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March 22, 2016

Hospital Pharmacies Cope with Surge in Drug Prices

WHEN THE STAFF AT BAYSTATE HEALTH in Massachusetts observed an alarming series of price increases for the vasodilator drug nitroprusside last year, the integrated health system took a strong step in response.

“Over a period of time during 2015, we just basically booted nitroprusside out of the building,” said Gary Kerr, chief pharmacy officer for the health system.

Nitroprusside and an inotropic drug, isoproterenol, sold by Valeant Pharmaceuticals International, Inc., were among the medications discussed during a December 9 Senate Special Committee on Aging hearing that examined sudden price spikes affecting off-patent drug products.

Valeant’s website states that the company markets more than 200 prescription drug products. The company has made headlines and angered legislators by purchasing the rights to older drugs and then dramatically increasing their prices.

“We’re very acutely aware of drug prices,” Kerr said. “Part of our modus operandi here has always been to manage our drug utilization, our drug selection, and our budgets as thoughtfully as we can.”

He said the “dramatic and sudden” increase in the price of nitroprusside was debated in a series of pharmacy and therapeutics committee meetings last year, with active input from three surgical departments and the emergency department physicians.

Kerr said the group compared normalized treatment costs for nitroprusside and two alternative drugs—clevidipine and nicardipine—and ultimately decided to drop nitroprusside from the formulary.

The new treatment cost for nitroprusside would be 8 to about 60 times the cost for the alternative drugs’ vials or premixed injection, according to Kerr’s figures.

Kerr said the health system’s physicians supported the formulary decision even though it meant changes to patient care.

“There are some nuances with the drugs and their indications, but the docs are very, very cooperative with us. They know that the . . . drug formulary is a critical management tool for us,” Kerr said.

Joel Melroy, manager of adult inpatient pharmacy services for Medical University of South Carolina (MUSC) Hospital Authority, similarly emphasized pharmacy’s role in managing drug costs.

“We, as pharmacists, are in the business of ensuring that our patients have the best therapy and the most cost-effective therapy to the patient, to the hospital, and to the payer,” Melroy said.

Melroy said last year’s increases in the price of nitroprusside, a relatively low-use drug, weren’t a major issue for the health system. But the increased cost of isoproterenol was a problem.

Melroy said the pharmacy team analyzed where and how the drug was being used in the hospital and concluded that stocking smaller vials of the drug would blunt the price increase.

“We’ve tried to soften the impact as much as we can by doing what we can—which is actually very little—to decrease the cost that the hospital and the health system is actually incurring,” he said.

Jerome Wohleb, director of pharmacy services at Bryan Medical Center in Lincoln, Nebraska, said the pharmacy previously prepared i.v. bags with isoproterenol for use as needed in the cardiology service and the intensive care unit.

“Now, we don’t mix it up until [it’s time] to hang it, which means a physician says, ‘I’ve got to have it,’ ” Wohleb said.

To similarly minimize the waste of nitroprusside, he said, “We’ve tried to reduce the sizes of our mixed products and watched how we are administering it.”

Wohleb emphasized that the problem of price increases affects “substantially more” than just the two Valeant drugs.

He said the price for the 20 most costly drugs purchased by the hospital in the past 18 months has increased by 11%, on average, or about $2 million. For workhorse drugs that are widely used throughout the hospital, such as analgesics, anesthesia drugs, and surgical drugs, the cost increases over 18 months have ranged from 126% to 5,000%.

Wohleb said his medical center “really is counting on the pharmacy to be a solution” to the problem of high drug costs.

“What we’ve done here to counter this change is to really beef up our clinical services, and try to work collaboratively with physicians, and target some of our expensive drugs so that we can appropriately use drugs that are needed,” Wohleb said. He said an active therapeutic interchange program is a big part of that effort.

Jason Mills, pharmacy supply chain manager for MUSC Hospital Authority, noted that there are drawbacks to changing long-established medication therapy for reasons other than clinical benefit.

“The drugs in the Valeant catalog are staples. They’re old drugs. They’ve got the proof that the evidence-based practice is there. It’s really hard to drive practice change when you’ve got decades of proof that this agent is effective,” Mills said.

Such changes also affect the implementation of order sets and various parts of the medication-use process.

“We heavily use barcode scanning on different phases of our distribution process,” Melroy said. That means, he said, that whenever MUSC’s pharmacy distributes a drug product that has a different National Drug Code number than a previously distributed product, “there is a lot behind the scenes that has to happen” to ensure the change is recognized by the order sets that specify the drug.

Mills said the same issues arise when the hospital makes purchasing changes in response to drug shortages. But he said there’s often less mystery associated with shortages than with price increases.

“With a shortage, you’re kind of dealing with a fixed timeline. Typically, you reach out to the manufacturers, and they give you an estimate as to when the product in question is going to get back into the supply chain or if it’s been discontinued outright. So you have a little more clarity,” Mills said.

Kerr said that in the past, Baystate took little notice of the weekly reports on drug price changes from the health system’s wholesaler.

“We’re paying attention right now,” Kerr said. “You’ve got to have an infrastructure, and you’ve got to have people committed to this. . . . This is something you’ve got to manage every week, if not every day.”

A statement posted on Valeant’s website in response to the December 9 Senate hearing explains that because most hospitals use small amounts of isoproterenol and nitroprusside, the price increase “has had a limited impact on the average hospital’s cost.” The company also stated that it is working with “the small number of hospitals who use a large volume of the drugs” to provide “significant volume discounts.”

Erin R. Fox, director of the drug information service for University of Utah Health Care, testified during the Senate hearing that she had called Valeant to negotiate price concessions for isoproterenol and nitroprusside.

“Each time I called, I was referred back to my wholesaler for the purchase price,” she said. “Each time, the answer was, ‘Talk to your distributor.’ ”

–By Kate Traynor, reprinted with permission from AJHP (February 15, 2016; volume 73, pages 182, 184)




March 17, 2016

Medicare Project Helps Put Pharmacists in Primary Care

AN ONGOING MEDICARE demonstration program with a medication management component shows some hope of reducing healthcare costs through the use of team-based primary care services.

An analysis of first-year data from the Comprehensive Primary Care Initiative (CPCI), which started in the fall of 2012 and runs through this year, found that the cost savings to Medicare nearly equaled the $141 million in care-management incentives paid to the participating practice sites.

A report commissioned last year by the Centers for Medicare and Medicaid Services (CMS) called this finding “promising,” since savings weren’t expected during the program’s first year. But the report noted that the cost offsets varied by region and urged caution in interpreting the initial data.

Nearly 100 CPCI sites have implemented comprehensive medication management services.

The CPCI includes about 500 primary care practices in seven geographic regions. Each participating site receives per-member-per-month (PMPM) payments from CMS and other payers and may be eligible for additional shared-savings incentives.

Among the initiative’s requirements are that all participating sites implement one or more primary care strategies—comprehensive medication management, integrated behavioral health services, or patient self-management support services—as part of CPCI’s focus on population health.

Sites are encouraged, but not required, to implement all three of these strategies by the end of the demonstration project, according to CMS.

The most recent data from CMS indicate that nearly 100 CPCI sites have implemented comprehensive medication management services and 74 practices have brought at least one pharmacist onto the healthcare team to provide the services.

Katherine O’Neal

Katherine O’Neal

Clinical pharmacist Katherine O’Neal of OU Physicians, an internal medicine clinic affiliated with the University of Oklahoma School of Community Medicine in Tulsa, is one of those pharmacists.

“I am completely integrated into the clinic,” O’Neal said. “I do medication reconciliation and daily prescription reviews and medication monitoring for all medications prescribed in our clinic, and I provide support for medication use and self-management.”

She also works to resolve medication-related issues that occur during transitions in care and sees patients by referral to help them control chronic conditions such as diabetes, hypertension, chronic obstructive pulmonary disease, and dyslipidemia.

O’Neal is the internal medicine clinic’s only pharmacist and is onsite 4.5 days per week. Her position is funded through the University of Oklahoma College of Pharmacy, where she holds the titles assistant professor and adjunct associate professor.

Nearly a quarter of the pharmacists working at CPCI sites are funded through an academic appointment, according to CMS. About half have been directly hired by the practice group, and 14% work under contract. Other sources fund the remainder of the positions.

According to CMS, all of the CPCI sites that focus on medication management provide medication reconciliation services, and most also address medication coordination during care transitions and medication review and assessment. Nearly half have collaborative drug therapy management agreements in place.

Jessica Binz, director of clinical pharmacy education at the University of Arkansas for Medical Sciences—West Family Medical Center in Fort Smith, said her practice site participates in several quality initiatives, including CPCI.

The new payment mechanisms… are going to open up tremendous opportunities for pharmacists.

Binz practices under a collaborative drug therapy management agreement—known in Arkansas as a “written protocol”—and also works closely on medication-related issues with the transitions-of-care team.

“I do smoking cessation and medication management for smoking cessation as well,” Binz said. “We have an interdisciplinary team that works with patients that are interested in stopping smoking.”

Binz said the smoking-cessation program started last October and is going well. She said one of the positive trends is that her patients, many of whom have “issues with transportation,” find ways to get to their follow-up appointments.

All of the Medicare beneficiaries in the practice—about 650 people—are considered part of the CPCI population, Binz said. Overall, according to CMS, the CPCI practice sites are responsible for the care of about 2.7 million patients, including more than 400,000 Medicare and Medicaid beneficiaries.

F. Alison Gray

F. Alison Gray

F. Alison Gray, ambulatory care pharmacist at the Little Rock Family Practice Clinic in Arkansas, said she was initially brought into the CPCI-participating clinic to help patients reduce their medication costs, mostly by increasing the use of generics and ensuring that prescribing is aligned with each patient’s pharmacy plan.

After she found that the healthcare team was already doing a good job of keeping drug costs down, she turned her focus to warfarin management because it is “fairly straightforward” to implement and manage.

“Once I got that off the ground, then I moved on to diabetes education, which is really my passion,” said Gray, who worked with the clinic’s dietitian to develop a diabetes education program for patients.

“We have individual and group visits as well as a monthly support group that we have put together. And so far, it’s been pretty successful. We’ve seen some pretty good outcomes with patients,” Gray said.

Gray said she will be evaluating diabetes outcomes measures for CPCI. For warfarin-management patients, she is collecting data on their International Normalized Ratio (INR) values and examining whether patients are having their INR checked regularly.

Outcomes measures like these may help practice sites qualify for incentive payments from insurance programs that participate in the CPCI.

CMS initially identified 31 payers that covered a substantial portion of the practice sites’ patients, agreed to contribute to PMPM payments, and, in some cases, offered pay-for-performance bonuses or other incentives to improve population health.

Marie Smith, assistant dean for practice and public policy at the University of Connecticut School of Pharmacy in Storrs, said the multipayer participation is an unusual cornerstone of the CPCI.

Smith explained that it’s difficult for practice sites to disrupt their processes to participate in individual initiatives by different payers. She said having payers working in concert, as they do in the CPCI, minimizes this problem.

But she said it’s the PMPM payments, which largely come from CMS, that have really boosted the CPCI by providing start-up funds for sites to hire the pharmacists and other staff needed to meet the program’s milestones. She contrasted that strategy to shared-savings incentives, which are generally paid out only after outcomes have been assessed and long after the care is delivered.

Smith spent six months during 2013 on faculty leave at the CMS Innovation Center, where she focused on creating a road map for the integration of clinical pharmacy services into CPCI practice sites. She said the near-universal existence of state collaborative practice laws in 2012 gave CMS staff the confidence that pharmacists would be able to work effectively under the CPCI model without running afoul of scope-of-practice regulations.

CMS’s implementation guidance for CPCI participants recommends that practices focusing on medication management include a clinical pharmacist on the healthcare team. According to CMS, the pharmacist should be involved in patient care either directly or by performing chart reviews and making therapy recommendations.

The pharmacist should also help the practice identify patients who are at high risk for poor health outcomes and would benefit from medication management. And, according to CMS, the pharmacist should participate in care team meetings and help develop processes to improve medication use and safety.

“It’s an exciting time to be in primary care because there’s so much experimentation going on,” Smith said. “The new payment mechanisms, I think, are going to open up tremendous opportunities for pharmacists.”

–By Kate Traynor, reprinted with permission from AJHP (March 15, 2016; volume 73, pages 346, 349, 350)

January 22, 2016

Drug Price Hikes and Shortages Have Similar Roots, Experts Say

Filed under: AJHP News,Current Issue,Uncategorized — Tags: , — jmilford @ 11:13 am

photo by Matthew LesterEXPERTS SAY THAT RECENT INCREASES in the prices of off-patent generic drugs are closely tied to the drug shortages that have plagued hospitals for years.

“They have the same root cause: a lack of competition in certain parts of the generic market,” said Gerard Anderson, professor of health policy and management, medicine, and international health at Johns Hopkins University in Baltimore.

Anderson was one of four experts who testified at the Senate Special Committee on Aging’s December 9, 2015, hearing on the cause of sudden price spikes affecting off-patent medications.

“The first indication we had of problems in the generic market were not prices; they were shortages. Hospitals were having serious problems filling prescriptions,” Anderson said. “The second manifestation we’re getting now is the higher prices for certain generic drugs.”

Anderson said that without competition, drug companies “can raise their prices several thousand percent simply overnight.”

Several companies have done just that, as exemplified by price increases for the pyrimethamine product Daraprim, which was developed in the 1950s and is used to treat Toxoplasma gondii infections.

“In 2005, a patient . . . with toxoplasmosis could expect to spend $70 on a typical course of Daraprim,” said Senator Claire McCaskill of Missouri, the committee’s ranking member.

This type of arbitrary and unpredictable inflation is not sustainable for our hospitals.

She said that in 2010, after CorePharma bought the rights to the drug, the cost of a course of treatment rose to “roughly $900.”

“In August of this year, the rights of Daraprim were once again sold, this time to Turing Phamaceuticals,” which again raised the price, McCaskill said. “An almost 1200% increase in 2010 was bad enough, but an additional 5500% price increase on a 62-year-old drug shocks the conscience.”

David W. Kimberlin, codirector of the pediatric infectious diseases division at the University of Alabama in Birmingham, said Turing’s price hike has seriously affected the ability to care for infants and immunocompromised people with serious or life-threatening toxoplasmosis.

Not only has pyrimethamine’s price risen astronomically, he said, the product is now available only through a specialty pharmacy that will not sell the drug to compounding pharmacies. Kimberlin said this has disrupted the hospital’s established relationship with the pharmacy that compounds a liquid formulation of pyrimethamine from the commercially available tablets.

Kimberlin, a past president of the Pediatric Infectious Diseases Society, said the infectious disease organization is aware of “at least 30-plus cases where people could not, in a timely fashion, get pyrimethamine” because of price or distribution network issues.

Turing, Valeant Pharmaceuticals, Retrophin, Inc., and Rodelis Therapeutics are the initial focus of the Senate committee’s investigation of companies that purchase the rights to off-patent medications and then greatly increase their price.

The tactics employed by these drug companies were universally reviled during the hearing, with speakers describing the actions as arbitrage, hostage taking, ransom, price gouging, and, in the words of committee chair Susan M. Collins of Maine, “just plain wrong.”

Collins said additional hearings will be scheduled to examine the problem and seek solutions.

Erin R. Fox, director of the drug information service for University of Utah Health Care in Salt Lake City, told committee members that the prices for nitroprusside and isoproterenol increased dramatically after the rights to the drugs were sold to Valeant in 2015.

“When we became aware of these new price increases, we calculated the potential impact to our pharmacy budget . . . if we continued to purchase the same amount of each drug,” Fox said. She said that compared with 2014, the additional cost to the health system would be “$1.6 million for isoproterenol [and] almost $300,000 for nitroprusside.”

“This type of arbitrary and unpredictable inflation is not sustainable for our hospitals, especially when we receive capitated payments for most of our patients,” Fox said.

She said hospitals handle such high prices in the same way they do drug shortages: by rationing drugs, stocking smaller quantities, and devoting “huge hours of manpower” to managing the problem.

Fox said University of Utah Health Care has not found a way to appreciably cut its use of nitroprusside.

But the health system responded to the increased price for isoproterenol by removing the medication from approximately 100 crash carts, where it had been freely available for emergencies. Now, she said, pharmacists bring the medication with them when responding to codes, which has reduced the routine use of the drug.

She said physicians strongly supported the change.

“They were very willing to work with us,” Fox said. “Our physicians were appalled. They were so frustrated to learn that these old medications that they had given forever had just skyrocketed in price.”

Fox said she’s unaware of any instances in which patients have been harmed because their physicians no longer have unfettered access to isoproterenol. But she lamented that the change in access was driven by cost instead of clinical factors.

“It is concerning when you have to make changes based on price alone,” Fox said.

Mark Merritt, president of the Pharmaceutical Care Management Association (PCMA) in Washington, D.C., said the business strategy driving the price hikes affects a relatively small number of drugs but is destabilizing reimbursement practices surrounding those medications.

“This is really a pretty new development that we’ve had to deal with rapidly,” Merritt said.

Merritt said PCMA hasn’t found a silver bullet to solve the problem. But he praised the decision of Imprimis Pharmaceuticals, a compounding pharmacy, to offer a low-cost alternative to Turing’s pyrimethamine product.

Imprimis has announced that it will, upon receipt of a prescription, provide customized formulations of pyrimethamine–leucovorin priced at “$0.99 per capsule.”

Several committee members asked the panelists whether compounding pharmacies could play a greater role in preventing price hikes affecting off-patent drugs.

Fox emphasized that compounded products are critically important for some individual patients, but she said compounding is not a “blanket, one-size-fits-all solution” to the problem of price hikes.

“Compounding is not perfect. Patients have been harmed by poorly compounded drugs,” she said.

Other potential solutions raised by the committee and panelists included speeding FDA’s review of marketing applications for older generic drugs that have no competition in the marketplace and instituting price regulations for these drugs akin to the regulations that affect public utilities.

ASHP has submitted an official statement to the committee about the issues Congress is investigating.

“We are eager to learn more about why these price spikes are occurring and to explore potential policy options and market-based solutions that may exist to minimize the likelihood of this occurring in the future,” said Kasey K. Thompson, ASHP vice president of policy, planning and communications, in a press release accompanying the statement.

–By Kate Traynor, reprinted with permission from AJHP (February 1, 2016; volume 73, pages 98-99)



October 27, 2015

Pharmacists Find Ways to Make ADCs Work in the ED

Filed under: AJHP News,Clinical,Current Issue,Innovation — Tags: , , , — Kathy Biesecker @ 11:03 am

PHARMACISTS SAY AUTOMATED DISPENSING CABINETS (ADCs) can bring efficiencies to the care of patients in the emergency department (ED), but it’s important to ensure that nurses aren’t worried about being administratively locked out of the devices during a crisis.

PatriciaKienlePatricia C. Kienle, director of accreditation and medication safety for Cardinal Health Innovative Delivery Solutions, gave two examples of how such a crisis might come about: “A patient presents as a ‘John Doe,’ or it’s a trauma patient who you just have to take care of right away.”

At such times, she said, patient care trumps everything—including the usual procedures for logging the patient into the electronic medical record (EMR) system, routing medication orders to the pharmacy for verification, and releasing the drugs to nurses at the ADC.

“It happens in every hospital,” Kienle said. And, she said, hospitals devise different solutions to give ED nurses quick access to medications in such situations.

Michelle C. Corrado, system director of pharmacy services for Hallmark Health System Inc., of Medford, Massachusetts, said her organization’s ED nurses can use a “911 dummy” account in the Pyxis ADC when medications are needed for a patient whose information has not been entered into the EMR system.

“This was a way . . . for them to get access to the life-saving meds that they need without the patient’s name,” Corrado said. “It’s [for] somebody who’s unresponsive or unconscious or has no identification, and there’s no family there to help with the registration process, and they just need meds to get the patient out of the critical stage.”

William W. Churchill, chief of pharmacy services at Brigham and Women’s Hospital in Boston, said there’s no such dummy account to allow urgent access to the Omnicell ADCs in his institution’s ED. But nurses can manually create an entry in the devices for specific patients whose information isn’t available when a medication is urgently needed.

“They might type in ‘Smith, John, medical record number 123456789.’ And the Omnicell will accept that, and the nurse can get the drug,” Churchill said.

Corrado said any medication in the ADC can be removed by using the 911 dummy account. But she said the nursing staff is expected to use the patient’s correct account as soon as it’s available instead of continuing to remove medications using the 911 dummy code.

Both pharmacists said these solutions require pharmacy staff to be diligent about following up to make sure their dispensing records are accurate.

“Our informatics team gets a report of all the 911 entries that are made,” Corrado said. “So we can go back and get the information from the nurse in terms of who is ultimately attached to that so that we can get all the billing and everything correct.”

MichelleCorradoCorrado said the reconciliation process isn’t difficult, but it does involve manual data entry to correct the patients’ accounts.

A critical component of ADC use at Brigham and Women’s was the development of a list of medications subject to automatic pharmacy verification through the EMR system. Nurses can pull those medications from the ADCs, effectively overriding the pharmacy review.

“We have a defined list, which was done collaboratively between the ED, medical, nursing, and pharmacy. And we also collaborated and agreed upon which orders would be ‘autoverify’ and which would require a pharmacist’s review,” Churchill said.

He said an ADC in a trauma room will contain more autoverify medications than a dispensing device located elsewhere in of the ED.

“When a patient is in need, we need to be able to provide that drug,” Churchill said.

Overrides, like dummy accounts, must be reconciled, he said.

“We get a report that’s generated the next day. Then we ask the pharmacists that are staffing in the area to take a look at the overrides and make sure that they’re appropriate,” Churchill said.

Andrew Kaplan, pharmacy supervisor at St. Catherine of Siena Medical Center in Smithtown, New York, said his hospital installed ADCs in the ED nearly a decade ago after consulting with the ED staff about which medications to stock in the cabinets.

For situations when seconds count, as during “an absolute emergency,” Kaplan said, “we’ve created a dummy patient account called ’emergency patient’ to allow them to pull something out that’s urgently needed.”

We’re trying to leverage our electronic medical record and our automated dispensing cabinets to improve patient care.

In somewhat less urgent situations (e.g., a patient is not yet registered), nurses can type whatever information they have about the patient directly into the Pyxis unit and then obtain the medications, he explained.

“We encourage them to put in as much information as possible, so at least it gets entered as a temporary patient,” Kaplan said.

He said the hospital’s Epic EMR system is the brains behind the successful deployment of the Pyxis unit in the ED and the ability to reconcile dispensing records.

“Our Epic EMR knows everything that happens in Pyxis. So there’s a linkage between the two,” Kaplan said.

Kaplan said ADCs allow the pharmacy to store and manage “hundreds of units of medicines” in the ED and improve the drug delivery process in various ways.

“We’re trying to leverage our electronic medical record and our automated dispensing cabinets to improve patient care,” Kaplan said.

For example, he said, the Pyxis unit in the ED has “auxiliary towers” for the storage of i.v. antimicrobials and large-volume medication preparations. With this feature and changes to the EMR system, he said, nurses no longer “run back and forth from the emergency department to the pharmacy” to obtain i.v. aztreonam for patients with penicillin allergy. Now, he said, the drug is administered within an hour of ordering 64% of the time, compared with 16% of the time before the changes were made.

Linda Lipsky, director of pharmaceutical services at Methodist North Hospital in Memphis, Tennessee, since 1992, recalled that drug dispensing in the ED used to be “kind of a free-for-all,” with nurses essentially taking whatever they needed for their patients from medication carts.

When ADCs were first introduced, they didn’t really fix that problem, she said.

“There was no control over it at that point, because we didn’t have profiles,” Lipsky said, referring to the system through which the pharmacy views information in the EMR and reviews and verifies drug orders, allowing the release of medications from the ADCs. Without the profile process, she said, every medication in the ADC was essentially on override status.

Now, she said, her community hospital uses Omnicell ADCs with profiling enabled to ensure that a pharmacist reviews the orders before administration, with overrides allowed for emergencies.

Lipsky said pharmacy, nursing, and medical staff worked together to create the override list. Once the nurses became familiar with the profiling capabilities and the override drugs, the ADCs were better accepted, Lipsky said.

“Like any change that you make, it’s slow when you start because you’re not real familiar. But then once you get into it, it’s no big deal,” she said.

–By Kate Traynor, reprinted with permission from AJHP
(November 15, 2015; volume 72, pages 1921-1922)





February 23, 2015

Know What’s in Airplane’s Emergency Medical Kit, Two Pharmacists Say

Filed under: AJHP News,Clinical,Managers,Quality,Residents,Students — jmilford @ 6:34 pm

AS TWO PHARMACIST LEARNED ON A RECENT TRIP, domestic passenger-carrying airplanes with a flight attendant also have onboard an emergency medical kit with a small assortment of medications and supplies.

The Federal Aviation Administration (FAA) has required such a kit since 1986.

Since 2004, this kit (see sidebar) at a minimum has contained several medications in addition to the originally required 50% dextrose injection, epinephrine injection 1 mg/mL, diphenhydramine injection, and nitroglycerin tablets.
That was also the year by which airplanes with a capacity of at least 30 passengers had to start carrying an automated external defibrillator (AED).

FAA in addition requires the airlines to ensure that each crewmember receives training for in-flight medical events.

Some of that training was put to the test this past December, after a passenger lost consciousness on a United Airlines flight from Houston to Los Angeles.

DeeDee HuDeeDee Hu, a clinical specialist in critical care at Memorial Hermann Memorial City Medical Center in Houston, said she reached the man ahead of the flight attendants, did not detect a pulse, and repositioned him across the row of coach-class seats in preparation for chest compressions.

When he suddenly regained consciousness, albeit temporarily, Hu said she further assessed him and asked about his medical history.

The flight attendants “immediately pulled out the AED,” said Sapana Desai, a clinical pharmacy specialist in emergency medicine at Memorial Hermann who, like Hu, happened to be seated near the ill passenger.

But the emergency medical kit did not surface until a physician asked for an i.v. set to infuse fluid, she said.

The family practice physician and a nurse had responded to the overhead page for medical personnel.

Before the physician arrived, however, Hu had called out for aspirin in case the man was having a myocardial infarction.

“I didn’t know that they had this kit,” she said, “so my first thought was, let’s find someone on the plane with aspirin.”

A passenger did provide a tablet of low-dose aspirin, Desai said, and the ill man chewed it between episodes of unresponsiveness.

Desai said the flight attendants’ primary focus had appropriately been on pulling out the AED from where it had been stowed in the cabin.

“But it would have been helpful to have known that the kit was available to us for use,” she said.

The list of minimum contents for the current FAA-approved emergency medical kit was proposed in 2000 and finalized in 2001.

An FAA-led study of in-flight medical care provided in 1996–97 found justification for addition of the following items to the 1986-issued list: oxygen, supportive care items, equipment for closely monitoring a patient, analgesics, a bronchodilator inhaler, and an oral antihistamine.

In at least 70% of the cases in which one of the foregoing items had been deployed, the research team reported in 2000, the passenger in need of medical care improved.

The research was based in part on a survey of U.S.-based air carriers that contract with MedAire Inc. for in-flight medical support.

Heidi MacFarlane, a vice president at MedAire, said FAA undertook the research because passenger-carrying airplanes would soon be equipped with AEDs.

The Aviation Medical Assistance Act of 1998 had directed the FAA administrator to decide whether to require AEDs on passenger-carrying airplanes. If the answer was yes, the law required a decision as to the AED-associated equipment and medications that must be in the emergency medical kit.

At the time, the American Heart Association’s algorithm for providing advanced cardiac life support to an adult after defibrillation for cardiac arrest included the possibility of i.v. injections of epinephrine followed by an antiarrhythmic drug.

FAA selected lidocaine as the antiarrhythmic drug for the emergency medical kit.

In 2010, the American Heart Association declared amiodarone the first-line antiarrhythmic drug to be given during cardiac arrest.

Sapana DesaiDesai and Hu said the lack of amiodarone is not the medical emergency kit’s only deficiency.

They pointed to the need to have an injectable drug product for passengers having a breakthrough or acute seizure.

In addition, the pharmacists said, the medical emergency kit should have glucagon for injection, which would immediately help passengers having an episode of hypoglycemia and, unlike dextrose injection, does not require i.v. access.

MacFarlane said the airlines can augment their medical emergency kits without seeking FAA’s approval but cannot provide a substitute for or smaller amount of any item on the agency’s list.

“We recommend that they have EpiPens onboard,” she said, referring to a branded version of 1-mg/mL epinephrine injection 0.3 mL in an autoinjector. “But they’re significantly more expensive, and even if they have the EpiPens they still have to have the [1-mL] epinephrine as it’s . . . required by the regulation.”

That regulation specifies two strengths of epinephrine injection. The 1-mg/mL concentration, commonly used in the emergency treatment of allergic reactions, must be present as two single-dose 1-mL units. The 0.1-mg/mL concentration, which is the common strength of epinephrine for treating cardiac arrest, must be present as two single-dose 2-mL units, which would provide two 0.2-mg doses; the American Heart Association’s recommendations for advanced cardiac life support of adults call for 1-mg doses.

MedAire’s Paulo Alves, global director of aviation health, said the requirement for 2-mL units, rather than 10-mL units, must be a typo or mistake. To his knowledge, every supplier of medical emergency kits to the airlines provides the 0.1-mg/mL epinephrine in 10-mL units, said Alves, who is chair of the Air Transport Medicine Committee of the Aerospace Medical Association.

Heidi MacFarlaneMacFarlane said her company uses data from its ground-based medical advisory service to suggest to airlines the drugs that would be useful onboard from a risk-management standpoint.

“There are some basic things that we do recommend . . . , typically drugs that are in a form that could be delivered by a layperson under the instruction of somebody from our ground-based medical service,” she said.

Ondansetron, an antiemetic available as an oral disintegrating tablet, is another common recommendation, especially for long-haul flights, MacFarlane said. “If you can stop [the passenger] from vomiting, then we can prevent dehydration, which may allow the flight to continue rather than having to make a medical diversion.”

As for the task of finding items in the kit, MacFarlane said the presumption is that items, some of which are prescription drug products, “would only be dispensed by someone who’s qualified to do that.”

For example, a flight attendant would not pull out items from the kit unless under the direction of a ground-based physician who knows the arrangement of the kit, she said.

Airlines’ medical emergency kits have not escaped the nation’s drug shortages. FAA has at times granted temporary exemptions from the onboard requirements for specific drugs. For example, an exemption from the requirement for dextrose injection is in place until March 31, 2016, unless FAA rescinds or modifies the exemption.

FAA has not updated the kit’s list since 2001, an agency spokeswoman confirmed, and has not scheduled a review of it. Suggestions, however, may be directed to Federal Air Surgeon James R. Fraser, Office of Aerospace Medicine, Federal Aviation Administration, 800 Independence Avenue, SW, Washington, DC 20553-0001.

–By Cheryl A. Thompson, reprinted with permission from AJHP
(Feb. 1, 2015; volume 72, pages 176, 178, 180)


California Strengthens Antimicrobial Stewardship Mandate for Hospitals

A CALIFORNIA LAW THAT GOES INTO EFFECT this summer strengthens the state’s previous requirement for acute care hospitals to practice antimicrobial stewardship.

Starting July 1, acute care hospitals in California must put into effect antimicrobial stewardship programs that follow federal and professional society guidelines and include a process to evaluate the judicious use of antimicrobials. The law specifies that the stewardship teams must be multidisciplinary and include “at least one physician or pharmacist” who has expertise and training in antimicrobial stewardship.

California is the only state that has enacted legislation mandating antimicrobial stewardship for hospitals.

The law, which was passed last September, supplements legislation from 2006 that mandates stewardship programs for California’s acute care hospitals and requires the state health department to assess them for compliance.

The older law required hospitals to “develop a process for evaluating the judicious use of antibiotics” but didn’t define the process.

As a result, said Olga DeTorres, infectious diseases (ID) clinical pharmacist at Palomar Medical Center in Escondido, “hospital administrators have been very creative in what they define as antibiotic stewardship.”

DeTorres serves on the antimicrobial stewardship subcommittee of the state health department’s Healthcare Associated Infections Advisory Committee. She said many hospitals in the state have not invested in hiring staff to perform tasks like chart reviews and prescriber follow-up and education to improve antimicrobial use.

“Many hospitals just leave it up to the pharmacist to do it at the end of the day, if they get caught up with their work,” she said.

About half of the 233 California acute care hospitals that responded to a state health department survey during 2010–11 reported having a stewardship program, according to a report published in the April 2013 issue of Infection Control and Hospital Epidemiology.

The report stated that 20% of the survey respondents either did not plan to implement a stewardship program or were uncertain of their ability to do so. Among these respondents, 47% cited staffing constraints and 42% named lack of funding as barriers to implementing stewardship programs.

Nonfederal U.S. hospitals in 2012 spent about $375 billion on antibacterial, antifungal, and non-HIV antiviral drugs, according to the 2014 version of AJHP‘s annual article on national trends in prescription drug expenditures [see March 15, 2014, AJHP Special Feature].

DeTorres said California did the right thing by mandating antimicrobial stewardship in order to decrease antimicrobial use and combat the spread of antimicrobial-resistant bacteria.

At Palomar, she said, antimicrobial stewardship is an interdisciplinary project carried out with strong support from the hospital administration and a “physician champion” who fully supports DeTorres’s efforts.

Those efforts include running daily reports on all inpatients who are receiving an antimicrobial and checking culture and susceptibility test results to determine whether the appropriate agent was selected.

DeTorres said Palomar’s antimicrobial prescribing is mostly automated, thanks to a large front-end investment in medication-use and drug-susceptibility evaluations and the development of treatment guidelines endorsed by the hospital’s medical departments.

“All the physician has to do is type in the infection—urinary tract infection, pneumonia, cellulitis—and they’ll get a drop-down box with the preferred agents,” DeTorres said.

If a prescriber strays from the recommendations, “I leave electronic notes for the physician and then . . . I go upstairs to hunt down the physician and persuade him or her to switch to what was suggested,” DeTorres said.

She said Palomar’s stewardship program follows Infectious Diseases Society of America (IDSA) guidelines, with modifications on the basis of the hospital’s antimicrobial susceptibility data.

Palomar is one of about three dozen hospitals that have shared their stewardship progress through the state’s online Antimicrobial Stewardship Spotlight program. Twelve hospitals, including Palomar, have met all 11 predefined criteria for an advanced stewardship program, according to the website.

“Our stewardship program is so successful, we’ve actually seen, since we’ve implemented it, a reversal of the increasing trend of resistance—we’ve seen susceptibility improve in many situations. So we’re able to use much narrower-spectrum antibiotics,” said Jeremy Lee, interim district director of pharmacy services for Palomar Health.

The Centers for Disease Control and Prevention (CDC) strongly encourages all hospitals to implement evidence-based antimicrobial stewardship practices.

“We shouldn’t accept inappropriate antibiotic prescribing from a person who should know better, just as we should never accept someone not washing their hands before they touch a patient,” said Arjun Srinivasan, associate director for CDC’s Healthcare Associated Infection Prevention Programs, during a January 22 antimicrobial stewardship webinar.

Srinivasan said that despite good evidence that strong antimicrobial stewardship programs work and are cost-effective, many hospitals have not implemented the programs.

“When we go talk to people, we oftentimes hear, ‘This is not a priority for us, because it’s not required by anyone,'” Srinivasan said.

That could be changing.

President Obama issued an executive order last September requiring the Department of Health and Human Services to work toward mandating that hospitals implement strong antimicrobial stewardship programs.

Tied to the executive order was the September 2014 “Report to the President on Combating Antibiotic Resistance.” The report urges that the Centers for Medicare and Medicaid Services (CMS), by the end of 2017, require U.S. hospitals to implement evidence-based antimicrobial stewardship programs in order to participate in Medicare and Medicaid.

Private-sector organizations, led by IDSA and the Society for Healthcare Epidemiology of America (SHEA), had previously asked CMS to make antimicrobial stewardship a condition of participation (CoP) in Medicare and Medicaid.

A CMS spokesman stated that the agency is “looking at” this issue but cannot comment on it specifically during the rulemaking process.

Christopher Topoleski, ASHP’s director for federal regulatory affairs, said ASHP consulted with “relevant stakeholders” and opted not to endorse the IDSA–SHEA letter.

“While we would agree with the importance of having antimicrobial stewardship programs in hospitals, having it be a CoP in Medicare may make it more difficult for hospitals to tailor the programs to their specific needs,” Topoleski said. “One alternative approach could be to house it within the Joint Commission; that way, it would allow for more flexibility.”

Kasey Thompson, ASHP’s vice president for policy, planning, and communications, noted that if CMS mandates antimicrobial stewardship for hospitals, this would present a major opportunity for pharmacists to lead their hospitals’ stewardship programs.

–By Kate Traynor, reprinted with permission from AJHP
(March 1, 2015; volume 72, pages 338-340)

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