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Senator introduces bill to end PBM drug rebates in commercial plans
Posted on March 8, 2019 by Pharmaciststeve
Senator introduces bill to end PBM drug rebates in commercial plans
The Trump administration has made moves to eliminate drug rebates in federal payers, and now, thanks to a bill introduced in Congress on Wednesday, such contracts in the commercial sector are also on the chopping block.
Sen. Mike Braun, R-Ind., introduced the Drug Price Transparency Act alongside two other bills aimed at lowering drug prices. The bill looks much like the Department of Health and Human Services’ plan: prohibit pharmacy benefit managers from receiving rebates from drug companies and instead require that such discounts be passed directly on to consumers.
Braun also introduced legislation to clear the Food and Drug Administration’s approval backlog and boost transparency.
“I’m offering solutions to address rising healthcare prices by adding transparency to our drug pricing, clearing the backlog on pending drug applications at the FDA and providing oversight and accountability in the healthcare industry,” Braun said.
HHS unveiled its plan to nix the rebates in January, and in the proposed rule it said it intended to eliminate anti-kickback protections to rebates negotiated by PBMs and instead offer the protections to point-of-sale discounts.
HHS Secretary Alex Azar said when the agency’s proposal on the matter was unveiled that he hoped Congress would follow suit to ensure it was extended nationwide. And even if legislators hadn’t acted, the administration expected that its rule would have ripple effects beyond Medicare.
JC Scott, president of the Pharmaceutical Care Management Association, a PBM trade group, said in a statement that the legislation doesn’t target the true culprit in high drug prices: pharmaceutical companies.
“The legislation appears to do absolutely nothing to address the root cause of the problem: the high list prices that only the drug manufacturers have the power to set,” Scott said. “Despite drug manufacturers’ rhetoric, their pricing strategies are unrelated to the rebates they negotiate with PBMs.”
The bill comes on the heels of a House hearing in which executives at some of the largest drug companies backed eliminating drug rebates.
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HOW TO BUY A ROLEX AT RETAIL
Posted on March 8, 2019 by Pharmaciststeve
HOW TO BUY A ROLEX AT RETAIL
Buying a Rolex watch at retail has always been somewhat of an event. Back in the good old days, it usually meant that you were celebrating something (even if you were just celebrating yourself). However, buying a Rolex at retail is now considered an occasion simply because it means that you were lucky enough to get a call from your authorized dealer telling you that the wait is finally over and that you can finally purchase the watch that you want. Check more from these fake rolex deals.
People often talk about the dreaded “waitlist” in regards to Rolex watches and their retail availability, but there are a lot of misconceptions about how allocation is actually determined. While it is certainly true that global demand far exceeds supply, buying a Rolex at retail isn’t actually completely impossible – assuming that you are a genuine enthusiast who is interested in owning the watch, rather than someone who is simply interested in flipping it for a quick profit. Nothing in life is certain (especially when it comes to the retail availability of luxury watches), but here’s how to buy a Rolex at retail.
LUXURY AND AVAILABILITY
Before we actually get into how to go about buying a Rolex at retail, it might be worth taking a brief moment to discuss the concept of luxury as it pertains to retail availability. I definitely understand where some people are coming from when they say that a luxury purchase should not involve having to cultivate a relationship with your dealer or spend any amount of time on a waiting list.
To a certain degree, I do agree with that sentiment. A luxury purchase is more than just receiving a premium item in exchange for a decent chunk of change. The process itself should feel luxurious, and (at least in my opinion) a “luxury” experience doesn’t involve being told that you need to wait, nor does it involve buying other items so that you can create a purchase history with your retailer.
However, regardless of our personal sentiments about what constitutes a luxury experience, there is an overwhelming global demand for Rolex watches, and not everyone who wants to buy one is going to be able to get one in a timely manner. I think everyone (including the staff members who work at your local retailer or boutique) would prefer if anyone who wanted a Rolex could simply purchase the watch of their choice (after all, selling watches is how they make money). However, the simple fact that global demand far exceeds supply means that there’s a shortage at a retail level, and whether you like it or not, you’re going to need some relationship with your authorized retailer if you want to buy a brand-new Rolex.
THERE ISN’T ACTUALLY A LIST
Now, I hate to be the one to break this to you, but there isn’t actually a Rolex waiting list. When people say they are on the “waitlist” or that they are waiting for their name to come up at their dealer, they really just mean that they are still waiting for their retailer to be able to allocate them a watch.
There isn’t a master list at Rolex’s headquarters in Geneva with all of the names of everyone who has ever asked an authorized dealer for a Rolex. Not only would that be impossible to track and enforce on a global level, but what would it even look like? A giant scroll of golden paper that is locked away behind a green door with your name printed next to the words, “Pepsi GMT-Master II” – absolutely not. That sounds a bit like what Santa Clause does up at the North Pole, which also happens to be pure fantasy.
While the global allocation of watches to its retail network is determined by Rolex, the actual allocation of watches to consumers is often left to the individual retailer. Rolex does have certain policies, guidelines, and rules for its retailers, but Rolex headquarters is not the one who decides whether or not you get your stainless steel Daytona. That being said, it’s also not like the retailers are just sitting on an unlimited number of stainless steel Rolex sports watches and are just being stingy with the distribution of them. They more-or-less receive what Rolex gives them, and have to then decide who actually gets one.
While a first come, first serve policy might seem like it would be the most fair, it would actually be an absolute nightmare. Everyone complains about all of the people who don’t even like watches and only want to buy a Rolex so that they can sell it for a profit (I know, I hate them too). However, if Rolex were to adopt a first come, first serve policy, it would only mean that an even greater percentage of the available watchers would end up in the hands of these people, rather than genuine enthusiasts who actually want to own the watch. It’s easy to be frustrated with Rolex, but the company and all of its retailers (for the most part) are truly trying their best to make everyone happy.
DON’T BE AN ENTITLED JERK
Not being an entitled jerk is something that should apply to all aspects of life, and that even includes when it comes time to splurge and buy yourself a luxury timepiece. I completely understand that it can be frustrating to save up for your dream watch and then not be able to purchase it once you finally have the means to buy it. However, it’s important to remember that it is not your retailer’s fault that global demand exceeds supply, so you certainly shouldn’t take out your frustrations on the staff members who work there, and who genuinely would love to sell you the watch of your dreams if only they had one available.
We all know that there are some people out there who don’t often hear the word “no” and they can sometimes turn into truly flagrant trash-humans when they don’t get what they want. Acting like an entitled jerk isn’t a good look for anyone, and it certainly isn’t going to win over the boutique staff and magically get Rolex to start producing more watches.
You haven’t been able to walk into a Rolex boutique and buy the model you want for several years now, and that isn’t likely to change any time soon. Just because you can afford something doesn’t mean that you are free from common courtesy, and it’s important to remember that regardless of whether or not they are able to provide you with what you want in a timely fashion, you and your dealer have the exact same goal: they want to sell you a watch.
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Sgt. Robert Rose Jr. (Ret.) on why he filed a $350 million lawsuit against the VA
Posted on March 8, 2019 by Pharmaciststeve
Filed under: General Problems | 5 Comments »
The US Food and Drug Administration (FDA) Is Requesting Input From The Public On The Re-Scheduling of Cannabis, aka (Marijuana) Delta 9, THC and CBDs. The Comment Period Ends 11:59 14 March 2019
Posted on March 8, 2019 by Pharmaciststeve
The US Food and Drug Administration (FDA) Is Requesting Input From The Public On The Re-Scheduling of Cannabis, aka (Marijuana) Delta 9, THC and CBDs. The Comment Period Ends 11:59 14 March 2019
Summary
The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments about the World Health Organization (WHO) recommendations to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States’ position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA).
Dates
Submit either electronic or written comments on the notice by March 14, 2019. The short time period for the submission of comments is needed to ensure that the U.S. Department of Health and Human Services (HHS) may, in a timely fashion, carry out the required action and be responsive to the United Nations.
Addresses
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 14, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.”
This notification reflects the recommendation from the 41st WHO Expert Committee for Drug Dependence (ECDD), which met in November 2018. In the Federal Register of October 10, 2018 (83 FR 50938), FDA announced the WHO ECDD review and invited interested persons to submit information for WHO’s consideration.
The following recommendations regarding the review of cannabis and cannabis-related substances are as follows:
Recommendation 5.1: The Committee recommended that Cannabis and Cannabis Resin be deleted from Schedule IV of the 1961 Single Convention on Narcotic Drugs.
Recommendation 5.2.1: The Committee recommended that dronabinol and its stereoisomers (delta- 9-tetrahydrocannabinol) be added to Schedule I of the 1961 Single Convention on Narcotic Drugs.
Recommendation 5.3.1: The Committee recommended that tetrahydrocannabinol (understood to refer to the six isomers currently listed in Schedule I of the 1971 Convention on Psychotropic Substances) be added to Schedule I of the 1961 Single Convention on Narcotic Drugs, subject to the Commission’s adoption of the recommendation to add dronabinol (delta-9-tetrahydrocannabinol) to the 1961 Single Convention on Narcotic Drugs in Schedule I.
Recommendation 5.4: The Committee recommended deleting Extracts and Tinctures of Cannabis from Schedule I of the 1961 Single Convention on Narcotic Drugs.
Recommendation 5.5: The Committee recommended that a footnote be added to Schedule I of the 1961 Single Convention on Narcotic Drugs to read: “Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control.
Recommendation 5.6: The Committee recommended that preparations containing delta-9-tetrahydrocannabinol (dronabinol), produced either by chemical synthesis or as a preparation of cannabis, that are compounded as pharmaceutical preparations with one or more other ingredients and in such a way that delta-9-tetrahydrocannabinol (dronabinol) cannot be recovered by readily available means or in a yield which would constitute a risk to public health, be added to Schedule III of the 1961 Convention on Narcotic Drugs.
It is now time for ACTION to #ENDtheMADNESS
Here is your opportunity to make a difference. The short timeline is restrictive but we must deal with it. If you want to change it takes action.
Remember;
If You Do NOTHING, NOTHING will Be Done!
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stage 4 pancreatic cancer has a < 5% 5 yr survival rate
Posted on March 7, 2019 by Pharmaciststeve
He has stage 4 pancreatic cancer and this is the insanity they put him through here !!! As someone called the police claiming to have “Smelt” Marijuana in his hospital room, He didn’t have any marijuana and had taken THC oil in a capsule while outside. And his doctors were aware of it
Nolan’s Tribe of Warriors Against Cancer
stage 4 pancreatic cancer has a < 5% 5 yr survival rate
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More than 1,000 accidental drug intoxication deaths in Connecticut in 2018
Posted on March 7, 2019 by Pharmaciststeve
More than 1,000 accidental drug intoxication deaths in Connecticut in 2018
(WTNH) – More than 1,000 people died from accidental drug intoxication in 2018.
This statistic comes from the Office of the Chief Medical Examiner.
According to the office, 948 of the 1017 deaths involved an opioid, while 760 involved fentanyl.
The total number of deaths marks a small drop from 2017, when 1,038 people from Connecticut died from accidental drug intoxication.
However, it is still a sharp increase from 2012 when that number was 357.
Below is a town-by-town list of accidental opioid overdose deaths in the state for 2018 using data from the Office of the Chief Medical Examiner.
| City or town | Number of people who died from accidental opioid overdose in city or town |
| Andover | N/A |
| Ansonia | 3 |
| Ashford | 1 |
| Avon | N/A |
| Barkhamsted | N/A |
| Beacon Falls | 1 |
| Berlin | 1 |
| Bethany | N/A |
| Bethel | 2 |
| Bethlehem | 1 |
| Bloomfield | 2 |
| Bolton | 1 |
| Bozrah | N/A |
| Branford | 9 |
| Bridgeport | 58 |
| Bridgewater | N/A |
| Bristol | 26 |
| Brookfield | N/A |
| Brooklyn | N/A |
| Burlington | 2 |
| Canaan | N/A |
| Canterbury | 1 |
| Canton | 2 |
| Chaplin | N/A |
| Cheshire | 1 |
| Chester | 1 |
| Clinton | 6 |
| Colchester | 4 |
| Colebrook | N/A |
| Columbia | 1 |
| Cornwall | N/A |
| Coventry | N/A |
| Cromwell | 2 |
| Danbury | 18 |
| Darien | N/A |
| Deep River | N/A |
| Derby | 10 |
| Durham | 1 |
| East Granby | N/A |
| East Haddam | N/A |
| East Hampton | 1 |
| East Hartford | 17 |
| East Haven | 4 |
| East Lyme | N/A |
| East Windsor | 2 |
| Eastford | 2 |
| Easton | N/A |
| Ellington | 2 |
| Enfield | 11 |
| Essex | 2 |
| Fairfield | N/A |
| Farmington | 3 |
| Franklin | N/A |
| Glastonbury | 2 |
| Goshen | 1 |
| Granby | N/A |
| Greenwich | 2 |
| Griswold | 1 |
| Groton | 9 |
| Guilford | 1 |
| Haddam | N/A |
| Hamden | 8 |
| Hampton | N/A |
| Hartford | 128 |
| Hartland | N/A |
| Harwinton | N/A |
| Hebron | 1 |
| Kent | N/A |
| Killingly | 1 |
| Killingworth | N/A |
| Lebanon | 1 |
| Ledyard | 1 |
| Lisbon | 1 |
| Litchfield | 1 |
| Lyme | N/A |
| Madison | 1 |
| Manchester | 23 |
| Mansfield | 1 |
| Marlborough | 3 |
| Meriden | 22 |
| Middlebury | 3 |
| Middlefield | N/A |
| Middletown | 17 |
| Milford | 11 |
| Monroe | 2 |
| Montville | N/A |
| Morris | N/A |
| Naugatuck | 7 |
| New Britain | 52 |
| New Canaan | 1 |
| New Fairfield | N/A |
| New Hartford | 2 |
| New Haven | 69 |
| New London | 22 |
| New Milford | 5 |
| Newington | 2 |
| Newtown | 1 |
| Norfolk | 1 |
| North Branford | N/A |
| North Canaan | N/A |
| North Haven | 2 |
| North Stonington | N/A |
| Norwalk | 10 |
| Norwich | 18 |
| Old Lyme | 2 |
| Old Saybrook | 2 |
| Orange | N/A |
| Oxford | N/A |
| Plainfield | 3 |
| Plainville | 2 |
| Plymouth | 1 |
| Pomfret | N/A |
| Portland | 4 |
| Preston | N/A |
| Prospect | N/A |
| Putnam | 5 |
| Redding | 1 |
| Ridgefield | 1 |
| Rocky Hill | 2 |
| Roxbury | N/A |
| Salem | 1 |
| Salisbury | N/A |
| Scotland | N/A |
| Seymour | 4 |
| Sharon | 1 |
| Shelton | N/A |
| Sherman | N/A |
| Simsbury | N/A |
| Somers | N/A |
| South Windsor | N/A |
| Southbury | 1 |
| Southington | 4 |
| Sprague | N/A |
| Stafford | 1 |
| Stamford | 13 |
| Sterling | 2 |
| Stonington | N/A |
| Stratford | 11 |
| Suffield | 1 |
| Thomaston | 2 |
| Thompson | N/A |
| Tolland | 3 |
| Torrington | 26 |
| Trumbull | 1 |
| Union | N/A |
| Vernon | 10 |
| Volluntown | N/A |
| Wallingford | 4 |
| Warren | N/A |
| Washington | N/A |
| Waterbury | 77 |
| Waterford | 1 |
| Watertown | 8 |
| West Hartford | 7 |
| West Haven | 5 |
| Westbrook | 2 |
| Weston | 1 |
| Westport | 1 |
| Wethersfield | 5 |
| Willington | 1 |
| Wilton | N/A |
| Winchester | N/A |
| Windham | N/A |
| Windsor Locks | 2 |
| Wolcott | 1 |
| Woodbridge | N/A |
| Woodbury | N/A |
| Woodstock | 1 |
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research found actually the smaller independent pharmacies really consistently offered cheaper options for the same medications
Posted on March 7, 2019 by Pharmaciststeve
The price of the same prescription drug can vary by hundreds or even thousands of dollars, depending on where you buy it, according to a new report by the U.S. Public Interest Research Group which surveyed hundreds of pharmacies and found large price differences for identical medications.
Nearly one in four Americans struggle to pay for their medications and this year already, more than 250 prescription drugs have seen price hikes averaging 6 percent, according to an analysis by RX Savings Solutions.
Adam Garber is the consumer watchdog for the U.S. PIRG. The group surveyed more than 250 pharmacies across the country for the cash prices of common medications, the price someone pays if they don’t have insurance or are under-insured and do not qualify for coupons or savings programs sometimes offered by drug manufacturers.
“These real price variations we’re seeing have huge health consequences for Americans,” Garber told CBS News’ Anna Werner. “These prices are often how they determine how much insurers are going to pay for the drugs … it sort of sets the whole pricing scheme up.”
The study found consumers could save anywhere from $100 to $5,400 a year just by price shopping. In Ohio, they found the same inhaler being sold for $11.99 at one pharmacy and $1,136 at a different pharmacy. In North Carolina, a generic medicine to lower cholesterol could cost $7 or $393 depending on where it was purchased.
“You expect like when you go to the bigger pharmacy you’ll get a better deal, but our research found actually the smaller independent pharmacies really consistently offered cheaper options for the same medications,” Garber said.
Like 30 million other Americans with diabetes, Brianna Hamilton needs insulin to stay alive. Last year, she says she paid $60 for a 90-day supply of NovoLog pens, the brand of insulin she uses. But then her insurance coverage changed this year.
“Anytime I eat anything, even with a small amount of sugar in it, I have to take insulin or my blood sugar goes really high, I could end up in a coma and I could be dead,” Hamilton said. “I showed up at the pharmacy to pay for my 90-day supply and it was $1,400.”
Hamilton said the two types of insulin she uses as well as supplies, like needles and testing strips, will now cost her $1,000 per month, even with a coupon from the manufacturer until she hits her new insurance plan’s $3,000 deductible.
“It’s one of those things where I try to do everything right financially. You know, get my degree, get a good job and I still … If I don’t like cut back on a lot of stuff, I could be homeless. Or dead without my insulin and that’s not fair,” Hamilton said.
Stephen Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, said, “At all levels of the marketplace from the manufacturer to the wholesaler, to the retailer, and then to the insurer and the pharmacy benefit manager, they all kind of hide the prices and don’t like to make their prices transparent or known to anyone.”
The National Association of Chain Drug Stores told us in a statement that cash transactions only account for eight percent of prescriptions written and “these prices vary according to many factors, including: the exact time when the drugs were purchased from the supplier; fluctuations in product supply and thus pharmacies’ costs; and other factors throughout the entire supply chain.”
It also says surveys like U.S. PIRG’s don’t take into account “widely prevalent savings programs” made available to patients who pay cash. But Schondelmeyer said big chains take advantage of their name recognition and “charge higher prices typically than your medications would cost at the local independent pharmacy.”
Brianna Hamilton said her family will cut back more and possibly move until her deductible kicks in.
In response to growing concerns, Eli Lilly announced on Monday it will start selling a cheaper, generic insulin. Novo Nordisk, the company that makes the brand of insulin Hamilton uses, told CBS News they “want to find additional solutions that address access and affordability” of their medications.
Some tips for getting the best price on your medications include calling multiple pharmacies, both large and small, to compare costs and asking for prices with insurance as well as cash prices. It’s also important to consult with your doctor about generic options and check out websites that do cost comparisons with drugs.
In a statement to CBS News, B. Douglas Hoey, the CEO of the National Community Pharmacists Association, said, “We really can’t speculate why certain large chains are significantly more expensive, but community pharmacies answer to citizens on Main Street, not shareholders on Wall Street.”
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Doctors and insurers are using federal guidelines as cover to turn away patients, experts tell the C.D.C. and Congress.
Posted on March 7, 2019 by Pharmaciststeve
Doctors and insurers are using federal guidelines as cover to turn away patients, experts tell the C.D.C. and Congress.
www.nytimes.com/2019/03/06/health/opioids-pain-cdc-guidelines.html#commentsContainer
Three years ago this month, as alarms about the over-prescription of opioid painkillers were sounding across the country, the federal government issued course-correcting guidelines for primary care doctors. Prescriptions have fallen notably since then, and the Trump administration is pushing for them to drop by another third by 2021.
But in a letter to be sent to the Centers for Disease Control and Prevention on Wednesday, more than 300 medical experts, including three former White House drug czars, contend that the guidelines are harming one group of vulnerable patients: those with severe chronic pain, who may have been taking high doses of opioids for years without becoming addicted. They say the guidelines are being used as cover by insurers to deny reimbursement and by doctors to turn patients away. As a result, they say, patients who could benefit from the medications are being thrown into withdrawal and suffering renewed pain and a diminished quality of life, even to the point of suicide.
The letter writers form an uneasy alliance spanning differing positions on opioids — professors of addiction medicine as well as pain specialists, some patient representatives who have taken money from the pharmaceutical industry, and the former drug czars, from the Obama, Clinton and Nixon administrations.
Michael Botticelli, who served as the drug czar under President Obama and now leads the Grayken Center for Addiction at Boston Medical Center, said he signed the letter because “there has been enough anecdotal evidence to raise the alarm bells” about the misuse of the guidelines leading to pain patients losing effective treatment.
“The C.D.C. really does need a rigorous evaluation of this because we don’t know how big the problem is,” he said. “Minimally, we need some level of clarification on appropriate use of the guidelines.”
Specifically, the letter asks the C.D.C. to emphatically state that treatment decisions for these patients be left to their doctors.
“It is imperative that health care professionals and administrators realize that the guideline does not endorse mandated involuntary dose reduction or discontinuation,” the group wrote in the letter, which it also sent to members of relevant congressional committees.
A spokeswoman for the C.D.C., Julie Eschelbach, said the guidelines “do not endorse mandated or abrupt dose reduction or discontinuation.” She added that the agency has several studies underway to examine the guidelines’ impact, and has published a “pocket guide” for doctors on tapering.
The guidelines are nonbinding, but many of them have become enshrined in state regulations. Therefore, said Dr. Stefan G. Kertesz, an author of the letter who teaches addiction medicine at the University of Alabama at Birmingham, “it’s normal to say from the top: ‘This needs a clarification because we don’t want people hurt.’”
Others say the problem lies not with the guidelines, which urge non-opioid therapies as the first-line treatment for chronic pain, but with their misapplication.
“What the guidelines are being blamed for versus what they actually recommend are two different things,” said Dr. Thomas R. Frieden, who ran the C.D.C. when the guidelines were developed.
Experts in addiction medicine distinguish patients who need opioids for chronic pain from people addicted to the drugs: while some patients are physically dependent and will go into withdrawal if the drugs are withheld, the opioids help them function, despite severe pain.
“But just because you’re on a higher dose doesn’t mean you’re addicted,” said Dr. Daniel P. Alford, a professor who directs addiction medicine education at the Boston University School of Medicine, who signed the letter.
Addiction, he said, is “a behavioral maladaptation where the medication takes over their lives, and they continue to use despite negative consequences.”
The guidelines say doctors should discuss the costs of a high-dose regimen with pain patients and press for a prudent taper. They do not say those patients’ drugs should be summarily reduced. They advise doctors to prescribe opioids to new patients only for a short time, and with a daily dose below 90 morphine milligram equivalents. That recommendation has prompted many states and monitoring systems to impose a hard stop at that level for all patients except those with cancer or in end-of-life care.
“Who says that 90 is a magical threshold?” Dr. Alford asked. “There’s no good evidence. Yes, we should avoid escalating doses, but how do we treat people who are already on high doses?”
Dr. Frieden defended 90 M.M.E., as the measurement is known, as a responsible ceiling. “The death rates just go up exponentially,” he said, for people on very high doses of opioids.
Dr. Frieden said more doctors should be allowed to get federal permission to prescribe buprenorphine, a lower-risk opioid drug that can effectively manage opioid dependence while treating pain, as an alternative to more dangerous painkillers.
(Dr. Frieden was charged last summer with groping a woman; he pleaded not guilty and the case is still pending.)
The letter to the C.D.C. echoes a November resolution by the American Medical Association, which protested the “misapplication” of the guidelines “by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia.”
A central question is how many patients have suffered from their doses being reduced or from being taken off opioids entirely. A report by the inspector general at the Department of Health and Human Services estimated that in 2016 about 500,000 beneficiaries of Medicare drug plans had been getting prescriptions of 120 M.M.E. or greater for three months or longer — a figure that doesn’t fully capture the current affected population.
Accompanying the experts’ letter are testimonials by hundreds of pain patients detailing struggles in the wake of the guidelines.
The opioid prescribing rate has been falling since 2012, but the amount prescribed per person is still about three times higher than it was in 1999, at the beginning of the addiction crisis, according to the C.D.C. While overdose deaths because of prescription opioids have begun leveling off, deaths from illicit fentanyl and its analogues increased by more than 45 percent in 2017 alone, a phenomenon that the letter writers attribute in part to the crackdown on pain pill prescriptions.
Dr. John Brooklyn, who runs two large addiction treatment programs in Vermont, gave one example. A 61-year-old patient, disabled by a back injury, had been functioning well for years on 225 M.M.E., he said. Invoking the guidelines, his pain doctor started cutting his dose by 40 milligrams a month.
“When he was at 120 M.M.E.,” said Dr. Brooklyn, “he was in such severe pain that he was buying opioids on the street. He barely ate, lost 40 pounds, couldn’t pay rent and then turned to cheap heroin. His doctor continued to reduce his dose and, at 30 M.M.E., the patient called our program.”
Dr. Brooklyn put the patient on methadone, a type of opioid approved to treat addiction as well as to manage chronic pain. “It was like watering a dehydrated plant,” he said.
Dr. Joanna L. Starrels, an associate professor of medicine at Albert Einstein College of Medicine and one of the experts who helped draft the C.D.C. guidelines, said chronic pain patients are an especially fragile group. “Some with severe persistent pain are barely getting by,” she said. “They are sometimes homebound, unable to work or fully participate in most of the rewarding aspects of life.” Their rates of depression are high, she said, and they have few reliable treatment alternatives.
Research that looks at the effect of dose reduction on such patients is in its infancy, she said.
In fact the guidelines include a plea for research to evaluate their efficacy.
That the guidelines have had widespread impact is not in question. While a handful of hospital systems and states had adopted opioid prescription limits before 2016, the number of institutions have since shot up.
In its annual survey of hospital-based pharmacies last year, the American Society of Health-System Pharmacists asked about opioid monitoring for the first time. In preliminary results, 41 percent said they had done so and some cited the C.D.C. guidelines.
By the end of 2016, seven states had passed legislation limiting opioid prescriptions; by October 2018, 33 states had enacted laws with some type of limit, guidance or requirement related to opioids, according to the National Conference of State Legislatures.
Aetna, one of the country’s largest health insurers, placed a limit of 90 M.M.E.s per day on its members last year based on the C.D.C. guidelines, said Ethan Slavin, a company spokesman. The stricter daily limits “are part of our efforts to help reduce the potential for misuse and diversion of the drugs,” he said, adding that prescribers who believe higher doses are needed can seek special permission by consulting with Aetna’s experts.
A study last year found that insurers overall were not doing enough to increase access to alternative pain treatments, including therapeutic massage, acupuncture and non-opioid drugs.
Dr. Anna Lembke, medical director of addiction medicine at Stanford, declined to sign the letter, saying the guidelines were sufficiently moderate.
The remedy to the problems detailed in the letter, she said, was to educate primary care doctors about how to provide “safe, compassionate, patient-centered tapers when medically indicated,” which can be a protracted, delicate process.
Dr. Kertesz acknowledged that tapering was a worthy goal. “But more typically what we are seeing,” he said, “are people who report non-consensual tapers.”
Correction:
An earlier version of this article misstated Dr. Thomas Frieden’s views on the C.D.C. guidelines for opioid prescriptions. He said higher doses greatly increase risk; he did not say they were not worth the risk.
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patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit
Posted on March 7, 2019 by Pharmaciststeve
Clients shrug as FDA slams Canadian firm shipping cheap drugs to U.S.
The FDA has again lashed out at a Canadian company that it has been feuding with for more than a decade for helping U.S. consumers get drugs on the cheap. Its clients, however, are shrugging off the warning that the products they have been buying for years might not meet U.S. standards.
The FDA last week slapped a warning letter on CanaRx for hooking U..S. consumers up with Canadian pharmacies to buy at discounted prices drugs that range from cancer drug Gleevec to HIV drug Truvada.
While the agency acknowledged that the Canadian “first-class drug regulatory process” assures high-quality drugs that come from the country’s pharmacies, it said there is no guarantee drugs that come through Canadian websites have been vetted by Canadian regulators.
“Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit.,” the FDA said.
Consumers for years have crossed the border to buy drugs. In 2003 CanaRx was formed to provide mail-order service from Canada for public employee health plans in states that include Illinois, Vermont and Rhode Island and elsewhere.
An attorney for the company said the FDA has mischaracterized the CanaRx business model and operating protocols, and that it intends to continue to serve its U.S. clients.
One of those clients, Schenectady County, New York, defended the Canadian company that it has worked with for 15 years.
“This is a good program, and on the merits it looks lawful, and they are not doing the terrible things that the FDA is suggesting,” County Attorney Chris Gardner told Kaiser Health News.
He said about a quarter of the county’s 1,200 employees get their drugs from the Windsor, Ontario, company with no co-pays and that the program saved the county about $500,000 last year. He said the county will see how the situation plays out, but for now the program is being kept in place.
The FDA’s warning letter and announcement came after Florida Governor Ron DeSantis claimed he had President Trump’s backing to start a program to import drugs from Canada. Kaiser Health said that White House officials have chimed in since then that Florida would need approvals from state and federal officials to launch such a program.
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