New Clozapine Risk Evaluation and Mitigation Strategy (REMS) requirements Starting November 15, 2021

The FDA approved modifications to the Clozapine REMS program to ensure that the benefit of clozapine outweighs the risk of severe neutropenia that can lead to severe infections. Alterations to the clozapine REMS program will go into effect on November 15, 2021. The new REMS program will help clarify and enhance the prescribing information for clozapine, further explaining how to monitor patients for neutropenia and manage patients with severe neutropenia. The REMS program recommends that patients taking clozapine who shows signs of moderate neutropenia with an Absolute Neutrophil Count (ANC)  <1000µL should discontinue clozapine and restart once ANC levels normalize to ≥1000µL. Patients with severe neutropenia with an ANC <500µL should stop taking clozapine and only resume clozapine if the physician determines the benefit outweighs the risk.  (Clozapine and the Risk of Neutropenia: A Guide for Pharmacists: Table 1 Page 7)

The modifications to the clozapine REMS program will require physicians and pharmacies to re-certify in the clozapine REMS program and make changes to their current monitoring procedures to continue prescribing and dispensing clozapine to patients. Prescribers and pharmacies can re-certify through the clozapine REMS website.

Although patients are not required to take any action due to REMS program changes, prescribers must re-enroll or enroll their patients. Prior to enrolling patients into the REMS program, physicians must make sure their recertification into the clozapine REMS program is complete.

  • For patients currently taking clozapine, healthcare professionals will continue monitoring patients according to the current REMS requirements. However, providers can begin to re-certify and re-enroll all existing patients into the new REMS program now and must have that completed by November 15, 2021.
  • For patents starting clozapine between now and November 15, 2021, prescribers will enroll patients in both the current and new REMS programs.
  • For patients starting clozapine after November 15, 2021, prescribers will only enroll patients in the new REMS program.

The changes also make improvements to the process of submitting ANC results, which will reduce the burden on prescribers and reduce treatment interruptions for patients. Prescribers will now submit ANC documentation monthly, which is a change from daily, weekly, or biweekly documentation, depending on the patient’s monitoring frequency.

Pharmacists and authorized representatives of pharmacies should know that the current “switch” system will no longer be available.  This system allowed pharmacies to send prescription information simultaneously through (1) the Clozapine REMS Program to obtain the Pre-Dispense Authorization (PDA); and (2) their Pharmacy Management System (PMS) to adjudicate with the third party. Pharmacies will need to develop new processes and procedures to complete both transactions when dispensing clozapine.

The REMS Dispense Authorization (RDA) will replace the current Pre-Dispense Authorization (PDA). Pharmacies can access the new RDA forms through either the clozapine REMS website or by calling the REMS Contact Center. The first time a patient fills clozapine under the new REMS program, the RDA for outpatient pharmacies will verify that the pharmacy is certified, the patient is enrolled, and the patient’s treatment is not interrupted or discontinued. For subsequent fills, the RDA will verify that outpatient pharmacies are certified, the patient is enrolled, a Patient Status Form has been completed in the last 37 days, and the patient’s treatment is not interrupted or discontinued. There are no changes for inpatient pharmacies that dispense clozapine for inpatient use.

Wholesalers or distributors will have no changes to their current requirements. However, wholesalers or distributors will have to re-enroll in the Clozapine REMS by November 15, 2021 to purchase and distribute clozapine. Wholesalers and distributors will continue to verify pharmacy certification through the Clozapine REMS.




Posted: October 2021

National Women’s Small Business Month

October is National Women’s Small Business Month.  Approximately 40% of US businesses are women-owned.  Pharmacy Healthcare Solutions, LLC is proud to be certified as a Women’s Business Enterprise by the Women’s Business Enterprise National Council (WBENC), the nation’s largest third-party certifier of businesses owned and operated by women.  As a certified women-owned small business, we can help our clients meet their supplier diversity initiative goals. If you are a current PHSL client and your company has a supplier diversity program, reach out to register PHSL with your program and receive a copy of our certification.


Posted: October 2021

Drug Take Back Day – October 2021

The 21st National Prescription Drug Take Back Day is set to take place later this month on Saturday, October 23rd from 10:00 am to 2:00 pm. This event, sponsored by the Drug Enforcement Administration (DEA), serves a means for safely and conveniently disposing of your expired, unused, or no longer wanted prescription and over the counter (OTC) medications. The purpose of this public safety event is to prevent misuse of medications and overdose deaths in the United States. A National Survey on Drug Use and Health found that “9.7 million people misused prescription pain reliever, 4.9 million misused prescription stimulants, and 5.9 million misused prescription tranquilizers/sedatives in 2019”. This event is our opportunity to responsibly dispose of medications and potentially protect the lives of others.

The last Drug Take Back Day on April 24th, 2021 collected 839,543 pounds of prescription drugs, with Pennsylvania alone collecting 32,206 pounds. This is about 4,000 pounds less than the last four Take Back Days (Oct. 2020 – 36,949 lbs.; Oct. 2019 – 36,880 lbs.; Apr. 2019 – 39,440 lbs.; Oct. 2018 – 35,876 lbs.).

Please take your OTC or prescription pills, patches, liquids, drops, creams/ointments, and controlled substances to a sponsored disposal site on October 23rd. You can find a local Drug Take Back Day disposal site by visiting Take Back Day ( and using the collection site locator. Drug drop off is safe and anonymous.

Please note that the following items are usually not accepted at drop off locations:

  • Syringes, needles, and sharps
  • Inhalers
  • Aerosol cans
  • Mercury thermometers
  • Iodine-containing medications
  • Illegal substances, including marijuana

If you are unable to attend the 21st National Prescription Drug Take Back Day this October, you can still dispose of your medications at a permanent pharmacy disposal location. These disposal sites can be located by visiting Controlled Substance Public Disposal Locations – Search Utility (

For more information regarding questions about Drug Take Back Day and rules for disposing, please visit National Take Back Day: How to Dispose of Old Meds –


Posted: October 2021

Comparison of Spending on Common Generic Drugs by Medicare vs Costco Members

A recent cross-sectional study compared the pricing of common generic medications paid by Medicare vs. Costco Members.  The study looked at the most common 184 generic prescription medications filled at Costco Wholesale Pharmacy over a 2-year period and evaluated both 30- and 90-day supplies.

In two years, there were 1.4 billion Part D claims submitted for these products, totaling $12.5 billion in 2017 and $12.6 billion in 2018. According to the study published in JAMA Internal Medicine, the authors asserted that Medicare had overspent by $1.7 billion and $2.6 billion in 2017 and 2018 respectively. In total, it was estimated that Medicare overpaid on 43.2% of prescriptions for the most common 184 drugs as compared to Costco cash prices. Generic medications were used in 88% of the Medicare Part D prescriptions filled in 2018. However, generic coverage accounts for 22% of Medicare Part D spending.

With these pricing comparisons, there are still many issues to discuss.  Comparing Costco cash pricing, which is based on cost plus a small markup, to Medicare Part D generic pricing that is part of a program that also covers brand and specialty medications, is comparing apples and oranges.  A more accurate comparison would be to evaluate the Medicare Part D generic prices versus prices paid through commercial plans.

Medicare Part D requires transparent transactions between PBMs, pharmacies (including Costco), and all other intermediaries involved in the prescription adjudication transaction. This study performs a comparison between Medicare Part D spending versus a single organization’s prices, but it does not provide enough evidence to generate an actionable solution. Like all pharmacies, Costco submits their usual and customary drug price to the Medicare Part D plan for reimbursement. Furthermore, Costco may operate as a loss-leader on many generic pharmaceutical products, knowing that increased store traffic will lead to the increased sale of non-pharmaceutical products.  This pricing methodology is not practical or sustainable in many retail pharmacies, specifically those that are independently owned with a high percentage of sales generated through their prescription department.

One always wonders what the political motivation for these studies could be.  How did the researchers account for these Costco prices in the Medicare Part D dataset and where is the “counterfactual” inefficiency translating to overspending in the system?  Is every patient expected to utilize Costco pharmacies?  How would these results vary if a different pharmacy’s drug prices were analyzed?  How are retrospective DIR fees accounted for in this analysis, which if not included, would have inflated the Medicare drug spending?  While the study shows that savings may be available, it lacks actionable recommendations to realize those savings in Medicare Part D.  Please share your thoughts with PHSL on this study.


Trish E, Gascue L, Ribero R, Van Nuys K, Joyce G. Comparison of Spending on Common Generic Drugs by Medicare vs Costco Members. JAMA Intern Med. Published online July 06, 2021. doi:10.1001/jamainternmed.2021.3366


Posted: September 2021

2021 World Pharmacists Day

Pharmacy: Always trusted for your health

September 25, 2021 is World Pharmacists Day according to the International Pharmaceutical Federation (FIP). This year’s theme is “Pharmacy: Always trusted for your health”.  Trust is fundamental and essential to health care.  Pharmacists are consistently one of the most highly trusted professionals and can positively impact patient care.

As a pharmacist-led consulting firm, PHSL focuses on the business of pharmacy and encourages pharmacists to innovate to advance the profession and continually strive for improved patient outcomes.  We celebrate this World Pharmacists Day with pharmacists from across the world.


Posted: September 2021

Amazon vs. Walmart – Do the Savings Stack Up?

Back in June, we saw reports, such as the one in Chain Store Age, that Walmart and Amazon were beginning competition in the prescription discount program space.  Amazon’s offering is through its Prime subscription service and Walmart’s through its Walmart + subscription service.

Walmart touts that some select medications will be available at a zero cost, while many others will be discounted up to 85%.  Walmart charges $98 per year or $12.95 per month for Walmart + membership.  This compares to $119 per year or $12.99 per month for Amazon Prime membership.  However, a Bloomberg article points out that Amazon is providing some six-month prescriptions starting at $6.00.  The $1 per month pricing may be attractive, but the concept of discounted prices for bulk purchases of generics is not an invention by Amazon.  This is a method to avoid invoking U&C on 30- or 90-day supplies because the discounted price is only available at the 180-day quantity. Also, it is not known yet if Amazon will run into issues in states where prescriptions cannot be sold at a price below acquisition cost.

PHSL looked at two commonly prescribed generic medications to compare the savings.  The zip code of PHSL’s office (15237) was used to identify the Walmart seven miles away that would fill the prescription and provide the savings.  On the other hand, Amazon Pharmacy provides free two-day delivery.

The first example is Metformin 500 mg, 60 tablets.  The Walmart + price was $3.00 using a savings card, compared to Amazon’s $3.50 Prime member price.  Prime also offers discounts through other pharmacy retailers such as CVS, Walgreens, Walmart, Costco and other regional chains, supermarkets, or mass merchants.  Those discounted prices ranged from $6.48 to $15.54.  PHSL also checked GoodRx, which does not require a membership, and found they offered discounted prices from $4.00 (at Walmart) to $13.82 using a free coupon for the retailer selected by the user.

The second example is Atorvastatin 20 mg, 30 tablets.  The Amazon Prime member price was $14.90 compared to the Walmart + price of $15, again using a savings card.  The Prime discounted prices at the pharmacy retailers mentioned above ranged from $6.98 to $61.45.  GoodRx discounted prices ranged from $8.18 to $19.95, which included $15 at Walmart.

Lastly, PHSL looked at one commonly prescribed brand medication that is not available generically – Eliquis 5 mg, 60 tablets.  The Amazon Prime member price was $509.80 compared to the Walmart + price of $510.05, again using a savings card.  The Prime discounted prices at the pharmacy retailers mentioned above ranged from $510.46 to $551.88 (at Walmart) – most were $511.46.  GoodRx discounted prices ranged from $493.19 to $531.03.

What’s more interesting is that Metformin 500 mg, 360 tablets was priced $18.50 by Amazon Prime and $13 by Walmart +, and as low as $15.81 using a GoodRx free discount at Kroger.  Checking Atorvastatin 20 mg, 180 tablets, it was priced $86.90 by Amazon Prime and $76 by Walmart +, but as low as $16.70 using a GoodRx coupon at Kroger.

Of course, the Amazon Prime and Walmart + memberships offer much more than discounted prescription prices.  However, it appears that joining these programs solely for prescription savings may not be the best idea, seeing how other free on-line services are just as competitive, if not less expensive, than the discounted prices offered by the subscription services.


Drug and Quantity Pricing Plan Patient Price
Metformin 500mg:
60 Tablets
Walmart + Pricing $3.00
Amazon Prime Pricing $3.50
Amazon Prime Pricing (Other Rx Retailers) $6.48 – $15.54
GoodRx Pricing $4.00 – $13.82
GoodRx Pricing (Walmart) $4.00
Atorvastatin 20mg:
30 Tablets
Walmart + Pricing $15.00
Amazon Prime Pricing $14.90
Amazon Prime Pricing (Other Rx Retailers) $6.98 – $61.45
GoodRx Pricing $8.18 – $19.95
GoodRx Pricing (Walmart) $15.00
Eliquis 5mg:
60 Tablets
Walmart + Pricing $510.05
Amazon Prime Pricing $509.80
Amazon Prime Pricing (Other Rx Retailers) $510.46 – $551.88
Amazon Prime Pricing (Walmart) $551.88
GoodRx Pricing $493.19 – $531.03
Metformin 500mg:
360 Tablets
Walmart + Pricing $13
Amazon Prime Pricing $18.50
GoodRx Pricing $15.81
Atorvastatin 20mg:
180 Tablets
Walmart + Pricing $76
Amazon Prime Pricing $86.90
GoodRx Pricing $16.70



Posted: September 2021

2020 Michigan Pharmacy Laws Reflect Response to COVID-19 Pandemic

In response to the coronavirus pandemic that surged in early March 2020, the Michigan senate passed multiple laws to make access to healthcare easier during the crisis. One of the main legislative points to this bill allowed pharmacists to use their professional judgement and dispense up to a 60-day emergency supply of any non-controlled prescription that could result in a significant effect on the patient’s well-being if not taken. The bill continues with multiple subpoints and criteria that the pharmacist must meet to dispense this 60-day emergency supply. Some of these points include informing the patient that the prescription was dispensed under this law and informing the prescriber through writing within a reasonable time of all emergency refills given.

This Michigan law mirrors similar laws passed in Pennsylvania in response to the COVID-19 crisis. Pennsylvania will allow up to a 30-day emergency supply on non-controlled medications instead of the previous 72-hours. These medications must also significantly affect the patient’s well-being if not taken. When deciding on whether a medication is significant enough, the pharmacist may consider health, quality of life, and preventative measures. There are many medications that would not directly affect the patient’s health and therefore could be controversial, but when the patient’s quality of life is considered, most non-controlled medications could be dispensed under this emergency law.

The Michigan senate bill also grants pharmacies the ability to temporarily operate in a location that is not designated on their pharmacy license. This law states that sterile drugs may not be prepared beyond low-risk preparations; products must be for immediate patient administration. The law also states that a pharmacist may dispense and administer a drug to treat an individual with COVID-19. The dispensed drug must follow protocols set forth by the Centers for Disease Control and Prevention, the National Institute of Health, or the chief medical executive within the department of health and human services. While many drugs have been granted emergency use authorization (EUA) for COVID-19, at the time this article was written, only remdesivir is FDA-approved.

The next piece of legislation was passed to set standards for virtual work. The intention of these laws was to limit personnel at pharmacies to ultimately reduce the chance of spreading COVID-19. The senate approved remote supervision of student pharmacists by their preceptors to avoid delays in graduation. Pharmacists could also oversee pharmacy technicians remotely using continuous, real-time video. This camera system must let the pharmacist visually identify all markings on tablets and capsules. The pharmacist must have access to all relevant patient information to be compliant will this law. This is a major step for Michigan, as pharmacists were only recently allowed to conduct remote pharmacy practices as of April 2020. This new piece of legislation added even more clarity surrounding remote pharmacy. Michigan joins 23 other states legally allowing remote pharmacy. This technology improves the efficiency of the pharmacy without the added cost of possible COVID-19 spread. Legislation also let out-of-state pharmacies in good standing conduct business in Michigan, and the out-of-state pharmacy is not required to designate a pharmacist-in-charge for the pharmacy. The exception to this law is that the out-of-state pharmacy must not deliver controlled substances into the state.

Michigan enacting laws revolving around the legality of virtual pharmacy rotations were a major step for the state. The state has never taken a stance on whether this style of learning was appropriate or not. At the start of the health crisis, many hospitals and retail pharmacies were cancelling students’ experiential rotations. With no clear guidance, this led to a frenzy of students scheduling new rotations on short notice and others having to delay graduation. This law (taking effect December 30, 2020) gave pharmacy preceptors the official approval to conduct their rotations in this fashion. Virtual rotations were a tough transition for both preceptors and the students, but when needed, they provided the proper experience while keeping everyone as safe as possible.

The legislation passed by the Michigan senate impacted many different aspects of pharmacy practice. Despite covering various pharmacy operations, they all had the focus to increase accessibility to healthcare, reduce unnecessary staff in the workplace, and provide clarity to pharmacy students and preceptors. The senate acted in a reasonable time frame to address these issues. Their actions, along with many other states, have shown that pharmacy can change quickly to meet the needs of patients, colleagues, and students.


Pharmacy direct and indirect remuneration fees not included in point-of-sale ‘negotiated rates,’ known as DIR pharmacy fees, have continued to rise at an unprecedented pace. This growth has impacted patient healthcare costs and the profitability of small business community pharmacies for many years. According to CMS, DIR fees applied against pharmacies involved in Medicare Part D Programs rose by 1,600% since 2015. The rise in cost is unsustainable for the community pharmacies that patients rely on for their Part D prescription medications.

The National Community Pharmacists Association (NCPA) filed a federal lawsuit against the Department of Health and Human Services regulations. The case, NCPA vs. BECERRA, argues that:

  1. The rule’s definition of “negotiated price” violates the plain language and intent of Congress when they passed legislation creating the Medicare Part D program.
  2. The rule is invalid as arbitrary and capricious and unsupported by substantial evidence.
  3. The Final Rule was not adopted through proper notice-and-comment rulemaking.

The complaint also presents an exception found in a provision of the Centers for Medicare & Medicaid Programs that specifies that all negotiated rates must include price discounts from network pharmacies, except for those contingent price concessions that cannot be reasonably calculated at the point of sale. PHSL will continue to monitor for outcomes of the NCPA lawsuit and any impact to Medicare Part D programs.




Posted: May 2021

COVID-19 Vaccine Administration

On January 31, 2020, the secretary of Health and Human Services (HHS), one of the agencies leading the federal government’s response to the COVID-19 pandemic, declared a public health emergency for the United States due to the 2019 novel coronavirus disease (COVID-19). Since then, various measures have been taken to help ensure the safety of the public. On March 12, 2021, the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (PREP Act) was amended with the purpose of authorizing additional healthcare professionals to be eligible to administer the COVID-19 vaccines with a condition that these personnel meet all the required criteria for training, supervision, and other expectations.

Over the years, pharmacists have been established as the most accessible healthcare professional. For that reason, there has been a huge increase in immunization rates due to the accessibility of vaccination at pharmacies across the country. The PREP Act expanded its guidance, allowing not only pharmacists, but also pharmacy staff, to order and administer COVID-19 vaccinations and tests. HHS recognized that pharmacy interns and qualified pharmacy technicians can administer the COVID-19 vaccine, but they must meet certain requirements and provide their services under the supervision of a qualified pharmacist. If a qualified pharmacy technician works in a state with licensure and/or registration requirements, then they must be licensed and/or registered in accordance with the state requirement. If a pharmacy technician is working in a state without state licensure or registration requirements, then the qualified pharmacy technician must have a Certified Pharmacy Technician (CPhT) certification from either the Pharmacy Technician Certification Board (PTCB) or National Healthcareer Association (NHA). At this time, the Pennsylvania State Board of Pharmacy does not have any regulations for pharmacy technicians or any requirements for pharmacy technicians to register or obtain certification. To fulfill the PREP Act, pharmacy technicians in Pennsylvania must have a CPhT certification from either the PTCB or NHA. Additionally, there are specific COVID-19 administration requirements that must be met to immunize under the PREP Act:

  • The vaccination is ordered by the supervising qualified pharmacist who is readily and immediately available
    • In the case of a COVID-19 vaccine, the vaccination is ordered and administered according to Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation(s)
    • In the case of a childhood vaccine, the vaccination is ordered and administered according to ACIP’s standard immunization schedule
  • The state-authorized pharmacy intern or qualified pharmacy technician has completed a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE), including hands-on injection technique and the recognition and treatment of emergency reactions to vaccines
  • The state-authorized pharmacy intern or qualified pharmacy technician has a current certificate in basic CPR
  • The state-authorized pharmacy intern or qualified pharmacy technician has completed two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant state licensing period(s)
  • The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s)

As millions of vaccine doses are being manufactured and distributed throughout the country, more locations and qualified healthcare personnel are needed to administer those vaccines. The Pennsylvania Health Department published a list of additional “qualified personnel” who can administer the COVID-19 vaccine under the PREP Act. As of February 9, 2021, under certain regulations, the following are authorized to administer COVID-19 vaccines: pharmacist, pharmacy intern, qualified pharmacy technician, certified nurse midwives, dentists, dental students, optometrists, optometry students, physician assistants, physician assistant students, podiatrists, podiatry students, respiratory therapists, respiratory therapy students, veterinarians, veterinary students, even recently retired professionals. The list is broken down by the type of license with the PA legal authority and when they are authorized to immunize. PHSL expects that other states have similar lists of authorized personnel.

Although this expansion of services is limited until the end of the COVID-19 pandemic, the pandemic has significantly impacted the healthcare system and how it operates by allowing different health professionals to administer not only the COVID-19 vaccine but also the testing. The addition and expansion of “qualified personnel” could impact how we will handle immunization administration in the future.


Posted: May 2021

Medicaid Drug Rebate Program Changes

Before covering the latest Medicaid Drug Rebate Program changes, let’s start with a brief review of the recent state and historical changes.

Prior to 2019:

The Medicaid Drug Rebate Program (aka OBRA 90 rebates) is a mandatory program for pharmaceutical manufacturers if they want their products covered under the Medicaid Program and requires participation in the 340B program.  The rebates are based on Average Manufacturer Price (AMP) as the starting point, but manufacturers must also report the Best Price.  Using AMP, Best Price, and the Consumer Price Index (CPI) adjustment a rebate, up to a maximum 100%, is calculated for a drug in a given month for Medicaid.  CMS calculates a unit rebate amount (URA) and provides it to the states.  The URA times the quantity dispensed for the product equals the rebate due from the manufacturer.

Limiting rebates to a maximum of 100% generated net brand costs that were less than generics when high or maximum CPI adjustment was included for Medicaid.


The authorized generic effects on the AMP, and ultimately on the Medicaid Rebates calculated with the CPI adjustment, was impactful to the market.  In 2019, prices for authorized generics were removed from the brand AMP calculations to increase the AMP and generate increased Medicaid Rebates. and

Preparing for 2024:

The American Rescue Plan Act of 2021 removes the maximum cap on Medicaid Rebates.  Beginning January 1, 2024, the rebate calculation will change, and all CPI adjustments will be included without a cap.  Therefore, a manufacturer of a brand drug with cumulative price increases that are greater than 76.9% of the CPI will be required to pay Medicaid plans for dispensing their drug, i.e., rebates will be greater than the price of the product.  Previously, these products were known as penny products in the 340B program, where the 340B price was equal to $0.01/unit.  Going forward in 2024, the manufacturer could be paying the 340B covered entity for using their product.  The pricing calculation timing lag means the late 2023 monthly sales will determine the January 2024 Medicaid rebates.


Expect manufacturers to re-evaluate their product portfolios for brands that approach or exceed the 100%+ Medicaid Rebate.  Multiple data points will be required to evaluate the impact, including the mix of business between Commercial, Medicare Part D, Medicaid, and other payors.  Options to reduce or avoid the expanded Medicaid Rebate focus on the brand AMP, which is impacted by price changes compared to the CPI and sales volume.  The other options are to halt sales for that brand product.  Will manufacturers adjust their pricing decisions with this upcoming change?


Posted: April 2021