Blog

The Battle Continues Over 340B

In November, we published a post detailing how several drug manufacturers would no longer be providing 340B drug pricing to most contract pharmacies.  As we predicted, the Department of Health & Human Services (HHS) reacted to this move, issuing an eight-page advisory opinion on contract pharmacies under the 340B drug program.

This guidance was published on December 30th and can be found here.  Within the HHS publication, the Office of the General Counsel (OGC) reiterated that contract pharmacies are acting as agents of the covered entity.  Furthermore, HHS notes that “manufacturers’ rationale for precluding the use of contract pharmacies is not supported by the language of the statue and leads to absurd results.”  HHS concludes by saying that drug manufacturers are required to deliver covered outpatient drugs to contract pharmacies and charge covered entities no more than the 340B ceiling price for those drugs.

On January 12th, three manufacturers sued HHS over this advisory opinion, with each company filing a separate lawsuit.  The manufacturers claim that the advisory opinion contradicts the 340B program statues and does not require manufacturers to recognize contract pharmacies.  On the other side, the American Hospital Association (AHA) and similar groups have also sued HHS to get the agency to clamp down on these manufacturers.  Getting sued from both sides, HHS will likely act on this issue and defend themselves in court.  With the 340B program seeing exponential growth in the past decade, it was only a matter of time before this issue came to a head.  PHSL will continue to monitor the situation and provide updates.

 

Posted January 2021

Emergency Use Authorization (EUA) Product vs FDA-Approved Product

The COVID-19 pandemic prompted the rapid development of diagnostic testing products to identify patients with the virus and vaccines to protect patients from contracting the virus.  This rapid development created broad awareness of the FDA’s Emergency Use Authorization (EUA) authority to help protect the public in health emergencies.  The number of products that received EUA in 2020 appears to exceed the number of EUAs seen for Anthrax, Ebola, Zika, or other health crises prior to this pandemic. EUAs are needed because the typical approval process takes too much precious time, prolonging a public health emergency.  Looking forward to when these products receive FDA approval for non-emergency use, there are industry considerations to facilitate a smooth transition from utilizing EUA products to using FDA-approved products.

Currently, EUA tests and vaccines are provided free of charge.  However, it is likely that once the same product receives FDA approval for commercial use, pharmaceutical manufacturers will charge for these products.  Therefore, for the purposes of inventory tracking, patient profile management, and claims submission, it is important that EUA product does not become confused with the FDA-approved commercial product.

To accomplish that, manufacturers should obtain an NDC for the commercially approved product that is different than the NDC given to the EUA product.  The product code of the NDC (middle segment) and/or the package size identifier of the NDC (last segment) should change in a way that clearly distinguishes between the EUA and approved product.  National Council for Prescription Drug Programs (NCPDP) encourages manufacturers to obtain new NDCs in this situation.

Since the NDCs for EUA products are listed by the drug compendia with no associated cost, the new NDC can be listed with the cost determined by the manufacturer, without affecting the EUA NDC. Different NDCs will provide the means for proper claims submission, indicating the product that was utilized, and allows the healthcare provider to log the appropriate product on the patient’s profile.  This will also help to track and separate inventory of unapproved EUA products in the channel before and after FDA approval of the commercial product.

Lastly, and most important, obtaining a new NDC for approved commercial products will help ensure there is no delay or denial for vaccine administration because of confusion stemming from EUA and FDA-approved product represented by the same NDC.

 

Posted: December 2020

Amazon’s Pharmacy Announcement

Three years ago, we wrote an article describing Amazon’s options in the pharmacy market and expected challenges.  Their announcement this morning confirms a number of our expected services, and we were three years ahead of time!  Please see our previous article at:

http://phsirx.com/wp-content/uploads/2017/10/SeptOct_Viewpoints_2017.pdf

Program Highlights

Amazon Pharmacy has been able to enroll in third party plans and will be accepting these prescriptions.  However, the focus appears to be on the cash market. They have partnered with Inside Rx to offer discount cash prices.  This appears to prevent losing margin dollars on third party prescriptions by avoiding the lower of clause in many third party agreements.  For insured patients, Amazon will provide patients with both their insurance copay and the cash pay amount, enabling them to choose the lower cost fill option.

Amazon will be leveraging Amazon Prime membership by offering free 2-day shipping on prescriptions compared to free 5-day shipping or $5.99 2-day shipping for non-Prime patients.  Amazon will offer their branded discount card for use at retail pharmacies, giving them additional information and opportunity to market to those patients.  It’s unclear why a retail pharmacy chain would want to support these programs.  Finally, Amazon Pharmacy is not including Schedule II controlled substances in its pharmacy offering at this time.

What impact do you think the Amazon Pharmacy will have on the market?

 

Posted November 2020

The Growing Concern of Medical Bankruptcy

Having health insurance may not always be enough to ensure that Americans can afford their medical expenses. The Affordable Care Act (ACA) had a positive impact on the number of people who have health insurance but did not affect the yearly percentage of people who filed for bankruptcy due to medical issues. Bankruptcy effects an estimated 530,000 families in the United States each year, with approximately two-thirds citing medical issues as a key contributor to their financial problems. These factors may include the high cost of medical care or the time required to be off work due to a medical condition.

A 2020 Gallup and West Health survey showed that 50% of American adults are concerned that a household health event could lead to the need to file for bankruptcy. This is an increase of 5% in just one year. The percentage of non-white adults who are concerned about medical bankruptcy has increased from 52% to 64% during this same period. Individuals aged 18-29 expressed a 12% increased concern, and adults 30-49 expressed a 9% increase in reported concerns over the possibility of having to file for bankruptcy due to medical expenses in the same one-year period.

Individuals who file for bankruptcy are not the only ones struggling from rising medical costs. A survey conducted by Bankrate reported that 75% of all workers in the United States say they are living paycheck to paycheck. This limits their ability to save for unexpected medical expenses or other emergencies. The COVID-19 pandemic has worsened the medical debt crisis for those that are uninsured and individuals who have lost their jobs due to business closures.

A 2019 KFF (Kaiser Family Foundation) Health Tracking Poll shows that 69% of Americans believe that reducing health care costs should be a priority for the president and Congress, second only to the economy. In the presidential election, differing health care coverage approaches allowing for expanded coverage was an important topic of discussion.  While the approaches to handling this growing issue may differ, pharmacists are perfectly positioned to help patients lower prescription drug costs.  Whether through evaluating product substitution alternatives, applying copay cards, or researching available patient assistance programs, pharmacists are the forefront.  A solution to minimize medical bankruptcy is not clear cut and will likely require cooperation among all industry stakeholders.

 

Posted November 2020

HRSA Response to Manufacturer 340B Changes

In September, several drug manufacturers announced that they would no longer be providing 340B pricing to most contract pharmacies.  You can read about those actions in our Fall 2020 Newsletter.  In response to those manufacturer actions, Apexus, the 340B Prime Vendor Program, published a sample form for covered entities to report instances where covered outpatient drugs are not available at a 340B ceiling price and/or are charged at the incorrect 340B ceiling price.

The form specifically asks if the issue reported is limited to a contract pharmacy purchase.  This question could help Apexus target where availability or pricing issues are specifically related to the recent manufacturer changes.  The form also asks the reporting party to note if purchasing is affected by a shortage-related issue, relates to a specialty drug, or is subject to limited distribution.  These questions may identify availability or pricing issues unrelated to recent manufacturer 340B actions.

Perhaps most telling is the instruction to “contact the wholesaler and manufacturer directly to determine the reason for unavailability and/or to document incorrect pricing” prior to submitting the form.  Per the form, “HRSA investigates allegations of non-compliance brought to its attention and will follow-up with all parties once the issue is reviewed.”  The form also asks if the covered entity has verified that the product is a covered outpatient drug, as listed on the Medicaid Drug Rebate Program file.  While this step is not listed as “required,” it may help to further validate a covered entity claim.

Completed forms, along with manufacturer and/or wholesaler responses, are to be emailed to HRSA.  Based on the availability of this form and its uptake and use by covered entities, HRSA may begin to quantify the extent and impact of manufacturers’ refusal to provide 340B pricing to all contract pharmacies.  Stay tuned as this chess match continues.

 

Posted November 2020

Ohio Provider Status for Pharmacists

On January 4th, 2019, the Governor of Ohio signed into law SB 265, which gave pharmacists provider status in the state and allowed Ohio pharmacists to perform services and receive payment after successful credentialing. Ohio’s Medicaid and Managed Medicaid programs are in the initial phases of including pharmacists as providers.

In April, United Healthcare Community Plan of Ohio announced that it would begin working with two independent community pharmacies in Ohio to expand access to care and help improve health outcomes in Ohio. During the COVID-19 pandemic, United Healthcare utilized the expertise of pharmacists to focus on caring for patients transitioning out of hospitals, assisting patients with the management of their chronic diseases (e.g. High Blood Pressure, Diabetes, etc.), helping to prevent adverse events, and optimizing therapies. This program also enabled pharmacists to bill and receive reimbursement for providing services using existing CPT codes for evaluation and management, virtual check-ins, and transitional care management.

Ohio’s Centene managed care organization, through Buckeye Health Plan, launched a program in June 2020; during the initial phase, participating pharmacists worked with physicians at a health system and two federally qualified health centers.  Pharmacists served patients living with chronic conditions through monitoring and adjusting medication, demonstrating medical equipment use, ordering lab tests, and providing preventative care, including vaccinations.

CareSource, an Ohio Managed Medicaid plan, announced a provider status program focused on two independent community pharmacies near Dayton, Ohio: an independent pharmacy in a rural community, Camden Village Pharmacy, and an inner-city independent pharmacy, ZIKS Pharmacy. The pharmacists in this pilot program will focus on CareSource patients that have been identified as being at high-risk or in need of care for tobacco cessation, opioid management, diabetes, and/or asthma. The CareSource pharmacist provider status pilot will also be added to the Value-Based Reimbursement opportunity that was released by CareSource in January 2020. This will allow pharmacists the ability receive payment for increasing the quality of care of patients.

The Ohio Department of Medicaid announced they will create provider identification numbers for pharmacists in January 2021.  The Ohio Department of Medicaid has begun compensating pharmacists for conducting COVID-19 testing.

Ohio pharmacists will not be included as providers for Medicare plans until federal changes occur.  Commercial plans may choose to include pharmacists as providers but are not required.  Will we see other states following Ohio’s lead? Are you advocating for this type of change in your state?

https://www.pharmacytoday.org/article/S1042-0991(20)30871-9/fulltext

 

Posted October 2020

Recognizing Pharmacists’ Contributions During American Pharmacists Month

American Pharmacists Month represents a celebration of pharmacists across the country to appreciate their hard work, dedication, and their contributions for improving patient health outcomes. Pharmacists provide massive contributions to health care and the well-being of communities. They are the most patient-accessible primary health care professionals. This year more than ever, front-line pharmacists are of particular importance to patients and communities during the COVID-19 pandemic.

Whether filling medications in community pharmacies, managing patient regimens in the ICU, or working to develop and deliver a vaccine, pharmacists continue to play an important role in managing and preventing the spread of COVID-19. The American Pharmacist Association (APhA) aims to commemorate and bring awareness to the wide array of traditional and new services pharmacists provide.

These are just a few of the ways pharmacists are fighting COVID-19:

  • Offering Point-of-Care testing for COVID-19 to help alleviate future surges of infections
  • Providing and advocating for immunizations
  • Encouraging patients, especially those with an increased risk of severe illness, to use curb-side pickup and home delivery services
  • Compounding hand sanitizers
  • Managing medications and ensuring quarantined patients have adequate supplies
  • Educating communities
  • Checking in on patients with chronic conditions who struggle to access their primary care providers during the pandemic

The challenges of the pandemic allow pharmacists to showcase their skills and shine a light on their importance in the healthcare system. The emergence of new roles and innovative practices for pharmacists will likely arise post-pandemic to further improve patient and population health.

To get involved in recognizing and celebrating the pharmacists of our country, use the link below to access ASHP’s engagement calendar of National Pharmacist Month events:

https://www.ashp.org/Pharmacy-Practice/Resource-Centers/Public-Relations/National-Pharmacy-Week/Engagement-Calendar

 

Posted October 2020

National Prescription Drug Take Back Day

The next National Prescription Drug Take Back Day, sponsored by the Drug Enforcement Administration (DEA), is scheduled for Saturday, October 24, 2020 from 10:00 am to 2:00 pm. Based on the 2019 National Survey on Drug Use and Health, 9.7 million Americans misused controlled prescription drugs in the previous year, a slight decline from the numbers reported in 2018. Having unused medications at home has been shown to contribute to this misuse. The previous Take Back Day scheduled for April 25, 2020 was cancelled due to coronavirus concerns, which may have left you or your patients with medications to get rid of. This event is a safe, convenient, and responsible way to dispose of unused, unwanted, or expired prescription drugs at locations in communities throughout the country. Take your pills and patches for disposal to the event on October 24th. Sites cannot accept liquids, needles, or sharps. The drug take back service is free and anonymous, no questions asked.

The last National Prescription Drug Take Back Day held in October of 2019 collected 441.5 tons of medication at 6,174 participating sites across the country.

You can search for a participating Drug Take Back Day disposal site near you by visiting https://takebackday.dea.gov/

If you are unable to attend the National Prescription Drug Take Back Day, you can dispose of your medications at a year-round pharmaceutical disposal location. Visit the U.S. Drug Enforcement Administration Diversion Control Division at https://apps2.deadiversion.usdoj.gov/pubdispsearch to locate a site near you.

 


 

Posted October 2020

Pediatric Pharmacy Association Develops First-of-its-Kind List of Drugs to Avoid for Children

Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List

For almost 30 years, the Beers Criteria, a list of potentially inappropriate drugs for use in patients 65 years and older, has guided safe medication prescribing in older adults. Until recently, no similar document has existed to improve the prescribing standard of care in pediatric patients. In 2017, the Pediatric Pharmacy Association (PPA) commissioned an expert group of pediatric pharmacists to compile a list of drugs, both prescription and over-the-counter, that should be avoided in the pediatric population. The list of identified medications associated with a high risk of adverse drug reactions (ADRs) will be a tool used to evaluate and enhance the quality of care and identify research needs in the pediatric population.

The World Health Organization (WHO) defines ADRs as “any noxious and unintended response to a drug that occurs in man at doses normally used for prophylaxis, treatment of diagnosis of disease, or the modification of physiological function.” Despite many attempts to quantify, the rate of ADRs in the pediatric population has been difficult to discern. Factors confounding researchers include the prevalent off-label use of medications and the altered pharmacokinetics. Investigators find that 50% of medications in the United States are not labeled for use in children, forcing practitioners to prescribe unvalidated and potentially dangerous dosing regimens. Further complicating safe dosing are the maturational changes in body compositions and organ function that occur throughout adolescence. The absorption, distribution, metabolism, and excretion of the same drug occurs differently in 2-year-old versus a teenager.

With the pediatric populations’ unique risk factors for ADRs in mind, the panel researched and identified potentially inappropriate medications for use in the pediatric population. The researchers defined the list as “medications or medication classes that should generally be avoided in persons younger than 18 years because they pose an unnecessary high risk for children and a safer alternative is available.” Utilizing the strength of their recommendation, quality of evidence in the literature, and the severity of potential adverse effect, the panel labeled medications either “avoid” or “caution use.”

Systematic search of PubMed, Lexi-Drugs, FDA communications, and expert opinion resulted in inclusion of 67 drugs and 10 excipients on the KIDs List. Thirty-nine (39) drugs/excipients were listed as “avoid” and 23 as “use with caution.” Frequent classes of medications included were anti-infectives, antipsychotics, dopamine antagonists, and gastrointestinal agents. The authors further provided specific recommendations for each drug to account for the unique risks of each stage of adolescence.

The authors intend for health care professionals in acute and ambulatory care settings to use the list as an evidence-based guide to improve the safety of medication use in pediatric patients. Investigators also warned that the list is not a substitute for practitioner’s clinical judgement or other resources, such as the WHO Model List of Essential Medicines for Children.

Investigators excluded aspirin, fluoroquinolones, antidepressants, and cough preparations from the KIDs List. While these medications present safety concerns in pediatrics, in some instances their benefit outweighs the risk. Following extensive review, the expert panel excluded medications in the table below based on a lack of sufficient evidence of the pediatric risks.

Medications and Classes Excluded from the KIDs List
Products/Class Reason for Exclusion
OTC Pediatric cough and cold preparations Safety issues linked to overdoses. The panel found no toxicity issues when recommended doses were utilized.
Fluoroquinolones Evidence of the historical recommendation to avoid use was not found to be robust. The benefits in certain populations (cUTI, Cystic Fibrosis, CAP) outweigh the potential risk.
Aspirin* Recent literature has contested the association with Reye’s syndrome. Benefits outweighs risk in certain populations – Kawasaki disease, post ischemic stroke, and cardiac surgery patients.
Antidepressants FDA issued a black box warning on the entire class of antidepressants, indicating their association with increased risk of suicidality and suicidal ideation in children. The panel felt the evidence of clinical benefit was too strong to include the entire class of medications on the KIDs List.

*Aspirin was included on the list with a weak recommendation to use with caution in children with suspicion of viral illness (influenza and varicella).

The impact of the KIDs List will depend upon its adoption by pediatric and general healthcare practitioners. The fastest path to usage in clinical decision-making and safe prescribing will involve inclusion in drug information resources, electronic health records, and e-prescribing systems. Much like the Beer’s Criteria, medications placed on the KIDs List should have pediatric safety warnings added to their drug information pages. Lexicomp, for example, has updated the drug information for all KIDs List medications to reflect the recommendations made by the panel. Integration of the KIDs list across all drug compendia will increase impact on prescribing patterns and pediatric patient safety.

The panel stated they expect significant feedback, and they intend to update the KIDs List when a critical mass of new information is received. Throughout their research, the authors continually cited a paucity of evidence and lack of sufficient drug safety data in the pediatric population. While the current version of the KIDs List represents a starting point for safe medication use in the pediatric population, continued research and data collection is more important than ever.

The entire alphabetical list can be found at the following address: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7134587/pdf/i1551-6776-25-3-175.pdf

 

References:   

  1. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. doi:10.5863/1551-6776-25.3.175

KIDs List

 

 

 

 

 

 

 

Posted September 2020

COVID-19 Vaccine Development and the Pharmacist’s Role

In the United States, new cases of COVID-19 have been on the rise with daily numbers ranging between 50,000 and 60,000 since late June. Predictions are showing a larger spike in new cases through mid-August.  Luckily, while numbers continue to surge, so do efforts to develop a vaccine.

As the United States’ leading expert on infectious disease, Dr. Anthony Fauci and his team have plans for a large clinical trial involving approximately 30,000 participants that will be underway later this month. This large-scale study would help determine if the vaccine they have been developing with the National Institute of Health and Moderna Inc. has potential to shield against COVID-19. For this vaccine to be effective it must induce T-cells to create memory cells, as well as specialized T-cells that activate B-cells to produce the appropriate antibodies to tag or neutralize the virus for elimination. Additionally, Oxford and AstraZeneca have been working together on a vaccine currently in the Phase III clinical trial. Data on immunity and safety for this vaccine is expected August 2020. Globally, with hundreds of vaccines under development and testing, the possibility of seeing one soon may no longer be just wishful thinking.

However, initial trials for both vaccines have shown concerning signs of side effects. The Phase I and 2 results for Moderna’s vaccine showed signs of chills, headaches, and fatigue appeared in participants after the second dose. Oxford’s initial trials showed that about a third of participants had moderate to severe side effects including muscle aches, chills, low grade fever, headache, malaise, and fatigue. Currently, participants for Oxford’s vaccine in the Phase III trial are given acetaminophen along with the vaccine; possibly to reduce the side effects already seen in previous trials. Once on the market, side effects will be a large concern and pharmacists should be prepared to help with side effect management for those getting the vaccine.

The limiting factor could be the vials and syringes needed for the vaccines. Current supplies will not meet the demands of approximately 6 billion people globally who will require vaccination to obtain “herd immunity.” With rising demands, governments and pharmaceutical companies around the world are contracting with multiple manufacturers in hopes of producing enough vials once vaccines are launched. In the US, the Trump administration has contracted with domestic manufacturers; some of which produce their products in Asia or Europe. Some of the companies include Corning, a US glass maker; BD, a worldwide medical supply company; Retractable Technologies, a company in Texas that produces syringes; and ApiJect Systems, a company that makes prefilled syringes. To push demands even further, most vaccines under trial require two doses to be administered. If this is the case with the final vaccines, pharmacists will need to track the patients first and when the second dose is needed. In addition, pharmacists should know the CDC expects 10 ml vials holding 8 to 15 doses to be the standard once vaccines are available.

As of 2019, 46 states, as well as D.C. and Puerto Rico, have given authority for pharmacists to administer any type of adult vaccinations. The remaining 4 states; New Hampshire, New York, West Virginia, and Wyoming; have limitations on what immunizations pharmacist can administer. This progress in public health has allowed easier and quicker access to immunization for the public and will be essential in the context of a possible COVID-19 vaccine. Pharmacists should not only be prepared to administer vaccinations once available, but also provide education on the topic.  Staying informed about the latest developments on COVID-19 and the vaccines in progress will help prepare pharmacists for any questions or concerns that their patients may have. Once a vaccine is developed, pharmacists should discuss with patients that a vaccine is not a cure but rather a preventative measure. Providing written materials and verbal counseling discussing potential side effects and risks associated with the vaccine will further patient education. In addition, pharmacists will need to discuss methods of side effect management with patients. Pharmacists will prove to be a valuable resource in the fight against COVID-19.

References

  1. John Hopkins. COVID-19 United States Cases. https://coronavirus.jhu.edu/us-map. (Accessed 2020 July 17).
  2. Neergaard L. First COVID-19 vaccine tested in US poised for final testing. AP News. https://apnews.com/e4d5259bfc6c74fcb090d885737c55a6. (Accessed 2020 July 17).
  3. Early-Stage Trial Data on AstraZeneca COVID-19 Vaccine Due Monday – Lancet. U.S.News. 2020. https://www.usnews.com/news/top-news/articles/2020-07-15/positive-news-on-oxford-astrazeneca-covid-19-vaccine-could-come-on-thursday-itv. (Accessed 2020 July 17).
  4. Bastian H. Covid-19 vaccines with ‘minor side effects’ could still be pretty bad. 2020. https://www.wired.com/story/covid-19-vaccines-with-minor-side-effects-could-still-be-pretty-bad/ (Accessed 2020 Aug 3).
  5. Rowland C. A race is on to make enough small glass vials to deliver coronavirus vaccine around the world. The Washington Post. (July 2020).
  6. APhA/NASPA. Pharmacist Administered Vaccines. (January 2019). https://naspa.us/wp-content/uploads/2019/04/IZ-Authority-012019.pdf. (Accessed 2020 July 17).

 

Posted August 2020