News & Events

PHSL Renews WBE and WOSB Certifications

Pharmacy Healthcare Solutions, LLC (PHSL) is pleased to announce national recertification as a Women’s Business Enterprise (WBE) and as a Women-Owned Small Business (WOSB) by WBENC East, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC).  This marks three years of WOSB and WBE certification for PHSL.

We know that supplier diversity initiatives are important.  By including women-owned businesses among their consulting support suppliers, pharmaceutical manufacturers, payers, PBMs, and other industry stakeholders demonstrate their commitment to fostering diversity.  PHSL asks any current clients with supplier diversity initiatives to contact PHSL’s principals Ann Johnson or Melissa Krause for a copy of the certification. We would welcome the opportunity to have our WBE and WOSB certification listed with your company!

Founded in 1997, WBENC is the nation’s leader in women’s business development and the leading third-party certifier of businesses owned and operated by women, with more than 13,000 certified Women’s Business Enterprises, 14 national Regional Partner Organizations, and over 300 Corporate Members. More than 1,000 corporations representing America’s most prestigious brands as well as many states, cities, and other entities accept WBENC Certification. For more information, visit www.wbenc.org.

PHSL to Attend NACDS Total Store Expo

PHSL President Ann Johnson, Vice President Melissa Krause, Co-Founder Tim Kosty, and Director of Business Development Jeff Cook will be attending the 2022 NACDS Total Store Expo in Boston, MA on August 27-29. PHSL will have an exhibit set up at booth #1914. If you would like to schedule a meeting with a PHSL team member, please click here to send us a message.

To learn more about this conference, visit the Total Store Expo website at http://tse.nacds.org

Pennsylvania Pharmacist Leadership Feature

PHSL President Ann Johnson and Vice President Melissa Krause were featured in the March/April 2022 issue of the Pennsylvania Pharmacists Association’s (PPA) publication Pennsylvania Pharmacist. In this feature, Ann and Melissa share their leadership advice and lessons as Principals of PHSL. Both Ann and Melissa are active members of PPA and the Allegheny County Pharmacists Association (ACPA). Click here to read the Leadership Feature, or access the entire Pennsylvania Pharmacist publication here.

Vaccine Profitability Increases for Pharmacies

There is no doubt that pharmacists’ role in immunizations dramatically increased with the COVID-19 pandemic, as pharmacies administered vaccinations to much of the country’s population.  In addition to solving a public health crisis, at approximately $40 per dose, the Medicare Part B administration fees for COVID-19 initial and booster vaccines created additional revenues for pharmacies.  With declining drug ingredient cost reimbursement rates and negligible dispensing fees, vaccines were a welcomed revenue stream for many pharmacies.

As we approach the annual flu season, another vaccine opportunity will present itself to pharmacies.  Medicare Part B payments for vaccine administration have increased 77%  this year.  For influenza, pneumococcal, and hepatitis B vaccines, the administration reimbursement increased from $16.94 per dose in 2021 to $30 per dose in 2022.  This change is a nice reversal in immunization reimbursement rate trends, after we saw the rate decrease from $20.88 to $16.94 in 2019.

For 2022, the Medicare Part B pharmacy payment for COVID-19 vaccine administration remains at $40 per dose.  Because commercial reimbursement rates often follow the rates set by Medicare, it is expected that this administration rate increase will have wider reaching effects, beyond simply those of the Medicare population.

For the 2022-2023 flu vaccine, two of the four strains included in the quadrivalent vaccine will differ from the 2021-2022 version.  This coming fall, the influenza vaccine will include the following strains:

  • H3N2 component: A/Darwin/9/2021 (H3N2)-like virus (for egg-based vaccines) or A/Darwin/6/2021 (H3N2)-like virus (for cell culture or recombinant vaccines)
  • Influenza B: B/Austria/1359417/2021-like virus
  • Influenza B: B/Phuket/3073/2013 (B/Yamagata lineage)-like virus
  • Influenza A: A/Victoria/2570/2019 (H1N1) pdm09-like virus (for egg-based vaccines) and A/Wisconsin/588/2019 (H1N1) pdm09-like virus (for cell culture or recombinant vaccines)

Knowing that two new strains are included should enable pharmacists and healthcare practitioners to have more educated discussions with their patients concerning the importance of receiving the 2022-2023 influenza vaccine.  With the increased reimbursement rates available to pharmacies, we expect that vaccines will continue to play a key role in retail pharmacy profitability, as pharmacies continue to seek alternative revenue streams outside of traditional drug dispensing.

 

Posted June 28, 2022

Summer 2022 Newsletter:

U.S. Reliance on Foreign Sources of API

U.S. Reliance on Foreign Sources of API

Active Pharmaceutical Ingredient (API) production is a complex and global process. APIs are the active biological or chemical components of any drug. The process of converting raw ingredients and turning them into APIs through various chemical, biochemical, or fermentation processes can be expensive and can lead to a considerable portion of the total drug cost. The production of APIs has been concentrated overseas to reduce costs, with 72% of those facilities found outside of the US. In the chart below, we can see the total production of APIs used in the US market.  Interestingly, although not unexpectedly, only 30% of the API facilities used for US drugs comes from North America.

API Sources Image 1
U.S. Food & Drug Administration. (2019, October 29). Safeguarding pharmaceutical supply chains in a global economy. U.S. Food and Drug Administration. Retrieved May 30, 2022, from https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019

The below graph shows the API sources of the top 100 brand name drugs in Medicare Part D in 2018.  Although this data is a few years old, we do not expect that significant changes in API origin have taken place since that time.

API Sources Image 2 Revised

*Multiple countries may be represented for a single API

Adapted from Levitt, G., & Mueller, L. (2022, January). Not Made in the USA: The Global Pharmaceutical Supply Chain and Prospects for Safe Drug Importation. Pharmacy Checker. Retrieved May 30, 2022, from https://cdn.pharmacychecker.com/pdf/Not+Made+in+the+USA+-+2022.pdf

Comparing the two charts above, a large discrepancy is noted for India and China.  While India and China account for over 30% of the API facilities for all drugs, they account for only 2% of the top 100 brand drugs.  The following table indicates that China and India account for 44% of the kilogram mass of pharmaceutical imports, yet only 11.7% of the dollar value (i.e., generics).  Meanwhile, Germany and Ireland account for 60% of the dollar value and less than 10% of kilogram mass (i.e., brands).

API Sources Image 3

Public Citizen. “China Is the Top Source of U.S. Pharmaceutical Imports, with India and Mexico Also Major Sources.” Public Citizen, 7 Apr. 2020.

The PharmacyChecker report focuses on top brands, and therefore China and India each only account for a single imported brand API.  These results make sense due to the high cost of single-source brand drugs.  Brand companies typically rely on high quality materials from trusted sources and labor to ensure continued supply to avoid disruptions and lost sales, oftentimes from the large number of registered API facilities in Europe.

These APIs, often imported from various countries, are critical to the development of drugs which enter the supply chain to be delivered to patients in healthcare facilities and pharmacies. Errors in containment, contamination, and other aspects of the supply chain can cause drug shortages in pharmacies and hospitals.  These shortages may delay treatment, potentially affecting hundreds of thousands of people. During the pandemic, supply chain issues were abundant. China, which doubled the number of registered facilities producing APIs between 2010 and 2019, has seen many disruptions in supply of its products. 57% of companies reporting worsened lead times in getting their products to the market to meet demand, according to the Institute for Supply Chain.

With supply chain issues being a continued and growing problem for American markets, the FDA suggests the use of new technologies in advanced manufacturing, such as continuous manufacturing or the Emerging Technology Program (ETP), to streamline processes and guarantee safety and efficacy or products. The FDA states that these innovations, “can be used to reduce the Nation’s dependence on foreign sources of APIs, increase the resilience of our domestic manufacturing base, and reduce quality issues that trigger drug shortages or recalls.” With the increasing production of APIs overseas, it is important to consider the supply chain and quality control issues that may arise.  Manufacturers may consider the use of homegrown production of APIs to combat those risks. Domestic supply and European supply of drugs and biologics can alleviate or lessen the risk for these products.

PHSL expects that more manufacturers, even commodity generic manufacturers, will have an increased emphasis on using US or EU-sourced API for their drugs in the future, if the cost is comparable.  The COVID-19 pandemic is a reminder that worldwide events can have a significant impact on Americans receiving their daily medications.

 

Posted June 28, 2022

Summer 2022 Newsletter:

Vaccine Profitability Increases for Pharmacies

ComputerTalk for the Pharmacist May/June 2022

PHSL Senior Consultant Patty Milazzo and PHSL Intern Logan Graham contributed to the May/June 2022 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Patty and Logan discuss the “test to treat” initiative, including its current purpose, challenges for the program, and the potential for expansion of these types of services at the pharmacy.

Click here to read the article “The Pharmacist Will See You Now… and Treat You Now, Too.” You can also access the full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

Interchangeable & Unbranded Biologics: Cutting Through The Confusion presented at ASAP by Melissa Krause

PHSL Vice President Melissa Krause presented at the American Society for Automation in Pharmacy (ASAP) 2022 Annual Conference. Melissa’s presentation discussed different perspectives on interchangeable biologics, addressed how interchangeable biologics and unbranded biologics are being displayed in pharmacy management systems, and included recommendation on what pharmacists need to cut through confusion and ensure correct dispensing and reimbursement.

Click here to view Melissa’s presentation slides.

PHSL President Ann Johnson Joins AMCP Digital Therapeutics Advisory Group

PHSL President Ann Johnson will be participating in AMCP’s newly developed Digital Therapeutics Advisory Group.  Ann, along with other leaders in the field, will be providing guidance to AMCP in its efforts to establish the leadership role of managed care pharmacy professionals in digital therapeutics. The Digital Therapeutics Advisory Group will identify potential partners and assist in the creation and dissemination of tools and resources to enhance the coverage and utilization of digital therapeutics.  Ann’s knowledge surrounding the drug pricing compendia and the importance of listing new digital therapeutic products should be an asset to the organization.  Find out more about the Digital Therapeutics Advisory Group at https://www.amcp.org/corporate-opportunities/partnership-forums.

ComputerTalk for the Pharmacist January/February 2022

PHSL President Ann Johnson and Co-Founder Tim Kosty contributed to the January/February 2022 edition of ComputerTalk for the Pharmacist. In their Viewpoints article, Ann and Tim discuss recently announced changes to Walgreens’ and CVS’s corporate strategies concerning their retail pharmacy locations and the impact this may have on the rest of the retail pharmacy industry.

Click here to read the article “Rethinking the Pharmacy Business Model.” You can also access the full versions of current and past ComputerTalk issues at https://www.computertalk.com/issue-archive/.

Track-and-Trace Implementation Update

It has now been more than eight years since the Track-and-Trace law, known as the Drug Supply Chain Security Act (DSCSA), was signed.  The Act outlines the steps that participants in the pharmaceutical supply chain and pharmacy industry must take to build a system that identifies and traces pharmaceuticals and facilitates the exchange of information at the individual package level by showing where a drug has been in the supply chain.  The deadline to implement all of this is the tenth anniversary of the Act being signed, November 27, 2023.

Recently, the HDA (Healthcare Distribution Alliance) Research Foundation published a survey[1] that assessed the industry’s progress.  The Foundation’s survey concluded that industry business partners are just now beginning to establish interoperable connections and work with data exchange in a production environment.

Even though over 80% of manufacturers have prepared to send data downstream, few are exchanging data in production today. Currently, almost 60% of manufacturers say they are not sharing data with distributors.  A little over 60% of manufacturers plan to connect directly with distributors, but nearly 40% of manufacturers will rely on third-party logistics providers, adding a layer of complexity to the process.  Only 16% of manufacturers are connected to dispensers.  Manufacturers stated they have run into obstacles like a lack of resources, slow movement in the industry as a whole, and delays caused by “either past or potential future enforcement discretion.”[2]

Around 50% of distributors are setting up connections currently, while approximately 40% are connected to manufacturers in a production environment; none have any connections with dispensers.  Even when implemented, 45% of distributors don’t plan to establish a direct connection with dispensers.  This indicates many distributors have a significant amount of work to do over the next two years to meet the November 2023 deadline.  Some survey respondents said COVID-19 has curtailed adoption of the standard.  There is also a question as to the number of business partners that prefer a direct connection versus a portal connection. The top distributor obstacle identified was a lack of trading partner understanding or commitment.

Currently, the only “widely recognized”[3] international standard developed to comply with the Track-and-Trace law is GS1’s Electronic Product Code Information Services (EPCIS), which allows trading partners to exchange the transaction data required to comply with the law.  Responses from the survey indicate that industry movement to implement EPCIS is slow possibly due to a lack of IT resources for testing and implementation, the obligation to make IT upgrades required before implementation, or the need to concentrate on error resolution stemming from this process.

Implementation of DSCSA processes has been difficult based on the survey responses.  If funding exists, the Foundation plans to conduct more surveys over the next two years to gauge progress.  Based on the progress still required for a November 2023 implementation, there is a possibility that this deadline, established in 2013, will be extended.  In the meanwhile, PHSL encourages organizations to talk with their software vendors or IT support to determine if the requisite steps are being taken to address this issue.

PHSL has written about Track-and-Trace since President Obama signed this Act in 2013. Please see the below publications for more information:

http://phsirx.com/news-events/publications/computertalk-januaryfebruary-2015

http://phsirx.com/news-events/publications/computertalk-marchapril-2014

http://phsirx.com/blog/update-track-and-trace-enforcement-delayed

http://phsirx.com/blog/track-and-trace-staggered-deadlines-may-lead-to-workflow-disruption

 

[1] https://www.hda.org/resources/epcis-implementation-benchmarking-survey EPCIS Implementation Benchmarking Survey (hda.org)

[2] https://www.hda.org/~/media/pdfs/industry-relations/hda-foundation-epcis-report.ashx

[3] https://www.hda.org/~/media/pdfs/industry-relations/hda-foundation-epcis-report.ashx

 

Posted January 5, 2022

Winter 2022 Newsletter:

National Drug Price Reduction Plan