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Meningitis trial: Massachusetts board let NECC off with warningsBOSTON – The Massachusetts Pharmacy Board got multiple notifications that a drug compounding company it licensed was violating state law but let the firm off with advisory letters that imposed no discipline.
Eight years later, that same company was identified as the cause of a deadly meningitis outbreak that killed 76 patients. The early warnings were detailed today by a state board official who testified in the trial of six former employees of the New England Compounding Center. They are charged with racketeering and mail fraud, but the state board official reported today that five of the six still have their pharmacist licenses.
The sixth defendant, Gregory Conigliaro, was an officer and part owner of the company but was never a licensed pharmacist.
Samuel Penta, executive director of the pharmacy board, testified that his agency received complaints from three other states that NECC was selling drugs without patient-specific prescriptions, a requirement under state law.
Penta said the complaints that NECC was selling prescription drugs out-of-state without prescriptions came in 2004 from pharmacists and health providers in South Dakota, Idaho and Wisconsin.
Penta said the board also learned a year later that NECC was attempting to sell drugs in bulk and without prescriptions to Partners Health, a Massachusetts health care firm.
In yet a fifth instance, a board inspector, after reviewing company records, cited NECC for selling a prescription drug with invalid patient names.
All of the three out-of-state violations were dealt with in a Sept. 21, 2004, meeting of the state board, according to records entered into the court record by federal prosecutors.
That meeting came just three months after Sophia Pasedis was named to the pharmacy board. Pasedis was an officer of Ameridose, another drug company with common ownership with NECC. Her name has surfaced in prior court testimony about an unlicensed pharmacy technician at NECC who was trying to get his state credentials restored.
Massachusetts officials initially stated that Pasedis abstained from any votes involving NECC or Ameridose. They later said some board records were unclear. When the outbreak became public, state officials — including then Gov. Deval Patrick — called on Pasedis to resign. She refused and remained on the board until her term expired just weeks later.
Penta, under questioning Wednesday by Assistant U.S. Attorney George Varghese, said NECC had told Partners Health that they could sell up to 5 percent of their drugs in bulk without prescriptions.
Though some states do have a so-called 5 percent rule, Penta said that was not the case in Massachusetts and individual prescriptions are required. He said he advised Health Partners of that fact.
In other testimony, Kristina Donohue, an official of the U.S. Food and Drug Administration, recounted her visit to NECC in response to an adverse event complaint registered against the company in 2002. She said that NECC President Barry Cadden was cordial and cooperative the first day she went to the company’s Framingham, Massachusetts, offices, but the next day she said Cadden refused to answer questions or provide any documents.
Cadden was convicted of racketeering and mail fraud charges and is now serving a nine-year federal prison sentence.
Donohue said that when she returned to NECC a year later, the company had grown from eight to 12 employees. She said that reviews of NECC’s operations raised concerns about the sterility of its products. The FDA, however, deferred to the state board for any further action.
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Dear U.S. Pain Foundation volunteers,
U.S. Pain Foundation belongs to the Indiana Stable Patient Protection Coalition. Together, we oppose the unfair practice called non-medical switching, or NMS. NMS occurs when insurance companies make changes to coverage that ultimately force patients to switch medication.
These coverage changes take place during the plan year, long after open enrollment. NMS locks consumers into a plan that no longer meets their needs–all for the profit of insurers.
If you believe you have been a victim of non-medical switching, we encourage you to share your experiences by taking this survey.
We, along with 12 patient and provider groups which make up the state-based coalition share the same goal: make stakeholders aware of the need to change NMS practices. In the coming months, we plan to propose a common-sense bill that will eliminate non-medical switching by private health plans. The survey data will be used to better inform legislators about the impact of NMS.
Thank you for your interest in helping to end this unfair and dangerous practice.
With gratitude,
Shaina Smith
Director of State Advocacy & Alliance Development
U.S. Pain Foundation
contact@uspainfoundation.org | uspainfoundation.org
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Suite B
Middletown, CT 06457
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https://www.medscape.com/viewarticle/904885
The US Food and Drug Administration (FDA) is alerting healthcare providers about the risk for complications with intrathecal administration of pain medications that are not approved for use with implanted intrathecal pumps.
These complications may include dosing errors, pump failure, opioid withdrawal, and infection, as well as pain, fever, vomiting, muscle spasms, cognitive changes, weakness, and cardiac or respiratory distress.
“The treatment of pain has become increasingly complex,” FDA Commissioner Scott Gottlieb, MD, said in a news release.
Implanted pumps that deliver medication directly into the spinal fluid can play an important role in treating pain, but their use must be “judicious and their instructions for use must be carefully followed. This is especially true when it comes to implantable pumps that deliver analgesic medicine directly into the nervous system,” said Gottlieb.
In a safety communication, the FDA reminds providers that the only approved medicines identified in FDA-approved implanted pump labeling for intrathecal infusion to treat or manage pain are morphine sulfate preservative-free injectable solution (Infumorph, West-Ward Pharmaceuticals) and preservative-free ziconotide sterile solution (Prialt, TerSera Therapeutics).
The FDA advises providers to review current labeling (ie, instructions for use) of the implanted pump, because not all pumps are currently approved for use with Prialt.
In reviewing medical device reports and other information, the FDA discovered that patients are sometimes treated with medications that are not approved for use with an intrathecal implanted pump. Such drugs include compounded medicines, hydromorphone, bupivacaine, fentanyl, and clonidine.
Any mixture of two or more different kinds of medicines and any compounded medicine (eg, to achieve higher concentration or different formulation of an FDA-approved medicine) are not approved for use, the FDA said.
Using drugs not approved for use with these pumps “may lead to serious risks to patients due to pump failure or dosage errors,” the FDA said.
The FDA has determined that implantable intrathecal pump failure is more common with the use of medicines not approved for use with the pump. Some medicines or fluids may contain preservatives or other characteristics that can damage the pump tubing or lead to corrosion of the pumping mechanism, it points out.
Dosing errors are also a risk with unapproved medicines. Programmable implanted pumps employ dose calculation software, and the accuracy of calculations depends on use of the approved medicine, approved medicine concentration, and approved medicine characteristics. A problem may arise, for example, if there is more than one medicine in the pump reservoir. In such cases, the pump software can calculate the dose only on the basis of the infusion rate of a single medicine, the FDA said.
Healthcare providers are encouraged to report problems with implanted pumps to the FDA’s MedWatch Adverse Event Reporting Program.
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Obviously this dr. Was a pcp and not a pain. Specialist. Which is a red flag for any pharmacy!! Understand acute pain but that patient should only need 28 tablets as a 7 day supply not 60-270 as most drs. Prescribe. He was continuing at a rate of a pain. Expert which prompted walmart to stop and investigate. The dr should have started referring his patients to specialist, then he wouldn’t be having this issue right now. As for the patients not being aware… the dr should have informed them that he was currently being blocked as shown above he did get a notification. He really has no right to file a lawsuit.
The above comment in RED was posted by someone on the blog post on my blog linked above. I don’t know if this person is a pharmacist, another healthcare provider, a chronic pain pt or no idea of their background.
This post would seem to confirm the fact that some people believe that only certain medical specialists can treat pts who are dealing with chronic pain.
what most non-healthcare professionals don’t realize/understand is that most “freshly minted” healthcare professionals are – at best – minimally knowledgeable and competent and hopefully proficient enough not to do any harm to pts. These “freshly minted” healthcare professional’s skills and knowledge base is highly influenced by professors, instructors, medical literature and as they advance in their career… some/many will develop talents and skills that may be in conflict of what they were taught during their educational process, and that is not all bad.
Once the reason for a pt’s chronic pain is determined, and whatever can be done by to make physical changes.. via surgery, PT or some other corrective treatment. If all other options have been explored, the only type of treatment that remains as a option is some sort of medication(s), perhaps ice/heat, on going PT and such treatments.
There are not enough chronic pain specialists practicing that could even begin to handle even a minority of the total chronic pain population.
Many/most healthcare professions (doctors, pharmacists, nurses and other mid-level practitioners) will become very knowledgeable and/or specialize in one or more areas within their scope of practice/license.
Treating most subjective diseases (pain, mental health) is mostly a trial and error in finding the right cocktail of medications to optimize the pt’s quality of life.
Let’s look at what is typical – as pts have posted – for pain clinics… many will provide ESI’s ( Epidural Spinal Injection) using a medication (Depo-Medrol) that has huge caution of using such a drug in ESI’s and many countries have banned its use in ESI’s. Some/many will insist on the pt continuing to have ESI’s even though they are providing little/no relief and the pt is coerced to get this procedure in order so that the prescriber will provide the pt a Rx for oral opiates.
It is claimed that there are some 10 million ESI’s given every year in this country and that 5% of those pts will develop https://en.wikipedia.org/wiki/Arachnoiditis which is an extremely painful irreversible disease because of the ESI med accidentally being injected directly into the spinal fluid. There are other potential adverse events in receiving ESI’s including meningitis due to a contaminate med , compromised sterile field or poor sterile technique of the pain clinic staff.
Generally, providing a medical service/procedure that is not medically necessary is generally considered INSURANCE FRAUD.
Likewise many of these same pain clinics – that do implanted pain pumps – will use compounded opiates because they can purchase these compounded meds for 10% – 25% of the commercial morphine product ( Infumorph) which is the only opiate approved by the FDA to be used in implanted pumps.
So it would appear in this incident – and others that are coming to light – that WalMart is making some arbitrary decisions about the dose of opiates that some who are not “pain specialists” are providing chronic pain pts on a regular/scheduled basis.
Of course, most PCP would not venture out into the area of complex surgeries and most pts would not go down that path outside of an emergency, but how many pts have you heard about having “failed back surgery”… done my a SPECIALIST ?
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https://www.cnn.com/2018/11/13/health/alcohol-use-screening-guidelines-uspstf-study
You can expect a “drinking checkup” when you visit the doctor. All adults, including pregnant women, should be screened for unhealthy alcohol use by their primary care physicians, the United States Preventive Services Task Force advises. For those patients who drink above the recommended limits, doctors should provide brief counseling to help them reduce their drinking, according to the new task force statement published Tuesday in the medical journal JAMA.
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A Nevada doctor plans to sue Walmart after the big-box company told its patients it will no longer fill their prescriptions.
Dr. Gary Ridenour has been a Fallon doctor for more than 30 years. He’s a country doctor who still makes house calls.
“I like the smallness of the town. I like the people of the town. The simplicity of the town,” Ridenour said.
One day last summer he said the billion dollar company stomped on his small-town practice. Walmart sent Dr. Ridenour a letter that said, “In our efforts to meet our compliance obligations… and to help combat prescription drug abuse and diversion, we routinely review the prescribing patterns and practices of the prescribers whose prescriptions are presented to us for filling… we will not be able to continue filling your controlled substance prescriptions.”
Dr. Ridenour was surprised and upset.
“They said you can’t write prescriptions, controlled substances for any Walmart in the United States. Oh, that’s nice,” he said. “I got no phone call. I got no letter from these people, what are they doing? “
Walmart will no longer fill his controlled substances prescriptions like Fentanyl, Oxycodone and Hydrocodone. But it also won’t fill scripts for Valium, Xanax and cough medicine with Codeine.
Dr. Ridenour’s patients said they didn’t get any notice that Walmart wouldn’t fill their pain meds anymore.
“I couldn’t believe it,” Susan Harrison, a Fernley resident said.
Harrison said she was on a deck when it collapsed and crushed her leg and ankle. She said a surgeon had to put 12 pieces of steal in her body. Harrison said her orthopedic specialist asked Dr. Ridenour, her primary care physician, to continue her pain medication. Harris said she takes a half a pill in the morning and a half in the evening.
“If I didn’t have any pain pills I wouldn’t be able to get out of my bed in the morning. I wouldn’t be able to walk anywhere,” she said.
For nearly two months, News 4 has e-mailed, called and left messages with Walmart several times for an explanation as to why it won’t fill Dr. Ridenour’s prescriptions. The company has not commented. But a news release on Walmart’s website announced a new company policy that would restrict initial acute opioid prescriptions to no more than a seven-day supply. Dr. Gary Ridenour does prescribe beyond a seven-day supply.
Walmart is a private company and is not required to fill all prescriptions. But Dr. Ridenour’s patients say this is unfair.
“For Walmart to not understand what medical conditions people are coming in for and for just making assumptions without calling the physician and finding out that these people have real issues,” Harrison said.
Walmart is following the crack-down on opioids across the country. Nevada passed AB 474 that went into effect this year. The law requires prescribers do a risk assessment of the patient, run them through a state-wide database and justify the quantity written.
The Board of Pharmacy and The Nevada State Board of Medical Examiners are primarily responsible for enforcing the new law. Dr. Ridenour says neither state agency has ever investigated him for wrong doing. He says he’s planning on filing a lawsuit against Walmart.
“I’ve never overprescribed. In fact, this year we kicked out 12 patients because we drugged screened them and they had,” he said.
Doctors complain the new law makes more work for them. And in Dr. Ridenour’s case, he believes the law scared Walmart into no longer filling his patients’ prescriptions.
“It’s not fair to my patients,” he said.
It also limits where his patients can fill prescriptions.
“Most of us in small towns don’t have a lot of options,” Harrison said.
http://www.ncpanet.org/home/find-your-local-pharmacy
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Chronic pain pts are considered part of a protected class under the Americans with Disability act and discriminating under this act is considered a civil rights violation. The CDC guidelines is some 90 pages and apparently Walgreens has found a couple of sentences or paragraphs out of that document that they like…
Here is four quotes from the CDC opiates guidelines that they don’t seem to like:
https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”
“Clinicians should consider the circumstances and unique needs of each patient when providing care.”
“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”
“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”
Many in healthcare seem to believe that “corresponding responsibility” is a ONE WAY street and all actions under that term should be to reduce/eliminate – at all costs – the possibility of a pt becoming a substance abuser – even if it means that the valid chronic pain pt has to be denied appropriate pain management care and suffers a reduction in quality of life issues.
I find Ms Polster’s corporate title somewhat ironic — VP Pharmacy Quality Compliance and Patient Safety. How safe is a pt’s quality of life if they can’t get the amount of medications that they need to optimize their quality of life and pain reduction ? I wonder how many other health/disease issues that they are sending out letters to prescribers … recommending that the pt’s medication be reduced. If they are not… then it would further suggest that Walgreens is practicing corporate civil rights violations on a fairly selective group of pts.
For those pts who are tired of corporations telling your prescriber how to practice medicine and what medications you are entitled to… here is a website to help a pt find a local independent pharmacy who is more likely to work with a pt’s prescriber and the medications they need, instead of interfering with what the pt’s medications needs are.
http://www.ncpanet.org/home/find-your-local-pharmacy
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