Christine Blank

The National Headache Foundation (NHF) has issued new migraine care recommendations challenging health insurance payers for uneven treatment of migraine patients.

The “current care models have not kept pace with the many advances in treatment,” NHF said in a statement.

Payers should adopt care models that are patient-centric, in which the clinician—in collaboration with the patient—is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs, NHF said.

“Clinicians and patients are naturally upset that payers are forcing them to use older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist,” said Tom Dabertin, NHF CEO and executive director.

“For too long, migraine patients have been treated differently than others with medical issues as it related to prescription medications,” Dabertin added.

The scientific understanding of migraine has advanced considerably in recent years, bringing better tolerated and better-studied treatments to patients, most notably, anti-calcitonin gene-related petptide (CGRP) monoclonal antibodies (mAbs), oral CGRP antagonists (gepants), and agents targeting serotonin receptors, NHF noted.

“There is also growing awareness among clinicians that what was once thought sufficient efficacy for successful migraine control is, in fact, inadequate,” NHF said. “Unfortunately, the care models set by payers and the consequent treatment paradigms have not kept pace with these advances.”

NHF’s position is that the selection of a migraine therapy:

should ultimately be determined by the clinician, in collaboration with the patient, based on the individual needs of that patient and that patient’s outcomes

should not be determined solely by a step-care model

should not be determined by a one-size-fits-all algorithm, including models focused predominantly on costs instead of outcomes

The organization’s specific recommendations are outlined below.

For patients with a minimum of 8 migraine days per month—a number that constitutes high-frequency or chronic migraine—NHF recommends that the clinician have the ability to select the most suitable preventive therapy, with unfettered access to FDA-approved preventive drugs, for the following reasons:

8 or more migraine days constitutes a significant fraction—25% or more—of the month; 

patients with less time to recover between incidents are more likely to experience a transformation to chronic migraine and more than 15 days per month; and studies suggest patients with 8 to 14 headache days/month have a level of disability similar to those with 15 to 19 headache days/month.

For patients with a 4 to 7 migraine days per month, a modified step-care model is recommended. In this model, patients must first try 1 generic drug for migraine prevention, unless a patient has a contraindication or, per clinician judgment, should not receive it. 

Topiramate, divalproex, sodium valproate, timolol, and propranolol are FDA-approved for migraine prevention. The remaining drugs are commonly used, but not have not been approved for that indication.

“If a drug from this list has failed to provide the patient with benefits in the severity and/or frequency of migraine, or is found to have intolerable side effects, the clinician should be free to select the next most suitable FDA approved preventive therapy, based on the individual patient’s needs and situation,” NHF said.

In the NHF-recommended model for preventive care, a patient is considered to have “tried and been failed by” a given drug if at least 1 of the following applies:

The patient does not experience an adequate treatment response after a 2- to 4-month trial, where response is defined as a 50% reduction in the number migraine days per month during preventive therapy compared with the number of migraine days per month prior to the start of therapy.

The patient cannot tolerate the drug due to its side effects, such as hypotension on beta-blockers, impaired cognition on topiramate, and weight gain on amitriptyline.

At the time of decision, the patient has a previously documented history of having “tried and been failed by” the drug due to intolerability or lack of treatment benefit.

The patient has a comorbidity and/or other contraindications that preclude the clinician from prescribing the drug.

For the treatment of acute migraine, NHF endorses a modified step-care model, in which patients must try 2 generic drugs: first a generic triptan, then any other generic drug, including another triptan or NSAID.

After a patient has “tried and been failed by” 2 of these generic drugs, the clinician can select another suitable therapy based on patient needs. These therapies include FDA-approved acute agents such as lasmiditan (Reyvow) or a gepant (ubrogepant [Ubrelvy], rimegepant [Nurtec ODT]; or atogepant [Qulipta]).

As with the NHF-recommended preventive care model, a patient is considered to have “tried and been failed by” a drug for acute migraine if at least 1 of the following applies:

The patient is not migraine pain-free and functional within 2 hours of treatment after the majority of attacks OR the patient has recurrence of migraine symptoms within 24 hours following treatment.

The patient cannot tolerate the drug due to its adverse effects (eg, tightness in the throat and/or chest with triptans).

The patient has a documented history of the drug having proved either lacking in efficacy or intolerable due to side effects.

The patient has a comorbidity and/or another contraindication that precludes the clinician from prescribing the drug. This list includes uncontrolled hypertension, coronary artery disease and reversible cerebral vasoconstriction syndrome for triptans or gastric ulcer disease and renal insufficiency for NSAIDs.

1. National Headache Foundation position statement on the treatment of migraine. National Headache Foundation. January 19, 2022. Accessed January 20, 2022. 

https://headaches.org/2022/01/19/national-headache-foundation-position-statement-on-the-treatment-of-migraine/

Articles

Current migraine care recommendations do not reflect recent advances in the scientific understanding of migraine disease.  

 Group Calls for New Model of Care for Migraine  

Parents around the country breathed a sigh of relief late last October when the FDA issued an emergency use authorization for the Pfizer-BioNTech mRNA vaccine for children aged 5 to 11 years.

 Pharmacies, along with pediatricians’ offices and schools, have been identified as a major distribution point to administer the vaccines in children.

Prior to the FDA ruling, the White House announced that “tens of thousands of pharmacies across the country will offer the vaccine to their local communities.”

“Pharmacists are a trusted source of information for parents, and local pharmacies will be a convenient, accessible option for many families. Pharmacies will o.er family-friendly in-store clinics to best meet the needs of local communities,” according to a statement from the White House.

“Pharmacy partners will launch comprehensive campaigns to reach parents and families, including texts, calls, and outreach to meet local communities where they are.”2 The US government has purchased 50 million more doses of the Pfizer-BioNTech COVID-19 vaccine to prepare for the pediatric vaccine rollout, the companies said in a news release.

“These important planning actions by the federal government will help ensure that pharmacies—the most accessible health care destinations in the country—are ready to continue to meet the needs of the American public when the time comes and when the science confirms that COVID vaccines for that age group are safe and effective,” said National Association of Chain Drug Stores (NACDS) President and CEO Steven C. Anderson in a statement.

“Pharmacies remain critical access points in the ongoing vaccination effort and, as the 2021-2022 flu season persists, pharmacies continue to meet the nation’s preventive care vaccination needs, all in one visit,” he added.

“The expectation is that pharmacists will play a major role in the administration of [children’s COVID-19] vaccines,” said Mitchel C. Rothholz, RPh, chief of governance and state affiliates at the American Pharmacists Association (APhA). Both chain and independent pharmacies are vital players within the national plan, he noted.

“Pharmacies within the federal COVID vaccination network (about 40,000 sites), as well as pharmacies that are part of their state/local jurisdiction plan, will have access to the Pfizer-BioNTech pediatric vaccine,” Rothholz said.

“Many of these pharmacies have been reviewing their operations and preparing for receipt and administration of the pediatric vaccines.” Pharmacists are also collaborating with their local school districts, Rothholz added. The vaccine is a 2-dose primary series, administered 3 weeks apart, at one-third of the dose—10 mcg—compared with the dose of 30 mcg for individuals 12 years and older.

How to Handle Children’s COVID-19 Vaccinations

“There is a lot being asked of vaccine providers across the health care system,” Rothholz said. Pharmacies are managing COVID-19 vaccines—including booster shots—along with seasonal influenza vaccines and numerous other immunizations. Some organizations are also providing staff to volunteer at COVID-19 vaccination clinics. As a result, Rothholz noted, it is “critical that both the public and private sectors devote the resources necessary to adequately and safely staff this enhanced campaign. The health of America depends on it.”

In addition, those who manage the pharmacy enterprise need to talk with their staff about how best to manage the workflow. “We are really encouraging that dialogue to happen so that workload can be talked through and supported where needed,” Rothholz pointed out. Managing the workflow will also help prevent pharmacist and pharmacy technician errors and reduce workplace stress. It will also reduce the likelihood of pharmacists and pharmacy technicians leaving the job or profession, Rothholz noted.

“Across the whole system—medicine, nursing, nursing assistants, [and] pharmacy team members—people are moving out of their professions and jobs. That is putting a strain on the system,” Rothholz said. “We are really trying to encourage discussions between management and their teams to talk through solutions.”

Many pharmacies are also utilizing appointment-based software systems to help manage the COVID-19 vaccine workload, according to Rothholz. The administration of the COVID-19 vaccine to children ages 5 through 11 is a collaborative e ort between the pharmacist and the parent or caregiver, who must work together to make the vaccine experience as nontraumatic as possible, Rothholz said.

Engaging the support of parents and caregivers in the process can help with managing the child’s concerns, Rothholz added. When possible, pharmacists

should avoid showing the needle to the child prior to vaccination. Parents can also be encouraged to bring iPads or other electronic devices to help with distraction. As always, pharmacists should confirm the vaccine the child is receiving with the parent or caregiver, Rothholz advised.

As trusted source of information for parents, pharmacists are a key part of the
plan to distribute the COVID-19 vaccine to newly eligible children.

Pharmacists Central to Distributing Pediatric COVID-19 Vaccines

Walmart has filed suit against the United States Department of Justice (DOJ) and the Drug Enforcement Administration (DEA), asking a US District Court judge to clarify the roles and responsibilities of pharmacists and pharmacies under the Controlled Substances Act (CSA), the retailer said in a news release.

Although Walmart’s pharmacies have blocked “thousands” of questionable physicians from having their opioids scripts filled by its pharmacists, “certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis,” the retailer said. “They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions.”

Walmart is the third-largest pharmacy retailer in the US, with more than 5000 pharmacies nationwide. The supermarket chain has expressed its commitment to fighting the opioid epidemic, which has worsened over the years; overdose deaths from opioids were 4 times higher in 2018 than in 1999.

However, there is no federal law requiring pharmacists to interfere in the phyisician-patient relationship to the degree that DOJ is demanding, according to Walmart. “In fact, expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” Walmart said.

On one hand, DOJ is criticizing Walmart for not taking further actions to second-guess opioid presciptions; on the other, state health regulators argue that Walmart is unnecessarily meddling with physician-patient relationships, according to the news release.

“DOJ is forcing Walmart and our pharmacists between a rock and a hard place,” Walmart asserted in its statement.

The confusing dichotomy requires a federal court to clarify the roles and responsibilities of pharmacists and pharmacies, according to Walmart.

“Walmart and our pharmacists are committed to helping address the opioid crisis that has affected so many. We are proud of our pharmacists, who help patients understand the risks about opioid prescriptions, and who have refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic,” Walmart added.

 was filed on October 22 in the US District Court for the Eastern District of Texas.

Walmart sues DOJ and DEA seeking clarity for pharmacists in dispensing prescription opioids. News release. Walmart; October 22, 2020. Accessed October 26, 2020. 

https://corporate.walmart.com/newsroom/2020/10/22/walmart-sues-doj-and-dea-seeking-clarity-for-pharmacists-in-dispensing-prescription-opioids

Redman R. Walmart sues DOJ over pharmacists’ role in dispensing opioid prescriptions. Supermarket News. October 23, 2020. Accessed October 26, 2020. 

https://www.supermarketnews.com/health-wellness/walmart-sues-doj-over-pharmacists-role-dispensing-opioid-prescriptions

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Walmart filed a pre-emptive suit against 2 government agencies that are threatening to sue Walmart over its pharmacists filling opioid prescriptions.

Walmart Sues DOJ, DEA to Clarify Pharmacists’ Role in Filling Opioid Prescriptions

Shortages of vital generic drugs—particularly since the start of the coronavirus disease 2019 (COVID-19) pandemic in the US—are well known by pharmacy teams in both health systems and community settings.

And, although pharmacy associations appreciate the Trump administration’s efforts to move more pharmaceutical and active pharmaceutical ingredient (API) manufacturing to the United States via a recent executive order, they say government initiatives must include an overall plan for drug pricing, payment model, and supply chain transparency.

Since the start of COVID-19, the incredible demand for medications relating to patients being on ventilators—including sedatives, vasopressors, and neuromuscular blockers—led to several shortages. Fentanyl injection, midazolam injection, rocuronium injection, and propofol injection were among those that were most in short supply, according to Erin Fox, PharmD, senior director of drug information and support services at the University of Utah

However, the COVID-19-related shortages have largely been resolved, with the exception of neuromuscular blockers, ASHP Vice President of Government Affairs Tom Kraus, told 

Although generic drug shortages have been a serious challenge during the pandemic, there are hundreds of drug shortages that occur each year, Kraus pointed out. “In the hope of getting a response from policymakers, COVID-19 shines a light on this, but it is not a new problem.”

Major Initiatives Underway to Solve Problem

Although generic drug shortages have been around for years, new government and industry initiatives may help alleviate future problems.

ASHP is urging the US government to provide “economic incentives” for foreign manufacturers to produce high quality generic drugs and APIs.

“Over half of drug shortages relate to quality problems, which result in a plant coming offline and not producing product. Particularly for low-cost generic drugs, there may not be nearly enough economic incentives for that manufacturer to bring that plant online quality,” Kraus said.

In addition, hospitals and other drug purchasers need some clarity and transparency in relation to when their products will be available. “One way we could connect the dots is let’s publish transparency around the supply chains. Purchasers could steer volume to manufacturers that have a more robust supply chain and could potentially pay a premium for that. That could be a reward for manufacturers,” Kraus said.

In another major effort to prevent generic drug shortages, President Donald Trump recently issued the “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States”, which says the federal government should buy “essential” drugs and supplies made in the US rather than from overseas companies.

“We wouldn’t buy all our essential equipment for a military operation from China or from Russia, so why should we rely so heavily on international rivals for our essential prescription drug supply of generic medications which make up 90 percent of all prescriptions in the US?” NCPA CEO B. Douglas Hoey said in a news release supporting the Order.

“We have seen so many active pharmaceutical ingredients moved offshore, particularly to China and India. When there is a hitch in the supply chain, it ripples through the distribution channels and causes shortages for pharmacies and the patients,” Hoey told 

, there have been problems with generic manufacturing overseas,” Scott Knoer, executive vice president and CEO of APhA told 

®. “I don’t know the right answer to fix it…the pharmaceutical manufacturers can make it cheaper over there. There are potential advantages to making more [drugs and APIs] in the US; however, there will be offsetting increased costs.”

However, although ASHP believes that there is a need for more medications and APIs to produced domestically—and using government purchasing power to incentive manufacturers to produce more domestically is one avenue—that should not come at the expensive of disrupting private sector supply chains and it should not preclude purchasers from utilizing foreign manufacturers, Kraus said.

“We are highly dependent on foreign manufacturers. While we should diversify manufacturing, we shouldn’t do that at the expense of foreign APIs, because they are an important source,” Kraus said. The pharmaceutical supply chain should be more diversified, he pointed out, in order for APIs to originate from a “broad range of foreign countries, so we are actually less dependent on one country.”

The Association for Accessible Medicines (AAM) supports the diversification of the pharmaceutical supply chain, but noted n a news release

that generic manufacturers already make “tens of billions of doses of safe, effective and affordable medicines here in America each year.”

“The pharmaceutical supply chain has demonstrated its resilience during the pandemic by responding to unprecedented demand with strategies that ensured uninterrupted access to essential medicines for millions of patients,” said Jeff Francer, interim CEO of AAM.

However, without addressing the undervaluation of generic and biosimilar medicines in the US with sustainable market supply plans, “we simply cannot secure the domestic market and supply chain with scale and sustainability,” Francer said. To that end, AAM drafted recommendations, 

A Blueprint for Enhancing the Security of the U.S. Pharmaceutical Supply Chain

, which it is discussing with the Trump administration and Capitol Hill.

The resulting rulemaking from the Order must also include a broader solution that does not just mandate increased US manufacturing of medications and APIs, Hoey pointed out. “The payment model has really driven manufacturers offshore because there is so much pressure to get cheap [medications] over quality and over accessibility. If the Administration is going to make a change, it needs to be a holistic change,” Hoey said.

The entire distribution model, including the payment model, must be more transparent because “if the squeeze is going to make pennies per bottle, then there is going to be pressure to repeat the same mistakes that have been made that have resulted in so much of our APIs being offshore,” Hoey said. “This helps, but in a vacuum it is not going to address the issue of shortages and a reliance on a foreign source for critical drugs.”

Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States. White House; August 6, 2020. Accessed August 21, 2020. 

https://www.whitehouse.gov/presidential-actions/executive-order-ensuring-essential-medicines-medical-countermeasures-critical-inputs-made-united-states/

NCPA statement on ‘Buy American’ Executive Order. News release. NCPA; August 6, 2020; Accessed August 21, 2020. 

https://ncpa.org/newsroom/news-releases/2020/08/06/ncpa-statement-buy-american-executive-order

Generic and biosimilar industry statement on Essential Medicines Executive Order. New release. Association for Accessible Medicine; August 6, 2020. Accessed August 21, 2020. 

https://accessiblemeds.org/resources/press-releases/statement-on-essential-medicines-executive-order

A Blueprint for Enhancing the Security of the U.S. Supply Chain. Associaton for Accessible Medicine; April 2020. Accessed August 21, 2020. 

https://accessiblemeds.org/sites/default/files/2020-04/AAM-Blueprint-US-Pharma-Supply-Chain.pdf

Pharmacy organizations stress that government initiatives must include an overall plan for drug pricing, payment model, and supply chain transparency.

Generic Drug Shortage Solutions on the Horizon

The National Association of Boards of Pharmacy (NABP) has issued nearly 50,000 “passports”, or temporary licenses, for pharmacists and pharmacy technicians.

“Launched in response to the [coronavirus disease 2019 (COVID-19)] crisis, this new service supports member state boards of pharmacy in processing requests for temporary and emergency licensure to pharmacists and pharmacy technicians,” NABP said in an email sent to 

NABP Passport allows those seeking temporary or emergency nonresident licensure to submit state-specific requests for an NABP Passport through their NABP e-Profile. NABP then conducts the necessary license verification and disciplinary history review at no cost to the individual or the boards of pharmacy. 

Pharmacy Job Demand Could Grow Because of COVID-19

To streamline the process for applicants, multiple states can be included in each request. As a result, the number of passports issued is higher than the number of requests-which reached 6800 by the end of May.

“Pharmacists must have at least 1 existing license to apply for the Passport, and pharmacy technicians must have a license/registration or hold a certification from the Pharmacy Technician Certification Board or Exam for the Certification of Pharmacy Technicians. Interns and pharmacy businesses can also apply for a Passport if allowed by the state in which they are seeking temporary or emergency licensure,” NABP said.

Currently, 19 jurisdictions have indicated they will make use of the passport program, and 8 states have approved the service for interns. 

Pharmacy licensure testing sites, which were closed at the height of the COVID-19 pandemic, are now reopened, Lemrey “Al” Carter, PharmD, executive director and secretary of NABP, told 

“Most test centers are open and are increasing the capacity in accordance with state and federal regulations,” Carter said. In addition, in late May, 

 gave access to 61 additional select sites to take the NAPLEX and MPJE, Carter said.

The National Association of Boards of Pharmacy (NABP) has issued nearly 50,000 “passports,” or temporary licenses, for pharmacists and pharmacy technicians.

NABP Issues Nearly 50,000 Temporary Licenses for Pharmacists, Techs

The Trump Administration’s Operation Warp Speed, formed to accelerate the development, manufacturing, and distribution of a coronavirus disease 2019 (COVID-19) vaccine, should rely on the “proven record of pharmacies and pharmacists for the rapid deployment of COVID-19 vaccines when they are available,” NACDS said in a 

“For more than a decade since the 2009 H1N1 pandemic, government planning to distribute and administer federally purchased pandemic vaccine to the American public rapidly, efficiently, and safely has included modeling that heavily draws on the strength of chain pharmacies, pharmacists, and private sector distribution channels,” NACDS President and Chief Executive Officer Steven C. Anderson, FASAE, CAE, IOM, wrote on behalf of NACDS in a 

 to the directors of Operation Warp Speed.

Among other objectives, which include the development of therapeutics and diagnostics for COVID-19, Operation Warp Speed is tasked with facilitating substantial quantities of a safe and effective COVID-19 vaccine by January 2021, according to the US Department of Health & Human Services.

Americans appreciate the opportunity to receive their vaccinations at pharmacies, NACDS noted. “With more than 60,000 community pharmacies nationwide-in which nearly 90% of all Americans live within 5 miles of a pharmacy-pharmacies stand ready to support Operation Warp Speed’s efforts to safely and efficiently bring the COVID-19 vaccine to the American public,” Anderson wrote.

NACDS COVID-19 Report: Top Reopening Priorities and How Pharmacies Can Help

In fact, around 1 in 3 adults, or 38 million, who received the influenza vaccine during the 2018-2019 season did so at their community pharmacy, according to the letter.

The organization’s letter detailed federal government studies showing that pharmacists can help vaccinate 25 million more Americans per week, and can help vaccinate 80% of the country seven weeks sooner than if neighborhood pharmacies were not engaged.

 that community pharmacies can mitigate up to 23.7 million pandemic symptomatic cases, yielding a cost savings of approximately $100 billion.

“Many community pharmacies can also deploy mobile vaccine programs that can be tailored to those in underserved, rural, or vulnerable communities,” NACDS said.

1. NACDS Urges Operation Warp Speed to Prepare Now to Accelerate COVID-19 Vaccinations through Pharmacies. News Release. NACDS; June 2, 2020. Accessed June 2, 2020. https://www.nacds.org/news/nacds-urges-operation-warp-speed-to-prepare-now-to-accelerate-covid-19-vaccinations-through-pharmacies/.
	2. Anderson SC. RE: Accelerate Distribution of COVID-19 Vaccines to Americans through Community Pharmacies. NACDS; June 1, 2020. Accessed June 2, 2020. https://www.nacds.org/pdfs/government/2020/NACDS-COVID-19-Vaccine-Operation-Warp-Speed-Letter-6-1-2020.pdf.
	3. Trump Administration Announces Framework and Leadership for ‘Operation Warp Speed’. News Release. HHS; May 15, 2020. Accessed June 2, 2020. https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html
	4. Bartsch SM, Taitel MS, DePasse JV, et al. Epidemiologic and economic impact of pharmacies as vaccination locations during an influenza epidemic. Vaccine. November 2018. doi: 10.1016/j.vaccine.2018.09.040

Pharmacies and pharmacists can help the rapid deployment of COVID-19 vaccines when available, NACDS said. 