Like a lot of puzzles, one cannot see what the final picture is going to look like until you get more and more pieces in place.  The same seems to be the same how about all the “things” that the DEA has done basically “behind the curtain”…  as people retire, some are starting to talk about what they did and what they saw while working in law enforcement, DEA or within our judicial system.

Richard A. Lawhern recently published a article A Good Man Speaks Truth to Power

Because I write and speak widely on public health issues and the so-called “opioid crisis”, people frequently send me references to others’ work.  One of the more startling articles I’ve seen lately was published November 20, 2018 in Pharmacy Times.  It is titled “Should We Believe Patients With Pain?”.  The unlikely author is Commander John Burke, “a 40-year veteran of law enforcement, the past president of the National Association of Drug Diversion Investigators, and the president and cofounder of the International Health Facility Diversion Association.”

The last paragraph of Commander Burke’s article is worth repeating here.

“Let’s get back to dealing with each person claiming to be in legitimate pain and believe them until we have solid evidence that they are scamming the system. If they are, then let’s pursue them through vigorous prosecution, but let’s not punish the majority of people receiving opioids who are legitimate patients with pain.”

This seems a remarkable insight from anyone in law enforcement — especially from one who has expressed this view in both Pain News Network, and Dr Lynn Webster’s video “The Painful Truth”.   Recognizing Commander Burke’s unique perspective, I followed up by phone to ask several related questions.  He has granted permission to publish my paraphrases of his answers here.

1. “Are there any available source documents which establish widely accepted standards for what comprises “over-prescription?” as viewed by diversion investigators?”Burke’s answer was a resounding “NO”.  Each State and Federal Agency that investigates doctors for potentially illegal or inappropriate opioid prescribing is pretty much making up their own standards as they go.  Some make reference to the 2016 CDC Guidelines, but others do not.
2. “Thousands of individual doctors have left pain management practice in recent years due to fears they may be investigated, sanctioned, and lose their licenses if they continue to treat patients with opioid pain relievers.. Are DEA and State authorities really pursuing the worst “bad actors”, or is something else going on?Burke’s answer:  “Regulatory policy varies greatly between jurisdictions.  But a hidden factor may be contributing significantly to the aggressiveness of Federal investigators.  Federal Agencies may grant financial bonuses to their in-house diversion investigators, based on the volume of fines collected from doctors, nurse practitioners, PAs and others whom they investigate.“No law enforcement agency at any level should be rewarded with monetary gain and/or promotion due to their work efforts or successes. This practice has always worried me with Federal investigators and is unheard of at the local or state levels of enforcement.”

Commander Burke’s revelation hit me like a thunder-clap.  It would explain many of the complaints I have heard from doctors who have been “investigated” or prosecuted.  It’s a well known principle that when we subsidize a behavior, we get more of it. Financial rewards to investigators must inevitably foster a “bounty hunter” mentality in some.  It seems at least plausible that such bonuses might lead DEA regulators to focus on “low hanging fruit” among doctors who may not be able to defend themselves without being ruined financially.  The practice is at the very least unethical. Arguably it can be corrupting.

I also inquired concerning a third issue:

3. “I read complaints from doctors that they have been pursued on trumped-up grounds, coerced and denied appropriate legal defense by confiscation of their assets – which are then added to Agency funds for further actions against other doctors. Investigations are also commonly announced prominently, even before indictments are obtained – a step that seems calculated to destroy the doctor’s practice, regardless of legal outcomes.  Some reports indicate that DEA or State authorities have threatened employees with prosecution if they do not confirm improper practices by the doctor. Do you believe such practices are common?”Burke’s answer:  “I hear the same reports you do – and the irony is that such tactics are unnecessary.  Lacking an accepted standard for over-prescribing, the gross volume of a doctor’s prescriptions or the dose levels prescribed to their patients can be poor indicators of professional misbehavior.  Investigators should instead be looking into the totality of the case, which can include patient reports of poor doctor oversight, overdose-related hospital admissions, and patterns of overdose related deaths that may be linked to a “cocktail” of illicit prescribing.  Especially important can be information gleaned from confidential informants – with independent verification – prior patients, and pharmacy information.”

No formal legal prosecution should ever proceed from the testimony of only one witness — even one as well informed as Commander John Burke.  But it seems to me that it is high time for the US Senate Judiciary Committee to invite the testimony of others in open public hearings, concerning the practice of possible bounty hunting among Federal  investigators.

for years Commander John Burke contributed a monthly op-ed in Pharmacy Time – one of the two major pharmacy magazine sent to all pharmacies in the country.  As I remember, just about every article that Burke wrote, seemed to be from the perspective of law enforcement that suggested that everyone taking prescribed opiates were doing so because they were addicted or selling the meds  to supplement their income.  Once I wrote Pharmacy Times and suggested that they discontinue publishing Burke’s biased op-eds…   Of course, they continued to publish his one-sided point of view..  Here is a list of various organization that he was affiliated with and his titles within these organizations:

• Executive Director @ International Health Facility Diversion Association
• President @ International Health Facility Diversion Association
• Commander @ Warren County Drug Task Force
• Past President @ Ohio Task Force Commanders Association

• Past President @ National Association of Drug Diversion Investigators
• Sergeant @ City of Cincinnati
• President and Owner @ Pharmaceutical Diversion Education

I guess that should help explain the contents of all the articles that he published in various medias. I did a search for his Pharmacy Times articles and her is a link to what I found  https://www.pharmacytimes.com/authors/cmdr-john-burke?page=17.  Apparently he stopped a few years back.

Here is a blog post from 5 yrs ago about a job posting by the DEA   Forfeiture Financial Specialist Supporting the DEA    and within the job description:  Provides support in conducting pre seizure analysis.   This would seem to validate what the previous DEA employee stated in the above video.

Here is a more recent blog post  wonder how many members of Congress is aware of this – and have turned a blind eye and deft ear to how corrupt the DEA is ?    A  DEA agent who is going to jail for 12 yrs and who “spills the beans” on all the diversion of confiscated money, drugs and what many of these agents spent the money on themselves. According to this article some agents that were involved, where allowed to just retire with out any legal consequences.  A quote from the agent in the article ….“You can’t win an unwinnable war. DEA knows this and the agents know this,” Irizarry said. “There’s so much dope leaving Colombia. And there’s so much money. We know we’re not making a difference.”

Here is another recent blog post  Is this why 90%+ of people taken to Federal Court – ARE FOUND GUILTY ?      Judge denial all the NINE expert witnesses from testifying for the physician/defendent and the only witness for The prosecution was expert, Dr. Timothy King, is an Indiana anesthesiologist who makes large amounts of money testifying for the federal government.  The 85 y/o physician, is currently serving a five-year prison term in a minimum security prison

Here is just one blog  post head of Suboxone mafia: testified at J&J opiate crisis trial  on the J&J trial in OK in the summer of 2019 where the judge decided that J&J COULD NOT HAVE A TRIAL BY A JURY … it was to be a BENCH TRIAL – where the judge acts as JUDGE, JURY & EXECUTOR  and J&N was being sued for being a PUBLIC NUISANCE because they were basically the WHOLESALER of raw opiate powder to the pharma industry. 

Doc’s office raided: purportedly treating addicts with a drug called buprenorphine

The “BAD AND THE UGLY – there is NO GOOD” of the PDMP’s and Narxcare and the INACCURATE CONCLUSIONS from those databases

The True Story of Morphine Milligram Equivalents (MME)

The “BAD SIDE” of Epidural Spinal Injections

Who said that dead bodies DON’T TALK ?

How DEA does a UNDER COVER INVESTIGATION

The FOUR DIFFERENT WAYS MME’S CAN BE CALCULATED

Filed under: General Problems | 1 Comment »

CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

You had better believe the Guidelines need work. CORRECTION: They need to be totally erased and gotten rid of. I arrived in California from my home in Virginia for an appt with my Pain Management Physician. Upon arrival, my wife turned on her phone and we were greeted by a text message from a friend, telling us that the previous day, my doctor had been “visited by the DEA-holes” and was handed an immediate order to stop all schedule 2 Rxs of any opioid pain meds. This unjustified action has already caused a double-suicide. This doctor is a very compassionate and caring doctor that hates to see people suffer. In his 52 years of practice, he has never had a single complaint or black mark on his record with the California Board of Medicine. Now my supply of legitimately prescribed pain meds are running low and soon I will not only be in agony from my pain caused by two incurable and painful diseases AND I will be facing painful and dangerous withdrawals from my medications. The DEA has forced my doctor to abandon his intractable pain patients, something the CDC has said repeatedly not to do. This abandonment will cause more deaths as immediate stoppage of pain medicine can cause blood pressure to spike and cause death by heart failure or stroke. This is our government executing people and the blood will be on the hands of the DEA for their murder of innocent, intractable pain patients. We called around to virtually all Los Angeles area Pain Management Doctors and NONE, I repeat NONE have returned any calls. Doctors are justifiably afraid to take on abandoned intractable pain patients because they know they will also be “visited” by the DEA. The DEA should be working to take down dealers of deadly street fentanyl but instead they are taking out doctors who are veritable “sitting ducks.” Am I angry? Yes, I am! These actions HAVE to stop b4 causing more needless deaths of some of the sickest people in our country.

Filed under: General Problems | 1 Comment »

CDC’s Updated Opioid Guidelines Are Necessary, but Not Sufficient

https://www.medpagetoday.com/opinion/second-opinions/101825

Additional steps are needed to calibrate opioid access and undo harm

Before the CDC suffered a loss of trust over its handling of the COVID-19 pandemic, the agency had fumbled its response to the overdose crisis. Under its leadership, overdose deaths have continued to spiral, as people living with pain have lost access to vital medications.

One of its key missteps was the formulation and implementation of its 2016 prescribing guideline for chronic pain. On November 3 this year, the agency took partial corrective action, revising its approach that contributed to so many harms to people with pain.

In its update, the 2022 Clinical Practice Guideline for Prescribing Opioids for Pain, the CDC emphasizes flexibility in pain pharmacotherapy. It also rejects controversial dose and duration limits that had been widely misinterpreted by policymakers. For this welcome change to have meaning, however, the CDC must work proactively with regulators to rescind harmful policies that resulted from its prior guideline.

What Went Wrong in 2016?

Recommendations in the 2016 CDC opioid guideline included concrete thresholds related to opioid dosing and the number of days opioids should be prescribed for acute pain. Regulators, eager for a ready solution to the overdose crisis, adopted these thresholds as one-size-fits-all laws and mandates.

The uptick was fast and far-reaching. State and federal lawmakers, quality metric agencies, pharmacy benefit plans, state medical boards, and the Drug Enforcement Agency, among others, embraced the thresholds, which had a chilling effect on providers. Patients who’d been placed on opioids were transformed into liabilities. Far too many lost access to care, creating “opioid refugees” with nowhere to turn. Nearly half of primary care providers, according to studies, will refuse to take on such patients.

People with pain were also subjected to dangerous opioid cessation practices — actually increasing their risks of overdose and suicide by three to five times, and needlessly destabilizing their health and lives.

What began as an appropriate call for caution in opioid prescribing turned into a crisis of under-treated pain.

To be fair, the problem can’t be laid entirely at the CDC’s door. The U.S. has undergone a rapid pendulum swing in opioid prescribing, which began to drop in 2012 and is now roughly at levels last seen in the early 1990s.

Further, opioids are not generally considered a first line of treatment for chronic pain. The updated 2022 guideline rightly urges careful balancing of benefits and risks and the expanded use and coverage of other treatments.

But some people do need opioids, one size does not fit all, and the CDC, as the agency in the proverbial driver’s seat issuing guidelines, is in the best position to undo ongoing harm and effect a course correction.

Taking the 2022 Prescribing Guidelines a Step Further

For many patients who have already lost access to care, the 2022 update is too little too late. But the issue still stands to affect millions. While it’s difficult to pinpoint exact numbers, given recent drops in prescribing, an estimated 5 to 8 million Americans, or up to as many as 13 million, use opioids to manage pain.

In light of documented harms and ongoing risks, the CDC must close the gap between rhetoric and action. In 2019, the agency came out publicly against misapplications of its 2016 guideline, but we witnessed no slowing in the number of patients suffering harm.

The language in the 2022 update is stronger; it repeatedly emphasizes clinician discretion and individualized care, and stridently warns regulators not to implement its provisions strictly. It also recognizes that people of color are at heightened risk of having their pain under-treated and spotlights equity.

But the 2022 update could still be misapplied. While dose benchmarks are notably absent from its recommendations, qualified dosage “guideposts” in the text remain. Numbers, history tells us, are temptingly easy for policymakers to adopt as mandates.

Furthermore, the urgency of this problem has not abated. Just recently, patients were abandoned when their provider was raided by the DEA. Desperate, one patient has sought help in a methadone clinic, even though she has no history of a use disorder. Another, who had recently experienced repeated impediments to care, died by suicide alongside his wife.

What Should the CDC Do?

In proactively working with regulators to undo harm, the CDC can begin in its own house at the Department of HHS. It should work with the Centers for Medicare and Medicaid Policy to rescind quality payment metrics based on dose thresholds. Moreover, it should offer technical assistance to the National Committee for Quality Assurance, payers, and pharmacy benefit plans to encourage similar redactions.

Likewise, the CDC should actively engage the DEA and state medical boards so that they cease policing providers based on the dosages they prescribe, and encourage the DEA to arrange transitional care for patients who fall through the cracks.

While the agency can’t tell state or federal lawmakers which laws to rescind or pass, they should conduct active outreach with regulators to educate them about what went wrong with strict thresholds and the genuine risks to patient safety that have resulted. As the nation’s premier public health agency, the CDC has the data and expertise to conduct empirically-based outreach to these decision makers.

The agency has developed implementation tools for providers. It must also disseminate those tools to policymakers, so it can help them understand how key presumptions in opioid regulation — that cutting the medical supply of opioids would reduce overdoses and that cutting people off medication will ensure their safety — have proven wrong with disastrous effects.

How Will the CDC Monitor and Prevent Misapplication?

Fortunately, the CDC already seems poised for vigilance. In a perspective piece in the New England Journal of Medicine, authors of the 2022 update state that the CDC will “monitor” against misapplication. We strongly urge the CDC to remediate past harm, in addition to engaging in forward-looking monitoring.

Monitoring is especially important because the 2022 update represents a significant expansion that now covers the full spectrum of pain from acute, to subacute, to chronic. Typically, it’s good practice to check safety equipment on an aircraft before you expand the fleet. Given the well-acknowledged misapplication of its prior guideline, proper implementation of this expanded guideline is essential.

The health and lives of tens of millions of Americans depend on it.

Filed under: General Problems | 3 Comments »

https://youtu.be/TKL-jkZA0mU

The first amendment really only applies to the federal government https://mtsu.edu/first-amendment/page/things-you-need

“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.” – The First Amendment to the U.S. Constitution

Our Founding Fathers could never conceive that any private entity could have sufficient influence to sway public opinion.   This survey of people claimed  79% say ‘truthful’ coverage of Hunter Biden’s laptop would have changed 2020 election

Elon Musk’s acquisition of Twitter could change  how the other entities, that has a major internet presence, are able to influence what people believe because certain news/information can no longer be throttled.  Facebook/Meta change may be a direct result of Musk’s acquisition of Twitter. Hopefully, other major internet news medias will follow suit.

Only time will tell how all of this shakes out.  If we are lucky, some of the media will not longer just regurgitate what the DEA pushes out via press releases https://www.dea.gov/

Filed under: General Problems | 1 Comment »

People always say, ‘Bob how did you know that?”

I stayed up most of the night thinking which is dangerous for me well that’s what Carol Adams says anyways! Vicki Latham says I’m a great talker because I’m full of shit! Lmao Andrew Hohenthaner says I have a certain way I bring things out in people Kathy Riddle used to say if I retain anymore information my head will explode. Jessamyn Butler feels I’m kind of a good egg. Shirley Buck relys on me to come up with answers to problems. Nanc Seefeldt wants me to think fast and hard to solve problems. Steve Ariens Is my go to guy for everything pharmaceutical. Cheri Mendes Karen Wilkinson Margaret Drumheiser think I’m a little crazy but are wonderful people Michelle Shepherd believes I try hard and I will accomplish what I set out to do Douglas Leigh Hughes is my information guy and a great writer and a great guy Maria Higginbotham is my mentor and anything I need I ask her. Karlyn Beavers and Evelyn Beavers are wonderful fundraisers and great folks. Stacy Siano is one smart business cat.. Sheila Kim Purcell writes bills and has groups of folks on groups who work for legislation big wigs! I can do this all day APDF awesome folks Jade Rose Shelli Rodenbaugh Shear Carol Benack Ashley Clark Sara, Gina, Kim, Dana, Jessica, Lesley, Karen, Julie, Lynn, Tammy, Mike, David Israel ,Dr Mimms, Lisa, and ect ect… Great Docs and nurses and pharmacist and people that make APDF works!What makes us different is we have been to State Houses, Oversight Committees, Washington DC, Fundraisers, to eachothers houses to eat dinner, traveled to other States together to help one another, Speaking Engagements, Court Houses, Childrens Hospitals, Band Concerts with eachothers kids, hell even Hooters ! Truth being I don’t do anything by myself and so many great people put their time and efforts for free and only for the cause of helping CPPs and themselves. That’s so many different organizations problems is you’re working for people you can’t see and hope they are real people! These folks from around the USA are absolutely real and a force to be reckoned with! It’s easy to be a fear monger if you don’t know the person or people your working with! Work together is what gets things done..and boy have we made waves this year! One thing for sure is I know I’m nothing without all these great folks from around the . They are called friends! Trusted friends! That’s how we roll! Different orgs or not. Common people with a common goal! So come help us and eat some food! Hahaha

Filed under: General Problems | 2 Comments »

I did not copy the entire article, but there is a hyperlink if anyone wants to read the whole “piece of pain mis-management for cancer pts “

What Are the Newest Guidelines for Nonpharmacologic Management of Cancer Pain?

https://www.medscape.org/viewarticle/984026

Clinical Context

Pain is a leading, disabling symptom among patients with cancer,

resulting from tumor burden or invasion of bones, muscles, or nerves. Many cancer treatments, including surgery, chemotherapy, radiotherapy, immunotherapy, or hormonal therapy can result in acute and chronic pain conditions, including aromatase inhibitor (AI)-induced joint pain or chemotherapy-induced peripheral neuropathy (CIPN) pain.

The Society for Integrative Oncology (SIO) and the American Society of Clinical Oncology (ASCO^®) panel included experts in integrative, medical, radiation, surgical, and palliative oncology; social sciences; mind-body medicine; nursing; and patient advocacy. Literature search identified 227 relevant studies (systematic reviews, meta-analyses, and randomized controlled trials [RCTs] from 1990 to 2021 to inform consensus- and evidence-based recommendations.

Study Synopsis and Perspective

New guidelines highlight the role that integrative pain management techniques, such as massage, acupuncture, and music therapy, can play in relieving certain types of cancer pain in adults.

The recommendations,^[1] published earlier this month in the Journal of Clinical Oncology, represent a joint effort between the American Society of Clinical Oncology (ASCO^®) and the Society of Integrative Oncology (SIO) to guide cliniciansicians how to best weave various nonpharmacologic pain management strategies into cancer care.

“Pain is a clinical challenge for many oncology patients and clinicians, and there’s a growing body of evidence showing that integrative therapies can be useful in pain management,” Heather Greenlee, ND, PhD, explained in a press release.^[2]

Still, clear clinical guidance as to when and when not to use these approaches is lacking, said Greenlee, co-chair of the SIO Clinical Practice Guideline Committee.

Previous guidelines from ASCO^® on managing chronic cancer-related pain^[3] largely focused on diagnosing pain and on pharmacologic interventions, and they only touched on evidence related to nonpharmacologic options.

The new guideline^[1] “takes a deeper dive on the use of integrative therapies, which is important because clinicians and patients need to have access to the latest evidence-based information to make clinical decisions,” Jun H. Mao, MD, SIO-ASCO® panel co-chair, noted.

In the guidance, the expert panel addresses 2 core questions: What mind-body therapies are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer, and what natural products are recommended for managing pain experienced by adult and pediatric patients diagnosed with cancer?

The panel conducted a literature search and identified 227 relevant studies. They included systematic reviews and randomized controlled trials published between 1990 and 2021 that evaluated outcomes related to pain intensity, symptom relief, and adverse events. After reaching a consensus, the expert panel made recommendations on the basis of the strength of the available evidence.

Regarding modalities for which there was stronger evidence, the panel highlighted several recommendations regarding acupuncture, reflexology, hypnosis, and massage.

The panel determined, for instance, that acupuncture should be offered for aromatase-related joint pain in patients with breast cancer and that it can be offered for general or musculoskeletal pain from cancer. It recommended reflexology or acupressure for pain experienced during systemic therapy for cancer.

While exploring complementary approaches to manage various aspects of the patient experience, it’s worth considering alternatives such as hypnosis. For instance, individuals undergoing cancer treatment or diagnostic workups may find relief from procedural pain through the application of hypnosis techniques. Additionally, for those in palliative or hospice care, as well as individuals recovering from breast cancer treatment, massage therapy emerges as another viable option for addressing pain and enhancing overall well-being. If you’re interested in exploring these methods further, you might find resources that allow you to learn hypnosis online, providing a convenient avenue for acquiring valuable skills in pain management.

These recommendations were considered moderate in strength and were based on intermediate levels of evidence that demonstrated that the benefits outweighed risks.

The panel added several recommendations it deemed to be weak in strength and that were based on low-quality evidence. These include Hatha yoga for patients experiencing pain after treatment for breast or head and neck cancers, and music therapy for patients experiencing pain from cancer surgery.

The experts also identified areas “potentially relevant to cancer care but needing more research,” such as the safety and efficacy of natural products, including omega-3 fatty acids and glutamine, and determined that there is insufficient or inconclusive evidence to make recommendations for pediatric patients.

“With improved oncology treatments such as immunotherapy and targeted therapy, more patients diagnosed with cancer are living longer; therefore, pain and symptom management is critical for improving quality of life,” Mao, chief of integrative medicine at Memorial Sloan Kettering Cancer Center, New York, New York, told Medscape Medical News. “The SIO-ASCO clinical guideline will provide very timely recommendations for physicians to incorporate nonpharmacological treatments such as acupuncture and massage to improve pain management for patients impacted by cancer.”

Nonetheless, clinical uptake of such treatments “is always a concern,” said panel co-chair Eduardo Bruera, MD, of The University of Texas MD Anderson Cancer Center, Houston, Texas. “We are hoping that by showing the growing evidence that is out there, healthcare systems will start hiring these kinds of practitioners and insurance systems will start covering these treatments, because more and more, these are being shown to be effective at managing pain for cancer populations,” Bruera said.

Filed under: General Problems | 6 Comments »

Filed under: General Problems | 1 Comment »

Filed under: General Problems | 1 Comment »

I have not had time to listen to this TWO HOUR webinar… just sharing it right now 

Filed under: General Problems | Leave a Comment »

Most all medications have a temperature storage requirement – typically 59-86 F – and pharmas, wholesalers, pharmacies are required to keep medications within that range and if they are outside of that temp range > 24 hrs…  the potency of the medications are generally considered “compromised”…  BUT… when a mail order pharmacy hands off a package containing Rx meds to a delivery carrier ( USPS, Fedex, UPS) seldom is there any concern about the temp that the medications are exposed to and for how long.  When specialty meds – that require being kept at refrigerator/frozen temps…  the mail order pharmacies will typically take extra efforts to try to make sure that the meds are kept in the required temp range.  Sometimes, the delivery carrier does not deliver the Rx meds in the expected time frame and they show up at the pt’s home… outside of the required storage temp and UNUSABLE.  Many times, the med involved is a life critical matter and getting a replacement in a timely manner is not always possible.

Oklahoma proposes landmark rule to keep mailed medications safe from extreme temperatures

https://www.nbcnews.com/health/health-news/oklahoma-proposes-rule-keep-drugs-safe-hot-cold-rcna57492

There is little regulation of how pharmacies ship drugs to patients, though extremes of hot or cold can make medicine unsafe or ineffective.

Patients who get their prescription medications by mail in Oklahoma may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts. 

“This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. “We’ve got a tremendous amount of prescriptions that get mailed to patients. … What we did today was make sure our patients in Oklahoma are receiving safe products.”

Exposure to extreme temperatures can degrade or weaken drugs, potentially changing their dosage or chemical makeup and rendering them ineffective or unsafe for patients. But while government oversight of how pharmacies store medications to keep them in defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found oversight of shipping to patients — during which drugs might be exposed to heat waves and below-freezing temperatures — is largely a system of blind trust. Mail-order pharmacy is a booming business, with soaring profits for some of the nation’s largest companies last year and more than 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data.

NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping. 

Industry standards are clear that pharmacies should ship medications in their safe temperature range — set by the manufacturer after extensive testing under Food and Drug Administration guidelines — yet many patients have no way of knowing if the medications that arrive at their door have stayed within that range.

“So many insurance providers are really pushing patients to use mail order,” said Erin Fox, director of drug information at the University of Utah Health hospital system, who researches drug quality and shortages. “Unfortunately, many patients don’t have a choice in their insurance coverage to be able to use a local pharmacy, so having these protections is important.”

The proposed Oklahoma rule is the first of its kind to set clear guidelines on temperature safety during transit. It would require all pharmacies shipping or delivering medication to use packaging tested to ensure drugs do not go outside their safe temperature ranges, require them to be able to assess the safety of a medication if there are delays in delivery, and mandate that they give patients notification of shipping and delivery. 

“Oklahoma is at the forefront in developing regulations on this topic,” said Desmond Hunt, the storage and distribution expert and senior principal scientist at United States Pharmacopeia, the nonprofit that sets the quality and safety standards for medications that are used by the FDA, manufacturers and pharmacy boards. “How this evolves within Oklahoma may be a blueprint or a template for other states.”

Filed under: General Problems | Leave a Comment »