Grieving mother urges more oversight for pharmacies that make errors

https://www.thestar.com/news/gta/2016/10/20/grieving-mother-urges-more-oversight-for-pharmacies-that-make-errors.html

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Are There Times When a Legal Duty Not to Dispense Exists?

http://www.pharmacytimes.com/publications/issue/2016/October2016/Are-There-Times-When-a-Legal-Duty-Not-to-Dispense-Exists

While there are a lot of details of this lawsuit missing… but.. the courts ruling that a Pharmacist could be held liable for failing to refuse to fill prescriptions over a time period.  Once again we are talking about treating “subjective disease”  – “stress syndrome”… where dosing can vary and stress/anxiety/depression can go hand in hand… and we all know that pts with these medical issue are at a higher risk of suicide.  I wonder if the Pharmacist had INSISTED with the doc to be more “truthful” with what the pt can take per day… would have exonerated the Pharmacist ?

ISSUE OF THE CASE
When pharmacists at a community pharmacy repeatedly honored prescriptions for controlled substances before the supply previously dispensed should have been exhausted, may a lawsuit be maintained by the representative of the patient’s estate for breach of a legal duty owed the now deceased patient?

FACTS OF THE CASE
A patient in a southern state consulted a physician, who gave a diagnosis of stress syndrome, and, therefore, prescribed alprazolam and either hydrocodone with acetaminophen or oxycodone with acetaminophen. Over a 2-year period, these prescriptions were repeatedly issued to the patient before the last refills should have been consumed. It was alleged that at least 30 such prescriptions were dispensed at the same pharmacy and no questions were raised by the pharmacist. This lack of questioning the refill requests persisted even when the prescriptions were “issued too closely in time and days before the preceding prescription should have been exhausted.” The patient died shortly before the 2-year anniversary of being on this regimen, with the cause of death identified as “combined drug intoxication with alprazolam and hydrocodone.”

An individual representing the estate of the now deceased patient filed suit against the physician and the pharmacy, with the physician settling the claim out of court. The legal complaint filed to initiate the lawsuit against the pharmacy alleged 7 different types of breaches of legal duty by the pharmacy. An abbreviated description of some of those claims is that the pharmacy and pharmacist have a legal duty to (1) use due and proper care, (2) exercise the level of care and skill recognized by reasonably prudent and similar pharmacists, and (3) not honor prescriptions that were unreasonable as presented.

The attorney representing the pharmacy filed a motion with the state trial court hearing the case, stating the matter should be dismissed based on earlier cases, decided by courts in that state, that established precedent that pharmacists had no legal duty to do the things the plaintiff alleged. The trial court granted that motion, and the representative of the patient’s estate filed an appeal of that dismissal with the state court of appeals.

THE COURT’S RULING
Following review and discussion of the decisions in a number of prior cases in the state, the appellate court ruled that the lawsuit should not be dismissed.

THE COURT’S REASONING
The appellate court began by pointing out that the trial court judge had concluded that the pharmacy owed no duty to the patient that would support the lawsuit. The appeals court emphasized that if a legal duty to act were absent, there could be no successful claim of negligence. However, in the view of the appellate court, there was a legal duty to act, so the dismissal was an error.

The principal point of departure for the court was that “pharmacists are required to exercise that degree of care that an ordinary prudent pharmacist would do under the same or similar circumstances.” Further, it reviewed an earlier decision by the court of appeals, which had concluded that “a pharmacy that fills a prescription that is unreasonable on its face may breach its duty of care, even if the prescription is lawful as written.”

Delving further into case precedent, the court also identified an earlier decision ruling that “negligence liability can be imposed on a pharmacy for failing to use due and proper care in filling prescriptions, even if the prescription is filled in accordance with the physician’s instructions.”

The appellate court in this case concluded that “a pharmacist’s duty to use due and proper care in filling a prescription extends beyond simply following the prescribing physician’s directions.” Continuing, the court said, “We refuse to interpret a pharmacist’s duty to use ‘due and proper care in filling a prescription’ as being satisfied by ‘robotic compliance’ with the instructions of the prescribing physician.”

This court looked at the precedent from an earlier case involving a pharmacist’s failure to act on a patient’s medication allergies. In that case, there was an allegation of negligence based on the pharmacist’s failure to alert a patient that a prescription contained a substance to which the customer was allergic, and the court ruled that the “pharmacy has a duty to use proper care in filling a prescription, beyond simply following the prescribing physician’s directions.”

At the end of its published opinion, the appellate court pointed out that further proceedings were required to determine whether the plaintiff would prevail once the trial was concluded, along with all testimony and evidence, but at least a legal duty to act to protect the patient was present in the facts presented.

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Much of World Suffers Not From Abuse of Painkillers, but Absence of Them

www.nytimes.com/2016/05/18/world/much-of-world-suffers-not-from-abuse-of-painkillers-but-absence-of-them.html?

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While Americans are confronting an epidemic of prescription drug abuse, particularly for addictive painkillers, the reverse problem prevails in much of the world.

Many ill people with a legitimate need for drugs like oxycodone and other narcotics known as opioid analgesics cannot get them and are suffering and dying in pain, according to health officials, doctors and patients’ rights advocates.

In Russia, India and Mexico, many doctors are reluctant to prescribe these painkillers, fearful of possible prosecution or other legal problems, even if they believe the prescriptions are justified.

In Kenya, health officials only recently authorized the production of morphine, one of the most effective drugs for pain relief, after criticism that it was available in only seven of the country’s 250 public hospitals. In Morocco, the advocacy group Human Rights Watch reported in February, only a small fraction of physicians are permitted to prescribe opioid analgesics, which the country’s law on controlled substances identifies as poisons.

And in most poor and middle-income countries, these drugs are restricted and often unavailable, even for patients with terminal cancer, AIDS or grievous war wounds.

The reasons include an absence of medical training, onerous regulations, costs, a focus on eliminating illicit drug use and, in some cultures, a stoic acceptance of pain without complaint. The problem has been amplified, public health experts say, by the stigmatization of the drugs, partly from fear of what has happened in the United States, where opioid misuse is a growing cause of death.

Reinforcing this view has been publicity about high-profile users like Prince, the pop star who died last month at his Minnesota mansion as friends sought help from an addiction specialist to treat what was apparently a dependence on opioid painkillers.

“While clearly there are issues with some prescribing practices, there’s also clearly a risk to vilifying these medicines,” said Diederik Lohman, associate director of the health and human rights division at Human Rights Watch.

In some countries, Mr. Lohman said, “a clerical error in a morphine prescription” can lead to criminal inquiries. “The fear associated with prescribing a medicine under strict scrutiny makes physicians afraid,” he said.

Afsan Bhadelia, a visiting scientist and palliative care expert at the Harvard School of Public Health, said “the biggest misconception” internationally regarding opioids was the need for tighter control.

“People do not have access to pain control for basic surgery,” she said. “People are going into the operating room and not having anyone mitigate their pain. It is a great injustice.”

Liliana De Lima, executive director of the International Association for Hospice and Palliative Care, a Houston-based advocacy group, said that global publicity about the American opioid epidemic “had brought this problem to the people, and that has had an effect on the fears.”

Despite international protocols dating back decades that entitle patients to pain relief and palliative care, access remains limited or nonexistent for many.

A report published in February from the International Narcotics Control Board, a United Nations agency, showed that most growth in the use of opioid analgesics has been in North America, Central and Western Europe, and Oceania. It remains low in Africa, Asia, Central America, the Caribbean, South America, and Eastern and Southern Europe.

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“Many low-income and middle-income countries continue to fail to provide adequate opioid analgesic medicine for pain,” the report said.

Stefano Berterame, who leads the board’s narcotic control and estimates section, said officials in many of these countries attributed the shortages to the expense of the drugs and a lack of suppliers. He also said that in some Asian countries, pain relief through the use of opioids or other drugs was an alien concept.

“They believe you can sustain the pain, work through the pain,” he said.

The pain-relief problem was addressed by the World Health Organization in a report published in advance of a United Nations summit meeting on international drug policy in April, the first such review in nearly two decades.

“Ensuring the adequate availability of controlled substances for medical and scientific purposes,” the W.H.O. said, was a commitment made by member states that had “yet to be universally achieved.”

It estimated that 5.5 billion people live in countries with “low or nonexistent access to controlled medicines for the treatment of moderate to severe pain.”

Dr. Dingle Spence, an oncology and palliative medicine physician in Jamaica, said that although opioids are available in her country, the supply is disrupted by so-called stockouts — demand exceeding supply — because of bureaucracy.

“There’s not enough understanding about timely ordering,” she said. “The amount of permits needed to bring them into the country slows down the timely flow.”

Still, Dr. Spence said Jamaica was fortunate compared with other countries in the region. In Trinidad, for example, she said, officials refused to allow “the simplest type of morphine” for pain relief. “It seems to be they are bound by the opiate-phobia problem,” she said.

Morphine consumption data from the International Narcotics Control Board, she said, tells part of the story. In 2013, the global average for 139 nations was 6.27 milligrams per capita. The only Caribbean nation above the mean was Barbados. In Jamaica, consumption was 1.63 milligrams; in the Bahamas, 0.24 milligram.

“That means there’s a ton of people in pain,” Dr. Spence said.

Felicia M. Knaul, an international health economist and expert in Latin American health systems, criticized what she described as a widespread overemphasis on the addictive risks associated with opioids. Although fear of opioids may be fed by American tragedies like Prince’s death, she said, strict regulations also are responsible for the pain-relief crisis elsewhere.

“It’s not that we shouldn’t be concerned about addiction,” she said, but “we basically have zero access in most countries around the world. You don’t go from zero to the situation in the United States.”

Ms. Knaul, a breast cancer survivor and global advocate of cancer patients, is chairwoman of the Lancet Commission on Global Access to Pain Control and Palliative Care, a group of experts created in 2014, in part to help integrate pain relief into health systems around the world. A major concern of the commission is the disparity between patients in rich and poor nations who have access to painkillers, which it called “an ongoing crisis that plays out almost entirely to the detriment of poor people.”

In Mexico, a 2009 amendment to its health law that required hospitals to offer palliative care to terminally ill people was basically ignored for years, prompting Human Rights Watch to issue a scathing report in October 2014 asserting that “tens of thousands” of Mexican patients entitled to pain relief were not getting it.

Ms. Knaul, who has worked extensively in Mexico, said that there had been “huge improvements” there more recently, but that drugs for palliative care remained difficult to obtain in many remote areas. She said Mexico’s war on drug cartels had actually increased illicit use of opioids.

“The irony for a pediatric oncologist is that it’s much easier to buy on the street than go to a hospital,” she said. “That’s what people turn to when they don’t have the appropriate means available.”

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http://www.cdc.gov/drugoverdose/pdf/pharmacists_brochure-a.pdf

Will need to DOUBLE CLICK on image to be readable

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Fentanyl patient ashamed to pick up prescription amid ongoing opioid ‘crisis’

globalnews.ca/news/3007708/fentanyl-patient-ashamed-to-pick-up-prescription-amid-ongoing-opioid-crisis/?

As the provinces and the federal government work to address a “public health crisis” amid growing rates of opioid overdoses and deaths across the country, one Ontario man says that without fentanyl his quality of life would be destroyed.

The 48-year-old agreed to speak to Global News under condition of anonymity due to the stigma he faces as a user of the drug and the negative implications speaking out publicly could have on his life and career. For the duration of this article he will be referred to as “John.”

“I feel unfortunate that these people are dying over this, but this medicine is a very good medicine because it’s better for your body than taking a morphine tablet,” he said.

“I’ve been using this for years, it’s never been a problem – now it’s a problem because people are dying.”

John was in a severe accident years ago and uses fentanyl to manage chronic pain.

“This is a medication that works for me. There’s probably other people that feel the same,” he said, adding he’s tired of feeling like a criminal for using a drug that helps him function.

“What about people that are relying on this product?”

For John, even picking up a prescription at his local pharmacy makes him feel like he’s doing something wrong.

“They looked at me like I had two heads that I’m using this product,” he said, adding that he often has to justify his need for the drug despite his doctor’s support.

“It just helps me get through my daily life as I am. Hey listen, I don’t like taking it and it has its bad with the good, but for me to get up and continue my day to do what I can do with my limitations — this is the system, the way I have to go.

“I’d love to get off of it but I need something and Advil doesn’t cut it.”

WATCH: Ontario government unveils strategy to combat growing problem of deaths linked to opioids

Health Minister Eric Hoskins announced Wednesday several steps as part of Ontario’s “comprehensive opioid strategy” to prevent the “public health crisis” of addiction and overdoses.

The new measures include expanded access to the addiction treatment drug Suboxone and an additional $17 million a year on 17 chronic pain clinics.

Dr. David Williams, Ontario’s chief medical officer of health, will also serve as the province’s first-ever overdose co-ordinator to better track patients who overdose on painkillers like fentanyl and hydromorphone.

READ MORE: Ontario expands use of Suboxone to battle growing opioid crisis

The Ontario government has been criticized over its response to the opioid crisis in the province over concerns it didn’t have up-to-date information on how many people were overdosing.

The latest publicly available data showed opioid overdose deaths rose to 553 people in Ontario in 2014, while fentanyl-related deaths climbed to 153, according to the Chief Coroner for Ontario.

In Ontario, statistics on opioid overdose deaths are overseen by the Ontario Chief Coroner’s Office — but that data was last released in 2014. Meaning there is no up-to-date picture of how bad the problem currently is.

Global News obtained preliminary data from the chief coroner’s office for 2015, which showed there were 529 opioid overdoses in Ontario last year — 162 of which involved fentanyl.

WATCH: Minister of health under fire after Global News reports on opioid overdose death crisis

As part of Williams’ new role, he will work with the coroner’s office, police, hospitals, and public health officials to monitor all opioid-related overdoses.

“They need to come up with a better solution with what they’re doing right now, John said.

“It’s almost like you’re a heroin user. That’s the feeling that I get and it’s like — but I’m not. I don’t do drugs. That’s the only thing I take.”

READ MORE: More fentanyl deaths in Ontario, but where are the detox programs?

John said he worked with his doctor to find a pain medication that suits him, after being prescribed drugs such as oxycodone and morphine in the past that have much stronger side effects.

He now takes a clinically controlled dose of 100 mcg/h of fentanyl in a patch that slowly distributes the drug over the course of two days.

“It’s not evil for people that need this product,” he said, adding he feels “horrible” when he’s forced to return his empty patches to pharmacies to prove he’s using it legitimately.

“I’m thinking there’s got to be another way.”

John said if the province were to restrict fentanyl prescriptions in the future in response to the growing issue of opioid overdoses, his life would be thrown into turmoil.

“Oh I’d be in trouble … I’d be probably going through lots of pain, not movement, plus probably the withdrawal of it too,” he said.

“It doesn’t fix it 100 per cent, but it makes me be able to move around and continue my life as much as I could. If I didn’t have it I know for sure I wouldn’t be able to do what I do.”

READ MORE: 5 people overdose after using cocaine laced with suspected fentanyl at Ontario party

John said that due to his severe pain, he often has to leave Canada for several months to warmer climates in the U.S., but getting a three-month supply of fentanyl is difficult and problematic.

“When I’m going in and out of the country now I’m thinking, ‘Jeez, am I going to get arrested because of a medication that I’m taking?’,” he said.

“I’m worried coming back into Canada or going into another country and the dog’s sniffing — if they smell it I’m going to get hauled out of line.”

READ MORE: Police, community groups warn fentanyl crisis looming in Ontario

John said he feels as though the government may move to further restrict fentanyl in the future and he will be left without another option to manage his severe pain.

“I have a feeling in the next six months I’m not going to have that opportunity and nobody’s going to seem to care,” he said.

“Very few ruined it for probably a lot.”

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Half of New York Overdoses Blamed on Fentanyl

http://www.painnewsnetwork.org/stories/2016/10/19/half-of-new-york-overdoses-blamed-on-fentanyl

By Pat Anson, Editor

Nearly half of the overdose deaths in New York City since July have been linked to fentanyl, according to a new report that adds to the growing body of evidence that illicit fentanyl is now driving the nation’s opioid epidemic – not prescription pain medication.

In an advisory sent to healthcare providers, New York’s health department said 47 percent of the city’s confirmed overdose deaths since July 1 have involved fentanyl. That compares to 16% of overdoses involving fentanyl in all of 2015. So far this year, 725 people have died from drug overdoses in New York.

“Data suggest that the increased presence of fentanyl is driving the increase in overdose fatalities,” the alert said. “While fentanyl is most commonly found in combination with heroin-involved overdose deaths, fentanyl has also been identified in cocaine, benzodiazepine, and opioid analgesic-involved overdose deaths.”

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. Because of its potency, healthcare providers are being warned that additional doses of naloxone – which reverses the effects of an opioid overdose – may be needed when fentanyl is involved.

Fentanyl is available legally by prescription in patches and lozenges to treat more severe types of acute and chronic pain, but illicitly manufactured fentanyl has become a scourge across the U.S. and Canada, where it is often mixed with heroin and cocaine or used to make counterfeit pain medication.

Unsuspecting buyers, including some pain patients who were unable to get opioid medication legally, often have no idea the drug they’re getting from a dealer or friend could contain a lethal dose of fentanyl.

dea image of fentanyl

In addition to New York City, several states in the Northeast and Midwest have reported that fentanyl is now involved in about half of their overdose deaths.

The sharp increase in fentanyl-related deaths has coincided with new restrictions on the prescribing of opioid pain medication. In the past year, the Drug Enforcement Administration has issued two public safety alerts about fentanyl, but the Centers for Disease Control and Prevention has remained relatively quiet about the problem – focusing instead on opioid prescribing guidelines that were released in March of this year.  

Those guidelines have led many doctors to reduce doses or stop prescribing opioids altogether, but they have failed to make a dent in the number of Americans dying from overdoses. There have also been anecdotal reports of a rising number of suicides by patients unable to get opioid medication.

“I know five people who have committed suicide from being denied pain medication by doctors after the CDC came out with their ridiculous statements of the ‘epidemic’ of prescription opioid use,” says Nina Stephens, a Colorado woman who suffers from chronic pelvic pain. 

“Doctors are so afraid of getting in the middle of this epidemic mess with the FDA that they have decided to stop prescribing opioids to their patients, even those patients who are in desperate chronic pain. We are now treating our patients worse than dogs when it comes to pain.”

Stephens says she has to drive 4 hours each month to see a doctor who is still willing to prescribe opioids. A local pain management doctor just 20 minutes away said he would take Stephens off opioids and give her epidural injections instead, which she refused.

“I am truly afraid that soon I will have to drive even farther to find a doctor who will still be willing to prescribe pain pills to me each month or I will have to start looking at the black market.  Maybe a veterinarian would be willing to start treating me?  No wonder the suicide rate is going up so dramatically!” Stephens wrote in an email to PNN.

Canada’s Fentanyl Crisis

Counterfeit fentanyl pills started appearing in British Columbia about two years ago and have since spread throughout Canada. The fentanyl crisis is so severe a two-day conference was held in Calgary this week for healthcare providers and law enforcement.  There were 153 deaths associated with fentanyl in Alberta province during the first six months of 2016.

Some attendees want Alberta to declare a public health emergency – as British Columbia did in April. But Alberta’s Minister of Justice says the current fentanyl situation doesn’t warrant such a declaration.

“None of those powers will assist us in this case but they do give the government a significant ability to violate civil liberties,” said Kathleen Ganley. “We think it’s important we use those powers that have significant impact on Albertans only where they would be helpful to us.”

On display at the conference was an illegal pill press seized by law enforcement that is capable of producing 6,000 fentanyl laced pills per hour.

“Some of the tablets we’ve been seizing in Calgary have ranged from 4.6 milligrams to 5.6 milligrams per tablet—which is very high obviously, considering a lethal dose is two milligrams,” said Calgary police Staff Sgt. Martin Schiavetta in Calgary Metro.

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Scientists may have found migraine trigger— in our mouths

http://www.foxnews.com/health/2016/10/19/scientists-may-have-found-migraine-trigger-in-our-mouths.html

Certain foods like chocolate, wine, and processed meats have long been linked to migraines, and while nitrates in those foods are often seen as the culprit, it’s not entirely clear why some people are more susceptible to ensuing headaches than others, reports Quartz.

Now scientists are reporting in the journal mSystems that, thanks to an analysis of 2,200 people participating in the American Gut Project, they’ve found that people with migraines tend to have more oral bacteria that process nitrates, reports Refinery29.

This means that people suffering from migraines could be creating more nitric oxide, which has been linked to migraines, as they process those nitrates. Scientists next plan to study the diets of people with migraines to look for links between nitric oxide levels in their blood and migraines, which would help confirm that nitrate-processing oral bacteria are behind the headaches.

If that’s true, we could eventually see a “magical probiotic mouthwash” that helps reshape oral bacteria to prevent migraines, reports the Guardian. In the meantime, researchers say, people who suspect that nitrates are behind their migraines should try to avoid them when possible—which could be difficult, considering they’re also present in leafy greens.

(The source of this man’s headache was highly unusual, and more than a little gross.)

This article originally appeared on Newser: Scientists May Have Found Migraine Trigger—in Our Mouths

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Wrongful death lawsuit filed against St. Thomas, NHC, others

http://www.murfreesboropost.com/wrongful-death-lawsuit-filed-against-st-thomas-nhc-others-cms-45398

A Texas woman is seeking $5 million in a wrongful death lawsuit claiming her elderly mother died from negligence by local healthcare providers, mainly involving a botched diuretic prescription. If you need attorney for wrongful death attorney case then check here.

Sharon Elizabeth Conway filed the complaint Oct. 5 on behalf of her mother, Clara Hamner Conway, who died Aug. 28, 2015, after gaining 30 pounds in only 18 days while being treated at St. Thomas Rutherford Hospital and NHC Murfreesboro, according to court documents.

The lawsuit names St. Thomas Rutherford, NHC Murfreesboro, Dr. Zakaria Botros, Dr. Evans Neal Mize, Dr. Susana Irias Donaghey, Wellness Solutions and nurse practitioner Miatta Kebee Hampton.

Conway was admitted to the hospital Aug. 6-10, 2015 for symptomatic anemia (shortage of iron), acute gastritis (inflammation or swelling of the stomach lining), COPD exacerbation (shortness of breath) and mild hypokalemia (a low potassium level).

She was discharged weighing 158 pounds and readmitted Aug. 18 due to shortness of breath. During those eight days, she gained 15 pounds but complained of decreased appetite, according to the lawsuit, and also showed signs of swelling in her extremities.

The lawsuit contends the weight gain was caused by abnormal fluid retention, which, if left untreated, can lead to heart failure and death. The problem often is treated through diuretics, increasing the excretion of water and salt in the body.

Conway was prescribed 20 milligrams of Lasix by mouth every other day, and Botros requested consultation by pulmonologist Dr. Richard Parrish, who recommended diuretics for failure of the left side of her heart. If that didn’t bring improvement, she was to undergo a procedure to remove excess fluid from her chest, according to the suit.

Despite Parrish’s recommendation, she received only one 20-milligram dosage of Lasix on Aug. 19 and not another until Aug. 24 when she was given a 40-milligram tablet of Lasix, according to the filing.

The lawsuit contends Botros and Mize should have known she suffered dangerous levels of fluid retention but failed to take appropriate steps to treat her.

After six days at St. Thomas, weighing 188 pounds, she was transferred to NHC Murfreesboro where a nurse noted significant swelling in her lower extremities, the lawsuit says.

In the transfer, a discrepancy occurred in orders for Lasix to be administered at 40 milligrams every day instead of every other day, and the conflicting prescription order was not recognized, according to the lawsuit.

“This dosage was insufficient to manage the abnormal fluid retention in her body,” the lawsuit states.

On Aug. 25, the patient suffered an episode of respiratory distress. Despite continuing problems and abnormal lab results, physicians were not notified and no changes were made in her medications, according to the lawsuit.

Even as the patient continued having problems with oxygen levels, repeated respiratory distress was not addressed with diuretic medication, the filing contends.

She was found unresponsive Aug. 28, 2015 and taken to St. Thomas Rutherford where she was pronounced dead.

The lawsuit contends the “volume overload of fluid retention caused her increasing respiratory distress” and made her gain 30 pounds in 18 days. “Left untreated, these conditions caused cardiac arrest and untimely and wrongful death,” the lawsuit states.

Officials with St. Thomas Rutherford Hospital and NHC Murfreesboro did not return phone calls.

Sam Stockard can be reached at sstockard44@gmail.com.

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