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April 9, 2020

Important Wins on the Advocacy Front in the Fight Against COVID-19

Dear Colleagues,

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

AS THE IMPACT OF THE COVID-19 PANDEMIC CONTINUES TO ESCALATE ACROSS THE COUNTRY, there is increased urgency to ensure that frontline pharmacists, pharmacy technicians, and our healthcare partners have the medications and equipment they need to successfully treat their patients. ASHP continues to spearhead multiple advocacy efforts that support your ability to provide the best care possible for those in need.

Mitigating shortages of critical medications like propofol, fentanyl, midazolam, paralytics, and others remains a high priority. We continue to engage with relevant federal agencies to improve access to medications. I am pleased to report that the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) have taken critical actions in direct response to ASHP’s advocacy efforts.

ASHP, in coordination with the American Medical Association, the American Hospital Association, the Association for Clinical Oncology, and the American Society of Anesthesiologists, sent a letter last week to the DEA requesting an immediate increase in the annual production quota allocations for Schedule II controlled substances. This would enable manufacturers and 503B outsourcing facilities to increase the supply of opioids critical to the care of COVID-19 patients on ventilators. As a direct result of this collaborative advocacy effort, the DEA announced yesterday that it is taking immediate actions to address this critical issue. These actions include increasing the annual production quota for controlled substances, including fentanyl, morphine, and hydromorphone, that are used for the treatment of mechanically ventilated COVID-19 patients, and increasing the amount of ketamine, diazepam, and other controlled substances that can be imported into the United States.

We also sent a letter to the FDA advocating for regulatory flexibility in compounding drugs in shortage and compounding in hospitals. ASHP’s advocacy efforts, including significant staff engagement on the issue, directly triggered the FDA to clarify existing compounding guidance, including the removal of the one-mile radius requirement for hospitals compounding medications. FDA’s quick action to reduce regulatory hurdles for health systems is an important step to help clarify compounding guidance during this crisis.

ASHP will continue to advocate for additional compounding flexibility, including the expansion of FDA’s drug shortage list to include products ASHP has identified as in shortage. We will also continue to seek 503B outsourcing facility flexibility, particularly for hospital-owned or affiliated 503B operations, to help ensure they can meet hospitals’ medication needs.

Yesterday, we were pleased to see that the Department of Health and Human Services (HHS) authorized pharmacists to order and administer COVID-19 tests pursuant to the Public Readiness and Emergency Preparedness (PREP) Act. The authorization is responsive to the joint COVID-19 recommendations we created with other national organizations. While this authorization does not address pharmacist reimbursement, we are encouraged to see HHS providing pharmacists with a greater role in supporting the COVID-19 response, and we continue to work on that issue.

We also continue to actively advocate for Congress to recognize pharmacists as providers in the Medicare program to further support the COVID-19 response and beyond. Yesterday, ASHP and 11 other national organizations sent a letter requesting that Congress immediately support legislation that would establish pharmacists as providers in Medicare Part B on an emergency basis to provide COVID-19 and flu testing. This authority is an important step in being able to rapidly expand access to testing across our country to support the national response to this crisis. We also see this as a step toward expanded recognition of pharmacists by payers, including Medicare.

Finally, ASHP is also working with our members and other stakeholders to gain access to medications from the Strategic National Stockpile (SNS). Most recently, we joined with several organizations to request that FEMA immediately release all available quantities of a number of critical drugs from the SNS to the New York and New Jersey Departments of Health to address urgent patient care needs. We are also working to support other state affiliates and members across the country with these important requests.

ASHP and its government relations team will continue to work tirelessly with our collaborating partners to ensure that U.S. regulatory authorities are responding to the current needs of pharmacists and healthcare providers.

While our collective attention is on the needs of frontline practitioners, I wanted to take an opportunity to highlight some positive news about the newest members of our profession. ASHP’s 2020 Residency Match concluded this week, and I want to congratulate the 5,269 future pharmacists who matched with 2,551 PGY1 and PGY2 pharmacy residency programs across the country. This number represents a 46% increase in the number of available positions over the past five years – a remarkable rate of growth. I am pleased that our accredited residency programs have demonstrated an outstanding commitment to training during the pandemic. While managing multiple critical priorities, these programs continued to interview applicants virtually. This undoubtedly will be a unique time during which to begin a residency program regardless of its focus. ASHP is committed to ensuring that these young practitioners and their programs have the needed resources to successfully conduct critically important resident training this year and beyond.

In the same vein, please know that ASHP stands ready to offer you and your healthcare colleagues that same level of steadfast support. In addition to advocating to give you access to critical medications, ASHP continues to update and create new resources and tools that can be found on our COVID-19 Resource Center. We have also opened access to many evidence-based online resources and tools on ashp.org, making them widely available to all pharmacists and the broader healthcare community.

Over the last few weeks, I have heard countless stories from members and others about the challenges they are facing, but I’ve also heard many stories of hope and heroism. I, and David Chen, ASHP assistant vice president for Pharmacy Leadership and Planning, have listened in on calls from pharmacy leaders at major health systems in New York City, the pandemic’s current epicenter. We are incredibly impressed by how these leaders have shared their information and experiences and how they support each other and their frontline staff. This is a tremendous example of how peer-to-peer connection and communication can aid in the pandemic response. Their experiences and willingness to share their stories will undoubtedly help others in responding to COVID-19 in facilities across the country. We applaud them for these efforts.

Please also know that ASHP is here to support your well-being, which should remain a priority for all healthcare personnel during this challenging time. Please make sure that you are taking care of yourself and your family.

“ASHP has our backs.” These are the words of a member who recently reached out to us. This really resonated with me, and I can assure you that we will continue to work across all fronts, leveraging our talented staff, our valued partners, and our amazing members to provide you with the information, connections, and resources you need today and in the future.

Thank you for everything you do for your patients and the profession.

Sincerely,

Paul

April 3, 2020

ASHP Update on COVID-19

Dear Colleagues,

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

WEDNESDAY EVENING I had the opportunity to participate on a director of pharmacy roundtable call with members of the New York State Council of Health-System Pharmacists. On the call, the current situation on the ground and lessons learned regarding the COVID-19 pandemic were shared by New York City pharmacy leaders. These individuals and their teams are true healthcare heroes. They are dealing with patient care situations that are beyond compare. Patient care needs have required an increase of propofol, fentanyl, and midazolam utilization by 400-600% in the past 14 days as they manage the demands of the intensive care unit and ventilated patients. One healthcare system shared that three weeks ago, it had 18 COVID-19 positive patients. As of Wednesday, they had 1,100.

We have all watched and listened to reports from New York, New Jersey, and other COVID-19 epicenters responding to this national pandemic. Listening firsthand to the heroic efforts of pharmacists on the front lines underscores the urgent need to proactively provide data to our health system, local, state, and national leaders on the pharmacy staff resources and drug supply needed to meet the needs of our COVID-19 patients. These extraordinary times will require remarkable coordination and responsiveness among our industry partners and government agencies.

ASHP has put the full weight of our advocacy efforts toward resolving these issues. This week, ASHP and the American Hospital Association, the American Medical Association, the Association of Clinical Oncology, and the American Society of Anesthesiologists, sent a letter to the Drug Enforcement Administration (DEA) requesting an immediate increase in controlled substances (CII) annual production quota allocations to manufacturers and 503B outsourcing facilities to increase the supply of opioids critical to COVID-19 patients on ventilators. ASHP’s letter notes the tightening CII supply and the need to increase production of fentanyl, hydromorphone, and other supportive CIIs as quickly as possible to avoid exacerbating existing shortages. ASHP will continue to work with the DEA, the Food and Drug Administration, manufacturers, and distributors to provide hospitals with the CIIs and other medications that are in short supply and critically needed to treat patients during the COVID-19 response.

Yesterday we sent a letter to Vice President Mike Pence, imploring him to encourage agencies to coordinate their efforts to increase manufacturing capacity for critical medications, including opioids, sedatives, and paralytics, to the greatest extent possible.

A colleague in New York expressed that a “tsunami” of drug shortages is coming as more hospitals and health systems struggle to manage the exponential rise in patient load. It is ASHP’s number-one priority to keep this issue at the forefront of public attention, and we will activate all of our partners and resources to help ensure you have the medications your patients need.

Launch of New Free Service: ASHP CareerPharm Rapid Connect

ASHP has been working on many fronts to assist you, our members, and all healthcare professionals to combat the COVID-19 pandemic. We continue to create new resources to support your valuable work on the front lines of patient care.

As the impact of the pandemic escalates, we are hearing from healthcare organizations nationwide that pharmacy departments are struggling to keep pace with the demands of the growing COVID-19 patient population. In response, I am pleased to share that ASHP has quickly developed and launched a new free service, ASHP CareerPharm Rapid Connect, to help healthcare organizations connect with pharmacists who can provide critical services including surge support with temporary onsite staffing, remote medication order review, remote clinical pharmacy specialist services, and other staffing needs. ASHP’s CareerPharm Rapid Connect also will help organizations connect with pharmacy technicians. We hope this free service will provide opportunities for hospitals, health systems, and others to fill a growing demand for pharmacy personnel during this urgent time of need.

PPE Shortages

In addition to the troubling issue of drug shortages related to COVID-19 patient care, ASHP members and other healthcare providers continue to face shortages of personal protective equipment (PPE). As I noted in last week’s blog, we are continuously surveying our members to understand the real-time impact of this issue. According to our most recent survey results, 58% of respondents whose organizations perform sterile compounding reported the need to reuse masks, and 42% reported a major or moderate disruption in the availability of medical masks. This is a substantial increase from the first survey, where 15% of respondents indicated disruptions in their supplies. We will continue to survey this situation and provide you with updates in the weeks ahead.

Given the data, ASHP is advocating for increased production and supply of PPE to ensure pharmacy personnel and other healthcare providers have adequate protection from exposure. We also continue to advance ASHP’s policymaker recommendations that address shortages of PPE for pharmacists and drug shortages to Congress, HHS, and the Vice President’s COVID-19 Task Force. Over 5,000 ASHP members have contacted their members of Congress to share those recommendations. If you haven’t yet, please consider reaching out to your members of Congress to ensure your concerns are heard.

We also created a dedicated section on ASHP’s COVID-19 Resource Center with the latest sterile compounding and PPE guidance and health policy statements. Resources include additional tools that ASHP created to support your needs as well as guidance from others, including the United States Pharmacopeia Compounding Expert Committee’s recommendations in response to shortages of garb and PPE for sterile compounding.

In addition, we continue to work on creating tools and resources to protect and assist you, our members, and all healthcare professionals as you work on the front lines of patient care. Today, we released our newest recommendations for pharmacists and pharmacy technicians on ways to prevent exposure to COVID-19 while in the workplace as well as recommendations on how to protect your family and friends to reduce exposure at home. Given the rapidly evolving guidance and recommendations supporting this effort, we will be updating these materials regularly.

Extending the Reach and Impact of the ASHP Community

ASHP supports our members by serving as a professional home and facilitating a sense of community. During this challenging time, we’ve expanded that community to include and support the interprofessional teams that are working together to treat patients in the face of unprecedented challenges.

In this spirit, you may recall that a few weeks ago, we opened access to our evidence-based online resources and tools on ashp.org, making them widely available to all pharmacists and the broader healthcare community. It gives us great satisfaction to know that members and non-members alike are using and sharing many of our important COVID-19 resources. More than 32,000 professionals have taken advantage of our free offering of ASHP’s Critical Care Pharmacy Specialty Review Course, Practice Exam, and Core Therapeutic Modules package, including more than 24,000 who are not currently ASHP members.

ASHP will continuously offer credible, trusted resources and share best practices, advice, and experiences from those on the front lines across the country. We recently launched a daily COVID-19 podcast on our @ASHPOfficial podcast channel with episodes featuring ASHP members and pharmacy practice leaders who discuss the evolving clinical, operational, and leadership challenges surrounding the COVID-19 pandemic. In the latest podcast episode, nationally recognized drug shortage expert Erin R. Fox and ASHP experts share the most recent information on drug shortages related to COVID-19 and the impact the recent relief bill passed by federal legislators will have on managing the supply chain. I encourage you to subscribe to @ASHPOfficial to receive this free, timely content.

As a reminder, we also recently established a COVID-19 Connect Community that ASHP members — and all healthcare providers — can use to ask questions, receive answers, share experiences, post resources, receive updates, and learn best practices related to COVID-19. Since it was launched less than two weeks ago, this active community has grown to more than 51,000 members and has generated nearly 500 discussions. It’s a wealth of real-time, real-life information. Please join and participate if you haven’t already.

Summer Meetings

Finally, I’d like to address our decision announced earlier this week to cancel the Summer Meetings in June. Our top priority is the safety of our meeting participants and staff, and supporting your patients’ needs. We are working on a plan to deliver many of the important activities from the Summer Meetings virtually, including educational programming and the House of Delegates. We’ll share the details as they become available.

In the meantime, please take care of yourself and your families. Be assured that we will continue to work tirelessly on your behalf. Thank you for everything you do for your patients and the profession.

Sincerely,

Paul

March 12, 2020

ASHP Update on Activities During and in Response to the COVID-19 Pandemic

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

THE COVID-19 PANDEMIC is taking a major toll on people in the United States and around the world. The pandemic is taxing our entire healthcare system and public health apparatus and has or will affect all of our daily lives. ASHP wants you to know that we are here for you as you work on the front lines of patient care to help ensure your healthcare organizations are ready and that your patients get the best care possible. We understand that you and your loved ones may be at risk and the difficulty that this presents as you work to serve your communities and care for your patients during this crisis. We also know that the risks of drug shortages present major challenges in the care of your patients. ASHP and our colleagues at the University of Utah will continue to work to keep the ASHP Drug Shortages Resource Center updated, and we will continue to advocate on your behalf through continued outreach to policymakers as you stand ready to fight this public health emergency.

Last week, we developed two white papers detailing recommendations for federal and state policymakers to address the outbreak. Today, we also sent a letter to Vice President Mike Pence urging the Administration to take immediate steps to maximize pharmacist engagement in COVID-19 preparedness and response efforts. We also asked that decisive action by the Centers for Medicare & Medicaid Services be taken to remove barriers to pharmacists’ patient care services.

ASHP also developed a COVID-19 Resource Center, and we are continually updating it with new resources from various sources, including ASHP.

Due to the current COVID-19 developments, the “Safe, Effective, and Accessible High-Quality Medicines as a Matter of National Security” summit, originally planned for next week, will be postponed. We will be working with the other co-conveners, including the American Hospital Association, American Medical Association, and United States Pharmacopeia, to reschedule this important event in the coming months to continue to drive solution-focused recommendations that address global pharmaceutical manufacturing as a national security priority.

In addition, I would like you to know what we are doing to protect our staff, members and volunteers, and everyone we interact with at ASHP headquarters in Bethesda, Maryland. This includes preparing the organization for a scenario that could include closing our offices. However, we also recognize the need to be able to continue to serve our members even if our physical offices must be closed. We are prepared to run the organization remotely so that we can continue to work on your behalf and provide the tools and resources you need to care for your patients and yourselves.

Furthermore, I would like you to know that ASHP is also assessing all of our upcoming member events on a daily basis. The ASHP Regional Delegates Conferences that are taking place at the end of April in cities around the country are being planned to be held virtually if necessary.

In regard to the ASHP Summer Meetings that are scheduled to take place in Seattle in early June, it is too early to make a final decision. However, we will be fully prepared to make that difficult decision if there is any risk whatsoever to our participants. Safety comes first, no exceptions.

During this crisis, ASHP will remain focused on how we can best assist you, our members, and work at the local, state, and federal levels to be a partner in bringing this unfortunate public health crisis to an end. If you need our assistance, please don’t hesitate to contact ASHP. Please also continue to look to ASHP for up-to-date information and resources on the COVID-19 crisis. We will get through this difficult time together, and be stronger as a profession, citizens, and as a country and global community. In the meantime, ASHP will do everything we can to support you and the patients you serve.

Thank you for everything you do, and please know that we are here for you during this very difficult time.

Sincerely,

Paul

 

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

 

# # #

July 31, 2018

Ohio Pharmacists Overhaul Drug Shortage Strategy

Wexner’s Crystal Tubbs (left) and Hannah Miller (right) participate in a meeting about drug shortages.

AS DRUG SHORTAGES CONTINUE TO AFFECT PATIENT CARE, health systems and hospitals across the country have begun to take steps to buffer the impact of additional medication scarcities. Pharmacists at the Ohio State University Wexner Medical Center spearheaded an approach in November 2017 to improve the organization’s response to drug shortages. The initiative focuses on rapid communication among all staff involved in the medication-use process.

Crystal Tubbs, Pharm.D., FASHP, is the Associate Director of Wexner’s Department of Pharmacy. After Hurricanes Irma and Maria damaged manufacturing facilities in Puerto Rico, which left organizations without access to small-volume parenterals and other critical drugs, Dr. Tubbs and the pharmacy staff took the lead in revamping Wexner’s drug shortage management strategy.

“Our previous process was to hold weekly drug shortage meetings, mostly with purchasing and operational staff. However, clinical staff began telling us they felt ill-informed to make operational and clinical changes when a shortage hit,” said Dr. Tubbs, an ASHP member since 2000.

In response to this feedback, Dr. Tubbs and her colleagues organized a retreat with roughly 75 staff members representing departments from across the medical center. The discussions at the retreat led to a number of significant changes, she said. “We now have two weekly drug shortage meetings that include not only pharmacy purchasing and operational leaders, but also senior pharmacy administrators, our drug information team, pharmacy technicians, pharmacy representatives from each clinical area in the hospital, medication safety experts, and information technology [IT] staff,” Dr. Tubbs explained. “Now, more people feel like they’re in the know.”

EMR Tools

To expedite the communication of drug shortage information, the team drew heavily on tools in the electronic medical record (EMR) system. “We created a drug shortage database that has become our source of truth for up-to-date and real-time information on clinical and operational action plans,” Dr. Tubbs said, adding that ASHP’s drug shortage resources often help her staff decide how to manage shortages.

Crystal Tubbs, Pharm.D., FASHP

The medical center also recently launched an EMR-integrated inventory management system that pharmacy staff across the health system can access to find real-time information about the inventory of any medication.

In addition, Dr. Tubbs and her team added banners on the EMR’s login page to convey particularly important information. “A red banner at the top of the login screen communicates urgent clinical and operational changes, and a tan banner lets staff know about less urgent measures or if a shortage has been resolved,” said Dr. Tubbs. This tool has been particularly useful in cases where actions need to be implemented quickly because a medication shortage has become critical, she noted.

Any information that is not included in the database or conveyed through banners is now sent out through a centralized drug shortage email account. According to Dr. Tubbs, the medical center’s staff members feel that this new process is “seamless and consistent” compared to the previous method, which included multiple emails from a number of accounts. “It has simplified the process for staff looking for answers to their drug shortage questions, because they can now query the single email account,” said Dr. Tubbs.

A Well-Oiled Machine

According to Hannah Miller, CPh.T., CMRP, Purchasing Manager in Wexner’s Department of Pharmacy, the new drug management process runs “like a well-oiled machine.” She added that the timing of communication with the old approach sometimes delayed an effective response and was an incomplete response to a drug shortage. The purchasing team would reach out to clinical staff only if they needed to find an alternative medication or if a shortage required a product switch or a more restrictive prescribing process.

“For example, when methylene blue 1% was discontinued in November 2016, following approval from our clinical staff, we switched to a 0.5% concentration from another manufacturer, but the transition didn’t go over very well at first,” she recalled.

Unlike the 1% concentration, which had to be mixed with saline, the 0.5% product had to be prepared with dextrose and, since it was a different concentration, the product fell under a different drug entry. “Those changes led to some hiccups, especially for our IT team and clinical staff,” said Miller. “Although the purchasing staff was able to get the necessary products through the door, we struggled to operationalize the changes associated with the alternatives on our own.”

Ultimately, they worked through the challenges by assembling methylene blue 0.5% kits that included dextrose, she explained. “With the new process in place, clinical and IT staff members are involved right from the beginning, and we manage drug shortages much more effectively,” Miller reflected.

Strategic Measures

The new approach, which elicited a “resoundingly positive” response from staff, was a boon for the hospital when it faced intravenous (IV) opioid shortages in November 2017.

“As soon as we were notified of the shortages, we held an emergency meeting to evaluate stock as well as the predicted availability of more medications and the number of days of supply on hand, which we found was quite low for several different medications,” said Dr. Tubbs.

In short order, staff developed a plan for each opioid, recommending measures like switching from IV to oral administration, or evaluating other non-opioid strategies for pain management. They also used the EMR banners to encourage clinicians to order patient-controlled anaesthesia judiciously and to select alternative agents for continuous pain management in the intensive care unit. Each time an affected opioid was prescribed, an electronic alert was triggered, and the drug shortage database was updated daily. Clinical pharmacists reviewed daily reports that listed all patients with active IV opiate orders. “Within 48 hours of implementing the restrictions, we had reduced IV opiate administration by over 50 percent,” Dr. Tubbs recalled.

Pharmacy Technicians’ Role

Miller noted that pharmacy technicians have long been important members of the drug shortage team. In addition to being the pharmacy’s buyers and purchasing managers, technicians on the hospital floors provided useful input that helped shape a drug shortage management strategy, she explained.

For example, when the hospital faced a shortage of emergency syringes in April 2017, crash cart technicians pointed out they rarely used the five syringes of epinephrine typically stocked in each cart. They also said they could turn to epinephrine vials stocked in the carts and automated dispensing cabinets, if needed. “They suggested that we reduce the number of syringes per cart to three,” Miller said. “Our clinical pharmacists agreed with that decision.” This insight freed up syringes to use with other injectable medications.

Comfort with the Unpredictable

Using a comprehensive and team-based approach to managing drug shortages that now draws on a variety of tools and strategies, Wexner has proven that, although shortages are inevitable, their impact can be mitigated. “Shortages are still uncomfortable,” said Dr. Tubbs, “but we are fortunate that we haven’t completely run out of any specific medications since changing our approach and improving how we communicate information on drug shortages.”

 

By David Wild

January 8, 2018

Drug Shortages Harm Patients

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

ASHP AND OUR COLLEAGUES AT THE UNIVERSITY OF UTAH have been leaders in providing ASHP members, policymakers, and the entire healthcare community with timely information on drug shortages for nearly 15 years. We have also worked hand in hand with numerous stakeholders to find solutions to help minimize or prevent drug shortages. These efforts have included passing federal legislation and holding numerous multidisciplinary summits on drug shortages, with the most recent stakeholder summit taking place on November 6, 2017, at ASHP headquarters.

Today, although progress has been made, drug shortages are still significantly threatening the ability of ASHP members and their healthcare colleagues to provide care to patients. It is unacceptable in the United States that drug shortages can happen as frequently as they do — and certainly not acceptable for them to harm patients. Regardless, the problem persists and grows, with the most recent being the severe shortage of small-volume parenteral (SVP) solutions.

Soon after we became aware that an SVP shortage had emerged, ASHP and the University of Utah released a resource on the conservation and management of SVPs. This resource has proven useful to ASHP members and other providers, and its use has been encouraged by the FDA Commissioner.

We have also been working on a daily basis with the FDA, Congress, and numerous other concerned organizations to find solutions for all drug shortages and advocate for needed changes. Further, we are working to keep the entire shortage situation on the radar of the media. ASHP also immediately conducted a survey to better understand the magnitude of SVP and other shortages, and to use that survey data in our advocacy and media outreach on behalf of our members and their patients.

ASHP believes that it is time for Congress to get involved to stop this threat to safe and effective patient care. ASHP recently led the development of a congressional call to action with other key stakeholders. In that letter, ASHP and our partners asked Congress to examine the following questions to address the underlying causes of shortages:

  • Should manufacturers be required to disclose to the medical community their manufacturing sites and the products produced in those sites, in terms of volume and percentage of product line?
  • Should sole-source products be allowed to be produced in a single plant?
  • Should there be redundancy in production of critical products?
  • Should the FDA identify a list of “critical medications” that would require manufacturers to develop a reasonable contingency plan in the event of a production interruption or shutdown?
  • What incentives could be developed for other manufacturers to increase production when drug shortages occur?
  • What can be done to determine the best locations of pharmaceutical plants in addition to ensuring that backup systems can quickly accommodate needs in the event of a disaster, given there are several types of natural disasters that can occur?

We strongly believe that the current drug shortage situation is unacceptable and unsustainable. It threatens harm to patients, wastes valuable healthcare resources, causes great uncertainty, and disrupts the healthcare system. Congress should not wait to take action on drug shortages until the current crisis worsens even further. The time for leadership and action is now.

ASHP will continue to be the leader on this critical patient care and patient safety issue until we and our partners find solutions that ensure that no patient is ever affected as a result of a drug shortage. Please contact your member of Congress through ASHP’s call to action, and please continue to review ASHP’s website and other communications for updates. Also, please don’t hesitate to contact us if you have any questions or need assistance from our drug shortages staff team. ASHP is looking for both short-term relief to current shortages and long-term solutions. Therefore, fixing the drug shortage problem will remain a top priority for ASHP until meaningful and systemwide solutions are identified and implemented.

Thanks so much for being a member of ASHP, and for everything that you do for your patients.

Paul

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