Tzipora Lieder, RPh

As of 2019, more than 37 million Americans—11.3% of the population—had diabetes, according to the American Diabetes Association.

 Diabetes is a major risk fac- tor for chronic kidney disease (CKD), a condition with which approximately 1 in 3 adults with diabetes—type 1 (T1D) or type 2 (T2D)—is living.

 Many of these patients may progress to end-stage kidney disease (ESKD), requiring dialysis or transplantation.

Although the progression of CKD can be slowed or even reversed by appropriate drug therapy and lifestyle changes, many patients do not get the treatment they need. In fact, many patients may not receive a diagnosis, as early-stage CKD is asymptomatic.

Wendy L. St. Peter, PharmD, professor at the University of Minnesota College of Pharmacy and an investi- gator with the United States RenalData System, is leading a national initiative to advance kidney health through optimal medication management, including incorporat-ing pharmacists into team-based care. “Primary care physicians, where a lot of these patients are being seen for their diabetes or high blood pressure, may not have the time or expertise to manage all these new medications for the purpose of reducing progression of kidney disease,” St. Peter said. Coupled with a shortage
of nephrologists, this creates an ideal opportunity for clinical pharmacists with advanced training to work with an interdisciplinary team and manage medication use in diabetic kidney disease (DKD).

As frontline health care workers who know patients, their diagnoses, and their prescriptions well, community pharmacists can be instrumental in the identification and appropriate treatment of DKD, said St. Peter. Urine screening can be valuable in identifying albuminuria (

 which
is often one of the first signs of CKD, whereas regular blood work is needed to detect declines in estimated glomerular filtration rate (eGFR).

Two recent clinical trials—CREDENCE (NCT02065791) and Dapa-CKD (NCT03036150)—have represented important developments in demon- strating the beneficial renal and cardiovascular effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors, which were initially approved for T2D. “This has really changed our practice and treatment options for patients [who] have CKD and diabetes with albuminuria,” said Abby Hines, PharmD, an ambulatory care clinical pharmacist in the Division of Nephrology, Bone and Mineral Metabolism at UK HealthCare in Lexington, Kentucky.

The Kidney Disease: Improving Global Outcomes (KDIGO) 2020 Clinical Practice Guideline

 for the management of CKD in diabetes recommends SGLT2 inhibitors with metformin as first-line antidiabetic therapy for patients with T2D and CKD. Metformin can be initiated as long as the patient’s eGFR is 30 mL/min/1.73 m

 or greater but must be discontinued if the eGFR drops below that (

 For patients with T1D, there is no strong evidence for the use of SGLT2 inhibi- tors, which carry a risk of euglycemic diabetic ketoacidosis, Hines said.

KDIGO guidelines also recommend patients with diabetes, albuminuria, and hypertension be treated with the highest-tolerated dose of angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker to reduce decline in kidney function. For patients with diabetes and CKD who are not meeting personalized glycated hemoglobin A

 goals, despite being prescribed maximal doses of metformin and SGLT2 inhibitors, KDIGO guidelines recommend adding a glucagon-like peptide 1 receptor agonist (GLP-1 RA). There is ongoing research on the benefits of GLP-1 RAs in CKD that appears promising, Hines said.

An even more recent development that is not included in the most recent KDIGO guidelines is the July 2021 FDA approval of finerenone (Kerendia),

 a first-in- class nonsteroidal selective mineralocorticoid antagonist shown to reduce risk of serious kidney and heart complications in adults with CKD and T2D. Hines expects to see finerenone used more frequently in the coming months and years.

Because patients with DKD often have other comorbidities, they usually have very complex drug regimens that may feel overwhelming. “We can give all these medications to patients, but unless they take them, they don’t work,” said Candis M. Morello, PharmD, APh, CDCES, FCSHP, FASHP, a clinical pharmacist specialist and director of the Diabetes Intense Medical Management Clinic at the Veterans Affairs San Diego Healthcare System in California. Pharmacists can play a crucial role in reducing the number of prescribed drugs, tailoring regimens, and accounting for lifestyle, cultural beliefs, and medication preferences, from how frequently medications should be taken to decisions on oral vs injecta- ble drugs and the size of ingestible tablets or capsules. Patients often appreciate taking a combination SGLT2 inhibitor with metformin, which reduces the daily pill count, Morello noted.

St. Peter stressed the importance of patient education. “Pharmacists can work with patients to [explain] why they are taking these medications, why they’re important, [and] why these medications can avert future disasters, [such as] ESKD,” she said. Awareness of racial disparities in kidney risk is also imperative, St. Peter noted. African American individ- uals are more than 3 times as likely as White individuals to develop ESKD. Asian, Hispanic, and American Indian individ- uals are also at increased risk.

Patients taking SGLT2 inhibitors need to be counseled about the adverse effects associated with these agents, including hypovolemia (when taken with diuretics), urinary tract infections, and genital yeast infections. Hines urges patients taking diuretics with SGLT2 inhibitors to increase their fluid intake and monitor their urine color to make sure they are not becoming dehydrated. In some cases, she advises decreasing the dose of the diuretic. Even though the black box warning for amputations has been withdrawn from SGLT2 inhibitors, Morello still advises patients taking these agents to check their feet daily for changes.

Although hypoglycemia is not usually a risk with SGLT2 inhibitor therapy, it is possible in patients taking other anti- diabetics, particularly insulin. Hines often works with providers to decrease insulin doses by 10% to 20% in patients starting SGLT2 therapy. Pharmacists must be mindful of which drugs are excreted by the kidneys so doses can be adjusted as necessary as kidney function declines, St. Peter noted. This includes metformin and antibiotics.

Patients should be reminded to monitor their blood glu- cose and blood pressure and be made aware of the die- tary and lifestyle changes that play a part in diabetes con- trol.“We don’t want to lose sight of [the] big things, [such as how] controlling diabetes plays such a positive role in delaying the progression of kidney disease,” Morello said.

Statistics about diabetes. American Diabetes Association. Updated February 4, 2022. Accessed February 10, 2022. 

https://www.diabetes.org/about-us/statistics/about-diabetes

Diabetes and chronic kidney disease. CDC. Reviewed May 7, 2021. Accessed February 10, 2022. 

https://www.cdc.gov/diabetes/managing/diabetes-kidney-disease.html

Chronic kidney disease in the United States, 2021. CDC. Reviewed March 4, 2021. Accessed February 10, 2022. 

https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html

CKD related health problems. CDC. Reviewed March 4, 2021. Accessed February 10, 2022. 

https://www.cdc.gov/kidneydisease/publications-resources/annual-report/ckd-related-health-problems.html

How to classify CKD. National Kidney Foundation. Accessed February 10, 2022. 

https://www.kidney.org/professionals/explore-your-knowledge/how-to-classify-ckd

de Boer IH, Caramori ML, Chan JCN, et al. Executive summary of the 2020 KDIGO Diabetes Management in CKD Guideline: evidence-based advances in monitoring and treatment. 

. 2020;98(4):839-848. doi:10.1016/j.kint.2020.06.024

FDA approves drug to reduce risk of serious kidney and heart complications in adults with chronic kidney disease associated with type 2 diabetes. News release. FDA; Published July 9, 2021. Accessed February 10, 2022. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease

Articles

How can pharmacists help slow the progression of diabetic kidney disease?

Managing Chronic Kidney Disease in Patients With Diabetes

It’s no secret that the United States is facing an obesity epidemic: Over 40% of the adult population is living with obesity, which can increase the risk for a multitude of health conditions including heart disease, stroke, and type 2 diabetes.

 Besides its impact on quality of life, obesity can be a burden on both individual finances and the health care system. Can pharmacists—positioned as trusted health care professionals in the communities they serve—play a role in bringing weight loss programs to the public?


Meagen M. Rosenthal, PhD, associate professor, Department of Pharmacy Administration, University of Mississippi School of Pharmacy, has taken part in research investigating the role of pharmacists in weight loss programs, including a scoping review of literature on the topic and research into pharmacists’ and patients’ attitudes toward pharmacy-based weight loss programs. “We have community pharmacists who are interested in doing this kind of work, and we have patients who are willing to see community pharmacists to make this work happen, which to me is the perfect storm of opportunity to do more of this work,” she said. In small rural communities dealing with recent hospital closures, Rosenthal noted, community pharmacists can play an important role in improving health outcomes.


In a review of 9 studies of pharmacist-run weight loss programs published between 2010 and 2017, Rosenthal and her colleagues found that patients in these programs lost a mean 3.8 kg over the course of the programs

 which, she said, “translates to important clinical reductions in...glucose levels for people who have diabetes and blood pressure levels for folks who have hypertension.”


Kathy M. Campbell, PharmD, owner of Medicap Pharmacy in Owasso, Oklahoma, who has had over 300 patients complete her pharmacy-based weight loss program over the past 6 years, reported dramatic results over the course of the 12-week program in some patients, including reductions in glycated hemoglobin A1c from 13.5 to 6.5 and a 107-point reduction in low-density lipoprotein cholesterol.

In focus group interviews with potential participants, many highlighted their desire for programs that are tailored to their individual needs, with a mix of one-on-one and group counseling sessions.

 Instead of a program with a specific defined curriculum, Rosenthal noted, they wanted opportunities to say things like “I can exercise fine on my own, but what I really need to know more about is how to cook for myself.”

Campbell’s 12-week pharmacy-based weight loss program typically includes 6 half-hour individual counseling sessions, but also offers group activities such as cooking demonstrations. Some pharmacy-based weight loss programs feature pharmacists working in conjunction with other providers to manage patients who are taking weight loss drugs. Campbell takes a more biochemical view of weight loss, and incorporates a Mediterranean diet–based meal plan, pharmaceutical-grade supplementation with multivitamins, omega-3 fatty acids, and vitamin D, as needed, and counseling on movement (“It doesn’t have to be formal exercise,” she emphasized), stress management, and sleep. “The biggest secret is that it’s not a weight loss program. It’s a health program; it’s a lifestyle program,” Campbell said. “The by-product of a healthy body is a healthy weight.”


In sessions with patients, Campbell assesses whether they have drug- or disease-induced nutrient deficiencies that may cause weight gain and can be corrected by diet and supplementation. In some cases, she may recommend that a patient switch to a different drug.


Desiree Gaines, PharmD, health and wellness director at Avant Pharmacy and Wellness Center in Charlotte, North Carolina, does lab work before and after her 12-week weight loss program, examining patients’ lipid panels as well as vitamin D, magnesium, vitamin B12, and folate levels to identify potential chronic conditions that require further evaluation by a medical provider. Gaines also uses these data to give patients recommendations on supplements and nutrition education outside counseling sessions, and she offers an app that allows patients to contact the pharmacist with questions at any time.


Pharmacists have a unique perspective on weight loss, as they recognize not only the effects of prescription drugs on weight, but also the effects of weight on prescription drugs. Most of the patients Campbell works with are taking between 3 and 5 medications.She coaches patients on communicating with their providers so they can, for example, adjust the dose of their antihypertensive medications.


“Many supplements actually enhance the effects of our traditional medications. Eventually, these patients are able to either lower their doses, or…come off some of their medications,” Gaines said.

As in so many areas of pharmacy practice, lack of insurance reimbursement for services is a major impediment. Campbell’s motto is “no margin, no mission,” and she has moved beyond the dispensing fee model to charge patients for counseling services. After a great deal of market research, she introduced her weight loss program with a price tag of $1000—which patients were willing to pay. She also offers related products for sale in her pharmacy, such as cast-iron cookware and microgreens, and has even started her own line of supplements.


Gaines offers weight-loss counseling packages tailored to patients’ needs for cash prices that can range from $199 to $1500. “We are working on trying to find grants that will cover the cost of this program for our community so that we can make this accessible to everyone,” she said.


There is room for pharmacy advocacy in this area, Rosenthal added, to convince payers that reimbursement for health and weight management education will yield tremendous savings in health care costs.


Gaines advises pharmacists who want to start a weight loss program to focus on their goals and training. Education on topics related to health and weight loss is important. One such source is a course that Campbell teaches through the National Community Pharmacists Association, but there are other avenues of education as well.


One major challenge is figuring out how to fit weight loss counseling into pharmacy workflow. Gaines began by offering these classes in the evenings and on weekends and, once she had built up enough business, designated 1 day a week when she does only counseling while another pharmacist handles dispensing.


Promotion can be done through a combination of word-of-mouth, point-of-sale, print, and online advertising. Gaines’ pharmacy uses social media and hosts free events where it gives out products and showcases its offerings to specific demographic groups.


“I think that the biggest thing with marketing is telling people what you can do for them and then doing it,” Campbell said.


“Reach out to other pharmacists who may be doing similar programs,” Gaines advised. As an individual who struggled with her own weight challenges before establishing a program to help others, she added, “Start your program with yourself, family members, and close patients that you feel comfortable with. This is a great way for you to tweak your program the way you feel is best for you and your patients.”


Adult obesity facts. CDC. Reviewed September 30, 2021. Accessed January 4, 2022. 

https://www.cdc.gov/obesity/data/adult.html

Rosenthal M, Ward LM, Teng J, Haines S. Weight management counselling among community pharmacists: a scoping review. 

 2018;26(6):475-484. doi:10.1111/ijpp.12453

Arnold A, Holmes E, Rosenthal M. Building a patient-centered weight management program: a mixed methods project to obtain patients’ information needs and ideas for program structure. 

. 2019;7(4):165. doi:10.3390/pharmacy7040165

As some of the most accessible health care professionals, pharmacists are uniquely positioned to help patients manage their weight

Lose Weight, Gain Health: How Pharmacy-Based Weight Loss Programs Can Fight the Obesity Epidemic

Constipation is among the most common gastrointestinal complaints and can be a cause of considerable discomfort.

Although constipation used to be defined by bowel movement frequency (fewer than 3 per week), its definition has been broadened to include other symptoms, including hard or lumpy stools, straining while passing stools, a sensation of incomplete evacuation or anorectal blockage, and manual maneuvers needed to facilitate defecation. According to Rome IV criteria, chronic functional constipation is defined by experiencing 2 or more of these symptoms during at least 25% of bowel movements over 3 months, with symptom onset at least 6 months earlier.

Constipation is more prevalent among women, especially pregnant women and in the immediate postpartum period, and its incidence increases with age. It can also be associated with the development of hemorrhoids due to straining.

A common culprit in constipation is a poor diet with insufficient fluid and fiber; lack of exercise can also be a contributing factor.

Systemic diseases associated with constipation include metabolic disorders such as diabetes and hypothyroidism, neurologic disorders such as stroke, Parkinson disease (PD), head injury, and multiple sclerosis, and connective tissue disorders such as scleroderma.

Constipation is extremely common in patients taking opioids—hence the diagnosis of opioid-induced constipation—but there are many other drugs that can also contribute to constipation. These include anticholinergic drugs (eg tricyclic antidepressants, antispasmodics, antipsychotics, antihistamines, and drugs for PD), anticonvulsants, antihypertensives (eg calcium channel blockers, diuretics, antiarrhythmics, and beta-blockers), and cation containing agents (eg aluminum, calcium, bismuth, iron supplements, and lithium).

The cornerstone of constipation relief and prevention is lifestyle changes. The following are tips that pharmacists can give patients with acute constipation:

1. Eat more fiber. Fiber helps prevent constipation by increasing the bulk of stool and speeding transit in the gastrointestinal tract. According to the US Department of Agriculture, recommended daily fiber intake ranges from 22 to 34 grams, depending on gender and age. But the average American’s diet contains far less, reportedly approximately 15 grams daily. A high fiber diet has numerous benefits aside from softening stool, including lowering cholesterol, controlling blood glucose, and aiding in weight loss. Good sources of fiber are beans, nuts, whole grains, fruits, and vegetables.

2. Drink water. Increased consumption of fiber should always be paired with increased fluid intake. Higher water content in the stool makes it softer and easier to pass. Many experts recommend that adults drink 8t cups of water daily; some say even more.

3. Exercise. Physical activity enhances gastric motility in addition to its many other beneficial effects on health.

4. Go when you feel the urge. Withholding stool can cause stool to become dry and difficult to pass.

5. Consider fiber supplements. Lifestyle changes are easier said than done. Although increasing fiber in the diet is ideal because fiber-rich foods contain vitamins and minerals, patients who are unable to consume enough dietary fiber can benefit from fiber supplements containing wheat, psyllium, or methylcellulose. Since fiber supplements can cause abdominal bloating and flatulence, patients should start at a low dose and slowly increase.

6. Ask about constipation in patients with hemorrhoids. Tips to relieve their constipation may help prevent hemorrhoids from developing or worsening.

7. Refer to a doctor. Patients with more severe constipation symptoms, such as rectal bleeding, abdominal pain, inability to pass gas, and unexplained weight loss, should be referred for evaluation.

What pharmacists should know about constipation.

Constipation: Causes and Tips for Prevention

It’s nearly a year since August 2020, when the US Department of Health & Human Services (HHS) authorized licensed pharmacists throughout the country to provide childhood immunizations to patients aged 3 to 18 years during the public health emergency. This is a significant, albeit temporary, expansion of pharmacist authorization to administer pediatric vaccines in many states. Although about half of states and territories allow pharmacists to administer vaccines to patients of any age, many have age limitations and other restrictions pertaining to specific vaccines.

Yet it seems that most pharmacies nationwide have not gotten involved in pediatric vaccinations. “We’re trying not to bite off more than we can chew,” said Kevin Day, PharmD, president of Day’s Miami Heights Pharmacy in Cincinnati, Ohio.“[COVID-19] testing and vaccines have been plenty.”

Perhaps now that the initial rush of COVID-19 vaccination has subsided, pharmacies should consider establish- ing pediatric vaccination programs, as this is an opportunity that can benefit both individual pharmacists and the profession as a whole.


The HHS authorization was intended to bolster childhood immunization levels after the CDC collected data in May 2020 indicating a significant drop in childhood vaccinations in the early months of the pandemic, raising fears of outbreaks of vaccine-preventable disease.

 Even if vaccination levels now appear to have returned to prepandemic levels, there may remain a backlog of patients who are behind on their immunizations, according to Jeffery Goad, PharmD, professor and chair of the Department of Pharmacy Practice at the Chapman University School of Pharmacy in Irvine, California.

Administering childhood vaccines gives pharmacists the opportunity to practice at the top of their license while improving immunization rates in their communities.“Expanding into pediatric vaccines expands the range of providers that you’re able to network with, and that creates more collaboration among providers that you may not have dealt with,” Goad noted. In addition, he said, a childhood vaccination program helps build parents’ trust in pharmacists.

Although the bulk of pediatric immunizations are given to infants up to 18 months of age, the 3-to-18-years group includes 4 recommended vaccines at ages 4 to 6, 3 at ages 11 to 12, and 1 at age 16 years (see Table).

Goad believes the main benefit of pharmacy childhood vaccination, outside the pandemic, is to close the gap for adolescent vaccinations.“The 3 shots that are given at the preadolescent phase, 11 to 12 years, is an important area for pharmacists to help the community get their vaccination rates up,” he said.

Recommended Immunization Schedule for Children Aged 3-18 Years


Setting up to provide childhood vaccines should not be a major investment for most pharmacies, Goad said, as the basic infrastructure of an immunization administration area and vendors to order vaccines and supplies are already in place.“ They just need to order the right vaccines,” he said.

What may require more attention is establishing the infrastructure to identify children who need vaccination, document appropriately, and communicate with other health care providers to ensure that children are not being under or overvaccinated. This can be accomplished easily if pharmacists have access to electronic health records or if their state has a comprehensive immunization registry that pharmacists can access (in some cases, directly through their dispensing software). But not all states mandate that all providers document vaccinations in the state registry, resulting in incomplete immunization registries. Pharmacists who cannot access vaccine information electronically must find other ways to communicate with pediatricians to share immunization information (eg, faxing records).

Pharmacists who can check immunization registries while filling prescriptions can identify children who are due or overdue for specific vaccines. In fact, COVID-19 vaccinations for adolescents may provide a key opportunity for pharmacists to identify other vaccines these teens need. Importantly, although previous recommendations were to separate COVID-19 and other vaccines by 14 days, the CDC now allows COVID- 19 and other vaccines to be administered without regard to timing.

 Generally, however, the major source of pediatric vaccine business is from physician referrals, so it is crucial for pharmacists to cultivate relationships with local pediatricians. Before establishing a pediatric vaccine program, pharmacists must perform a needs assessment in their community, Goad said, by reaching out to local pediatricians to find out whether “they are struggling to meet the backlog of vaccines.”

Day said a main reason his pharmacy has not jumped in on childhood vaccines is to respect relationships with pediatricians in his area who, he said, “do an excellent job.” In contrast, Travis Wolff, PharmD, owner of Med-World Pharmacy in Sapulpa, Oklahoma, reported that his local physicians find ordering and storing vaccines to be a huge barrier, so they are happy to refer their patients to the pharmacy for vaccination. Establishing which local physicians this is the case for is important.

Although the American Academy of Pediatrics came out strongly against pharmacists providing childhood vaccines at the time of the HHS announcement, Goad believes the academy’s main concern is communication and the potential for under or overvaccination.“ We have to reassure pediatricians that we are not disrupting [the normal visits pediatricians have], that we are simply acting to help them offload some of the patients where they now are behind.” For example, he said, physicians can send their patients to the pharmacy for later doses of a multidose series of vaccines, and pharmacists should encourage parents to schedule their kids for physicals if they haven’t seen the pediatrician in a while.

Before establishing a pediatric immunization program, pharmacists must ensure they’ll be reimbursed for their services. Medicaid and commercial insurance rules vary by state. “The state of Oklahoma currently does not pay pharmacies through our state Medicaid for immunizations in patients under age 19,” said Wolff. “This has proven to be a huge barrier to vaccinating those that need it most.” And, he noted, many commercial insurers cover pediatric vaccines on the medical but not the pharmacy side.

Pharmacies can apply to participate in their state’s Vaccines for Children Program, which covers vaccine costs for children 18 years and below. For more information, go to https://www. cdc.gov/vaccines/programs/vfc/provid- ers/questions/qa-join.html.

According to Goad, the emergency declaration has shown that you can enact a national standard, rather than what he calls “the patchwork of immunization laws” throughout the country.

“As the only pharmacist serving on our state board of health, I am working to educate and encourage reform in the practice privileges of pharmacists every day,” Wolff said.

“This is a window of opportunity,” Goad concluded.“ Pharmacists need to advocate to their legislators and their stakeholders that this is something they can do and they want to do, so that everyone just thinks that the pharmacy is the place to go to get a vaccine.”

1. Pharmacist administered vaccines. National Alliance of State Pharmacy Associations, American Pharmacists Association. Updated September 18, 2020. Accessed May 27, 2021. 

https://naspa.us/wp-content/uploads/2020/08/IZ-Authority-9_2020.pdf

2. HHS expands access to childhood vaccines during COVID-19 pandemic. News release Department of Health and Human Services. August 19, 2020. Accessed May 27, 2021. 

https://public3.pagefreezer.com/browse/HHS%20–%C2%A0About%20News/20-01-2021T12:29/https:/www.hhs.gov/about/news/2020/08/19/hhs-expands-access-childhood-vaccines-during-covid-19-pandemic.html

3. Recommended child and adolescent immunization schedules for ages 18 years or younger, United States, 2021. CDC. Updated February 12, 2021. Accessed May 27, 2021. 

https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html

4. Interim clinical considerations for use of COVID-19 vaccines currently authorized in the United States. CDC. Updated May 14, 2021. Accessed May 27, 2021. 

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fcovid-19%2Finfo-by-product%2Fclinical-considerations.html

Administering pediatric immunizations can be a window of opportunity for pharmacists to demonstrate their value.

Childhood Vaccines During COVID-19 and Beyond

There are an estimated 34.1 million adults with diabetes, accounting for 13% of all US adults and a staggering 26.8% of US adults aged 65 or older.

 Every day, patients with diabetes are in the aisles of local pharmacies in search of OTC products to help them with various symptoms, whether diabetes-related or not. What should pharmacists consider when helping these patients choose appropriate OTC products?

Patients with diabetes frequently come to the pharmacy in search of relief for peripheral neuropathy—but experts say pharmacists shouldn’t rush to recommend OTCs.

“[If I were] a community pharmacist, if somebody told me that they’re having pin and needles or tingling in their fingers or their toes, I’d actually recommend that they go back to their doctor because usually, that’s a sign that their diabetes is not under control,” said Candis M. Morello, PharmD, CDCES

, FCSHP, FASHP, professor of clinical pharmacy at UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences in La Jolla, California. Morello is director of the diabetes intense medical management clinic at the Veterans Affairs San Diego Healthcare System, where her team creates unique treatment protocols for very complex patients with type 2 diabetes.

According to Morello, when glycemic control is improved, diabetes complications, including peripheral neuropathy, are “absolutely reversible.” She found that this usually takes about 3 months using a multiprong approach, including diet, exercise, and drug therapy. In the interim, there is a place for OTC treatment for peripheral neuropathy.

Although the supplement α-lipoic acid has demonstrated positive effects on peripheral neuropathy, Morello is hesitant to recommend it to patients who are already taking a slew of oral prescription drugs. She prefers topical options, including capsaicin cream (0.075% 4 times daily, according to the American Academy of Neurology

Morello said patients should be cautioned to wash hands well—including under their nails—after using capsaicin cream to avoid accidentally getting it in their eyes. Lidocaine patches can be cut to fit the affected area and may be worn for up to 12 hours per day.

In considering the root cause of peripheral neuropathy, pharmacists should determine whether the patient is a smoker, as smoking can decrease blood flow to extremities and lead to nerve pain, noted Danielle Hambrick, PharmD, manager of a Walgreens pharmacy in downtown Chicago, Illinois. According to her, this symptom might be the impetus for patients with diabetes to quit smoking. Pharmacists can assist such patients in selecting smoking cessation aids, such as nicotine patches for long-term control and nicotine gum for breakthrough cravings.

“Ulcers, amputations, all of that is preventable,” Morello said, as long as patients look at their feet every single day and visit their physician at the first sign of a problem. Hambrick added that any sign of infection on the feet, such as an open wound, swelling, or fever, is a huge red flag and should be referred to the patient’s physician. 

OTC moisturizers are important in the prevention of foot problems. “If you have dry skin, you can get fissures, and bacteria and fungi love to invade and cause infection,” Morello explained. There are a variety of diabetic foot creams on the market; she recommends those containing urea or ammonium lactate. Hambrick pointed out that moisturizers should only be used on the tops and soles of feet, not between the toes, which could lead to fungal growth.

According to Hambrick, patients with diabetes should be educated about proper foot care. This includes always drying feet entirely after bathing and protecting feet by wearing socks in the house and shoes outside. Nail files are preferred for cutting toenails, but if clippers must be used, they should only be straight-edged, not curved, to avoid cutting the skin.

Although various vitamins and supplements are promoted for diabetes, there is limited data on their efficacy. In fact, supplements such as St. John’s wort, prickly pear cactus, aloe, and ginseng may interact with conventional diabetes drugs. Certainly, patients should not take dietary supplements in place of medications they have been prescribed for diabetes.

Studies have found that various vitamins play a role in glucose metabolism and the risk for diabetes and its complications, but there is not enough data to recommend routine supplementation in the general population with diabetes. An exception is vitamin B12 supplementation in patients with type 2 diabetes taking metformin. Patients should be encouraged to eat a varied diet to ensure sufficient vitamin intake.

Although the American Diabetes Association does not recommend routine multivitamins for patients with diabetes, Morello said that she and the dieticians she works with still recommend multivitamins because it can be difficult for patients to get all their nutrients solely from food sources.

Morello noted that patients who decide to take dietary supplements should be urged to choose only products that have been validated by a third party, such as the USP Dietary Supplement Verification Program or ConsumerLabs.com. “You just want to make sure that it was manufactured properly, that the amount and concentration that it says is in the bottle is actually in the bottle,” she said. “They’re spending valuable money, and we want to make sure they’re getting a product that actually contains what it says it does.”

Pharmacists should be mindful that patients seeking relief from cold and flu symptoms might also have diabetes. “Any patient that comes up with an over-the-counter question, there's always a chance they could [have] diabetes, so part of our counseling is making sure that we understand their pre-existing conditions,” said Hambrick. These patients should be counseled to steer clear of products containing sugar, including cold syrups and throat lozenges. Fortunately, there are still many options labeled sugar-free. They should also avoid products containing pseudoephedrine and other nasal decongestants, as they have been shown to increase blood glucose.

Hambrick noted that pharmacists should make sure patients with diabetes who have respiratory infections have an adequate supply of test strips. “Any time that a diabetic patient is ill, even if they're well controlled outside of that illness… they may have fluctuations with their blood glucose control, so they may need to test a little bit more often,” she said. These patients should also stock up on glucose tablets, she added, in case their blood sugar drops as a result of reduced appetite during illness.

According to Morello, for patients with diabetes complaining of constipation, psyllium is in excellent choice because it increases fiber intake and has been shown to decrease postprandial glucose concentrations.

Hambrick also stressed the importance of making sure patients with diabetes are adequately vaccinated. “With diabetes, your immune system is a little bit more compromised, and so those things like flu and pneumonia can be more severe,” she explained.

National diabetes statistics report, 2020. Centers for Disease Control and Prevention. Accessed December 7, 2020. 

https://www.diabetesresearch.org/file/national-diabetes-statistics-report-2020.pdf

AAN summary of evidence-based guideline for clinicians: Treatment of painful diabetic neuropathy. American Academy of Neurology. 2011. Accessed December 7, 2020.

Lidocaine transdermal patch. Medline Plus. Last updated March 15, 2016. Accessed December 7, 2020. 

https://medlineplus.gov/druginfo/meds/a603026.html

Diabetes and dietary supplements. National Center for Complementary and Integrative Health. Last updated May 2018. Accessed December 7, 2020. 

https://www.nccih.nih.gov/health/diabetes-and-dietary-supplements#:~:text=For%20example%2C%20chromium%20might%20help,diabetic%20neuropathy%20(nerve%20problems)

Valdés-Ramos R, Guadarrama-López AL, Martínez-Carrillo BE, Benítez-Arciniega AD. Vitamins and type 2 diabetes mellitus. 

. 2015;15(1):54-63. doi:10.2174/1871530314666141111103217

Over-the-counter product selection for patients with diabetes.

OTC Basics for Diabetes

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.