The other opioid crisis

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Even as Rochester health care providers grapple with the community epidemic of opioid addiction, they are hard at work averting another type of opioid crisis: a shortage of injectable opioids for home hospice and other outpatients who truly need them.

“Certainly, we are seeing some of the effects of the shortages within the community,” says Thomas Caprio M.D., associate professor of medicine/geriatrics, dentistry, clinical nursing, and public health sciences at the University of Rochester Medical Center, and chief medical officer of UR Medicine Home Care. “It’s much more challenging (now) to put together the plans for some of our patients who have intravenous infusion pumps (and certain other medications) at home.

“We’ve been successful doing that, but it has taken much more planning and effort to ensure that we have sufficient quantities and the right concentrations of the medications.”

Unintended consequences

Opioid addiction is a national crisis. More than 130 people a day die of opioid-related drug overdoses, according to the U.S. Department of Health and Human Services. In response, the U.S. Drug Enforcement Agency, which sets the aggregate production quota for opioid manufacturing, has for several years running cut production allowances. The move has had unintended consequences, however, contributing to nationwide shortage of injectable opioids.

Morphine, hydromorphone (also called Dilaudid) and fentanyl are the three most commonly used parenteral opioids—drugs administered by intravenous, epidural (spinal) or subcutaneous injection. They are used in hospitals to treat the pain of interventional procedures such as colonoscopies; in intensive care units for surgical, trauma, burn and oncology patients; in ambulatory surgical centers; and for patients—in and out of the hospital—with acute or chronic pain who cannot tolerate oral medications.

In February 2018, a group of professional organizations including the American Hospital Association and the American Society of Health-System Pharmacists asked the Drug Enforcement Agency to ease cutbacks planned for 2019.

“As DEA may be aware, hospitals and other providers are currently facing critical shortages of a number of injectable opioid medications, including morphine, hydromorphone, and fentanyl,” the letter stated.

Surveying its members in April, the ASHP found that 98.4 percent of respondents had experienced severe or moderate shortages of these drugs.

Caprio supports efforts to combat national and local opioid abuse, diversion and overdose. But he doesn’t want to lose sight of the fact that opioids still play a vital role in managing pain and easing breathing difficulties for some patients.

“The concerns…that keep me up at night is that I worry…the pendulum could swing (too far) the other way,” Caprio says. “(Opioids) may be very appropriate for patients who are at the end of life and require this for pain management.

“We need to have access and availability.”

Scarcity hits Rochester

Rochester specifically has experienced a shortage of parenteral opioids for community/at home hospice patients who need subcutaneous infusion pumps. In May, URMC found itself unable to locate hydromorphone for injection from any contracted home care pharmacy in New York State—and anticipated no resolution to the shortage any time soon.

“The community pharmacies,” Caprio says, “are not always carrying some of the medications in stock because the overall prescribing of the opioids has decreased, so there may be certain formulations or dosages they don’t have, or they have much more limited supplies.”

This does not by any stretch mean patients are coming out of surgery or going home without pain control. It does mean that some clinicians on hospital floors are concerned about discharge plans for patients who need parenteral opioids at home.

“I had a patient, a quadriplegic man who was in chronic severe pain, who had been on a subcutaneous infusion pump with Dilaudid at home because he had no other way to tolerate pain medication—he has an intestinal absorption problem,” says Judy Brustein, a palliative care nurse practitioner in Rochester. “The outpatient pharmacy tried to get medication for him and couldn’t.

“He eventually went home but his discharge was delayed for weeks. I worry about the prospect of patients having to die in a hospital or in a nursing home because the medication they need to go home is unavailable.”

Local hospital representatives say they know of no instance of this happening. They are working hard to make sure it does not.

“I remember even just three or four years ago we could pretty much get things set up within hours of having someone being discharged from the hospital to a community setting,” Caprio says. “Now we give it as long a lead time as possible (and) we’ve had to be much more proactive in talking with our community pharmacy partners that supply these medications.”

Fragile supply chain

Not all of the opioid shortage is due to DEA restrictions. Nationwide, opioid shortages have occurred periodically over the years. The latest one began when Pfizer Inc., which supplies 60 percent of U.S. hospitals with injectable opioids, in 2017 had to halt production at a newly acquired Kansas plant after the U.S. Food and Drug Administration found unsterile conditions. The company projected in June that shortages of injectable opioids will continue into 2019 as it deals with facility upgrades and quality issues.

It isn’t just injectable opioids in short supply. The ASHP website, which hospital pharmacists nationwide consult for procurement planning, in early November listed 195 “Current Drug Shortage Bulletins”—everything from morphine injections to yellow-fever vaccine.

Although the U.S. pharmaceutical industry is a giant approaching $500 billion in annual sales, its supply chain is vulnerable to shifting regulatory controls, manufacturing glitches, inaccurate demand projections, market forces and natural disasters. Hurricane Maria last year damaged a manufacturing plant in Puerto Rico that made IV fluid bags.

“We were scrambling to get the patients what they needed,” recalls Greg LoPresti, CEO of Upstate Homecare, a regional provider of home healthcare services including pharmacy and infusion therapies in Rochester.

He says Upstate Homecare has not been impacted by the injectable-opioid shortage because that’s not a niche it much serves. He has, however, had difficulties obtaining other drugs, including Edaravone for ALS, and “boutique drugs” for cancer and multiple sclerosis. Manufacturers favor the “big box” pharmacies such as CVS and Walgreens, LoPresti says.

“There’s a distributor lockout. …Artificial scarcity drives up prices,” he says.

Other Rochester pharmacists question the idea that scarcities are artificial—but they do agree that market forces impact their access to medications. Timothy Warner is associate director of Home Care Pharmacy Services at URMC, which supports the health system’s home hospice patients. With morphine and hydromorphone in short supply, Warner says, manufacturers and wholesalers are allotting the drugs according to customers’ past purchasing history. As a relatively new service without a long or sizable purchasing history, the URMC home care pharmacy has been restricted from ordering enough to meet demand.

“We’ve been unable to support the hospice program under Dr. Caprio until the product is in better supply,” Warner says. “We certainly have our hospital as a resource if we needed to obtain a drug from the hospital for short-term needs, but the hospital’s facing the exact same shortage that we are.”

“That puts more pressure on other community providers (such as CVS and Walgreens) that may have access to drugs because they’ve had a better purchase history with manufacturers,” he adds.

What that looks like on the ground is a lot of hospital and pharmacy-staff-time spent calling around to see what pharmacy has the drugs patients will need at home.

“It is not uncommon that we have to call out to maybe two or three community pharmacies, or utilize our outpatient pharmacy at the hospital, in order to identify that particular pharmacy that has that medication,” Caprio says. “It’s taken more effort but I think it’s well worth it. We don’t want any inappropriate delays in patients going home or to a community setting.

“When we’re dealing with a patient who’s approaching the end of life, the most important gift we can give them is the time that they have to be in those kinds of settings.”

Caprio says his team will “move heaven and earth” to get those patients into their home or community setting.

URMC now strives now to inform community pharmacies of medication needs days in advance of discharging a patient, he says, adding that the pharmacies have been very responsive, even calling partner pharmacies to locate medications.

Does this all take more staff time? Yes, absolutely, Caprio says. Does it raise health system costs? It certainly does.

Shortages raise health care costs

Prescription drug shortages cause an estimated $230 million in additional costs each year because of the rising prices of drugs under shortage and the higher costs of substitute drugs, according to a study published in September in the Annals of Internal Medicine. Conducted by researchers from the University of Pittsburgh, Harvard Medical School and other institutions, the study found that between 2015 and 2016, prices rose twice as fast for drugs in short supply.

Shortages also increase hospital labor costs. A 2010 survey of U.S. hospital pharmacists by Premier Healthcare Alliance found that drug shortages cost hospitals at least               $216 million annually in additional labor required .

Rochester General Hospital today devotes some 80 hours a week—the equivalent of two full-time jobs—managing pharmaceutical supply chain and availability issues, says Bob Reiss, associate director of clinical pharmacy for Rochester Regional Health.

Bob Reiss

“Ten years ago, you could order drugs and the next day they would arrive; there weren’t shortages,” he says. “(Today) you’ve got the business manager, you’ve got the purchaser, you’ve got your clinical pharmacists and people like myself (dealing with shortage issues).”

Reiss is talking about drugs used in Rochester Regional Health hospitals, not by outpatients or people in home hospice. To avert problems, he regularly checks ASHP and FDA shortage lists, and closely watches some 40 medications that impact the health system. The anesthetic agents lidocaine and bupivacaine have been in short supply, on and off, for a long time. Also scarce are generic injectables, including injectable opioids.

Mitigating risks

DEA quotas are a factor but so is the nature of the generic drug business. Without patent protection, margins are low, so fewer manufacturers serve the market. If one experiences production issues, sometimes no one else has the necessary plant capacity or FDA licensure—a safety protection—to take up the slack.

“It is a very fragile (supply) chain, especially for the generic compounds,” Reiss says. “It appears to be that their profit margin is so low…there are only a few plants that are out there, and they’re old, redundancies aren’t in place. If something happens, it just seems to fall apart, and we feel the effects of it.”

And it falls to clinicians and pharmacists to prevent these effects from harming patients. Reiss not only watches drug-shortage lists, he reads pharmacist blogs nationwide; a shortage in California might ultimately impact Rochester, so he wants to be proactive. If Drug A is scarce, Drug B will probably be next, when everyone starts using it instead.

“We’ve never had a patient not receive a medication they needed,” Reiss says. “That has never happened. …Maybe the physician is used to using hydromorphone and the patient will do just fine with fentanyl (with dosage adjustments).”

At the same time that he’s heading off or compensating for shortages, however, Reiss deals with the inherent risks of supply variability. In any system, standardization and repeatability reduce error. Of course, people aren’t factory widgets—when prescribing a drug, the clinician is always balancing the risks and benefits to that particular patient. But if the pharmacy has to recommend an alternative because the prescribed medication is unavailable, a different risk/benefit calculus comes into play—maybe not the optimal one. And, different medications come in different packaging sizes and strengths, raising the chances of dosage mistakes.

“Shortages…increase the risk of medication errors,” the Feb. 27 letter to the DEA stated. “Rather than selecting a product that might be most clinically efficacious for patients, during shortages prescribers are forced to order whichever IV opioid is available. Furthermore, dosing equivalency between the IV opioids differs significantly, which can lead to dosing errors.”

Hospitals mitigate these risks in interlocking ways. They use electronic communications to inform clinicians about supply changes and any dosing adjustments needed. They scan patient data at the point of care before administering medications. Their pharmacies repackage drugs into familiar sizes to avoid dosage errors. “We try to provide what people (clinical staff) are used to on the floors,” Reiss says. “If a pharmacy can’t get a certain size of morphine or hydromorphone/Dilaudid or fentanyl, we’ll see if we can get a larger bottle, and repackage it, and send it to the floors in the form they’re used to receiving.”

At URMC hospitals, the injectable opioid shortage of earlier this year has largely been resolved, says Travis Dick, associate director of pharmacy/clinical services. He is speaking specifically about his area of focus, which is hospital settings, not home and community settings.

“On the hospital side, we’re doing well at this time with supply of injectable opioids,” Dick says. “(W)e have adequate supplies to treat our patients for weeks and months, even, depending on the opioid that we’re talking about. …We were very proactive in keeping an eye on it and maintaining adequate supplies in the area.”

The shortages that peaked in the spring also have been averted for patients out in Rochester home and community settings. Nancy Horn is vice president of clinical operations for Lifetime Care, the home health care and hospice service slated to merge with Rochester Regional Health, and Lifetime Care Pharmacy, LLC. Horn says shortages of morphine and hydromorphone that Lifetime Care experienced a while ago now have eased.

“We keep more meds on hand than previously, as unsure when there might be another shortage,” she says.

Rochester health systems and community pharmacies—along with the school of pharmacy at St. John Fisher College—collaborate closely to stave off the impact of supply issues, RGH’s Reiss says.

“Pharmacy is a small world,” he says. “It’s a very close pharmacy family in the community. We talk about shortages, and share management strategies and information. We really are a partnership throughout the community for patient care.”

A new, non-profit model 

Some U.S. hospital systems are going a step further. Seeing no end in sight of drug shortages and rising prices, they have taken matters into their own hands. Civica Rx is a not-for-profit generic drug company formed in 2018 by a consortium seven organization—including the Mayo Clinic, Catholic Health Initiatives, Intermountain Healthcare and Trinity Health—representing approximately 500 U.S. hospitals. Its mission is to ensure that essential generic medications are accessible and affordable.

“The pharmaceutical industry for-profit manufacturing model has not measured up,” says Karl Williams, professor of pharmacy ethics and law at the Wegmans School of Pharmacy at St. John Fisher College, and a former hospital pharmacist. “Health systems are starting to fix the problem themselves by creating a not-for-profit manufacturing environment where they pool resources to solve ongoing supply issues. That is a creative and forward-thinking idea whose time has come.”

The FDA, meanwhile, has formed a drug shortages task force to advance long-term solutions. The DEA in April put out a statement that it is “committed to making further adjustments to individual procurement quotas as necessary and will also consider other measures that may be necessary to address potential shortages.” In August, however, it announced planned 2019 cuts averaging 10 percent for commonly prescribed opioids—including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl—consistent with President Donald Trump’s plan to cut nationwide opioid prescription fills by one-third within three years.

“None of the things about the plan of action for opioids at a Federal level has really, specifically, addressed some of the unique needs, particularly of older adults,” URMC’s Caprio says.

Comfort care kits

On the front lines of patient care in Rochester, Caprio says the health system is making sure home hospice patients are provided with “comfort care kits” containing medications for pain, anxiety, nausea, insomnia and breathing problems. UR Medicine Home Care works closely with inpatient teams at Strong and Highland hospitals to ensure patients can pick up necessary medications at the outpatient pharmacy as they head home, rather than rely on availability at community retail pharmacies. When hospice nurses visit patients at home, they call pharmacies until they find one that has needed medications.

“In past years, it maybe they just got prescriptions and were instructed to fill it once they got home,” Caprio says. “We’re not taking that chance with it. We’re trying to ensure that we’re getting those recommended medications right up front.”

Supplies for those comfort care kits themselves can be variable. In October, a community-pharmacy shortage of haldol and lorazepam tablets, used to treat end-of-life symptoms such as anxiety, had URMC able to maintain a small supply for home-delivered comfort care kits but alerting clinicians to consider alternative medications since patients would likely be unable to find the drugs at their community pharmacies for months. The merger of two manufacturers shut down production for weeks, and existing supplies were quickly depleted.

A balanced approach 

In grappling with health care needs throughout the Rochester community, Caprio sees education as a powerful tool. He is director of the Finger Lakes Geriatric Education Center at the URMC, which works on workforce development and family engagement to improve health outcomes for older adults. FLGEC is collaborating with the Monroe County Department of Public Health and Lifespan, which provides services for seniors and caregivers, to directly address the opioid epidemic for older adults and what it means for their families.

Since the nation started grappling with the crisis of opioid abuse, patients have grown more concerned about using the medications, pharmacists are warier of filling prescriptions, and clinicians are more hesitant to prescribe them, Caprio says. Many people don’t understand the special needs of hospice patients and the laws easing prescription barriers for them.

“I’ve had to provide education even just on the phone to pharmacists, when we are prescribing what would be viewed as large doses or exceeding certain thresholds in their minds,” Caprio says.  “There’s still a lot of confusion in the community.”

The crisis of opioid abuse has changed the national dialogue and awareness in positive ways, he says. Vigilant attention to the dangers of opioids is critically important. At the same time, patients with severe pain, such as cancer-related pain, still need access to the drugs, as prescribed by practitioners who use the medications appropriately—as long as they can get them.

“It is definitely more of a challenge,” Caprio says. “I think people are much more mindful now, appropriately. (But) the things that keep us up at night involve finding the right balance…maintaining that level of caution, but also ensuring access for the patients who really need it.”

 

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