Mandating Price Reporting in Prescription Drug Advertisements

In May 2018, the Trump Administration released a blueprint titled “American Patients First”, detailing their plan to lower drug prices and reduce out-of-pocket costs for patients. While there are many approaches under evaluation, one strategy was to incentivize manufacturers to lower list prices by mandating list price reporting on prescription drug advertisements.  On May 8th, 2019, the Department of Health and Human Services agreed to move forward with requiring manufacturers to show the list price on drug advertisements. This requirement applies to prescription drugs covered by Medicare or Medicaid and that are priced at $35 or more for a course of treatment or 1-month supply. The rule will soon appear in the Federal Register and take effect 60 days after publication.

Manufacturers have begun to adapt to these new changes prior to the new rule taking effect. In February, Johnson & Johnson became the first company to provide pricing for their blood thinner, Xarelto®. Xarelto® commercials now give the drug’s list price plus typical patient out-of-pocket costs. The information appears on screen at the end of the commercial and includes a website where people can enter their insurance information to get more specific cost information. Consumers are able to see that without insurance, Xarelto® costs $450-$540/month.

It is doubtful whether mandating drug prices on advertisements will reduce drug prices; however, patients and providers will have access to costs that were previously difficult to obtain.

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To read J&Js actions, visit:

In June 2018, PHSI asked our followers about the impact of advertised list prices.  Find the results here:

What impacts do you expect from the inclusion of list prices in drug advertisements?  Will the cost information reduce the number of patients discussing these medications with their health care providers?


Posted May 2019


Read more at the update post: Update: Mandating Price Reporting in Prescription Drug Advertisements

World Health Organization 2019-2020 Influenza Vaccine Recommendations

Every February, the World Health Organization (WHO) releases their recommended compositions for the influenza virus vaccines for the coming influenza season. These recommendations consist of four strains of influenza to be included in egg-based vaccines.

On February 21, the WHO released their recommendations for the 2019-2020 influenza season for 3 of the 4 strains, which included:

  • An A/Brisbane/02/2018 (H1N1)pdm09-like virus
  • A B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)
  • A B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage)

The WHO delayed their recommendation for the final influenza A component for the 2019-2020 influenza season due to the high mutation rates seen in the H3N2 strain. After an additional month of observation, the WHO released their final recommendation to vaccinate against an A/Kansas/14/2017 (H3N2)-like virus.

Egg-based vaccine production is the slowest vaccine production method, due to the many complicated and time-consuming steps involved in the process, and remains the most common production method for influenza vaccines. The WHO aims to release their recommendations as early as possible, while still accounting for accuracy and allowing enough time for vaccine production to take place. Delaying their full recommendations is extremely unusual.

PHSI predicts that the WHO’s month-long delay in releasing the recommendations will likely have an impact on influenza vaccine supply and may lead to more vaccine shortages. PHSI also believes that this delay may lead to an increased demand for cell-based flu vaccines in the upcoming and in future influenza seasons. This will be an interesting story to follow as the 2019-2020 influenza season approaches.


Posted: May 2019

FDA Pushes for Over-the-Counter Naloxone

In early 2019, the FDA announced that they would be supporting efforts to move naloxone from a prescription drug to an over-the-counter product. In an effort to speed up the process, the FDA developed and tested naloxone Drug Facts labels (DFL) required for OTC products.  The Drug Facts label is the panel published on all OTC products and contains information on active ingredient, purpose, uses, warnings, and directions for taking the product.  The FDA has never preemptively developed and tested an OTC DFL, which is a testament to their commitment to provide better naloxone access. There are two DFLs available from the FDA, one for naloxone nasal spray and another for a naloxone auto-injector. There is no denying that naloxone is a valuable tool to prevent opioid overdose deaths, but there may be additional barriers that limit uptake of OTC naloxone.


While the cost of saving a life is immeasurable, those who do not know they or their loved ones are at risk for an opioid overdose may not see the value in obtaining naloxone. Manufacturers and the FDA should work to ensure that access to OTC naloxone is not cost prohibitive.


The ease of access to naloxone may also factor into a patient’s interest in obtaining the product. If they are required to purchase it behind the counter and present an ID, that may scare off some from purchasing naloxone.  If/when naloxone can be purchased in the front-end of a store, access could increase for patients/caregivers.  The price point of the OTC product may influence access even in the front end as this could prove to be a highly pilfered item.


While no one knows who patients are buying the naloxone for, there is still a stigma surrounding naloxone as a medication to save drug addicts. The general public may not be aware of the potential for accidental overdose of legal opioids and the benefits of naloxone. There are also people who believe that naloxone shouldn’t be so widely distributed when other lifesaving medications (i.e., epinephrine injections and insulin) are restricted and have a high out-of-pocket cost.


Pharmacists should be sure patients using opioid medications and their caregivers are aware of the risks of opioid overdoses and the potential for naloxone to reverse the effects. Family members and friends of someone with a drug problem should also be educated on the availability and uses of naloxone as a lifesaving medication. Pharmacists and healthcare providers should use each opportunity to educate patients, caregivers, and the general public about the benefits of purchasing naloxone in case of emergency.

All states currently allow for naloxone to be obtained at the pharmacy without previously obtaining a prescription. OTC naloxone will expand access to the product and ideally get it in the correct hands to prevent overdose deaths.

You can learn more details by reading the FDA’s statement on efforts to develop over-the-counter naloxone at


Posted: April 2019

Safe Needle Disposal Resource provides comprehensive resources for consumers to learn how to safely dispose of used medical sharps (i.e. needles, lancets, auto-injector, infusion sets, etc.). The website provides guidance and regulations on safe needle disposal for each state in the US. An interactive map allows the user to click on their state and review the disposal instructions.  A list of all the places where sharps can be safely disposed is included by state or by zip code search. The location name, address, contact phone number, service area, and if the site provides sharps containers is listed for each location. The information is also available to print.

This website provides a resource center for patients or providers with several quick-reference guides and educational materials about safe disposal of sharps. Resources for businesses include state agency contacts so that businesses and healthcare facilities can learn more about the laws in each state and obtain referrals for medical waste disposal companies in the area. Federal resources listed on this website include links to The Bloodborne Pathogen Standard and the Hazardous Materials Regulation laws in the United States.

The website also lists drug specific programs for safe disposal.

The website provides a very nice overview of where to dispose of sharps products as well as several excellent resources for consumers and providers.  Pharmacists can benefit by incorporating the resources into patient awareness and education efforts.  How will you incorporate the safety resources into your processes?


Posted: April 2019

Allied Against Opioid Abuse Toolkit

Allied Against Opioid Abuse (AAOA) collaborated with the National Community Pharmacists Association (NCPA) and individual state pharmacy associations to develop a collection of resources specific to community pharmacy and their patients. AAOA is a national organization dedicated to increasing education and awareness to prevent abuse and misuse of prescription opioids.

These materials are designed to help pharmacists engage and educate patients and prescribers about safe use, storage, and disposal of prescription opioids. The toolkit can help pharmacists raise awareness among patients and caregivers through patient handouts, engagement guides, tips for talking with patients and caregivers, social graphics, and safe storage and disposal training.

Independent pharmacies in Connecticut, Florida, Minnesota, Ohio, Pennsylvania, and Tennessee who contributed to the development of these resources will receive this toolkit in the mail. Pharmacists in other states can access the materials online here.

The toolkit materials are presented in a very easy-to-read format and would be helpful for patients and caregivers with opioid prescriptions. The AAOA Toolkit serves as a great starting point for pharmacies.  PHSI would like to see information on communicating with patients and caregivers about naloxone availability for appropriate patients.

Educating patients on the rights, risks, and responsibilities associated with prescription opioids is key to solving the opioid crisis.

Poison Prevention Week 2019

The third week of March was declared National Poison Prevention Week by President John F. Kennedy in 1962. In 2019, National Poison Prevention Week is March 17th – March 23rd. Save the Poison Help number (1-800-222-1222) in your cell phone so you’ll have it in case of an emergency.

The best way to prevent poisonings is to identify harmful substances and safely store or remove them from your home. Poisonings can occur through a variety of forms, including:

  • Medications (prescription, over-the-counter, vitamins, and supplements)
  • Art supplies
  • Snow salt
  • Pesticides
  • Alcohol (for children)
  • Household cleaners
  • Carbon monoxide
  • Liquids such as windshield wiper fluid, gasoline, paint thinner, and baby oil
  • Snake and spider bites

Thoroughly search your kitchen, bathroom, bedroom (cosmetics, nail polish, perfume, cologne), laundry room, garage, basement, and storage areas for potentially unsafe items.

While poisonings are most common among children under 6, people of all ages should be aware of the risks of poisons in the home and at work. Poisonings can occur by ingestion or inhalation, or through contact with the eyes or skin. If contact with a harmful substance is suspected, you should immediately call the Poison Help Line at 1-800-222-1222, even if there are no signs of a poisoning. You will be connected to your local poison center, one of 55 national poison control centers in the United States. Expect to be asked questions about the exposed person, the potential poison, the method of contact, and timing of the exposure.

You can safely dispose of medications during the upcoming National Prescription Drug Take-Back Day. Learn more at

DEA National Prescription Drug Take-Back Day

Do you have expired or unused prescription medications in your medicine cabinet? Each year millions of prescription medications are misused, and often obtained from friends and family. Safely dispose of your unwanted medications at the next National Prescription Drug Take-Back Day on April 27, 2019 from 10 AM to 2 PM! Visit to find a location site near you and learn more about Drug Take-Back Day. Previous National Drug Take-Back Day events have collected an average of over 400 tons of medications at over 5,000 sites nationwide.

Certain medication that cannot be taken at the collection sites are liquids, needles, sharps, and anything that can be pressurized such as inhalers. Examples of medicine that can be taken at collection sites are any over-the-counter drugs and controlled or noncontrolled medications in tablet, capsule, or patch form.

If you cannot make it to the scheduled event to dispose your medication, you can use the DEA’s collection site locator to find authorized collectors in your area all year-round.

CVS Unveils HealthHUB®

In mid-February 2019, CVS Health unveiled their new HealthHUB® store concept at three pilot locations in Houston, TX.  The new concept represents CVS Health’s effort to “transform the consumer health care experience in America.”  According to CVS Health, these stores will “offer a broader range of health care services, new product categories, digital tools and on-demand health kiosks, trusted advice and personalized care. With the new format over 20 percent of the store is now dedicated to health services, including new durable medical equipment (DME) and supplies and new product and service combinations for sleep apnea and diabetes care.”  This new concept is the first strategic concept coming from CVS Health’s acquisition of Aetna, which was completed in November 2018.

I first saw this reported by MMR (Mass Market Retailers), an industry journal, and wondered what retailers thought of CVS Health’s approach to improve their position as a health care provider in a retail outlet.  Accompanying the article was a picture of a wide-open space in the HealthHUB® location.  My first thought was that retailer traditionalists will see all that empty space and wonder how will health care services “sales” generated in that space be enough to maintain a decent “sales per square foot” figure?  My next thought was has CVS thrown that old thought process out of the window with this new concept?

USA Today reported that “traditional retail sales at CVS are increasingly less important to the company’s finances,” which evidently allows them to free up all that space seen in the picture.  USA Today said that in the first nine months of 2018 retail product sales were less then one-third of its prescription sales in that period.  Think about it – how many bottles of aspirin, tubes of first aid cream and boxes of bandages need to be sold to equal the revenue a single health care service will generate?

“Sales per square foot” is likely still important to CVS Health, but they are betting on health care services to drive that figure.  This concept is likely the future of pharmacy and healthcare increasing patient convenience and access.  Pharmacy retailers need to look at their business from a new perspective and determine how providing health care services will work for them.  CVS Health has the benefit of being aligned with a health care provider (Minute Clinic) and a payer (Aetna).  Other retailers have included clinics in there offering.  Being associated with an insurer should help drive patients to those HealthHUB® locations.

With prescriptions for high priced pharmaceuticals going to specialty pharmacies, retail pharmacies need to position themselves for the future, which all of a sudden is now!

Dave Schuetz, RPh.


Read more:


Posted March 2019

Medicare Part D Opioid Safety Alerts

As the nation continues to battle the opioid epidemic, CMS has implemented new Medicare Part D opioid policies in 2019. These new policies make pharmacists responsible for identifying potential risks and relaying that information to prescribers. The following safety alerts will be applied to specific opioid prescriptions:

  • Seven day supply limit for opioid naïve patients: Patients who have not filled an opioid prescription in the past 60 days will be limited to a seven day supply on a new opioid prescription. A hard edit will stop the pharmacy from processing these prescriptions without an override or authorization from the plan. Prescribers can request a coverage determination in advance if they believe patients will need a longer course of treatment. Prescribers are encouraged to re-assess the patient before prescribing additional opioid therapy following the seven day course of treatment. The goal is to limit opioid use for acute pain.
  • Opioid care coordination alerts: When a patient presents one or more opioid prescriptions resulting in a cumulative morphine milligram equivalent (MME) greater than or equal to 90 MME per day, an alert will be triggered at the pharmacy. The pharmacist should contact the prescriber to confirm intent and document the discussion before entering an override code. Plans have the option to implement a hard edit at a cumulative 200 MME per day. The goal of these care coordination safety alerts is to make prescribers aware of patient opioid usage, especially when patients see multiple prescribers.

Health plans, prescribers, and pharmacies will need to work together to ensure patients are receiving adequate pain management treatment while limiting the potential for opioid abuse.  PHSI also expects the Medicare Part D safety alerts to become standard offerings in the commercial sector.

Additional information and resources for patients, prescribers, and pharmacists is available at


Published February 2019

Biosimilar Listing in the Drug Compendia – GPI and GSN Identifiers

Currently, approved biosimilars are not interchangeable with the original biologics according to the FDA.  Drug compendia such as Medi-Span and FDB represent biosimilars as unique compared to the original biologic by classifying them in separate  GPIs and GSNs (clinical formulation IDs).  This is different than small molecule products where similar products (including B-rated products) are classified in the same GPI or GSN.

Future Scenarios

What will happen with interchangeable biosimilars when approved by the FDA?  Will Medi-Span and FDB group those in the same GPI or GSN as the original biologic?  Will they continue to differentiate interchangeable products in unique GPIs and GSNs?

If the drug compendia decided to keep the unique GPI and GSN classification for interchangeable biosimilars, PHSI would suggest the following methodologies to group biosimilars and innovator biologics together:

  • Using Medi-Span data, the GPI-8, Product Strength, and Dosage Form would group all biosimilars and the original biologic together.
  • Using FDB data, the Enhanced Therapeutic Classification (ETC), Strength, and Dosage Form groups all biosimilars and the original biologic together.

Another enhancement could be to create a common code linking interchangeable products (like the FDA’s Orange Book therapeutic ratings for small molecules).  This would differentiate biosimilars from interchangeable products within the proposed grouping methods above.


Contact PHSI with your questions and challenges with biosimilar drug compendia classification.


Published January 2019