Have you ever had a patient balk at getting their prescription filled when they find out the cost and then look to you for advice about their prescription? Or have you ever wondered why a generic manufacturer isn’t offering all strengths of a drug product for sale? Substituting a generic version of a brand-name drug can often be a cost-saving way for patients to purchase their prescription and maintain medication adherence. But what are some of the factors affecting whether a brand-name drug has generic competition?

The FDA knows that competition from multiple generic drugs for 1 brand-name drug can save money. In fact, multiple generic companies are often approved by FDA to market a single product. This creates greater competition in the marketplace, typically resulting in lower prices. Research shows that consumers may see a significant price reduction

 when there are at least 3 FDA-approved generics available.

The legal and regulatory framework that provides for FDA’s approval of generic drugs seeks to balance the public health goals of spurring innovation for new drugs and encouraging competition through generic drugs. Congress created the basic structure under which generic drugs are approved in the 

Drug Price Competition and Patent Term Restoration Act of 1984

, commonly referred to as the Hatch-Waxman Amendments.

Generic drug competition with a brand-name drug can only begin after a generic drug has been approved by FDA. Patents and exclusivities for brand-name drug products are forms of protection for drug makers that may affect how and when a generic drug is approved and can be sold.

 The following are some of the overarching principles behind patents and exclusivitiesthat affect the timing of the FDA’s approval of generic drugs.

Patents can protect a company’s intellectual property investments (eg, by preventing other manufacturers from entering the market with the same product). Issued by the US Patent and Trademark Office (USPTO), patents can be issued before the drug has been approved by FDA.

When a brand-name drug applicant seeks FDA approval for a drug product via a New Drug Application (NDA), they must submit information to FDA specifying which patents claim the drug substance, drug product, and method of using the drug. The FDA publishes this information in the 

Approved Drug Products with Therapeutic Equivalence Evaluations (

. These are referred to as “listed patents.” The FDA updates patent listings daily. The FDA’s role related to patents is essentially limited to ensuring that the patent information published in the Orange Book accurately reflects what the brand-name applicant submitted FDA. The FDA does not interpret patents or participate in patent infringement litigation between brand-name and generic drug companies. 

The Hatch-Waxman Amendments are designed to achieve a balance between innovation and access to affordable drugs. To incentivize the development of brand-name drugs and new uses for approved brand-name drugs, the law provides sponsors of brand-name drugs with different marketing exclusivities, independent of patent protection, that could delay when a generic drug can be approved.

These exclusivities may be available for products containing new active moieties, new uses for previously-approved products, products treating rare diseases, products for which the brand-drug applicant conducted studies in pediatric patients, and certain antibacterial or antifungal drugs intended to treat serious or life-threatening infections.

The exclusivities can also block the submission or approval of generic drug applications for set periods of time depending on the exclusivity. For example, if a brand-drug product is awarded exclusivity for a new use of a previously approved product, generic applications may be blocked from approval for three years from the time that the new use was approved by the FDA. The Orange Book

 provides information on what exclusivities a brand-drug product has. Information on how brand-drug sponsors qualify for these exclusivities is available on FDA’s website.

How do generic drug companies challenge a brand-name company’s patent? 

If there are patents listed in the Orange Book, the generic drug applicant must address each patent by “certifying” to the patents.

If the generic drug applicant believes that the listed patents are either invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the generic version, the applicant would provide a “paragraph IV” certification to that patent. The brand-name company or patent owner then can sue the generic drug applicant for patent infringement before the generic application is approved. Approved generic drug may be allowed to enter the market before the patent(s) expires if the generic drug applicant is not sued by the patent owner or brand-name company or if it is sued and either wins or the litigation is dismissed.

It is not uncommon for patent litigation between a brand-name company and the generic company to end with a settlement agreement between the parties. In a settlement agreement, the brand-name drug and generic drug companies agree on a date when the generic drug can go to market. The lawsuit is dismissed as part of the settlement agreement. Specific information related to settlement agreements and when a generic drug could go to market pursuant to such an agreement are not managed by FDA and are not available in the Orange Book.

The Hatch-Waxman Amendments provide an incentive of 180 days of marketing exclusivity which can be granted to the "first" generic drug applicant that challenges a patent listed in the Orange Book for the brand-name drug by filing a paragraph IV certification and assuming the risk of having to defend a patent infringement lawsuit. A generic drug applicant can potentially retain eligibility for 180-day exclusivity even if it is not sued over its proposed generic drug or, if sued, the case is resolved or settled. This 180-day period starts when a “first” generic drug applicant startsmarketingits product.on published in the Orange Book accurately reflects what the brand-name applicant submitted to FDA. The FDA does not interpret patents or participate in patent infringement litigation between brand-name and generic drug companies.

Given the complex patent and exclusivity landscape surrounding generic drug approval, it can be difficult to know when a generic drug may enter the market. The Orange Book is a great resource to find out if there are patents or exclusivities that protect the brand-name drug and when those patents will expire. Patients will appreciate your knowledge of this information! The Orange Book can be found online at: 

https://www.fda.gov/drugs/drug-approvals-and- databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

Additional resources for information on patents, exclusivity and Generic Drugs 

: Information and resources related to patents, Paragraph IV certifications. 

https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and- suitability-petitions

Frequently Asked Questions on Patents and Exclusivity:

https://www.fda.gov/drugs/drug- approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations- orange-book

Overview and Basics of Generic Drug Approval Process: 

https://www.fda.gov/drugs/generic- drugs/overview-basics

1. Berndt ER, Mortimer R, Bhattacharjya A, et al. Authorized generic drugs, price competition, and consumers' welfare. 

2. FDA. Generic Drug Facts. FDA's website. 

https://www.fda.gov/drugs/generic-drugs/generic-drug-facts

3. FDA. Approved Drug Products with Therapeutc Equivalence Evaluations (Orange Book). 

https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book 

Articles

What are some of the factors affecting whether a brand-name drug has generic competition?

The Impact of Patents and Exclusivities on FDA’s Approval of Generic Drugs 

All-cause deaths dropped 59% for adults who received methadone within 12 months of an opioid overdose, according to a study published in the 

 The study also found that taking buprenorphine within 1 year of an overdose led to a 38% reduction in all-cause deaths.

These 2 statistics spurred Kavita Babu, MD, chief of medical toxicology at UMass Memorial Health Care in Worcester, Massachusetts, to launch a telehealth-based program to connect patients with credentialed clinicians who can prescribe medication-assisted treatment (MAT). UMass Memorial is the second largest health system in Central and Western Massachusetts.

For context, the Massachusetts legislature passed a law in August 2018 requiring hospital emergency departments (EDs) to provide MAT to patients who present after an opioid overdose. To prescribe MAT, clinicians must have a Drug Enforcement Agency Category X waiver, which requires 8 hours of training. Seventy percent of UMass Memorial’s clinicians have participated in the training.

According to the CDC, Massachusetts ranked among the top 10 states with the highest rates of opioid overdose deaths.

 Synthetic opioids, mainly fentanyl, cause many of those deaths. The federal agency reports

 that opioids were involved in 68% of all drug overdose deaths in 2017. West Virginia, Ohio, and Pennsylvania had the highest rates of deaths due to drug overdose that year.

Since the UMass Memorial program launched in January, 1 patient has received a telehealth-based consult from a credentialed toxicologist. Babu described the patient as a young man with longstanding opioid use disorder. “He needed a prescription for Suboxone to continue treatment in a new facility,” she told 

Babu explained that, 5 years ago, the opioid overdose treatment protocol started with a first responder providing naloxone to reverse a patient’s overdose. After arriving in the ED, the patient was told by a physician that they almost died. The physician also told the patient to stop taking drugs, gave them a list of community resources, and discharged them.

Today, at UMass Memorial - Marlborough Hospital, the patient presents in the ED, after getting naloxone. Then a clinician captures their history and their interest in MAT. If the patient agrees, the ED clinician connects the patient with one of the trained toxicologists on Babu’s team via a HIPAA-compliant telehealth platform.

The toxicologist’s goal is to empower the patient by getting them to take home a prescription for MAT, said Babu. After providing consent, the patient is sent home with a prescription and a handout prepared by the National Institute on Drug Abuse that asks a series of questions such as the number of hours since opioid use and the patient’s experience with symptoms such as yawning, nausea, and diarrhea. This guides the patient’s home induction of MAT, she explained.

Pharmacists have been at the forefront of creating access to naloxone and MAT, said Babu. That’s why they can help increase access to MAT, especially if clinicians at their hospitals aren’t trained or are resistant to providing treatment.

For example, a pharmacist in a rural ED could struggle to expand access to MAT treatment without trained prescribers in the hospital, said Babu. Ensuring that clinicians receive training is part of the solution, but clinicians also need access to decision support to determine the appropriateness, as well as the timing and safety of the approach, she added.

Hospital committees focused on pharmacy and therapeutics and ED oversight, where pharmacists are involved, should be interested in this offering, said Babu.

This initiative received $200,000 in funding from UMass Memorial Medical Group.

1. Larochelle MR, Bernson D, Land T, et al. Medication for Opioid Use Disorder After Nonfatal Opioid Overdose and Association With Mortality: A Cohort Study. Ann Intern Med. 2018; 169:137–145. [Epub ahead of print 19 June 2018]. doi: 

2. National Institute on Drug Abuse. Massachusetts Opioid Summary. 

https://www.drugabuse.gov/opioid-summaries-by-state/massachusetts-opioid-summary

 Revised March 2019. Accessed February 13, 2020.

3. Centers for Disease Control and Prevention. Drug Overdose Deaths. 

https://www.cdc.gov/drugoverdose/data/statedeaths.html

 Last reviewed June 27, 2019. Accessed February 13, 2020.

4. Babu K, Lai J, Cushman P, et al. (2020) An emergency department order set for buprenorphine-naloxone (SUBOXONE®) initiation, Toxicology Communications, 4:1, 5-8, DOI: 10.1080/24734306.2019.1704978

A UMass Memorial telehealth-based program connects patients with credentialed clinicians who can prescribe medication-assisted treatment for opioid use disorder. 

Massachusetts Hospital Uses Telehealth to Increase Access to Opioid Treatment

Harmons is an upscale family-owned grocery chain with its headquarters in Salt Lake City, Utah. The chain features 19 grocery locations, 18 of them with pharmacies. Greg Jones, RPh, MBA, Director of Pharmacy Services, and his team are doing some amazing things in pharmacy.

First, the pharmacy department works closely with the company’s 7 registered dietitians to help pharmacy patients benefit from a variety of nutritional support programs. The dietitians work with all of the fresh food teams and the employee wellness program, as well as provide dietitian support to Harmons shoppers. This includes food tours, diabetes education, and a carefully orchestrated program that provides special shelf labels on products throughout the store that meet specific nutritional criteria. 

Specifically, the dietitians place a special label on the shelf to highlight products that are gluten free, organic, local, or that are considered “Dietitians Choice.” The items tagged as “Dietitians Choice” meet nutritional guidelines for the healthy choices in specific categories across the store. Manufacturers are very good at creating food confusion–is this healthy or is it just marketing? The “Dietitians Choice” program makes it easy to find the healthy products– just look for the green tags on the shelves.   Another one of the labels they use points out OTC or other health products that the Harmons’ pharmacist recommends. All in all, the program is exceptionally well run and helps to build on the grocery chain’s image of providing fresh and nutritious foods.

Their second program, focusing on specialty pharmacy, is a bit more sophisticated and clearly positions Jones and his team as pharmacy trailblazers.

Harmons has a full-time sales representative that calls on prescribers all over the Salt Lake Valley. His job is to let health care professionals know about the specialty pharmaceuticals Harmons can supply and support services they provide. 

The company website has a link to the documents for specialty disease states and medications designed for prescriber use in submitting prescriptions to the Harmons Specialty Pharmacy program. Prescribers can visit the site to see exactly what products Harmons has access to, obtain all the necessary prior authorization (PA) or other forms they need, and then write the prescription. 

Jones says the range of services they provide allows them to help people with HIV, hepatitis C, multiple sclerosis, and other serious ailments requiring specialty medications. The PAs and any co-pay assistance is coordinated by the central processing center for Harmons pharmacies. Once a prescription is ready for the patient to pick up, the specialty medication is ordered from the wholesaler and the patient picks up the prescription from their normal Harmons pharmacy. Harmons is providing specialty medication services through local pharmacies, building on their existing patient/pharmacist relationships. The Harmons Specialty Pharmacy program is currently accredited through the Center for Pharmacy Practice Accreditation.

Jones says this works well for everyone. The physician knows the Harmons team will do all that is necessary to meet the manufacturer requirements and help the patient qualify for insurance coverage or any other payment assistance. The patient gets to work with the Harmons pharmacist for all training and support they need.

Jones makes it clear that building such a system is not easy. Fortunately, he says they already had a central call/processing facility, which made the process a bit easier. The service is also supported through their partnership with KloudScript, who helps provide hub support services and specialty pharmacy services software. The challenges in specialty pharmacy–access to specialty medications and access to third party plans– remain, but the program continues to grow, showing 6-fold growth after 2 years. 

Combine all this with the retail pharmacy’s wide variety of customer services and it is easy to see why Harmons pharmacies are special.

Greg Jones, RPh, MBA, director of pharmacy services and his team are doing some amazing things in pharmacy.

Harmons Pharmacies Are Special 

The FDA is carefully tracking shortages of personal protective equipment (PPE) such as surgical masks, as well as pharmaceutical raw materials from China due to the novel coronavirus.

This is just one of the important updates about coronavirus disease 2019, also known as COVID-19, that pharmacists need to know.

1. The FDA is “keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the US,” said FDA Commissioner Stephen M. Hahn, MD, in a statement.

“We are not waiting for drug and device manufacturers to report shortages to us-we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages," he said. 

Although there are no vaccines, gene therapies, or blood derivatives licensed by the FDA that are manufactured in China, raw materials used in manufacturing do come from China and other locations in Southeast Asia, Hahn noted. “We are in contact with biologics manufacturers to gauge any supply concerns regarding raw materials,” Hahn said.

However, FDA has received reports of increased ordering of some essential medical devices through distributors, such as PPE (eg respirators and surgical gowns, gloves, and masks).

“If a potential shortage or disruption of medical products is identified by the FDA, we will use all available tools to react swiftly and mitigate the impact to US patients and health care professionals,” Hahn said.

“These tools include closely working with manufacturers and expediting review of alternate supply to prevent shortages, among other measures, with the common goal of minimizing any negative impact to public health in America.”

2. The Chinese CDC found that COVID-19 may be more contagious than the related viruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), according to new research published in the 

The study, which is the largest of its kind, includes 72,000 confirmed and suspected cases of the coronavirus, CNN reported.

However, the mortality rate is lower than SARS and MERS, according to the study. The Chinese CDC found a crude mortality rate of 2.3% among coronavirus patients, while SARS had a mortality rate of 9.6% during the 2003 outbreak

3. Sanofi Pasteur is developing a COVID-19 vaccine, in collaboration with the Biomedical Advanced Research and Development Authority (BARDA).

Sanofi will leverage previous development work on a SARS vaccine, “which may unlock a fast path forward for developing a COVID-19 vaccine,” the vaccine unit of Sanofi said in a statement.

"Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate," said David Loew, global head of vaccines at Sanofi. "While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak."

In non-clinical studies, the SARS vaccine candidate was immunogenic and afforded partial protection as assessed in animal challenge models, Sanofi Pasteur said.

4. The Center for Science in the Public Interest (CSPI) 

 that the FDA and the FTC should take immediate action against televangelist Jim Bakker and his organization for making false claims about dietary supplement products. 

According to CSPI, thejimbakkershow.com claims that the Silver Solution dietary supplement products on the website can cure the coronavirus “within 12 hours.”

The preacher previously claimed the same product cures “all venereal diseases” and HIV.

“There’s no evidence that the element silver prevents or treats any condition, according to authorities such as the National Center for Complimentary and Integrative Health, part of the National Institutes of Health, and the Food and Drug Administration,” CSPI said in a statement.

5. Healthcare Ready (formerly Rx Response) launched a separate page on its website devoted to updating the industry on shortages related to the virus, emergency preparedness information and other news.

Healthcare Ready is liaising with components of the supply chain to “better understand the current demands of supplies including pharmaceuticals and personal protective equipment (PPE),” the organization said on its website.

1. FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad [statement]. FDA’s website. 

https://www.fda.gov/news-events/press-announcements/fdas-actions-response-2019-novel-coronavirus-home-and-abroad

2. Griffiths J, Gan N. Chinese CDC study finds Covid-19 virus to be more contagious than SARS or MERS. CNN. Published February 19, 2020. 

https://edition.cnn.com/2020/02/19/health/coronavirus-china-sars-mers-intl-hnk/index.html

3. CDC. Update: Severe Acute Respiratory Syndrome – Worldwide and United States, 2003. MMWR Weekly. July 18, 2003. 

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5228a4.htm/

4. CDC. MERS Clinical Features. CDC’s website. 

https://www.cdc.gov/coronavirus/mers/clinical-features.html

5. Sanofi joins forces with US Department of Health and Human Services to advance a novel coronavirus vaccine  [news release]. Sanofi’s website. 

http://www.news.sanofi.us/2020-02-18-Sanofi-joins-forces-with-U-S-Department-of-Health-and-Human-Services-to-advance-a-novel-coronavirus-vaccine

6. CSPI Urges FDA Enforcement Action on Televangelist Jim Bakker’s Fake Coronavirus “Cure” [news release]. CSPI’s website. 

https://cspinet.org/news/cspi-urges-fda-enforcement-action-televangelist-jim-bakkers-fake-coronavirus-cure-20200218

7. Novel Coronavirus Outbreak: How We’re Responding to the Newly Identified Disease [news release]. Healthcare Ready’s website. February 6, 2020. https://healthcareready.org/novel-coronavirus-outbreak-how-were-responding-to-the-newly-identified-disease/.

FDA responds to shortages, plus other important updates.

Top 5 Things to Know About COVID-19

According to the CDC, approximately 30.3 million people in the United States have diabetes.

 Pharmacies that offer ongoing diabetes care and counseling do more than deliver a valuable service; providing such services makes sound business sense. 

“Patients need help navigating their care and managing the disease,” said Dorinda Martin, PharmD, RPh, FACA, FASAP. “Diabetic patients fill more prescriptions and visit the pharmacy more often than most of our other patients. The more services and products we offer, the more patients we will see. It's the ‘build it and they will come’ story. Offering individualized patient care and not just prescriptions increases patient trust, dedication and loyalty.”

One common way pharmacists help patients with diabetes is by showing them how to properly use prescribed devices. Although basic instruction in the self-monitoring of blood glucose levels is the set-up and demonstration of the device, pharmacists can use the opportunity to present information on glycemic goals. What should glucose levels be during fasting, before meals, after meals, and bedtime? What are the signs/symptoms/treatment of high and low glucose values and how often should I test?

Answering the simplest questions can be a game changer. “Interestingly, ‘How often should I test my blood glucose?’ is repeatedly asked-patients often state they have never been told how often or when to check glucose levels so this is an excellent opportunity for pharmacists,” said Jennifer Smith, PharmD, BCACP, BCADM, CDE. 

“My one question I always ask takes 2 seconds. ‘Where do you inject your insulin?’ You would be amazed at the responses received (ie calf, breast, back, forearm). This becomes the easiest diabetes education moment that will profoundly impact absorption that takes less than 10 seconds to complete. Even the busiest pharmacist can spare 10 seconds.”

Monitoring medication use and adherence may be a more time-consuming task, but it’s something pharmacists are uniquely positioned to do. Pharmacists can recognize when medications are not optimized, if another medication is recommended for comorbid diseases, but not prescribed, and note any adverse or intolerable effects. 

Ideally, counseling on the importance of medication adherence, plus the risks of the newly-diagnosed disease, should begin when a patient first shows up at the pharmacy with a new prescription for diabetes.

“If they don't have time at that moment of POS, then promise to call them the next day and outline what services the pharmacy offers, such as 1-on-1 diabetic counseling,” Martin said. “Create a summary and a template sheet for each pharmacist to create a plan for each of these patients, then place in ticker to ensure a follow-up call to monitor the patient every few months. This follow-up could include taking their weight and blood pressure as well as A1c and checking on their immunization records.”

Whether diabetes care and counseling happens in an independent pharmacy or at a nationwide pharmacy chain, systems that monitor patient adherence are an essential tool. At Walgreens pharmacies, pharmacists use a program with predictive analytics to identify patients most likely to become nonadherent to their maintenance medications, including those with diabetes, then provide personalized recommendations.

“By providing patient specific solutions to help them effectively manage their chronic condition, lifestyle modifications and medication regimen, diabetes patients can be empowered to meet their health goals,” said Alexandra Broadus, PharmD, director, Patient Outcomes Performance for Walgreens. 

Prominently displaying diabetes products and services in the pharmacy is a good way to let customers know what you offer, but pharmacists can also help spread the word in the community “Outside of our stores, it’s important that pharmacists are participating in local community events and organizations to raise awareness of the care and services they can provide,” said Broadus. “Our pharmacists participate in community outreach programs. As part of these, we offer presentations on diabetes care and solutions.”

Walgreens recently launched the “Missing Therapy–Statin Use” program to help identify patients with diabetes who are not currently taking a statin and provide education and physician outreach around the heart health benefits of statins. “The American Diabetes Association (ADA) recommends that diabetes patients over the age of 40 include a statin as part of their drug therapy to lower their risk for heart disease,” Broadus said. “Yet, many patients with diabetes have never been offered a statin.” 

CVS launched its Transform Diabetes Care program in 2017 and expanded it in 2019 to focus on prevention and early identification of diabetes, as well as hypertension, a common comorbidity of diabetes. The program helps pharmacy benefit manager (PBM) members control their diabetes through a combination of personalized support and coaching focused on improving medication adherence and better control of HbA1c. 

“More than 50% of members with uncontrolled diabetes who enrolled in the program have moved to a controlled status and, on average, members have improved HbA1c by 1.2 percentage points,” said Peter Simmons, RPh, vice president of Chronic Care Optimization at CVS. 

Personalized coaching and support for healthy lifestyle behaviors can be delivered at the pharmacy or by phone. Members can also receive diabetes monitoring at MinuteClinic locations at no out-of-pocket cost, including A1C checks.

“In addition, members are offered a connected glucometer, which shares their blood glucose levels with a pharmacist-led team via a health cloud, enabling the team to identify potential issues and intervene with 1-on-1 coaching,” said Simmons.

Patients have the option of not only getting refill reminders by text but can also text their requests for refills.

“Patients commonly convey that they’re frustrated, and that they find their diabetes to be challenging, inconvenient, and difficult to manage,” Simmons said. “Our expanded program is designed to make it easier for a broader range of patients to keep their diabetes under control, prevent complications, and manage related conditions like high blood pressure in a coordinated way.”

As well as counseling patients already diagnosed with diabetes, pharmacists can screen those who may be at risk.

“Per the American Diabetes Association (ADA) Standards of Medical Care in Diabetes, an informal assessment of risk factors for [type 2 diabetes mellitus] or the use of a validated tool should be used in asymptomatic adults,” Smith said. “The ADA Risk Test is readily available on page S21 of the 2020 guideline and is a good tool for pharmacists to review with patients.”

Screenings can provide an opportunity for pharmacists to suggest preventive steps that can reduce an individual’s risk, such as healthy eating habits and exercise. 

“Often, pharmacists feel they need to be a Certified Diabetes Educator (CDE) in order to effectively provide diabetes education to patients, which is inaccurate,” Smith said.

Many health care professionals hold the title of diabetes educator while working toward the hours of hands-on education required before the CDE exam. 

“Ideally, pharmacists should have basic knowledge of counseling tips for available diabetes medications, basic diet information for patients living with diabetes, an understanding of guideline recommendations for glycemic goals and pharmacologic treatment, and the ability to recognize glucose patterns from home monitoring,” Smith said. “These are all covered in the APhA Diabetes Certificate Training Program which offers online modules for learning at a self-set pace and a hands-on live seminar for application of the material covered in the modules.” 

As pharmacy schools offer more diabetes management education, newer graduates may need less additional training, but there are multiple options should training be needed.

“I wanted to be sure my pharmacists were knowledgeable,” said Martin of her Texas-based pharmacy Martin’s Wellness Dripping Springs Pharmacy. “So I sent 4 of us to a certified diabetes education class (20 hours of CE) at a local college of pharmacy. This allowed a confidence level that benefited the pharmacists and our patients."

1. New CDC report: More than 100 million Americans have diabetes or prediabetes [news release]. CDC’s website. 

https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html

Creating a place where patients seek diabetes care and counseling.

How To Turn Into A ‘Diabetes Pharmacy’

Walk into a pharmacy in 2030 and there’s a good chance you’ll see a pharmacist. And there’s a good chance the pharmacist will have little or nothing to do with dispensing. “We will have less to do in the future with actual medications,” predicted Michael Rea, PharmD, founder and chief executive officer of Rx Savings Solutions, a medication therapy management firm in Kansas City. “Pharmacists might still be responsible for dispensing, but they won’t be counting by fives and maybe not looking at pill vials. Automation, robots, software can probably do the job faster and more accurately when it comes to dispensing. Pharmacists will be adding value and improving health outcomes in other ways.”

State practice acts still make pharmacists responsible for safe and accurate dispensing, but economics are squeezing pharmacists out of the process.

Amazon bought PillPack in 2018 and is seeking pharmacy trademarks in more than a dozen countries. The company also advised patients in 2019 that it would be adding Amazon Pharmacy to packaging.

However, Amazon isn’t alone in squeezing prescription profit margins. Other e-pharmacy startups are also offering fast, low-cost delivery of Rx medications as payers and pharmacy benefit managers (PBMs) continue to trim already-low product reimbursement and pharmacy profit margins.

“Dispensing is dying,” said Becky Winslow, PharmD, senior pharmacogenomics specialist, Medical Affairs, Admera Health. “I was a pharmacy manager for Walmart 21 years ago and started plotting my way out within 2 years. I could see the business model just wasn’t sustainable.”

Traditional dispensing will be even less sustainable in 2030, Rea predicted. Independent pharmacies have long offered home delivery. Facing increasing pressure from Amazon and other on- line sellers as well as independents, CVS, Walgreens, and other chains are rolling out their own delivery programs.

But growing home delivery means shrinking foot traffic, Rea noted. That means lower retail prescription volume and lower non-Rx sales on a per-store basis. Major chains have been closing lower performing stores for years, increasing pressure on pharmacist employment.

On the flip side, patients, like other consumers, want convenience. That means more care at home, at work, and in community locations.

“Pharmacy has the potential to be one of the points of access,” said Lucinda Maine, PhD, RPh, executive vice president and chief executive officer of the American Association of Colleges of Pharmacy.

Pharmacists continue to be the most trusted and most accessible health care providers. Patients visit a pharmacy an average of 35 times per year compared with just 4 visits to see medical providers, according to Jennifer Zilka, group vice president of Good Neighbor Pharmacy Field Programs and Services. New business models play to those 2 strengths. “We are seeing a move from financial models based on volume to models that are clinically focused on quality, keeping people healthy and out of the hospital,” Zilka said. “The goal is better clinical outcomes and pharmacists are poised to play an important role on the health care team to improve outcomes.” Focus on outcomes is already a reality in health system settings, she continued. Most systems currently have pharmacists on the floors monitoring interactions, evaluating therapy, adjusting medications, and working with the rest of the health care team to optimize outcomes. Retail pharmacists have an opportunity to play a similar role in the community.

“I see more point-of-care testing in 2030 in community pharmacy and prescribing on the spot,” she predicted. “More immunizations, more compounding. The next 10 years is transforming practice from dispensing a product to providing a flexible, high-touch, personalized service experience with better clinical outcomes.”

Reimbursement is in flux. Payment from public and private payers is mov- ing toward value-based, but fee-for-service still dominates some sectors, including pharmacy.

“Changing payment models are conducive to cobbling together the resources to support a pharmacist,” explained Anne Burns, RPh, vice president of professional affairs for the American Pharmacists Association. "Practices that have moved to value-based have the incentive to bring providers to the table who can impact their quality metrics and outcomes. There is an increasing appetite for the role that pharmacists can play. The evidence is building that pharmacists can contribute to outcomes.”

The key to pharmacy success in 2030 is focusing on the specialized knowledge and training of pharmacists. Every provider in health care has a niche. Physicians are trained to diagnose, nurses to support, and physical therapists to improve physical function. Pharmacists are the providers trained in medication science.

Not understanding the science of drug delivery, activity, and interactions is an important reason so many patients get the wrong drug at the wrong time, said Calvin Knowlton, PhD, founder, chair, and chief executive officer of health care informatics provider Tabula Rasa Healthcare. This is also 1 reason adverse drug events (ADEs) have become the third leading cause of death in the United States after heart disease and cancer.

“The most common therapeutic intervention in the world is pharmacotherapy,” Knowlton said. “For every dollar we spend on prescription medication, we spend more than another dollar trying to address problems caused by the medications. Pharmacists can change that, pharmacists are being paid to change that. Don’t worry about prescriptions- let Amazon or 1 of their competitors do it.”

Patients typically fall into 1 of 2 categories, Zilka said. They need a familiar prescription refilled with no changes, no questions, no complications, and no worries. They need a channel to get their medication as conveniently and as cheaply as possible. They need a pharmacy.

Or, they need personal attention due to a new prescription that requires counseling or multiple medications with the potential for interactions and ADEs. They need someone who can walk them through the quirks of 3 different asthma inhalers, someone who help them afford their medications, and someone who understands the underlying science of all of the factors that play into drug activity. They need a pharmacist.

“Payers are realizing that when pharmacists are involved with patients, they can have a significant impact on lowering the total cost of care,” said Kurt Proctor, PhD, RPh, senior vice president of strategic initiatives for the National Community Pharmacists Association (NCPA) and president of the NCPA Innovation Center. “Increasingly, payers are going to want to work with pharmacists and pharmacies that are achieving good patient outcomes.”

Dispensing won’t go away, Proctor predicted, but pharmacies that can demonstrate improved outcomes will earn the privilege of dispensing as well as providing services. And patients will be incentivized to use specific pharmacies that show positive results.

Look for technology to update familiar processes such as drug utilization review (DUR). The basic DUR technology is nearly 50 years old and scans for interactions between 2 agents. That’s a problem when approximately half of older adults are taking 5 or more medications.

One-to-one DUR embedded in electronic health records, pharmacies, PBMs, and other systems is archaic, Knowlton said.

Tabula Rasa is currently testing MedWise, a simultaneous, multi-drug DUR incorporating pharmacodynamics, pharmacokinetics, pharmacogenomics, and chronopharmacology in multiple Part D populations. Clinical pharmacists provide personalized follow-up with patients and prescribers with specific recommendations for deprescribing, substitutions, and timing changes to improve outcomes.

In 6 months, medication use decreased about 27%, hospitalizations by 43%, and emergency room visits by 20%. Per patient per year savings were approximately $4,000 and the total return on investment was 13:1.

Science and reimbursement are the only limits on pharmacist roles in 2030, Proctor said. As pharmacotherapeutic science advances, so do potential niches for pharmacists.

“We are already seeing point-of-care testing,” Maine said. “Pharmacogenomic analyses are beginning to be applied to drug selection and dosing. There is going to be a lot more health information technology that impacts diagnosis, therapeutic, and patient management. Pharmacists can help solve our medication problems-if we let them.”

Looking Ahead at Pharmacogenomics, Nutrigenomics

Pharmacogenomics and nutrigenomics are early contenders for the hottest new area in pharmacy. Neither is board-certified, but the American Society of Health-System Pharmacists launched its first pharmacogenomics certificate program in 2018.

“Pharmacists need to take a very involved pharmacogenomics role with both patients and providers,” said Jaclyn Boyle, PharmD, MS, PhD, associate professor of pharmacy practice at Northeast Ohio Medical University. “Once we know how a variant in an individual’s genome affects the way they can process a particular medication, there are many implications for the selection, effectiveness, and safety of therapies and interactions. Pharmacogenomics data can help inform decision about whether a patient should try a medication, stay on it, whether a given med is going to either positively or negatively impact the patient.”

Boyle is chief executive officer of Synerji, a startup turning pharmacogenomics and nutrigenomics into everyday tools for pharmacists.

Think clopidogrel. “Plavix (clopidogrel, Bristol-Myers Squibb) helped put pharmacogenomics on the map,” said Winslow. “But the bulk of pharmacogenomics research is in oncology, psychiatry and most recently, pain. Only about 50% of women who are getting chemotherapy for breast cancer can even benefit. They don’t need chemotherapy, they need hormone receptor medications, but only genetic testing can show that. Medication selection and counseling based on genomic data is a huge unmet need.”

Winslow founded inGENEious RX to commercialize pharmacogenomics. As the list of cardiovascular, oncology, and other specialty medications with known pharmacogenomic interactions grows, more and more payers are covering genomic testing. Self-insured employers are leading the way, she said, but commercial payers are starting to recognize the value of pharmacogenomic testing-and paying pharmacists to evaluate therapeutic choices based on pharmacogenomic data. Nutrigenomics is close behind.

“Nutrigenomics counseling could play a big role in disease states where nutrition plays a role, which is most of our chronic diseases,” Boyle said. “Nutrition impacts the development and progression of diabetes, cardiovascular disease, kidney disease, irritable bowel syndrome and other GI conditions, and so much more.”

Genetic variants can play a huge role in response to both medications and nutrition. Metformin, the most commonly prescribed agent for type 2 diabetes, depletes vitamin B12, Winslow noted. And some individuals are genetically disposed to process B12 poorly.

“We know that metformin depletes vitamin B12 and processing B12 poorly is a compounding factor,” she said. “Nutrigenomics data can help us spot that potential problem to improve the patient’s medication outcomes. Once we start showing improvements in outcomes, payers are negotiating reimbursement.”

Walk into a pharmacy in 2030 and there’s a good chance you’ll see a pharmacist. And there’s a good chance the pharmacist will have little or nothing to do with dispensing.

Going Beyond Dispensing: The Future of Pharmacist Roles

Approximately 1 million individuals are living with multiple sclerosis (MS) in the United States, according to the National MS Society.

 The condition is caused by the immune system attacking the protective sheath (myelin) that covers nerve fibers and can result in a wide range of symptoms such as the inability to walk.

 Most patients with MS experience a relapsing-remitting disease course, which involves periods of new symptoms or relapses that occur over days or weeks and usually improves partially or completely.

 There is no cure for MS, so treatment usually involves therapies that improve recovery from attacks, slow disease progression, and manage symptoms.

Treatments for MS include pharmacotherapy and physical therapy. Corticosteroids can help to treat MS attacks by reducing nerve inflammation. Adverse effects include increased blood pressure and blood glucose, mood changes, and fluid retention.

  The American Academy of Neurology (AAN) recommends a careful evaluation of the risks/benefits of disease-modifying therapies (DMTs).

 The DMTs can help to slow the disease process and assist with keeping the condition stable by decreasing the number of new lesions that can form, preventing existing ones from becoming larger, and decreasing the number of relapses.

Treatment options include injectable medications, oral treatments, and infusions. Beta interferons, such as interferon beta-1a (Avonex), are injectable treatments, and common adverse effects include flu-like symptoms and pain at the injection site. Glatiramer acetate (Copaxone, Glatopa) is a subcutaneous injection, and adverse effects may include injection site reactions.

Three new oral medications were approved for MS in 2019: cladribine (Mavenclad), siponimod (Mayzent), and diroximel fumarate (Vumerity).

 The dose of cladribine is a cumulative dosage of 3.5 mg/kg orally divided into 2 yearly treatment courses, and the drug carries a Boxed Warning for an increased risk of cancer and fetal harm. Siponimod dosing is determined by genotype testing and is either 1 mg or 2 mg orally once daily. Adverse effects may include headache, bradycardia, increased blood pressure, and increases in liver function tests. The starting dose of diroximel fumarate is 231 mg twice a day orally for 7 days followed by a maintenance dose of 462 mg (two 231 mg capsules) twice per day. Diroximel fumarate can cause liver problems and a rare brain infection known as progressive multifocal leukoencephalopathy, which has also been reported in patients taking a similar drug called dimethyl fumarate (Tecfidera). Evidence suggests that diroximel fumarate may cause less gastrointestinal adverse effects than dimethyl fumarate.

Individuals with MS receiving immunosuppressive therapies are at a higher risk of developing vaccine-preventable infections.

 Pharmacists should ensure that patients are up-to-date on their immunizations and recommend that individuals receive an influenza vaccine annually. The AAN recommends that patients needing live vaccines receive them at least 4 to 6 weeks before initiating treatment with immunosuppressive medications.

 Individuals currently receiving immunosuppressive therapies or have recently discontinued them should not receive live vaccines unless the risk of infection is high.

Celgene has submitted a New Drug Application (NDA) for ozanimod, an oral sphingosine 1-phosphate receptor modulator, with an anticipated approval date of March 25, 2020.

 The NDA is based on positive results from the SUNBEAM and RADIANCE trials demonstrating that ozanimod was effective at preventing MS relapses.

 Ponesimod is an investigational drug being studied by Janssen for relapsing MS.

Approximately 1 million individuals are living with multiple sclerosis in the United States, according to the National MS Society.

Drug Topics March 2020

The Impact of Patents and Exclusivities on FDA’s Approval of Generic Drugs

Massachusetts Hospital Uses Telehealth to Increase Access to Opioid Treatment

Harmons Pharmacies Are Special

Top 5 Things to Know About COVID-19

How To Turn Into A ‘Diabetes Pharmacy’

Going Beyond Dispensing: The Future of Pharmacist Roles

What Pharmacists Should Know About Multiple Sclerosis

Ubrogepant: A Novel Drug Mechanism for Migraine Treatment

Prepare for Allergy Season

Making A Career Pivot

Growing Your Business With Supplements

7 Pharmacist-Friendly Apps You Should Be Using

Why Did You Become A Pharmacist?

Addressing the ‘Glut’ of Pharmacists

NASH Drug Pipeline Shows Promise

Preparing for Evolving Pharmacist Roles