seek medical attention, or receive medical attention outside the Veterans Affairs system. They also note that they were unable to adjust for the severity of illness or substance use disorders and that other confounders may be present at baseline, although they write that baseline confounders are unlikely to explain the elevated risk at the beginning of treatment.
"The best solution is to avoid prescribing opioids for chronic pain because there is no high-quality evidence that they are effective for this indication, and the risk of adverse effects, including death from unintentional overdose, is great," writes Mitchell Katz, MD, the journal's deputy editor, in an editorial. Despite the possibility of confounding factors, he writes, "it would be wise to avoid long-acting agents when initiating opioid therapy for chronic pain.... Meanwhile, there is an urgent need for better nonopioid treatments for chronic pain."
The authors and Dr Katz have disclosed no relevant financial relationships.
JAMA Intern Med. Published online February 16, 2015. Abstract
Dangers of Atarax (Hydroxyzine, Vistaril)
Physicians should take certain precautions in prescribing the first-generation antihistamine hydroxyzine to minimize the drug’s risk for potentially fatal heart arrhythmias, the European Medicines Agency (EMA) announced recently.
Hydroxyzine (Atarax, Vistaril) is approved in the European Union (EU) for treating anxiety disorders, sleep disorders, and pruritus as well as premedicating patients before surgery, with the indications varying by individual EU nation. Similar indications are approved in the United States. It is also used off label as an antiemetic/antinausea agent in the United States for adults.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed the safety of hydroxyzine at the request of Hungarian drug regulators, who were worried about adverse cardiac effects. PRAC confirmed a small but definite risk for QT interval prolongation and torsades de pointes, which can trigger ventricular fibrillation. However, the committee determined that clinicians could continue to prescribe the drug under the following conditions:
- Prescribe hydroxyzine at the lowest effective dose for the shortest time possible.
- Hydroxyzine must not be used by patients with known risk factors for heart arrhythmias or who are taking drugs that increase the risk for QT prolongation.
- The maximum daily dose should not exceed 100 mg in adults and 2 mg per kg of body weight in children weighing up to 40 kg.
- Hydroxyzine is not recommended for the elderly, but if clinicians believe that its use is unavoidable, the maximum daily dose for this age group should be 50 mg.
PRAC also recommended the continued monitoring of hydroxyzine to ensure that these precautions protect the public.
The committee’s recommendations now go to another EU regulatory body, the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human, for further action. This agency represents individual EU member states, each of which approves drugs for marketing within its borders.
Another Statin Side Effect
Statins are one of the most popular drugs. They reduce serum lipids implicated in producing cardiac and vascular disease. Statins have side effects and are well-known, such as liver disease and muscle pain. Now a new side effect has been discovered.
Statin therapy significantly elevates the risk of developing cataracts severe enough to warrant surgery, suggests analyses of two distinct cohorts, one from Canada and another from the US.
For now, the possibility of such a risk from statins and its potential mechanisms should be explored in prospective trials, "especially in light of increased statin use for primary prevention of cardiovascular disease and the importance of acceptable vision in old age, when cardiovascular disease is common," according to the report, published in the December 2014 issue of the Canadian Journal of Cardiology with lead author Dr Stephanie J Wise (University of British Columbia, Vancouver).
"However, because the relative risk is low and because cataract surgery is effective and well tolerated, this association should be disclosed but not be considered a deterrent to use of statins when warranted for cardiovascular risk reduction," they write.
"For those of us who have prescribed high doses of statins for almost 3 decades, there is certainly no epidemic of cataracts among our longtime lipid-clinic patients," write Drs Steven E Gryn and Robert A Hegele (Western University, London, ON) in an accompanying editorial in the same journal.
"Nevertheless, if the findings of Wise et al are confirmed, physicians might need to factor in this potential risk when discussing statin use with patients," they continue.
And, in patients at high CV risk, "the prevention of CVD, stroke, and their associated morbidity and mortality vastly outweighs the risk of cataracts. Even among lower-risk patients, for whom the benefit/risk ratio is less dramatic, most patients would still probably prefer having to undergo earlier non–life-threatening cataract surgery over suffering a major vascular event."
Breaking News: Dozens of Drugs to be Removed from the Market!
A committee of the European Medicines Agency (EMA) has just a few days ago recommended suspending the sale of roughly four dozen generic drugs that are used for conditions including diabetes, depression, and hypertension because they noted that their approvals were based on flawed clinical studies conducted only in India. The US Food and Drug Administration (FDA) has not yet taken action on the issue. But they are in the process of reviewing this issue now.
Familiar names of commonly prescribe drugs on the list include candesartan, donepezil, escitalopram, esomeprazole, and metformin. The list extends more than 120 pages because the drugs are marketed individually in multiple European Union (EU) nations in various dosages, and therefore appear over and over.
Abbott Laboratories, Actavis, Dr Reddy's Laboratories, Mylan Pharmaceuticals, Sandoz, and Takeda Pharmaceuticals are some of the many well-known manufacturers involved in this scandel.
The EMA recommendation to suspend the drugs would apply across the entire EU. Drug regulators in France, Germany, Belgium, and Luxembourg have already acted to stop the sales of 25 of these drugs.
The clinical studies in question were conducted by GVK Biosciences, a contract research organization in Hyderabad, India.
The recommendation of the EMA's Committee for Medicinal Products for Human Use to suspend the drugs was based on an independent French inspection of GVK Biosciences that revealed "data manipulations of electrocardiograms during the conduct of some studies of generic medicines," apparently over the course of at least 5 years. The systematic and prolonged nature of these manipulations and the number of staff involved "cast doubt" on the integrity of the trial methodology and the reliability of the data generated according to the EMA.
FDA Has Taken No Action After Its Own GVK Inspection
When queried the FDA said that some 40 drug applications received from 2007 to March 2012 contained GVK clinical data, and that some of these applications were approved.
The FDA declined to identify the drugs in question or indicate those that had been approved.
According to the FDA statement, the agency inspected GVK Biosciences in September 2014 on the heels of the French inspection in May 2014 and failed to find any evidence "that affects the safety or efficacy of drug products subject to pending applications or products approved in the US."
The agency promised to take "swift and appropriate action" to protect American consumers if it "identifies issues concerning GVK Biosciences that relate to products approved by the FDA."
Exceptions Can Be Made
The EMA investigation of drugs studied at GVK Biosciences encompassed more than 1000 individual generics in various forms and strengths as individually approved in 29 EU nations. Of this group, 300 generics had enough supporting clinical data from other sources to warrant staying on the market, according to the EMA.
That left roughly 700 generics — reiterations of the core four dozen or so drugs — that should be suspended, the EMA said. However, individual countries can make an exception for drugs that are critically important because there are no alternatives to meet patients' needs.
The EMA recommendation goes to the European Commission, the EU's executive agency, for a legally binding decision that will apply to all EU nations, including those that already have suspended the generics in question.
In the meantime, American physicians are waiting for the results of the independent FDA evaluation of this situation. If the FDA concurs, then this will be the biggest debacle ever in U.S. pharmaceutical history.
Ecstasy Use Increases Dramatically
As Emergency Departments swell while suffering the repercussions of the Affordable Healthcare Act, our nation's youth increase their use of mind-altering drugs, in particular, Ecstasy (Mollys).
The number of emergency department (ED) visits related to the use of Ecstasy (MDMA) (3,4-methylenedioxymethamphetamine) has increased by a staggering 128% in just 6 years, new research shows.
Also known as Ecstasy or Molly, a new report from the Substance Abuse and Mental Health Services Administration (SAMHSA) shows that MDMA-related visits among individuals younger than 21 years jumped from 4460 in 2005 to 10,176 in 2011.
In addition, 33% of ED visits involving MDMA use in this patient population also involved alcohol use.
"These findings raise concerns about the increase in popularity of this potentially harmful drug, especially in young people. Ecstasy is a street drug that can include other substances that can render it even more potentially harmful. We need to increase awareness about this drug's dangers and take other measures to prevent its use," Peter Delany, MD, SAMSHA's director of the Center for Behavioral Health and Statistics and Quality, said in a release.
MDMA has both stimulant and hallucinogenic properties. Although it is usually taken by mouth, it can also be snorted or smoked. The drug produces feelings of increased energy and euphoria and distorts users' sense and perception of time.
The report authors also note that the drug can produce a variety of negative health effects, including anxiety and confusion, that can last a week or longer. In addition, it has been associated with hypertension, as well as renal and cardiac failure.
The increase in this population is "a cause for concern due to the serious health risks involved with Ecstasy use and the higher potential for abuse when Ecstasy is mixed with alcohol," the report authors write.
The full report is available on the SAMSHA Web site.