Whether working in a hospital, specialty, or retail pharmacy, pharmacists will tell you special considerations are needed when dealing with children and infants. Pharmacists must contend with challenges like weight-based dosing calculations, metabolic differences, adverse reactions, and the use of off-label medications and compounds. Combine those concerns with the fact that many patients are too young to communicate about how medications are affecting them, and you have a recipe for potential errors.

A study on pediatric medication safety in emergency departments, published in 

 in March, notes the ED presents a high risk for medication errors including problems caused by a lack of standardized pediatric drug dosing and formulations, lack of clinical pharmacists, and weight-based dosing. For patients outside the hospital setting, medication errors can happen because of confusing product packaging or use of the wrong dosing tools.

“It’s definitely a challenge,” says Anita Siu, PharmD, BCPPS, of weight-based dosing issues. She is a clinical associate professor at the 

, Rutgers University, and a clinical neonatal/pediatric pharmacotherapy specialist at Jersey Shore University Medical Center. “You’re not going to treat a neonate within the first days of life the same way as we treat an infant or give the same doses as a child. Whether it’s younger children or older children, there is a lot of weight variation,” she says.

Drugs can be metabolized at different rates between pediatric and adult populations and within pediatric age ranges. Younger children, who weigh less, may metabolize certain medications faster so they might need a dose three times a day rather than twice as for adults. Body water volume impacts medication distribution and pharmacodynamics affects it, too. “Young kids are basically bags or buckets of water,” says Siu. “Because they have a larger volume of distribution, based on weight, we may need to give them more medicine.”

Related article: Pediatric Pharmacogenomics Offers Treatment Insights

This is often the case with neonates. For example, they may need more gentamicin than older patients, says Susan Warrington, PharmD, BCPPS, clinical pharmacy specialist at the 

Capturing and documenting patient weight accurately and converting pounds to kilograms is crucial because dosages are based on kilograms. If a parent says a child weighs 22 pounds but the weight is recorded as 22 kg, the child could get 2.2 times the dose he or she should be getting, Siu says. The Joint Commission recommends all pediatric hospital patients be weighed in kilograms at admission and within four hours of an emergency situation.

Siu asserts that clinicians should always write the weight on prescriptions and pharmacists should double check the calculations.

Warrington, who does clinical rounds as part of the hospital’s medical team, says she and her colleague, Kristin Held Wheatley, PharmD, BCOP, are able to assess how patients are handling medications and make modifications. Warrington says they also look at polypharmacy issues to “make sure every medication on the list is truly needed” and avoid therapeutic duplication.

Wheatley, a clinical pharmacy specialist in pediatric oncology and infectious diseases, says she often asks if a patient needs to receive a medication by IV or recommends an IV if an oral medicine nauseates the patient.

Another challenge is dealing with off-label medications that haven’t been studied for effectiveness in children. A 2014 statement from the American Academy of Pediatrics (AAP) noted that use of off-label drugs “remains an important public health issue, especially for infants, young children, and children with rare diseases.” AAP noted pediatric labeling information exists in less than 50% of products.

Wheatley says that, at Lehigh, they “use the best data available” and “make the best judgment as to best safely use the medication.”

 Skywalk Pharmacy is an independent community pharmacy that provides specialty pharmacy services for pediatric patients at four locations in Wisconsin. Many of its patients require compounding services for commercially available medications that are dosed, formulated, or FDA-approved only for adults, says Steven Finkenbinder, PharmD, AE-C, manager of clinical pharmacy services.

Making tablets and capsules into pleasantly flavored liquids for children who can’t swallow solid dosage forms.

Creating liquids compatible with enteral tubes or creating topical creams that are not otherwise available.

Creating capsules with the pediatric dose of medication.

Compounding sugar-free suspensions for neurology patients on a ketogenic diet or medications with no dyes and excipients for patients with allergies.

For example, ciprofloxacin liquid is labeled for oral use only, and is thick and can clog enteral or nasogastric tubes. Skywalk compounds ciprofloxacin in a formulation compatible with enteral tubes, Finkenbinder says. They also create gelatin capsules for oncology patients and educate them on how to encapsulate bad-tasting tablets, such as prednisone, to make them more tolerable.

Related article: Pediatric Asthma: An Update for Pharmacists

Finkenbinder emphasized the need for standardization of concentrations for compounded pediatric liquids.

He says Skywalk uses the same manufacturer for liquid compounds with narrow therapeutic windows, such as tacrolimus. Switching manufacturers of these medications can result in variations in blood levels, which could in extreme circumstances result in organ rejection. Skywalk is encouraging health systems to adopt programs like the 

Michigan Pediatric Safety Collaboration guidelines

, an initiative to standardize compounded liquid concentrations for pediatric patients. ASHP has also created an initiative called 

 to reduce errors associated with varying concentrations of compounded medications.

Children need to be watched closely for adverse drug reactions. A British study found at least one in 500 children will experience adverse drug reactions each year; and one in ten for hospitalized youngsters. Siu says children may be more vulnerable to different adverse reactions than adults.

Transitioning care and educating caregivers is a key role for all pharmacists. “Discharge can be overwhelming, particularly for the more chronically ill or complex pediatric patient,” says Warrington, adding that Lehigh Valley Health Network emphasizes creating a partnership with retail pharmacies and outpatient clinics.

Pharmacists may do all they can to ensure patients receive the appropriate medications, but caregivers can make errors. For Finkenbinder, education is a big part of ensuring caregivers understand how to administer medication appropriately. He uses demonstration bottles to show caregivers how to use syringe adapters to remove a dose from the bottle and how to properly measure the dose in milliliters.

Many pediatric patients need doses that require a medication patch be cut into smaller pieces, he says. If a patient needs portions of a patch, he demonstrates how to cut and properly apply the patch. He educates on the proper way to dissolve hazardous medications such as methotrexate to reduce exposure to parents or caregivers.

With education, “it’s important to go the extra mile and ask open-ended questions,” he says. 

Articles

The smallest patients can sometimes present the biggest issues.

Pediatric Problems, and How Pharmacists Can Solve Them

Pharmacists have long been touted as the medication experts, but to maintain that title they will need to expand their knowledge of pharmacogenomics, and they need to do so quickly.

“We need them to take leadership and ownership in this space now rather than later because it’s harder to try to get something back than it is to start showing interest and potential early on,” says Amina Abubakar, PharmD, AAHIVP, owner of 

Related article: The 3 Keys to a Successful Genetic Testing Program

Each year, the field of pharmacogenomics, which is also known as pharmacogenetics and explores how genetics affect patient response to medications, evolves. FDA data show that more than 260 therapeutic agents now have information on how genes affect them in their drug labeling. That number continues to grow as new research emerges. Information obtained from pharmacogenomics can reveal how medication dosing might need to be altered for a patient, or how certain medications might lead to an adverse reaction.

“The science advances in the field are just making it more critical that pharmacists have a really strong understanding of how to blend this into their training,” says Kathleen Jaeger, senior vice president of Pharmacy Care and Patient Advocacy for the 

While the emerging field requires pharmacists to add to their knowledge base, it also presents an important opportunity to enhance their role as a member of the care team.

“In my opinion, they should be the people that own pharmacogenetics,” says Daniel Dowd, PharmD, vice president of medical affairs at 

, a personalized medicine platform that offers a genetic test to guide treatment for a range of psychiatric conditions. “It’s a relatively new field, and who better than pharmacists to optimize drug therapy?”

Community pharmacies, including chain and independents, have already begun offering point-of-care pharmacogenomic services, including taking buccal swabs and sending them to a lab for genetic testing, counseling patients on the results, and working with physicians to develop optimal care plans for individual patients.

Here’s more on how pharmacists are stepping into this field, and how their actions are benefiting patients-and their bottom line.

 announced a pilot program with Genomind to bring genetic testing and counseling to 21 of its Sav-On pharmacies in Boise, ID; five of its Jewel-Osco pharmacies in the Chicago area; and two Sav-On pharmacies at Acmes in the Philadelphia area.

The pharmacies will use the genetic test designed by Genomind to optimize treatment for patients who have had unsuccessful experiences with medication for depression, anxiety, obsessive-compulsive disorder, or other mental illnesses.

Genomind’s specialty in mental health dovetails with Albertsons’ focus on mental health in its company specialty care pharmacy.

“We are already seeing some of these patients in our stores to administer long-acting injectables and so we are able to coordinate that in with this,” says Kimberly Hecht, PharmD, who works in patient care and specialty services/new service development for Albertsons.

According to Hecht, patients can either request the screening on their own, be referred by a physician, or receive a recommendation from a pharmacist.

“It would be patients who maybe are newly diagnosed and they want to pay for the test before they try their first treatment so they don’t try and fail treatment,” Hecht says, adding that other good candidates for the test would be those who have already tried several treatments and haven’t been successful.

One of the goals of the pilot program is to gauge the interest patients and physicians have in the service, and assess whether pharmacists feel it’s an area where they can make a difference in improving medication use. “We’re hoping to see how this new tool helps us better serve patients and improves their outcomes more quickly as they face mental health challenges such as depression, anxiety and obsessive-compulsive disorder,” explains Hecht.

Related article: Precision Medicine: A New Role for Pharmacists

Hecht says they also plan to study whether the consultations pharmacists have with patients regarding the test results are more effective in person or over the phone. Expansion of this service will be determined based on patient and physician satisfaction and the ability of Albertsons Companies pharmacists to make medication interventions to improve patient outcomes. “Because of our expertise and experience in mental health with Specialty Care, we hope to prove this new service is a natural fit for our pharmacy staff helping patients who are dealing with mental health issues.”

Brian Hille, BSPharm, RPh, vice president of Patient, Specialty and Wellness Services for Albertsons, says the company will make the decision whether to expand the services to more stores after assessing what kind of uptake the program receives.

Albertsons may be just beginning their foray into personalized medicine, but 

, a regional chain serving West Virginia, Ohio, and Kentucky, has been offering genetic testing at all its 30 retail stores for more than a year. The pharmacy offers the pharmacogenetic program known as 

 developed by MD Labs. The test uses DNA taken from a cheek swab to evaluate how an individual’s genetic profile may influence treatment decisions. According to the company’s website, the test covers more than 200 prescription and OTC medications.

Lynne Fruth, president of Fruth Pharmacy, says since they’ve begun offering the service they’ve seen a lot of interest in assessing mental health medications and screening children to find the best treatment option whether it’s for ADHD, depression, or other conditions.

The pharmacies have had good feedback from parents of school children who had struggled with finding the appropriate selection and dosing of ADD medications, Fruth says. Testing can help patients determine which specific medications to treat ADD or ADHD may be more effective in a given patient and which may not work as effectively due to an individual’s metabolism, she notes. 

Pharmacogenomics can also be effective in selecting pain medications or deciding whether a patient should take clopidogrel, she adds.

The pharmacy has teamed with Marshall University in Huntington, WV, and MD Labs to address the opioid crisis and will be doing genetic testing on opioid-addicted pregnant mothers, new mothers, and babies to identify the appropriate dosages of buprenorphine for them. “We’re excited to be doing that,” Fruth says.

Related article: What Home DNA Tests Really Tell Us

After the results from the test are received, patients have a personal medication review with a pharmacist who walks them through the results and explains any implications from the findings.

The clinical benefits of using pharmacogenomics are vast, but adopting a pharmacogenomics program can yield significant business advantages for a pharmacy.

As an independent owner, Abubakar has been committed to developing what she calls a “journey beyond dispensing” at her pharmacy, but she found that services such as medication therapy management weren’t helping her generate revenue.

Offering genetic screening has allowed her to establish herself as an expert in personalized medicine, and boost her pharmacy’s revenue. The lab she partners with bills the pharmacies a flat fee of $200 for the testing. Abubakar’s pharmacy then charges $395 for the service and uses it to enhance their medication therapy management program. She says some pharmacies charge as much as $500 for the testing and counseling services.

Fruth reports that her pharmacies charge $400 for the service. Several insurance companies and Medicare part D plans will pay for the service when testing is done for cardiology or behavioral health reasons, otherwise patients may take on the cost themselves. She says those who have paid have reported that the results and its implications for medication therapy choices have been well worth the cost.

The additional revenue has been a bonus, but Abubakar says she’s most excited to be able to use a complex science to improve the lives of her patients.

Related article: Four Business Tips That Make Cents for Community Pharmacy

Fruth says offering the genetic testing services also helps pharmacists solidify their role as a patient’s regular pharmacist because it gives the pharmacist an opportunity to get to know the patient during the counseling session. Pharmacists are able to demonstrate their knowledge during these sessions and communicate an individualized understanding of the patient.

“It’s really just makes that pharmacist stand out as really a part of that care team. So to me, that’s where the real opportunity is for independents and smaller operators,” she says.

There’s also advocacy work that still needs to be done on a national scale, to establish the pharmacist’s role in pharmacogenomics.

Abubakar has spoken at the White House and to the FDA about her work in pharmacogenomics and the role she believes pharmacists can play, but she says there’s still a lack of knowledge in Washington that pharmacists have the skill set and capabilities to be a leader in pharmacogenomics.

“Not everyone has the same information about pharmacists,” Abubakar says. “Many asked me, ‘Are you sure pharmacists can do that?’”  

Why it’s vital for pharmacists to learn about this emerging field.

Pharmacogenomics and the Future of Pharmacy

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Clinical pharmacists who provide comprehensive medication management (CMM) services in primary care networks (PCNs) are helping diabetic patients meet therapeutic goals.

A study at UC Davis Health System PCN, which is made up of 13 patient-centered medical homes (PCMHs), revealed that adding pharmacists to these care settings helped achieve target A1c rates, and improved blood pressure and adherence rates among patients taking statins. The 

 was conducted between October 2014 and October 2015. It was published in the May 2018 edition of the 

Journal of Managed Care & Specialty Pharmacy

Related article: Missing Teeth Could Be Linked to Diabetes Risk

Jarred Prudencio, PharmD, the lead author, says the goal of the study was to see if pharmacists in those settings can improve patient outcomes. Although a pharmacy presence is strong at UC Davis ambulatory clinics, that wasn’t the case in the PCN before the study.

“It’s hard to justify a pharmacist’s salary in a patient-centered medical home because we’re not able to bill it. We needed to prove that with a pilot project. We were able to fund two pharmacists where the outcomes were going to be good enough to justify expanding to the rest of the clinics,” he tells Drug Topics. 

Prudencio, assistant professor of pharmacy practice at the University of Hawaii in Hilo, says that there was a lot of support for CMM in the PCMHs. “But there was nothing really comparing a good comparison group before and after adding a pharmacist. We thought that because of the way that our network was set up, we’d be able to have as close of a real control group as possible.”

The pharmacists connect with patients through an outreach list or from referrals from primary care physicians. In a 40-minute care appointment with patients in the clinic, they conduct medication record reviews to optimize medications and assess adherence. They then conduct motivational interviewing, diet and exercise counseling, and implement their plan.

The pharmacists have a collaborative practice agreement that allows them to change medication regimens and order labs without discussing it with the physician. “From a unique perspective, pharmacists are able to drive home specific details and optimize medications,” Prudencio says. Having the time to communicate with patients, getting them to understand their condition, and why they’re being prescribed certain drugs, makes a big difference, he adds.

Prudencio says that although it’s still not widespread, pharmacists are playing a greater role in primary care settings. “We’re really pushing interprofessional education, so the physicians who are coming out of residencies are used to being trained alongside clinical pharmacists, they know that pharmacists are well trained.”

Related article: Integrating Pharmacists into Medical Homes Significantly Improves Outcomes

He predicts that as PCMHs move toward pay-for-performance reimbursement, more will utilize pharmacists to help satisfy value-based metrics.

Under a fee-for-service model, the only way to receive payment for pharmacist services is to bill under “incident to physician-billing codes,” Prudencio says, where reimbursement rates are very low and not enough to justify the salary of a pharmacist.   

A study has found that pharmacists in primary care networks can help lower A1c levels. 

Why Pharmacists Should Be in a Primary Care Setting

On January 1, 2018, CMS enacted significant cuts to the 340B Drug Pricing Program, which offers discounts on brand name drugs to help compensate eligible hospitals for treating a disproportionate amount of uninsured or underinsured patients. However, the cuts do not affect all hospitals or the pharmacies they may be contracted with, including retail pharmacies.

Hospitals which have already contracted with community pharmacies to fill their prescriptions will not be affected as all previously signed con-tracts are being honored. It is too soon to tell how in-hospital pharmacies will be affected since the planned redistribution of funds from the cuts may affect individual hospitals differently.

“For those hospitals subject to this payment cut, it is a cut of approximately 30% on the amount otherwise received for these drugs,” says Emily Cook, MSPH, JD, a partner at 

, a law firm that works with hospital associations on 340B programs.

Medicare now pays these hospitals average sales price (ASP) minus 22.5% for 340B program drugs, rather than the prior payment of ASP plus 6%. “It is a significant cut,” she tells Drug Topics. “What is interesting about the payment cuts, is that the revenue that was generated by payment reduction is being redistributed to all hospitals [in the 340B program]. The difference in net payments made under Outpatient Prospective Payment System (OPPS), as a result of this payment cut is zero.” The savings from this will be redistributed equally to all 340 B participating hospitals covered under the OPPS.

Related article: The Winners and Losers of 340B Changes

How much the redistribution money compensates for loss of revenue varies by hospital. The amount redistributed depends on what the participating hospitals’ patient and service mix looks like, says Cook. “Hospitals dispensing a large volume of drugs payable under OPPS to Medicare beneficiaries and purchased at 340B price, may see a decrease in payments,” says Cook, noting that some hospitals may have to consider cutting services. “Other hospitals that participate in the 340B program may see an increase in payments.”

Chris Hudson, who serves as a man-aging director and healthcare industry lead at the consultancy firm 

, says it’s too soon to tell whether the reimbursements will adequately compensate some hospitals. “Hospitals are faced with declining reimbursements and increasing costs, which is placing continued pressures on operational excellence and clinical out-comes.”

Lynne Antonio-Lonie, RPh, director of pharmacy services at 

 in Brooklyn, says her hospital is minimally affected by the cuts. “Mostly it affects Medicare Part B drugs that are administered in a physician’s office that the hospitals will buy and bill. There used to be a margin of revenue for that and it’s gone.” Interfaith does not use many physician-administered drugs. It outsourced prescriptions to community retail pharmacies registered with the 340B program, which are not directly affected by the cuts.

“We have a very busy behavioral health clinic that administers long-acting drugs once a month,” says Antonio-Lonie. “It’s very expensive, $1,000 to $3,000 per injection.”

In 2017, a coalition of hospitals fi led a lawsuit against HHS to stop the cuts from being enacted. The case was dis-missed on jurisdictional grounds in December and an appeal is pending, Cook says.

CMS made significant cuts to its drug pricing program, impacting hospitals and patients alike.

Will 340B Cuts Affect Clinical Outcomes?

Pharmacists who offer genetic testing point to several strategies to ensure the successful implementation of a pharmacogenomics program.

It’s essential to understand the complex science and the implications of the test results. For example, Amina Abubakar, PharmD, AAHIVP, owner of 

 in Charlotte, NC.,  received additional education through the College of Pharmacy at the University of Florida.

NACDS has partnered with the University of Pittsburgh School of Pharmacy to create a 

 Community-Based Pharmacogenomics Certificate Program. The 20-hour program includes 12 hours of home study and eight hours of live training.

Related article: Pharmacogenetics in the Community Pharmacy

“It’s going to cover the fundamentals of genetic testing, ethical issues, very specific disease state summaries, and clinical guidelines,” Jaeger says, adding that the course also includes patient counseling strategies and tips on how to work with physicians to become an integral member of the care team. It’s targeted to pharmacists who are already working in the field who want to enhance their knowledge about this growing area.

Many of the labs who produce the genetic tests, including 

, offer their own training programs for pharmacists.

Some genetic tests require a prescription from a physician before they can be administered, but Abubakar says even if it isn’t a requirement, she recommends all pharmacists reach out the patient’s physician before administering a test.

She learned the value of this after screening her first patient four years ago. She hadn’t contacted the patient’s physician until she got back results indicating the patient was not a candidate for clopidogrel. When she sent the results to the physician she was surprised to get an angry phone call in return asking who she was and why she was ordering tests.

Abubakar decided to meet with the physician in person and learned that he saw the test as opening himself up to a lawsuit. Since he had not ordered the test himself, it could have been possible that it got filed away, without ever being reviewed by the doctor and could later present a liability if the patient had later had a stroke.

He also admitted that he didn’t know a lot about the field, so Abubakar decided to reach out to other physicians to find out their views on the emerging science.

Her survey showed that primary care providers thought it was a valuable test if only they knew more or, if they had the time to even review it, because the tests were coming up with so many results that they didn’t prescribe. 

She decided to become the expert herself, enhancing her education, so that she could work closely with physicians to assess the test results. “I was able to bring studies and suddenly I was a go-to person,” she says. “Then they started referring patients to me.”

Now, whenever a new patient comes in, Abubakar or one of her other pharmacists reaches out to the physician before the test is given to communicate that if they receive actionable results they will work with the physician to determine treatment implications.

“Through that approach we’ve got nothing but yeses or the nurse would call and say, ‘Hey, the doctor has never heard of this can you tell us more?’” she says.

Pharmacists also have to educate physicians and the general public that the service exists and is offered at their pharmacy. Fruth advertised through television, radio, and newspapers, even offering a newscaster an opportunity to take the test and announce the results on live television. She also did a lot of speaking events at Rotary Clubs and women’s groups.

“I really found that the market that was most receptive to the messaging was women over 35 because they are really making a lot of the healthcare choices,” she says, adding that often they are often directing the healthcare choices of children, spouses, and aging parents.

Interested in pharmacogenomics? Here’s how you can get started.

The 3 Keys to a Successful Genetic Testing Program

Healthcare in the United States is facing serious problems when it comes to patient access, quality of care, and cost of care. Healthcare delivery continues to evolve toward a value-based system where quality and cost outcomes determine success or failure.

As this evolution unfolds, the challenges of producing higher quality outcomes at lower costs are significant. But where there are big challenges, there are also big opportunities. For too long, healthcare has relied on incremental change methodologies to drive improved results. Systems or tools are changed, but the basic way organizations think does not change. The new tools or systems allow for improved outcomes, but only to a point.

Related article: Do Pharmacists Care About Prevention?

To truly achieve the kinds of breakthrough results needed for U.S. healthcare, transformational change is required, which means changing the way organizations think. To quote the old maxim “If you always think what you’ve always thought, you will always do what you’ve always done, and you will always get what you’ve always got.”

A major opportunity for innovative thinking includes how pharmacy is positioned in the healthcare system. Pharmacy is a fragmented service with distinct demarcations between key practice areas, such as retail, hospital, and managed care. For too many organizations, pharmacy is viewed as an ancillary service and they tend to manage it more like a commodity than a unique clinical and business enterprise. Unfortunately, pharmacy as a profession has not done enough to change this view. We have approached our position from our individual silos and have not created a powerful enough story to change thinking-and we have a very powerful story to tell.

The primary treatment modality for the majority of patients in the ambulatory setting is medication. In hospitals, virtually every patient receives at least one medication. From the perspective of quality, effectively optimizing medication management is a major opportunity to enhance outcomes. No profession is better trained or positioned to do this than pharmacy.

An aging population coupled with more insured patients via the Affordable Care Act has accelerated access and demand issues. At the same time, we are looking at future shortages of physicians. Using pharmacists practicing at the top of their license as the medication therapy experts on the healthcare team frees up physicians to see more patients and helps keep patients out of high cost limited sources of care like hospitals.

 of U.S. healthcare. They currently consume approximately 17% of healthcare dollars. By the end of 2019, prescription drug spending in the United States could top half a trillion dollars. The most effective way to address medication use is to ensure that the optimal therapeutic regimen is chosen and that patients adhere to it. Pharmacists are the best-trained individuals in healthcare to support and drive optimal medication use.

Medication errors are the number one source of medical error and account for approximately $21 billion annually in the United States. Using pharmacists to support patient education and accurate utilization of medications presents a significant opportunity to reduce medication errors with the associated reduction in cost and increase in quality.

Related article: Pharmacists Trapped in the Middle of Drug Price Wars

Healthcare leaders need to change the way they think about pharmacy and better understand how pharmacy can materially contribute to solving the challenges of access, quality, and cost. Pharmacy needs to act as a unified entity, speak with one voice that represents all facets of pharmacy practice, and tell our story more effectively.

The opportunities are significant, but it will take stronger influence and advocacy to change thinking and help us realize our full potential to contribute to the advancement of healthcare.

James A Jorgenson, RPh, MS is CEO and board chairman of Visante, Inc. and Visante Ltd. St. Paul, MN, and a member of the Editorial Advisory Board of Drug Topics.

Healthcare is at a dangerous place right now-but pharmacists can be the ones to help save it.