Drug and Medical Supply Shortages Impacting Patient Safety at ‘Alarming Rate’

By Pat Anson, PNN Editor

Over half of U.S. hospitals are reporting shortages of drugs and supplies used in anesthesia, pain management and emergency care, according to a new survey by a nonprofit healthcare organization. Nearly nine of out of ten (86%) respondents said they were rationing or restricting the use of medications in short supply.

The survey of nearly 200 hospital administrators, pharmacists and supply chain managers was conducted by the Emergency Care Research Institute (ECRI) in July.

“Their responses suggested that providing safe and appropriate drugs, supplies, and equipment has become extremely challenging and led to numerous instances of unsafe practices, compromised care, and potentially harmful errors. Many of the respondents clearly communicated their struggles to address shortages which are occurring at an alarming rate,” the ECRI report said.

Respondents reported shortages of over 20 drugs, single-use supplies, or medical equipment. The shortages primarily affect surgery and anesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).

“While medication and supply shortages have been widely reported across healthcare, we now know with certainty that these shortages are causing preventable harm and have the potential to cause even more if they are not addressed soon,” Marcus Schabacker, MD, president and CEO of ECRI, said in a statement.

“There are strategies hospitals can use to reduce the impact of shortages, but they are a deviation from standard practice and resource-intensive -- two characteristics that themselves can increase the likelihood of preventable harm.”

Many hospitals (42%) are stretching supplies by using medications after their expiration date, reusing single-use devices, or using drugs for purposes outside of their specific labeling. Nearly a quarter of respondents (24%) said they knew of at least one medical error related to a drug, supply or device shortage.

Specific examples of how shortages have impacted patient care include:

• Interruption or delays in chemotherapy

• Use of more opioid analgesia due to lidocaine shortages

• Incorrect medication instructions given to patients

• Postponement or cancellation of surgeries 

To address shortages of masks, gowns and other personal protective equipment, many hospitals have turned to non-traditional sources that supplied products with “alarmingly poor performance,” according to ECRI.

For example, tests on KN95 masks obtained from nontraditional suppliers found that up to 70% did not filter particulates the way manufacturers claimed. And tests on disposable gowns revealed that over half failed to meet even minimum standards for protection.

“The extent to which medication, supply, and equipment shortages are negatively impacting patient care is inexcusable,” said Rita Jew, PharmD, president of the Institute for Safe Medication Practices, an ECRI affiliate. “While pharmacies and hospitals can triage shortages short-term, we need long-term, nationally coordinated solutions to solve the persistent shortages we’ve witnessed repeatedly over the last several years.”

Supply Interruptions

Many respondents also expressed concern about drug shortages worsening after a Pfizer plant in North Carolina was heavily damaged in July by a tornado. The Rocky Mount plant was a leading supplier of sterile injectable drugs used in surgery, pain management and emergency care. Pfizer recently resumed production at the plant, but doesn’t expect full operations to be restored until later in the year.     

“While manufacturing has resumed, it is important to note that some medicines may not be back in full supply until next year,” the company said in a statement.

The American Society of Health-System Pharmacists (ASHP) recently expanded its shortage list for injectable morphine to include morphine vials made by Pfizer. The company said the vials are on back order and could not estimate a release date. The lack of supply is having a snowball effect on other drug manufacturers, who say they’re running out of injectable morphine and hydromorphone due to increased demand.

The ASHP recommends that providers use “extreme caution” when switching morphine concentrations or interchanging them with other injectable opioids because patients could react to them differently.

Limited supplies of morphine, hydromorphone and other injectable opioids were being reported long before the tornado damaged Pfizer’s plant or the pandemic disrupted the global supply chain. Despite that, the Drug Enforcement Administration has aggressively cut the supply of many opioids, reducing production quotas for hydromorphone by 71% and morphine by 65% from their peaks in 2016.       

GRAPHIC COURTESY OF MONTY GODDARD

The Food and Drug Administration put injectable morphine and hydromorphone on its drug shortage list in 2017, the year after DEA started cutting the opioid supply.  In recent months, the ASHP added oxycodone and hydrocodone tablets to its drug shortage list, but their limited supply has not yet been acknowledged by the FDA.

A recent federal lawsuit accused the DEA of “incompetence” in its handling of the nation’s drug supply, specifically the production quotas the agency sets for amphetamines used in ADHD medication.

Drug makers are required to report shortages and supply interruptions to the FDA. Doctors, pharmacies and consumers can also report them by email to the FDA at drugshortages@fda.hhs.gov. To report a drug shortage to the ASHP, click here.

Patients Squeezed in Fight Over Costly Infusion Drugs

By Samantha Liss, KFF Health News

Health insurers and medical providers are battling over who should supply high-cost infusion drugs for patients, with the tussle over profits now spilling into statehouses across the country.

The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.

Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.

Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms.

PAULA SHEPARD

But at times, she said, her treatments were delayed due to UnitedHealthcare’s white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.

“I once had to use a toilet lift and it was kind of demoralizing to say, ‘I’m a 50-year-old woman and I have to use a toilet lift,’” Shepard said of the medication delays.

This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. While insurers claim the arrangement reduces costs, she said, that doesn’t mean insurers pass along savings to patients.

“I don’t think we should have more sympathy toward one party or the other,” Bai said. “Nobody is better than the other. They’re all trying to make money.”

The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn’s, cost on average $1,106 per unit in 2015 under hospitals’ traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.

But the report also found patients, on average, faced higher cost sharing — what they are responsible for paying — for Remicade and other drugs when white bagging was used. While some patients had only modest increases to their costs under the policy, such as $12 more for a medication, the review found it could mean much greater cost sharing for some patients, such as those on Medicare.

Delays in Care

At Citizens Memorial Hospital in rural Bolivar, more than 1 in 4 patients who receive regular infusions are being forced to use an outside pharmacy, said Mariah Hollabaugh, the hospital’s pharmacy director. Shepard was among them.

Even if the hospital has the exact drug on the shelf, patients must wait for a separate shipment, Hollabaugh said, potentially interrupting care. Their shipped drugs may sometimes be unusable when the doctor needs to change the dosage. Or the medicine comes in a nondescript package that doesn’t get immediately flagged for the pharmacy, potentially subjecting the drugs to damaging temperature fluctuations. For patients, that can mean delays in care.

“They’re in pain, they’re uncomfortable,” Hollabaugh said. “They may be having symptoms that don’t allow them to go to work.”

Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center’s size has helped it largely avoid such insurer policies.

John DiPersio, a Siteman oncologist and researcher who led the university’s oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.

“You’re talking about cancer patients that are getting life-threatening treatments,” DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. “It doesn’t make any sense to me. It’s all stupid. It’s all lunacy.”

At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, Louisiana, and Virginia.

ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.

“This is a major issue,” said Tom Kraus, a vice president at the trade group. “We see this as central to our ability to coordinate patient care.”

At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.

The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.

The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation’s roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug’s cost, according to the Health Resources & Services Administration, which oversees the program.

‘People Got Greedy’

The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.

“The fact is, people got greedy,” Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas City, said during a Missouri state Senate hearing in March.

Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America’s Health Insurance Plans. The markups thrusted on commercial plans are “widely out of line” with what Medicare will pay, he said, and that is driving up costs without providing additional value.

Legislation that targets white bagging hinders an insurer’s ability to rein in such costs, Dickson said, especially when an area lacks competition.

“What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety,” Dickson said.

Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.

For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly’s recent session.

Shepard, though, won’t need such legislation.

UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens’ in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a “bureaucratic mess” trying to get the medication shipped.

“We are driving unnecessary costs out of the health care system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care,” UnitedHealthcare spokesperson Tony Marusic wrote.

But after KFF Health News inquired about Shepard’s case, Marusic said UnitedHealthcare stopped white bagging Shepard’s medication to “prevent potential delays in shipping.” And during her latest infusion in June, her hospital was again able to supply Shepard’s medication directly.

“I'm just so relieved,” Shepard said. “I don't have to take phone calls. I don't have to reply to emails. I just show up.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

100,000 ‘Unnecessary’ Hospital Procedures Performed in First Year of Pandemic

By Pat Anson, PNN Editor

U.S. hospitals performed over 100,000 “low-value” procedures on Medicare patients in the first year of the Covid pandemic, including tens of thousands of spinal surgeries and knee arthroscopies, according to a recent study by the Lown Institute, a non-profit that seeks to reduce the use of unnecessary and ineffective medical treatments.

In 2020, no vaccines were available, the elderly were particularly vulnerable to the Covid-19 virus, and intensive care units were filled with infected patients. Yet many hospitals continued to perform questionable elective procedures at the same rate they did in 2019.

“You couldn’t go into your local coffee shop, but hospitals brought people in for all kinds of unnecessary procedures,” Vikas Saini, MD, president of the Lown Institute, said in a statement. “The fact that a pandemic barely slowed things down shows just how deeply entrenched overuse is in American healthcare.”

Lown researchers analyzed Medicare claims from U.S. hospitals for eight procedures that the non-profit considers to have “little to no clinical benefit” and are potentially harmful.  

Coronary stents were the most overused procedure, with over 45,000 balloon angioplasties performed to open up blocked arteries. The Lown Institute has long maintained that stents are unnecessary and risky in patients with stable heart disease.

Two spinal surgeries also made the list: 13,541 spinal fusions and 16,553 vertebroplasties were performed on older patients. In vertebroplasty, bone cement is injected into fractured vertebrae to stabilize the spine; while spinal fusions are used to join two or more vertebrae together to prevent them from moving and causing more pain. The Lown Institute considers fusions and vertebroplasties inappropriate for patients with low back pain and osteoporosis.

Nearly 1,600 knee arthroscopies were also performed in 2020, a type of “keyhole” surgery in which a small incision is made in the knee to diagnose and repair ligaments damaged by overuse or osteoarthritis. Recent independent studies have found arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long term.

“There are certain things, certain practices that are just insane. You shouldn’t be doing this. Nobody should pay for this,” said Saini.

Highland Hospital in Rochester, New York was rated as the top hospital in the country for avoiding overuse procedures. Richardson Medical Center in Rayville, Louisiana was ranked as the worst hospital.

The American Hospital Association disputed Lown's ranking system, calling it misleading.

"Throughout the pandemic, but especially in the early months, many nonessential services and procedures were put off due to government restrictions or voluntary actions from hospitals to make room for massive surges of COVID-19 patients," Aaron Wesolowski, AHA's VP of policy research, said in a statement to Becker’s Hospital Review.

"Studies have shown that these delays or sometimes even cancelations in nonemergent care have had some negative outcomes on the health and well-being of patients, who continue to show up at the hospital sicker and with more advanced illnesses. Many of these services may alleviate patients' pain or provide other help to patients. Lown may define these services as 'low value,' but they can be of tremendous value to the patients who receive them."

Does Transparency in Pricing Really Lower Healthcare Costs?

By Barby Ingle, PNN Columnist

Each year I get asked to support multiple legislative bills that could impact the chronic pain community. I look through them, think them through, and have written, called, testified and shared many over the years.

But sometimes a bill I supported comes back to haunt me as a patient. The intended consequences are not what I thought they would be.

Such is the case in Arizona, where I live. A state law was passed in 2013 calling for transparency in healthcare pricing (HB 2045). The law requires most healthcare providers to tell patients the “direct pay price” for a service or procedure. I always thought it was a good thing to have transparency in pricing and for patients to know what their responsibility is, so I supported the bill.

In 2019, Arizona passed another law (HB 2166) that authorized providers to collect “advance payments” from patients before a service is performed and without waiting for insurers to pay. The new law was quick to be adopted and providers have already started using it more than expected. This is causing an issue in getting the healthcare we need in a proper and timely manner.

The law really didn't affect me until this year, when I went through all the testing and multiple office visits with a new provider. Then I was called to the office of the “scheduling manager.” This was right after the doctor told me that I need a procedure on my bladder. I have an issue known as neurogenic bladder, where I lose control of my bladder nerves and muscles.

In the office, the woman wrote on a piece of paper the cost of the procedure ($30,000) based on my insurance (Medicare) and how much I would have to pay in advance, which was $6,000.

Before the law went into effect, I could pay the bill over time and get the procedure done when I needed it. But now, she says, I had to pay the entire $6,000 before even scheduling the procedure. I do not have $6,000 to pay upfront, so I am unable to schedule it.

New Hospital Rules

Arizona is not the only state that has passed healthcare price transparency laws; California, Connecticut, Louisiana, Maine, Maryland, Nevada, Oregon, Tennessee and Vermont have similar laws.

Federal rules are slated to go into effect in January, 2021 that will require hospitals to disclose their price information, including their negotiated prices with insurers. It is part of an effort by the Trump administration to increase price transparency in hopes of lowering healthcare costs on everything from hospital services to prescription medicines.

The federal efforts are controversial and have already faced court challenges. For good reason, seeing how transparency is being implemented in Arizona.  

Both HB 2045 and HB 2166 are good examples of bills I advocated for that are now being used against me and others in the chronic pain community who are low income or under-insured. It’s just a new way to stop healthcare or slow it down. Instead of having insurance companies delay care with prior authorizations and step therapy -- which I have been through as well -- they stop you at the doctor's office now.  

The same thing happened when I came down with Valley Fever pneumonia this past November. My provider ordered chest x-rays, but before I could get them, I had to pay my portion of the bill. I had to borrow money to get the x-rays done.  

Turns out I was way sicker than my provider thought and he apologized afterwards. Once I was diagnosed, follow up x-rays were covered, except when one lady was at the desk. She always charges me and says she has to because of the price transparency rules.  

I am hearing more and more stories about HB 2166 being used against the chronic and rare disease communities. As I said, it is odd to not want full transparency, but I would rather have access to healthcare when it is needed and then work on paying the bill afterward. Otherwise, like me, many of you may not receive the care you need, making our health worse and more expensive. 

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

Hospitals ‘Ready to Get Back to Work’ After First Wave of COVID-19

By Pat Anson, PNN Editor

One of the biggest ironies of the coronavirus pandemic is that – in the middle of a healthcare crisis -- many hospital emergency rooms, surgery centers and waiting rooms sat empty. Elective surgeries and non-essential medical tests were cancelled to clear the decks for the first wave of COVID-19 patients.

In PNN’s recent survey of over 2,200 patients with chronic pain or chronic illness, over 71 percent said they had a medical appointment cancelled or postponed.   

“My surgery for a tumor has been postponed because of the pandemic, yet there are more than enough hospital beds to provide for my needs. I am angry and disappointed,” one cancer patient told us.

“I am very upset to have had my shoulder surgery delayed again. I have already waited over 2 years and now this! My pain level is something terrible,” another patient said.

“I need to have surgery for my hernia but I'm not sure when I can get the surgery now. It's frustrating because it hurts every day,” said another.

It’s not just doctors cancelling appointments. Many patients in life-threatening situations, with chest pain or stroke symptoms, are staying home rather than go the ER and risk exposure to the virus.

“In the past, people went to the ER maybe a little bit too often for minor conditions. And now we’re seeing a complete swing of the pendulum to another dangerous level where people are not going when they should,” says Mary Dale Peterson, MD, a hospital administrator in Corpus Christi, Texas who is President of the American Society of Anesthesiologists (ASA).

In March, many hospitals were forced to cancel elective surgeries because of chronic shortages of surgical gowns, face masks and other personal protective equipment (PPE) that were needed for the care of COVID-19 patients.

The ASA recently joined in a campaign to reassure patients that it’s safe to reschedule those surgeries. Peterson say the supply chain is “still somewhat fragile,” but most hospitals are well-equipped to perform surgeries again.

“We’re ready to get back to work,” she told PNN. “I understand people’s concerns and we want people to shelter in place, but at the same time, they should be confident that the healthcare facilities have worked really hard to make the environment as safe as possible. A lot safer than going to your local grocery store.”

Pent-Up Patient Demand

The ASA recently joined with medical societies representing nurses and surgeons in adopting new guidelines for healthcare facilities to resume elective surgeries when the following conditions are met:

• Sustained reduction of at least 14 days in new COVID-19 cases in a geographic area

• Regular testing of patients and hospital staff for the virus

• Adequate supplies of anesthesia drugs and PPE, including an emergency supply for a potential second wave of cases

• Prioritize surgery scheduling based on medical need and availability of staff.

“When the first wave of this pandemic is behind us, the pent-up patient demand for surgical and procedural care may be immense, and health care organizations, physicians and nurses must be prepared to meet this demand,” the guideline warns.

Peterson says patients should expect to be tested for COVID-19 and to self-isolate before their surgeries. She’s also encouraging patients to ask questions.

“I think patients are free to ask, ‘What have you done to make your hospital safe?’ I think that’s a fair question,“ Peterson says. “We’ve worked really hard to do that. We’re testing patients before they come in for coronavirus and asking them to isolate themselves after the test to protect themselves and others.”

Drug Diversion Widespread in Healthcare Facilities

By Pat Anson, PNN Editor

The Drug Enforcement Administration recently completed another National Prescription Drug Take Back Day, collecting over 468 tons of unused or expired medications. The idea is to get risky drugs – particularly opioids – out of medicine cabinets before they wind up on the streets.

“The current opioid crisis continues to take too many lives, and many people get their first pills to abuse from the home medicine cabinet,” said DEA New Jersey Special Agent in Charge Susan Gibson.

But the DEA’s Take Back program overlooks a growing problem in the healthcare industry: Opioid medications are increasingly being stolen before they even reach home medicine cabinets.

According to a new report by the healthcare analytics firm Protenus, over 47 million doses of medication were stolen in 2018 by doctors, nurses, pharmacists and other healthcare workers, an increase of 126% from the year before. Opioids were involved in 94% of the incidents, with oxycodone, hydrocodone and fentanyl the most common drugs stolen.

“For both doctors and nurses, the high stress of the profession, long shifts, fatigue, physical and emotional pain, along with easy access to controlled substances, contribute to why they might divert medications,” the report found.

“Drug diversion poses a great deal of harm to patients because it puts them at risk of being treated by care providers working under the influence of controlled substances as well as receiving the incorrect amount or type of medications.”

Among the incidents cited in the report are a Texas nurse stealing opioid medication from elderly patients and a Maryland pharmacist filling bogus opioid prescriptions in return for sexual favors. According to Protenus, the average amount of time it took to discover a case of healthcare drug diversion was 22 months, giving diverters plenty of time to continue their thefts and cover their tracks.

To combat in-house drug diversion, Protenus recommends that hospitals, pharmacies, nursing homes and other healthcare providers establish drug monitoring programs – similar to those used for patients – and educate their employees about detecting and preventing diversion.

“Drug diversion occurs in virtually every hospital and health system in America, but many are in denial that it is happening in their own organization,” said Russ Nix, Director of Drug Diversion Prevention at MedStar Health. “Very few resources exist today on how to identify and combat drug diversion, and what’s out there is siloed.”

Nix belongs to the advisory board of Healthcare Diversion Network, a new non-profit that has an online portal where healthcare employees can report drug thefts anonymously. The goal is to collect data and raise awareness about drug diversion in healthcare facilities. 

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals.”

— Tom Knight, Healthcare Diversion Network

“I think thefts out of home medicine cabinets happen, but I also know that thefts out of healthcare systems and hospitals happen,” said Tom Knight, Chairman of the Healthcare Diversion Network. “Many of those thefts are for self-use, where the person stealing is going to consume them themselves. But sadly, many of those thefts are where the person is planning to distribute them, typically for profit on the street illegally.

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals. There are numerous cases where people working in hospitals stole hundreds of thousands of doses that were sold on the street for years before they were eventually caught.”

Knight says about 10 percent of all healthcare workers are stealing opioids and other controlled substances. He told PNN there is no good data to indicate how much of the stolen medication sold on the street comes from medicine cabinets and how much comes from healthcare facilities or the drug distribution system.

“Pretty much anywhere they exist they’re being stolen. We’re trying to raise the visibility, particularly on the part of the healthcare facilities,” he said.

Cutting Rx Opioid Supply Is Not Stopping Diversion

By Roger Chriss, PNN Columnist

Drug diversion is an increasingly important factor in the opioid overdose crisis. A new report from Protenus found that 18.7 million pills, valued at around $164 million, were lost due to drug diversion in the United States during the first half of 2018. This represents a vast increase over 2017, when 20.9 million pills were diverted during the entire year.

As we’ve described previously, drug diversion in the supply chain is a vast, complex and old phenomenon. And it is rapidly worsening.

According to the textbook, “Prescription Drug Diversion and Pain,” drug thefts from hospitals “have increased significantly within the past decade as street prices have climbed sharply for diverted prescription opioids and benzodiazepines.”

In other words, the steep cuts in opioid production that began in 2017 aren’t working. And Attorney General Jeff Sessions was wrong when he said, "The more a drug is diverted, the more its production should be limited." A tightening supply has actually resulted in more diversion.

Drug diversion can be broadly divided into three categories: clinical diversion, personal diversion and industrial diversion. The first, according to Protenus, is drug diversion by healthcare workers. The second is the sale or transfer by a patient who received a legitimate prescription to a third party. And the third is everything else, from diversion by employees at manufacturing facilities to theft in distribution centers or pharmacies.

Personal diversion has gotten substantial attention in recent years. Prescription drug monitoring databases, pain agreements, and urine drug testing are all intended to help prevent such diversion.

Clinical drug diversion is a long-standing problem in healthcare that has garnered more interest recently. The bipartisan opioid bill recently passed by Congress includes a provision that allows hospice workers to destroy opioid medication that has expired or is no longer needed by a patient. The National Institutes of Health has also awarded a grant to further expand efforts to detect opioid and other drug theft in hospital systems.

Industrial diversion is less well known, but appears to be a longstanding problem. In the book “Dopesick,” journalist Beth Macy writes that as early as 2001 the DEA was investigating lax security standards at Purdue Pharma manufacturing plants after the arrest of two Purdue employees accused of trying to steal thousands of pills.

Between 2009 and 2012, over 63,000 thefts of opioids and other controlled substances were reported to the DEA. Pharmacies (66%) and hospitals (19%) accounted for the vast majority of those drug thefts.

And in 2007, an audit of CMS Medicare Part D payments identified 228,000 prescription payments with invalid prescriber identifications for Schedule II drugs.

In other words, tens of thousands of drug thefts and hundreds of thousands of fraudulent prescriptions are occurring annually, leading to millions of prescription pills entering the illegal market. This may help explain how OxyContin entered the black market so quickly and completely.

As Beth Macy writes: “The town pharmacist on the other line was incredulous: “Man, we only got it a month or two ago. And you’re telling me it’s already on the street?””

The National Association of Drug Diversion Investigators and the DEA Diversion Control Division are attempting to address industrial diversion. But available evidence suggests there is much more work needed to secure the entire prescription drug supply chain.

As the opioid overdose crisis continues to evolve toward poly-drug substance abuse, drug diversion will play an increasingly significant role in the illegal supply of prescription pharmaceuticals unless the entire supply chain is secured. This will require far more than the easy tasks of checking a prescription database or legislating pill counts. The hard part of reducing drug diversion remains to be done.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

DEA Takes Steps to Reduce Hospital Opioid Shortages

By Pat Anson, Editor

In response to a growing number of complaints about shortages of opioid pain medication in U.S. hospitals, the Drug Enforcement Administration is allowing some drug makers to increase their production of injectable opioids.

The shortages were first reported last summer but have intensified in recent months – leaving some hospitals scrambling to find morphine, fentanyl and other injectable opioids to treat patients suffering from acute pain after surgery or trauma. The shortages are largely due to manufacturing problems at Pfizer, which controls 60 percent of the market for injectable opioids.

“DEA is working closely with the U.S. Food and Drug Administration, drug manufacturers, wholesale distributors and hospital associations to ensure that patients have access to necessary hospital-administered pain medications. These include certain injectable products that contain morphine, hydromorphone, meperidine, and fentanyl,” the agency said in a statement.

The DEA said it gave permission to three other drugs makers to produce the injectable drugs after Pfizer “voluntarily surrendered” part of its quota allotment.

“It is important to note that an increase in DEA procurement quotas to various manufacturers cannot alone prevent future shortages as DEA does not control the quantity or the speed by which manufacturers produce these or any of their products,” the agency said.

But critics say the DEA itself is partly responsible for the shortages. The agency may not control how companies manufacture drugs – but it has a big say on the amount. Under federal law, the DEA sets annual production quotas for each drug maker to produce opioids and other controlled substances.

Because of growing concerns about the overdose crisis, the DEA ordered a 25 percent reduction in opioid manufacturing in 2017 and an additional 20 percent cut in 2018. This year’s cuts were ordered despite warnings from three drug makers that reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

A group of 16 U.S. Senators – led by Illinois Democrat Dick Durbin – urged the DEA to make the production cuts. 

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the senators wrote in a September 2017 letter to then acting DEA administrator Chuck Rosenberg.

According to Kaiser Health News, shortages of injectable opioids have led to an increasing number of medical errors and left trauma patients suffering in pain. Some hospitals are rationing opioids like Dilaudid, and using nerve blocks, acetaminophen and muscle relaxants instead.

The DEA said it would make further adjustments to opioid quotas if they are needed and would “also consider other measures that may be necessary.”

Hospital Opioid Shortages Cause Pain & Medical Errors

By Pauline Bartolone, Kaiser Health News

Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.

The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.

As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.

In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which can be up to 10 times more powerful than fentanyl, the ideal medication for that situation.

In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can.

Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases.

Other patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.

The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed.

In a Feb. 27 letter to the U.S. Drug Enforcement Administration, a coalition of professional medical groups — including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists — said the shortages “increase the risk of medical errors” and are “potentially life-threatening.”

In addition, “having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients,” the group wrote.

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.

Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.

Small Mistakes Lead to Big Errors

Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.

Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.

Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.

“The system has been set up safely for the drugs and the care processes that we ordinarily use,” said Dr. Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women’s Hospital in Boston. “You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”

Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.

“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.”

During the last major opioid shortage in 2010, two patients died from overdoses when a more powerful opioid was mistakenly prescribed, according to the institute. Other patients had to be revived after receiving inaccurate doses.

Pfizer Manufacturing Problems

The shortage of the three medications, which is being tracked by the FDA, became critical last year as a result of manufacturing problems at Pfizer, which controls at least 60 percent of the market of injectable opioids, said Erin Fox, a drug shortage expert at the University of Utah.

A Pfizer spokesman, Steve Danehy, said its shortage started in June 2017 when the company cut back production while upgrading its plant in McPherson, Kansas. 

The company is not currently distributing prefilled syringes “to ensure patient safety,” it said, because of problems with a third-party supplier it declined to name.

That followed a February 2017 report by the U.S. Food and Drug Administration that found significant violations at the McPherson plant. The agency cited “visible particulates” floating in the liquid medications and a “significant loss of control in your manufacturing process [that] represents a severe risk of harm to patients.” Pfizer said, however, that the FDA report wasn’t the impetus for the factory upgrades.

Other liquid-opioid manufacturers, including West-Ward Pharmaceuticals and Fresenius Kabi, are deluged with back orders, Fox said. Importing these heavily regulated narcotics from other countries is unprecedented and unlikely, she added, in part because it would require federal approval.

DEA Reduced Opioid Supply

At the same time, in an attempt to reduce the misuse of opioid painkillers, the Drug Enforcement Administration called for a 25 percent reduction of all opioid manufacturing last year, and an additional 20 percent this year.

“DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances,” the agency said in August.

When the coalition of health groups penned its letter to the DEA last month, it asked the agency to loosen the restrictions for liquid opioids to ease the strain on hospitals.

The shortages are not being felt evenly across all hospitals. Dr. Melissa Dillmon, medical oncologist at the Harbin Clinic in Rome, Ga., said that by shopping around for other suppliers and using pill forms of the painkillers, her cancer patients are getting the pain relief they need.

Dr. Shalini Shah, the head of pain medicine at the University of California-Irvine health system, pulled together a team of 20 people in January to figure out how to meet patients’ needs. The group meets for an hour twice a week.

The group has established workarounds, such as giving tablet forms of the opioids to patients who can swallow, using local anesthetics like nerve blocks and substituting opiates with acetaminophen, ketamine and muscle relaxants.

“We essentially have to ration to patients that are most vulnerable,” Shah said.

Two other California hospital systems, Kaiser Permanente and Dignity Health in Sacramento, confirmed they’re experiencing shortages, and that staff are being judicious with their supplies and using alternative medications when necessary.

At Helen Keller Hospital’s emergency department in Sheffield, Ala., earlier this month, a 20-year-old showed up with second-degree burns. Dr. Hamad Husainy said he didn’t have what he needed to keep her out of pain.

Sometime in January, the hospital ran out of Dilaudid, a drug seven times more potent than morphine, and has been low on other injectable opioids, he said.

Because Husainy’s patient was a former opioid user, she had a higher tolerance to the drugs. She needed something strong like Dilaudid to keep her out of pain during a two-hour ride to a burn center, he said.

“It really posed a problem,” said Husainy, who was certain she was in pain even after giving her several doses of the less potent morphine. “We did what we could, the best that we could,” he said.

Bernell, the St. Louis nurse, said some trauma patients have had to wait 30 minutes before getting pain relief because of the shortages.

“That’s too long,” said Bernell, a former intensive care nurse who now works in radiology.

Dr. Howie Mell, an emergency physician in Chicago, said his large hospital system, which he declined to name, hasn’t had Dilaudid since January. Morphine is being set aside for patients who need surgery, he said, and the facility has about a week’s supply of fentanyl.

Mell, who is also a spokesman for the American College of Emergency Physicians, said some emergency departments are considering using nitrous oxide, or “laughing gas,” to manage patient pain, he said.

When Mell first heard about the shortage six months ago, he thought a nationwide scarcity of the widely used drugs would force policymakers to “come up with a solution” before it became dire.

“But they didn’t,” he said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Heroin Overdoses in ER's Surpass Rx Opioid Overdoses

By Pat Anson, Editor

The number of patients admitted and discharged from U.S. hospitals for abuse of opioid pain medication has declined significantly this decade, while the abuse of heroin and illicit fentanyl has surged, according to a new study that documents the shifting nature of the nation’s overdose crisis.

Researchers at Stanford University analyzed national trends in hospital inpatient and emergency department (ED) discharges for opioid abuse, dependence and poisoning from 1997 to 2014, the last year data was available.

They found that hospital admissions for overdoses from pain medication started falling in 2010, the same year that opioid prescriptions began declining.

At the same time, hospital discharge rates for heroin poisoning increased at an annual rate of over 31 percent. By 2014, heroin overdoses exceeded those from prescription opioids in emergency rooms by almost a 2 to 1 margin.

“After 2008, ED discharge rates for heroin poisoning increased more sharply than the rates for any opioid poisoning -- signaling that the scope of heroin harm is worse than previously suggested -- while discharges for prescription opioid poisoning recently began to decline in both the ED and inpatient settings,” researchers reported in the journal Health Affairs.

“While these changes could be the result of national and local policies aimed at reducing the prescribing of opioids, the expanded availability of heroin and new lethal illicit drugs, such as nonpharmaceutical fentanyl, could mean that they are being used instead of prescription opioids.”

The findings add evidence to recent public health concerns that people misusing or addicted to prescription opioids are switching to heroin and synthetic opioids such as fentanyl because they are cheaper and easier to get.

"This suggests that the expanded availability of lethal illicit drugs are being used to replace prescription opioids in some cases," said Tina Hernandez-Boussard, PhD, associate professor of medicine, of biomedical data sciences and of surgery at Stanford University School of Medicine.

source: health affairs

The Centers for Disease Control and Prevention has been reluctant to admit that efforts to reduce opioid prescribing could be backfiring, although their own statistics indicate otherwise.  Deaths involving heroin and synthetic opioids overtook overdoses linked to prescription opioids in 2016, the same year the CDC released its opioid prescribing guidelines.

As PNN has reported,  the CDC last week launched a public awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the scourge of heroin and illicit fentanyl.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC explained.

The Stanford study found that discharge rates for prescription opioid poisonings declined annually by about 5 percent from 2010 to 2014, while discharge rates for heroin poisoning increased at an annual rate of 31.4 percent from 2008 to 2014. The trend has likely worsened since 2014, as heroin and illicit fentanyl are even more widely available on the black market.

"I'm cautiously optimistic that prescribing clinicians are positively reacting to the opioid crisis and therefore prescription opioids are contributing less to the overall drug epidemic," Hernandez-Boussard said. "That's the good news. The bad news is that although prescription opioid use decreased, heroin and methadone greatly increased.”

Anna Lembke, MD, an associate professor of psychiatry at Stanford and a board member of Physicians for Responsible Opioid Prescribing (PROP), says she has no doubt many people addicted to prescription opioids have switched to using heroin or illicit fentanyl.

"My patients have told me that's exactly what they did," said Lembke. "Heroin was cheaper and easier to get."

Medicare Pain Questions Being Dropped in 2017

By Pat Anson, Editor

Hospital patients will no longer be asked about the quality of their pain care under new rules released this week by the Centers for Medicare and Medicaid Services (CMS) for 2017.

Medicare uses a funding formula that rewards hospitals that provide good care and are rated highly in patient satisfaction surveys. Critics claimed that three questions in the survey asking patients about the quality of the pain care created a financial incentive for doctors to prescribe opioid pain medication to boost their hospital’s scores.

The three questions being dropped, which don’t even mention opioids, are as follows:

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

CMS said it was still developing and field testing alternative pain questions to replace the ones being eliminated.

“Today’s final rule would address physicians’ and other health care providers’ concerns that patient survey questions about pain management in the Hospital Value-Based Purchasing program unduly influence prescribing practices," CMS said in a statement.

"While there is no empirical evidence of such an effect, we are finalizing the removal of the pain management dimension of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey… to eliminate any financial pressure clinicians may feel to overprescribe medications.”

The American Medical Association (AMA), one of the groups that lobbied CMS to drop the pain questions, applauded the move.

"CMS understands that these policies effect how physicians practice medicine and how patients receive treatment," said AMA President Andrew Gurman, MD, in a statement. "By listening to our concerns, CMS made clear that patient care was the top priority. We look forward to continuing to work with CMS to improve patient health and enhance access to affordable quality care."

CMS was under intense political pressure to drop the pain questions. Twenty-six U.S. senators sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell claiming “physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance."

Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group,also said the patient survey "fosters dangerous pain control practices."

But a top Medicare official disputed those claims in an article published in JAMA, saying “nothing in the survey suggests that opioids are a preferred way to control pain.”

Pain patients have long complained about the poor quality of their treatment in hospitals. In a survey of over 1,250 patients by Pain News Network and the International Pain Foundation, nine out of ten said patients should be asked about their pain care in hospital satisfaction surveys. Over half rated the quality of their pain treatment in hospitals as poor or very poor, and over 80 percent said hospital staffs are not adequately trained in pain management. 

Medicare Drops Pain Questions in Patient Survey

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) has caved into political pressure from Congress and healthcare lobbying organizations by proposing to drop all questions related to pain in patient satisfaction surveys.

The proposed rule change is the latest in a series of steps by the federal government aimed at fighting the so-called opioid epidemic by reducing the prescribing of narcotic pain medication. The policies are meant to prevent addiction and abuse, but have left many pain patients without access to opioids, and feeling marginalized and abandoned by the healthcare system.

At issue in the Medicare rule change is a funding formula that requires hospitals to prove they provide quality care through patient satisfaction surveys. The formula rewards hospitals that provide good care and are rated highly by patients, while penalizing those who do not. 

Critics claim that three pain care questions in the survey -- known as the Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS) -- encourage doctors to overprescribe opioid pain medication to boost their hospital's scores.

"While there is no empirical evidence of this effect, we propose to remove the pain management dimension from the Hospital Value-Based Purchasing program to eliminate any potential financial pressure clinicians may feel to overprescribe pain medications," CMS said in a statement.

"CMS continues to believe that pain control is an appropriate part of routine patient care that hospitals should manage and is an important concern for patients, their families, and their caregivers."

CMS has been under intense political pressure over the last few months to drop the pain questions. In March, 26 U.S. senators sent a letter to Health and Human Services Secretary Sylvia Mathews Burwell claiming "the evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures."

Several physician groups have also made the same claim, without offering anything more than anecdotal evidence. Physicians for Responsible Opioid Prescribing (PROP)  said the survey "fosters dangerous pain control practices" and even the American Medical Association recently said the surveys "are clearly motivating forces for opioid prescribing."

A top Medicare official disputed those claims in an article published in JAMA. 

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD. “Nothing in the survey suggests that opioids are a preferred way to control pain.”

These are the three pain questions in the CMS patient survey::

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

The agency said it would develop and "field test" alternative questions related to pain and include them in the survey. Public comments on the proposed rule change will be accepted until September 6, 2016.

CMS said the rule changes "are based on feedback from stakeholders, including beneficiary and patient advocates, as well as health care providers, including hospitals, ambulatory surgical centers and the physician community."

While some politicians and lobbyists may support the CMS decision, pain patients clearly do not. 

Pain News Network and the International Pain Foundation recently conducted a survey of over 1,250 pain patients. Nine out of ten said patients should be asked about their pain care in hospital satisfaction surveys. Over half rated the quality of their pain treatment in hospitals as poor or very poor, and over 80 percent said hospital staffs are not adequately trained in pain management. 

The Centers for Disease Control and Prevention has adopted guidelines that discourage primary care physicians from prescribing opioids or chronic pain. The Obama administration has also proposed spending over a billion dollars on opioid addiction treatment. Not one cent is proposed for pain research or for funding alternative treatments for pain.  

ER Doctors Lobby to Silence Pain Patients

By Pat Anson, Editor

A professional organization for emergency room physicians has joined in a lobbying effort to stop asking hospital patients about the quality of their pain care.

At issue is a Medicare funding formula that requires hospitals to prove they provide good care through patient satisfaction surveys. The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

In a letter to Health and Human Services Secretary Sylvia Mathews Burwell, the head of the American College of Emergency Physicians (ACEP) claims that asking patients about their pain care could lead to overprescribing of opioid pain medication. To see the letter, click here.

“Patient experience/satisfaction surveys are important, particularly regarding issues of treating patients with dignity and respect, but questions about pain have resulted in unintended consequences and the pursuit of high patient-satisfaction scores may actually lead health professionals and institutions to practice bad medicine by honoring patient requests for unnecessary and even harmful treatments,” wrote Jay Kaplan, MD, President of ACEP, which represents over 30,000 emergency room physicians in the U.S.

“Any questions which provide an opportunity for patients to express dissatisfaction because they didn’t get the drugs they sought, provide disincentives for physicians to prescribe non-opioid analgesics which will negatively affect their scores.”

Only two questions are asked about pain in the 32-question survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS):

During this hospital stay, how often was your pain well-controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

In his letter, Kaplan states “there is no objective diagnostic method that can validate or quantify pain” and until one is developed, both pain questions should be dropped from the survey.

“We are concerned that the current evaluation system may inappropriately penalize hospitals and physicians who, in the exercise of medical judgment, opt to limit opioid pain relievers to certain patients and instead reward those who prescribe opioids more frequently,” Kaplan wrote. “We urge the Department to undertake a robust examination of whether there is a connection between these measurements and potentially inappropriate prescribing patterns, and, until that is completed, we urge you to remove pain questions from the various CAHPS surveys.”

Kaplan’s letter is similar to one sent to Secretary Burwell in February by Sen. Susan Collins (R-Maine) and 25 of her colleagues in the U.S. Senate. To see that letter and the senators who signed it, click here.

“The evidence suggests that physicians may feel compelled to prescribe opioid pain relievers in order to improve hospital performance on quality measures,” wrote Sen. Collins.

Both Collins and Kaplan cite only one piece of “evidence” – a 2013 magazine article in The Atlantic  -- that mentions a small study of “drug seeking behavior” by emergency room patients. The article's author, who is a physician, also mentions anecdotal comments from colleagues and concludes “this problem is widespread.”  

Pain News Network and the International Pain Foundation recently conducted a survey of over 1,250 pain patients and found that what is actually widespread in hospitals is poor pain care. Over half the patients surveyed said the quality of their pain treatment was poor or very poor and over 80 percent said hospital staffs are not adequately trained in pain management. Nine out of ten patients said they should be asked about their pain care in hospital satisfaction surveys.

“Before eliminating patients' right to critique their pain care, a better idea would be to ask doctors what they know about pain!” wrote one patient. 

When Pain News Network provided ACEP with the survey results, a spokesperson declined to comment on the findings.

A top Medicare official recently wrote an article in JAMA defending the HCAHPS survey.

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD, Quality Measurement and Value-Based Incentives Group, Centers for Medicare & Medicaid Services.

"Although opioids are sometimes appropriate, depending on the underlying cause, other nonpharmaceutical approaches and multiple nonopioid pain medications are available to treat pain. Nothing in the survey suggests that opioids are a preferred way to control pain. On the other hand, good nurse and physician communication are strongly associated with better HCAHPS scores."

“I find this notion that we would stop asking patients how well their pain was controlled in the hospital appalling,” said Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation. “I find it perverse that we would be more concerned with whether doctors in a hospital setting felt ‘pressure’ to provide pain relief than whether patients felt the hospital staff did all they could to help them with their pain. What ever happened to the focus on ‘patient-centered’ care?"

Hospital Pain Care Needs Improvement

By Barby Ingle, Columnist 

Most hospital staffs are poorly trained in pain management, in my opinion. They are used to acute emergency situations and seeing many of the same ones over and over. So when a “zebra” (someone with a complex chronic condition) gets pushed in on a stretcher, they tend to have thoughts like these:

“Oh boy, I am going to have to work.”

“I don’t believe that this person is as bad as they say.”

“I have seen others in worse physical condition and this person looks ‘normal’ so they can’t be experiencing what they say is going on.”

I had an emergency room doctor tell me once that I didn’t have a blocked bladder. He got out a machine to measure how full my bladder was, but I think he never even turned it on. He said my bladder was empty.

I was in so much pain at the time that I told him he was reading it wrong and that my bladder was extremely full and hurt dramatically. I begged him use a catheter on me. Finally, probably after being sick of hearing me cry out in pain, he let the nurse use a catheter. Guess what? I was right. After my bladder was drained, the pain subsided and I was released to go home. The doctor apologized.

Another time I was taken to the hospital with multiple kidney stones. The ER rooms were full and patients on stretchers were lining the hallways. I was quietly crying from pain, curled up in a ball on my stretcher, watching as other patients were being paid attention to and given pain care. What were they doing different than me? They were loud and obnoxious.

I finally reached my breaking point. I allowed myself to yell out in pain and a few choice words also followed. In less than a minute, a nurse who had told me before that she couldn't give me anything for pain until they got me in a room was beside me with a dose of pain medication.

I know my body. Most people living with a chronic condition know their body and what is new, different, worse, or better. We just know. It’s time that providers trust us and realize that we are there for a reason. The vast majority of us are not trying to score opioids, but trying to get relief because we have reached our breaking point. 

One of the most important issues in an emergency room after lifesaving measures is the patient’s pain care. This is especially true in an acute situation, which is typically why we go to the emergency room in the first place. I don’t know many people who go to the ER or are hospitalized for chronic pain only.

The need for optimal pain care during hospitalization is high, but unfortunately proper and timely pain care is hit and miss at best.  

That’s why Pain News Network and the International Pain Foundation (IPain) are conducting a survey of pain patients about their treatment in hospitals.

The survey, which you can take by clicking here, will help us document how bad the problem is and what can be done to fix it.

Patients who try to be their own best advocate and take personal responsibility for their health should not be discarded because addicts or a small number of pain patients are abusing medications. Yes, abuse needs to be addressed. But pain should not be neglected. Controlling pain is important to the overall outcome of the emergency situation.

In past columns I have discussed the importance of asking for your pain medication at least 30 minutes before you may need them while in the hospital. That is because hospital nurses are trained to wait for you to ask for the medication before they order it -- even if the provider has it marked in your chart that pain medication is allowed. If you do not know to ask, your pain cycles and levels will become harder to control. I have been in this situation many times myself.

I know if I go to the hospital closest to my house, I will not get as good assistance with pain management as I would if I drove a little farther to another hospital. I have to consider other issues as well, such as how long I may have to stay at the hospital, will they have my regular medications, and will they have a staff that understands reflex sympathetic dystrophy and the secondary challenges that come with treating a ‘thick case file’ patient.

When I know I am being listened to as a valuable and knowledgeable patient and team member in my care, my pain will be better managed and I will rate the hospital higher in patient satisfaction surveys. When my underlying condition is not addressed, they’ll get a negative review.

Should a doctor be worried about how I am going to score them? Not if they treat me fairly, individually and as part of my treatment team. Does this mean they should just hand me whatever I ask for? No. It means that they need to use my personal assessment of pain as part of the planning for my care. Not doing so is neglecting the patient.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Shocked by Senators’ Letter on Patient Surveys

By Janice Reynolds, Guest Columnist

Last week I felt like my world had shattered.  Sounds extreme, I know, but someone who I believed in had turned on me both as a professional and someone living with persistent pain. It was not only me that Sen. Susan Collins (R-Maine) denied, but the pain community as a whole. 

An article and editorial in the Portland Press Herald told how Collins and 25 other senators had written a letter to the Secretary of Health and Human Services questioning whether patients should be asked about their pain control in hospital satisfaction surveys. After reading it, I felt sucker punched.  I have always supported and believed in Susan Collins, but how can I now? 

“I believe the pendulum has swung too far in favor of controlling pain, although I am not suggesting that the pain people experience is not real,” Collins said, although the rest of her letter certainly suggests that she does just that. (See “Senators Seek to Silence Pain Patients”)

The comment that I find truly disturbing is, “Currently, there is no objective diagnostic method that can validate or quantify pain. Development of such a measure would surely be a worthwhile endeavor.” 

The pain community has battled this notion forever. In 1968 Margo McCaffery wrote that pain is what the person says it is and exists when the patient says it does.  She was heavily ridiculed for that, although the World Health Organization included it in both their position statements on cancer pain and on chronic pain, and considers pain treatment a human right.

SEN. SUSAN COLLINS (R-MAINE)

So much of what Collins said appears to be from the Centers for Disease Control and Prevention (CDC) and Physicians for Responsible Opioid Prescribing (PROP). The comments rather prove my belief that the CDC’s attack on opioids and addiction is really more of an attack on people with pain, no matter the reason. To see the letter and the list of senators who signed it, click here.

The next day the Press Herald had an editorial which proved even worse. “Collins and the other senators question whether it’s wise to put such a high premium on these subjective judgments. Prompt pain relief is appropriate for some patients, but overuse of painkillers can cause harm, and a person in pain will not always be the best judge of whether the care was appropriate,” the paper said.

Please note they are no longer distinguishing between acute pain, pain in a cancer setting, pain in a non-cancer setting, or end of life pain.  They also ignore the fact that “no prompt treatment of pain” causes harm as well (that is why they call it torture). Both articles claim opioids are gateway drugs for heroin. Of course, no acknowledged expert in pain management was even consulted for the articles (because they are all in the pockets of the evil pharmaceutical companies mu-ha-ha-ha).  Interestingly, nobody seems to care that non-opioid pain medication is also brought to us by pharmaceutical companies.

What about these patient satisfaction surveys?  Are they really a problem or is this more hype to discredit people with pain?

As a hospital nurse for over 20 years I cannot think of one time where a provider wrote a prescription for opioid pain medication just to avoid getting a bad patient satisfaction score.  In reality the problem is the exact opposite; doctors and nurses who are bad at pain management, who don’t believe a patient’s report of pain, and who lack the knowledge to effectively relieve pain really don’t give a darn about a bad evaluation. 

There are, unfortunately, still many providers who fit into those categories.  I can’t tell you the number of times I got in trouble with a physician for advocating for a patient. But there are many providers who are good at pain management, knowledgeable, and compassionate as well.  I imagine these are the ones the senators really have a problem with.

Could someone please give me a definition of overprescribe?  It seems, in this case, it would mean prescribing any opioid or making a legitimate effort to manage a patient’s pain. 

In a hospital setting there are many reasons for opioids to be used, as it is the only medication shown to be effective for severe pain.  People can be in pain due to surgical procedures, trauma, intractable pain (pain was out of control at home), broken bones, pain flares, post stoke pain, shingles, gallstones, kidney stones, cellulitis, deep vein thrombosis, myocardial infarctions, cancer metastasis, organ impingement by a tumor, and many more reasons including comorbidities when someone is dying. 

Most times there is a combination of opioids, non-opioids, and non-pharmaceutical interventions (such as warmth or cold, physical therapy; some hospitals even have therapeutic touch and Reiki available).  Many patients’ may have opioids ordered but never need them all. There are also times when opioids are ordered, correctly, for reasons other than pain (gasp).  One thing we know is that untreated or undertreated pain in surgical or trauma cases can lead to persistent chronic pain

The person experiencing the pain knows it best.  Managing it should be a partnership between patient and provider.  There will never be an objective test for most types of pain, partially because it occurs for many different reasons. Someone may have multiple reasons for pain as well, which complicates it even further. 

Pain has a long history of stigma, prejudice and bias.  It may be the stoic nature of many cultures, and partly the bully syndrome that perceives someone in pain as weaker.  People in pain have been seen as malingers, drug seekers, liars, tricksters, and worse.  In women it has been called anxiety or worse. 

The senators want to eliminate two questions used in patient satisfaction surveys: “How often was your pain well-controlled?” and “How often did the hospital staff do everything they could to help you with your pain?”

To say the person experiencing pain is not the best judge of those questions is ludicrous.

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.