Pharmacies warned to observe opioid regulations

Posted on July 24, 2017 by Pharmaciststeve

Pharmacies warned to observe opioid regulations

https://www.abqjournal.com/1037063/pharmacies-ripe-for-liability.html

Between May and November 2009, the teenager filled numerous prescriptions for Oxycodone and Oxycontin at a New Mexico pharmacy. The prescriptions were all valid, signed by a licensed physician.

If the teenager had been taking the opioids as directed, each prescription would have been sufficient for a certain number of days. But often the teenager arrived at the pharmacy with a new prescription before the last one should have run out. At least some of the prescriptions bore notations saying “OK to fill early” or words to that effect. Seven times over the course of four months the pharmacy filled prescriptions early.

The teenager’s prescriptions were covered by Medicaid, so she could get the pills for free – if she waited. Medicaid didn’t permit early fills. But that financial incentive wasn’t always enough to make her wait. In September, she paid $1,107 in cash to fill a script early. The next month, she again offered to pay cash, just three days before she would have received the same pills for free. That time, the pharmacy called the doctor to make sure the early fill was really okay.

On top of pain medication, the teenager was also filling prescriptions for Alprazolam, an anti-anxiety drug. According to WebMD, Alprazolam can slow a person’s breathing, an effect potentially magnified if the drug is taken with opioids. The Court of Appeals’ recent opinion in the case, from which I’m drawing these facts, is blunt: “When used in conjunction with other CNS depressants (such as Oxycontin and Oxycodone), Alprazolam can be toxic even at low concentrations.”

As you’ve probably guessed, this story doesn’t end happily. The teenager died of “multiple drug toxicity” on December 1, 2009, just 19 years old.

As the Court of Appeals notes, “The nation’s ongoing ‘opioid crisis’ (is) the subject of news reports and commentary almost daily.” The Journal of the American Medical Association reports that “the amount of opioids prescribed in 2015 [was] more than 3 times higher than in 1999.” 2015 saw 33,091 opioid-overdose deaths in the U.S., about half involving prescription drugs. With so much suffering, there is plenty of blame to go around. The teenager’s estate sued the doctor and the doctor’s clinic, and also added claims against the pharmacy.

The pharmacy’s argument against legal liability was straightforward. The prescriptions it filled were signed by licensed physicians and in every way valid. It’s not a pharmacist’s job to second-guess a doctor’s treatment decisions. Imagine how obnoxious it would be if the person behind the counter said, “Well, I disagree with your doctor about this choice of medication. I’m not going to fill your prescription.” A pharmacist who did that would arguably be practicing medicine without a license, and that’s a felony offense. A pharmacist’s paramount professional responsibility is simply to fill legitimate prescriptions with scrupulous accuracy, which the pharmacy did.

The teenager’s estate argued that more is required of a pharmacy. Its argument was supported by the state Board of Pharmacy’s regulations. Under the regulations, a pharmacist is required to be alert for signs of “clinical abuse/misuse” of opioids. Specifically, pharmacists should be suspicious whenever a patient fills an opioid prescription early or pays cash despite the existence of insurance, two things the teenager in this case did repeatedly. Once suspicions are aroused, the pharmacist is required to obtain the patient’s prescription history (known as a PMP report). And then? The regulations require the pharmacist to exercise professional judgment to decide whether to consult with the doctor or counsel the patient, and to document the decision-making process. No more forceful intervention is required.

The Court of Appeals agreed with the teenager’s estate that the standard of care owed by all New Mexico pharmacists to their patients includes strict compliance with the regulations. And the record before it did not reveal whether the pharmacy had complied in this case. That’s because the trial judge decided the case before trial on an incomplete factual record. In reversing the grant of summary judgment, the Court of Appeals didn’t find the pharmacy liable but only sent the case back to the trial court for more evidence. Specifically, the trial court was to determine whether the pharmacy did, in fact, take the steps laid out in the regulations. Even if the pharmacy fell short, a serious question would remain whether the lack of a PMP report and follow-up documentation really contributed in any meaningful way to the teenager’s sad end.

While this particular case continues, New Mexico’s other pharmacies are reminded that strict compliance with the opioid regulations can be an effective antidote to claims of legal liability.

If there are topics you would like to see Joel Jacobsen cover in future columns, please write him at legal.column.tips@gmail.com

Filed under: General Problems | 1 Comment »

Share your denial of adequate pain therapy/care: email dsapatkin@phillynews.com

Posted on July 24, 2017 by Pharmaciststeve

‘I am the other side of the opiate crisis’

http://www.philly.com/philly/health/addiction/pain-patient-speaks-out-on-opioids-20170607.html

Lynn Frank, 64, of Northeast Philadelphia, a former records and information manager at a law firm, experienced a serious foot injury in a car accident 12 years ago and was later diagnosed with CRPS/RSD (Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy), a chronic neuro-inflammatory disorder.

 If you have had a similar reaction to opioid painkillers – they provided clear relief for pain but have become difficult to obtain due to actions intended to prevent addiction – and want to publicly share your story, please email staff reporter Don Sapatkin.

The opiate crisis is finally getting the recognition it should. It destroys families, increases crime, and causes heartbreak. People in all socioeconomic groups legally and illegally obtain and use these drugs.

 

I cry when I hear about deaths that should have never happened. I weep when babies are born addicted. I mourn when I read about families forever destroyed by the loss of a teenager or young adult.

But there is another side to this problem that you have not read about and may not have considered. My side.

I stand with other chronic pain sufferers off in the shadows. We have been forgotten. No research. No treatment. Now there are laws and a movement of public outcry condemning opioid use. Our pain medicine is being taken from us. We have been treated without compassion, humiliated, stripped of dignity. People don’t understand that we are not abusers but simply seek temporary relief from our endless pain. We are always tired, often depressed, and feeling hopeless. We are just trying to overcome the obstacles our bodies have presented to us. We are made to feel shame because we need to use pain medicine to cope with everyday life.

 

I stand in the shadows, sit, and watch. I usually don’t have the energy to do much more than lie in bed. Every movement can cause pain. Bright lights can bring on a headache; any touch to my skin can cause pain. I often keep to myself because my illness is not understood and I don’t usually look ill. I’m told that I am a hypochondriac, drama queen, socially inept, not responsible for keeping commitments. People — especially those who are closest to me —  don’t take the time to educate themselves and to understand my illness.

And so depression will often seep in, along with a decreasing sense of self worth. I am a mother and a grandmother. Having to take a urine test in order to get a one-month prescription of pain medicine that my doctor agrees I need is embarrassing. Having to visit the doctor every month in order to get that prescription takes away the little energy I have. Not being able to physically pick up my grandchildren — or have the energy to visit with them — is a defeat that means I have lost. Pain affects everything: thought, relationships, sleep … every aspect of my life.

Now I need to speak up. Will you hear me?

I am the other side of the opiate crisis. I am not an addict. I take pain medication to function at a minimal level and not allow my chronic pain get the better of me. It lets me feel normal for a short time every day. I never feel “high” from taking it, just almost “normal.” It allows me to focus and to do simple tasks that I could not otherwise perform

There are other things chronic pain sufferers do to relieve pain. In an effort to distract ourselves we meditate, pray, and have hobbies such as knitting (my personal favorite) and reading. We do many things to take our minds off of our pain, We attempt to stay positive even when it feels impossible. A short relief from pain helps. Pain medicine helps us function, at least for a short time, in a way that most people take for granted.

Please acknowledge those of us who suffer from chronic pain. Recognize our need for these powerful medications. Understand that we are only trying to live our lives by managing the nonstop pain. We want to survive and overcome. We will.

Filed under: General Problems | 3 Comments »

One man’s OPINION … how, when laws are enforced… all that counts ???

Posted on July 23, 2017 by Pharmaciststeve

Image result for graphic dragnet just the facts

Trump Administration Expected to Announce Marijuana Crackdown, Possibly Link Usage to Violent Crimes

http://www.thenewcivilrightsmovement.com/ryanjent/trump_administration_expected_to_announce_marijuana_crackdown_possibly_link_usage_to_violent_crimes

Attorney General Previously Called Marijuana Usage ‘Slightly Less Awful’ Than Using Heroin

Donald Trump’s Task Force on Crime Reduction and Public Safety, led by Attorney General Jeff Sessions, is expected to announce its crackdown on marijuana usage next week.

As The Hill reported, the expected crackdown is one that “criminal justice reform advocates fear will link marijuana to violent crime and recommend tougher sentences for those caught growing, selling and smoking the plant.”

They further cited a memo that Sessions sent to U.S. Attorneys and component heads on the work of the task force at the Department of Justice (DOJ), which requested review of “existing policies in the areas of charging, sentencing, and marijuana to ensure consistency with the Department’s overall strategy in reducing violent crime with the Administration goals and priorities.”

“The task force revolves around reducing violent crime and Sessions and other DOJ officials have been out there over the last month and explicitely the last couple of weeks talking about how immigration and marijuana increases violent crime,” Inimai Chettiar, director of the Bennan Center’s Justice Program told the outlet.

“Our attorney general is giving everyone whiplash by trying to take us back to the 1960s,” California Democratic Representative Jared Huffman recently told The New York Times.

In March, Sessions called marijuana usage a “life-wrecking crisis,” calling it “only slightly less awful” than using heroin:

“I reject the idea that America will be a better place if marijuana is sold in every corner store,” the Attorney General said. “And I am astonished to hear people suggest that we can solve our heroin crisis by legalizing marijuana – so people can trade one life-wrecking dependency for another that’s only slightly less awful.”

Mirroring these assertions, the U.S. Drug Enforcement Administration (DEA) announced last August that it would not reschedule its classification of marijuana under the Controlled Substance Act, keeping the drug in the same class as heroin despite a majority of Americans favoring its legal use.

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Filed under: General Problems | 4 Comments »

SAVE the ADDICTS… ABUSE those in CHRONIC PAIN ?

Posted on July 22, 2017 by Pharmaciststeve

First Opioid Court in the U.S. Focuses on Keeping Users Alive

http://www.nbcnews.com/storyline/americas-heroin-epidemic/first-opioid-court-u-s-focuses-keeping-users-alive-n781121

BUFFALO, N.Y. — After three defendants fatally overdosed in a single week last year, it became clear that Buffalo’s ordinary drug treatment court was no match for the heroin and painkiller crisis.

Now the city is experimenting with the nation’s first opioid crisis intervention court, which can get users into treatment within hours of their arrest instead of days, requires them to check in with a judge every day for a month instead of once a week, and puts them on strict curfews. Administering justice takes a back seat to the overarching goal of simply keeping defendants alive.

“The idea behind it,” said court project director Jeffrey Smith, “is only about how many people are still breathing each day when we’re finished.”

Funded with a three-year $300,000 U.S. Justice Department grant, the program began May 1 with the intent of treating 200 people in a year and providing a model that other heroin-wracked cities can replicate.

Two months in, organizers are optimistic. As of late last week, none of the 80 people who agreed to the program had overdosed, though about 10 warrants had been issued for missed appearances.

Buffalo-area health officials blamed 300 deaths on opioid overdoses in 2016, up from 127 two years earlier. That includes a young couple who did not make it to their second drug court appearance last spring. The woman’s father arrived instead to tell the judge his daughter and her boyfriend had died the night before.

Image: Court Judge Craig Hannah presides over Opiate Crisis Intervention Court in Buffalo
City Court Judge Craig Hannah presides over Opiate Crisis Intervention Court in Buffalo, New York on June 20, 2017. AP file

“We have an epidemic on our hands. … We’ve got to start thinking outside the box here,” said Erie County District Attorney John Flynn. “And if that means coddling an individual who has a minor offense, who is not a career criminal, who’s got a serious drug problem, then I’m guilty of coddling.”

Regular drug treatment courts that emerged in response to crack cocaine in the 1980s take people in after they’ve been arraigned and in some cases released. The toll of opioids and profile of their users, some of them hooked by legitimate prescriptions, called for more drastic measures.

Acceptance into opioid crisis court means detox, inpatient or outpatient care, 8 p.m. curfews, and at least 30 consecutive days of in-person meetings with the judge. A typical drug treatment court might require such appearances once a week or even once a month.

“This 30-day thing is like being beat up and being asked to get in the ring again, and you’re required to,” 36-year-old Ron Woods said after one of his daily face-to-face meetings with City Court Judge Craig Hannah, who presides over the program.

Woods said his heroin use started with an addiction to painkillers prescribed after cancer treatments that began when he was 21. He was arrested on drug charges in mid-May and agreed to intervention with the dual hope of kicking the opioids that have killed two dozen friends and seeing the felony charges against him reduced or dismissed.

Drug overdose deaths in US jump 19 percent0:33

In addition to the Monday-through-Friday court dates, Woods attends daily outpatient counseling, submits to drug testing, works at his family paving business and, although they are not required, attends Narcotics Anonymous meetings.

“This court makes it amazingly easy. Normally I’d be like … ‘This is stupid,'” said Woods, who has been through programs before. “But for the first time I have an optimistic outlook and I wanted to get clean.”

Buffalo’s get-tough court is part of a nationwide push to come up with ways to use the criminal justice system to address the opioid crisis. In April, the National Governors Association announced that eight states — Alaska, Indiana, Kansas, Minnesota, North Carolina, New Jersey, Virginia and Washington — will together study, among other things, how to expand treatment within the criminal justice system.

The grant pays for the coordinator and case managers from UB Family Medicine, a University at Buffalo medical practice, who enforce curfews, do wellness checks and transport patients. Insurance is billed for treatment.

Related: Opioid Prescriptions Are Down But Not Enough, CDC Finds

Judge Hannah hasn’t taken a day off since the program started, determined to show participants he is as committed as they are. Although he still carries a full City Court load, he meets unhurriedly and one by one with the people in the opioid program during prolonged sessions on the bench.

These are not interrogations about whether they’ve used drugs the previous night; they are chats about the weather, the weekend and work. Some have missed check-ins or otherwise slipped and are brought before him in handcuffs after being picked up by law enforcement.

“I don’t want to die in the streets, especially with the fentanyl out there,” Sammy Delgado, one of the handcuffed defendants, said. After his arrest for drug possession, Delgado left inpatient treatment after six days but wants another chance.

Hannah, as much counselor and cheerleader as judge, told him: “You have a lot of people pulling for you. We need you to pull for yourself.”

Later, in his office, Hannah described his philosophy as tempering justice with mercy. He said he’s willing to overlook defendants’ occasional lies and attempts to fool him, “because we’ve got them now. We’re just trying to save their life at this point and to stabilize them, get them back on track.”

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Second Opinion: Doc Says Blue Cross Opioid Policy Is Flawed

Posted on July 21, 2017 by Pharmaciststeve

Second Opinion: Doc Says Blue Cross Opioid Policy Is Flawed

http://www.wbur.org/commonhealth/2014/04/10/second-opinion-doc-says-blue-cross-painkiller-policy-is-flawed

Amidst concerns over a massive national increase in the use and abuse of prescription painkillers, health insurer Blue Cross Blue Shield of Massachusetts instituted a new policy to reduce pain medication addiction and misuse.

This week The Boston Globe reports that as a result of the new policy, Blue Cross has cut prescriptions of narcotic painkillers by an estimated 6.6 million pills in 18 months.

But Daniel P. Alford, MD, an associate professor of Medicine and director of the Safe and Competent Opioid Prescribing Education (SCOPE of Pain) Program at Boston University School of Medicine and Boston Medical Center, calls the policy “flawed and irresponsible.” Here’s Alford’s response:

By Dr. Daniel P. Alford
Guest Contributor

The Blue Cross Blue Shield of Massachusetts opioid management program was implemented to provide members with “appropriate pain care” and reduce the risk of opioid addiction and diversion.

In a recent Boston Globe report they claim “very significant success” with this program after 18 months because they have cut opioid prescriptions by 6.6 million pills.

Dr. Dan Alford
Dr. Dan Alford

Is this really a measure of success and if so, for whom? It likely saves Blue Cross money but has it successfully achieved their program’s stated goals? Does decreased opioid prescribing mean more appropriate pain care? Does decreased opioid prescribing reduce the risk of addiction or diversion, or does it decrease access to a specific pain medication (opioids) for treating legitimate chronic pain? Is the observed decrease in opioid prescribing evidence that opioids have been overprescribed, as Blue Cross claims, or is it proof that instituting a barrier to opioid prescribing (prior authorization) will decrease prescribing even for legitimate need? Are patients with chronic pain really benefiting from this program? I doubt it.

Adding yet more paperwork for physicians will not improve pain care, decrease addiction or the numbers of accidental overdoses from prescription opioids. Those physicians who are unwilling (or ambivalent) to prescribe opioids even when indicated will use the prior authorization requirement as an excuse to continue not prescribing. Those who are overly liberal in prescribing will figure out the most efficient way to satisfy the insurance requirements for approvals. Physicians who responsibly prescribe opioids – that is, prescribing them only when the benefits outweigh any risks — will be saddled with more administrative burdens to justify their well thought-out treatment decisions.

Some physicians may ultimately decide that prescribing opioids isn’t worth the trouble despite known benefits for some patients.

Some physicians may become overwhelmed and burned out with the large number of desperate patients seeking a doctor willing to consider prescribing opioids for chronic pain.

The Blue Cross program ignores an important principle highlighted in the 2011 Institute of Medicine’s blueprint for transforming pain care in the US — chronic pain is a chronic disease. As opposed to acute pain — that is, a symptom that resolves — chronic pain persists and often gets worse over time. By requiring prior approvals to prescribe any opioid for more than 30 days, Blue Cross is assuming that chronic pain will resolve by 30 days. This is a false assumption.

As a primary care physician who manages a large number of patients suffering from chronic disabling pain, I appreciate the complexities of balancing appropriate pain management with the safe use of opioids. I understand the clinical challenges of the subjective determination of whether a patient on opioids is benefiting (i.e., improved pain control and function) or being harmed (i.e., addiction). In addition I understand the difficulties of distinguishing the patient who is inappropriately “drug seeking” due to addiction, from the patient who is appropriately pain-relief seeking, as they both can present as equally desperate for help.,

However, if Blue Cross were serious about improving my ability to manage chronic pain safely, they would increase access to new, yet more expensive, abuse-deterrent opioids (e.g., reformulated OxyContin, Opana and Embeda) rather than continuing to prefer (Tier 1) easily altered and abused opioids such as methadone and morphine.

I worry about this flawed and irresponsible policy, and that while Blue Cross congratulates itself on a job well done — decreasing the number prescriptions of opioids — we are swinging the pendulum unnecessarily too far back to the days of under-treating chronic pain in a patient population that is too often stigmatized and lacks a unified voice.

Each year 16,000 to 18,000 pts die because they have acquired a “bug” that is resistant to all available antibiotics because antibiotics are – and have been – prescribed too often and inappropriately.  That is a similar number to the pts that they claim die of a prescription opiate overdose – and we don’t know how many actually obtained them legally… YET.. we don’t see any entity saying that we should be prescribing less antibiotics across the board.

 

Filed under: General Problems | 2 Comments »

PROP Founder Calls for Forced Opioid Tapering

Posted on July 21, 2017 by Pharmaciststeve

PROP Founder Calls for Forced Opioid Tapering

https://www.painnewsnetwork.org/stories/2017/7/20/prop-founder-calls-for-forced-opioid-tapering

Have you or a loved one been harmed by being tapered off high doses of opioid pain medication?

The founder of an anti-opioid activist group wants to know – or at least he posed the question during a debate about opioid tapering with colleagues on Twitter this week.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses.  Where exactly is this done in a risky way?” wrote Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP). 

“I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

It’s not an idle question. About 10 million Americans take opioid medication daily for chronic pain, and many are being weaned or tapered to lower doses — some willingly, some not — because of fears that high doses can lead to addiction and overdose.

Kolodny’s Twitter posts were triggered by recent research published in the Annals of Internal Medicine that evaluated 67 studies on the safety and effectiveness of opioid tapering. Most of those studies were considered very poor quality.

“Although confidence is limited by the very low quality of evidence overall, findings from this systematic review suggest that pain, function, and quality of life may improve during and after opioid dose reduction,” wrote co-author Erin Krebs, MD, of the Minneapolis Veterans Affairs Health Care System. 

Krebs was an original member of the “Core Expert Group” – an advisory panel that secretly helped draft the CDC opioid prescribing guidelines with a good deal of input from PROP. She also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Curiously, while Krebs and her colleagues were willing to accept poor quality evidence about the benefits of tapering, they were not as eager to accept poor evidence of the risks associated with tapering. 

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health systems,” wrote Krebs.

But the risk of suicide is not be taken lightly, as we learned in the case of Bryan Spece, a 54-year old chronic pain sufferer who shot himself to death a few weeks after his high oxycodone dose was abruptly reduced by 70 percent.  Hundreds of other pain sufferers at the Montana clinic where Spece was a patient have also seen their doses cut or stopped entirely.

Spece’s suicide was not an isolated incident, as we are often reminded by PNN readers.

“A 38 year old young lady here took a gun and put a bullet in her head after being abruptly cut off of her pain medication,” Helen wrote to us. “Her whole life ahead of her. This is happening every day, it just isn’t being reported.”

“I too recently lost a friend who took his own life due to the fact that he was in constant pain and the clinic he was going to cut him off completely,” said Tony.

“I have been made to detox on my own as doctors who were not comfortable giving out these meds would take me off, not wean me,” wrote Brian. “Was a nightmare. Thought I was gonna die. No, I wanted to die.”

“In the end when you realize that you’re not going to get help and that you have nothing left, suicide is all you have,” wrote Justin, who is disabled by pain and no longer able to work or pay his bills after being taken off opioids. “I don’t want to hurt my family. I don’t want to die. However it is the only way out now. I just hope my family and the good Lord can forgive me.”

Patient advocates like Terri Lewis, PhD, say it is reckless to abruptly taper anyone off high doses of opioids or to aim for artificial goals such as a particular dose. She says every patient is different.

“There is plenty of evidence that persons treated with opiates have variable responses – some achieve no benefit at all.  Some require very little, others require larger doses to achieve the same benefit,” Lewis wrote in an email to PNN.

“It is an over-generalization to claim that opiates are lousy drugs for chronic pain. Chronic pain is generated from more than 200 medical conditions, each of which generate differing patterns of illness and pain generation. For some, it may be reflective of its own unique disease process. We have to retain the ability to treat the person, not the label, not to the dose.”

Patient ‘Buy-in’ Important for Successful Tapering

And what about Kolodny’s contention that high opioid doses should be reduced even if a patient refuses? Not a good idea, according to a top CDC official, who says patient “buy-in” and collaboration is important if tapering is to be successful.

“Neither (Kreb’s) review nor CDC’s guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial in the Annals of Internal Medicine.  “Clinicians have a responsibility to carefully manage opioid therapy and not abandon patients in chronic pain. Obtaining patient buy-in before tapering is a critical and not insurmountable task.”

The CDC guideline also stresses that tapering should be done slowly and with patient input.

“For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline states. “Experts noted that patients tapering opioids after taking them for years might require very slow opioid tapers as well as pauses in the taper to allow gradual accommodation to lower opioid dosages.”

The CDC recommends a “go slow” approach and individualized treatment when patients are tapered.  A “reasonable starting point” would be 10% of the original dose per week, according to the CDC, and patients who have been on opioids for a long time should have even slower tapers of 10% a month.

The Department of Veterans Affairs takes a more aggressive approach to tapering, recommending tapers of 5% to 20% every four weeks, although in some high dose cases the VA says an initial rapid taper of 20% to 50% a day is needed. If a veteran resists tapering, VA doctors are advised to request mental health support and consider the possibility that the patient has an opioid use disorder.

Have you been tapered at a level faster than what the CDC and VA recommend? Let us know by leaving a comment below.

If you think you were tapered in a risky way, you can let Dr. Kolodny know at his Twitter address: @andrewkolodny.

Filed under: General Problems | 2 Comments »

How technology can help government fight the war on drugs

Posted on July 21, 2017 by Pharmaciststeve

How technology can help government fight the war on drugs

http://thehill.com/blogs/pundits-blog/crime/343106-how-technology-can-help-government-fight-the-war-on-drugs

Earlier this month, the Nashville District Attorney completely retired charges against a man named Christopher Miller who was arrested in May by the city’s police for attempting to sell the botanical substance called kratom.

The move brought renewed attention to this naturally occurring product that the Drug Enforcement Agency (DEA) last year proposed classifying as an illegal Schedule I substance — a plan which the DEA uncharacteristically withdrew, following a public comment period characterized by opposition from a wide range of constituents.

In a previous blog post about competing interests in the e-cigarette market, I described the so-called “Bootlegger and Baptist” theory of regulation, a realpolitik analysis of perhaps the single most effective type of issue-driven coalitions.

The theory’s title refers, of course, to the historical case of alcohol prohibition in America. At the time, those who favored criminalizing booze, beer and wine included mercenary figures who profited handsomely from a black market created by prohibition, along with teetotaling “do-gooders” concerned with saving souls.

The common purpose of these two disconnected groups with profoundly divergent motivations who nonetheless shared the same goal, led to the prohibition of alcohol in 1920.

It was arguably the government’s appetite for lost revenue from taxes on the sale of booze which eventually fueled a successful constitutional amendment in 1933, overturning what the Bootlegger-Baptist coalition had achieved thirteen years earlier.

With current annual opioid sales of around $11 billion in the U.S., projected to grow to $18 billion by 2021, an epidemic of addictions plagues nearly every demographic group in the country.

The fact that kratom helps many hooked individuals kick the dangerous habit, according to various experts and observers, means it has potentially significant economic impacts for pharmaceutical companies selling opioid painkillers.

Given the major addiction epidemic, clearly not all customers for the pharmaceutical companies’ products are consuming them for legitimate medical reasons.

On the issue of whether kratom should be criminalized, viewed one way opioid pharmaceutical makers approximate the Bootlegger part of the equation, without implying any nefarious intent or negligence.

Ostensibly, these companies would profit — or continue to profit, rather — from the DEA making kratom a Schedule I substance, since it purportedly functions as a “reverse gateway” drug, helping opioid addicts beat their habits.

During the public notice and comment process for the DEA’s plan to criminalize kratom, no vocal grassroots constituency emerged in support of the rule — no Baptist to match whatever economic interests (Bootleggers) may have favored the plan.

According to Regendus data, an analytics solution that applies Natural Language Processing to rapidly analyze sentiment contained in public comments, the vast majority of more than 24,000 submissions were strongly opposed to the DEA’s plan.

As a former federal prosecutor and criminal defense attorney, I was personally familiar with the DEA, whose policies and agents I regularly encountered on one side of a courtroom or the other.

On the defense side in particular, the courtroom is where the DEA normally faces opposition to its policies from certain elements of the public, i.e. the accused.

In the war on drugs, the agency’s rules have major, life-changing impacts on individuals, their families and communities.

Many observers of the DEA’s proposal to outlaw kratom and the agency’s eventual withdrawal in the face of strong public opposition on the issue have noted the rarity of the outcome.

In this case, the public leveraged its legal right to comment and influence a rule-making process, to stop a rule in its tracks before their government acted to make them defendants or criminals.

Instead of a loss in the courtroom, anti-kratom interests inside and outside the DEA lost their case in the rule-making process.

John W. Davis II is founder and CEO of N&C Inc., a provider of solutions such as Regendus that help advocates analyze complex content, discover insights, and better represent the interests of clients and stakeholders.

 

Filed under: General Problems | 1 Comment »

Pharmacists wants to be recognized as healthcare providers… not everyone is ready ?

Posted on July 21, 2017 by Pharmaciststeve

Steve,

 

I just read your webpage concerning the interaction and legalities between pharmacists, physicians and patients.

 

Briefly, this is what happened to me. I’d like to know if I can file a civil lawsuit against this pharmacist.

For the last 6-years I have been on prescription pain medications. I’ve had 12 spine surgeries, and as such my entire lumbar spine is fused as is my entire cervical spine. Both are fused with “ladders and girders” with posterior and anterior entries. I’ve also had a lateral entry to fuse T12 to L5. Al the rest are fused, and I have chronic pain as a result. 

My Primary Care physician has monitored my surgeries, and has prescribed 120 mg of morphine and 120 mg of oxycodone to treat my pain. As such, my pain is a 0 or 1 throughout the day and night. Without it, my pain is easily a 4, and it can spike up to a 6-7 if I am active, or turn the wrong way with a fused spine.

I’ve used a Walgreens pharmacy for 5 of those 6 years. The Pharmacy Manager, “Dan,” has always monitored me closely, and has looked at me with a cocked eye. In short, he is routinely looking for some reason to deny me those medications. I am a Ph.D. Medical researcher. I travel frequently. As such, I sometimes need to fill the script early. Other times I am late in picking up my meds. Whether I am early or late, Dan is always grilling me with pill count questions, as well as questioning my reasons for being early. When I travel, I often have to refill a few days early. Sometimes, I’m late getting back from out of state, and I don’t pick up the medications until I’m obviously back in town. How I manage that medication (early or late) is between myself and my physician. I see him in office every time these meds are refilled. He asks me to provide proof of a flights or reasons for having to refill early. He is my physician, and he monitors my refill schedule and the reason for that early or late refill requirement.

I provide “Dan” photo copies of my plane tickets when I refill early. And my last refill was 06 June 2017. When that refill occurred, the pharmacist who refilled it, had a conversation with my physician. The physician was angry, accused the pharmacist of playing doctor, and produced other extenuating and mitigating issues—bottom line, he made it clear that he would not tolerate a pharmacist playing doctor and directing me to withdrawal. The pharmacist agreed to refill the meds on the phone. However, when I walked up to the pharmacy counter, the pharmacist present, said she would refill the morphine, and oxycodone this time, that she would refill the morphine on 6 JUL, but stated, she would not refill the oxycodone until 13 JUL 2017. This meant I would not have full medications on the 06 JUL refill date, instead, I would be forced to wait until 13 JUL to refill my oxycodone.

As such I was forced to managed my medications with what I had available. Since the female pharmacist told me she would not refill my oxycodone until 13 JUL; this meant I could not take the medication as prescribed. In other words, she and Dan did not care about the 06 JUL date—they were going mandate that I not refill until 13 JUL.

I understood I would have to miss doses and stretch the medications out until after 13 JUL for refill. This is why I did not visit my physician until the 19th of JUL, and then try to have the pharmacy refill on the 20th.

On 20n JUL, “Dan” refused to refill the medications. Further, he grilled me on pill counts, asked horribly personal questions and made absolutely inappropriate allegations that I had been deceptive with him, that I had lied to him, and more. He wanted to know if I’d gone into withdrawals. He wanted to know if my physician knew I was in withdrawal. He then started telling me (with the entire staff listening) that I lied about plane flights, and that I did not take my medications as prescribed. My efforts to tell him that it was his staff who pushed my refill date out of range for me. I also asked him if he was calling the airlines to see if I canceled my flights or not. He admitted he had done this. I told him he had greatly exceeded his scope of practice; that he was not a private investigator, and I doubted Walgreens would stand behind him on that kind of conduct. He continued speaking disrespectfully of me, and of my doctor, and said, “you are not answering my questions to my satisfaction, perhaps that “hot shot doctor” you have can do it, but I’ve been on hold with his office for 20 minutes.…etc., etc..

Angry, I snatched my scripts back and walked out.

I want to sue him civilly, for his calling the airlines to check on my flights, for calling me a liar, for telling me in front of everyone that I was deceptive. I want to wipe that smart ass smirk off his face. My physician, is going to call him and let him have a piece of his mind as well, but I want to take it further. I feel he violated my civil rights, among other things. To be clear, I did cancel my flight one time—why? Because I thought I was having a heart attack. The flight attendant called paramedics and I was escorted off the plane and taken to the closest emergency room. I was admitted into the hospital where I stayed for the next five days undergoing cardiac work ups.

What do you think? What can I do to remedy this?

I have migrated my entire prescription file (15 scripts + 2-pain meds) to another pharmacy that was ecstatic. The other 15 meds are cardiac and hormonal meds.

I would appreciate any feedback you might provide.

Thank you.

 

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DEA clarifies guidance on forwarding unfilled e-prescribed controlled substances

Posted on July 21, 2017 by Pharmaciststeve

DEA clarifies guidance on forwarding unfilled e-prescribed controlled substances

http://www.drugstorenews.com/article/dea-clarifies-guidance-forwarding-unfilled-e-prescribed-controlled-substances

WASHINGTON — The Drug Enforcement Administration recently clarified for pharmacists the protocol for forwarding unfilled prescriptions for controlled substances. The DEA’s associate section chief of the liaison and policy section of the DEA’s Diversion Control division Loren Miller clarified that an original e-prescription can be forwarded one DEA-registered retail pharmacy to another in the event they can’t fill it for any reason.

“As posted in the preambles of the [notice of proposed rulemaking] and the [interim final rule], an unfilled original EPCS prescription can be forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy, and this includes Schedule II controlled substances,” Miller said in an email to National Association of Boards of Pharmacy CEO Carmen Catizone.

The clarification represents a victory for patients, according to the National Association of Chain Drug Stores, who reached out to the DEA for clarification on the issue in a May letter to the DEA’s Demetra Ashley, the Diversion Control division’s deputy assistant administrator. It removes the step for pharmacists of contacting a physician to send a new prescription when another pharmacy is unable to fill a patients e-prescription.

“Simply put, this guidance encourages the use of electronic prescribing for controlled substances, and removes a substantial barrier to doing so,” NACDS president and CEO Steve Anderson said. “Electronic prescribing has significant advantages over other forms of transmitting a prescription because it reduces opportunities for fraud and abuse.”

The organization has championed e-prescribing of controlled substances as a way to better track prescriptions to monitor for fraud and abuse while ensuring patient access to their medications and reducing the risk of fraudulent prescribing.

“NACDS is unwavering in its commitment to working with all parties to help find and implement solutions to opioid issues, while providing appropriate patient care,” Anderson said. “This has been, and remains, a top priority of NACDS, and we appreciate the DEA’s action on this guidance, which we consider to be entirely consistent with patient care and with the proper handling of controlled substances.”

NACDS recently provided comments to the President’s Commission on Combating Drug Addiction and the Opioid Crisis, highlighting the role pharmacies play in curbing the issue.

“Chain pharmacies engage daily in activities with the goal of preventing drug diversion and abuse,” the comments said. “Since chain pharmacies operate in almost every community in the U.S., we support policies and initiatives to combat the prescription drug abuse problem nationwide.”

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The WAR on Pain Patients Continues ! Politicians Don’t Care People Are Living in PAIN !

Posted on July 20, 2017 by Pharmaciststeve

The WAR on Pain Patients Continues ! Politicians Don’t Care People Are Living in PAIN !

https://www.dailykos.com/stories/2017/7/8/1678907/-The-WAR-on-Pain-Patients-Continues-Politicians-Don-t-Care-People-Are-Living-in-PAIN

  I have not written a Pain diary in a little while. I have been kind of busy dealing with my own medical issues including continued pain and cancer. However I have been keeping up on what is going on around the country in regards to Pain Patients. I have to say I am so saddened by the current atmosphere of negativity towards Pain Patients as well as the demonization of opioids by those in government like the CDC, the DEA and even idiot politicians who are reacting to the so called opioid epidemic as they react to most things, by doing the worst possible things that won’t fix the situation. So many states are passing Opioid prescription laws based off of the supposedly “Voluntary” CDC guidelines it is ridiculous. Many are including exceptions for chronic pain patients but many are not. Meanwhile we have doctors dumping patients as they run in fear of the DEA investigating them. The overall result is many chronic pain sufferers are feelling like the Government has declared war on THEM specifically and individually ! 

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Can you imagine what it is like to feel your government has declared war on you ? It sure as hell is not fun ! Study after study have shown that chronic pain patients are the least likeliest to become addicts with rates of addiction in the studies from 1% to about 5%. The CDC’s own information is showing that illegal Fentanyl has replaced prescription opioids as the leading cause of opioid deaths yet the persecution continues for chronic pain patients while doing exactly ZERO to help with the addiction issues facing America. Politicians at both the State and Federal level are cutting funds to addiction counseling and treatment at a time when addictions are rising. Politicians on all levels are

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scrambling to be seen as doing something to combat the addiction menace yet they don’t want to spend money to do that ! The result is chronic pain patients are being made the scapegoats and that is resulting in a rise of pain patients receiving less treatment or even no treatment to combat their daily pain. Can anyone guess what that will lead to and has been leading to ? Yep ! A rise in chronic pain patients taking their own lives. This is adding to the statistics because the idiots at the CDC are including them into the opioid death stats. 

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     The CDC guidelines rolled out last year are a nightmare for chronic pain patients. As I stated above these are supposed to be Voluntary yet we have politicians pushing the 90 MED dosing limits as law plus Insurance companies are getting into the act as well. What is worse is that those very guidelines were developed not with input from those directly involved in the care of chronic pain but rather almost exclusively by a group called PROP. This group runs a bunch of addiction treatment centers and has a very vested interest in getting everyone off of opioids as it will greatly increase their business ! Every single chronic pain patient who has been on opioids for any length of time will be dependent upon the

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drugs. This is not to say that they are addicted as Andrew Kolodny insists in every possible forum he can, but rather it means that when the drugs are withdrawn the patient will fall into withdrawal. To Kolodny this means one thing ! ADDICTION ! To the rest of the thinking medical profession it means that the person has basically gotten used to having the drugs and care needs to be used when lowering the dose or cutting it off all together. Some prescribers advocates not for titration down but rather cold turkey yanking of all opioids. ( Titration is the stepping down or up of a dose of medicine to find the best result for the patient or in the case of down to counter the withdrawal symptoms so they are not life threatening. ) Yes going cold turkey from a high dose of opioids can be life threatening fro the withdrawal symptoms. This does not even cover the fact that the patient will have a return to high levels of pain. Pain that they had thought and HOPED was behind them. It also means a loss of quality of life. It means no longer working or in some cases even getting out of bed. To many chronic pain patients this is a DEATH SENTENCE and all because a group of greedy doctors decided to increase their business by proclaiming opioids BAD !  

    Let’s take a look at what chronic pain feels like ! Most people are lucky enough to have had no real experience with pain. Some may have experience with acute pain. This is short lived pain such as breaking an arm or other bone. Unfortunately sometimes acute pain turns into chronic pain and other times there is no real start to the pain. No one things that can be pointed at to say There is the cause” ! This is more likely in the case of back injuries where the damage is not done in one big event but rather by misuse or abuse over time, lifting wrong, doing more than you should and so on. The spine becomes more and more damaged over time leading to more and more pain. This is a lot of my chronic pain. I was a dumbass when I was younger and figured I could do anything. Yeah where is my time machine so I can go back and kick myself in the ass ? Because of that stupidity I have endured multiple operations on my back as well as multiple procedures such as epidurals and RF Ablations and other shots to try and block the pain. I have also endured living with a pain level of 8 for years. Most people would have headed for the ER when it got above 6 or 7 but chronic pain patients have learned how to function at that level of pain. To us it seems NORMAL ! Think about that for a minute. Such intense pain that you should go to the ER is your normal state. What you wake up in the morning to ( If you were able to sleep at all. I was lucky if I got 4 hours a night) and what you go to bed at night with. It NEVER goes away ! It NEVER Stops ! It changes your thinking. You become depressed. Your life gets smaller. You stop going out with friends or family. You may miss work a lot ! This causes you to become more depressed. You do what you have to get through each day and then do it again the next day. That kind of life SUCKS ! You jump at every chance to get the pain down. Trying new therapies until you have tried them all. Then you find a doctor who will prescribe an opioid to you and the pain drops. You work with the doctor and increase your dosage and now the pain is manageable, it is down to a 4 or less if you are lucky. You have your life back. Now you have someone who wants to end all of that and you can do nothing to stop them. It’s not because you are bad or did anything wrong other than to use opioids to get a handle on your pain. You have become almost a criminal in the eyes of society. Doctors and others in the medical profession suddenly are looking at you like you are a drug addict. You have to go to multiple pharmacies just to get your script filled while dealing with the looks and accusations both silent and aloud of the pharmacy staff. Your life still SUCKS but at least the pain is down. That is what chronic pain looks like and feels like. Before you condemn someone for using opioids as they have been prescribed by a doctor, you might want to think for a moment.Think if you want to be stigmatized for trying to get out of pain. 

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