ASHP InterSections ASHP InterSections

September 14, 2018

Michigan Pharmacists at the Center of Injectable Opioid Shortage Management

Michigan’s drug shortages team meets twice a week and includes clinical pharmacists, pharmacy technician buyers, and pharmacy managers.

AS SHORTAGES of injectable hydromorphone, morphine, and fentanyl show few signs of abating, health systems across the country are finding themselves in a perpetual state of crisis management. Although coping with a shortage of drugs as essential as opioids is a systemwide task, pharmacists have been at the center of many organizations’ shortage management strategies.

Staying Above Zero Stock
At the University of Michigan Hospitals – Michigan Medicine in Ann Arbor, pharmacy-led operational changes, collaborative decision-making, informatics tools, and clear communications have helped stave off total inventory depletion, ensuring that opioids are reserved for the patients who need them the most.

“We spend a lot of time and energy managing opioid shortages, and our work has paid off and kept us above zero stock,” said Janine Lee, Pharm.D., Coordinator for Medication Contracting and Purchasing at Michigan Medicine. “I think there are a lot of institutions that haven’t been as lucky.”

Injectable opioid shortages have been widespread, according to a nationwide ASHP survey conducted in April 2018. The survey found that 98% of 343 pharmacist respondents had been affected by these shortages, with nearly 70% considering them severe. Hydromorphone has been the hardest-hit injectable opioid, with nearly 20% of surveyed pharmacists reporting that they had no drug on hand and nearly 39% indicating that their supply would last seven days or less. Access to injectable fentanyl was least impacted, the survey found.

Coping with a Shortage
With this degree of scarcity, drug shortage leaders like Sharon Salah, B.S.Pharm., Medication Use Systems Clinical Pharmacist at Michigan Medicine, have been devoting a significant amount of time to encouraging use of injectable opioids only when necessary.

Sharon Salah, B.S.Pharm.

“When the hydromorphone shortage began affecting our health system in the fall of 2017, we had some stock but not enough to ensure widespread use,” recalled Dr. Salah, who heads Michigan Medicine’s drug shortage management team.

She quickly convened a team meeting, bringing together a pharmacy buyer, assistant directors of pharmacy, pharmacy and technician managers, clinical specialist pharmacists, electronic health record and automated dispensing cabinet (ADC) managers, clean room staff, and infusion managers.

“We documented our existing supplies and started identifying steps we could take to help with the shortage,” Dr. Salah recalled. Clinical specialist pharmacists consulted with the pain service and identified measures they could take to conserve medication inventory without compromising patient care, she said. “One thing they did was recommend that clinicians use oral morphine when possible, unless a patient had a true allergy or a special consideration, like a strict nothing-by-mouth order,” said Dr. Salah.

Juggling Multiple Shortages
That restriction helped conserve the supply of hydromorphone, but several months later Michigan Medicine’s drug shortage team had to also contend with emerging shortages of most forms of injectable fentanyl and morphine. This time, the drug shortage and clinical specialist pharmacists met with anaesthesia experts and devised a management plan that included using alternate sizes and concentrations of these drugs.

“Where we used to have 20 mL fentanyl vials in cardiac kits, we now began stocking four 5 mL vials,” Dr. Salah said. “We also reserved smaller doses or concentrations of morphine for pediatric patients in order to reduce the risk of patient harm if a medication administration error were to occur.”

The team also made some operational changes, such as moving opioids from low- to high-use areas where they were most needed, centralizing stock in pharmacies, and loading injectable opioid doses into ADCs only if there were active approved orders. “These inventory management strategies were essential in helping us make it through these shortages,” Dr. Salah emphasized.

Getting in Front of Shortages
According to drug shortage team member Matthew Tupps, Pharm.D., Manager of Central Pharmacy at Michigan Medicine, “Getting in front of a shortage makes all the difference” in helping to manage existing stock.

“In two instances, we identified shortages early on while we still had a two-week supply on hand and were able to make some quick changes that our providers could easily buy into, such as switching concentrations of morphine for certain populations,” said Dr. Tupps, an ASHP member since 2008. “Changes like this allowed us to stretch our inventory for eight weeks.”

Ramping Up In-House Compounding
Another prong in the health-system’s drug shortage management strategy has been to increase in-house compounding, said Dr. Tupps, who manages the pharmacy clean room. Although this helped fill some of the need for injectable opioids, increasing production has also had operational implications.

“Products made by 503B vendors can be stored at room temperature and have beyond-use dates upwards of 90 days, but the same products compounded in-house need to be refrigerated and have to be used within nine to 14 days after compounding,” Dr. Tupps explained.

Because of this change, he and his colleagues have had to closely monitor usage patterns to avoid potential waste, “particularly since it’s difficult to procure sterile ingredients for some of the injectable opioids,” Dr. Tupps added. They also had to allocate more refrigerator space for storage of in-sourced drugs.

Using Informatics Tools
Computerized physician order entry (CPOE) alerts and other informatics tools have also proved helpful in preserving opioid stocks for the most appropriate patients, according to Dr. Tupps. Some alerts recommend alternative medications and can be bypassed by the prescribing physician for developing shortages.

During critical shortages, however, a more stringent alert appears when an order for a drug in short supply is placed, Dr. Tupps said. These alerts also recommend alternatives and use stronger wording, reflecting the greater urgency of the situation. “They require providers to contact a pharmacist to place the order if they wish to proceed,” he said.

Communication Is Critical
Barriers like CPOE alerts can frustrate some providers, noted Barbara Higgins, Pharm.D., Assistant Director of Pharmacy, Medication Use Systems at Michigan Medicine. For example, she has had to counter misperceptions among some providers that these usage restrictions were due to pharmacists’ mismanagement of stock rather than supply shortages.

“In one instance, we had to strictly ration papaverine [an opioid alkaloid antispasmodic drug], which our surgeons use for certain patient populations,” said Dr. Higgins, an ASHP member since 1996 and a member of Michigan Medicine’s drug shortage team. “Shortly after we put this restriction in place, one of our surgeons called up a pharmacy buyer and complained that a sister institution just down the street had plenty of the medication and that we must be doing something wrong in managing our stock.”

After receiving that complaint, one of the pharmacy buyers contacted that sister institution and found out the drug was used much less frequently at the other hospital. “We had to explain to this particular surgeon that a month’s worth of the drug at our institution would have lasted the other hospital a year,” noted Dr. Higgins.

As this example illustrates, pharmacists at the University of Michigan have had to not only put their drug knowledge and inventory management skills to use during shortages, but they have also been called on to exercise softer skills. “It’s been an ongoing priority for us in pharmacy to make sure our providers always understand that we’re rationing a drug so that the patients who really need it can access it,” said Dr. Higgins.

 

By David Wild

 

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March 27, 2017

ASHP’s 75th Anniversary: Celebrating the Past, Creating the Future

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

ASHP TURNS 75 THIS YEAR, and we have a yearlong campaign filled with surprises and exciting events for our members to celebrate this significant milestone. The last 75 years have been marked by so many ASHP-led advances in pharmacy practice, including: the creation of postgraduate residency training, clinical pharmacy, enhanced recognition of pharmacists as vital members of the interprofessional team, the largest gathering of pharmacists in the world — the ASHP Midyear Clinical Meeting — and so many more.

Although much has been accomplished over the last 75 years, our focus remains on the future, and ensuring that more and more people have access to the direct patient care services of pharmacists. Therefore, the theme of our yearlong celebration is Celebrating the Past, Creating the Future.

The founders of ASHP were visionaries who understood and learned from the past but realized that pharmacists must transform their practices. They worked hard to create a practice future designed to dramatically improve the care of their patients. These leaders included legends such as Gloria Niemeyer Francke, ASHP’s first CEO; Harvey A.K. Whitney, ASHP’s first president; and Donald Francke, ASHP’s second president; and, of course, Joseph A. Oddis, ASHP’s CEO for over 37 years. These are just a few of the great leaders who realized very early that pharmacists must do so much more than dispense drugs, and that ASHP should be the organization that makes it happen on behalf of patients.

Prior to the 1920s, hospital pharmacy was not a strong, well-organized component of the profession. In 1936, a subsection of hospital pharmacists in APhA was formed and, for the first time, hospital pharmacists had a voice on the national pharmacy stage. In 1942, the American Society of Hospital Pharmacists was formed with 153 charter members who worked exclusively in hospital settings.

Today ASHP has nearly 45,000 members who treat patients in every healthcare setting, including in ambulatory clinics, hospitals, and throughout the entire continuum of patient care. ASHP members are involved in all facets of pharmacy practice and include inpatient pharmacists, ambulatory care pharmacists, clinical specialists and scientists, informatics experts, practice managers, student pharmacists, residents, new practitioners, pharmacy technicians, and others.

We owe our success to our dedicated members, which is why we would like you to help us celebrate our diamond anniversary. We have a number of special activities scheduled throughout the year, culminating in a grand finale celebration at the Midyear Clinical Meeting in Orlando in December. We also are planning significant activities for key ASHP events including the Summer Meetings in June, the Preceptors Conference in August, Policy Week in September, and the Leaders Conference in October.

Thank you so much for being a member of ASHP, and for everything you do for your patients. With your help, we can continue to improve patient care and support you in your professional endeavors.

Please join us in celebrating this important anniversary — and stay tuned for more details as we roll out our 75th anniversary celebration.

Sincerely,

Paul

February 27, 2017

ASHP Continues Working on Solutions to Rising Drug Prices

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

RISING DRUG PRICES have affected virtually every segment of healthcare. From consumers to hospitals to third-party payers, all have been forced to make difficult decisions regarding healthcare choices. Patients and ASHP members’ organizations are feeling the impact of escalating drug prices, as is the entire healthcare system. ASHP is well aware of this alarming trend and is diligently working with a wide array of stakeholders and bipartisan policymakers to explore practical and sustainable solutions.

This problem is about public health and the downstream effects that high drug costs have on the health of patients and the ability of our healthcare institutions to care for them. For example, we know that when patients face higher costs they are more likely to not fill their prescriptions and may even ration their medications. Nonadherence often leads to more expensive therapies or hospital stays due to complications resulting from untreated or undertreated conditions. Payers have also had to make difficult choices in the face of spiraling drug costs, including challenging formulary decisions. Hospitals and health systems may be forced to make difficult decisions to offset rapidly rising drug costs.

Even generic drugs widely used to manage the cost burden on individual patients and our hospitals and clinics are now experiencing dramatic price increases. Instead of a robust marketplace flush with competition that drives prices lower, sometimes there appears to be little or no competition, resulting in a single company producing a generic product. Without competition, manufacturers can raise their prices as high as the market will bear. In 2016, a study commissioned by the American Hospital Association and the Federation of American Hospitals noted that drug spending increased 8.5% in 2015, while inflation increased only 0.7%. This trend cannot be sustained. The study provided an example of one hospital where “the price increases for just four common drugs, which ranged between 479 and 1,261 percent, cost the same amount as the salaries of 55 full-time nurses.” Unfortunately, while this may be an extreme example, the typical drug price increases in a hospital or health system place a heavy burden on the healthcare team and its organization to ensure their patients have access to medication therapies.

In 2016, ASHP joined the Steering Committee of the Campaign for Sustainable Rx Pricing (CSRxP), a coalition consisting of physicians, consumers, payers, hospitals, health systems, and patient advocacy groups. We believe that CSRxP, as a coalition of nationally prominent organizations, has the best chance of effecting change at the national level regarding drug price increases. With ASHP’s input, CSRxP developed a policy platform that seeks to address this problem through market-based solutions, focusing particularly on competition, value, and transparency. ASHP and other members of the Steering Committee have begun conducting joint meetings with congressional staff to discuss bipartisan policy solutions. CSRxP has also been implementing an ongoing media strategy to call attention to drug pricing and place this issue on the national agenda.

Efforts to address the problem through legislation are already underway. For example, S. 297 and H.R. 749 would require the Food and Drug Administration (FDA) to expedite approval of an Abbreviated New Drug Application (ANDA) when a drug is in short supply or little or no competition exists. Another bill, S. 124, would prohibit brand companies from paying generic manufacturers to delay introduction of a generic version, otherwise known as “pay for delay.” ASHP believes these are steps in the right direction, but more can and should be done to promote competition and limit marketplace manipulation through pay-for-delay or restricted distribution.

Also under consideration in Congress is legislation (S. 92, S. 183) that would allow drugs to be imported from other countries, such as Canada, where prices are significantly lower. This approach, however, is not one that ASHP supports, due to safety concerns over the origin of the drug and the disconnect of the pharmacist-patient relationship. Another policy option would be to allow the government to negotiate drug prices directly with manufacturers for drugs covered by Medicare Part D. However, this legislation (S. 348, H.R. 242, S. 41) does not have bipartisan support.

Finally, the Prescription Drug User Fee Act (PDUFA) is up for reauthorization this year and may serve as a legislative vehicle to address this problem. This reauthorization is considered must-pass legislation, and we have already begun discussions with key congressional staff about the policy goals of CSRxP and their potential fit within PDUFA.

ASHP remains an active leader in CSRxP and will continue pushing for solutions to the problem of rising prescription drug prices. As the only national pharmacy organization on the Steering Committee, we will continue to work collaboratively with our partners to provide the perspective of our members and to help ensure that affordable medications are accessible to those who need them.

Thank you for all that you do on behalf of your patients and for being members of ASHP.

Paul

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December 20, 2011

Innovative Technician Practices Debuting in Hospitals

Technicians at Wishard Health Services in Indianapolis are an integral part of the pharmacy team.

ASHP has long advocated that properly educated and trained pharmacy technicians take a more active role in drug-dispensing duties, thus freeing up pharmacists to spend more time on medication management and direct patient care.

“Highly skilled technicians are key players on a pharmacy team,” said Stan Kent, M.S., FASHP, ASHP president. “As we move forward with pharmacy practice model change, we must deploy our workforce in a way that optimizes pharmacists’ clinical capabilities.”

A number of pioneering pharmacy departments are leading the way with innovative technician services. One of them is at Mercy Hospital in Coon Rapids, Minn. In 2008, the pharmacy department instituted a tech-check-tech program, in which a certified pharmacy technician checks the accuracy of orders filled by another technician and provides final verification prior to patient administration.

“We have technicians checking other technicians for 75 to 80 percent of our medications,” said Brent Kosel, Pharm.D., M.S., pharmacy operations manager. “Our auditing data shows that technicians do just as good a job as pharmacists. The pharmacists are champions of this program because they can focus more on our patients’ clinical needs.”

Samantha Murray, CPhT

The last audit, which covered about 7,500 doses, resulted in a 99.8 percent accuracy rate, according to Kosel. For now, the technicians check doses for automated dispensers, while pharmacists still conduct the final review for high-risk and intravenous drugs. According to an article in the American Journal of Health-System Pharmacy, some form of “tech-check-tech” is authorized for use in at least nine states. The results of 11 studies published since 1978 indicate that technicians’ accuracy in performing final dispensing checks is comparable to pharmacists’ accuracy.

Fulfilling a Core Purpose
“I’ve found tech-check-tech to be a great way to extend my role and feel more accomplished and gratified in my work,” said Heather Burley, CPhT, an inpatient pharmacy technician at Mercy. “Our core purpose, especially in a hospital, is to assist the pharmacists in any way we can. This really gives us an opportunity to do that.”

Burley’s training involved a didactic component with a written test, followed by one-on-one, hands-on sessions with pharmacists and an extensive validation test. “We had to correctly check a total of 500 line items with a 99.8 percent accuracy rate,” she said.

In another initiative at Mercy, pharmacy technicians now review medication dose adjustments of bedtime medications in adults age 65 and older (such as benzodiazepines), which can increase a patient’s risk of falling. Such dose adjustments are frequently overlooked during the order verification process.

An evaluation of the pilot program found that “technicians are as capable as pharmacists in performing tasks not requiring clinical judgment (i.e., identifying bedtime medications in need for dose adjustments in certain patient populations).”

Dianna Gatto, Pharm.D., BCPS

Techs and Med Rec
At Good Samaritan Hospital in Puyallup, Wash., pharmacy technicians have pretty much taken over the medication-reconciliation process at admission. In too many cases, the medication lists at the time of a patient’s admission are inaccurate—a common story at hospitals across the country.

“We wanted to see how we could get a better list up front, because it’s not a primary focus of nursing and we don’t have enough pharmacists to obtain medication histories on all of our patients,” said Dianna Gatto, Pharm.D., BCPS, manager of pharmacy clinical services. “I thought we could train our technicians to do this.” So she did.

Gatto discovered that there was no precedent in the state for technicians doing reconciliations, so she went before the Washington State Board of Pharmacy to make her case. The board quickly granted permission.

After a month-long pilot program involving two technicians, the program rolled out in the emergency department (ED), which treats about 175 patients daily (20 percent of whom are admitted). Since the program’s debut, it has expanded significantly, with three technicians working daily to spend an overlapping 28 hours on medication reconciliation. Medication lists are obtained for ED patients and direct admissions. A pharmacist reviews each updated medication list before physician reconciliation.

Samantha Murray, CPhT, a pharmacy technician at Good Samaritan, enjoys the social aspect of medication reconciliation, which occupies most of her work day.

“I’m constantly dealing with patients, their families, doctors, nurses and retail pharmacies. It’s more hands-on than what I was doing before,” she said.

The work is also more challenging: “You have to be a people person because the last thing that people want to do when they’re in the ED and don’t feel well is talk about their
medications when they’ve already talked about them three or four times,” Murray said. “You have to meet them on their own level and make them feel comfortable enough to tell you what you need to know.”

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