During my freshman year in high school, my science teacher assigned us to interview people in the community about how they use science in their careers. Although I don’t remember most of the people I spoke with, I can tell you that I spent meaningful time with a local community pharmacist who changed my life.
What I saw was a man who loved his career and truly cared for his patients. In an instant, I knew that I wanted to become a pharmacist, and I never wavered from that goal throughout high school.
Knowing what you want to be when you grow up at age 14 is unusual, but it is very liberating. I simply had to work backwards to figure out how to achieve my goal of becoming a pharmacist.
After high school, I chose to attend Ohio Northern University (ONU) because it had a unique pharmacy program. Rather than attending college for 2 years and then applying to the pharmacy program, ONU students were admitted to the College of Pharmacy from day one.
Although it was expensive, being in pharmacy school from day one and avoiding the risk of rejection made it worthwhile for me.
In college, I spent a lot of time in the library. Although the classwork was difficult, I did well with one exception: organic chemistry.
I did fail organic chemistry—a notorious “weed out” course—but I successfully retook the class over the summer and graduated on time with the rest of my classmates. Failing a course is a difficult stumbling block, but I stood strong and persevered.
Today, I’m thankful for the wonderful pharmacy profession for so many reasons.
First, I’m thankful that community pharmacists are the health care professionals most accessible to the public. If my local pharmacist wasn’t accessible to me, then I likely would have taken a different career path.
Second, I’m proud of the work we pharmacists do, the diversity of our career options, and the relationships we share with our patients and fellow health care providers.
Pharmacy is a profession that makes a real difference in people’s lives. It certainly has made all the difference in mine.
As patients grow weaker and more fatigued, they may also experience shortness of breath that stems from anemia or, in much rarer cases, masses in the chest. “They’re panting, they’re out of breath,” says Dr. Levis. “Walking across the room might be difficult.” Shortness of breath also makes the list of lung cancer symptoms
Unexplained bruises without any physical trauma may be one of many leukemia symptoms, according to Pamela Crilley, DO, chair of the department of medical oncology at the Cancer Treatment Centers of America and chief of medical oncology at the Eastern Regional Medical Center. Unusual bruising is a result of a low platelet count or clotting issues, explains Dr. Levis. “You will bruise spontaneously, seemingly doing nothing,” he says. “It can be anywhere, but typically they’ll be on the extremities—legs and arms.”
Similar to bruising, unusual nosebleeds or bleeding in the gums, bowels, lungs, or the head may be a sign of platelet deficiency and clotting problems, which can indicate acute forms of leukemia, says Dr. Crilley.
Cancers don’t develop overnight. These cancer-fighting foods and other lifestyle moves can significantly reduce your cancer risk. Of course, you should always check with your doctor with any concerns.
Petechiae (small red spots under the skin caused by bleeding)
Dr. Crilley describes petechiae as “like someone painted little red dots with a pen.” The spots, which you might not notice because of their size, painlessness, and placement in the lower extremities, indicate a low platelet count and are one of the symptoms of leukemia. According to Dr. Levis, petechiae are typically found around the ankles because gravity results in the accumulation of bodily fluids in the lower legs throughout the day.
Although an increase in the size of the gums, also known as gingival hyperplasia, is usually only found in a small portion of acute leukemia patients, it’s one of the most obvious leukemia symptoms. “If you have a patient with leukemia, you always look in their mouth to see if the gingiva has gotten bigger,” says Dr. Crilley. The gum may look swollen, says Dr. Levis, and you nearly always feel a strange tightness in your mouth
One sign of chronic—and sometimes acute—types of leukemia is an enlarged spleen, which may result in a loss of appetite. You might have what’s called “early satiety,” according to Dr. Crilley. “Patients eat a little bit of food, they feel full quickly because the spleen is pushing up on the stomach,” she says
An enlarged spleen caused by leukemia sometimes results in abdominal discomfort or even sharp pain. “A patient that presented to me with chronic leukemia a few weeks ago, part of his spleen had died off from spleen enlargement,” says Dr. Levis. “It hurt like heck. It was a sharp pain in his abdomen.” Because the spleen is located in the upper-left quadrant of the abdomen, the discomfort usually occurs there. Don’t miss the 29 things you think cause cancer but actually don’t.
FDA is advancing major new policies to lower insulin prices in the United States.
In a statement published on April 2, 2019, FDA announced plans to transition certain biological products—including the diabetes medication insulin—that have been historically regulated as conventional drugs (a.k.a. small-molecule drugs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be regulated as biologics under the Public Health Service Act (PHS Act). PHS Act typically regulates FDA approval of most biologic drugs.
FDA explained that this transition will allow biosimilar insulin products and substitutes to come to market for the first time, stimulating competition and hopefully lowering the drug’s prices.
The price of insulin has been a pressing issue in public minds, especially among patients with diabetes, pharmacists, and physicians. While the medication has been around for nearly a century, its price continues to skyrocket by double digits annually.
These soaring prices are due in part to a lack of effective competition in the market for insulin products and biosimilar substitutes. Until recently, insulin and other biologic drugs did not have an “abbreviated pathway for bringing follow-on versions to market under the PHS Act,” according to the statement. This changed with the 2010 Biologics Price Competition and Innovation Act through which Congress authorized FDA to open biologics regulated under the PHS Act to competition.
FDA will hold a public hearing on May 13, 2019, to discuss this transition and the unique challenges the introduction of competitive insulin products may bring. The agency hopes to gain feedback from stakeholders and patients alike regarding different factors it should consider as it works to build a “solid regulatory foundation for the review and approval” of these products. FDA added that the input from the hearing will also help to inform the agency on further steps it can take to make high-quality, affordable insulin options more accessible to the public.
Pharmacy pet care: Benefits for animals, their owners—and pharmacists
Kristin Wiisanen
, PharmD, FAPhA (Editor-in-Chief, Pharmacy Today)
As pharmacists, we work every day to make sure people get the right drug at the right dose at the right time. An increasing number of pharmacists are focusing their efforts on veterinary medications to help ensure the same level of care for our animal patients.
This month’s Innovations cover story (page 24) holds a special place in my own heart, as I have seen two beloved family pets pass away in the last 6 months—our 12-year-old golden retriever, who suffered from genetic pigmentary uveitis; and our 10-year-old chocolate lab, who passed away within a few days of being diagnosed with lymphoma and acute kidney failure.
Getting involved with pet care is more than simply a good business opportunity or diversification strategy for many pharmacists. It’s also an important area of specialized practice. Animals are not simply “smaller, larger, fuzzier, scalier, featherier versions of humans … extrapolating [animal doses] from human pharmacotherapy is rarely appropriate,” said Gigi Davidson, RPh, DICVP, director of clinical pharmacy services at North Carolina State’s College of Veterinary Medicine. Check out our cover story to learn more about business model opportunities, common pet care medications, and even some personal stories from veterinary pharmacists.
In this month’s Pharmacy Today, you’ll also learn the latest on newly approved drugs (page 10), updated American Heart Association guidelines for blood pressure measurement (page 19), and recent FDA warnings about deaths with febuxostat (page 22). Catch up on your continuing education with this month’s CPE article reviewing diabetes self-management technologies (page 43).
My family will always have a special place in our hearts for the pets we have lost this year. We will also be forever grateful to the pharmacists who helped us afford up to 16 doses of eye drops per day, compounded custom formulations of pet medications, and provided guidance on administering medications to our pets after surgery and in dialysis. Never underestimate the benefit to your human patients of providing excellent and compassionate care for their pets
What’s the right treatment plan for imbalances in pharmacist workforce supply and demand?
Thomas E. Menighan
, BSPharm, MBA, ScD (Hon), FAPhA (Executive Vice President and CEO, APhA)
Imbalances between workforce supply and demand are notoriously difficult to resolve. Market corrections can take decades to work themselves out, and leaving the market to self-correct doesn’t help those who are suffering today. APhA aims to tackle the problem, yet this stuff is hard! Still, our proactive efforts have opened some potential avenues to progress.
We’re making headway, but just as market and practice changes took time, so will solutions. Since June 2017, APhA’s leadership has targeted the challenges that affect the well-being and resiliency of pharmacists and pharmacy personnel, and our efforts picked up through the discussions of our 2018 House of Delegates. The complexities we’re facing include workforce changes, health care and societal economics and their associated pressures, payer policies, and provider status. It isn’t as simple as “too many schools”!
We’re still working on the profession’s “big picture issues,” including provider status and other regulatory, financial, and legislative remedies. We’re also tackling these short-term issues:
■Payment policies that harm the sustainability of pharmacy practices and their ability to safely provide services to patients.
■Pharmacy safety concerns that are very real and must be addressed.
■Workplace conditions that make many frontline pharmacists feel like they’re in an assembly line. System efficiencies, use of technology, and reductions in administrative burdens can reduce practitioner pain points and allow enhanced focus on patient care.
■Concerns about retaliation against staff who speak up. Retaliation is a violation of the most basic tenets of patient safety systems. At APhA2018 and APhA2019, the APhA House of Delegates adopted a policy officially opposing retaliation and expressing support for systems that allow pharmacists to share their patient safety concerns without fear of losing their job or facing sanctions.
■Pharmacist and pharmacy personnel well-being. Self-care and resilience are essential for any health care professional, and pharmacist well-being is at the center of a major new APhA initiative we’re getting off the ground. Our November 2018 statement on pharmacist and pharmacy personnel well-being and resilience identifies important parts of the equation, such as employer and workplace issues, payment policies, pharmacist recognition, and system issues.
We will convene a consensus conference in July 2019 to facilitate collaborative, respectful dialogue among employers and pharmacy staff, educators, regulators, and policymakers that balances their respective needs and objectives. Stay tuned to learn more about the outcomes of our July 2019 consensus conference.
23andMe releases pharmacogenomics test that doesn’t require prescription
Loren Bonner
Upwards of 20 companies and more than 70 labs offer pharmacogenomics testing through a health care practitioner, giving patients and providers insight into how patients might respond to certain medications.
As pharmacists and other practitioners are trying to get up to speed with this new science, the consumer genetics testing company 23andMe announced in late 2018 that it gained FDA approval for a first-of-its-kind pharmacogenomics test that can bypass a practitioner completely.
According to reports from FDA and 23andMe, the test examines 33 different variants for eight different genes that produce drug metabolizing enzymes. This roughly translates to providing information on how a patient metabolizes about 50 different prescription and OTC medications. While 23andMe has yet to say when the test will be available to patients and for how much, FDA issued a strong statement warning patients and health care practitioners not to use the results to make any treatment decisions.
“FDA is basically saying ‘buyer beware,’ ” said Manju T. Beier, PharmD, BCGP, FASCP, senior partner at Geriatric Consultant Resources LLC and adjunct associate professor of pharmacy at the University of Michigan in Ann Arbor.
For some time now, Beier has been advocating that more pharmacists need to be educated about pharmacogenomics. She believes the recent news from 23andMe can serve as a wake-up call.
“This is yet another tool to utilize judiciously to manage and monitor therapy,” she said.
“Pharmacists are really furthest down the path on pharmacogenomics education,” said David Kisor, PharmD, director of pharmacogenomics education at Manchester University College of Pharmacy in Indiana. “The education that pharmacists are receiving through current certification programs, [continuing education], or graduate programs is necessary to put the pharmacist in the position to discuss this with the public appropriately.”
Kisor hopes the direct-to-consumer test from 23andMe, called the Personal Genome Service Pharmacogenetic Reports test, can ignite a broad discussion with the public about pharmacogenomics testing.
“When we look at educating individuals about pharmacogenomics, we tend to work from the health care provider down to the patient level, and this is really an opportunity to work at the patient or public level,” said Kisor.
Where’s the risk?
Some confusion and even contradiction surround how the new test is supposed to work. In press statements, both 23andMe and FDA
New and emerging considerations in Parkinson’s disease
Joseph Ladd
With roughly 1.5 million Americans diagnosed and 50,000 new incurable cases each year, Parkinson’s disease (PD) has become prevalent in the United States. For some time, the cornerstone of treatment was with levodopa and carbidopa, but in our ever-aging population, medications are needed to address “off” episodes when drugs simply do not work and to treat debilitating symptoms of PD, such as tremor and gait difficulties.
“We need neuroprotective therapies that can be started much earlier than we currently start treatment,” said Jeannette Wick, MBA, RPh, FASCP, assistant director of pharmacy professional development at the University of Connecticut School of Pharmacy. “That is, right now we tend to treat the symptoms, when what we really need is to get to the root of things and have some treatments that are preventive.”
To offer patients gold standard care and prepare them for what to expect in the future, health care providers must become familiar with current and developing therapeutic options for PD.
PD now and in the future
Recently, FDA extended its goal date for review of a levodopa inhalation powder (Inbrija—Acorda Therapeutics) from October 5, 2018, to January 5, 2019.1
If the drug makes it to market, it will be the second drug approved for PD in more than 10 years, following safinamide’s (Xadago—Newron Pharmaceuticals SpA) approval in 2017. Inbrija claims to have improved bioavailability through bypassing the digestive tract with inhaled delivery.
Safinamide is an add-on treatment for patients who are taking levodopa/carbidopa (Rytary—Impax Laboratories) and can help reduce “off” episodes. Dopamine agonists like ropinirole and pramipexole may also be considered, but note the two- to threefold increase in the odds of patients experiencing impulse control disorder. Pimavanserin (Nuplazid—Acadia Pharmaceuticals) helps manage nonmotor symptoms such as depression, dementia, psychoses, and constipation, and has robust effects in patients with cognitive impairments.
“One of the most significant changes in PD has been wider use of deep brain stimulation,” said Wick. “This is an area where pharmacists frequently can be helpful to patients and clinicians, as medications need to be adjusted in the perioperative period.” In contrast to other PD surgeries, deep brain stimulation (DBS) is reversible and causes minimal damage to brain tissue. DBS also allows adjustments to be made externally on the basis of symptoms.
The glucagon-like peptide-1 receptor agonist exenatide has shown trends toward less deterioration of motor function for patients in early studies. It might also provide some improvement in nonmotor symptoms and quality of life, but further research is needed.
Medications commonly associated with drug-induced parkinsonism
High risk
Medium risk
Low risk
Dopamine D2-receptor blockers Some second- and third-generation antipsychotics Antiarrhythmics
Reserpine, alpha-methyl dopa, tetrabenazine Calcium-channel blockers with dopamine agonist activity Some antidepressants
Metoclopramide Antiepileptics (valproate) Immunosuppressants
Amoxapine Statins, some antivirals/antifungals, and antibiotics
View Table in HTML
Note: This is not a complete or totally inclusive list.
Source: Reference 2
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Likewise, more evidence on the use of cannabidiol (CBD) oil for PD symptoms would be helpful. While CBD oil is now used fairly often across the United States, much of the information gathered is anecdotal.
PD in practice
Pharmacists can have an integral role in educating patients with PD and helping them manage their medications safely and effectively. They can also monitor for motor and nonmotor symptoms and postsurgical complications, as they may have frequent access to patients. While assessing new prescriptions, help patients avoid drugs that could cause troubling symptoms. The table reviews some medications that risk inducing parkinsonism.
Levodopa absorption is decreased by high-protein meals, so encourage patients to take this drug 1 hour before or after food to help maintain consistent plasma concentrations.
A synergistic effect has been recognized between DBS and levodopa therapy that allows levodopa to work more effectively and helps some patients use less medication. Immediately after surgery, however, this effect may temporarily magnify levodopa-induced dyskinesias. Patients and clinicians must be prepared for this possibility.
Before DBS surgery, patients should discontinue medications for at least 12 hours. Rarely, patients can stop medications completely following DBS, but this is unrealistic; and clinicians should help patients manage expectations for goals both short term and in the future.
“Hopefully, we’ll have considerably more options to deal with our Parkinson’s patients,” Wick said. “Ideally, they will be drugs that address symptoms evenly, and will have a better selection of less toxic medications.”
Guidelines add latest evidence for managing opioid-induced constipation
Joseph Ladd
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The American Gastroenterological Association (AGA) updated its guidelines on medical management of opioid-induced constipation (OIC), which were published last October in AGA’s journal Gastroenterology.1
Considering the climbing rate of opioid use in the United States and the rate at which OIC accompanies opioid therapy, clinicians may find that reviewing this latest evidence will confer benefits to many of their patients with chronic pain.
Approximately 9 to 12 million Americans suffer from chronic pain annually, and 4% to 5% of the U.S. population uses prescription opioids regularly. OIC is estimated to affect 40% to 80% of patients on chronic opioid therapy. While rates of opioid prescribing have risen throughout several decades, a true representation of those affected by opioid-induced adverse effects and dependence is greater because of increased nonmedical or illicit use.1
As a condition specifically associated with the effects of opioids, OIC differs mechanically from other forms of constipation. For this reason, it deserves dedicated attention and an approach to treatment individualized for specific patients’ needs.
“In my palliative care practice, I have found that untreated constipation—or suboptimal treatment of constipation—can significantly impact a patient’s quality of life,” noted Leah Sera, PharmD, MA, BCPS, assistant professor of pharmacy practice and science at the University of Maryland School of Pharmacy. “We know that constipation is a predictable opioid-related adverse effect, and that patients don’t become tolerant to it. Several new drugs have been approved to treat OIC in the last few years. Guidelines help clinicians translate medical evidence into clinical practice and provide optimal care to patients.”
Recommendation review
This guideline was developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology and best practices determined by the Institute of Medicine. Strong recommendations indicated that most individuals should receive the recommended courses of action, while conditional recommendations suggested that different choices would be appropriate for different patients and that clinicians should spend more time on these decisions. See the table for a graded summary of AGA recommendations for medical management of OIC.
Traditional laxatives were recommended as first-line agents for treatment of OIC because of their low cost, few safety concerns, and wide accessibility in generic or OTC formulations. To avoid potentially undertreating laxative-refractory OIC, the panel suggested treatment combining use of at least two types of laxatives from different classes before escalating therapy. These should also be administered in a scheduled fashion, versus “as needed” use, before considering alternative OIC therapy.
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Four peripherally acting μ-opioid receptor antagonists (PAMORAs) were reviewed, with naldemedine and naloxegol receiving strong recommendations. “Because PAMORAs all have similar mechanisms of action,” said Sera, “the authors of this guideline based their recommendation primarily on the quality of available evidence for each agent.”
Naldemedine was the only prescription drug evaluated by AGA with available long-term safety data available. The overall quality of evidence for use of naldemedine in OIC refractory to laxatives was considered high, but cost may pose limitations. Naloxegol was the first PAMORA approved by FDA, but its moderate-quality evidence for OIC management and high cost denote judicious use. Evidence supporting the use of methylnaltrexone was marked low, receiving downgrades for indirectness, inconsistency, and imprecision across outcomes. The availability of a S.C. formulation, however, may convey advantages in some clinical situations.
Limited consistent evidence exists to support a recommendation for use of lubiprostone or prucalopride for OIC treatment. In the literature, 6.4% of patients who received lubiprostone experienced adverse effects leading to treatment discontinuation, compared with 3.0% in the placebo arm. The quality of evidence for OIC treatment with prucalopride was inconsistent and marked down for suspected publication bias and imprecision.
Distinguishing OIC
OIC has variable descriptions throughout the literature. The most widely used definitions include not only a change in stool frequency, but also changes in stool consistency with or without difficulty upon defecation. On the other hand, opioid-induced bowel dysfunction more generally refers to a group of GI adverse effects associated with opioid therapy, including constipation, gastroesophageal reflux disease, nausea and vomiting, bloating, and abdominal pain.
The Rome IV definition for OIC1
, 2
is new or worsening symptoms of constipation when initiating, changing, or increasing opioid therapy that must include at least two or more of the following:
■Straining during more than one-fourth (25%) of defecations
■Lumpy or hard stools with more than one-fourth (25%) of defecations
■Sensation of incomplete evacuation with more than one-fourth (25%) of defecations
■Sensation of anorectal obstruction/blockage with more than one-fourth (25%) of defecations
■Manual maneuvers to facilitate more than one-fourth (25%) of defecations
■Fewer than three spontaneous bowel movements per week
A consensus definition of OIC, determined at a roundtable meeting by a multidisciplinary working group and published in the journal Neurogastroenterolog y & Motility, is “a change when initiating opioid therapy from baseline bowel habits that is characterized by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, or harder stool consistency.”1
, 3
Treating OIC
OIC is a common and debilitating GI effect of opioids, and some degree of constipation is near universal in patients taking opioids.1
These GI effects of opioids are mediated by κ-receptors in the stomach and small intestine and μ-receptors located in the small intestine and proximal colon. Activation of μ-receptors by opioid medications, resulting in increased tonic nonpropulsive contraction, increased colonic fluid absorption, and stool desiccation, is the primary driver of OIC. Opioids may also increase the minimum sensory threshold of the rectum and anal sphincter tone. Overall, these effects result in harder, dryer stool and less-frequent defecation.
One of the first steps to managing patients with OIC is ensuring that the indication for opioid therapy is appropriate. Patients should participate in a pain management program, ideally in conjunction with a pain specialist, and take the minimum necessary opioid dose. The guideline focuses on medical management of OIC and presumes that patients have had a prolonged requirement or dependence on opioids.
The AGA recommendations do not address the role of psychological therapy, alternative medicine approaches, surgery, or devices used to treat OIC. In addition, combination opioid agonists/antagonists are not specifically addressed, though these agents may result in less constipation than pure opioid agonists when used for management of chronic pain. “There is evidence that fixed-ratio combination prolonged-release oxycodone/naloxone may have a more favorable side effect profile with regards to constipation than other opioids,” said Sera.
Appropriate lifestyle modifications for patients with constipation include increasing fluid intake, getting regular moderate exercise as tolerated, and toileting as soon as possible in response to urges. “Opioid switching”—changing to an equianalgesic dose of an alternative, less-constipating opioid—may also be beneficial. Oral or parenteral morphine, for example, may induce more constipation than transdermal opioids like fentanyl.
The Bowel Function Index is a three-question tool that has been validated in the OIC patient population. A score of 30 or higher is consistent with clinically significant constipation, and a consensus panel recommended using this score cutoff to determine which patients would benefit from escalation of therapy after an inadequate response to two concomitant first-line laxative agents.
“Pharmacists can play a huge role in preventing OIC by counseling patients receiving new prescriptions for opioids about this predictable side effect,” said Sera. “Most patients who are taking a long-acting opioid should also be taking a traditional laxative, as described in the guidelines. Pharmacists can also help to identify exacerbating factors by taking a thorough patient history, and can triage patients who present with red-flag symptoms such as abdominal pain, vomiting, or bloody stools.”
Adolescence is an awkward time for everyone. There can even be awkward moments for pharmacists treating patients of that age.
“Oral contraceptives are an awkward thing to discuss with a teenager when their parents are nearby. They don’t want to ask questions. But we still have the responsibility to counsel them on appropriate use, including using extra protection for at least a week if they miss doses,” said Jake Olson, PharmD, owner of Skywalk Pharmacy, which has three locations in Children’s Hospital of Wisconsin in Milwaukee.
“That can be a difficult conversation if mom is standing right there. We need to be prepared for those real-life situations that didn’t come up when we were learning the art of consultation in pharmacy school,” Olson said.
It can get worse. “I’ve had a dad come storming in and say, ‘Is my daughter on birth control?’ ” he added.
A different world
“We are a pharmacy dedicated to working with children, and it’s a bit of a different world. Much of the medication information that’s out there is about adults and dealing with the health challenges that come when you’re older. Trying to find information on children and what they’re going through, especially in dealing with chronic pediatric illnesses, is a challenge,” Olson said.
But what did Olson do about that dad? “I looked at him and said, ‘That is a conversation you should have with your daughter, not me.’ My mind was racing to figure out what HIPAA says about discussing a minor’s medication with a parent. This is not addressed in fraud, waste, and abuse training,” he said. “I have also had parents say, ‘I’m paying for those medicines on my insurance, so you need to tell me.’ I have even had a parent in a divorced home ask for their year-end tax form to try to get information about the medications their child was filling that the other parent was picking up,” he said. “It’s really challenging to figure out how to respond without breaking confidentiality laws and maintaining the trust that the young adult has in me.”
What to say and to whom is a theme when it comes to treating teens and adolescents, Olson said. “Many times you think, ‘Should I talk to the parent, or should I talk to the child themselves? When is the appropriate time to transition from speaking with a parent about the child’s illness versus speaking to the child directly?’
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Boghossian; Gall; Maria Perez, sales associate; Carly Jones, student pharmacist; Brian Halm, PharmD.
“You want to include adolescents and teenagers in their own health care knowledge and treatment, but at the same time, you need to make sure that they’re actually taking their meds and being responsible,” he said. “We all know that ‘responsibility ’ is not the first word that comes to mind when you think about teenagers,” Olson said.
“If they have chronic illnesses—cystic fibrosis, juvenile rheumatoid arthritis, Crohn’s disease—there are very important medications that they need to take consistently. If they’re not taking their medications appropriately, then they end up getting sick,” Olson said. “But as a 13-year-old, is it supposed to be your job to remember to take your inhaler twice a day, or is that mom’s job to tell you that? And when does that start to transition to become your responsibility?”
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Boghossian and Olson.
Olson noted that, unfortunately, he’s seen kids as young as 5 who are forced to become their own primary health care provider because of issues in the home. “It’s eye-opening how young some children are who call in their own refills and receive their consultations when they pick up their medications.” But there’s another side to that coin. “We see 25-year-olds who are still waiting for mom to tell them when to take their pills.”
And then there’s that rebellious phase. “A child who’s 16 years old may start to experiment with alcohol,” Olson said. “A 60-year-old realizes that drinking too much alcohol with certain medications can have serious side effects. But teenagers sometimes have to learn that for themselves the hard way, and that can cause problems.”
Warning teens can be uncomfortable. “You need to say, ‘No driving with this medication and no drinking,’ and a helicopter mom is not letting you talk directly to the child,” Olson said. “Sometimes we ask mom, ‘Hey, mom, why don’t you go check out the candy over there in the corner,’ or ‘Why don’t you go next door for a second? I need to have a conversation with your child about some things.’ ”
Mental health
“Kids are really stressed out,” said Julie Dopheide, PharmD, professor of clinical pharmacy, psychiatry, and the behavioral sciences at University of Southern California and Keck School of Medicine. “Adults are stressed out, too, but adults have learned some coping strategies. Kids are figuring everything out all at once. They’re really anxious.”
Teens and adolescents might engage in self-injurious behavior and have suicidal thoughts and behaviors. “There are so many things that could make a youth think that suicide is their only way out. Some of it’s related to bullying, some of it’s related to anxiety, depression, not fitting in, gender identity issues,” Dopheide said. “They don’t have the futuristic thinking of, ‘Maybe when I’m 30, I’ll feel differently.’ ”
Dopheide said teens are highly reactive to their environment, with many variables that affect how they present from one day to the next. “They’ve got their friend group, they’ve got their parents, they’ve got their other extended family members. They tend to not be mature enough to think things through. They’re more impulsive,” Dopheide said. “It’s important to see them over time to get an accurate diagnosis.”
That can be a challenge for pharmacists. “Pharmacists only see the parents and the family members for a particular window in time,” Dopheide said. “I think the best thing practically for a pharmacist to do is to encourage the family not to jump to a diagnosis too quickly. Parents may want easy answers. Sometimes it’s a relief for them to know, ‘My child has this. So, I can just put them on that, or we can just get him this therapy, and then they’ll be fixed.’ But it’s not that simple.”
Pharmacists should encourage a systematic approach. “You have to look at what’s predominant in the child: is the anxiety predominant, the ADHD predominant, the depression predominant? And then you treat that first. Once that is better, you re-evaluate to see if the other conditions also need a medication,” she said.
“I’ve seen patients on five or six, even seven to nine meds. And they’re doing okay finally, so nobody wants to take anything off. That’s the fear: ‘Well, this combination’s working, so I don’t want to change anything,’ ” she said. “A child might be on clonidine and Risperdal, and they’ve got some aggression and they’ve got some ADHD, but they’re also anxious. And then they’re getting Benadryl for sleep and maybe they’ve also got melatonin, and then they’re adding Zoloft or Prozac, and then finally, they start to do well. But maybe it’s because they were depressed or anxious all along!”
Dopheide said that all pharmacists should learn certain principles of psychiatric pharmacotherapy. “The special thing about giving youth antidepressants is that they could potentially have a hyperarousal or activation type of reaction. They could get restless, jittery, more amped up or hyper. They could become more impulsive,” she said.
Pharmacists should refer patients experiencing activation syndrome to their psychiatrist. “It could be a sign that they might have an underlying bipolar disorder, or it could be a sign that they are at risk for acting on any suicidal thoughts.” She emphasized that this should not preclude antidepressants. “But we have to watch for that behavioral activation within the first month of starting the antidepressant,” she said.
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“Another premise for kids is that withdrawal symptoms are worse in youth than in adults. So, everything must be tapered off gradually,” she added.
Counseling teens on mental health
“While we might be talking to the parents the most, sometimes it is good to talk to the kids, especially if you’ve got someone who’s 14, 15, 16, 17. The medical model works well with those kids—they’ve had some biology, some biochemistry. You can talk to them about rebalancing chemicals in their brain and staying on a medicine to make sure their brain is healthy,” Dopheide said. She believes that message can destigmatize mental health conditions.
Sometimes cultural issues are at play. “A lot of cultures believe if you have a mental health condition, it’s embarrassing or a smear on the family, and maybe you’re a bad parent if your kid has some mental health condition. So, pharmacists can try to help develop a culture of anti-stigma,” she added. “It’s a very delicate area.”
Dopheide once treated a patient on the autism spectrum who was acting aggressively and hitting his mother when she tried to get him to eat. “Part of autism is you have particular food texture issues, and you don’t eat everything. But in that family’s culture, you’re supposed to eat! It’s a big deal if you’re not eating.”
She recommends pharmacists visit the National Alliance on Mental Illness (NAMI) website at www.nami.org to learn more about issues in various cultures. “And I typically recommend patients and families call their local NAMI groups, which sometimes have cultural chapters. In Santa Ana there’s a large Vietnamese community, so there’re NAMI groups that specialize in cultural issues in that area.”
Birth control
Sally Rafie, PharmD, is assistant clinical professor of health sciences at the University of California San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences. She is also the founder of birthcontrolpharmaci st.com and helped develop the California statewide protocol for self-administered hormonal contraceptives.
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Look out for adverse effects
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ADHD is one the most studied neuropsychiatric conditions in youth, and there are numerous ADHD formulations with different release forms that pharmacists should know about. “There’s now Jornay PM (Ironshore Pharmaceuticals), which is given at bedtime and takes effect in the morning. And there’s a recent meta-analysis that showed methylphenidate should be first-line in adolescents because of tolerability issues,” Dopheide said. She noted the availability of several new amphetamine compounds, variations of mixed amphetamine salts, and a triple-bead amphetamine, Mydayis (Shire). “Pharmacists need to stay on top of and help patients and families manage side effects and find the right ADHD medication for them.”
Dopheide urges pharmacists to scrutinize indications for antipsychotics to make sure that there is a valid indication, such as schizophrenia or bipolar disorder with psychotic features. They shouldn’t be used for anxiety, insomnia, or behavior control for conduct disorder for longer than a 3-month trial.
“Long-term use of antipsychotics like risperidone can lead to decreased bone density, and kids could be more at risk for fractures when they are playing sports or in general,” she said. She noted that there is evidence that this is a particular issue for kids with autism spectrum disorder.
“And then there’s the metabolic side effects of things like olanzapine and clozapine. You can develop diabetes, hyperlipidemia, and weight gain—it’s much harder to reverse if you develop these as a child or teenager than if you develop them as an adult.”
Emergency contraception
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Pharmacies typically stock Plan B emergency contraception (EC) products—the levonorgestrel-containing emergency contraceptives. A newer method, ulipristal acetate (Ella—Afaxys), is also available. “EC is extremely safe. There are essentially no contraindications for anyone of any age to be using those products,” Rafie said.
“Given all of the changes that happened in the last decade with the regulatory status of the Plan B products being prescription only, then OTC for 18 and over, and now fully OTC, it’s been really hard for pharmacies to keep up with all of that, especially because there isn’t targeted academic detailing or outreach to pharmacies. I think that is part of the reason why sometimes there’s misinformation out there,” said Rafie.
Rafie said pharmacies are the go-to source for EC. “We want to make sure pharmacists are knowledgeable about the products and are offering counseling, but not requiring it. Ideally, they are keeping the product out on the OTC shelves unlocked, because locking it just makes it more stigmatizing and intimidating. Then we should also be keeping some in the back in the pharmacy, because some patients will prefer to come straight to the pharmacist.”
For those times when you can’t help, “there are some really great resources out there. If a pharmacy is in a state where prescribing a birth control is available, but the pharmacy doesn’t provide that service, [pharmacists] can hop on BirthControlPharmaci es.com and find another pharmacy nearby to send the patient to. If the patient, for example, wants something like an IUD, something the pharmacy obviously can’t provide, [the pharmacist] can hop on Bedsider.org and find a clinic that can help them with that,” said Rafie.
Rafie encourages pharmacists to consider why their adolescent patients are pursuing hormonal contraceptives. “Sometimes, they may be seeking it for noncontraceptive reasons. So, they may not even be sexually active but may want to treat their acne, or maybe they have really heavy periods. So, while it’s not required in California that we get into the indications, it does allow for more patient-specific counseling and a better experience for the patient.”
Rafie advocates that pharmacists “think about making sure that we’re welcoming our younger population—so have literature that’s appropriate for youth, and have a confidential space to speak to young people so that it’s not in front of everyone.”
While some pharmacists may have personal biases toward teenagers having sex, “as long as they can acknowledge that and actively work around it to serve their patients’ needs, then I think they can still provide really respectful competent care to patients,” Rafie said. “Teens don’t want to have someone speak to them in a condescending fashion. So we want to make sure that we are respectful toward them and helpful and friendly. Our facial expressions, our tone—all of that makes an impact on their experience at the pharmacy.”
When dealing with sexually active adolescents, keep in mind that they “are typically at higher risk for STDs, so we should counsel them about safe-sex practices such as using condoms, as well as getting at least annual screenings for STDs,” Rafie said. Pharmacists should make sure that “our counseling is comprehensive, listening to the patient about their values and what they’re comfortable with. If they want a birth control method that they can hide from their parents, take that into consideration, and help them understand the importance of adherence for the effectiveness of the medication.
“There is one kind of additional counseling point when it comes to the Depo injection, which is the shot that’s good for 3 months. That does cause some reversible bone density loss in young people. We would just encourage them to use calcium and vitamin D supplements [and do] weight-bearing exercises, and then there’s a return of that bone density after they stop the medication,” Rafie added.
Opioids and other considerations
“Another challenge for pharmacists dealing with patients this age is when they stop getting weight-based doses and begin getting regular dosing for adults. When does that transition occur?” said Skywalk’s Olson.
“If you’ve got an 11-year-old who’s 5’11”, and you see there’s a weight-based dose for her, sometimes you have to think that through. Sometimes we get 18-year-olds with special needs who are really small, and you think, ‘Well, this is an adult, I should treat them as an adult.’ But no, they’re not big enough yet.”
Controlled substances for pain, ADHD, and other uses also pose consultation challenges at Skywalk. “We consult patients and families on postsurgical pain medications on a daily basis. We once again have to mention the risk of driving while taking opioids and the dangers associated with mixing it with alcohol,” Olson said. “We also have to say, ‘This is what you read about every day. This prescription is a gateway to potential abuse problems down the road.’ ”
He also tries to educate parents on the potential for abuse. “They need to know that it is important to dispose of unused medications promptly to make sure they don’t fall into the wrong hands,” Olson said. “We feel we can help combat the opioid problem with this initial education.”
New AHA/ACC cholesterol guideline recommends use of statins, new drugs
Loren Bonner
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The American Heart Association (AHA) and the American College of Cardiology (ACC) released a new guideline that emphasizes a more patient-centered approach to cholesterol management. The guideline, which was published in the November 2018 issue of the Journal of the American College of Cardiology, updates the 2013 AHA/ACC cholesterol guideline and incorporates all recent evidence relevant to the treatment of hypercholesterolemia .
Even though statins continue to be the cornerstone of therapy in the new guideline, health care practitioners—includ ing pharmacists—should know that just starting a statin is not sufficient, according to Joseph Saseen, PharmD, BCPS, BCACP, who was a part of the writing committee for the guideline, serving as APhA’s representative.
“Patients need to be evaluated after implementing therapy to ensure they are adherent, and to also ensure that an adequate response is achieved,” said Saseen, who is vice chair of the department of clinical pharmacy at University of Colorado Skaggs School of Pharmacy.
The updated guideline not only calls for a more personalized assessment of risk for patients, but also recommends nonstatin cholesterol lowering medications, including ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, for patients who are at the greatest risk.
Maximally tolerated statin use is recommended to reduce LDL-C levels by at least 50% in patients who have atherosclerotic cardiovascular disease (ASCVD). But when statins are not working and the patient is very high risk, the guideline endorses the use of new drugs, PCSK9 inhibitors, that have been developed since the 2013 cholesterol guideline—but after starting ezetimibe. The guideline stresses a healthy diet and exercise as the primary intervention for patients who do not fall into these categories.
APhA is listed in the AHA/ACC guideline report as an official partner organization that endorsed the new guideline.
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Individualized treatment decisions
The new guideline, like the 2013 version, still strongly recommends statin therapy for patients who are at an increased risk of ASCVD. It’s recommended that patients use a maximally tolerated statin to reduce LDL-C.
“However, there is now strong emphasis on evaluating the response to therapy by evaluating the LDL-C lowering while on therapy,” said Saseen. “It’s all about the LDL-C lowering achieved—if it’s not acceptable, then it’s recommended to intensify therapy,” he said.
If the threshold LDL-C value is not reached, the guideline recommends enhancing statin therapy and then adding ezetimibe. In some patients, then adding a PCSK9 inhibitor may also be an option.
However, it’s noted in the guideline that PCSK9 inhibitors are likely cost-prohibitive to patients, based on mid-2018 pricing. Evolocumab (Repatha—Amgen) and alirocumab (Praluent—Sanofi-Aventis) both launched in 2015 with a list price of more than $14,000 a year. One manufacturer announced a price reduction this past October to less than $6,000 a year, with the other one expected to do the same.
Karen McConnell, PharmD, FCCP, BCPS-AQ Cardiology, ASH-CHC, system director of Clinical Pharmacy Services at Catholic Health Initiatives in Colorado, found it interesting that the guideline incorporated the cost of PCSK9 inhibitors in the recommendations.
“They used cost considerations to add a value statement on high-cost therapies. I think more guidelines should incorporate this information so clinicians understand the overall cost for medications,” said McConnell, who was appointed by APhA as an expert reviewer of the guideline.
Tools for personalized assessment of risk for patients are included in the guideline. Also emphasized is the need for health care practitioners to have a clinical discussion with their patients, which they can use to guide their choice of therapy.
Assessing an individual’s other risk factors can help further determine risk and allow a patient and clinician to discuss treatment options on the basis of the patient’s specific risk factors. These include metabolic syndrome, a family history of premature ASCVD, kidney disease, chronic inflammatory conditions, HIV, race and ethnicities at a higher risk, elevated lipoprotein(a), or elevated high-sensitivity C-reactive protein.
“It is allowing for more individualized treatment decisions,” said Janelle Ruisinger, PharmD, FAPhA, clinical professor of pharmacy at the University of Kansas School of Pharmacy. She said pharmacists can aid in risk assessment and discussion with patients about treatment decisions.
“Physicians are already pushed to see more patients in less time, so this is an area where pharmacists can assist by engaging in the clinician–patient risk discussion, help patients understand their CV risk, and determine the appropriate treatment route based on the patient’s preferences,” said Ruisinger, who also served as an APhA-appointed expert reviewer of the guideline.
She said the same is true for conversations about lifestyle modifications that the guideline calls for. Pharmacists are fully equipped to educate patients about the importance of diet, exercise, and more.
Separate sections in the guideline discuss recommendations for special populations, such as older adults, and for patients with certain conditions, such as heart failure.
Pharmacists influence adherence
The guideline specifically mentions the important role of pharmacists on the health care team when treating patients with hypercholesterolemia .
“The 2018 version recognizes that pharmacists can have a positive impact on adherence, which is a constant struggle with lipid-lowering medications,” said Ruisinger.
McConnell said pharmacists in all settings can contribute. Those working in ambulatory care can make sure their chronic care patients are on appropriately dosed statins, are adherent to their medications, and have had an appropriate response to therapy. Pharmacists working in inpatient settings need to ensure patients are discharged on an appropriate secondary prevention medication, including those for lipids. In the community setting, a pharmacist can play a role in making sure patients are adherent to their medications, McConnell said, and if they are complaining about adverse reactions, pharmacists can work with their provider to find alternatives.
In addition to the AHA/ACC guideline, other guidelines exist for managing patients’ cholesterol: The National Lipid Association (NLA) Recommendations for Patient-Centered Management of Dyslipidemia; the American Association of Clinical Endocrinologists and the American College of Endocrinology Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease; and the U.S. Preventive Services Task Force’s statement on Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: Preventive Medication.
Ruisinger said she thinks it’s important to be aware of the other guidelines. However, pharmacists should ultimately follow whatever their health care team chooses.
“Most practitioners follow the AHA/ACC guidelines, and a few follow the NLA guidelines,” said Ruisinger. “If the pharmacist is working with a primary care practitioner group that prefers to follow the NLA guidelines, that is reasonable. I think it is important that the team is on the same page and following the same guidelines or recommendations.”
The 2018 AHA/ACC guideline is based on a few key studies that were published since the 2013 guideline, including HOPE-3 (Heart Outcomes Prevention Evaluation-3); IMPROVE-IT (The Improved Reduction of Outcomes: Vytorin Efficacy International Trial); FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk); and ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab).
These strategies can prevent accidental daily methotrexate dosing
Institute for Safe Medication Practices
Methotrexate is a folic acid antagonist that was originally approved to treat a variety of cancers. For oncologic indications, methotrexate is administered in cyclical frequencies and in variable doses based on body surface area and the type of cancer being treated. The labeled indications for methotrexate later expanded to include treatment of nononcologic conditions, including psoriasis and rheumatoid arthritis. Methotrexate also is prescribed for other nononcologic off-label uses (e.g., Crohn’s disease, multiple sclerosis). For most nononcologic indications, a low dose of methotrexate is administered just once or twice weekly (e.g., 7.5 mg/wk when treating rheumatoid arthritis).
A high-alert medication
Relatively few medications are dosed weekly; thus, accidental daily dosing of oral methotrexate has occurred all too frequently. This type of wrong frequency error has originated in all stages of the medication use process, from prescribing to self-administration. These errors have resulted in serious overdoses that have led to vomiting, mouth sores, stomatitis, skin lesions, liver and renal failure, severe myelosuppression, GI bleeding, life-threatening pulmonary symptoms, and in some cases, death.
Since early 1996, harmful or fatal errors with daily oral methotrexate for nononcologic use have been reported to the Institute for Safe Medication Practices (ISMP). ISMP has designated oral methotrexate for nononcologic use as a high-alert medication since 2003. Although the risk of errors with oral methotrexate for nononcologic use has been known for a long time, harmful and fatal errors are still occurring today.
Fatal error
The most recent event involved an error that was caught during hospitalization but continued upon discharge when an incorrect entry for daily methotrexate on a patient’s home medication list was not corrected. An older adult with rheumatoid arthritis was admitted to a hospital with renal failure. At home, he had been taking oral methotrexate 2.5 mg twice weekly. When completing the list of the patient’s home medications, the admitting physician mistakenly documented that the patient had been taking 2.5 mg of oral methotrexate twice daily instead of twice weekly. He then made this an active order during the patient’s hospitalization.
Noticing the daily order for methotrexate, a pharmacist contacted the physician to let him know that he must prescribe daily methotrexate on a hospital-mandated chemotherapy order template. However, the pharmacist did not verify that the patient had an appropriate oncologic indication for the order. The physician then prescribed the daily methotrexate via a chemotherapy order template. Fortunately, an oncology pharmacist identified the error after talking to the patient and corrected the active order to twice weekly. However, it never occurred to the pharmacist to correct the methotrexate entry on the patient’s home medication list.
The patient received the correct dose during his hospital stay before being transferred to a skilled nursing facility. The physician reconciled the patient’s list of home medications for continuation upon discharge. In doing so, he pulled the erroneous methotrexate entry from the patient’s home medication list and prescribed oral methotrexate 2.5 mg twice daily. The patient received twice-daily methotrexate at the skilled nursing facility for more than a week before he was rehospitalized with a change in mental status, severe neutropenia, and mucositis.
Sadly, he died in the hospital about a week later.
Strategies
Most of the wrong frequency errors with methotrexate could be prevented by fully implementing long-standing risk reduction strategies, including the following:
■Defaulting to a weekly dosing schedule in prescriber and pharmacy order entry systems
■Requiring verification and entry of an appropriate oncologic indication in order entry systems for daily orders
■Educating patients and providing them with verbal and written instructions that specify the weekly dosing schedule, and emphasizing the danger with taking daily or extra doses
■Asking patients to repeat back the instructions for taking oral methotrexate to validate understanding
■Verifying the dose and frequency of all medication lists and discharge instructions
■Limiting the prescription quantity to a 30-day supply (e.g., dispensing just eight 2.5-mg tablets for a 5-mg/wk dose would reduce the risk of a serious overdose)
Pharmacists have duty to consult prescriber, court says
David B. Brushwood
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Pharmacists have a legal duty to screen prescriptions for potential problems and to consult with the prescriber when necessary to resolve problems in the patient’s best interests. An Ohio court has addressed the basis of this responsibility and the argument that prescribers either do not welcome, or will not heed, concerns expressed to them by pharmacists.
Background
The plaintiffs alleged negligence by the defendant pharmacy in dispensing lamotrigine to a 6-year-old patient. The lawsuit claimed that the dispensing pharmacist erred by not providing warnings to the patient and by failing to consult the prescriber about an excessive dose and off-label use to treat bipolar disorder.
The court said that the pharmacist testified “he knew lamotrigine was a dangerous antipsychotic drug when used for a child under 16 years of age. He knew that dosing was calculated by age and weight. He knew the prescription was ‘red flagged’ by [the pharmacy’s] computer DUR system. He failed to obtain the 6-year-old plaintiff’s weight and failed to call the minor plaintiff’s physician. He testified he could have easily done so and that he could have obtained the necessary information in 5 minutes or less. He was also aware that exceeding the dosage guidelines carried an increased dangerous risk for children. He failed to warn the plaintiffs of the dangers associated with the use of the drug at this dosage level.”
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The defendant pharmacy moved to dismiss the case, arguing that “courts across the country have ruled as a matter of public policy that a pharmacist has no duty to warn a patient of a drug’s contraindication, or to warn a patient of the consequences of taking the drug.”
Rationale
In considering the motion, the court said, “The better public policy argument for imposing a duty to warn is the pharmacist’s role as a ‘safety net.’ Pharmacists have an equal (if not greater) knowledge of the pharmacology and contraindications of drugs than many physicians. Why have any DUR policies if a pharmacist is merely the processor of the physician’s prescription and simply the pill counter? Certainly, most pharmacists would be insulted to know that physicians and courts of law view pharmacist expertise as limited to the perfunctory manual rote duty of filling prescriptions. This court fails to see the logic in not adding a duty to warn as one last layer of protection for a patient when a physician prescribes a drug that a pharmacist has reason to know has potentially disastrous side effects.”
The pharmacy contended that even if the pharmacist had consulted the prescriber, there would have been no changes in the prescription because prescribers do not accept advice provided by pharmacists. The court disagreed, noting testimony provided by a physician expert witness. That expert testified, “The pharmacist’s job is to educate the doctor when a prescription is written that is dangerous or inaccurate. I think that if a pharmacist calls you up and says that you’re giving a potentially dangerous dose of a drug and you don’t change it, you probably won’t be practicing medicine very long.”
The court concluded from this testimony that “a physician called by a pharmacist and warned of the high potential for harm for an overdosage of the drug for the child’s weight and age would likely modify the dosage or cancel the prescription.”
The pharmacy’s motion to dismiss the case was denied.
Discussion
Prescriptions that pose potential problems for patients rarely need to be processed immediately. There is ample time to consult the prescriber and resolve questions that a pharmacist may have. This is not a matter of obstinately refusing to process a prescription without consultation. Rather, it is an inability to provide medication to a patient without clarifying matters related to dosage, drug–drug interactions, or other concerns about patient safety. It is the prescriber who has caused these concerns, and it is the prescriber to whom a pharmacist must turn for resolution.
A man goes into a drugstore and asks the pharmacist if he can give him something for the hiccups. The pharmacist promptly reaches out and slaps the man's face.
"What did you do that for?" the man asks.
"Well, you don't have the hiccups anymore, do you?"
The man says, "No, but my wife out in the car still does!"
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