Given the popularity of cannabidiol (CBD), patients are curious about this natural remedy, asking more questions than ever. We consulted 4 pharmacists knowledgeable about CBD for advice on counseling patients. Our experts are:

, PharmD, ND, MBA, RPh, owner of Owensboro Family Pharmacy and Wellness in Owensboro, Kentucky, and certified endocannabinoid specialist

, RPh, CEO of MyCureAll, based in Fair Lawn, New Jersey

, PharmD, owner of Alpine Apothecary in Whitefish, Montana

, PharmD, owner of Malley’s Compounding Pharmacy in Richland, Washington

Our experts recommend that pharmacists advise patients to discuss CBD use with their health care providers before starting it. Here are some of the most frequently asked patient questions and our experts’ answers.

: Patients will typically ask how CBD works and whether it will really help with pain, inflammation, [gastrointestinal] issues, anxiety, etc. We explain that CBD works by allowing the cannabinoids their body makes [eg, (anandamide) AEA and (2-arachidonoylglycerol) 2-AG] to stay in their body longer and that it helps to strengthen the endocannabinoid system [ECS]. The ECS is a system that functions to bring the body back into balance and to decrease inflammation. It reduces inflammation by decreasing proinflammatory chemicals (eg, cytokines and chemokines) and helping the immune system become better at recognizing what it should attack (ie, T-cell upregulation). If they have a symptom that is due to inflammation…it should help.

: As a pharmacist who is a certified endocannabinoid specialist, I love providing education and counseling my patients on the benefits and effective use of CBD. When a patient [is deciding] what product to try, I ask what they are interested in using it for. If they have pain in the wrist, elbow, or knee, or skin conditions, we will start using a balm or topical product. If they have pain in multiple joints, autoimmune conditions, inflammatory diseases, or mental health issues such as anxiety, I recommend using an oil or capsule.

: Match your intention with the application. Topical applications are great for localized support of your muscles and joints. Oral and under-the-tongue formulations are better for systemic absorption and support of your whole body. Supporting your sleep with CBD is a great way to start and then adjust when or if necessary.

: Patients often ask about the dose they should use, how long it takes to work, and how they should use it. I advise starting low and going slow. I recommend a starting dose of 15 mg once or twice daily, explaining that the timing of effectiveness typically depends on the state of their endocannabinoid system. If they have had illness or pain that the body has tried to bring back into balance for a while, it typically takes longer for the full benefit to show. I recommend [for the patient to try] the product for at least 10 days and to increase the dose every 3 days if needed. For oils and tinctures, I advise them to hold it under the tongue for at least 30 seconds, but 1 minute is usually best.

For capsules, I let them know that it takes longer for the effects to kick in, because they must wait for the stomach to empty. We discuss how oils have the fastest absorption rates, because there are a lot of blood vessels under the tongue. For my patients [who are] taking antacids, [proton pump inhibitors], have gastroparesis, or any condition of the gut that makes me question the intestinal permeability and function, I recommend the oils, because bioavailability will differ in edibles or capsules depending on how the gut is functioning.

: Remind the patient to consult a professional when adjusting, because more is not always better. Switching up routes or sites may be more beneficial. Teaching patients to read and understand a label is also crucial. Product labeling isn’t always standard or clear, so advising consumers to pay attention and understanding things like mg per bottle vs mg per serving becomes important. Serving sizes can be listed as per ml or per dropperful, and those distinctions can make a difference and often lead to confusion with consumers.

: More is not always better. Once someone has found an effective dose… taking more can either decrease the effect, increase [adverse] effects [AEs], or provide no further benefits. In my experience, most patients take between 10 and 40 mg daily in divided doses every 12 hours. 

Is it safe to purchase CBD from anywhere?

: I recommend that patients only purchase CBD from a reputable source, because some preparations can become contaminated with fungus, which may be especially harmful to patients with a compromised immune system. If the patient needs to take a drug test, [they] should always ask for the certificate of analysis when purchasing CBD to ensure the product is [tetrahydrocannabinol] THC free. 

: Verify your product with the certificate of analysis, and never buy from a company that doesn’t provide lot-specific analysis that is conducted by a third-party lab.

: I always ask the patient whether they are in a profession where they are drug tested or in pain management. If so, I recommend a product that is THC free. I always recommend THC-free CBD for children. We discuss that products can have the legal limit of THC, and although that amount will not cause any psychoactive [AEs], the urine test limit is so low that they can still fail a drug test for THC.

: In my experience, the most common adverse events [AEs] of CBD are tiredness and drowsiness, dry mouth, dizziness and lightheadedness, and changes in appetite. I recommend taking the first dose in the evening and not doing anything else for the day until one knows how they respond to the CBD. We often forget that most accidents happen in the home. With any prescription, over-the-counter [OTC] medicine, or supplement that might affect cognition, I recommend that one does not do tasks around the house where they could hurt themselves afterward until they have adjusted to the medication.

: We educate that the ECS is a different system than the central nervous system and that added sedation is not a concern. As far as CBD AEs, clinically we have had patients say they would become drowsy, which can be mitigated by decreasing the dose and checking the product to make sure it doesn’t have melatonin or other ingredients. We have had a few patients say the oil caused mild stomach discomfort, to which we suggest taking it with food and allowing it to sit under the tongue for 30 to 60 seconds.

: CBD is a strong inhibitor of both cytochrome P450 3A4 (CYP3A4) and cytochrome P450 2D6 (CYP2D6). CBD may increase levels of:

macrolide antibiotics (azithromycin, erythromycin, clarithromycin)

calcium channel blockers (verapamil, diltiazem)

benzodiazepines (lorazepam, diazepam, alprazolam, clonazepam)

erectile dysfunction drugs (sildenafil, tadalafil, vardenafil, avanafil)

certain statins (atorvastatin and simvastatin)

CYP2D6 metabolizes many antidepressants, so CBD may increase levels of these drugs in the patient’s body:

selective serotonin reuptake inhibitors (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)

tricyclic antidepressants (amitriptyline, nortriptyline)

β-blockers (atenolol, metoprolol, propranolol, bisoprolol)

Levels of opioids, such as oxycodone, codeine, hydrocodone, morphine, or tramadol, increase when CBD is introduced.

: CBD can have potential drug interactions with prescription medications. Some of these drug interactions may cause increased AEs of either the medication or the CBD. Other times the drug interaction may cause an increased level of the medication or the CBD. It is vital for the patient to inform the pharmacist and medical provider about CBD usage. Another valuable tool for screening for drug interactions includes an interaction checker, such as on drugs.com, which helps screen for interactions between cannabis, CBD, and THC and prescription drugs.

 Retail CBD comes from the hemp plant and has no high or psychoactive effect. When given with THC, CBD inhibits the psychoactive effects of THC.

: We counsel our patients that although CBD can help with a wide variety of symptoms, it may not be their miracle or silver bullet and solve every problem they have. It can help decrease inflammation, but the source of the inflammation is the root cause, and we should work to correct the source.

 As medical professionals, it is very important to ensure collaboration with other caretakers of the patient. Informed and shared decision-making is a must. We need to ensure ongoing monitoring and adapting the treatment plan as needed.

, PharmD, graduated from the University of Pittsburgh School of Pharmacy, and her experience includes chain and independent pharmacy as well as medical writing and reviewing.

Articles

How to discuss CBD and answer questions frequently asked by patients 


Boosting Confidence in CBD Counseling 

Wayne Salverda, RPh, senior director of clinical services for National CooperativeRx, remembers visiting Eli Lilly and Company while in pharmacy school. “They had a crazy supercomputer working on drug design and that was 30 years ago,” he said. “About 1 in 10 drugs in development makes it to market, but companies like Vertex or Regeneron that have invested in and leveraged AI see 30% to 40% of their new molecular entities make it to market. It’s not a coincidence; it’s putting smart science and AI into drug development.” 

AI can be just as useful in medication management. Pharmacy benefit manager Prime Therapeutics worked with AI provider SAS to save clients $355 million over 18 months by consolidating and analyzing data from pharmacy, drug claims, and medical services to target fraud.

“We have gotten some good recoveries and great cost avoidances with AI,” Salverda said. “We will be able to leverage AI even more in the future to help make sure that individual patients are getting the most appropriate medications at the most appropriate dose by factoring in their specific genetics and health conditions. We’re going to see a lot of advances in pharmacogenomics with AI.”


AI is a concept, not a gadget like the robot Maria in the 1927 film Metropolis or R2-D2 in Star Wars 50 years later. “AI is nothing more than a means to an end, improving processes and improving outcomes,” said Codrin Arsene, chief marketing officer for Digital Authority Partners. “It’s just an automation of data, rules, and statistical processes that help people do their jobs more efficiently.”

When the American Society of Health-System Pharmacists (ASHP) and the American Medical Association discuss AI, they mean augmented intelligence: leveraging the strengths of computers and clinicians to improve outcomes for patients. “AI today is everywhere in pharmacy: drug discovery, drug design, drug development, trial design, participant selection, clinical decision support, drug response and risk prediction, personalized therapy, everywhere,” said Wei-Hsuan Lo-Ciganic, PhD, MS, MSPharm, associate professor in the Department of Pharmaceutical Outcomes and Policy at the University of Florida College of Pharmacy.


AI has come to pharmacy in 3 waves, noted Chenglong Li, PhD, a professor in the Medicinal Chemistry, Biochemistry, and Biophysics Department at the University of Florida College of Pharmacy (see Sidebar). Pharmacy management systems, IVR, and DUR screens are first-wave products. Second-wave AI powers some of the more advanced decision-support tools and systems that are starting to track fraud. Third-wave applications will change pharmacy in ways that are difficult to imagine, Li explained.

“AI is going to have the kind of impact we see with digital cameras,” Lo-Ciganic said. “When I was in school, people laughed at digital cameras. But when the iPhone came out, with its smart camera, the world changed. We are going to see the same kind of change in the world of pharmacy.” Lo-Ciganic is using AI to improve risk prediction for opioid misuse by linking Medicaid, human services, and criminal justice data. AI helped her identify 30 key predictors of opioid overdose.

“The methods used today can predict about 30% of opioid overdoses,” she said. “When we use our machine learning rule, we can improve to 70% to 90% accuracy for individuals who have an opioid overdose or misuse. That helps focus time and resources on the people at highest risk.”

Li’s lab modeled an enzyme that represses tumor suppressor genes and a native compound that blocks the enzyme, which allows suppressor genes to be expressed and kill the tumor. “We have a few collections of really potent compounds, maybe 10,000-fold more potent than the native compounds that work in cell culture,” Li said. “We are trying them in animal models to see if they are active in vivo.”

More changes in drug discovery are coming. In July 2021, DeepMind announced the latest version of its AlphaFold platform has identified the 3D structure of 98% of the entire human protein complement. More than 350,000 protein structures are available in a public database hosted by the European Molecular Biology Laboratory’s European Bioinformatics Institute.


AI isn’t making any of these advances on its own. AI needs human intervention as much as humans need AI.

“AI has the potential to help pharmacists improve their workflows.,” said Sophia Chhay, PharmD, assistant director of the ASHP Innovation Center. “Any pharmacist will tell you that ‘anything that gets me away from the computer and spending more time with patients is going to be an answer.”

Freeing up pharmacist time is key, said Ken Perez, vice president of healthcare policy and government a¡airs at Omnicell. The typical pharmacist spends 75% of working hours on nonclinical tasks.

“If you think about every medication as a node on a network, every drug has a journey, and where every dose goes is important,” he said. “Pharmacists spend too much time as de facto supply chain specialists, figuring out where drugs are [and] how to get them to the right patient at the right time. That time would be better spent with patients, not products. And that’s where AI can make a huge difference. The real prize of AI is helping pharmacists [to] practice at the top of their licenses, spending more time with the patients who need them the most.”


AI may shift pharmacist roles by giving them more hands-on time with patients, but don’t expect massive layoffs. “I don’t think any state board is at all comfortable with turning over critical decision-making to automation or AI,” said Lisa Schwartz, PharmD, senior director for professional a¡airs at the NCPA. “AI might make a recommendation, maybe a medication adjustment to avoid an interaction or adjusting the time of day a patient takes something, but it’s up to the pharmacist to decide what needs to be done.”


US clinicians, including pharmacists, are slow to adopt AI, Arsene noted. About 25% of European Union physicians are using voice assistants in daily practice. “For all the research that goes on, this is an industry that has a very low level of innovation and too much bureaucracy to change quickly,” he said. Arsene likened pharmacy to the financial services industry. It wasn’t until Credit Karma, Mint.intuit.com, and other new entrants began to affect customer preferences and banking profits that traditional providers moved to AI.

New entrants in pharmacy are presenting similar challenges. Kit Check uses AI to audit 100% of hospital-controlled substance use in less time than a conventional 5% random audit.

“Nobody can track controlled substances manually; there is just too much information,” said Doug Zurawski, PharmD, Kit Check’s senior vice president of clinical strategy. “We and our competitors can give you a dynamic picture of everything and everyone in your system relative to controlled substances.”

AI systems developed for the relatively closed universe of health systems can be expanded to ambulatory care and retail pharmacy, he added. On the dispensing side, InterLink-AI is expanding Rx verification by identifying every pill as it goes into a patient vial. Different versions of image-based verification can be adapted for a single pharmacy, telepharmacy, load sharing across multiple pharmacies.

“You have a clean record of the chain of custody from the raw materials used in a batch of medication through distribution of the stock bottle,” said Ram Subramanian, PhD, InterLink’s chief business officer. “But from the stock bottle on, there are questions. Verifying 100% of the pills that go into every vial optimizes the pharmacy workflow and frees up time for technicians and pharmacists. Improving the workflow puts the pharmacist in the driver’s seat regarding patient care.”

Artificial intelligence has been an integral part of pharmacy for decades. It is called the pharmacy management system: the collection of digital tools that houses patient utilization and drug data in virtually all pharmacy settings. 

Artificial Intelligence Has Come in Waves

Despite long-standing challenges, independent community pharmacies continue to fight on the front lines of the pandemic and prioritize the health of their patients. AmerisourceBergen (AB) and 

 (GNP) are committed to fighting for independents in Washington and in the states to improve and expand pharmacy practice.

During ThoughtSpot 2021, Beth Mitchell, senior director, government affairs, AmerisourceBergen, and Brian Nightengale, president, 

 to discuss current federal and state legislation affecting independent pharmacies, how pharmacists can support policies that will help advance the profession, and the ways that AB and GNP are investing and advocating on behalf of customers to protect their long-term viability.

AmerisourceBergen was the first pharmaceutical wholesale distributor to have a presence in Washington DC. Since 2004, AB’s government affairs and policy team has continuously supported issues affecting provider customers and independent community pharmacies in particular. 

“I think independent pharmacists have clearly shown, throughout the COVID-19 pandemic, just how critical and essential…they are to our health care system,” Mitchell said.

The team collaborates with legislators from both sides of the aisle and at the state and federal levels. “We work with all parties, so Republicans, Democrats, Independents in Congress, state legislatures, governors, and the administration,” Mitchell said. “I am fortunate to spend a lot of time on pharmacy legislation, which is very fulfilling because pharmacists provide such an important element of care to their communities which I have felt and seen because I grew up going to a community pharmacy in my home town in North Carolina, and this pharmacy continues to provide quality care for my parents and many friends in the community.” she added.

AmerisourceBergen and Good Neighbor Pharmacy Invest in Independents

AB and GNP recognize the unique and trusted experience independent pharmacies offer their customers and have continually supported their viability. Through the Elevate Provider Network, AB’s pharmacy services administrative organization (PSAO), the company has heavily invested in add-on services that may bolster the financial viability of independents. “We really enhanced our service offerings,” Nightengale said. “We built, with our partners, a central pay mechanism to complete cash flow visibility, incorporated pre and post-edit services so small mistakes don’t jeopardize their full reimbursement, as well as reconciliation services, where pharmacy owners can simply verify their payments. We also enabled a patient engagement center that gives owners all the data they need to focus their efforts on patients,” he added.

During the pandemic, one of AmerisourceBergen’s most significant investments centered around enlisting GNP pharmacies into the Federal Retail Pharmacy Program (FRPP), which was designed to leverage pharmacy networks to quickly disseminate COVID-19 vaccines to Americans.

“We invested heavily in personnel time, content training, education materials, and IT infrastructure to be able to do the ordering and recording [of COVID-19 vaccinations] to make sure our customers could participate in this program,” Nightengale said. “Hundreds of thousands of personnel hours, millions of dollars in hard development costs, in order to enable our pharmacies to be able to order, receive, administer, and report the vaccines back to the CDC.” The investments helped nearly 1600 GNP pharmacies in nearly every state the ability to administer COVID-19 vaccines to patients. “We have shipped more than two million vaccines to independents since the start of our program,” Nightengale said.

Federal and State Priorities for Pharmacy

Amid COVID-19 vaccination rollouts, the last several months have also been witness to a surge of legislation impacting pharmacies. “At the same time that our staff and teams are working full time on supporting customers in our network, the legislative and regulatory activity escalated quickly,” Nightengale said.

At the federal level, Mitchell explained that for pharmacists to administer COVID-19 vaccinations and be reimbursed by Medicare, the federal government had to issue several guidances under the Public Readiness and Emergency Preparedness (PREP) Act.“ At the onset of COVID-19, the AB Government Affairs & Policy team partnered with many pharmacy entities to advocate for the federal government to empower pharmacists to be able to provide COVID-19 vaccinations and additional services to patients during the pandemic, including fair reimbursement by Medicare and Medicaid.We are grateful that our advocacy efforts were successful as these federal actions had to take place for the FRPP to be successful for independent pharmacies and patients,” Mitchell said.

Mitchell also explained that many pieces of legislation pending in state legislatures and Congress aim to address big-picture issues on drug pricing. “We know that the Democrats in the House and the Senate have ideas of what they’d like to do on drug pricing, and President Biden does as well,” she said. In addition, the Department of Health and Human Services (HHS) is expected to release its drug pricing plan, per President Biden’s July Executive Order, in the next few weeks. This is an opportunity to push for policy changes that can address long-standing drug pricing and reimbursement challenges that have been affecting pharmacies.

“I think a broader focus in Washington on drug pricing provides a great opportunity for many important pharmacy priorities to be included in some of those larger packages that Congress is likely to consider this fall,” Mitchell said.

Nightengale pointed to the complex issue of reimbursement as being one of those priorities. Reimbursement issues can severely impact other facets of a pharmacy, Nightengale explained, including patient and product access. “You’ve got this balance between patient access and reimbursement, and it really hits the independents hard,” he said.

Direct and indirect PBM remuneration (DIR) fee reform is currently facing Congress, Mitchell noted. AmerisourceBergen’s pharmacy segments fully support the legislation in Congress that would give Medicare beneficiaries greater access to prescriptions and create necessary reforms that would result in fair, accurate and timely reimbursement to pharmacies. 

The Pharmacy DIR Reform to Reduce Senior Drug Costs Act

, or H.R. 3554, has bipartisan support and was introduced by Reps. Peter Welch (D-VT), Morgan Griffith (R-VA), Vicente Gonzalez (D-TX), Buddy Carter (R-GA), Raja Krishnamoorthi (D-IL), John Rose (R-TN), Abigail Spanberger (D-VA), and Diana Harshbarger (R-TN) and S. 1909 by Sens. Jon Tester (D-MT), Shelley Moore Capito (R-WV), Sherrod Brown (D-OH), and James Lankford (R-OK). 

“Even the Centers for Medicare and Medicaid Services (CMS) recognize [that] the astronomical growth of retroactive PBM DIR fees,” Mitchell said. Mitchell noted that a recent report from CMS, which was sent to Congress, found that DIR fees in Medicare have grown by more than 91,500% in the last decade.

“I think there’s no denying that this is an issue that needs to be addressed,” Mitchell said.

As senior director of government affairs, part of Mitchell’s job is to share pharmacist experiences that demonstrate the crushing impact that DIR fees can have on pharmacies and patients. “I was actually in communication with a pharmacist customer today, who is based in Ohio, on how we can work together to share some of the real-world examples that this customer is facing related to DIR fees…and how we translate that and share those examples with Congress to try to garner more support and then drive the legislation forward,” she explained.

One of the most encouraging legal and policy developments has been the Supreme Court decision in the 

Rutledge v. Pharmaceutical Care Management Association (PCMA)

 case, which involves a challenge to an Arkansas law regulating the conduct of pharmacy benefit managers (PBMs). The Supreme Court ruled that PBMs must reimburse pharmacies for generic drugs at a price equal to or higher than the pharmacies’ acquisition cost for the drug from its wholesaler.

“That decision is notable because I think it paves the way for other states to enact similar legislation or take similar regulatory action,” Mitchell said. In fact, many are already following in the footsteps of 

, according to Mitchell. “Just this year…our team has seen more than 300 bills introduced in 48 states across the country that are seeking to regulate PBMs or create some form of accountability or transparency related to PBMs,” she said.

Other relevant policies include those that aim to recognize pharmacists as providers in Medicare, according to Mitchell.

The PREP Act gave pharmacists expanded ability to serve their patients during the pandemic, particularly reaching under-resourced communities that serve Medicare patients, “these are not guaranteed permanent reimbursement infrastructure pathways, and so that is something that we’re working on with many pharmacy allies,” Mitchell said.

“There’s a renewed effort amongst the pharmacist community to really come together and advocate for some form of a permanent pharmacist provider status in Medicare,” Mitchell said. 

Even prior to COVID-19, independent pharmacies were juggling myriad challenges. The pandemic doubled down on pharmacy workflow disruptions, according to Nightengale. “You’re trying to fill prescriptions and be on the phone, counsel patients, do medication synchronization…and not being identified as an essential business by many communities – it was a huge downside,” he said. And while, in theory, the pandemic gave pharmacists the opportunity to be a bigger player in point-of-care (POC) testing, many independents faced barriers where larger chains and retailers were given opportunities. “What that did – coming back to patient access – it took away the patient’s ability to go to their normal independent pharmacy and forced them to elsewhere,” Nightengale added.

Mitchell also stressed that AmerisourceBergen is supportive of new ideas and solutions for pharmacies in all settings: independent, specialty, long-term care, hospital, chain, and retail, to develop creative and sustainable pathways for permanent Medicare reimbursement. “I think the time is now, and this is the opportunity to ensure pharmacists are recognized as providers in Medicare for critical services, such as COVID-19 and flu tests and immunizations,” she said.

AB often collaborates with the National Community Pharmacists Association (NCPA). The partnerships that AmerisourceBergen and GNP have with their customers also provide valuable support and effective advocacy for pharmacy-related policies. Pharmacy customers often reach out to Mitchell and her team asking for advice on how they can support grassroots and grasstops calls to action.

At the state level, policies related to vaccine authority are top of mind right now. AmerisourceBergen is a member of the American Disease Prevention Coalition (ADPC), an organization with the goal of improving health by eliminating restrictions on pharmacists’ authority to administer vaccines. Although all 50 states currently allow pharmacists to administer vaccines, “there are several state laws that have limitations on how or which vaccines pharmacists can administer, such as limitations based on age, consent, or physician authorization,” Mitchell explained. For pharmacies to be able to provide timely and convenient disease prevention, particularly for under-resourced patients, removing barriers is key. So far, ADPC and its members have been successful in helping to enact legislation in in several states in 2021, such as Georgia and Florida, that would remove some of those limitations.

For Mitchell, the importance of pharmacists getting involved and supporting policies that affect them cannot be understated. “At the end of the day, while we actively and directly advocate on behalf of pharmacists in Washington and the states, the pharmacist's own direct voice is the most effective because they are constituents, local business owners, voters, and health care providers in their community,” she said. 

“It’s important [for pharmacists] to be involved, because elected officials need education from subject matter experts…and the best person to do that education is the person closest to the issue. At AB, we try to create opportunities to rally our pharmacy customers to support an issue – help educate them and connect them with legislators to tell their stories,” Mitchell said.

There are many ways for pharmacists to support pharmacy legislation, such as calling their state senator, a member of Congress, or their staff, sending a handwritten letter, or writing a personalized email. No matter what it is, “continued action is vital,” Mitchell highlighted.

“It doesn’t happen overnight, but the continued involvement, the continued fight, will yield positive change,” said Mitchell.

For Nightengale, AB and GNP’s investments in independents are more than financial. “We are invested emotionally, because we believe that the best health care is delivered locally,” he said. “We are united in our responsibility to create healthier futures.”

This article was written in partnership with AmerisourceBergen and Good Neighbor Pharmacy.

AmerisourceBergen and Good Neighbor Pharmacy are working to support policies that will help advance the pharmacy profession. 

Challenges and Opportunities Facing Independent Community Pharmacies 

Pharmacists can play a key role in treating patients with ovarian cancer through counseling, drug information consults, and adherence. September is Ovarian Cancer Awareness Month and an important time to educate patients about the latest treatments and research.

 New targeted therapies known as PARP inhibitors (PARPis) used to treat patients with advanced ovarian cancer are transforming the treatment landscape through precision medicine.

PARPis are a type of targeted therapy, and there are 3 FDA-approved medications in this class taken orally for the treatment of ovarian cancer: olaparib (Lynparza), rucaparib (Rubraca), and niraparib (Zejula).

PARPis work by preventing cancer cells from repairing. The National Comprehensive Cancer Network indicates for post primary treatment that certain patients with newly diagnosed stage II-IV disease may benefit from maintenance therapy with PARPis if a complete or partial response is achieved after primary treatment with surgery and platinum-based first-line therapy.

 There also are promising drugs in the pipeline from different classes being studied for the treatment of ovarian cancer. Studies are now examining the causes of racial and ethnic disparities among women with ovarian cancer. These studies aim to examine disparities in patient care and survival.

 The ACS research programs are evaluating ovarian cancer topics such as diagnosis, prevention strategies, and effective treatment options.

One long-running study from the Dana-Farber Cancer Institute and cofunded by the Ovarian Cancer Research Alliance found that the antibiotic novobiocin can target and kill tumor cells in laboratory cell lines and tumor models with BRCA1 or BRCA2 genetic mutations. It is also effective in tumors that have become resistant to PARPis.

One recent study showed that the PARPi rucaparib is effective in treating certain types of ovarian cancers if used early in treatment, before the cancer builds resistance to chemotherapy.

 Researchers at the University of Alabama at Birmingham identified a gene called DOT1L, and inhibitors of the DOT1L enzyme could be a new approach to treating ovarian cancer.

Researchers examined patient data and found that DOT1L expression was much higher in tissues from patients with ovarian cancer compared with tissues from healthy patients.

Patients with ovarian tumors that had high DOT1L expression showed shorter progression-free survival and shorter overall survival rates compared with patients whose ovarian tumors had lower DOT1L expression.

Pharmacists’ Role in Ovarian Cancer Management

Pharmacists can aid in monitoring patients on PARPi therapy and determining the appropriate dose based on renal function, adverse reactions, and potential drug interactions. Patients with renal impairment require a dose reduction with olaparib, but not for niraparib and rucaparib.

 The starting dose for niraparib should be reduced in patients with moderate hepatic impairment, and further dose reductions may be needed.

The NCCN recommends that patients receiving PARPi therapy have careful monitoring of blood counts and renal and hepatic function.

Blood pressure monitoring is required for niraparib and recommended for all other PARPis.

Pharmacists can provide medication therapy management services, such as patient counseling, refill synchronization, and follow-up.

New targeted therapies known as PARP inhibitors (PARPis) used to treat patients with advanced ovarian cancer are transforming the treatment landscape through precision medicine.

Ovarian Cancer Treatment Update and Pharmacists' Role

Drug Topics® Journal, September 2021 Digital Edition

 will be available on drugtopics.com. Topics featured include Artificial Intelligence in Pharmacy, Ovarian Cancer, Immunization for Pneumonia, CBD Counseling, and more.

Good Neighbor Pharmacy Reflects on the Success of the Federal Retail Pharmacy Program

Good Neighbor Pharmacy (GNP) has allocated 1.9 million doses of COVID-19 vaccine to more than 1500 independent pharmacies through its partnership with the Federal Retail Pharmacy Program.

A Look Ahead at the Independent Pharmacy Landscape and How Good Neighbor Pharmacy is Responding

AmerisourceBergen and Good Neighbor Pharmacy are working to support policies that will help advance the pharmacy profession.

In Case You Missed It: Biden Pushes for Lower Drug Prices in an Executive Order

President Biden issued an executive order, with a plan unveiled today pushing the US Department of Health and Human Services to increase support for biosimilars to combat high prescription drug prices.

Here’s a preview of the featured content to watch for this week on Drug Topics®.


This Week on Drug Topics: September 13 to 17 

How To Continue to Thrive in the New Normal: Tips for Pharmacy Owners

 Hi, everyone, my name is Jennifer Shannon. I'm a clinical pharmacist and owner of Lily's Pharmacy in Johns Creek, Georgia, and a proud member of AmerisourceBergen Good Neighbor Pharmacy. And I am super excited to be here today to talk to you about the stage that independent pharmacy has been placed upon over the last year and a half.I am so, so proud to be an independent pharmacy in my community. And I'm even more proud of my colleagues across the country who have showed the world how vital our care and our services are to our community. And I think it's safe to say that never before have we been placed in such a spotlight.

Across the country, we're patient see everywhere that independent pharmacists are caring for their community, not only during the pandemic, but always in a at a different level. And I think now is also the time for independent pharmacies to really take the time not to capitalize, but to make sure patients understand all the services you provide, and how well you provide them. And even more importantly, how much you care. And I think anybody that's listening to this right now could shake their head and say, you care all day every day about your patients.

So, I wanted to give you a few tips today on how you might be able to enhance that communication with patients who are coming to your pharmacy, maybe for the first time just for a vaccine, maybe it's just because they're walking through the door, and they've never been there before. But if you're not touching them in a different manner than you normally are, you're missing out on an opportunity to show even more people how much you care. 

One thing that I wanted to impart on you today is the importance of making patient connections and being present and active as much as you can. So, during our mass vaccination clinics, we really made it a point to show patients in our community, the village that it takes to make our pharmacy move.

And so, when patients would come to get their vaccine, they would first meet my dad who would direct them where to park, then they would meet my mom who was giving vaccines, and then they would meet me and what I would do when I would get to the patient, sometimes, not only would I give them a vaccine, but I'd also give them a letter thanking them for coming to our pharmacy. And one thing that a lot of people have told me that struck them was I kept saying thank you for coming today, I hope you can be here for us the same way we are for you today.

So, make sure that you're active, you're present, and you're putting your smiling proud face out there for patients to see and know another thing I like to say is make it personal. You know, I mentioned that my whole family was involved in our vaccine program. It wasn't just our family, but it was our friends, it was our kids, teachers, it was everyone in the community came out to help us. And not only were they just here giving vaccines or helping run tickets out to cars, but they were telling those people why they love our pharmacy. 

So, when I say make it personal, don't just make it personal, because you are there, but make it personal with the people around you that support you. So maybe it's your whole pharmacy team. Maybe it's your family, and then make those connections with people in different ways.

So, I think it's really important to remember our place in our community. It's not just to hand out medicine, but it's to be here at a different level. And I think that this covid 19 pandemic has brought a whole new level of need for personal touch. So, find your personal touch and make it personal.

And finally, if you're not involved actively in a legislative manner, it's time but I would imagine many of you are involved. And so, I think it's really important to communicate that to your patients. So, take this opportunity, seize the moment, and make sure patients understand how awesome your care is. Not just today, but every day. Thank you.

Videos

Jennifer Shannon, PharmD, BCPS, owner of Lily's Pharmacy and a member of AmerisourceBergen's Good Neighbor Pharmacy®, gives tips for independent pharmacy owners to connect with their patients and enhance community outreach. 

Biden Pushes for Lower Drug Prices in an Executive Order

https://www.drugtopics.com/view/biden-pushes-for-lower-drug-prices-in-an-executive-order

Early-Stage Trials Begin for Dual COVID-19, Flu Vaccine

Novavax Incorporation announced on Monday that its combined flu and COVID-19 vaccine elicited working antibodies against the viruses in a preclinical study.

https://www.drugtopics.com/view/early-stage-trials-begin-for-dual-covid-19-flu-vaccine

Pembrolizumab Approved in China for Frontline Advanced Esophageal Cancer

The National Medical Products Administration in China has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for the frontline treatment of patients.

https://www.drugtopics.com/view/pembrolizumab-approved-in-china-for-frontline-advanced-esophageal-cancer

COVID-19 Vaccine Safe for Pregnant Women, Analysis Shows

The Centers for Disease Control and Prevention released new findings that reveal the safety of COVID-19 vaccination in pregnant women.

https://www.drugtopics.com/view/covid-19-vaccine-safe-for-pregnant-women-analysis-shows

Here’s a roundup of the latest news coverage from Drug Topics®.

News Roundup: Biden Executive Order, Vaccines for Pregnant Women

An executive order by President Joe Biden was issued, with his plan unveiled today, directing the FDA to work with states and tribes to import prescription drugs from Canada and pushing the US Department of Health and Human Services (HHS) to increase support for generic and biosimilar drugs, to combat high prescription drug prices and price gouging. 

The July 9, 2021, order encourages the Federal Trade Commission (FTC) to ban so-called pay-for-delay agreements, in which pharmaceutical manufacturers pay generic manufacturers to stay out of the market. This has raised drug prices by $3.5 billion a year, according to the fact sheet. A separate provision of the executive order also announces a policy for antitrust agencies to focus enforcement on several industries including health care. 

The order pushes the FTC to ban or limit the use of noncompete agreements in employment contracts. These agreements limit employees’ opportunities when they leave the company, and can lead to costly lawsuits. It is not clear what impact any limitations would have on physicians currently working under a noncompete agreement. 

The order also calls on the FTC to ban unnecessary occupational licensing, which limits a person’s chance to find employment across states where licensure may be different. It also encourages the FTC and the US Department of Justice to limit employers’ ability to share information on worker pay, which may amount to collusion.

 today, "the plan pushes to encourage the government to negotiate for Medicare drug costs and to pass the lower rates onto the private sector. There are three broad principles: support for price negotiation with drug manufacturers and limits on drug-price increases, promotion of industry competition and support for public and private research into new treatments."

"Other measures include drug importation programs that reduce costs. According to the plan, the HHS could collect data from insurers and third-party benefit managers to improve transparency about prices, rebates and out-of-pocket spending on prescription medications."

1. Armour S. WSJ news exclusive | Biden Administration Unveils Plan to Cut Prescription-Drug Prices. The Wall Street Journal. https://www.wsj.com/articles/white-house-unveils-plan-to-cut-prescription-drug-prices-11631181600. Published September 9, 2021. Accessed September 9, 2021

Novavax Incorporation announced on Monday that its combined flu and COVID-19 vaccine elicited working antibodies against the viruses in a preclinical study. The NanoFlu/NVX-CoV2373 vaccine elicited strong responses to both influenza A and B and protected against the SARS-CoV-2 virus.

"Seasonal influenza and COVID-19 combination vaccines will likely be critical to combating emerging COVID-19 variants," said Russell Wilson, Novavax Executive Vice President, NanoFlu General Manager.

Animals who received the combined vaccine showed heightened levels of COVID-19 antibodies two weeks after their first immunization. This increased significantly after a second dose, compared to animals that received the COVID-19 vaccine, NVX-CoV2373, alone, the company said. Novavax said it expects to start clinical studies of the combined vaccine by the end of 2021.

Novavax announces Positive Preclinical data for Combination influenza and Covid-19 Vaccine candidate. Accessed September 8, 2021. http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn%3Anewsml%3Areuters.com%3A20210510%3AnPn9tWFTsa&default-theme=true

Novavax combined influenza/COVID-19 vaccine shows promise in animal study. Reuters. Accessed September 8, 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-combined-influenzacovid-19-vaccine-shows-promise-preclinical-study-2021-05-10/ 

Novavax begins early-stage trial for Combined influenza/COVID-19 vaccine. Reuters. News Release. Accessed September 8, 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-begins-early-stage-trial-combined-influenzacovid-19-vaccine-2021-09-08/ 

Early-Stage Trials Begin for Dual COVID-19, Flu Vaccine 


Gina Mauro is your lead editorial contact for 

. She joined the company in 2015 and has held various positions on 

; she is also the on-air correspondent for 

. Prior to joining MJH Life Sciences, she worked at Gannett as a full-time reporter with the Asbury Park Press. Email: gmauro@onclive.com

The National Medical Products Administration in China has approved pembrolizumab (Keytruda) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or gastroesophageal junction (GEJ) cancer.

The approval is based on findings from the phase 3 KEYNOTE-590 trial (NCT03189719), in which pembrolizumab demonstrated a statistically significant improvement in progression-free and overall survival (OS) vs 5-fluorouracil (5-FU) and cisplatin alone in this patient population. The median OS was 12.4 months (95% CI, 10.5-14.0) with pembrolizumab compared with 9.8 months (95% CI, 8.8-10.8) for chemotherapy alone (HR, 0.73; 95% CI, 0.62-0.86; 

Additionally, the median progression-free survival (PFS) was 6.3 months (95% CI, 6.2-6.9) and 5.8 months (95% CI, 5.0-6.0), respectively, in the overall population.

“Compared to the rest of the world, China has a disproportionate number of patients who are diagnosed with and who die from esophageal cancer, the fifth most commonly diagnosed cancer and the fourth leading cause of cancer-related death in the country,” said Shen Lin, MD, vice president, Clinical Oncology, Beijing Cancer Hospital and Peking University, and deputy director, Beijing Institute for Cancer Research in China. “This approval for Keytruda provides an important new option to patients with advanced esophageal carcinoma in China who currently have limited available treatment options in the first-line setting.”

Safety findings of 51 Chinese patients with esophageal carcinoma enrolled on the study showed that the profile of pembrolizumab in this population was consistent with prior safety data with the PD-1 inhibitor.

Pembrolizumab is also approved in China as a second-line treatment for select patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (≥10).

In the multicenter, double-blind, placebo-controlled KEYNOTE-590 trial, 749 patients with locally advanced unresectable or metastatic esophageal or GEJ carcinoma (Siewert type I) who were ineligible for surgery or definitive chemoradiation were randomized 1:1 to receive cisplatin at 80 mg/m2 on day 1 every 3 weeks for up to 6 cycles plus 5-FU at 800 mg/m2 daily on days 1 to 5 every 3 weeks, with or without pembrolizumab at 200 mg on day 1 every 3 weeks. 5-FU could also be given per local standard for up to 2 years. All treatment was given intravenously.

To be eligible for enrollment, patients had to have metastatic esophageal cancer or esophageal squamous cell carcinoma, be treatment naïve, have an ECOG performance status of 0 or 1, and have measurable disease. Patients were stratified based on region (Asia vs non-Asia), disease (ESCC vs esophageal cancer), and performance status (0 vs 1).

The primary end points were investigator-assessed PFS and OS via RECIST v1.1 criteria in the overall study population, in those with PD-L1 expression (combined positive score ≥10), and in those with squamous histology. Secondary end points included investigator-assessed objective response rate and duration of response.

“In China, esophageal and gastroesophageal junction cancers are leading causes of death, and there have been few treatment advances for patients over the past several decades,” said Scot Ebbinghaus, MD, vice president, clinical research, Merck Research Laboratories, the developer of pembrolizumab. “With this approval of Keytruda plus chemotherapy – the first for an anti-PD-1 regimen in the first-line setting – we can now provide patients with an immunotherapy treatment option earlier in the course of treatment that has been shown to significantly improve survival.”

In March 2021, the FDA approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation. The decision was also based on the phase 3 KEYNOTE-590 findings.

Merck’s KEYTRUDA® (pembrolizumab) Approved in China in Combination With Chemotherapy for First-Line Treatment of Patients With Locally Advanced Unresectable or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma. News release. Merck. September 7, 2021. Accessed September 7, 2021. https://bit.ly/3kXmZeC

Kato K, Sun J-M, Shah MA, et al. Pembrolizumab plus chemotherapy versus chemotherapy as first-line therapy in patients with advanced esophageal cancer: the phase 3 KEYNOTE-590 study. 

. 2020;31(suppl 4):S1192-S1193. doi:10.1016/j.annonc.2020.08.2298

 Hi, my name is Beth Mitchell and I'm senior director of government affairs at AmerisourceBergen.

The power and the impact of independent pharmacy has been on full display throughout the pandemic as independent pharmacists maintain consistent care for patients and helped create equitable access to COVID-19 vaccines and tests. There has never been a more important time for independent pharmacists to get their voices heard by lawmakers and knowing where to start is often one of the biggest hurdles to overcome when engaging in advocacy at the local, state, or federal level.

So, I'd like to share 3 tips for pharmacists to consider to advocate for pro pharmacy legislation.

Tip 1 – Position yourself as a resource and tell your story

The first tip for pharmacists is, when meeting with an elected official - whether it's state or federal - definitely take the approach of positioning yourself as a resource and tell your story.

Legislators and their staff deal with hundreds of bills every legislative session, and every Congress, on a variety of policy topics. And they also have to serve and be a representative to thousands of constituents. Given the sheer number of issues that legislators work on and that they represent, care about, it's next to impossible for every elected official to be an expert on every piece of health care legislation.

However, pharmacists are in a unique position because pharmacists can help position themselves as the subject matter expert on pharmacy, medication, and reimbursement issues. And as health care subject matter experts, pharmacists really know the intricacies of their industry and the regulations that govern what they do. And I think that puts pharmacists in a very unique position to offer the insight, explanations, and technical information on pharmacy and many health care issues that an elected official really needs to hear in order to make an informed decision on a piece of legislation or public policy.

Independent pharmacist also have an incredible story and a wealth of knowledge to share with legislators. They're obviously an incredibly accessible point of health care in our country. And independent pharmacists have also proven themselves as essential health care destinations throughout the COVID-19 pandemic.

In addition to that, independent pharmacists are voters in their state or local community and constituents of several elected officials, so they have that unique perspective that a lot of health care experts don't have because they're not only providing care directly to the patient, seeing their patients and knowing them every day, but they're also coming from a voter and a constituent perspective, in addition to having that expertise in health care.

I think pharmacists, when they take the time to really highlight their real world experiences and share stories with elected officials about issues, that they'll find a highly receptive audience in elected officials. If a pharmacist is preparing for an upcoming meeting with a legislator, whether it's local, state, or federal, I would really encourage the pharmacist to do their homework before the meeting and come prepared with facts and data on whatever the policy topic may be, so that they can show the legislator their expertise and help to build that trust and relationship with the elected official.

Doing that homework ahead of the meeting will also help to make your advocacy arguments that much stronger. Being prepared with real world, real life stories that you can share with an elected official on a topic that you care about and helping connect that back to the elected official about why those legislative issues important to them – sharing examples of a real world scenario in your pharmacy that impacted you or impacted your patients, having data related to percentage of Medicare, Medicaid population you share – doing all of that homework and taking the approach of positioning yourself as a resource will really go a long way and help to make your advocacy arguments and your presence that much more effective.

Tip 2 – Do your homework and be clear with your ask

In an exclusive interview with Drug Topics, Beth Mitchell, senior director of government affairs at AmerisourceBergen, explores the ways that pharmacists can take action on legislation that affects their practice. 

Three Actions to Advocate for Pro-Pharmacy Legislation

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CBD Legislation Remains in Limbo

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