ASHP InterSections ASHP InterSections

November 12, 2020

ASHP’s Standardize 4 Safety Initiative Helps Pharmacists Reduce Medication Errors

Nathaniel Sims, M.D.

ASHP released its recommended list of concentrations and dosing units for intravenous continuous medications for pediatric patients in November 2020, representing the culmination of a multi-year, multidisciplinary effort to improve medication safety for children and adults nationwide.

The Standardize 4 Safety (S4S) initiative, funded by the U.S. Food and Drug Administration (FDA) and helmed by ASHP, is the first national, interprofessional effort to standardize medication concentrations to reduce errors resulting from confusion over non-standardized drug concentrations and errors that result from concentration differences when patients transition their care from one setting to another. Expert committees with the program previously released two lists—standardized concentrations for adult continuous infusions and compounded oral liquids.

ASHP standardization leadership

Many health care systems have developed their own local standardized concentrations, or formularies, for how drugs are mixed or compounded for administration, and have shared these widely, said Nathaniel Sims, M.D., a cardiac anesthesiologist and medical device developer at Massachusetts General Hospital (MGH) in Boston. Dr. Sims served on the expert committee to develop the MGH intravenous continuous medications for pediatric patients. However, the S4S initiative is “special in that it arose as a project of the FDA,” he said. Because the FDA does not have authority to mandate such lists, it partnered with ASHP and other entities with high credibility. “The S4S initiative is exceptionally well-positioned to influence clinical practice,” Dr. Sims said.

For over a decade ASHP has supported the creation of nationally standardized drug concentrations for adult and pediatric medications, but the work began in earnest in 2015, when the FDA awarded ASHP a three-year contract to develop and implement lists of such concentrations for intravenous and oral liquid medications. That contract, which was later renewed, was part of the FDA’s Safe Use Initiative—an effort to reduce preventable harm from medications by fostering and facilitating public and private collaborations within the healthcare community.

Through these efforts, ASHP gathered a variety of pharmacist, physician, and nurse experts from across the care continuum and partnered with national patient safety organizations such as the Pediatric Pharmacy Association, the Institute for Safe Medication Practices (ISMP), and the Association for the Advancement of Medical Instrumentation, as well as regional and local health care organizations.

Although additional lists are planned, finalization of the first three lists is timely. Concurrent with many hospitals launching ambitious initiatives to integrate drug infusion pumps with their clinical information systems for automatic programming. Dr. Sims noted that since smart IV pumps will not accept auto programming instructions unless there is a perfect match between the concentration in the pump’s drug library and the pharmacy order, hospitals including MGH are working hard to create compatible systems using the ASHP standard lists as a benchmark.

Benefits of standardization

Standardization is helpful in many ways, said Rachel Meyers, Pharm.D., B.C.P.S., B.C.P.P.S., F.P.P.A., a pediatric pharmacy specialist at Saint Barnabas Medical Center in Livingston, N.J., who served on the committee for the pediatric continuous infusion list. It can simplify medication ordering for providers; enhance efficiency for pharmacies, who can then purchase less stock; and streamline production and allow for the formulation of premixes.

Rachel Meyers, Pharm.D., B.C.P.S., B.C.P.P.S., F.P.P.A.

“It might sound meaningless, caring what concentrations other hospitals use,” said Dr. Meyers, also a clinical associate professor of pharmacy practice administration at Rutgers University’s Ernest Mario School of Pharmacy. “But it’s actually really important, because we often transfer our patients between hospitals. It helps a lot if we’re all using the same concentrations.”

Having a standardized library for syringe pumps also is beneficial, she noted. “When you think about smaller hospitals who might not have a pediatric pharmacist on staff, then when they get a pediatric patient admitted to the Emergency Department, they’ll have a syringe pump ready to go already programmed with the appropriate concentrations,” Dr. Meyers said. “It just makes this whole process that much safer for the patient, so we can fully utilize tools at our disposal to their maximum effect.”

In the pediatric population, wide variations of weight range, dosing units, and fluid tolerance need special consideration, Dr. Sims cautioned. These factors may require multiple concentrations. Out of about 43 unique drugs in the ASHP pediatric concentration list, approximately 10 have three recommended standard concentrations and 30 have two recommended standard concentrations.

The key benefits of ASHP’s lists are several-fold, Dr. Sims said. The ASHP standard concentrations were created by many health care system experts using a disciplined consensus process informed by best practices for all patient groups, from “micro-preemies” in the neonatal intensive care units to adults. They also include stability data and other information essential to validate the safety of these standard concentrations. ASHP can use its broad network to publicize the lists, as well as additional educational materials, including an online course directed by Dr. Sims. Launched in November, it covers a comprehensive overview of syringe pumps and considerations for use at low flow rates. The online course offers free continuing education credits for pharmacists, nurses, and physicians, emphasizing the importance of ASHP’s standard concentrations for the safe use of infusion pumps.

Pharmacists at the helm

Pharmacists, as the “original safety champions for drug safety,” are primed to help lead efforts to adopt these lists at their home institutions, said Jared Cash, Pharm.D., M.B.A., B.C.P.S., F.P.P.A., director of pharmacy at Intermountain Primary Children’s Medical Center, in Salt Lake City. “Pharmacists are both the production crew as well as the clinical crew involved with communication of medication information and assuring the correct dose.”

Jared Cash, Pharm.D., M.B.A., B.C.P.S., F.P.P.A.

Pharmacists can employ various strategies to help push for adoption of these lists at their hospitals and health systems, Dr. Sims said. For example, they can leverage a “sentinel safety event” to convene a discussion about adoption of S4S.

A second approach is to combine a discussion about the ASHP standards with a local initiative, such as a planned revision of infusion pump drug libraries. Additionally, pharmacists can create a multidisciplinary initiative within a hospital or health system to validate and benchmark the ASHP standard concentrations against what they already are doing. They could use the ASHP lists as a prompt to “spring clean” the infusion pump drug libraries, Dr. Sims suggested, or run queries in electronic medical record systems to capture utilization of each of the medications, and learn the range of real-world dose rates clinicians program into infusion pumps to see whether resulting flow rates match patient needs.

“Be aware of the lists as you’re reviewing your formularies and EMR product selections,” Dr. Cash added. “Many places are already compounding these items and to change their compounding to the specific concentration is strongly encouraged.”

Process improvements

Some hospitals have already adopted a list of standard concentrations for neonatal drug infusions that was published several years ago by the Vermont Oxford Network, a nonprofit voluntary group of healthcare professionals, and the ISMP, Dr. Meyers said, so there is a precedent. ASHP’s working group was conscientious to include considerations of that previous list in their own work, Dr. Cash noted.

“The ASHP list is bigger, and I think it’s important for pharmacists to stress the safety of standardizing those concentrations,” Dr. Meyers said. “It not only makes transfer between hospitals easier, but if you’re part of a health system, it can help make all processes of care safer, from your EMR to your syringe pumps.”

Experts working on the S4S standards hope that the work may motivate drug manufacturers to produce some of the recommended standard concentrations, Dr. Meyers added.

“One thing we really struggle with in pediatrics is we have to compound so many of these medications,” she said. “By making this list and selecting standards, we’re hoping some drug manufacturers will pick up on this and say it may be worth it to make these items, because we know that commercially available products are safer.”

While pediatrics may have the most to gain from standardized lists, Dr. Cash said, there is still a lot of medication safety the lists can improve for adults, too. “The amount of compounding within the adult population is more significant than people recognize, and having standardized concentrations for any of that compounding reduces risk,” he said.

 

By Karen Blum

# # #

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

March 26, 2020

Update on ASHP Resources and Efforts to Help Combat COVID-19

Dear Colleagues,

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

I WANT TO CONTINUE TO UPDATE YOU on our most recent efforts on your behalf to face the rapidly evolving impact of the COVID-19 pandemic.

New COVID-19 Resources for All

ASHP continues to work to create up-to-date, evidence-based tools and provide the most current resources that you can trust to support your work on the front lines of patient care.

ASHP, through the leadership of our drug information staff in AHFS, created an evidence table to help practitioners better understand current approaches related to the proposed treatment and care of patients with COVID-19. ASHP’s Assessment of Evidence for COVID-19-Related Treatments also includes an assessment of the evidence around supportive treatments and selected chronic medications that may be used in this population.

This resource provides a concise summary – for pharmacists, physicians, and other health professionals – of published studies related to the use of hydroxychloroquine, azithromycin, and remdesivir and other antivirals in the treatment of people with COVID-19. We are updating this document regularly as new evidence becomes available.

We have made this valuable resource available for free to everyone, both domestically and internationally. We encourage you to share it with anyone who you believe would benefit from it, including your colleagues in medicine, nursing, state and local government, and others.

Earlier this week, we published our newest resource, supporting the stewardship of off-label treatments for COVID-19. Inappropriate prescribing can lead to an inadequate supply of medications for those who need them most. Stockpiling and hoarding may also create or exacerbate shortages. This resource was created to support the interprofessional care team as it makes decisions about the off-label use of medications for confirmed or suspected COVID-19 cases, allowing clinicians to weigh supporting evidence, risks, and potential benefits.

Yesterday we issued a joint statement with the American Medical Association and the American Pharmacists Association addressing the inappropriate ordering, prescribing, or dispensing of medications to treat COVID-19. The statement cautions about the lack of strong evidence for the off-label use of medications for COVID-19 as well as stockpiling medications, and opposes the prophylactic prescribing of medications currently identified as potential treatments for COVID-19.

You can find the full text of the joint statement, tools, and many other resources on ASHP’s COVID-19 Resource Center, which is updated frequently with the latest information and news. Our resources, along with many other practice and educational tools on ashp.org, are now open access and available to all healthcare professionals. We encourage you to share these materials with anyone who may need them in your network and community. 

Personal Protective Equipment Survey

ASHP is closely monitoring personal protective equipment (PPE) shortages that we know are affecting many of our members and other healthcare providers. We are conducting a bi-weekly survey to obtain an updated status of supplies and the availability of medical masks, including surgical masks, N-95 respirators, or mask alternatives currently being used in healthcare settings.

According to the results of our first survey, 15% of respondents indicated either a major or moderate disruption in the availability of medical masks, and over half indicated their vendor is allocating supplies of PPE. ASHP has been in contact with The Joint Commission, United States Pharmacopeia, and other experts and stakeholders to call attention to the critical nature of some PPE supplies and to develop guidance for compounding pharmacies. The United States Pharmacopeia Compounding Expert Committee has developed recommendations in response to shortages of garb and PPE for sterile compounding.

The second ASHP PPE survey is currently in the field, and we will continue to update you on the results.

ASHP Connect Community

Last week ASHP launched the COVID-19 Connect Community. ASHP members — and any healthcare provider — can use this resource to ask questions, receive answers, share experiences, post resources, receive updates, and learn best practices to support your patients and each other. We will also post updates about new resources, guidance documents, news, and announcements to this community. I encourage you to join your healthcare colleagues in the new ASHP Connect Community.

ASHP Advocacy Efforts

Finally, I’m pleased to share with you that several of ASHP’s recommendations to mitigate the risks that drug shortages pose to patients and the healthcare system were included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that Congress voted to advance yesterday. The legislation, passed unanimously in the Senate, includes five key drug shortages provisions, including:

  1. Prioritizing reviews of drug applications, including expediting inspections and reviews for abbreviated new drug applications
  2. Mandatory manufacturer reporting of some drug shortage information that is currently voluntary
  3. Expansion of current manufacturer reporting requirements to include interruptions or disruptions of a drug’s active pharmaceutical ingredient’s availability
  4. Requiring manufacturers to develop risk management and redundancy plans for their supply chains
  5. Including medical devices in shortage reporting requirements during a public health emergency

While the CARES Act provides significant resources to assist hospitals in responding to COVID-19, unfortunately, pharmacist provider status in Medicare, which is language that we have been working to include, is not in this legislation. Please know that we will continue to actively advocate for Congress to recognize pharmacists as providers in the Medicare program, including and beyond the current pandemic.

ASHP is here to support you in every way we can during this public health emergency. We will continue to bring you new and updated resources to meet your evolving needs and advocate on your behalf. Thank you for being a member of ASHP and for everything that you are doing for your patients and our profession during this pandemic.

Sincerely,

Paul

September 25, 2013

HENs Offer Opportunities for Pharmacists to Improve Patient Care

 

Hospital Engagement Networks are bringing together pharmacists, physicians, and nurses to improve patient outcomes in areas such as preventable infections, adverse drug events, and preventable readmissions.

A COLLABORATION BETWEEN ASHP and the American Hospital Association is yielding exciting opportunities for pharmacists to improve patient care across the country.

The two organizations are working together to increase pharmacist participation in Hospital Engagement Networks (HENs), part of the Centers for Medicare & Medicaid Services’ (CMS’s) Partnership for Patients program.

Approximately 3,700 hospitals participate in HENs, choosing among 10 areas in which to improve quality measures, including surgical site infections, adverse drug events, central line-associated bloodstream infections, venous thromboembolism, catheter-associated urinary tract infections, ventilator-associated pneumonia, and preventable readmissions.

The hospitals then share their successes with partnering organizations to help others replicate what they have achieved.

Pharmacists are a Natural Fit

Because so many of the primary goals for HENs involve medication therapy, pharmacists are in a perfect position to help as medication experts on the health care team. And when the American Hospital Association’s Health Research and Educational Trust (HRET) received a CMS grant to create a HEN, approaching ASHP seemed like a no-brainer.

The HRET HEN is focused on identifying solutions that are already reducing health care-acquired conditions and disseminating them to other hospitals and health care providers, according to David G. Schulke, HRET’s vice president of research programs in Washington, D.C.

“It was natural to reach out to ASHP because many readmissions are attributable to breakdowns in drug therapy, and pharmacists are well-trained and have tremendous knowledge in that area,” Schulke said. “I’ve worked with pharmacists and ASHP for many years, and HRET wanted to see if we could use that existing relationship to knit pharmacists into the HEN’s implementation teams.”

Beverly L. Black, MHSA, CAE

Beverly L. Black, MHSA, CAE

ASHP then turned to its strong network of state affiliates to reach members who might be interested in participating.

“Depending on what a state affiliate is focusing on, they may be able to recruit pharmacists to get involved,” said Beverly L. Black, MHSA, CAE, ASHP’s director of affiliate relations. She added that pharmacists attend workshops as presenters or participants, work within their health systems to design and implement quality improvement programs as part of the HEN, and forge strong partnerships among state health-system pharmacy groups and state hospital associations.

“These relationships are important because we are common stakeholders in ensuring that patients receive optimal therapy.”

Narrowing the Focus

Developing initiatives relevant to a hospital’s or health system’s needs, measuring outcomes, and sharing information with other providers in the network are major facets of the HRET HEN.

At Purdue University’s Center for Medication Safety Advancement in Indiana, pharmacists collaborated with the Indiana Hospital Association to create the Indiana Medication Safety Alliance. Last November, the Alliance hosted a conference about medication safety, ADEs and readmissions. Now the group has its own website, provides ongoing coaching, and hosts conference calls every other month or so.

The group initially focused on two measures, successful anticoagulation with warfarin and avoidance of hypoglycemia among insulin users, but has since whittled its efforts down to improving anticoagulation.

John B. Hertig, Pharm.D., M.S.

John B. Hertig, Pharm.D., M.S.

Narrowing the focus was essential because the HEN’s guidance offers so many possible areas for improvement, said John B. Hertig, Pharm.D., M.S., the Center’s associate director.

“The HRET HEN’s Encyclopedia of Measures contains more than 100 distinct measures. So, zeroing in on warfarin was a strategic decision because the HEN was looking at patient harm with regard to ADEs and the hospitals in Indiana were reporting [issues with anticoagulation] more than anything else,” Hertig said.

At the University of Arkansas for Medical Sciences in Little Rock, the focus is on reducing readmissions for heart failure patients.

“When Medicaid announced penalties for pneumonia, acute myocardial infarction, and heart failure, we decided to take a look at how that would affect us,” said Niki Carver, Pharm.D., assistant director of pharmacy.

“After working on medication reconciliation for years, I wondered if there was a way the pharmacy could be notified when heart failure patients were admitted so the pharmacy could obtain medication histories for those patients.”

Carver knew such an effort would have an impact on the pharmacy’s workload, so she created an elective rotation for fourth-year pharmacy students that tasks them with obtaining medication histories and assisting in quality improvement efforts. Thus far, reductions in monthly readmission rates for patients with congestive heart failure have ranged from 1.67 to 4.43 percent.

Pharmacists at The Johns Hopkins Hospital are working to improve HCAHPS scores related to educating patients about their medicines. Above, a pharmacist talks to a patient about how to properly use an insulin pen.

Above left, Leigh Efird, Pharm.D., BCPS, clinical pharmacy specialist, The Johns Hopkins Hospital, teaches a patient how to properly use an insulin pen.

Working Smarter, Not Harder

The Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) served as a catalyst for involving pharmacists in the HRET HEN at The Johns Hopkins Hospital in Baltimore, where their goal is to improve HCAHPS scores for medication-related questions.

“When we partnered with the Maryland Hospital Association, they knew we were working on issues related to HCAHPS,” said Meghan Davlin Swarthout, Pharm.D., MBA, BCPS, division director, ambulatory and care transitions.

“We were able to take actionable steps toward our goals and share information with other hospitals about our successes.”

Swarthout said that the hospital has increased its “Always” HCAHPS score from the 48th percentile in the second quarter of FY2013 to the 84th percentile in the fourth quarter for the survey question, “When I left the hospital, I clearly understood the purpose for taking each of my medications.”

Swarthout also stressed the value of sharing information within the network. “Sometimes the goals for quality and safety can be overwhelming. HENs bring in the expertise of your peers, and they can help you target your biggest problems,” she said.

Carver noted that HENs eliminate redundancy. “You hear what other hospitals have done, take what you need for your institution, make changes that fit your setting and implement them, instead of starting something from scratch.”

Pharmacist involvement in the HRET HEN is still fairly sporadic. For example, in a statewide workshop of roughly 250 attendees that Swarthout attended, only about 10 participants were pharmacists. Yet despite the relatively small number of pharmacists there, they made an impact: Once the other participants heard what the pharmacists had to say about safe medication use, many indicated they would promote better use of pharmacists’ skill within their own institutions.

ASHP is hopeful that by encouraging affiliate members to participate in the state-level HENS, other health systems will likewise more fully understand the valuable role that pharmacists play in ensuring patient safety and optimal health outcomes.

“We believe that if more pharmacists knew the benefits of participating in the HENs network, they would be more interested in participating,” Swarthout said. “We all have days when it feels like we’re not making any improvements, and that can be discouraging. But when you hear other people in the HEN talk about the same things, you realize you are not alone. You come away with ideas and external motivation.”

Showcasing Pharmacists’ Skills

HENs are also an excellent way to advance the profession, according to Hertig.

“It’s an opportunity for pharmacists to showcase their skills and abilities as members of interdisciplinary teams,” he said. “But it’s also in line with ASHP’s Pharmacy Practice Model Initiative in that it helps pharmacists work at the top of their licenses. What better avenue to show the impact we can have than a federal program where we work with nurses, physicians, and other professionals?”

Shekhar Mehta, Pharm.D., M.S.

Shekhar Mehta, Pharm.D., M.S.

Shekhar Mehta, Pharm.D., M.S., ASHP’s director of clinical guidelines and quality improvement, agreed.

“ASHP is primarily concerned with patient care, medication-use safety, and ensuring that pharmacists are part of a collaborative care team. So, this initiative supports all those goals,” he said.

“Pharmacists are also the most knowledgeable members of the team when it comes to medication use, and that’s a big issue in health care reform in improving the quality of care and lowering readmissions.”

Ultimately, patients are the ones who benefit most, said Carver.

“Skeptics will say that it’s more work for pharmacists, and it is. But if you’re in hospital pharmacy, you’re in it to improve patient care. And the outcomes you will see with this program are astounding.”

—Terri D’Arrigo

Editor’s Note: Interested in getting involved with an HRET HEN program? Send an email to affiliates@ashp.org, and we’ll put you in touch with the right resources within your state.

 

August 6, 2013

Midwestern Glendale Students Dive into Drug Shortages Advocacy

From left, Mindy J. Burnworth, Nicole M. Wilson, and Benjamin J. Thompson display the drug shortages poster they created to educate others about this national problem.

ONGOING NATIONAL DRUG SHORTAGES that are negatively impacting pharmacists’ ability to care for patients can seem like an overwhelming problem to most practitioners.

But Benjamin J. Thompson and Nicole M. Wilson, students at Midwestern University College of Pharmacy, Glendale, Ariz., decided that they had a lot to contribute by educating fellow students, pharmacists, legislators, and other health care professionals about the issue.

They dove into the world of advocacy, partnering with mentor Mindy J. Burnworth, Pharm.D., BCPS, associate professor in the Department of Pharmacy Practice, to develop a poster on the issue.

Thompson and Wilson reached out to Burnworth during their first year of pharmacy school. Having settled into the routine of their studies, they were ready to expand their horizons in an area that interested them.

“We had gotten into the rhythm of tests and classes and were getting frustrated with not doing anything beyond that,” said Thompson. “We had talked about drug shortages and reached out to Burnworth through email with the idea of an introductory research project.”

From there, it was a matter of deciding on a project that would offer the students not only a chance to develop new skills, but provide a tool for advocacy.

“The poster format was short, sweet and concise, and it hit key points to discuss with pharmacists, physicians, and academicians,” Burnworth said.  “And, because legislation was being proposed in Congress at that time, the poster needed to include talking points to cover with legislators.”

Moving Through the Learning Curve

The team began by developing a timeline of tasks. All three conducted independent literature reviews, and together they narrowed their resources down to those that identified the impact of drug shortages on health care and highlighted legislation that proposed an early warning system as a way of addressing them.

Burnworth Melinda head shot

Mindy J. Burnworth, Pharm.D., BCPS

There was a learning curve in conducting the research, said Wilson. “We stumbled a little through trying to find the right articles and doing the literature search,” she said. “We needed to be detail-oriented, and because it was the first time we had done this, it took more time [than we expected].”

The poster took the form of a timeline that spanned from September 2010, when the Institute for Safe Medication Practice (ISMP) conducted a national survey of practitioners to assess the threat drug shortages pose to patient safety, to June 2012, when Congress reauthorized the Prescription Drug User Fee Act.

Highlights included the 2010 Drug Shortages Summit co-convened by ASHP and other stakeholders, several bills proposed to address the issue, and President Barack Obama’s 2011 Executive Order directing the Food and Drug Administration and Department of Justice to take action to reduce and prevent drug shortages. In her role as mentor, Burnworth shared resources and examples of posters for the students to use as a guide, and she discussed the nitty-gritty of poster production—how to find a printer, what the costs would be, and how to schedule poster reproductions.

She also gave the students pointers on submitting their work for presentation at meetings and conferences. All told, the process took two months from first meeting to printed poster. A mock poster session with fellow students and faculty gave Thompson and Wilson the chance to perfect their presentation and prepare them for their discussions with health providers and legislators.

The two then presented the poster four times in 2012: at the university’s Research Day, the Arizona Pharmacy Association’s Health-System Academy and Annual meetings, and ASHP’s Midyear Clinical Meeting in Las Vegas.

“Our mission was to make pharmacists aware that there was already a drumbeat for reform, and encourage them to contact their legislators and advocate support for the specific legislative items that had already been proposed,” said Thompson. “I found that people seemed much more inclined to take action once they realized that a proposed solution was already in place, and most of the people we spoke with indicated that they were strongly considering taking the time to contact their legislators.”

Poster Sparks New Interest in Advocacy

One goal of the project was to educate Thompson and Wilson about political advocacy. The students followed four key steps wherein they identified the salient issue; identified local, state, and national legislators; communicated with their legislators via telephone, email, or in person; and tracked the status of their efforts by following relevant legislation through government websites. It’s a formula the students plan to use going forward.

“Finding an opportunity to get involved during our first year of school was especially rewarding as it enabled us to share our experiences with our classmates, and take on roles as leaders and educators when other students wanted advice for similar projects,” said Thompson, who indicated that he continue advocating for ways to address drug shortages and is considering branching out into other issues. Wilson intends to advocate for provider status for pharmacists and advancing the profession as a whole.

The content of the poster and the steps the students took fit well with ASHP’s grassroots advocacy, said Joseph M. Hill, ASHP’s Director of Federal Legislative Affairs.

“The timeline presents the continuum of policymaking at the federal level. It shows the slow, multiyear process. It’s almost a case study of how an issue moves through Congress,” he said.  “Overall, the students’ process could be used as a guide to work on other issues, not just in meeting with members of Congress, but other stakeholders with an interest in an issue.”

—By Terri D’Arrigo

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July 30, 2013

Compounding Legislation: Your Voice Urgently Needed Now!

Filed under: Current Issue,From the CEO,Quality,Regulation — Tags: , , , , — jmilford @ 12:29 pm
Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

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

It’s hard to believe that after the many deaths and illnesses associated with the alleged practices at the New England Compounding Center last Fall, the bipartisan Senate bill (S.959) that is designed to prevent a tragic repeat could be facing tremendous opposition.

ASHP strongly supports this legislation. Yet, it appears that opposition to the Senate bill is forming, because certain interests want to protect the status quo, which we believe could be at the expense of protecting patients from another compounding tragedy.

These special interests are also threatening to severely limit how pharmacists in hospitals and health systems serve and protect patients. ASHP supports the provision in the bill that exempts health systems from being designated as compounding manufacturers. Without this important exemption, many hospitals and health systems would have to register with the Food and Drug Administration (FDA) as compounding manufacturers, since anticipatory compounding is required for us to meet the needs of our sickest and most vulnerable patients.  Also, without the exemption, many hospitals would not be able to prepare compounded preparations and send them to their wholly owned outpatient clinics, surgery centers, smaller inpatient facilities, and medical office practices.   This is a critical distinction, based on the fact that hospitals and health systems are fully accountable for the comprehensive care of the patient – as compared to a compounding manufacturer that sells its products across state lines without a prescription or knowledge of the patient to a third party for administration.

This distinction between health systems and compounding manufacturers is based on very important differences:

  • Hospitals and health systems have well-established quality improvement, infection control, and risk management committees, as well as adverse event monitoring and reporting systems.
  • Health systems must comply with the Centers for Medicare & Medicaid Services (CMS) Hospital Conditions of Participation and are accredited by quality improvement organizations such as The Joint Commission and DNV Healthcare, both of whom have deemed status with CMS.
  • Hospitals and health systems have Pharmacy and Therapeutics Committees that control approved drug formularies.

We must protect the important work that pharmacists do in hospitals and health systems to take care of their patients.  In addition, hospital pharmacists and other providers must be assured that when they need to purchase compounded products from outside suppliers that they can expect to receive products that are safe and effective for their patients.  Therefore, we must enact into law urgently needed regulatory control over compounding manufacturers to prevent another tragedy.

You can make a difference. Your voice really matters to your elected Senators and Representatives in Congress!

ASHP has made it as easy as just a few clicks on your computer for your voice to be heard.

Go to ASHP’s advocacy page and make a difference for patient safety!

Tell your Senators that you want them to vote “YES” in support of S. 959.  This legislation creates a new category, “compounding manufacturer,” which will be regulated by the FDA. Hospitals and health systems are considered traditional compounders in the legislation and will remain under the purview of state boards of pharmacy and other accrediting bodies.

Tell your Representative that the House should take a similar approach to the legislation and give the FDA the tools it needs to prevent another tragedy.

Your support today can go a long way in getting this important legislation passed!

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