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FDA Approves a New Medicine for Varicose Vein Treatments

Varithena is a new FDA approved drug for the treatment of varicose vein disease which will be introduced within the next month. 

More: http://www.pittsburghveindoc.com/2014/03/31/fda-approves-a-new-medicine-for-varicose-vein-treatments/

Source: www.pittsburghveindoc.com

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Bonus Army Forced from the Capital: July 28, 1932

On July 28, 1932, U.S. troops expelled thousands of American World War I veterans—known as the Bonus Army—from their camps in Washington DC, after months of protests and marches by the Bonus …

Source: blog.newspapers.com

“Sanctuary Cities” show a flagrant and criminal disrespect for our laws! Keyword “Illegal” Immigration … just saying. #OATH 1st

"Sanctuary Cities" show a flagrant and criminal disrespect for our laws! Keyword "Illegal" Immigration … just saying. #OATH 1st

Sample hospital code of ethics

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Multimodal analgesia guidelines for child

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Paediatric analgesia needs to be calculated on a mg/kg basis and physiological development; Children dont like intramuscular injections; Pain is best prevented rather than treated; Plans for postoperative pain management discussed with the child and family; A perioperative multimodal approach to analgesia is the
 7 Apr 2010 Acute and chronic pain management in children is increasingly characterized by either a multimodal or a preventive analgesia approach, in which smaller doses of opioid and nonopioid analgesics, such as nonsteroidal anti-inflammatory drugs, local anaesthetics, N-methyl-D-aspartate antagonists, a2-
 Eur J Anaesthesiol. 2010 Oct;27(10):851-7. doi: 10.1097/EJA.0b013e328338c4af. Multimodal analgesia in children. Yaster M(1). Author information: (1)Department of Anaesthesiology, The Johns Hopkins University, Baltimore, Maryland 21287, USA. myaster1@jhmi.edu. Acute and chronic pain management in children is
 Acute and chronic pain management in children is increasingly characterized by either a multimodal or a preventive analgesia approach, in which smaller doses of opioid and nonopioid analgesics, such as nonsteroidal anti-inflammatory drugs, local anaesthetics, N-methyl-D-aspartate antagonists, ? 2-adrenergic agonists,
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 26 Feb 2016 In a new American Pain Society guideline on postoperative pain management in children and adults, an expert panel recommends a multimodal approach.
 Unauthorized Use Prohibited. Multimodal Analgesia for Perioperative Pain Management. Asokumar Buvanendran, MD concept and theory of multimodal analgesia is not new; however several novel pharmacological agents have In 55 children undergoing hernia repair, 30 mg ketorolac and 20 mg/kg acetaminophen.
 Society of Anesthesiologists Task Force on Acute Pain Management. ANESTHESIOLOGY .. of a multimodal analgesic pain management program (Cat- egory D .. Many are the same as for adults, although some (e.g., caudal analgesia) are more commonly used in children. The Task Force believes that it is important.
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How to Prevent Healthcare Data Breaches (and What to Do If You’re a Victim)

Data breaches are unfortunately not uncommon in the healthcare industry. In the last three years, more than 500 breaches affecting 500 or more patient records have been reported to the Office for Civil Rights (OCR)within the U.S. Department of Health and Human Services. OCR estimates that close to 60,000 smaller breaches have occurred in the same timeframe.

Most data breaches begin with a moment of, "You’re not going to believe what just happened," says Robert Belfort, a partner with Manatt, Phelps & Phillips LLP. It could be a CD with patient data that goes missing from a storage firm when the employee who signs for it suddenly resigns, or it could be a laptop taken from a car parked in an otherwise nondescript residential neighborhood.

Facebook and Physicians: Not Good Medicine

Both incidents are real; the latter occurred in 2011 and involved the Massachusetts eHealth Collaborative (MAeHC), a small nonprofit that’s nonetheless active in influencing national healthcare IT policy. Given the organization’s role, "It was no small embarrassment to find out that we had make some critical mistakes," CEO Micky Tripathi says.

What to Do If You’re a Victim of a Healthcare Data Breach

Tripathi, Belfort and others spoke at last week’s Privacy & Security Forum, presented by Healthcare IT News and the Healthcare Information and Management Systems Society (HIMSS).

Once an incident is discovered, the first step is determining if a breach actually happened. That’s no small task, Belfort says, as there are differences between data breaches and system vulnerabilities or violations of an organization’s security policy. Vulnerabilities and violations should be noted, both for auditing purposes and to educate employees about data security, but they don’t automatically constitute breaches.

Even if a breach has occurred, Belfort continues, there are two additional questions to consider: Did unauthorized or improper access to personal health information (PHI) occur, and if so, is there any risk to the organization? If an unencrypted laptop containing PHI was in a car that was stolen and subsequently dumped at the bottom of a lake, then the risk of anyone having seen that PHI is low, he says.

Commentary: Who Should Be At the Root of Protecting the Nation’s Healthcare Data?

The MAeHC incident was a data breach, Tripathi says. Neither the laptop nor the data was encrypted, and although the files were password-protected, it was determined that an "enlightened amateur" could access the data. Of the nearly 15,000 patient records on the laptop, 1,000 put patients at a significant risk of harm, he says, as they contained a patient’s name and one of three other pieces of information: date of birth, Social Security number or reason for the appointment.

 The next step was notifying those 1,000 patients. Here differing state and federal laws complicated matters. Federal law puts a HIPAA-covered entity at fault. In this case, that would have been the practices for which the MAeHC was a contractor. (The agency was studying error logs for electronic data submissions.) Under Massachusetts law, though, the MAeHC, as the entity that lost the data, was responsible. To avoid confusion, Tripathi says, the eight affected covered entities sent the letters (to meet federal law) but mentioned MAeHC in the first sentence (to cover the state law).

In the end, data breach mitigation cost MAHC about $289,000. More than half went to legal fees and the bulk of what was left went to pulling staff from other tasks to focus on breach mitigation. "Basically, you have to sweep everything aside and focus on this," Tripathi says.

A breach involving one specific covered entity had to be reported to the Office for Civil Rights, as it affected more than 500 patients. The OCR concluded that MAeHC was "in substantial compliance" with federal rules and did not fine the organization; the federal agency even went so far as to tell Tripathi that overlapping state and federal laws left the OCR unsure if it even had jurisdiction over the incident.

Lessons Learned: How to Prevent a Healthcare Data Breach

Tripathi decided to use the incident as an educational experience for others, as a lengthy post on the HIStalk Practice blog and subsequent interview with The New York Times suggest. "This kind of detail just doesn’t get out there," he says.

It should. A recent analysis of healthcare data breaches by the Health Information Trust Alliance (HITRUST) finds that incidents such as the MAeHC breach—involving lost or stolen and unencrypted laptops—remain all too common in the healthcare industry despite new rules that dramatically increase fines for data breaches.

All told, theft and loss account for 66 percent of the breaches of 500 or more patient records, and 82 of the total records lost, that have occurred since September 2009, the HITRUST report notes. Small physician practices, which make up the vast majority of healthcare organizations in the United States, are particularly vulnerable, the report says: "This industry segment is struggling and requires significant assistance due to a lack of available expertise and resources."

In an interview, Christopher Hourihan, principal research analyst with HITRUST, says small practices should focus on the basics, including training, encryption, firewalls and antivirus software—the same technology that savvy users have on their home networks. "Don’t try to do anything all at once," he says. "Focus on the critical areas first and expand the program that way."

Speaking at the Privacy Security Forum, Leon Rodriguez, director of the Office for Civil Rights, agrees that encryption technology is key to avoiding breaches. (Under 2009’s HITECH Act, the loss of encrypted PHI, or of encrypted hardware that contains PHI, is not considered a data breach.) Training matters, too, he adds, as there is always "some human frailty" to a data breach that’s unrelated to technological vulnerabilities.

The HITRUST report notes that data breaches involving HIPAA business associates—which, as noted, HIPAA-covered entities are responsible for—have accounted for 21 percent of breaches in the last three years and 58 percent of the records lost. This points to a need for "proactive due diligence," Hourihan says. It’s been a problem, and it will continue to be a problem, because businesses sign a contract and then don’t do anything else."

To combat this issue, healthcare organizations should first ask for a business associate’s most recent security audit and risk analysis and then work with the BA to fill the gaps that could result in a data breach. Since some providers have hundreds, if not thousands, of BAs, Hourihan suggests giving the most attention to electronic health record vendors, vendors that support critical business functions and other companies that interact with customer data.

Healthcare organizations also need to be aware of hackers. While hacks account for only 8 percent of reported data breaches, Hourihan thinks the actual number is higher, as HITRUST has seen PHI for sale on underground message boards that often can’t be tied to a reported breach. With PHI worth up to 50 times more to hackers than credit card or Social Security numbers, Hourihan and HITRUST expect to see a "pretty significant rise" in hacks in years to come.

David Harlow, principal of The Harlow Group LLC, acknowledges that the industry "collectively need[s] to do a better job cracking down on those exploits."

Doing so requires a mix of technology, education and leadership. For Rodriquez, it’s that final point that matters most—not just for preventing hacks but also for preventing data breaches and doing the sort of due diligence that MAeHC did in order to avoid an OCR fine. "It comes down to leadership owning compliance issues and doing so consistently. It’s that leadership that makes all the difference," he says.

Source: www.cio.com

Pharmacists held criminally liable for opioid overdoses

Pharmacists Held Criminally Liable for Opioid Overdoses

Alicia Ault
June 30, 2017
14
As the US opioid epidemic continues to soar, physicians have been held criminally responsible for patients’ overdose deaths. Now, it appears pharmacists are also criminally liable.
That’s the opinion of pharmacy law experts who have watched the crisis unfold during the past decade.
Keith Yoshizuka, PharmD, JD, assistant dean for administration at the Touro University College of Pharmacy, Vallejo, California, notes, for example, that in 2015, a California physician, Lisa Tseng, MD, was convicted of second-degree murder for the overdose deaths of three patients. She was later sentenced to 30 years to life in prison.
"I don’t think it’s too large of a leap to expect a pharmacist to face criminal liability in the event that one or several of the patients overdose on medications that were filled by that pharmacy," Dr Yoshizuka told Medscape Medical News. "I can see the district attorney going after that pharmacy or the pharmacist for second-degree murder for, basically, recklessness — criminal negligence. But demonstrating that liability is still not clear-cut," he added.
I don’t think it’s too large of a leap to expect a pharmacist to face criminal liability in the event that one or several of the patients overdose on medications that were filled by that pharmacy. Dr Keith Yoshizuka
Brian Gallagher, RPh, JD, associate professor at the Marshall University School of Pharmacy, Huntington, West Virginia, agreed.
"It’s not illegal to dispense a controlled substance to someone who is an addict who has legitimate pain," Dr Gallagher told Medscape Medical News. "It’s a very, very gray area — it’s very subjective" for a pharmacist who is trying to decide whether a prescription should be dispensed, he said.
That’s true despite state and federal regulations that guide pharmacists in the dispensing of controlled substances. In 1971, the Drug Enforcement Administration (DEA) established the doctrine of corresponding responsibility, according to which a prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances falls upon the prescribing practitioner, and a corresponding responsibility rests with the pharmacist who fills the prescription.
The DEA has also warned pharmacists to address or resolve "red flags," such as cash payments for controlled substances or patients who come to a pharmacy for a prescription but who live far away, before dispensing.
"Corresponding responsibility is perhaps one of the most commonly misunderstood and/or unknown concepts found in DEA’s regulations," writes DEA compliance attorney Larry Cote in a 2013 blog post. "And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility," he adds.
And yet, enforcement actions against pharmacies are most frequently initiated when a pharmacist fails to exercise his/her corresponding responsibility. Larry Cote
Lost Licenses, Businesses, Careers

Some pharmacists in California seem not to be heeding the call to mind their corresponding responsibility or do their best to address red flags. Or perhaps they are just too harried — or don’t have the right tools ― to weed out inappropriate or illegal prescriptions.
But judging by the rising number of investigations and disciplinary actions relating to controlled substances by the California Pharmacy Board, more often, pharmacists are paying the price in lost licenses, pharmacies, and careers.
The board fired a significant warning shot in 2013 when, after a long investigation that uncovered multiple failures to address red flags, it revoked the licenses of Pacifica Pharmacy and its pharmacist, Thang Q. Tran. An appeal was rejected.
The decision was considered precedential because it contained "a significant legal or policy determination of general application that is likely to recur," according to the board.
Others, such as a long-time owner of a pharmacy in the Los Angeles area, believe the board is going too far. That pharmacist says he chose to give up his license — and sell his business ― rather than fight the board any further after an investigation that lasted a year. The inquiry started in 2011, when the family of a young man who died in 2010 of an opioid overdose initiated a complaint with the board.
The prescribing physician — who eventually became an addict — took his own life before a medical board investigation had been completed. The pharmacy board conducted an on-site inspection of the pharmacy in 2013, and in a subsequent report, said that between 2008 and 2010, the pharmacist had filled more than 4500 controlled substance prescriptions from the doctor but failed to call him to verify any of them. The report also cited numerous failures to address red flags, such as filling prescriptions too early and making unauthorized refills.
The pharmacy provided lengthy explanations to the board to justify its practices and hired an attorney to represent it and its pharmacists during conferences with the board and an administrative law judge.
The pharmacy also paid for a forensics expert, who provided the coroner’s records that showed that although the young man died from oxycodone intoxication, he had numerous other substances in his system, including MDMA (ecstasy) and metabolites of marijuana.
The pharmacist lost the case and chose not to spend more money on an appeal. The store paid a $35,000 fine, and the pharmacist paid a $7500 fine. Liability insurance covered some of the attorney’s fees, but nothing else.
In another recent case, two Santa Barbara pharmacists agreed to surrender their licenses and pay a $15,000 fee to cover the costs of a board investigation that determined that they had ignored red flags with patients who had received prescriptions for controlled substances from a local physician who had come to be known as the "Candyman." The doctor, Julio Diaz, MD, was convicted in 2015 of 79 felony counts and received 27 years in federal prison.
The California Board of Pharmacy expects pharmacists to "use their judgment," said Virginia Herold, executive officer of the board. For every prescription, "they are to evaluate and make sure it is the right drug for the patient," she told Medscape Medical News.
Errors are not unexpected, and "unless it is a grossly negligent error, we will cite and fine," she said.
Errors are not unexpected, and unless it is a grossly negligent error, we will cite and fine. Virginia Herold
Growing Scrutiny

The number of investigations "has gone up over time," said Herold. She attributed it in part to the board’s broadening responsibilities — the board regulates 33 types of licenses covering 45,000 pharmacists, more than 72,000 pharmacy technicians, more than 6800 intern pharmacists, and more than 3000 designated representatives.
The board has 49 investigators — up from 15 about 2 decades ago.
Dr Yoshizuka, who has consulted for the board, said that it is conservative in choosing investigations. "They won’t pursue something unless they are pretty sure they are going to win," he said. "In order for them to get to a point where they are actually suspending or revoking someone’s license, there has to be a lot of evidence."
As a consumer advocate who has worked for the board for almost 3 decades, Herold sees her agency’s mandate as primarily focused on consumer protection. That is accomplished through enforcement of corresponding responsibility, she said.
A family whose loved one has suffered because of a prescription overdose or error "would want us to discipline that pharmacist that committed that error," said Herold.
Pharmacists also have been under growing scrutiny in West Virginia, a state that has been among the hardest hit by the opioid epidemic. The liability pendulum swung against the state’s physicians and pharmacists in 2015, but it has recently taken a swing back toward the middle.
That year, West Virginia had the highest rate of drug overdose death in the United States, at 41.5 per 100,000, according to the Centers for Disease Control and Prevention.
The same year, the state’s Supreme Court ruled that substance abusers could sue prescribers and pharmacists who supplied medications ― even if the patients acknowledged engaging in illegal activities, such as misleading doctors and pharmacists, engaging in doctor shopping, and ingesting the medications in amounts greater than prescribed, said Dr Gallagher.
Fearing a tide of suits, the state legislature soon came up with a response, introducing and passing a bill prohibiting anyone engaged in illegal activities from suing doctors or pharmacists. The bill was approved by the governor in early 2016.
West Virginia has tried to provide some support for pharmacists through another recently approved bill that was signed by Governor Jim Justice on April 26. Marshall University had a hand in crafting the legislation, said Dr Gallagher, who in addition to his pharmacy experience previously served 8 years in the state legislature.
For instance, Senate Bill 333 requires that overdoses — not just overdose deaths — be reported to the prescription drug monitoring program (PDMP). Emergency department visits for overdoses "are a much bigger and better indicator that this person has a substance abuse problem," said Dr Gallagher. Pharmacists can check the PDMP, which means "they’ll have a real idea, rather than just red flags," said Dr Gallagher.
The law also gives the Board of Pharmacy the authority to require designated "drugs of concern" to be reported to the PDMP.
Any time a controlled substance is prescribed or dispensed, the physician or pharmacist must record a long list of items of information, including who picked up the prescription and whether it was paid for in cash or by other means. If a prescriber dispenses a controlled substance directly to a patient, it can only be enough to cover 72 hours of treatment. The Board of Pharmacy will enact rules to determine where the reporting will occur.
The West Virginia Board of Medicine will also now be required to report more quickly and publicly on disciplinary actions.
How to Spot Red Flags

Pharmacists are still vulnerable, said Dr Gallagher, adding that malpractice insurance won’t likely cover litigation costs if an opioid or other controlled substance was illegally dispensed.
The first line of protection is to ask questions. Although it may be hard to deny a patient a prescription — especially if it’s a first visit — a pattern of ignoring red flags will attract scrutiny, Dr Keith Yoshizuka
The first line of protection is to ask questions, said Dr Yoshizuka. Although it may be hard to deny a patient a prescription — especially if it’s a first visit — a pattern of ignoring red flags will attract scrutiny, he said.
Asking questions and checking PDMPs are time-consuming tasks. But Dr Gallagher noted that "a lot of pharmacies get themselves into trouble because they say, ‘I don’t have time to do all of this.’ "
Not knowing how to spot red flags means getting more training, Dr Gallagher and Dr Yoshizuka agreed. "Everyone has a responsibility in trying to end this," said Dr Gallagher, adding, "You shouldn’t have a pharmacy license if you don’t know there’s an opioid epidemic."
And the fight to end the epidemic is a major battle, with many casualties, including people who legitimately need pain medications, as well as physicians and pharmacists who aren’t sure of, or ignore, their corresponding responsibility.
"It’s unfortunate, but people everywhere are getting hit by the shrapnel of this," said Dr Gallagher.
Dr Yoshizuka has consulted for the California Board of Pharmacy and has been an expert witness for the Drug Enforcement Administration. Dr Gallagher has disclosed no relevant financial relationships.
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Cite this article: Pharmacists Held Criminally Liable for Opioid Overdoses – Medscape – Jun 30, 2017.