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June 28, 2019

Advocacy in Action: Utah Pharmacists Make Contraceptive Provision a Reality

David C. Young, Pharm.D.

A NEW LAW THAT WILL CHANGE the way Utah pharmacists work began with a question that was part of a classroom assignment: “If you had one wish for a pharmacy dream bill, what would it be?” At the time, Wilson D. Pace, Pharm.D., was a University of Utah College of Pharmacy graduate student in the school’s leadership and advocacy class taught by David C. Young, Pharm.D. He immediately thought of the need for broader access to contraception and how pharmacists can fill that gap.

This issue hit home for Dr. Pace because his wife had experienced problems obtaining a prescription for a contraceptive from an obstetrician since a shortage of providers made her wait several months to get an appointment. As he further looked into the challenges women face getting contraception in a timely manner, he found that his wife’s experience was far from unique. As a result, Dr. Pace came to the conclusion that if there were a law that gave pharmacists the power to provide contraception without a new prescription, it would go a long way toward advancing women’s health in the state. This idea moved Dr. Pace to seek out other student pharmacists to form a working group. Together they started an advocacy campaign that would make this dream bill a reality.

Garnering Support from Medical Stakeholders

Wilson D. Pace, Pharm.D.

Dr. Pace and his working group began by reaching out to pharmacist mentors about their desire to take action on this idea in the hopes that the legislature would act on it. The pharmacists discussed how the advocacy process would work, and based on his prior experience, Dr. Young knew they first had to gain the support of various stakeholders in the state. Although groups such as Utah Board of Pharmacy, professional pharmacy organizations, the Utah Medical Association, and nursing organizations agreed that it was essential to address the issues women face while trying to obtain contraceptives, they had yet to agree on the exact role pharmacists should play in solving them. Specifically, whether or not pharmacists should be able to provide contraceptives without a prescription from a doctor.

As a result, Dr. Pace’s original vision of pharmacists having prescribing power was a point of contention during the discussions and ultimately something on which Drs. Pace and Young needed to compromise to get the groups’ support and move forward. In the end, the stakeholders all decided it was best for pharmacists not to have full prescribing power, but to be able to provide contraception without a prescription on a limited basis.

“We didn’t sit around the fire singing ‘Kumbaya,’” said Dr. Young. “We had very healthy, open, and honest discussions about what the idea for a new law meant, how we were going to accomplish it, and how we were going to work together.”

Hammering Out the Details

After completing discussions with all of the healthcare stakeholders and getting their support, it was time to work with the legislative research office to refine the language of the bill. This was a complicated and lengthy process because it required that every interested group sign off on each revision that was made to the draft.

“Any tiny change had to have buy-in from all of the different groups,” Dr. Pace said. “So the next big step was working out all the nuts and bolts and then coordinating to make sure everybody was on the same page.”

Legislative Support

Karen M. Gunning, Pharm.D., BCPS

Once the language of the bill was finalized, it was time to get legislative support. Finding the right sponsor was vital. Sen. Todd Weiler agreed to sponsor the bill, and Rep. Ray Ward, M.D., a family physician with a history of working on legislation related to improving public health, co-sponsored the bill. “We actually had no opposition. We were concerned that there might be different groups testifying against us or they would push back, but there was none of that,” said Dr. Pace.

The process went so smoothly that there were no opposing testimony delivered when the bill was in committee and no opposing votes in the Utah Legislature. In March, Gov. Gary Herbert signed S.B. 184.

Thanks to the efforts of Dr. Pace, the other student pharmacists involved, and guidance from their mentors, women in Utah can now get contraception from pharmacists for two years before being required to check in with a doctor for a new prescription.

“I believe this law will allow pharmacists in the state of Utah to demonstrate the value they bring to patient care, and also the team-based approach to care that pharmacists have,” said Karen M. Gunning, Pharm.D., BCPS, a Professor (Clinical) at the University of Utah College of Pharmacy, who provided expert knowledge and support to Drs. Pace and Young as they navigated the legislative process. “There is great potential for pharmacists to work with medical providers in their communities to improve access, and to ensure that patients who need contraceptive care from a non-pharmacist medical provider are referred promptly to one.”

A Future of Advocacy

With this significant advocacy win under his belt, Dr. Pace admits that he’s been bitten by the political bug and will continue working toward furthering the interests of the pharmacy profession. Drs. Pace and Young, now co-chairs in the legislative committee of the Utah ASHP state affiliate, have already begun exploring new issues to tackle in the current legislative session.

“Whatever job I end up being in, I can’t imagine not being involved in some way in the advocacy process,” Dr. Pace said.

Although at first blush many pharmacists may shy away from doing advocacy work, Dr. Young urges all pharmacy professionals to consider getting involved because of the tremendous impact it can have on the way they work in their state.

“If you’re not interested in advocating for your profession, other people may change the laws and rules on you, and you may not like it,” he said. “If you want to control your outcomes, you’ve got to get involved. The best way to control your destiny is to create it — and that’s what happened with this bill.”

 

By Kenya McCullum

 

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

# # #

January 28, 2015

Provider Status Bill Reintroduced in Congress

 

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

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

HAPPY NEW YEAR! As we enter 2015 we can reflect on the success we had with last year’s introduction of pharmacists’ provider status legislation, H.R. 4190. This legislation, which enjoyed great support by both Republicans and Democrats, would amend the Social Security Act to recognize pharmacists as Medicare Part B providers working within their state scopes of practice in the large number of medically underserved areas—both urban and rural—throughout the United States.

I am happy to report that this important piece of legislation, now known as the “Pharmacy and Medically Underserved Areas Enhancement Act,” was reintroduced today by the original bipartisan sponsors. To add to that, we anticipate a companion bill will be introduced in the U.S. Senate by a bipartisan group of Republican and Democratic senators very soon. Now that’s the way to start the New Year off right!

ASHP and our members have taken a major leadership role in bringing this legislation to fruition and to helping advance it through Congress. The fact that all ASHP members provide exceptional care as generalists and specialists in hospitals, clinics, and other settings has made this effort possible, and it has clearly paid off.

These efforts by our stellar members who are already serving as patient care providers have been a shining example to Congress of what pharmacists can do to advance healthcare and improve patients’ lives. I am absolutely certain as I look to the future when provider status for pharmacists becomes the law of the land that ASHP members will lead the way in implementing the law and will serve as a source of inspiration to the entire healthcare community.

I would also like to recognize the efforts of our exceptional ASHP staff team that has worked tirelessly behind the scenes with Congress, CMS, and other stakeholders for more than a decade to lay the groundwork for this historic moment of opportunity. We couldn’t have gotten here without them! Regarding outreach and support from other stakeholders, the recent report by the National Governors Association expressed strong support for the expanding roles of pharmacists, including recognizing pharmacists as Medicare providers.

It is absolutely vital that every ASHP member continue to reach out to their members of Congress to express their support.

However, before we declare victory on behalf of our patients, we have a lot of work to do through 2015. It is absolutely vital that every ASHP member continue to reach out to their members of Congress to express their support and to ask them to co-sponsor (or thank them if they’re already co-sponsoring) this important legislation.

Further, we need you to form local coalitions with other patient and healthcare professional groups and colleagues you work with to get their support and to tell your stories as pharmacists and patient care providers through editorials and op-eds in your local newspapers, blogs, and social media outlets.

You can attend political rallies, fundraisers, and other events with your members of Congress and the Senate to ask them to support the legislation and to talk with them about how this legislation will help patients in your community and state. You can also support the ASHP PAC, which provides ASHP with the ability to support members of Congress who support your interests as pharmacists and patient care providers.

Most importantly, we want you to know that ASHP is here to support you every step of the way. Please visit ASHP’s advocacy center, and don’t hesitate to contact ASHP’s government affairs team.

ASHP continues to be a key leader in the Patient Access to Pharmacists’ Care Coalition (PAPCC), which currently includes almost every national pharmacy organization and a growing number of other influential stakeholders. The PAPCC will work to grow the national coalition, advocate to Congress, and create media campaigns in support of provider status.

I know you recognize the excitement and importance associated with this historic legislation, and the collective and individual role you will play in seeing the legislation get passed into law. I look forward to updating you again soon and to seeing all the great things you will be doing in your organizations, communities, and states now and in the coming months to support the legislation.

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

Sincerely,

Paul

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!

July 1, 2013

Moving Closer to Achieving Our Vision

Abramowitz-PREFERRED-Featured

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

In the last 20 years, the ASHP House of Delegates has debated and passed important proposals like support for the entry-level Pharm.D., universal health insurance, mandatory reporting of medication errors and “just culture,” collaborative practice, and the implementation of health information technology.

In recent years, the ASHP House of Delegates has approved policies that set future goals for residency training for all practitioners in direct patient care roles; defined the role of pharmacist prescribing in interprofessional patient care; called on federal officials to take action on compounding, drug shortages, REMS, and meaningful use standards; and pushed for standardized education, certification, registration, and licensure requirements for pharmacy technicians.

These policies touch every facet of pharmacy practice and have a profound impact on medication use in this country. ASHP’s professional policies offer a vision for the future of the profession in which pharmacists are essential members of every health care team and where medication use is optimal, safe and effective for all people, all of the time.

Last month, the ASHP House of Delegates approved more than 20 new professional policies during its session at the 2013 Summer Meeting in Minneapolis. Along with passing measures that support training in team-based patient care for student pharmacists and residents and the reclassification of hydrocodone combination products under the Controlled Substances Act, delegates also took strong positions on compounding safely and achieving provider status for pharmacists.

These actions are emblematic of the leadership that ASHP has taken on key medication-use issues throughout its history. ASHP’s professional policies provide a solid foundation for the Society to pursue transformative solutions to the issues that affect our ability to care for our patients.

In particular, the newly approved policies on compounding by health care professionals and pharmacist recognition as health care providers highlight this principle.

Compounding

ASHP is actively engaged in federal efforts to close gaps in the regulatory oversight of pharmaceutical compounding activities. We’ve worked closely with members of Congress and congressional staff on legislation that we expect the Senate to vote on this month; namely, the Pharmaceutical Quality, Security, and Accountability Act. While this legislation addresses federal authority, our new policy focuses on the laws and regulations that govern traditional compounding that occurs in hospitals, clinics, and other areas within health systems. It advocates for the adoption of applicable standards of the United States Pharmacopeia by state legislatures and boards of pharmacy.

The laws and regulations governing compounding vary from state to state. It is essential for the safety of all patients that all pharmacies that compound medications, regardless of the setting, adhere to the very highest standards. A uniform standard will help to ensure that the medications our patients receive are safe and that they are not harmed by agents that are intended to help them.

Pharmacist Recognition as a Health Care Provider

Pharmacists are health care providers. You demonstrate that each day. But we have some work to do to fix antiquated federal and state laws that place unnecessary limits on patients having access to the care we provide.

Our new policy on pharmacist recognition as a health care provider makes a strong case for changing the status quo. It points to the pharmacist’s role as a medication expert who provides safe, accessible, high-quality, cost-effective care. The policy also highlights that, as health care providers, pharmacists improve access to patient care and bridge existing gaps in care.

Achieving recognition as providers for pharmacists is ASHP’s top advocacy priority. We are devoting substantial time and energy with our partner pharmacy organizations to push for changes in the Social Security Act that will recognize the valuable role we play in the health care system.

Please take a look at the summaries of these policies below, and review the other professional policies that were recently finalized by the ASHP House of Delegates:

Pharmacist Recognition as a Health Care Provider

To advocate for changes in federal (e.g., Social Security Act), state, and third-party payment programs to define pharmacists as health care providers; further, to affirm that pharmacists, as medication-use experts, provide safe, accessible, high-quality care that is cost effective, resulting in improved patient outcomes; further, to recognize that pharmacists, as health care providers, improve access to patient care and bridge existing gaps in health care; further, to collaborate with key stakeholders to describe the covered direct patient-care services provided by pharmacists; further, to pursue a standard mechanism for compensating pharmacists who provide these services.

Compounding by Health Professionals

To advocate that state laws and regulations that govern compounding by health professionals adopt the applicable standards of the United States Pharmacopeia.

___________________________

I also encourage you to spend some time thinking about what you envision for the future of practice and what is needed to bring us closer to that goal. Share your thoughts with me in the comments section of this column or by sending an email to ceo@ashp.org. Members serve as the catalyst for our policy initiatives. Your input can help bring us even closer to achieving the vision we have for patient care.

May 9, 2013

Pharmacist Involvement Integral to Medical Home at Advocate Health

From left, a patient reviews his test results with Golbarg Moaddab, M.D., and Christie Schumacher, Pharm.D., BCPS, BC-ADM, CDE.

AS HEALTH CARE REFORM EVOLVES and providers are held to higher standards of quality and improved patient outcomes, more physicians and health systems are turning to the patient-centered medical home (PCMH) to offer comprehensive, cost-effective care.

At Advocate Medical Group, a subsidiary of the Advocate Health System in Chicago, administrators recognized the value pharmacists can bring to the medical home. When they needed a pharmacist who had experience working with heart failure patients, they contacted the Midwestern University College of Pharmacy for a candidate.

Enter Christie Schumacher, Pharm.D., BCPS, BC-ADM, CDE, assistant professor of pharmacy practice at Midwestern University Chicago College of Pharmacy, whose work with Advocate meets ASHP’s Pharmacy Practice Model Initiative recommendations for pharmacist involvement in the medical home. She is part of a PCMH that includes six primary care physicians, a cardiologist, a nurse practitioner, a physician assistant, a nurse educator, and a dietician.

Schumacher has a broad and well-integrated role in the PCMH. Through collaborative practice agreements, she initiates, discontinues, and titrates medications and provides medication reconciliation and education to improve patient adherence. She also orders and interprets laboratory values, arranges medical referrals, and provides disease-state and lifestyle education. Schumacher is also available for medication recommendations and physician consults.

A Key Member of the Health Care Team

Schumacher works closely with the team’s nurse practitioner, Monique Colbert, APN. The primary care physicians and cardiologist refer heart failure patients to Schumacher and Colbert through a “task” message in the patients’ electronic medical records.

Although physicians can select the team member whom they would like a patient to see, Schumacher and Colbert often review the medical history and make the determination themselves.

Patients who need more help with their medications see Schumacher, whereas those who need lifestyle management counseling see Colbert. Yet the two share the goals of improving patient outcomes and lessening the physicians’ load.

“We are extra help for the doctors. When patients need follow-up, the cardiologist and primary care physicians just can’t see them every two weeks. That’s where we step in and provide that in-depth care,” said Schumacher. Initial visits last about an hour, and follow-up visits last about 30 minutes.

Although Schumacher was initially tapped for her experience in treating heart failure, it soon became clear that patients needed assistance in managing coexisting conditions.

Christie Schumacher, Pharm.D., BCPS, BC-ADM, CDE

“We were seeing high A1Cs in people with diabetes, up around 10 or 11 percent, so we started making recommendations to the physicians about how to treat them. Then we did the same for patients with hypertension and dislipidemia,” said Schumacher. “The physicians asked us if we could handle treating this condition, and we went from there.”

Schumacher now uses pharmacist-created protocols and current guidelines to help her manage patients with diabetes, hypertension, dislipidemia, chronic obstructive pulmonary disease, and asthma. Plans are in the works to add chronic kidney disease to the mix.

Colbert said she has learned from Schumacher. “My background is heart failure, and Christie helped me come on board with diabetes. At first, I would see the patients with A1Cs of eight or lower, and Christie would see patients with more complex cases, but as I became more educated and more skilled, I began to take on complex patients as well.”

Proving the Case

The PCMH took six months to implement and, initially, there weren’t many patients to see: The primary care physicians and nurses were a bit wary of Schumacher conducting physical assessments. But support from the cardiologist, with whom she had worked before, helped, as did Schumacher’s own drive to show the value of pharmacist-provided care.

“I took the time to learn physical assessments. Many pharmacists aren’t comfortable with that, but it makes a difference. You need to show the physicians that you know what you are talking about,” she said. “At first, the physicians wanted us to run everything by them, but after two weeks of seeing what we could do, they told us to just go ahead [with our care].”

Although physicians still sign off on the care notes, both Schumacher and Colbert can now write prescriptions.

Golbarg Moaddab, M.D.

Goldbarg Moaddab, M.D., an internist on the team, finds the collaboration indispensible. “I can’t imagine practicing without the medical home anymore. The other professionals can be so much more thorough regarding patient history and medications, and they have more time to spend with patients than physicians do,” she said.

Advocate Medical Group is currently looking at outcome measures such as hospitalizations, readmissions, emergency room visits, blood pressure, LDL cholesterol, and A1Cs.

Regardless of how those measures come out, Moaddab said she has noticed a change among her patients.

“Before Christie was part of the medical home, it took much longer to get patients to their goals for A1Cs, blood pressure, and lipid control. Now that they are seen more frequently by other health care professionals on the team, they get there faster,” she said.

The patients appreciate the care, as well, said Schumacher, noting that for many patients, the in-depth follow-up is a new phenomenon.

“We have patients in their 60s who tell us that no one has ever sat down with them and discussed their medications,” she said. “We have a high turnout, and they like to come to their appointments. That’s going to go a long way toward increasing adherence and helping them to get better.”

–By Terri D’Arrigo

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