Narcan Nasal Spray approved by FDA

Details: Published: Sunday, 22 November 2015 15:57

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

Details: Published: Sunday, 22 November 2015 15:56

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

Details: Published: Sunday, 22 November 2015 15:54

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

Tort Review: Medical and Toxicology

Details: Published: Friday, 02 October 2015 15:11

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

www.medscape.com

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.

Cite this article: Brian S Kern. 5 Ways to Improve Our Medical Liability System. Medscape. Jan 14, 2015.

Bupropion Use is Increasing!

Details: Published: Friday, 31 July 2015 13:47

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

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