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

Impact of the Opioid Crisis Response Act

On October 24, 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities, or the SUPPORT for Patients and Communities Act. This bill, referred to as the Opioid Crisis Response Act, will have direct impacts on an array of areas within pharmacy and healthcare settings including The Centers for Medicare and Medicaid Services (CMS), the states themselves, naloxone prices, and patient education.

Some of the provisions from the bill that will impact pharmacy include:

  • Prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs
  • Medicare prescription drug plan sponsors must establish drug-management programs for at-risk beneficiaries
  • Each state must establish a qualifying prescription drug monitoring program (PDMP) and require health care providers to check the PDMP for a Medicaid enrollee’s prescription drug history before prescribing controlled substances to the enrollee
  • CMS must report on the adequacy of access to abuse-deterrent opioid formulations for individuals with chronic pain enrolled in a prescription drug plan under Medicare or Medicare Advantage (MA)
  • CMS must provide Medicare beneficiaries with educational resources regarding opioid use and pain management, as well as descriptions of covered alternative (non-opioid) pain-management treatments
  • CMS must develop an action plan to provide recommendations on changes to the Medicare and Medicaid programs to enhance the treatment and prevention of opioid addiction, as well as coverage and payment of medication-assisted treatment
  • CMS must also publish a report that includes an evaluation of price trends for opioid overdose-reversal drugs (e.g., naloxone) and recommendations on ways to lower consumer prices for such drugs
  • The bill also establishes criteria for individuals who are identified as at-risk beneficiaries for prescription drug abuse as qualifying participants in medication therapy management (MTM) programs under the Medicare prescription drug benefit
  • Medicare and MA prescription drug plan sponsors must annually disclose information to enrollees about the risks of prolonged opioid use, as well as coverage of nonpharmacological therapies, devices, and non-opioid medications

Many of these measures aim to improve patient education about the dangers of opioids and encourage the use of opioid alternatives. In 2017 alone, nearly 50,000 overdose deaths relating to opioids occurred. Educating patients through services such as MTM and suggesting alternative pain management therapies could go a long way in reducing that number. The bill also provides increased access to treatment for opioid addiction as well as other provisions all aimed at reducing opioid related deaths and protecting patients. CMS has released a tip sheet for preventing and combating opioid overuse as well as new opioid related policies in Medicare D beginning in 2019. More information can be found at

PHSI believes that while the passage of this bill plays a pivotal role in beginning to address the crisis, additional legislation is required to continue to slow and resolve the opioid epidemic. For example, requiring prescribers to electronically prescribe controlled substances for all patients would force adoption of the two factor authentication and minimize controlled substance diversion through paper prescriptions. The SUPPORT Act is one important component in a multifaceted plan to address the opioid crisis.  PHSI expects that the opioid epidemic will continue to be a relevant issue in both pharmacy and healthcare settings. The coming months will provide valuable insight into just how much of an effect the Opioid Crisis Response Act can have.

Posted: January 2019

A Primer on Partial GPIs and FDB Supersets

Drug compendia are excellent resources that are used either directly or indirectly by almost all stakeholders in the pharmaceutical industry. Two of the leading drug compendia providers are Wolters Kluwer (Medi-Span) and First Databank (FDB). Pharmaceutically equivalent products are those that share the same active ingredient(s), strength/concentration, dosage form, and route of administration. Both compendia group pharmaceutically equivalent products together. Medi-Span groups these products using the 14-character Generic Product Identifier (GPI) field, while FDB groups pharmaceutically equivalent products together using a five-digit Generic Code Number, or GCN. There are some therapeutic categories that drug compendia find challenging to code, and they require procedures outside of the normal categorization process.

Nutritional Supplements, Vitamins, and Devices
What happens to the hundreds, if not thousands, of unique vitamins, nutritional supplements, dietary management products, medical foods, and devices? Do the compendia create unique GPIs and GCNs for each of these slightly different products? The short answer is no. Due to the character-length limitations of GPIs or GCNs, it is impossible for the compendia to assign unique identifiers to each product formulation; thus, partial GPIs and FDB Supersets were born.

Medi-Span refers to partial GPIs as a general description of the product based on the therapeutic classification system. Partial GPIs can be identified and differentiated based on the presence of asterisks before and after the GPI Name, which is essentially the product’s generic name. Examples of GPI Names for partial GPIs include *Nutritional Supplement Caps** and *Blood Pressure Monitoring – Device***. Placing products in a partial GPI indicates to users that products are like one another, albeit not pharmaceutically equivalent. Similarly, FDB has created FDB Supersets, which group similar but not pharmaceutically equivalent products together. This is most commonly seen in the device space, such as with GCN 94200 that groups Medical Supplies and DME (durable medical equipment).

Partial GPIs and FDB Supersets can cause confusion in the marketplace. For organizations doing GPI/GCN crosswalks, it can be difficult to map these products from one compendium to another. When doing a GPI to GCN crosswalk (or a GCN to GPI crosswalk), products with partial GPIs or FDB Supersets may have a one-to-many relationship. Additionally, some physicians may choose to search for products by therapeutic category, and this can prove challenging if a product is in a partial GPI for FDB Superset, due to the vast number of products appearing. Finally, a partial GPI or FDB Superset could serve as an indicator to a payer that a product is not a typical drug and may affect formulary placement and/or coverage.

Understanding partial GPIs and FDB Supersets is important for manufacturers, especially those making vitamins, dietary supplements, medical foods, medical devices, and/or durable medical equipment. Other stakeholders should be familiar with these product identifiers to properly code their systems to ensure the business intent is captured correctly.

Published January 2019