In 2020, US drug overdose death rose by nearly 30% to a record 93,331 national deaths compared with the year before, according to provisional data reported by the CDC.

New Hampshire and South Dakota were the only states with a drug overdose death decline from December 2019 to December 2020. All other states in the United States had increases. These increases ranged from high in South Carolina with a 51.9 percent change to the lower end in New Jersey with a 1.1 percent change in predicted deaths, according to the report.

The National Center for Health Statistics analyzed drug overdose deaths reported monthly, with the cut-off being the first Sunday of each month. Death estimates include deaths occurring within the 50 states and the District of Columbia. Of note, provisional estimates of drug overdose deaths are reported 6 months after the date of death. This is because the lag time between when the death occurred and when the data became available for analysis is longer for drug overdose deaths compared with other causes of death. Thus, death counts are reported in “12-month ending periods.”

Mortality data were reported by the World Health Organization and the ICD index was used to classify deaths.

natural opioid analgesics, including morphine and codeine;

semisynthetic opioids, such as oxycodone hydrocodone, hydromorphone, and oxymorphone;

synthetic opioid analgesics other than methadone, including drugs such as fentanyl and tramadol, and;

psychostimulants with abuse potential, which includes methamphetamine.

Drug overdose deaths may involve multiple drugs, so a single death may involve more than 1 category when describing deaths. Therefore, there may be an overlap in the statistics, the report noted.

Drug overdose deaths often require lengthy investigations, and death certificates may be initially filed with a manner of death “pending investigation” and/or with a preliminary or unknown cause of death. When the percentage of records reported as “pending investigation” is high for a given jurisdiction, the number of drug overdose deaths is likely to be underestimated.

The 12 month-ending period and the percentage of records with the manner of death reported as “pending investigation” were used to predict the degree of underreporting in provisional data relative to the final counts. Results from these models were used to generate a set of multiplication factors that could be applied to the reported provisional counts of drug overdose deaths to estimate 

 provisional counts.These predicted provisional counts may represent a more accurate picture of recent trends by accounting for reporting delays related to the percentage of records in provisional data with the manner of death “pending investigation.” True declines or plateaus in the numbers of drug overdose deaths across the United States cannot be ascertained until final data become available.

The timeliness of drug overdose death reporting has improved in recent years. Adjustments for delayed reporting are based on final data from 2019. Relative to final data, 12-month ending provisional counts of drug overdose deaths for 2019 were 98.3% to 99.2% complete after a 6-month lag. The degree of underestimation was largest for 12-month periods ending in October and November. Completeness was slightly higher in 2019 than in 2018. With improvements in reporting and completeness, predicted values will be closer to reported values and the completeness of reported drug overdose death counts may be higher than in prior years.

Pharmacists have a unique role in the growing opioid crisis, as they can counsel about opioid risks and 

 reported that individuals with opioid misuse disorders may be experiencing a decrease in access to naloxone amid the COVID-19 pandemic. Naloxone distribution via pharmacies can help reduce some of the increases in fatal overdoses being seen during this time. Pharmacists can also help educate patients on safe opioid storage and disposal, utilize the prescription drug monitoring program, and provide resources for addiction treatment.

Vital Statistics Rapid Release - Provisional Drug Overdose Data. Centers for Disease Control and Prevention. Updated July 14, 2021. Accessed July 15, 2021. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.

Thakur T, Frey M, Chewning B. Pharmacist services in the opioid crisis: Current practices and scope in the United States. 

Articles

Drug overdose deaths, including opioid-related deaths, have increased rapidly in the United States in recent years, according to preliminary data from the CDC. 


US Drug Overdose Deaths Reach Record High in 2020

Part 4 - Jason Ausili interview 

Part 3 - Jason Ausili Interview 

Part 2 - Jason Ausili interview 

Part 1 - Jason Ausili interview 

®, Jason Ausili, PharmD, chief clinical officer at FDS, discusses the implications of Biden’s recent announcement of shifting vaccine supplies to local pharmacies and solutions to challenges that pharmacies may face, including managing daily responsibilities, patient consults, aligning pharmacy management systems (PMS) with expanded medical billing requirements, and reporting with state vaccine registries.

 Thinking a little bit into the next few months, now some of these authorized vaccines are starting to go through the process of approval. How can these community pharmacists be prepared for that as well?

 Yeah, there's a lot of speculation what this is going to look like over the next 6 months or so.

But I think that it's not going away. We still have a portion of our population to get to. There's a big push to get the X percent of people who haven't been vaccinated yet in our communities that may be willing to get vaccinated, we need to get them over the line.

The next step is the recent announcement about the 12 to 15 age group. Pfizer got the emergency use authorization (EUA) for that age group, so I think there's a big effort to get those adolescents vaccinated prior to the new school year happening. That's going to be an interesting and exciting effort over the summer for community pharmacists to help on that front. And I can imagine, beyond that, there's going to be additional studies that may look at younger children under the age of 12. We don't know much about that at this point in time.

But moving forward with the childhood vaccines. During the pandemic, pharmacists were authorized to help children get caught up on their recommended guidelines for vaccines, because they've fallen behind due to the pandemic. A lot of the normal wellness visits, where vaccines would normally be administered, kind of went away for a while because of the pandemic and the concerns on that front. So, pharmacists have a unique opportunity now to also increase the amount of childhood vaccines that they're doing for age groups that they may not have been able to do before, depending on what state they live in.

So over the next 6 months the role pharmacy plays is going to continue to increase. It may not be as high volume, or pockets of high volume, like it was back in the early phase 1 and moving into the general population. But likely boosters will be coming in the future, too. There's been research that shows the mRNA vaccines carry great immunity at 6 to 12 months. But where's that point between 6 and 12 months? We really don't know yet. But a lot of the research shows that boosters are going to be likely.

And there's going to be additional opportunities for pharmacists to play a greater role in vaccinations. And honestly, I'd like to see a larger play in vaccinations overall. I mean, you have you have the COVID piece that we've talked about. You've got the childhood vaccination piece, but now that pharmacists have been activated that may have not been vaccinated before. I think we picked some up along the way during the pandemic that will also be more involved in the pneumonia (flu) season and pneumococcal and Shingrix and the human papillomavirus (HPV). There's a lot of really important vaccines that pharmacists can help with, among other clinical services that are really ripe for the picking right now.

We're seeing pharmacists play a huge role in things like smoking cessation, medication therapy management (MTM) services, oral contraception, and many other public health focused initiatives. So the world is really exciting for pharmacy right now. I just hope, Gabrielle, that now that the bar has been raised, as a profession, we're able to really advocate for removal of the long term barriers and continue to, you know, focus on practice expansion.

 And what biggest takeaways do you want to leave us with today?

 Going back to the barriers, there are challenges out there.

The pharmacists are our heroes. I have to commend the courageous efforts of the frontline community pharmacists, who are really proving themselves as the epicenter of care. Pharmacists are the most accessible health care providers, and independent community pharmacists are really located in areas that are hard to reach.

So now that we're trying to refine our efforts to vaccinate the harder to reach parts of the population, community pharmacy is ideally positioned. By overcoming and really listening to your peers. Your peers have really experienced a lot of these challenges and barriers themselves. And there's no other profession like community pharmacy, where talking to your peers and leveraging that network is so beneficial.

The message I want to leave with full Is there are barriers out there. It can be a scary world. But there's people there to help. Leverage your peer network, leverage your pharmacy technology providers, because we have experienced a lot of these same barriers that you're going through. And we've come up with solutions and ways around those barriers - whether it's making some of these vaccination efforts scalable by leveraging and integrating with workflow solutions, making it as turnkey as possible so that you have less manual work to do and more automated work that we're doing for you.

 Jason, it's been a pleasure. Thanks so much for speaking with me today.

 Absolutely, Gabrielle. Let me know anytime I can help out and I'd be happy to share my story.

Expert Interviews

 "I just hope that now that the bar has been raised, as a profession, we're able to really advocate for removal of the long term barriers and continue to focus on practice expansion."

Part 4: Leverage Technology to Transform Pharmacy Practice and Move Beyond COVID-19

Health care systems have spent the bulk of 2020 and 2021 adapting to new norms in workplace safety and patient care to minimize transmission of COVID-19, while effectively rolling out vaccines. It hasn’t been easy, given the economic tolls of the past year and a half, including high rates of clinical staff turnover at some facilities.

But amid this evolving post-pandemic “recovery,” health care leaders have devoted fewer dollars, and less attention, to drug diversion, according to a newly released report by 

. As many as 38% of health care and diversion professionals surveyed in early 2021 said resources for drug diversion investigations were reallocated due to budget cuts because of the pandemic, whereas 47% said drug diversion became more difficult to track due to staff turnover.

Also, only 45% of percent of health care organizations said they have at least 1 full-time employee (FTE) dedicated to drug diversion. This is a substantial drop from the 2019 report, which showed that 58% of organizations employed at least 1 dedicated FTE.

But with the risk of diversion potentially greater than it was before the pandemic, these data should be viewed as a warning sign.

Cases of drug diversion have steep financial, clinical, and legal consequences. Recent incidents of health care diversion have culminated in 

, the spread of healthcare-acquired infections (HAI) including 

 said they strongly agree that most drug diversion goes undetected, a number that has increased compared with previous surveys. And 86% said they personally know someone that has diverted medications.

Yet there is the tendency to ignore what’s not in front of us and hyper-focus on only the immediate problems we can see. For the last 18 months, COVID-19 concerns have understandably eclipsed nearly everything else.

But multiple circumstances are, nevertheless, building up to a perfect storm. Between October 2019 and October 2020, drug overdose deaths among the general population increased by about 30% over a 1-year period, amid the larger mental health crisis. Meanwhile, health care workers are exhausted: 

 polled recently noted that the pandemic increased their feelings of burnout.

Also, hospitals nationwide must still focus on COVID-19-related priorities, such as overseeing vaccine distribution. But this, too, has raised ancillary concerns around drug diversion: One in 3 surveyed by Porter Research said they are more concerned about drug diversion given the distribution of the COVID-19 vaccine.

One silver lining in the data is the increased use of technologies that can identify drug diversion, and, in doing so, save organizations time and money.

Machine learning software, for example, enables technology providers to train machine learning systems to recognize known patterns of drug diversion in healthcare facilities. If, say, a hospital nurse dispensed 2 hydrocodone tablets from an automated dispensing machine but an hour later, the nurse reports in her electronic medical record (EMR) that she administered only 1 tablet, computer technologies would detect that the other tablet is missing.

More than 4 in 10 survey respondents (42%) said they use machine learning technologies to address drug diversion, up from 29% in 2019. Among those whose health systems use machine learning technology, 73% rated it favorably in effectively preventing diversion.

However, although the implementation of advanced technologies is encouraging, it’s only one solution. The issue of drug diversion is comprehensive and multifaceted. To successfully prevent diversion, or lower the risk, a health system needs leadership buy-in, staff cooperation, and potentially changes to hiring, education, and training practices.

Given the ongoing risk of diversion, health care organizations would benefit from strengthening the following areas:

 Having a dedicated professional to oversee systemwide initiatives around drug diversion — supply chain, investigations, reporting, IT purchases — is one of the best ways to bolster internal defenses. The fact that fewer health care organizations employed at least 1 full-time drug diversion professional may be to blame for a low level of investigations. In 2021, nearly 1 in five respondents (18%) respondents said they didn’t investigate any cases.

 Health care organizations need systems in place to ensure that packages and goods are tracked from the moment they’re taken off the loading dock to their ultimate destination.

 Every health care facility should ensure its educational programming goes beyond informational sessions on substance-use disorders (SUDs). Educators must specifically address the risks and consequences of both drug abuse and drug diversion, including addiction, job loss, and legal ramifications.

 Most clinicians and pharmaceutical workers are trained on what to do when they encounter patients with SUDs. Ensure clinicians and staff also understand the process of reporting a suspected incident of diversion, or suspicious activity. Organizations like 

National Association of Drug Diversion Investigators

 (NADDI), and the International Health Facility Diversion Association (IHFDA) offer resources to educate and train staff on drug diversion prevention best practices.

 Eighty-six percent of health care leaders already utilize automated dispensing cabinets. But for maximum benefits, the data derived from technology solutions like automated dispensing cabinets (ADCs) should be integrated with other data sets. For example, machine learning software can synchronize multiple sources of information — electronic health records, patient pain ratings, pharmaceutical records — from disparate sources, and dispatch alerts when patterns associated with diversion are detected.

Although health care organizations need to keep their focus on patient care and safety amid the ongoing pandemic, they also need to prepare for increased risks of medication theft and misuse. With the current state of declining hospitalizations of patients with COVID-19, now is the time to take another look at the protocols, policies, and technology used to reduce drug diversion.

With the risk of diversion potentially greater than it was before the pandemic, these data should be viewed as a warning sign.







Challenges of Drug Diversion in Health Care Settings Amid High Staff Turnover, Budget Cuts

Dapagliflozin (Farxiga; AstraZeneca) produced similar effects in patients with stage 4 chronic kidney disease (CKD) compared to those with mild-to-moderate kidney disease, according to a new analysis.

Studies have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, can provide kidney- and cardiovascular-related benefits for individuals with or without diabetes and with or without impaired kidney function.1 The 

 in May for use in patients with CKD at risk of progression.

For the pre-specified analysis, Glenn M. Chertow, MD, MPH, of Stanford University School of Medicine, and his colleagues examined data from the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial. This trial studied the effects of dapagliflozin on chronic kidney disease (CKD) in patients with varying health statuses. The study included patients with and without type 2 diabetes and mildly decreased to severely decreased kidney function, such as stage 4 CKD.

In the DAPA-CKD trial, 14% of patients had stage 4 CKD with an estimated glomerular filtration rate (eGFR) as low as 25 mL/min/1.73m2 at the beginning of the study. Patients were randomized to receive daily treatments of the SGLT2 inhibitor dapagliflozin or placebo. Those randomized to dapagliflozin experienced a 27% reduction in the primary end point (a composite of a sustained and large decline in kidney function, kidney failure, or death). Dapagliflozin-treated patients with stage 4 CKD also demonstrated a 29%, 17%, and 32% reduction in the kidney, cardiovascular, and mortality end points, respectively, compared with those randomized to placebo. The rates of adverse effects were similar in the 2 groups.

The effects of dapagliflozin in patients with stage 4 CKD are similar to effects in patients with mild-to-moderate CKD, the investigators concluded.2Among patients with stage 4 CKD and albuminuria, dapagliflozin's benefits were consistent with those observed in the DAPA-CKD trial overall, with no evidence of increased risks.

“While patients with screening eGFR as low as 25 mL/min/1.73m2 were enrolled, it is noteworthy that neither dapagliflozin nor placebo was discontinued when eGFR declined, even to below 15 mL/min/1.73m2,” Chertow said about the findings. “Therefore, a drug initially developed for the treatment of diabetes can benefit patients with CKD with and without diabetes, including those with moderate-to-advanced CKD.”

1. Chertow G, Vart P, Jongs N, et al. Effects of dapagliflozin in stage 4 chronic kidney disease. 

Journal of the American Society of Nephrology.

2. Dapagliflozin found effective and safe in adults with advanced kidney disease. News release. American Society of Nephrology; July 16, 2021. Accessed July 19, 2021. https://www.asn-online.org/about/press/releases/ASN_PR_20210716_JASN.Release.Cherto.pdf

Dapagliflozin was shown to significantly reduce the risk of kidney failure and prolong survival in patients with advanced chronic kidney disease regardless of diabetes status. 

Efficacy, Safety of Dapagliflozin in Stage 4 Chronic Kidney Disease

The CDC estimates that 68.3% of US adults have received at least 1 COVID-19 vaccine as of this article’s press time. Keeping up with pandemic news is more important than ever, so check back to 

 to stay informed on the latest coronavirus-related news and research.

Medicare Part B Provider Status for Pharmacists: ‘A Unique Solution to a Specific Problem'

Ken Perez, MBA, vice president of health care policy and government affairs at Omnicell, discusses current legislation circulating the House and Senate to grant pharmacists provider status in underserved areas.

 is now available on DrugTopics.com. In this issue, you’ll find great insights into the 

 in independent community practice, diabetes, respiratory and autoimmune diseases, and more.

Medical World News: Expert Interview with Jason Ausili

In the fourth and final segment, Jason Ausili, PharmD, considers the months ahead and why he believes the role of pharmacy will continue to increase through summer 2021.

On Demand: What You Don't Know Can Cost You: Simple Ways to Make Data-Driven Decisions in Your Pharmacy

In this podcast episode with Jeff Harrell, PharmD, learn simple tools and tips to optimize profitability and streamline operations using objective data straight from your pharmacy.

In Case You Missed It: FDA OKs Finerenone for Chronic Kidney Disease Associated With Type 2 Diabetes

A new medication called finerenone (Kerendia; Bayer) has been approved for the treatment of kidney disease and type 2 diabetes.

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

This Week on Drug Topics: July 19 to July 23

Molly Gombos earned her Doctor of Pharmacy degree from the University of Pittsburgh in 2014 and is currently enrolled at Pitt in the Master of Pharmacy Business Administration (MPBA) program, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Molly has spent the last 7 years working in community pharmacy, initially as a pharmacist and pharmacy manager and most recently working in pharmacy operations. Her current role is working in the patient safety and clinical space with focus on clinical decision support.

Vaccine hesitancy is not a new issue facing the health care industry, but with the COVID-19 pandemic, it has quickly become a more urgent concern.

Vaccinations are one of the most successful public health measures in history, making the growing perception of fear, lack of safety, and serious adverse events extremely alarming. The public’s unwillingness to get vaccinated is quickly becoming a threat to vaccine success in general. We know herd immunity is a large piece of preventing disease outbreaks and epidemics/pandemics. Vaccines have shown early promise in preventing the spread and reducing the mortality of COVID-19 infections but will likely only allow a full return to “normal” if a high percentage of the population is vaccinated. Although solving this issue will likely require a collaborative effort among all members of the health care community, pharmacists are well-positioned to help overcome this barrier with their patients. Even when this pandemic is over, pharmacists can be instrumental in overcoming similar hesitancy with other vaccines such as influenza, shingles, and pneumonia. As pharmacists are arguably the most accessible and visible health care professionals in our system, they have the unique opportunity to contribute significantly to public health in this way.

First, pharmacists need to recognize and identify the different types and causes of vaccine hesitancy:

Fear is one of the most common sources, whether it is fear of needles, adverse effects (AEs), feeling ill or “getting sick” from vaccination, or long-term complications resulting from a vaccine.

Hesitancy may also result from exposure to the growing number of anti-vaccination groups or individuals and misinformation that exists regarding vaccination.

 Out-of-pocket costs, copays, and general insurance coverage concerns are another source of hesitancy among patients.

 Many patients are unaware of which vaccinations they should be receiving and on what schedule, where they can receive vaccines, and the benefit of vaccines on their health and the health of others.

There is a lot of work to be done, much of which can be directly impacted by pharmacists. First and foremost, pharmacists can utilize the relationships they have already built with their patients. These relationships have likely created a level of trust with patients that may allow for more open-mindedness in conversations around vaccination. If pharmacists capitalize on this trust when conversing with patients, they will probably have significant success in getting through to patients who may be hesitant. Pharmacists can especially make an impact through education. Pharmacists are uniquely knowledgeable about pharmaceutical products such as vaccines and can clearly explain the benefits of vaccination and answer any specific patient questions. 

In addition, pharmacists can employ some simpler tactics in their day-to-day to encourage vaccinations. Simple tasks such as ensuring up-to-date insurance information for all patients and timely offerings of vaccines to patients as they become eligible can make a big difference. Pharmacists are the best in the industry at dealing with insurance claims, especially through the pharmacy benefit that often covers vaccines. If pharmacists can use these skills to make vaccinations accessible or very affordable for their patients, it will remove cost as a potential barrier. Pharmacists can also offer vaccinations to patients early when they become eligible, as they generally see patients more frequently than other health care providers. Making vaccinations fun can also be impactful for many patients, especially the younger generations. Pharmacists can do simple things like promoting vaccinations on social media to create photo opportunities for patients and handing out stickers to those who are vaccinated in the pharmacy to let them share with the public. This encourages some patients to get vaccinated directly and may also make a bigger splash with those patients’ friends and followers online. Lastly, for those patients who are simply fearful of needles or uncomfortable with the actual act of getting a vaccine, creating a pleasant and comfortable environment might make a difference. Pharmacists at all types of practice sites can ensure they have a comfortable and safe vaccination area to welcome patients and use personal connections and trust to quell their fears.

A pharmacist’s role in overcoming vaccine hesitancy in our communities is vital, and public health greatly relies on it. We’ve seen over the past year how effective pharmacists can be in contributing to public health in the eye of a global pandemic.Pharmacists’ success with the national COVID-19 vaccination effort has been extraordinary and will be even more impactful if we work towards improving the public’s hesitancy. Common issues patients may have specifically with the COVID-19 vaccines include its accelerated approval timeline, the unknown nature of long-term effects related to the novel mechanism of action, having already been infected and possessing antibodies, and in some cases, feeling like they are healthy enough to not need to be vaccinated. If pharmacists can employ the previously discussed tactics surrounding vaccine hesitancy, specifically to the COVID-19 vaccines, there is no doubt our country will be in a much better position with this pandemic very soon.

Molly Gombos earned her Doctor of Pharmacy degree from the University of Pittsburgh in 2014 and her Master of Pharmacy Business Administration (MPBA) in 2021 from the University of Pittsburgh, a 12-month, executive-style graduate education program designed for working professionals striving to be tomorrow’s leaders in the business of medicines. Molly has spent the last 7 years working in community pharmacy, initially as a pharmacist and pharmacy manager and most recently working in pharmacy operations. Her current role is working in the patient safety and clinical space with a focus on clinical decision support.

Pharmacists can work with their patients to address concerns about vaccinations. 

Overcoming Vaccine Hesitancy With Patients

Don’t waste time digging through articles to find the most up-to-date and important news.

has you covered with our weekly news roundup of the latest pharmacy-related news you should know before the weekend begins.

Here’s a roundup of the latest news coverage from

Pharmacy Groups Back Washington State Court Decision on ‘Unsustainable’ CMS Reimbursement Law

WSPA, NPCA, and NACDS fully support the court decision requiring CMS to reconsider the below-cost reimbursement plan.

Johnson & Johnson Recalls 5 Aerosol Sunscreen Brands with Benzene Traces

The consumer products giant voluntarily recalled 4 NEUTROGENA® and 1 AVEENO® spray sunscreen products July 14 after internal testing found low levels of benzene, a carcinogen, in some product samples.

Stanford Study Shows Memory T Cells Are Active Defense Against Severe COVID-19

Stanford study indicates that immune cells respond better to COVID-19 infection when patients have already been exposed to other, less deadly coronaviruses.

Novel Antifungal Treatment Approved for Vaginal Candidiasis

On June 2, 2021, ibrexafungerp (Brexafemme; Scynexis, Inc) was approved by the FDA for vulvovaginal candidiasis in adult women and girls who have begun menstruating.

FDA Grants Priority Review to Tezepelumab for Severe Asthma

Tezepelumab is the first biologic medication to show a reduction in severe asthma symptoms.

Rare Cases of Guillain-Barré Syndrome Reported in Janssen COVID-19 Vaccine

Johnson & Johnson released a statement providing more information on the risks and benefits of its single-shot COVID-19 vaccine.

FDA OKs Finerenone for Chronic Kidney Disease Associated With Type 2 Diabetes

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


News Roundup: Johnson & Johnson Recalls Sunscreen; FDA Adds Warning to Janssen COVID-19 Vaccine About Rare Guillain-Barré Syndrome 

The US District Court for the Western District of Washington state has approved a recently filed motion that requires the Centers for Medicare & Medicaid Services (CMS) to reconsider their below-cost reimbursement plan that was implemented in January 2021.

The decision was applauded by the Washington State Pharmacists Association (WSPA), the National Community Pharmacists Association (NCPA), and the National Association of Chain Drug Stores (NACDS) in a news release yesterday.

 Jenny Arnold, WSPA CEO, described the Washington State Medicaid reimbursement rate as “unsustainable” and “the lowest in the country and less than half what pharmacists are paid in every neighboring state.”

CMS approved the reimbursement plan on the last day of the Trump administration, a move that contradicted their initial position that Washington’s reimbursement was unlawful because it failed to consider the cost of dispensing. WSPA, NCPA, and NACDS filed a lawsuit, arguing that the unsupported reversal was in violation of its own rules.

 It also has the potential to disrupt reliable patient access and pharmacy viability, according to the 

“Washington’s reimbursement rate is completely unrealistic and unfair, and the outgoing administration made a hasty decision at the last possible moment to approve it in violation of its own rules,” said NCPA CEO B. Douglas Hoey.

“We’re proud to fight alongside WSPA and their members in a case that has national implications. If Washington state can get away with an unfair reimbursement rate, it could spread.”

CMS must now decide whether to support or reverse its January decision. The court decision also makes room for further litigation in the event that the pharmacy groups find CMS’ response inadequate. Should CMS disapprove of the below-cost plan, the next step is to submit a new Medicaid state plan amendment. Of course, the pharmacy groups are looking for fair reimbursement rates that support the continued viability of pharmacies.

“Pharmacy reimbursement rates can’t be haphazard shots in the dark; they must consider the actual pharmacy costs associated with filling patients’ prescriptions,” Hoey said. “The federal government formally rejecting this plan is a terrific development for patients and pharmacies in Washington and across the country. Officials should be on notice that you cannot get away with an unfair reimbursement rate.”

Federal Judge Sends Washington’s Below-Cost Medicaid Pharmacy Reimbursement Plan Back to CMS. News Release. NACDS; July 14, 2021. Accessed July 15, 2021. 

https://www.nacds.org/news/federal-judge-sends-washingtons-below-cost-medicaid-pharmacy-reimbursement-plan-back-to-cms/

Pharmacy Groups Applaud CMS’ Motion to Remand the Approval of Washington State’s Unreasonably Low Medicaid Reimbursement. News Release. July 9, 2021. Accessed July 14, 2021. 

https://ncpa.org/newsroom/news-releases/2021/07/09/pharmacy-groups-applaud-cms-motion-remand-approval-washington

Individuals with constipation have fewer than 3 bowel movements per week, and symptoms may include straining during bowel movements, bloating, and hard or lumpy stools.

 Additionally, chronic constipation has an estimated prevalence of 15% worldwide and can have a negative impact on daily activities.

 Pharmacists should assess patients for causes of constipation such as certain disease states (eg diabetes) or medications (eg opioids) as part of the management plan.

 Increasing fluids, fitness, and fiber are important lifestyle modifications to start with for treating constipation. However, if these changes do not help, then pharmacists can help patients select an OTC laxative to manage their constipation.

These include fiber supplements (eg psyllium, methylcellulose, calcium polycarbophil) that improve the frequency of bowel movements by retaining water in the stool and increasing stool weight and consistency.

 Patients should be educated to drink plenty of water with these products to prevent bloating, cramping, and bowel obstruction.

 Individuals who are immobile, on fluid restriction, or have trouble swallowing should avoid bulk laxatives. These laxatives typically take 12 to 72 hours to work.

Medications such as bisacodyl work by increasing intestinal motility, and oral products generally take about 6 to 10 hours for onset, with the most common adverse effect (AE) being cramping.

 Patients should begin stimulant laxatives at the initiation of opioid therapy to prevent constipation. Oral stimulant laxatives should be avoided in patients with intestinal obstruction.

 Laxative abuse can occur in patients with eating disorders and individuals who continue to use these medications long-term. Symptoms may include severe diarrhea, dehydration, and electrolyte disturbances.

 Therefore, pharmacists should follow up with patients taking stimulant laxatives.

These agents promote secretion of water into the intestinal lumen to soften stools and help stimulate bowel movements.

 Additionally, they usually take 2 to 3 days to produce a bowel movement.

 Osmotic laxatives should be used in patients after surgery or myocardial infarction, since it is important to avoid straining during bowel movements. These agents are another option for managing constipation in patients taking opioids. Osmotic saline laxatives that contain magnesium or sodium should be avoided in patients at risk for electrolyte disturbances (eg heart or renal failure, elderly, taking diuretics).

Enemas can be used for individuals with fecal impaction, but they should not be used frequently to treat constipation. Glycerin suppositories are a type of osmotic laxative considered safe for use in infants and children for managing constipation that will usually produce a bowel movement in 15 to 60 minutes.

 Parents should be counseled to use only 1 suppository in a 24-hour period. Polyethylene glycol preparations (Miralax; Bayer) are often recommended to treat constipation in children.

 Neuropsychiatric adverse effects have been reported in pediatric patients taking polyethylene glycol.

 One study found that taking the medication daily for 2 weeks did not result in toxic levels of blood glycol.

 However, more studies need to be conducted to determine the long-term effects of polyethylene glycol in the pediatric population and whether it may be associated with safety concerns.

Pharmacists should educate parents about the possible risk of neuropsychiatric AEs with long-term use of polyethylene glycol products in children. 

Medications such as docusate sodium work by moistening the stool by drawing water from the intestines and typically take 24 to 48 hours to work.

 Additionally, these products are often added to stimulant laxatives to treat constipation. Stool softeners are considered safe during pregnancy and can be a good option to help with pregnancy-related constipation.

 Pharmacists can also recommend stool softeners to prevent constipation in pregnant patients taking iron supplements for anemia. 

Jennifer Gershman, PharmD, CPh is a drug information pharmacist and medical writer who resides in South Florida.

1. Laxatives. Mayo Clinic. Updated May 1, 2021. Accessed May 7, 2021. 

https://www.mayoclinic.org/drugs-supplements/laxative-oral-route/description/drg-20070683

2. Bharucha A, Lacy BE. Mechanisms, evaluation, and management of chronic constipation. 

. 2020; 158(5):1232-1249.e3. doi: 10.1053/j.gastro.2019.12.034.

3. Bashir A, Sizar O. Laxatives. StatPearls. Updated September 23, 2020. Accessed May 7, 2021. 

https://www.ncbi.nlm.nih.gov/books/NBK537246/

4. Dabaja A, Dabaja A, Abbas M. Polyethylene glycol. StatPearls. Updated October 20, 2020. Accessed May 7, 2021. 

https://www.ncbi.nlm.nih.gov/books/NBK557652/

5. Williams KC, Rogers LK, Hill I, Barnard J, Lorenzo CD. PEG 3350 administration is not associated with sustained elevation of glycol levels. 

. 2018; 195:148-153.e1. doi: 10.1016/j.jpeds.2017.11.028.

6. Tobah YB. Is it safe to take stool softeners to treat pregnancy constipation? 

https://www.mayoclinic.org/healthy-lifestyle/pregnancy-week-by-week/expert-answers/pregnancy-constipation/faq-20058550

Pharmacists can play an important role in educating patients about the best options for managing constipation. 

OTC Medication Options for Managing Constipation

When counseling a patient with constipation, it is important to review the patient’s medication list to determine the potential cause.

Some of the most common drugs that cause constipation include:

Opioid pain medications such as oxycodone and hydrocodone cause constipation and hardening of the stool. Most patients with opioid-induced constipation (OIC) experience straining and incomplete emptying. OIC may occur immediately or may appear gradually during opioid treatment. Other gastrointestinal (GI) adverse effects (AEs) may occur, including nausea, vomiting, bloating, pain, and straining. OIC is a reason that many patients discontinue opioid treatment.

Nonpharmacological treatment: Increasing fiber, fluids, and exercise can help prevent OIC

Over the counter: Preventive laxatives should begin when opioid therapy begins. Any laxative is sufficient except for bulk-forming laxatives like psyllium. The most common preventive treatment for OIC is a stimulant such as senna or bisacodyl with or without a stool softener (docusate), or daily polyethylene glycol.

Rx: A prescription drug can be used for refractory cases of OIC. Methylnaltrexone bromide subcutaneous injection (Relistor) is the most effective. Other options are lubiprostone (Amitiza; Sucampo Pharmaceuticals), naloxegol (Movantik; AstraZeneca), naldemedine (Symproic; Shionogi), or methylnaltrexone bromide oral tablets.

Besides opioids, there are several other medications and supplements that can cause constipation.

Antidepressants, especially tricyclic antidepressants, selective serotonin reuptake inhibitors, and monoamine oxidase inhibitors

Blood pressure medications, notably calcium channel blockers such as verapamil

Anticholinergic medications, such as diphenhydramine (Benadryl), oxybutynin, and benztropine

Long-term use of cholestyramine or stimulant laxatives (may develop a dilated colon, which turns into a cycle of more laxative use and less efficacy)

In terms of nonpharmacological treatment, counsel patients to increase intake of fiber and fluids. Good sources of dietary fiber include:

Vegetables: cruciferous vegetables like broccoli, brussels sprouts, and cauliflower; asparagus; carrots

Nuts and seeds: almonds, walnuts, chia seeds

Beans and peas: navy, pinto, and kidney beans; split peas; lentils

Whole grains: barley; quinoa; oats; popcorn

A fiber supplement or laxative can be helpful, too. Pharmacists can help patients select an appropriate product based on symptoms, medical conditions, and potential drug interactions.

Patients should be encouraged to keep an open line of communication with their prescriber about the medications they take, making them aware of constipation so that laxative treatment (or possibly changing the offending medication) can be discussed.

What prescription drugs are available for constipation?

If OTC medications do not help constipation, a prescription drug may be another option. Prescription drugs for constipation include the following.

Linaclotide (Linzess; Ironwood and Allergan plc)

Dose: 72 or 145 mcg by mouth once daily on an empty stomach

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