“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
My husband has worked as maintenance for over 20yrs and been on fmla disability for most that time.he has iracnoiditis and degenerative disc disease. And has had kidney failer when he was 18 and suffered permanent damage from that and can’t take ibuprofen or anything that could effect his kidneys.he has went to neurosurgens and they recommended fentenyal he tried it and couldn’t take side effects. So his doctor put him on morphine and has been on high doses stable for years.even with his meds he has flare ups and has to take up to 4 days a month off.now the insurance he pays for tried to cut him to 1 3rd of what he used to take.we filed 1st appeal and they only gave him half of what he was stable on for only 2 months.he has become depressed stressed and defeated.he just wants to support his family. How can they have the power to hold his job over his head.he does nothing outside of work now and is starting to miss days and we can’t afford it.he supports 2 family’s.someone has to do something he cannot have any quality of life without pain relief. If he loses his job we will lose everything and his disease will progress.there is no cure for his disease so that means its pallative. We are in constant fear of our lives falling apart. This is not his fault that he has a disability and he should be allowed to support his family.
The West Virginia Attorney General’s office has filed an objection to the distribution of money from a settlement with a subsidiary of Johnson & Johnson.
Kanawha Circuit Judge Duke Bloom was on pace to approve the distribution of West Virginia’s share of a $33 million settlement by Feb. 23, but Douglas Davis, representing the DWI Guys serving all of Syracuse and nearby areas general’s office objected to how that money was going to be spent.
West Virginia was one of 42 states to reach the settlement with McNeil-PPC Inc. in May 2017, and the state is set to get $441,277.96, according to court documents.
The lawsuit alleged McNeil-PPC Inc. illegally promoted their over-the-counter drugs ( Medications involved included Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, Zyrtec and Zyrtec Eye Drops. )as meeting federal standards for manufacturing, when there were significant issues with the drugs’ quality and effectiveness, Attorney General Patrick Morrisey said when he announced the settlement. You should be planning out your estate for a better future.
In a proposed order to distribute the funds, nearly $400,000 would go to the West Virginia University College of Law for a program to develop a program to train law students(see more) to assist with drug and consumer related issues, Douglas said in the objection. You can get discrimination lawyers in Fresno if you are going through some issue.
Instead of sending settlement money to WVU’s law school, Douglas recommended the settlement be paid to the West Virginia Center for Drug and Health Information, which is operated by WVU’s School of Pharmacy. You can continue reading here about the accident attorneys.
Nick Casey, former chief of staff for Gov. Jim Justice, is the guardian ad litem in the case, meaning he’s in charge of reviewing the proposed judgment and distribution of the funds.
In a previous report, Casey outright rejected sending the money to the law school.
Casey most recently filed a report in the case on March 13.
In the latest report, Casey said sending the money to WVU’s law school wouldn’t be the best use of the funds, saying the proposed law program wouldn’t “result in one support of individual consumers of medication.”
Casey additionally suggests settlement money could be distributed to programs run through the University of Charleston School of Pharmacy and the West Virginia Board of Medicine.
Casey said the settlement would be most beneficial to West Virginians if it’s used to support programs “where there is regular interaction with citizens of West Virginia on a diverse array of health and medication issues.”
Casey supports the attorney general’s office taking costs and reasonable attorney’s fees from the settlement amount, but he argues that the rest of the settlement money should not go to the attorney general’s consumer protection fund. know what one can do legally after getting injured by someone else.
The West Virginia Legislature has the ability to move money from that fund to the state’s general revenue fund. As of Casey’s March 13 filing, that fund had more than $11 million, Casey said in his report.
Once attorney’s fees and other costs are taken out of the $441,277.96 settlement, Casey said the total consumer recovery was represented as being $96,000.
As of Thursday, no hearing had been scheduled in the case.
The attorney general’s office subtracted their “reasonable attorney’s fees and office costs”… leaving 96,000 – about 20% of the total settlement – and was UNHAPPY because the remainder wasn’t going to a LAW SCHOOL… but proposed to be sent to a Board of Medicine and Pharmacy school to deal with “health issues” within the state. Once again, the law profession demonstrates that it is self-serving ?
Just remember the number in the first paragraph.. of the 64K overdose deaths that they always throw around 66.4% involves opiates… it is claimed that NSAID’s kill 15,000/yr.. but.. a lot of people – in talking about opiate deaths – like to throw out that 64K overdose deaths and never explains that they are not all opiate related deaths..
The authors of this article want a better stat on pharmaceutical grade of opiates vs illegal opiates… what they also ignore.. is that once a opiate gets into the hand of someone other than who it was legally prescribed for.. it becomes an ILLEGAL OPIATE. Doesn’t make any difference if they got them from a friend’sa legal prescription, robbed a pharmacy or bought them on the street… THEY ARE ILLEGAL OPIATES and needs to be counted as such in opiate related deaths.
I don’t know if you remember me, we spoke awhile back about someone whose was having issues getting her pain meds. You helped me navigate things and in the end we got her what she needed. Thank you again for your time with that. Since then I have been doing my best to advocate for Kratom as well as pain patients and today I’m sad to say that the war on chronic pain sufferers has his a new low. I’m docimenting this horrific journey with video and pictures, so there will be more. However I wanted to share with you as I’m seeing it more and more.
Laying on my couch right now is my dear friend Nikki. She introduced me to Kratom years ago, I owe my life to her as the path she set me on was what prompted me to stop taking 17 medications and go the alternative route. She is a fierce fighter who was dx with breast cancer three years ago. For many that can be a death sentance as you know. Not for Nikki, see she didn’t have time for any of that. She opted for a double mastectomy and chemo, followed by radiation. I watched in awe as this woman drove herself to her appointments, I watched as she got her chemo that she was allergic to, a team standing near in case the steroids and Benadryl weren’t enough. I watched her rock her wigs and never once, not one single time, let the thought she wasn’t going to make it cross her mind. If it did she refused to give it life. She is an inspiration and I remember watching her go through all of that and thinking I’d be lucky if I had even a fraction of her will and strength. At her lowest when she couldn’t make it to the bathroom, when she was void of all dignity, when those around her were at a loss for words. It was her who told us, it would be okay. Slowly but surely she recovered and for a year she did well.
Then she started having stomach issues. 15 ER visits and almost two years later she got a dx of ILC it’s all over her stomach… she is down to a weight we would be concerned of if in a dog. She can no longer eat as her stomach violently seizes. Weekly we make trips to the ER to get fluid drained from her stomach. This time is different than the last, she is still fighting but this time, she needs help with her fight. If there is a chance for her, she needs all the help she can get, and yet instead of fighting for her life. My sweet friend is fighting for her right to Pain meds.
Her refill date came and we made the call to her oncologist who sent it over to the pharmacy. However when we went to pick it up, she was given half of what she was previously being given. Her original scripts were for 10 fentanyl patches and 180 norco she was to wear a patch at all times and take the norco as needed up to 4 times a day. I can attest to the fact even at those doses I have sat by her as she screamed in pain, gasping for air, begging God to let it stop. Even for a moment. So it was quite horrifying when I called her oncologist to see why she had been cut back, and I was told it was not what the doctor wanted to do. She was being forced to cut all her patients down to a 90mg morphine or equiviant a day. I heard the pain in this doctors voice and I felt for her. She said the pressure to do this though not law, might as well be. Her frustration in with this situation was clear as she was quite candid about her feelings about being forced to do this.
I’m not writing you for help this time Sir. I have finally learned enough that I knew the next steps and we have signed her up with hospice and found a pain management doctor willing to go through the steps to get authorization to give her more meds etc etc My reason for writing you is to share her story. One thing that has never changed during this ridiculous crackdown on rx Pain meds has been the statement that cancer patients are exempt from all these cutbacks. The general consensus is that only addicts are being cut back, pill mills shut down, but true chronic pain patients in the end will have their access and as far as cancer, they wouldn’t encounter ANY issues. This is simply not true. I did a poll in a Pain group and within 45 Minutes over 30 cancer patients had clicked the option that said “have medication cut in half” some clicked the option for having their meds STOPPED.
The rage I feel right now is nothing I’ve ever felt before and as I record her, and document this horrifying journey for her in hopes this madness stops, all I can think of is standing in front of the powers that be with a video of her screaming while her body tightens ands her face turns red as she begs for relief. Justify this. No, matter where one stands in this fight, I dare anyone to argue that this is okay. That this is an acceptable side effect of this war. If Nikki were a dog she would get relief in fact a human could face legal ramifications if they allowed a dog to suffer the way she is suffering. I don’t want to live in a world where this is unacceptable for animals but perfectly fine for humans.
I’ve included a picture of Nikki with her permission. This is the face of someone who was supposed to be exempt from these new guidelines, this is her when the pain isn’t so bad. This is her reality and this is unacceptable. As time passes and we see more and more of this and the powers that be tell us that it’s all to address a greater problem. Please remember my friend. The only hope I can offer her at the moment is we won’t let her suffering be for nothing.
WASHINGTON — The U.S. Department of Justice plans to hold providers accountable per a new large-scale effort to tackle the opioid crisis, Deputy Attorney General Rod Rosenstein reiterated here Wednesday.
Addressing the annual policy conference sponsored by America’s Health Insurance Plans, Rosenstein said the new opioids task force announced by Attorney General Jeff Sessions last week will hold everyone accountable; he then specifically cited physicians.
The proliferation of prescription painkillers, including opioids, has countered the ethos of “do no harm,” Rosenstein said, noting that the average American life expectancy has decreased along with the 21st century opioid spread — after nearly doubling over a century. “These drugs have caused a lot of collateral damage,” Rosenstein said, including costing American healthcare more than $1 trillion this century.
In addition to the Task Force, Rosenstein cited as another solution the Justice Department’s involvement with the new Joint Criminal Opioid Darknet Enforcement team; it has been established in large part to counter the flow of painkillers, especially synthetics such as fentanyl, from foreign countries into the U.S.
“We ought to all be about prevention,” he said, citing over-prescription as a major cause of the opioids crisis.
Rosenstein asked insurance companies to utilize their monitoring systems to identify patients receiving too many painkillers and those receiving them for conditions that don’t warrant them. “We recognize that you have a financial incentive” to limit prescriptions, he noted.
Rosenstein also encouraged providers, insurers and others to follow the CDC’s 2016 opioid guidelines.
The deputy attorney general spoke just before a panel on the opioid crisis featuring Patrice Harris, MD, chair of the American Medical Association’s Opioid Task Force; Adriane Fugh-Berman, MD, a Georgetown University professor who leads the PharmedOut initiative; and Nick Szubiak, LCSW, of the National Council for Behavioral Health.
“The pharmaceutical industry is almost completely responsible for this epidemic,” Fugh-Berman said, citing misleading advertising and their practice of hiring “thought leaders” to shame providers into prescribing more opioids. These individuals told physicians they were “torturing our patients” by not issuing painkillers whenever they complained of pain.
Pharmaceutical companies “misused” medical literature by consistently citing small-scale studies and research letters as evidence for supporting opioid prescriptions, she said. They also published ghostwritten articles in medical and consumer publications, and launched disease awareness campaigns. In addition, they funneled money to medical advocacy groups, including the U.S. Pain Foundation ($2.9 million during 2012-2017) and the American Academy of Pain Medicine ($1.2 million) to promulgate messages such as “restricting opioids in any way disadvantages pain patients” and “the needs of patients with [opioid use disorder] must be balanced with the needs of pain patients.”
Such practices have not completely abated, she said. One in 12 physicians accepted money from opioid manufacturers from 2013-2015 totaling $46 million. Fugh-Berman also reminded the crowd that the phrase “abuse deterrent” does not necessarily mean “less addictive.”
She encouraged practitioners to suggest patients try alternative methods for treating pain, such as regular exercise, acupuncture and transcutaneous electrical stimulation. “Some of these treatments are as effective or more effective for pain than opioids,” one of her presentation slides said.
Alternative treatments indeed need to be more readily available to patients, said Melinda Becker, who directs a National Governors Association Health Division center.
Harris suggested decreasing administrative burdens for practitioners, such as prior authorization requirements, especially when treating patients with substance use histories.
Physicians are already making progress addressing the opioid crisis, Harris noted. Healthcare professionals more than doubled queries with prescription monitoring programs during 2014-2016, according to an AMA survey; a QuintilesIMS report noted that total opioid prescriptions declined from 259 million to 215.5 million from 2012-2016.
Szubiak listed several resources needed to combat the crisis, including:
Intensive case management
Recovery supports
Patient navigators
Certified community behavioral health clinics
Shifting healthcare to value-based care
Tracking patients who diverge from care plans
Barriers must also be overcome, Szubiak said, citing providers’ bias against opioid users, and other perceptions within American healthcare that have led to users being regarded as criminals. These patients should instead be educated about prevention and treated.
If we had medical professional in charge of dealing with the mental health issue of addictive personality, and not some of those opiophobic medical professionals that the media keeps seeking out and quoting their PROPaganda.
They keep recommending NSAID’s… which is known to cause 15,000/yr deaths.. and they quote the BIG NUMBER of 215 million opiate prescriptions as being – for some unknown reason – to be excessive.
If all those supposedly “bright/educated” people really looked at those numbers and the estimated number of chronic pain pts. It is easy to see that the reported numbers strongly suggests that chronic pain pts – especially those suffering from intractable chronic pain – are being grossly UNDER TREATED.
It is estimated that there are some 20 – 30 pts suffering from intractable chronic pain.. those requiring 24/7 opiates… follow standard of care and best practices… with each getting a long acting opiate and a short acting opiate for breakthru… presuming that they would get a 30 days Rx each time… those pts would require 480 – 720 million opiate prescriptions.
So those 215 million opiate prescriptions would not even begin to address the needs of those intractable chronic pain pts.. .let along… the other 70-80+ million chronic pain pts and those who are in need of opiates for acute pain for a short period.
Is it time to call for our judicial system to walk away from treating the mental health disease as a Crime and turn it over to our medical community ? After all, our judicial system has been “treating” addiction for over 100 yrs… and only those who are part of our judicial system and/or draws a paycheck from the war on drugs would consider it a success ?
Greater awareness of the dangers posed by prescription opioids is changing pharmacy practice.
Efforts to address the opioid epidemic are as complex as the problem, with involvement ranging from government agencies to state pharmacy boards to addiction specialists to medical professionals.
Pharmacists may be the first to suspect opioid abuse and misuse, and many have altered the way they interact with patients who take opioids. Studies have found that pharmacists say the epidemic has changed the way they counsel patients about pain management and potential problems.
“A growing awareness of the dangers posed by prescription opioids seems to be leading to more proactive discussions between pharmacists and patients regarding this issue,” says Lucas Hill, PharmD, BCPS, BCACP, clinical assistant professor at the University of Texas at Austin College of Pharmacy.
Here are some of the biggest ways pharmacy practice is changing.
1. Adopting New Protocols
Some chain and independent pharmacies are implementing policy changes to protect patients and pharmacists. CVS, for example, has strengthened counseling for patients filling a first-time opioid prescription.
“During this counseling, our pharmacists will talk to the patient about the recommendations from the CDC around opioid use,” says Tom Davis, RPh, vice president for pharmacy professional services at CVS Pharmacy. “The key message to patients initiating opioid treatment for an acute use is to use the lowest effective dose for the shortest possible duration of time. Pharmacists will also talk to patients about the importance of safely storing and appropriately disposing of opioids to prevent misuse or diversion.”
CVS uses the CDC Guideline for Prescribing Opioids for Chronic Pain to frame its prescribing policy, limiting the supply of opioids dispensed for certain acute prescriptions to seven days for patients new to the therapy.
“The program also employs MME [morphine milligram equivalent] limits consistent with the CDC Guidelines,” Davis tells Drug Topics. “And, it requires the use of immediate-release formulations of opioids before extended-release opioids are dispensed.” These changes went into effect in September 2017.
Tana Kaefer, PharmD, clinical coordinator at Bremo Pharmacies in Richmond, VA, says her protocol is to emphasize opioid alternatives. “If the patient gets two prescriptions, one for ibuprofen and one for an opioid, I may tell them to try the ibuprofen first.”
Kaefer also lets her patients know their options so they don’t have extra medication in the house, such as by only filling part of a prescription. Laws in Virginia allow pharmacists to split the prescription, for example, dispensing five pills when 10 are prescribed and having the patient come back if more are needed.
She also tells patients how to correctly dispose of leftovers. “We know this is a huge problem if medication is left in the medicine cabinet and other people come into the house looking for it,” she says.
2. Embracing a Team-Based Approach
Teamwork is helping reduce opioid abuse in hospital and long-term care settings, says Deb Pasko, PharmD, MHA, director of medication safety and quality with ASHP. Doctors, nurses, and pharmacists work together to determine and monitor the optimal medication for patients, and respond quickly when changes are needed. “We may have a trauma patient come into the ER who has acute needs, then go to the operating room and need a high dosage, then on to intensive care,” says Pasko.
She says pharmacists should help decide what medication is indicated, the best interval, and identify any potential interactions. They can also help determine if patients should continue receiving opioids, if medication should be tapered, or if an alternative should be considered.
3. Using PDMPs
More than two dozen states now require pharmacists to check prescription drug monitoring programs (PDMPs). These electronic databases that track controlled substance prescriptions are among the most promising state-level interventions to improve opioid prescribing, inform clinical practice, and protect patients at risk, according to the CDC.Click to expand
“For me the prescription monitoring program is very helpful,” says Kaefer. “If I have concerns it allows me to see the bigger picture of a patient. I can see if a patient is visiting other pharmacies. I find it very helpful that I can connect to other states.”
There have been “remarkable successes” in controlling the prescribing and dispensing of controlled substances, particularly opioids, when PDMPs are accessed, says Carmen Catizone, RPh, MS, DPh, executive director of the National Association of Boards of Pharmacy.
As more states embrace PDMPs, their potential to help curb the epidemic is growing. Promising developments in PDMPs, according to the CDC, include:
More seamlessly integrating them into electronic health records
Permitting physicians to delegate PDMP access to other allied health professionals in their office (physician assistants and nurse practitioners)
Streamlining the process for providers to register with the PDMP.
While monitoring is helping decrease the abuse of prescription opioids, some industry experts fear it may be contributing to more dangerous practices among abusers. In the last few years, overdoses from illicit opioids, such as heroin and fentanyl, have skyrocketed.
“The most serious concern about [PDMP] implementation is that it could push people who are misusing prescription opioids to an illicit drug market that is flooded with ultra-potent fentanyls.” says Hill. “In my opinion, that isn’t an argument against [PDMPs] so much as an argument for expanded access to evidence-based treatment with methadone and buprenorphine.”
4. Preparing for Worst-Case Scenarios
Expanding pharmacists’ authority to administer and dispense opioid-reversing medications such as naloxone may help pharmacists prevent patient overdoses from legal and illegal drugs.
Some states permit pharmacists to dispense naloxone through a collaborative practice agreement. In states where pharmacists can prescribe naloxone, they must complete training provided by their employer or a local school of pharmacy.
“This initiative requires significant outreach to pharmacists, patients and caregivers, first responders, and legislators,” says Catizone. “Besides educating people on when and how to properly administer such medications, there is the need to educate stakeholders and naysayers about addiction as a disease and not a stigma or indictment of an individual.”
More legislation empowering pharmacists, caregivers, and first responders to ensure the widespread availability of naloxone and other similar products across all states would help save many lives, Catizone says.
“Until the number of patients who are at risk or dying from the use and abuse of opioids is zero or as close to zero as humanly possible,” Catizone says, “there is much more than can be done by pharmacists, pharmacy boards, and other stakeholders.
Isn’t it amazing, Pharmacists are suppose to be scientists … suppose to be “drug experts”… here we have a article about them individually and collectively ignoring some of the basics of opiates used to treat pain.
It starts out with the apparent unquestionable belief that all of those opiate conversion tablets are an “exact science”.. apparently most/many/all have not read the “fine print” on these website.. here is just one “warning” from one such conversion websiteshttp://www.globalrph.com/narcotic.cgiPublished equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring.
Then there is this …pharmacists should help decide what medication is indicated, the best interval, and identify any potential interactions I wonder if when a pharmacist is to this evaluation – of subjective pain – and probably has no idea of the pt’s CYP-450 opiate metabolism rate status and those with a fast/ultra fast metabolism.. may or may not get an appropriate dose… since it doesn’t conform to the “cookie cutter” dosing guidelines that has been established as a standard of care and/or best practices within the hospital.
Then there is the apparent belief that the data within the PMP is infallible and no pts/diverters/abusers would present a fake/forged/stolen ID when they have a prescription filled.
If only those who are professing in trying to help pain pts and don’t know all the rules.. especially when they are dealing with treating a subjective disease.
The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.
As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.
In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which can be up to 10 times more powerful than fentanyl, the ideal medication for that situation.
In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can. Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases. Other patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.
The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.
In a Feb. 27 letter to the U.S. Drug Enforcement Administration, a coalition of professional medical groups — including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists — said the shortages “increase the risk of medical errors” and are “potentially life-threatening.”
In addition, “having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients,” the group wrote.
The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.
Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.
Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.
Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.
Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.
“The system has been set up safely for the drugs and the care processes that we ordinarily use,” said Dr. Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women’s Hospital in Boston. “You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”
Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.
“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.”
During the last major opioid shortage in 2010, two patients died from overdoses when a more powerful opioid was mistakenly prescribed, according to the institute. Other patients had to be revived after receiving inaccurate doses.
The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.
A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kan. The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.
That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.
Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.
At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.
“DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances,” the agency said in August.
When the coalition of health groups penned its letter to the DEA last month, it asked the agency to loosen the restrictions for liquid opioids to ease the strain on hospitals.
The shortages are not being felt evenly across all hospitals. Dr. Melissa Dillmon, medical oncologist at the Harbin Clinic in Rome, Ga., said that by shopping around for other suppliers and using pill forms of the painkillers, her cancer patients are getting the pain relief they need.
Dr. Shalini Shah, the head of pain medicine at the University of California-Irvine health system, pulled together a team of 20 people in January to figure out how to meet patients’ needs. The group meets for an hour twice a week.
The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.
“We essentially have to ration to patients that are most vulnerable,” Shah said.
Two other California hospital systems, Kaiser Permanente and Dignity Health in Sacramento, confirmed they’re experiencing shortages, and that staff are being judicious with their supplies and using alternative medications when necessary. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
At Helen Keller Hospital’s emergency department in Sheffield, Ala., earlier this month, a 20-year-old showed up with second-degree burns. Dr. Hamad Husainy said he didn’t have what he needed to keep her out of pain.
Sometime in January, the hospital ran out of Dilaudid, a drug seven times more potent than morphine, and has been low on other injectable opioids, he said.
Because Husainy’s patient was a former opioid user, she had a higher tolerance to the drugs. She needed something strong like Dilaudid to keep her out of pain during a two-hour ride to a burn center, he said.
“It really posed a problem,” said Husainy, who was certain she was in pain even after giving her several doses of the less potent morphine. “We did what we could, the best that we could,” he said.
Bernell, the St. Louis nurse, said some trauma patients have had to wait 30 minutes before getting pain relief because of the shortages.
“That’s too long,” said Bernell, a former intensive care nurse who now works in radiology.
Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl.
Mell, who is also a spokesman for the American College of Emergency Physicians, said some emergency departments are considering using nitrous oxide, or “laughing gas,” to manage patient pain, he said.
When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.
Margaret Scott had responsibility over the Ohio Department of Medicaid’s pharmacy program until she departed last fall. Within a month, she was working for a company that is receiving billions of pharmacy dollars from Ohio’s Medicaid managed care programs.
Scott and the contractor, pharmacy giant CVS, aren’t answering questions about what happened. But the state’s ethics watchdog — while not speaking specifically about Scott’s situation — said it’s illegal for a state employee to continue to be involved in decisions that might affect an outside business while negotiating a new job with that business.
Scott’s case might be of particular interest because CVS’s “pharmacy-benefit manager” contracts with Medicaid managed-care organizations are drawing scrutiny from legislative leaders. The Dispatch on Tuesday reported on accusations by independent pharmacists that CVS — which holds four of the five such contracts in Ohio — is charging an excessive price from taxpayers for drugs and reimbursing retail pharmacies with lowballed rates in an attempt to push out competition.
According to her LinkedIn page, Scott was with the Department of Medicaid from 2004 until last October. Then in November, she was a clinical adviser for CVS.
Melissa Ayers, a spokeswoman for the Department of Medicaid, said Friday the agency is still looking into the matter. But she said that Scott did not have authority over the CVS pharmacy-benefit manager contracts because those were between CVS and the managed-care companies that contract with the state.
I want to share a small parable with you… Please keep in mind that a parable is a made up story, written or told to illustrate a point… So here goes… A “manager” did everything in his power to schedule his pharmacy to what the company demanded… According to the company’s mandates, everyone was to schedule much lower than the manpower each “manager” needed to get their pharmacy’s work done… If the corporation could save money by giving employees less hours, the managers were supposed to do it, so the company could (somehow) make more money by saving on wages rather than make money by getting the work done… It was already a stressful environment with the phones ringing constantly, situations not working out as planned, and customers complaining loudly that everything was taking too long… But the corporation didn’t care about this… They wanted to see profits being made on the bottom line so that they looked good to the shareholders… Even if the stores were already financially successful, the corporation felt that these stores could be more successful… Even if the environment in the pharmacies went from stressful to impossible… It was hard before to get all the work done and the Rx orders checked accurately, but now it was next to impossible to get the order out in time and the employees were all stressed beyond belief… But still the “manager” tried his best to be a good little employee and to make his corporation happy… He scheduled his employees to the demands his company imposed… Several of his contemporaries had written letters to their state’s Board Of Pharmacy to alert them of these dangerous situations, but every letter had gone unanswered and ignored… On one particular night, the manager was working, and the customers were milling around and waiting impatiently for their Rxs… The “manager” could feel their eyes on him and felt the stress tightening his neck muscles, his chest, and his headache was roaring… He completed a 5 year old girl’s Rx order hurriedly, called her name, handed it to the technician, and her parents paid for it at the ultra slow register and left… The “manager” and his staff still had tons of work to complete because they were so shorthanded from his following of the understaffing requirements… The understaffed employees worked until closing, locked up the pharmacy, and went home to sleep to prepare for the next day… Of course, all the employees were so stressed out and wound up, they did not sleep well at all… The next morning began even more hectic than the previous day… The phone rang and the “manager” picked up the call… An emergency room Dr. was on the line and wanted to discuss the prescription that the 5 year old girl’s parents had picked up the night before… It had been filled for 10 times the recommended dosage, and the girl had died at the hospital during the night…
So shame on that corporation… Shame on them for putting their shareholders’ wants ahead of their patient’s safety… Shame on their Board Of Pharmacy for ignoring the pleas of the pharmacists who cared… And shame on that “manager” for following the demands of an uncaring corporation and for letting this unfortunate chain of events happen…
Broward County is going after opioid manufacturers it blames for the epidemic that has ravaged communities — and large pharmacy chains that it says were too ready to fill even questionable prescriptions for the drugs.
The county filed suit Monday in federal court against 19 companies in the opioid suit, including manufacturers such as Purdue Pharma, Cephalon and Teva Pharmaceuticals and pharmacies such as Walgreens, Walmart and CVS.
The complaint alleges deceptive and unfair trade practices, public nuisance, negligence, unjust enrichment and racketeering.
Broward, like many other local governments across the country, is suing or considering suing the companies because of the large costs incurred as the opioid epidemic taxes local police and emergency medical services. About 200 suits, including one by Delray Beach, have been filed nationally.
Palm Beach County this week selected a legal team to pursue its suit.
The prescriptions are for brand-name medications like OxyContin, Opana, Subsys, Fentora and Duragesic. Generic versions included oxycodone, methadone and fentanyl.
Overdose deaths have skyrocketed with the popularity of opioids, including heroin and super-potent synthetic versions of the drug.
“The overdose epidemic is estimated to have claimed more than 900 lives in South Florida in 2016 alone, including 582 drug deaths in Broward County,” the suit said. By the end of 2016, 10 people a week were losing their lives in Broward County to overdoses and another 17 a week had non-fatal overdoses, with most related to heroin, fentanyl and other opioids, according to the suit.
The suit says the opioid manufacturers misled the public for more than 20 years about the dangers of opioid addiction and problems with its long-term use. It alleges fraudulent activity on their part, saying they paid “front organizations” that published false and misleading marketing materials.
The suit seeks to stop the manufacturers from making any further false or misleading statements regarding opioids and to assure that pharmacies will report suspicious prescriptions. The county is seeking more than $75,000 in damages — including punitive damages — for injuries it sustained because of the epidemic.
Drug makers have denied wrongdoing. With the onslaught of legal action against them, they say they have made efforts to stem diversion of their pain medications into the black market.
