Oliceridine (Olinvyk; Trevena, Inc) is an intravenous (IV) opioid agonist indicated in adults for management of acute severe pain in a hospital or controlled clinical setting.

Oliceridine should only be used in patients who require an IV opioid analgesic and for whom alternative treatments are inadequate.

 Oliceridine is a novel μ-opioid receptor ligand with reduced β-arrestin recruitment.

 β-Arrestin signaling is thought to contribute to opioid-related adverse events (AEs) seen with conventional opioids.

 Common opioid-related AEs include nausea, vomiting, constipation, and respiratory depression.

 Oliceridine is intended to be an opioid with an improved respiratory safety profile and reduced incidence of nausea and vomiting. Controlled substance schedule for oliceridine is pending.

The APOLLO-1 and APOLLO-2 trials evaluated the efficacy and safety of oliceridine for acute pain following bunionectomy and abdominoplasty, respectively.

 In both trials, patients received a loading dose of either placebo, oliceridine (1.5 mg), or morphine (4 mg), followed by demand doses via patient-controlled analgesia (0.1, 0.35, or 0.5 mg oliceridine, 1 mg morphine, or placebo). The primary end point for both trials was the proportion of treatment responders to oliceridine compared with placebo. In APOLLO-1, oliceridine was shown to be an effective analgesic with responder rates of 50%, 62%, and 65.8% in the 0.1 mg, 0.35 mg, and 0.5 mg regimens, respectively, compared with 15.2% for placebo (all P < .0001).

 Oliceridine was also shown to be effective in APOLLO-2 with responder rates of 61%, 76.3%, and 70.0% for 0.1 mg, 0.35 mg, and 0.5 mg regimens, respectively, compared with 45.7% for placebo (all P < .05).

In both trials, the composite measure of respiratory safety burden was not statistically different from morphine; however, APOLLO-1 patients in the 0.1-mg and 0.35-mg regimens had a significantly lower risk of experiencing a respiratory safety event when compared with morphine.

 Of the 3 oliceridine regimens, 0.35 mg and 0.5 mg were shown to be noninferior to morphine at achieving treatment response in both trials.

The most commonly reported AEs for oliceridine were nausea, vomiting, headache, and dizziness.

 The proportion of patients experiencing 1 or more gastrointestinal-related AEs increased in a dose-dependent manner across the 3 oliceridine regimens.

 In APOLLO-1, the proportion of gastrointestinal-related AEs ranged from 40.8% to 70.9% in the oliceridine regimens compared with 24.1% for placebo and 72.4% for morphine.

The recommended initial dose is 1.5 mg given IV.

 Onset of analgesic effect is expected within 2 to 5 minutes after initial dose.

 Supplemental doses of 0.75 mg can be administered 1 hour after the initial dose and as needed hourly thereafter.

 For patient-controlled analgesia (PCA), the recommended demand dose is 0.35 mg, with a 6-minute lock out. The cumulative daily dose should not exceed 27 mg due to risk of QT prolongation. Oliceridine 1 mg is approximately equipotent to morphine 5 mg.

 Oliceridine is available as single-dose 2 mL (1 mg/mL) vials and as 30 mg/30 mL (1mg/mL) vials for PCA use only.

Patients with decreased cytochrome P450 2D6 function, patients taking a moderate/strong cytochrome P450 3A4 (CYP3A4) inhibitor, or patients who have very recently discontinued a CYP3A4 inducer are at risk of increased plasma concentrations of oliceridine.

1. Olinvyk. Prescribing information. Trevena Inc; 2020. Accessed August 31, 2020. 

https://olinvyk.com/docs/OLINVYK-FINAL-LABEL-07Aug2020.pdf

2. FDA approves new opioid for Intravenous use in hospitals, other controlled clinical settings. News release. FDA. August 7, 2020. Accessed August 31, 2020. 

https://www.fda.gov/news-events/press-announcements/fda-approves-new-opioid-intravenous-use-hospitals-other-controlled-clinical-settings

3. Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. 

4. Singla NK, Skobieranda F, Soergel DG, et al. APOLLO-2: a randomized, placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate to severe acute pain following abdominoplasty. 

. 2019;19(7):715-731. doi:10.1111/papr.12801 

Articles

Oliceridine (Olinvyk; Trevena, Inc) is an intravenous opioid agonist indicated in adults for management of acute severe pain in a hospital or controlled clinical setting.

Oliceridine (Olinvyk) Offers New Treatment Option for Acute Pain Management in Hospitals and Controlled Clinical Settings

The high school football teams in our area are playing football. Only 250 people are allowed in the stands, including the team, coaches, cheerleaders, band, and parents. Everyone is frustrated. Kids have sacrificed their teen years in the weight room, on the practice field, and in the classroom preparing for their time to shine on the gridiron. Risks versus benefits. Kids playing football regularly have risks of concussion, strains, sprains, and broken bones.

To a kid, the risk is worth the benefits of participating in a team sport and possibly getting their chance to be a “star.” Ask any 9th grader’s parents about the benefits of their kid playing football and you will hear in the conversation the chance of a college scholarship.

Our society seems willing to take a risk if it sees benefits. Immuniza-tions, for example, have a very slight risk but great benefit. Antivaxxers focus on the miniscule risks and pay no attention to the benefits. My mom, who had many friends affected by 

polio in the 1930s and 1940s, marched all 4 of us to the high school to get our dose of Sabin oral polio vaccine when it became available in the early 1960s. Mom knew the benefits.

My dad, a World War II veteran, like millions of others, risked his life for the benefit of his country serving in the US Army. What he witnessed in the European Theater of action, from Northern Africa, Anzio beach, Rome, and Germany was so horrific that he never shared it with his kids. Dad knew the benefits. Back home, the citizens of our country were called upon to ration fuel, sugar, tires, steel, and other necessities for the war effort. A collective effort was made for the common good. They were referred to as the “greatest generation.” The country knew the benefits.

And now, we are asked to wear a cloth face covering, to not only protect ourselves but also to protect oth- ers during the coronavirus disease 2019 (COVID-19) pandemic. I work
in the pharmacy for nearly 9 hours each day and wear my mask the entire time I’m near anyone. Do the masks help? We got off to a rocky start 

with masking when the CDC recommended not wearing them in February and early March. On April 24, the CDC officially recommended wearing a mask. However, folks that choose not to wear the mask simply point to the February recommendations.

On the other end of the spectrum are the “mask police,” who want to call out everyone at the pharmacy who removes their mask, even for a brief moment. Yes, one of my customers did that, stating, “The workers could cough and get COVID all over my pills.” The plastic barrier, the sanitizing of the surfaces every hour, and the abundance of hand sanitizer were not enough.

I’d like to offer a proposal to those mask police out there. Whether you are in academia or management, I’d like all licensed pharmacists to join in unity on October 30 to support their brothers and sisters in community pharmacy by wearing a mask for the entire work day. We community pharmacists will even let you take yours off to eat lunch!

In the absence of rock-solid data to the contrary, wearing a mask seems to be a small sacrifice to protect each other’s health. One of the wiser health care practitioners I work with offered this: “We as a country do not have the collective grit to make large-scale sacrifices for the greater good of the society.” Big benefits...I’m not sure, but definitely a very small risk.

In the absence of rock-solid data to the contrary, wearing a mask seems to be a small sacrifice to protect each other’s health.

Mask Wearing: A Small Sacrifice for the Greater Good

October is Breast Cancer Awareness Month, and it is important to educate patients about early detection, treatment, and pain management strategies for the second-most-common cancer in women in the US.

Current breast cancer treatment strategies include surgery, radiation, chemotherapy, hormone therapy, and targeted therapy.

 Adding targeted therapies to hormone therapy is a new strategy for advanced or metastatic hormone receptor–positive breast cancer to extend time until chemotherapy and prolong survival.

 Various early detection and treatment research programs are underway to develop enhanced technologies and novel therapies for breast cancer.

 Unfortunately, approximately 70% to 90% of individuals with metastatic breast cancer experience chronic pain.

 Breast cancer pain may be caused by the disease or result from surgery and treatments.4 Pharmacists can play an important role in breast cancer pain management through pharmacological therapy and integrative strategies.  

One systematic review revealed the following posttreatment results for prevalence of persistent pain in patients with breast cancer: postsurgery (29.8%), postradiotherapy (27.3%), and postcombination therapy (21.8%).

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Adult Cancer Pain recommend the following “5 A’s” of outcomes for pain management goals:

Activities: Optimize activities of daily living.

Aberrant drug taking: Avoid opioid misuse.

Affect: Understand relationship between pain and mood.

Different types of pain include chronic, acute, and breakthrough (sudden increase in pain even while receiving pain medication). An interdisciplinary approach can help ensure patients are appropriately managed.

Patients experiencing mild pain should first receive nonopioids such as acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs).

 It is important to educate patients receiving prescription opioids with acetaminophen to avoid taking any OTC products with the same active ingredient to prevent liver toxicity. Individuals should take the lowest effective dose of NSAIDs (eg, ibuprofen, naproxen) for the shortest duration, as many oncology patients may be at high risk for renal, gastrointestinal, cardiac, and bleeding AEs.

Radiation therapy usually affects the skin, which can be similar to a severe sunburn resulting in redness, tenderness, blisters, and peeling.

 Patients should bathe and shower daily using warm water and a mild unscented soap, rinse the skin well, and pat with a dry, soft towel. Patients should use moisturizers when starting treatment to minimize any skin reactions and should select ones without fragrances or lanolin.

Supplemental doses of analgesics should be given prior to procedures to minimize pain. Anxiolytics such as midazolam, lorazepam, or alprazolam can be given 30 to 60 minutes before a procedure to manage anxiety symptoms.

 Patients should be counseled to avoid driving or operating machinery when taking these medications.

Individuals experiencing moderate-to-severe pain can receive opioid therapy for breast cancer pain, which should be initiated at the lowest effective dose that controls pain with the fewest AEs. Patients who are opioid naïve experiencing pain intensity greater than or equal to 4 or less than 4 but whose pain is not being adequately controlled can be started on a dose of 5 to 15 mg of oral morphine sulfate or 2 to 5 mg of intravenous morphine sulfate or equivalent. Opioid options include oxycodone immediate release, hydrocodone with acetaminophen, and hydromorphone. If 4 or more doses are needed per day, then a long-acting opioid can be added. Opioid dose reductions (reduce by 10%-20%) can be considered for patients that rarely need breakthrough medication, have managed an acute pain event, or experienced pain control through a nonopioid therapy.

Patients should be monitored closely for opioid-related AEs including constipation, nausea and vomiting, pruritus, delirium, respiratory depression, motor and cognitive impairment, and sedation, especially when initiating and titrating therapy.

 Individuals receiving opioid therapy should be counseled to take laxatives to prevent constipation. When higher opioid doses are needed, then patients should be switched from combination products (including acetaminophen or aspirin) to pure opioids to reduce the risk of toxicity.

Opioid-tolerant patients are defined as those receiving at least 25 mcg/hour fentanyl patch, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.

 It is important to note that transdermal fentanyl should not be used for rapid opioid titration and should only be initiated after pain is managed by other opioids in opioid-tolerant patients. Fentanyl is typically the treatment of choice for individuals who are unable to swallow, patients with poor tolerance to morphine, and those with compliance issues.

Opioids should be administered on a regular schedule for continuous pain with supplemental doses for breakthrough pain. Tramadol and tapentadol are atypical opioids and should be used with caution or avoided in patients taking other serotonergic or monoamine oxidase inhibitor–like medications due to an increased risk of serotonin syndrome.6 Methadone should be reserved for the management of chronic, not acute, pain and should not be titrated more frequently than every 5 to 7 days or longer, usually by 5 mg/dose or less.

An electrocardiogram should be considered before patients start methadone, and it’s recommended to be performed prior to therapy in individuals with risk factors for corrected QT interval (QTc) prolongation (eg, taking medications that also prolong the QTc interval).

 Pharmacists should educate patients on the importance of storing opioids out of reach of children in a locked area and on appropriately disposing these medications if unused or expired. 

Antidepressants and anticonvulsants are frequently used as adjuvant analgesics in combination with opioids for the treatment of neuropathic pain. Tricyclic antidepressants (eg, amitriptyline, imipramine, nortriptyline, desipramine) can be used as adjuvant therapy; however, individuals should be assessed for any cardiac issues prior to initiating treatment because these agents can cause QTc prolongation.

Selective serotonin-norepinephrine reuptake inhibitors (SSNRIs) (eg, duloxetine, venlafaxine) are common adjuvant analgesics, and evidence supports the use of duloxetine for chemotherapy-induced peripheral neuropathy. Some clinical studies have shown an increased risk of breast cancer recurrence in patients treated with tamoxifen (treatment for hormone receptor–positive breast cancer) who are also taking selective serotonin reuptake inhibitors (SSRI) or SSNRI antidepressants versus those receiving tamoxifen monotherapy. The proposed mechanism of action is that SSRI and SSNRI antidepressants may inhibit the conversion of tamoxifen to its active metabolite, which can decrease the efficacy of tamoxifen. If concomitant use of an SSRI is required in a patient receiving tamoxifen, then a mild cytochrome P450 2D6 inhibitor (sertraline, citalopram, venlafaxine, escitalopram) should be used over a moderate-to-potent inhibitor (paroxetine, fluoxetine, fluvoxamine, bupropion, duloxetine).

Gabapentin and pregabalin (Lyrica) are common anticonvulsants used as adjuvant analgesics. Gabapentin can reduce mucositis pain in patients receiving concomitant radiotherapy and chemotherapy. Patients with renal insufficiency should receive dose adjustments for gabapentin and pregabalin. Corticosteroids (eg, dexamethasone) can also be used as adjuvant agents to reduce swelling and manage pain. These medications should generally be taken in the morning to prevent nighttime insomnia. Topical agents (eg, lidocaine patch) can be applied daily as an adjuvant analgesic.

Evidence suggests that in addition to pharmacologic interventions, integrative therapies can also be used for pain management, including physical therapy, exercise, heat and/or ice application, psychological services, massage, meditation, and yoga.

Applying heat can help relieve muscle soreness, whereas cold can decrease pain by numbing the area. It is important to avoid applying cold or heat over any area where patients are receiving radiation therapy and for 6 months after treatment has ended. Physical therapy is especially important for patients undergoing radiation therapy for range-of-motion arm exercises to prevent scar tissue from forming. And because anxiety and depression can worsen pain, joining an emotional support group may help alleviate these symptoms.

Breast Cancer Awareness Month. National Breast Cancer Foundation Inc. Accessed August 26, 2020. 

https://www.nationalbreastcancer.org/breast-cancer-awareness-month

How common is breast cancer? American Cancer Society. Updated January 8, 2020. Accessed August 26, 2020. 

https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html

Advances in breast cancer research. National Cancer Institute. Updated June 18, 2020. Accessed August 27, 2020. 

https://www.cancer.gov/types/breast/research

Breast cancer pain. Cleveland Clinic. Updated February 9, 2019. Accessed August 27, 2020. 

https://my.clevelandclinic.org/health/diseases/9006-breast-cancer-pain

Wang K, Yee C, Tam S, et al. Prevalence of pain in patients with breast cancer post-treatment: a systematic review. 

. 2018;42:113-127. doi:10.1016/j.breast.2018.08.105 

NCCN. Clinical Practice Guidelines in Oncology for Adult Cancer Pain, version 1.2018. Accessed August 28, 2020. 

https://www.nccn.org/professionals/physician_gls/pdf/pain.pdf

Skin care guidelines while you are receiving radiation therapy. Memorial Sloan Kettering Cancer Center. Updated December 12, 2018. Accessed August 29, 2020. 

https://www.mskcc.org/cancer-care/patient-education/skin-care-guidelines-patients-receiving-radiation-therapy

Non-medical treatments for pain. American Cancer Society. Updated January 3, 2019. Accessed August 29, 2020. 

https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/pain/non-medical-treatments-for-cancer-pain.html

Pharmacists are uniquely qualified to ensure patients receive sufficient pain relief.

Breast Cancer Pain Management Options

The common cold may be considered a mild illness, but the runny nose, congestion, sneezing, cough, sore throat, headache, and other symptoms that come along with it can make people feel miserable. OTC products to treat upper respiratory infections are not a cure; at best, they provide temporary symptom relief. And yet, US consumers, desperate for reprieve from cold-related discomfort, spent more than $9 million last year on these products, according to the Consumer Healthcare Products Association.

Pharmacists play an important role in helping patients choose the appropriate OTC product based on patient characteristics and specific cold symptoms.

Although a plethora of OTC cough and cold medications are on phar- macy shelves, many of them are very similar. Most oral cold medications contain a combination of some or all of the following active ingredients:

Acetaminophen for relief of fever, sore throat, headache, and body aches

Decongestant phenylephrine for the relief of nasal congestion and runny nose

A first-generation antihistamine such as diphenhydramine, pheniramine, chlorpheniramine, or brompheniramine to reduce postnasal drip and help with sleep

Expectorant guaifenesin, which thins mucous secretions in respiratory passages so they can more easily be coughed up

Various products are available in tablet and/or syrup form. Some products, such as the Theraflu line, are available as packets of powder to be mixed into a hot drink—an added benefit because hydration, particularly with hot liquids, helps relieve cold symptoms. Nasal sprays are also an option; some nasal sprays contain decongestants such as oxymetazoline and phenylephrine, whereas saline nasal sprays serve to simply moisten the nasal passages to reduce irritation.

Although most combination drugs contain the same basic active ingredients, the number of different formulations on the shelf can be dizzying. Various brand names such as Mucinex, Robitussin, and DayQuil/ NyQuil each include several different products for relief of different symptoms. Descriptors can include “cough and cold,”“cold and flu,” and 

“cough and chest congestion”—sometimes with the word “severe” thrown in for good measure. Many of these are available in daytime and nighttime formulations, which are often packaged together in 1 box.

Mainstay ingredients for daytime cold and flu formulations are usually acetaminophen for fever and pain, phenylephrine for congestion, dextromethorphan for cough suppression, and guaifenesin for loosening secretions. Nighttime formulations for cold and flu typically omit guaifenesin, which can increase coughing, replacing it with dextromethorphan to suppress the cough or an antihistamine to promote drowsiness.

But never make assumptions about what’s in a particular product—the active ingredient or its dosage. For instance, although most combination products contain 325 mg of acetaminophen, some contain 650 mg. Dosages of dextromethorphan and guaifenesin also vary among products. Always check the label to be sure.

Although young children are notorious for frequently acquiring colds, they are not always the best candidates for treatment with OTC cold medicines. The FDA states that OTC cold medicines containing decongestants or antihistamines should not be used for children under aged 2 years, as they can cause serious adverse effects (AEs).

 The American Academy of Pediatrics (AAP) states that OTC cold medications should not be used in children under aged 4 years due to the risk of dangerous AEs; research has shown little benefit in children under aged 6 years.

Various products are designed for children, and most state on the packaging that they are for children aged 6 years and older. Children under 12 years of age should not take adult formulations of cough and cold medications, as the dosages may be inappropriate for them.

Caution parents buying pediatric products to keep them out of children’s reach, as accidental, unsupervised ingestion is a leading cause of AEs with these drugs.

For children who should not or prefer not to take OTC medications, the AAP recommends using cool mist humidifiers and administering saline nose drops, with a nasal aspirator for infants. Mentholated rubs can help soothe nighttime coughs, and single-ingredient acetaminophen or ibuprofen can be used for fever. There is evidence of honey providing relief for upper respiratory infections, and it is a safe option for children older than 1 year. Babies under 1 year of age should never be given honey due to risk of infant botulism. The AAP recommends half a teaspoon of honey for children aged 1 to 5 years, 1 teaspoon of honey for children aged 6 to 11 years, and 2 teaspoons of honey for children aged 12 years and older. Parents should be cautioned to brush the children’s teeth after taking honey before bedtime.

Patients’ awareness of what is contained in the OTC combination cold medications they’re taking is key to ensuring that they don’t accidentally overdose. They should especially be cautioned not to take more than 1 acetaminophen-containing product at a time, as acetaminophen overdose is a leading cause of acute liver failure. Although historically the maximum daily dose of acetaminophen was 4000 mg, the makers of Tylenol have lowered the maximum daily dose of single ingredient Tylenol to 3000 mg/day to promote safe use of acetaminophen products.

Since systemic and nasal decongestants work by causing vasoconstriction, they can worsen conditions such as hypertension, glaucoma, and benign prostatic hyperplasia. Patients with these conditions should be directed to formulations labeled “HBP” for high blood pressure or any other products that do not include decongestants.

Special care should be taken for patients taking monoamine oxidase (MAO) inhibitors, as they interact with several components of cough and cold medications. The use of decongestants with MAO inhibitors can cause hypertensive crisis, and dextromethorphan with MAO inhibitors can cause serotonin syndrome.

Patients should be reminded that nighttime formulations containing antihistamines cause drowsiness, so they should only be taken at bedtime—not before driving a vehicle or operating dangerous machinery.

Because there is so much variability between products, reading labels for cough and cold medications is essential to making proper patient-specific recommendations. For example, while Corcidin HBP and DayQuil HBP are similar in that neither contain decongestants, they do not contain the same ingredients; Corcidin HBP Cold & Flu contains acetaminophen and chlorpheniramine, whereas Dayquil HBP Cold & Flu contains acetaminophen and dextromethorphan.

Suffixes can be confusing. Although HBP in a drug name indicates that it is safe for patients with high blood pressure, the DM in some Robitussin products does not indicate that they are formulated for patients with diabetes mellitus. Instead, the DM in those products indicates that they contain dextromethorphan. Patients with diabetes should be directed to cough formulations that do not contain glucose, such as Diabetic Tussin. And the CF in other Robitussin products stands for cough/cold formulation, although those products also contain dextromethorphan.

Careful consideration may sometimes lead to the conclusion that patients might be better off with
a single ingredient drug, such as acetaminophen, ibuprofen, or a second-generation antihistamine.

OTC sales by category 2016-2019. Consumer Healthcare Products Association. Accessed September 10, 2020. 

Use caution when giving cough and cold products to kids. FDA. Updated February 8, 2018. Accessed September 10, 2020. 

https://www.fda.gov/drugs/special-features/use-caution-when-giving-cough-and-cold-products-kids

Caring for your child’s cold or flu. HealthyChildren. Updated April 19, 2019. Accessed September 10, 2020. 

https://www.healthychildren.org/English/safety-prevention/at-home/medication-safety/Pages/How-to-Manage-Colds-and-Flu.aspx

Green JL, Wang GS, Reynolds KM, et al. Safety profile of cough and cold medication use in pediatrics. 

Tylenol dosage for adults. Tylenol. Accessed September 10, 2020. https://www.tylenol.com/safety-dosing/usage/dosage-for-adults

Cold versus flu. CDC. Updated August 31, 2020. Accessed September 14, 2020. 

https://www.cdc.gov/flu/symptoms/coldflu.htm

Similarities and differences between flu and COVID-19. CDC. Updated August 31, 2020. Accessed September 14, 2020. 

https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm

Help patients with upper respiratory infections choose an OTC product that’s right for them.

Combatting the Common Cold

The correlation between obesity and various diseases (eg, cardiovascular disease, certain cancers, diabetes, etc) points to a growing public health crisis. Obesity is a leading risk factor for developing type 2 diabetes, thus offering tremendous opportunity for pharmacists to improve patient outcomes.

Patients now have a variety of options to help them lose weight. These include pharmaceuticals, invasive surgeries, minimally invasive implants and devices, and lifestyle modifications such as diet and exercise.

 Similarly, health and wellness services in pharmacy have surged in recent years, with pharmacists offering a variety of specialized services to support their patients’ needs.

Although counseling patients at the time of medication dispensing seems the most obvious time to educate on weight-focused wellness, it is frequently not practical.

Some pharmacists carve out time slots dedicated to addressing individual patients’ needs by scheduling appointments. Planning is key, according to Christina Madison, PharmD, FCCP, AAHIVP, founder and CEO of The Public Health Pharmacist and associate professor of pharmacy practice at Roseman University of Health Sciences in Las Vegas, Nevada.

Madison describes the ideal scenario as a private space where the pharmacist has allotted 15 to 20 minutes during an off-peak period. She encourages pharmacists to document the encounter and follow up with the patient, which includes recording the patient’s weight before the encounter and at follow-up.

Richard Harris, MD, PharmD, MBA, founder of Great Health and Wellness in Houston, Texas, noted that some pharmacists use these assigned times to conduct wellness checks, review medications, or discuss other issues the patient may be facing.

“There are some pharmacists and pharmacies that offer specific weight- loss programs,” Harris said. “They’ll do functional medicine, which is getting to the root cause of the issues, as well as holistic, lifestyle, or integrative medicine.”

Brian Bisher, PharmD, BCPS, a clinical pharmacist and an Institute for Integrative Nutrition–certified health coach in Cincinnati, Ohio, works at an area hospital that provides some of these services.

“I would label our clinic as a pharmacy-run service that offers weight-loss/nutrition services,” he said. “We set aside 30- to 60-minute appointments specifically for diabetes patient care management in our outpatient wellness clinic.”

Bisher’s clinic sometimes recruits a registered dietician as well. However, unlike some community practice settings, patients cannot receive such services without a referral from their physician.

According to Harris, many pharmacies that offer these specialized services also carry high-quality, pharmaceutical-grade supplements—a feature he feels is critical, given the fact that OTC dietary health supplements are not regulated to the same degree of stringency as prescription pharmaceutical products.

“These are high-quality supplements you can trust,” Harris said of the supplements typically carried at pharmacy wellness centers. “There are plenty of these wellness centers out there, and the pharmacies that have these wellness centers are the ones I highly recommend people seek.”

Although they had different opinions about which supplements to stock in the pharmacy, Harris and Bisher did agree on a few products, namely, berberine. “Berberine is a supplement that can be used in place of metformin to start if a patient would prefer to use herbal therapy,” Bisher explained.

Results of a 2012 meta-analysis and systematic review concluded that berberine effectively treated hypoglycemia

 However, more studies are needed to evaluate the safety of berberine in long-term use.

Berberine is an isoquinoline alkaloid compound isolated from rhizoma coptidis. Its hyperglycemia-mitigating effects were first documented in 1988 when it was used to treat diarrhea in patients with diabetes, and the extract’s antidiabetic potential has since been studied in a variety of clinical trials.

However, a search in ClinicalTrials.gov using the key words “berberine” and “diabetes mellitus type 2” only resulted in 5 studies on berberine. Two of those studies explored the compound’s effect on diabetes (NCT02084004 and NCT00425009). The first study was withdrawn, and the second study was completed in December 2004.

A different trial helped illustrate berberine’s clinical potential. The pilot study was divided into 2 studies with the goal of evaluating the safety and efficacy of berberine in patients with type 2 diabetes.

In study A, 36 adults who had received a recent diagnosis of type 2 diabetes were randomly assigned to receive either berberine or 0.5 g of metformin 3 times per day for 3 months. Berberine’s hypoglycemic activity mirrored that of metformin with statistically significant decreases in hemoglobin A1C (HbA1c; from 9.5% ± 0.5% to 7.5% ± 0.4%; P < .01). Patients in the berberine arm also experienced significant decreases in fasting blood glucose (FBG), postprandial blood glucose (PBG), and plasma triglycerides.

Forty-eight patients with poorly controlled type 2 diabetes were enrolled in the second study (study B) and received berberine supplements for 3 months. Similarly, biomarkers for blood sugar improved. FBG and PBG improved within 1 week and HbA1c dropped (from 8.1% ± 0.2% to 7.3% ± 0.5%; P <.0001).

Although patients in the berberine arm did not lose weight, they experienced a redistribution of body fat. However, some data suggest that, like metformin, berberine may result in weight loss.

Despite the supplement’s benefits, Bisher does not foresee berberine replacing metformin.

In addition to berberine, Harris and Bisher also recommended stocking the following supplements that may help patients with weight management:

Magnesium: This mineral is responsible for more than 300 biochemical reactions in the body and an important cofactor for energy generation and metabolism.

Zinc: “Zinc deficiencies are associated with metabolic derangments,” Harris said.

Chromium: This mineral helps the body process sugars and facilitate insulin’s activity.

Vanadium and cinnamon help improve insulin sensitivity.

Patients now have a variety of options to help them lose weight, and pharmacists can offer a variety of specialized services to support their patients’ needs.

Pharmacists Offer Tips on Weight Management in Diabetes

Scope of practice and vaccination authority don’t usually grab much public attention. But when the US Department of Health & Human Services (HHS) preempted state practice acts to allow all pharmacists to order and provide coronavirus disease 2019 (COVID-19) tests and provide routine pediatric immunizations, the profession hit the headlines. What happens next in health care depends largely on COVID-19, especially in light of the breaking news at press time that the President has been diagnosed with COVID-19. And then, of course, on the 2020 presidential election itself. 

Presidential candidates regularly trade barbs on access to care, drug pricing, health insurance, and similar issues. But exactly how the 2 candidates, President Donald Trump and Joe Biden, might address health care issues is murky.

As vice president during the Obama administration, Biden was a strong supporter of the Affordable Care Act (ACA). As a candidate in 2020, he has called for broader access to health care and a national, science-based approach to the COVID-19 pandemic. Biden routinely wears a face mask in public and has called for a national policy favoring masks to reduce COVID-19 transmission.

As president, Trump has repeatedly criticized the ACA. When legislative attempts to derail ACA failed, the administration tried legal challenges. The Supreme Court will hear arguments to block the ACA in November.

On the COVID-19 front, the administration has taken contradictory positions. Trump has largely left pandemic response up to the states and said at the debate between he and Biden at the end of September, held days before this positive COVID-19 diagnosis, that he thinks masks are "ok," and that he wore them when thought they were needed. However, he has rarely appeared in public wearing a mask. 

At the same time, HHS has overruled states to expand the scope of practice for pharmacy, medicine, and other health care professions nationwide under the Public Readiness and Emergency Preparedness (PREP) Act.

Trump also appointed a science-heavy COVID-19 task force headed by veteran clinicians and Washington insiders Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and Deborah Birx, MD, global AIDS coordinator for the US Department
of State. However, he has derided both Fauci and Birx while touting purported miracle cures including hydroxychloroquine and convalescent COVID-19 plasma.

administration responses to COVID-19 leave pharmacists, and everyone else, with more questions on health care policy in 2021 than answers.

“We are asking all the candidates about their positions on pharmacy 

issues, and we don’t have clear answers yet,” said Michael Jackson, RPh, executive vice president and chief executive officer of the Florida Pharmacists Association. "We do know that the status quo can't remain. We have got to change dramatically."

Change should start in the pharmacy supply chain and payment models, Jackson continued. Both presidential candidates, as well as other candidates up and down the ballot, have to recognize that pharmacy is not a cost center, but a cost container. Current payment models are driving pharmacies out of business.

Independent pharmacists have been complaining about direct and indirect remuneration (DIR) fees for years. More recently, chains and hospitals have added their objections.

“It’s pretty dire when you get the entire pharmacy industry to stand behind one issue,” said Brian Caswell, RPh, president of the National Community Pharmacists Association (NCPA) and owner of 4 pharmacies in Kansas and Missouri.

“DIR fees mean that on a quarterly basis, you have somebody reach into your bank account and pull a big chunk of money out, which totally disrupts your budget [and your] plans
to improve your business [and] make capital investments so you can step up and do a better job of taking care of your patients. Everyone is being hurt by DIR fees, including patients.”

Caswell noted that one of his stores lost $100,000 to DIR fees in 2019. That kind of unpredictable loss made him reconsider a $200,000 automated multidose strip-and-pouch packaging unit that could help meet strong patient demand for drug packaging to ease adherence. No one knows how the next president might approach DIR fees.


“We have a president [whom] we know a little bit about related to pharmacy issues, and we have a candidate who wasn’t big in the pharmacy space in his previous elected positions,” said Karry La Violette, advocacy center director and senior vice president of Government Affairs for NCPA. “We have a lot of unknowns with Biden, but he wouldn’t be a hard sell. We know what we are getting with the Trump administration, sometimes unpredictable, but we know where they’re coming from.”

By the end of both parties’ conventions, neither candidate had staked 

out positions on DIR fees, pharmacy benefit manager (PBM) regulation, drug pricing, scope of practice, the 340B drug pricing program, or other key pharmacy issues. Nei

ther the Trump nor Biden campaigns responded to repeated information requests for this article. But the two have very different perspectives on how health care should be delivered.

“You could have a President Biden focused on public options,” explained Tom Krause, JD, MHS, vice president of Government Relations for the American Society of Health-System Pharmacists (ASHP).“You could have a President Trump preserving some selected aspects of the ACA but overall oppos- ing it. Trump has a preference for a very state-based approach to managing response to the COVID-19 pandemic. Signals we’re seeing from Biden would be a more nationally focused response. Those are fundamental contrasting visions of health care.”

If current trends continue, more than 200,000 Americans will have died from COVID-19 by election day on November 3. There are endless, unsolvable arguments over how many deaths might have been avoided had the federal government taken a different approach to the pandemic. But from the health care perspective, the pandemic has brought a few positives changes.


When the federal government declared a public health emergency on January 31, HHS was able to make sweeping changes to the provision of and payment for health care services under the PREP Act.

HHS authorized physicians and other clinicians to practice in states in which they were not licensed under some circumstances and allowed pharmacists to order and administer COVID-19 tests. HHS later authorized pharmacists to provide point-of-care testing for influenza and COVID-19, expanded pharmacists’ authority to provide pediatric immunizations, and adapted reimbursement mechanisms to pay pharmacists directly for some COVID-19–related services.

“With the pandemic, pharmacists and pharmacies have been able to work as providers,” said Ilisa Bernstein, PharmD, JD, FAPhA, senior vice president of Pharmacy Practice and Government Affairs for the American Pharmacists Association (APhA). “There have been a lot of flexibilities and gains that have been achieved for pharmacists and for patients during [COVID-19]. In the next administration, whether it’s the same party or a different party, we’re going to watch and push for those flexibilities and gains to be maintained [and] move to further gains that can continue to make a difference in patient care.”

The problem is that COVID-19– related improvements in patient care all depend on the public health emergency. Once the emergency expires, state regulations take over. And not all states changed their regulatory approaches.

“There have been national mandates, but the actual changes to practice acts have not been uniform,” said Ken Thai, PharmD, president of the California Pharmacists Association and chief executive officer of 986 Pharmacy Corporation. “The next administration needs to get rid of the barriers, the handcuffs, to allow everyone to pitch in as part of the provider team—nurses, doctors, pharmacists— to give patients the best possible care and the best possible outcomes.”

Provider status has been on the pharmacy wish list for years. Bipartisan provider status legislation has been introduced in Washington but has never moved out of committee. California pharmacists gained provider status in 2014.

“Even 6 years later, recognizing that if we perform a service, we need to get paid for it, hasn’t happened to the extent that we have been able to unleash pharmacists’ true powers to help their patients,” Thai said. “With DIR fees, pharmacists are paying to provide services because there is negative reimbursement because of actions taken by the PBMs. I’m hoping this election highlights what we have been doing and the outcomes we have provided. For too many people, we haven’t just been the most available health care provider, we have been the only provider because so many physician practices were closed or limiting visits.”

None of these changes will happen on their own. Political candidates don’t respond to stakeholders they don’t hear from. Pharmacists have to make 

their own case, time and again, until change happens.

APhA, ASHP, NCPA, and other pharmacy groups are lobbying both candidates, Krause said. ASHP has pointed out that a public option for health coverage has the potential to increase covered populations. That could expand government negotiating power when it comes to issues such as patient access and drug pricing.

APhA is emphasizing the improved patient outcomes that pharmacists and pharmacy have produced from the expanded flexibility and practice that authorities put into place during the pandemic.

Caswell at NCPA is pushing the need for pharmacists to speak individually as well as through their organizations.

“We have a pandemic that has become political, and pharmacists have to get involved,” Caswell said. “A Republican mantra for a long time has been local control. And a Democratic mantra has always been patient choice. That’s a perfect combination of working with the patient-provider decision-making process and we pharmacists have to be part of that discussion. Pharmacists have to speak their mind, talk to every one of their candidates at the local, state, and federal levels, [and] utilize their contacts to get our message out there. If we can move our solutions, our personal relationships with patients, to be unencumbered by the payment system, we’re going to see better outcomes, happier patients, and happier pharmacists.”

What happens next in health care depends largely on
COVID-19, especially in light of the breaking news that the President has been diagnosed with COVID-19. And then, of course, on the 2020 presidential election itself. 

Election 2020: What Pharmacy Needs from the Next Administration

October is American Pharmacists Month. This celebration—recognizing pharmacists’ contributions to health care and all they do for their communities—includes Women Pharmacist Day (October 12); Pharmacy Week (October 18-24), acknowledging the invaluable contributions of pharmacists and technicians to patient care; and Pharmacy Technician Day (October 20).

Pharmacists are busier than ever with flu season and the coronavirus disease 2019 (COVID-19) pandemic, making it particularly important this year to take the time to celebrate and acknowledge our pharmacy staff’s contributions.

Let’s take a look at a few ways that pharmacists are celebrating the value of the profession this month.

Trisha Winroth, PharmD, pharmacy manager at Walgreens in Lowell, Massachusetts, plans to celebrate her team during the month of October, showing her appreciation with gifts like jewelry, personalized mugs, wine, shopping bags, or water bottles.

“As a pharmacy manager, my team, both pharmacists and technicians, is the key to our success! I am only one person and can’t possibly meet the needs of a large and diverse patient population,” she said. "Their daily impact on patient care—from refilling prescriptions to calling doctors or patients [to] helping patients find resources to translating or explaining paperwork for a vaccine—touches far more lives than I could ever do alone.”

Cara Hoyt, PharmD, a pharmacist at Uptown Pharmacy in Westerville, Ohio, tries to celebrate her team all year round, particularly since October is prime time for flu shots. “October is always a busy month for our pharmacy,” she said. “Between doing vaccinations in house and onsite, we don’t get to celebrate every day. But we try to celebrate our fantastic team all year long! We provide meals, ice cream, and other treats during pharmacists month and [throughout] the year. We want to show our staff we care about them [because] we know we need our whole team to provide the best care.”

The Uptown Pharmacy team also works together to provide value to the community through other clinical services such as point-of-care testing for international normalized ratios, diabetes education, compounding, medication synchronization, a community residency program, and research projects.

October is American Pharmacists Month. This year more than ever, take time to acknowledge the valuable contributions of your pharmacy staff.