Diana M. Sobieraj, PharmD

A mother comes to your pharmacy counter with 2 cans of powdered infant formula that she is considering purchasing: 1 is milk protein—based and the other is a hydrolyzed formula (and significantly more expensive). She has chosen to transition her infant son to formula because of her medical conditions. She asks if the hydrolyzed formula is worth the extra money. Her son was born full-term without complications, has no known allergies, and is now 6 months of age.

What is the role of hydrolyzed formula in the nutrition of infants, and should you recommend such formula to this mother?

SG is a 65-year-old woman with hypertension who comes to your pharmacy regularly for her lisinopril/hydrochlorothiazide prescription. While taking care of her latest refill, you notice SG’s age and recall this qualifies her for the pneumococcal vaccination. After talking with SG, you learn she has not yet been immunized against pneumococcal infection as an adult.

As the pharmacist, should you offer the vaccination today, and with which pneumococcal vaccine?

 Both milk-based and hydrolyzed formulas use cow’s milk as the protein source, although a hydrolyzed formula contains milk protein that is partially broken down. Hydrolyzed formulas are indicated in infants with a milk-protein intolerance or milk-protein allergy because the broken-down proteins are less likely to cause an adverse reaction, such as bloody stool or any combination of cutaneous, respiratory, or gastrointestinal symptoms. Although 5% to 15% of infants have adverse reactions to cow-milk protein, a minority (an estimated 2% to 7.5%) have a true milk-protein allergy. Because this infant has no known intolerance or allergy to cow-milk protein, it is not necessary for the mother to use the more expensive, hydrolyzed infant formula. As the pharmacist, you should ensure that she has selected an iron-fortified term formula since it will be the infant’s primary means of nutrition. When formula is chosen over breast milk for infant nutrition, any milk-based term formula (as opposed to preterm infant formula) that is fortified with iron is recommended for healthy, full-term infants. To help prevent the development of iron-deficiency anemia, formulas that are iron-free or fortified with low-dose iron are not recommended.

 As of August 2014, the Advisory Committee on Immunization Practices recommends a 1-time vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) for adults 65 years and older, followed by the 23-valent pneumococcal polysaccharide vaccine (PPSV23), ideally 6 to 12 months later (at minimum, 8 weeks later). Previously, PPSV23 was recommended alone in this population. This change is a result of a large randomized trial comparing PCV13 to placebo in adults 65 years or older that found significant reduction in both community-acquired pneumonia and invasive pneumococcal disease in immunized patients. PCV13 was approved in adults 50 years and older in late 2011. Therefore, if a patient 65 years or older received this vaccine prior to turning 65, he or she would not be eligible for another dose. Adults 65 years or older who previously received a dose of PPSV23, however, should receive a dose of PCV13 at least 1 year after PPSV23. Administration of PCV13 with trivalent inactivated influenza vaccine has been found to be immunogenic and safe. No data are available on the coadministration of PCV13 with other vaccines among adults. Given these current recommendations, SG is eligible to receive 1 dose of PCV13 now, followed by 1 dose of PSV23 6 to 12 months later. As SG’s pharmacist, you should offer her the vaccination today.

Yunes Doleh is a PharmD candidate at the University of Connecticut School of Pharmacy. Celeste Karpow is a PharmD candidate at the University of Connecticut School of Pharmacy. Dr. Sobieraj is assistant professor of pharmacy practice at the University of Connecticut School of Pharmacy. Dr. Coleman is a professor of pharmacy practice, as well as codirector and methods chief, at Hartford Hospital Evidence-Based Practice Center at the University of Connecticut School of Pharmacy.

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Articles

Case Studies (May 2015)

MJ is a 44-year-old female who comes to the pharmacy to purchase a box of Oxytrol for Women. She states that she has been experiencing symptoms of urinary incontinence in which she “feels like I have to go but can’t control it,” and she feels embarrassed by the amount of times she has to go to the bathroom daily. Recently, she has had a few additional episodes of incontinence related to sneezing. She saw a commercial for Oxytrol on TV and thought she would try it before talking with her doctor. MJ denies any other significant medical history other than hypertension, which is well controlled by lisinopril 40 mg daily. She has no known allergies.

As the available pharmacist, do you believe MJ is a candidate for OTC Oxytrol for Women?

BT is a 65-year-old male with hypertension, type 2 diabetes mellitus (DM), osteoarthritis, and benign prostatic hypertrophy. He had a myocardial infarction 2 years ago and has been taking Lipitor 80 mg daily ever since. BT has tolerated therapy very well and has no complaints of muscle aches and pains. His liver function test results have always been within normal limits. He expresses concern about the strength of his statin therapy and questions the need for such a high dose.

Is high-dose statin therapy appropriate for BT according to the new American College of Cardiology—American Heart Association guidelines for the treatment of high cholesterol?

 Overactive bladder can be defined as urinary urgency with or without urge incontinence, usually accompanied by frequency and nocturia, in the absence of a urinary tract infection or other obvious pathology. Anticholinergic drugs are the treatment of choice for such incontinence, with several agents in the class having approval for this indication. Oxytrol, the transdermal delivery system of oxybutynin, has been available by prescription since 2003 but was recently approved for OTC use. Each patch delivers 3.9 mg of oxybutynin per day, although 1 patch is applied and worn for 4 full days before being removed and replaced with a new patch.

		MJ does not appear to have any contraindications to OTC use, which include the presence of pain or burning during urination; blood in urine; unexplained lower back or side pain; cloudy or foul-smelling urine; male gender; younger than 18 years; only accidental urine loss during sneezing, laughing, or coughing; and diagnosis of urinary or gastric retention, glaucoma, or hypersensitivity. MJ should be counseled on proper patch application and the risk of pruritus and anticholinergic side effects, specifically xerostomia and constipation, which are commonly reported with use of the patch. She should contact her physician if she doesn’t experience a benefit within 2 weeks or if she has any bothersome side effects.

 The newest cholesterol treatment guidelines were published in November 2013. The following patients are considered candidates for high-intensity statin therapy: those with clinically evident atherosclerotic cardiovascular disease, those with a low-density lipoprotein (LDL) level of 190 mg/dL or greater, and those aged 40 to 75 years with type 1 or 2 DM and a 10-year risk of 7.5% or higher with an LDL level of 70 to 189 mg/dL. Clinically evident atherosclerotic disease includes acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or arterial revascularization, stroke, transient ischemic attack, or peripheral artery disease presumed to be of atherosclerotic origin. Statin daily doses that can achieve at least a 50% reduction in the LDL level (eg, atorvastatin 40 to 80 mg daily or rosuvastatin 20 to 40 mg daily) are considered high intensity. For diabetics who have lower than a 7.5% 10-year risk, moderate-intensity statin therapy is recommended. For patients aged 40 to 75 years with an LDL level of 70 to 190 mg/dL with a 10-year risk of at least 7.5%, moderate- to high-intensity statin therapy is recommended. In general, moderate-intensity statin therapy is considered a daily dose of statin that can lower the LDL level by 30% to 50%.

		BT has clinically evident atherosclerotic cardiovascular disease given his history of myocardial infarction and should continue his current Lipitor regimen. Routine LDL monitoring after initiation of statin therapy is no longer recommended, as there are no longer target levels to which clinicians should treat. BT should continue to be monitored for safety of the regimen, namely muscle and hepatic injury.

Dr. Sobieraj is assistant professor of pharmacy practice, and Dr. Coleman is professor of pharmacy practice as well as codirector and methods-chief, at Hartford Hospital Evidence-Based Practice Center at the University of Connecticut School of Pharmacy.

Case studies involving urinary incontinence and the appropriateness of high-dose statin therapy.

Case Studies

IC, a 38-year-old man, arrives at the pharmacy with new prescriptions for Delzicol (mesalamine) capsules (dosage: three 400-mg capsules twice daily) and Canasa (mesalamine) suppositories (dosage: one 1000-mg suppository at bedtime). IC tells the pharmacist he was recently discharged from the hospital with a diagnosis of acute, mild to moderate ulcerative colitis and that his colonoscopy showed inflammation of his entire colon. IC says he is feeling better, having only 2 to 3 bouts of non-bloody diarrhea a day, but often has to use the bathroom in the middle of the night. The pharmacist gives IC his 2 prescriptions and, while explaining their use, says they both contain the same active ingredient—mesalamine. IC asks, “Why do I need to take the same drug in 2 different ways?”

ZK is a 32-year-old man who regularly comes to your pharmacy. He tried to quit smoking last year but failed because he followed the warning on the package that said “Do not use if you continue to smoke.” Although he tried to stop smoking cigarettes the day he began using the patch, he was unable to sustain this and, after a few days, stopped his attempt to quit smoking. Today, ZK comes to your pharmacy to talk to you about quitting again.

What information can the pharmacist provide to ZK?

 Ulcerative colitis (UC), which affects about 500,000 individuals in the United States, is a chronic disease characterized by mucosal inflammation restricted to the colon. It involves the rectum in about 95% of cases and may extend proximally to involve all or part of the large intestine. The hallmark clinical presentation is bloody diarrhea often accompanied by symptoms of rectal urgency and tenesmus (feeling a constant need to pass stool, despite an empty colon).

		The pharmacist should explain to IC that because his UC affects more than just his distal colon, the inflammation that needs to be treated extends outside the reach of topical therapies (eg, Canasa suppositories), and therefore oral therapy is required. According to current American College of Gastroenterology guidelines for UC, patients with mild to moderate extensive colitis should begin therapy with oral sulfasalazine in daily doses titrated up to 4 to 6 g a day or another aminosalicylate (eg, mesalamine) in doses up to 4.8 g a day (level of evidence: A). However, because IC is complaining of symptoms of rectal urgency and/or tenesmus at night, he may also benefit from taking the mesalamine suppositories, as they act directly at the site of the rectum and better target these specific symptoms. Guidelines suggest that the combination of oral and topical mesalamine may more successfully induce symptom remission by 8 weeks than oral mesalamine alone.

 The FDA recently suggested that manufacturers of OTC nicotine replacement therapy (NRT) change their labeling warnings to avoid impeding attempts to quit smoking. The FDA’s recommendations are based on “decades of research” on NRT, which does not suggest a significant risk of addiction or abuse associated with these products. The requirement for the “do not use” warning on all NRT has been removed by the FDA. In addition, in the product’s directions, instead of the label stating that smoking should be completely stopped when therapy begins, the language has been softened to “begin using the patch on your quit date.”

		The pharmacist should encourage ZK to set a quit date and to plan to stop smoking on that day. However, ZK should realize that if he is unable to fully stop smoking on his quit date, he does not need to stop his quit attempt. Although there does not appear to be excess harm from continued smoking while using the patch, ZK should strive to reduce his smoking until he is abstinent.

		In another label change under directions, the firm recommendation to stop using therapy after the designated duration was changed to a suggestion that if the patient feels he or she would benefit from longer therapy, the patient should discuss this with his or her physician.

Dr. Coleman is associate professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group, and Dr. Sobieraj is assistant professor of pharmacy practice, at the University of Connecticut School of Pharmacy.

This month's cases involve a patient prescribed 2 different medications with the same active ingredient and a patient who has struggled to quit smoking.

FK is a 68-year-old man who comes to your pharmacy with several new prescriptions. The day before, he was discharged from the hospital, where he spent 2 weeks in the intensive care unit due to sepsis from a complicated exacerbation of chronic obstructive pulmonary disease. You notice one prescription is for omeprazole 40 mg daily, a medication he has never filled before. You ask FK if he had any gastrointestinal problems during his hospitalization and why omeprazole was prescribed. He denies any new health problems and says he is unaware of why this medication was started.

As FK’s pharmacist, what should you do regarding his omeprazole prescription?

ML presents with a prescription for metronidazole 500-mg tablets to be taken twice daily for 7 days to treat bacterial vaginosis. She asks how long it will take for the prescription to take effect because she is flying to her sister’s wedding the next day. You begin discussing her prescription and how it will be important to abstain from alcohol while taking metronidazole and for up to 3 days after she is finished with the therapy. ML quickly replies that it won’t be possible to adhere to those restrictions until 2 days from now and that she will plan to start therapy then instead of today.

What alternative therapies could ML’s physician prescribe for her bacterial vaginosis?

 Case 1: Patients who are hospitalized in the intensive care unit are often prescribed acid-suppressing therapy for the prevention of stress ulcers. Although the risk of bleeding from a stress ulcer is low, there is an associated mortality of 50%. Risk factors for stress ulcers include major trauma, severe head injury, multiple organ failure, burns, major surgeries, severe sepsis, shock, mechanical ventilation, coagulopathy, high-dose steroids, and tetraplegia. Histamine

- receptor antagonists, proton pump inhibitors, antacids, and sucralfate can be used to prevent stress ulcers during a hospital stay. Appropriate discontinuation of therapy at discharge is important to avoid subsequent unnecessary therapy and adverse events associated with acid suppressive therapy (ie, increased risk of 

 infection, pneumonia, and fractures). The pharmacist should call the prescribing physician to verify the indication for FK’s omeprazole prior to filling the prescription.

 The Centers for Disease Control and Prevention suggest that symptomatic bacterial vaginosis in nonpregnant females be treated with oral metronidazole (500 mg twice daily for 7 days), vaginal metronidazole gel (0.75%, 1 applicatorful daily for 5 days), or vaginal clindamycin cream (2%, 1 applicatorful daily for 7 days). Patients treated with metronidazole should abstain from alcohol or the use of ethanol-containing products for the duration of therapy and for 3 days afterward due to the risk of disulfiram-like reactions. Such interactions have been reported in patients who have taken oral, intravenous, and vaginal tablet forms of metronidazole. In ML’s case, it is probably best to recommend clindamycin vaginal cream instead so that therapy is not delayed and the patient can be safely treated.

Diana M. Sobieraj is assistant professor of pharmacy practice and Dr. Coleman is associate professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group at the University of Connecticut School of Pharmacy.

SD is a 59-year-old man with stable coronary artery disease and exertional angina that is being medically managed. He also suffers from chronic obstructive pulmonary disease (COPD), hyperlipidemia, and is a current smoker. SD has received a trial of metoprolol succinate, requiring the maximal dose for angina relief. Unfortunately, SD was unable to tolerate the exacerbation of his COPD symptoms that resulted. SD has also tried nitrates, but had to discontinue therapy because he suffered intolerable headaches.

What other therapies are available for the treatment of SD’s angina?

MJ is a 63-year-old woman with type 2 diabetes, hypertension, and mild heart failure. Her glycemic control is consistently suboptimal (A1C = 7.9%) despite taking metformin 1000 mg twice daily and glyburide 10 mg daily for a few months. Today, MJ comes to pick up her refills and begins to discuss her diabetes control with you. She reports taking her medications daily and that gaining better control of her diabetes is a priority to her, but states, “I am not ready to start injecting myself and prefer to stick to pills.” Her provider would like to initiate a third agent.

 Beta blockers are the first-line therapy for the medical treatment of angina, however, like many patients with respiratory disease, he was unable to tolerate this therapy. Even the use of cardioselective beta blockers in patients with respiratory diseases may exacerbate symptoms, especially as the dose is increased, which can lead to the loss of cardioselectivity. Guidelines suggest the use of a calcium-channel blocker when a beta blocker is contraindicated or causes adverse events, or in addition to a beta blocker when additional angina relief is needed. SD may benefit from the initiation of a calcium-channel blocker given his intolerance of other therapies. If after trying a calcium-channel blocker he still experiences residual angina symptoms, ranolazine may be added for its additional antianginal effects.

 Given MJ’s heart failure (pioglitazone may not be optimal due to fluid retention) and her opposition to injectable drugs at this time, the provider is left with a few options, including dipeptidyl peptidase-4 inhibitors and canagliflozin (Invokana), the first approved sodium glucose-2 (SGLT2) cotransporter inhibitor. SGLT2 is a carrier that facilitates reabsorption of glucose from the urine at the kidney; therefore, blocking SGLT2 enhances urinary glucose loss. As monotherapy, canagliflozin has been shown to lower A1C by 0.91% to 1.16%, and compared to sitaglitpin (100 mg) as add-on therapy to metformin and a sulfonylurea, canagliflozin (300 mg daily) appears to decrease A1C to a greater extent (~0.37%). Canagliflozin use is often associated with weight loss of 2.2 to 3.3kg, while sitagliptin generally has a neutral effect on body weight. Rates of hypoglycemia appear similar between the agents (40.7% with sitagliptin vs. 43.2% with canagliflozin). It is important to note, however, that cangliflozin has been found to be associated with an increased rate of urinary frequency, genital mycotic infections, and urinary tract infections compared to placebo. MJ will have to discuss the trade-off between increased efficacy with canagliflozin and its possible adverse events with her provider.

Dr. Sobieraj is assistant professor of pharmacy practice and Dr. Coleman is associate professor of pharmacy practice and director of the pharmacoeconomics and outcomes studies group at the University of Connecticut School of Pharmacy.

MJ is a 45-year-old female patient who has a history of a purulent cough with a fever for 3 days. She complained of chest pain and difficulty breathing, and has no remarkable medical history. MJ made an appointment to see her primary care physician, who determined she had community-acquired pneumonia. MJ was given a prescription for azithromycin 250-mg tablets with instructions to take 2 tablets today and 1 tablet daily for the next 4 days. MJ approaches your pharmacy counter and is concerned because not long ago she saw a news story about the risk of azithromycin causing heart rhythm abnormalities. She asks if you believe she is at risk and if she should take the azithromycin?

SD is a 30-year-old female patient who is 30 weeks pregnant and is a patient at your pharmacy. She notices that you are able to administer vaccinations and proceeds to tell you about her best friend whose baby was diagnosed with pertussis when she was 2 months old. SD expressed that she is very concerned given the increased incidence of pertussis this year and how much her friend’s baby suffered. SD would like to know if there are any immunizations she is a candidate for that will provide her baby protection from pertussis. 

 On March 12, the FDA issued a safety warning for azithromycin and the risk of potentially fatal heart rhythms. This is based on a study published in 2012 in 

 as well as a manufacturer-sponsored study. Specifically, the FDA warns that azithromycin can lead to prolongation of the QT interval and possibly lead to Torsade de pointes. Patients at particular risk are those with existing QT prolongation, low serum potassium or magnesium levels, bradycardia, or who are taking certain anti-arrhythmic drugs. In such patients, alternative antimicrobials should be considered, although the other macrolides erythromycin and clarithromycin and the fluoroquinolones ciprofloxacin and levofloxacin also carry warnings for QT interval prolongation. MJ has no remarkable medical history and therefore should not be at increased risk of arrhythmias from her azithromycin regimen. She should take the medication as prescribed.

 The Advisory Committee on Immunization Practices recommends that all pregnant women receive the Tdap vaccination regardless of prior vaccination status. The optimal window for vaccination is between 27 and 36 weeks gestation in order to maximize the passive immunity transferred to the fetus. The peak immune response is observed 2 weeks after the vaccine is given. If the woman does not receive the Tdap during her pregnancy, the vaccine should be administered immediately postpartum, which is fully compatible with breastfeeding. There is also an advantage of the female herself being protected against pertussis to reduce the likelihood of transmission to the newborn. Of note, infants are not fully protected against pertussis until they are 6 months of age and have received their third DTaP vaccine. Ideally, SD should receive the Tdap now.

Case studies involving azithromycin and arrhythmias and the pertussis vaccine during pregnancy.