Julia Talsma is lead editor for Drug Topics magazine.

Julia Talsma, Content Channel Director

	The American Society of Health-System Pharmacists (ASHP) is providing quality improvement strategies for pharmacy practice settings across the continuum of care.

 has been updated to help pharmacist leaders and to encourage engagement in healthcare quality initiatives for improving patient outcomes and rewarding better performance, according to an ASHP statement.

	“Close to 40 percent of clinical quality measures are related either directly or indirectly to medication use. Pharmacists have the background to assess the scientific reliability and applicability of these quality measures, and are well-suited for offering ideas on how a proposed measure would be implemented in real practice,” said Shekhar Mehta, PharmD, MS, ASHP’s director of clinical guidelines and quality improvement.

	The new resource center also offers updates on 

 and reporting programs, including links to resources and organizations. In addition, pharmacists can access continuing educational activities, podcasts, webinars, and other media that supports quality improvement and medication safety. ASHP Pharmacy Accountability Measures Workgroup activities are available as well.

	ASHP members are encouraged to sign up to be Quality Advocates, ensuring that pharmacists’ medication expertise is recognized and used to support the 

. For more information on becoming a Quality Advocate, click 

Articles

The American Society of Health-System Pharmacists (ASHP) is providing quality improvement strategies for pharmacy practice settings across the continuum of care.

ASHP offers quality improvement strategies in new resource center

	Pregnant women exposed to environmental phthalates are at an elevated risk of preterm delivery, according to a recent 

	Kelly K. Ferguson, MPH, of the Department of Environmental Health Sciences, University of Michigan School of Public Health, and colleagues reviewed data from 130 women who had preterm babies from 2006-2008 and compared their exposure to phthalate metabolites with 352 randomly chosen case controls. Preterm was defined as fewer than 37 weeks of gestation.

	The researchers analyzed urine samples from study participants three times during pregnancy to determine the levels of phthalate metabolites. Phthalates are chemicals used in plastics and vinyl and are found in many consumer products, such as perfume, hair spray, soap, shampoos, nail polish, and skin moisturizers, as well as food packaging.

	The phthalate metabolites “were associated with significantly increased odds of preterm birth. When spontaneous preterm births were examined alone, MEHP, mono-(2-ethyl-5-oxohexyl) phthalate, MECPP, ∑ DEHP, MBP, and mono-(3-carboxypropyl) phthalate metabolite levels were all associated with significantly elevated odds of prematurity,” the researchers wrote.

	They concluded that environmental exposure to phthalates during pregnancy should be decreased to reduce the chance of preterm birth.

Pregnant women exposed to environmental phthalates are at an elevated risk of preterm delivery, according to a recent study in JAMA Pediatrics.

Phthalate exposure during pregnancy increases odds of preterm delivery

	Collaborative care with pharmacists helped to boost medication adherence in patients with acute coronary syndrome (ACS) after hospital discharge. However, after 12- month follow-up, the proportion of patients who achieved blood pressure and LDL-cholesterol goals were not significantly different from patients treated under usual care, according to a recent study published online for 

	That was the result of a randomized clinical trial of more than 250 patients with ACS released from one of four Department of Veteran Affairs medical centers. Half of the patients in the intervention group had a pharmacist consultation-either in-person or telephonic-within 7 to 10 days following discharge for medication reconciliation and discussion of any medication adverse effects or problems. Within 1 month of discharge, the pharmacist called the patients to assess any new medications and any adverse effects. Also, an attempt was made by the pharmacist to synchronize the prescription refills. Pharmacists also educated patients about the importance of medication adherence. Patients also received medication reminder and refill calls from a voice messaging system for 6 months following discharge, and medication refill calls from 7 to 12 months following discharge.

	“The pharmacists notified the patient’s primary care clinician and/or cardiologist (if the patient had one) that the patient was enrolled in the adherence intervention by having them cosign the pharmacists’ initial enrollment note in the computerized medical record,” P. Michael Ho, MD, PhD, and colleagues wrote.

	The enrollment note contained contact information for the physician to reach the pharmacists for any questions and concerns, Ho noted.

	The primary outcome of medication adherence, as measured by proportion of days covered (PDC), was greater in the intervention group (n=122) than in the control group (n=119) for the four classes of medications: statins, ACEI/ARB, clopidogrel, and beta-blockers. “The mean PDC for the 4 medications combined was greater for intervention patients (0.94 vs 0.87; 

	The secondary outcomes of reaching BP or LDL-C level were not statistically significantly different between the 2 groups. The intervention group did trend toward greater BP control (58.6% vs 48.9%), but the LDL-cholesterol levels were not statistically significantly different (-13 vs -12 mg/dL).

	“Additional studies are needed to understand the impact of the magnitude of adherence improvement shown in our study on clinical outcomes prior to broader dissemination of such an adherence program,” the authors concluded.

Collaborative care with pharmacists helped to boost medication adherence in patients with acute coronary syndrome after hospital discharge. However, after 12- month follow-up, the proportion of patients who achieved blood pressure and LDL-cholesterol goals were not significantly different from patients treated under usual care, according to a recent study published online for JAMA Internal Medicine.

Collaborative care to boost medication adherence may not improve outcomes significantly

	Statin therapy is now recommended for approximately 33 million more Americans who don’t have cardiovascular disease (CVD), but have an estimated 10-year CV risk of 7.5% or higher. These individuals also have LDL cholesterol between 70 mg/dL and 189 mg/dL, according to new guidelines issued Nov. 12 by the American College of Cardiology and the American Heart Association.

 identify four major groups of adults who could benefit from moderate- to high-intensity statin therapy: patients who are 75 years and younger with clinical CVD, patients with LCL cholesterol of 190 mg/dL or more, patients with type 1 and 2 diabetes who are 40 to 75 years old, and patients who are 40 to 75 years with an estimated 10-year CV risk of 7.5% or more and whose LDL cholesterol is between 70 mg/dL and 189 mg/dL.

	“Despite an extensive review, we were unable to find solid evidence to support continued use of specific LDL-C or non-HDL-C treatment targets,” said Neil J. Stone, MD, Bonow Professor of Medicine at Northwestern University Feinberg School of Medicine and chair of the expert panel for the cholesterol guidelines, quoted by the 

	This is a major shift from the 2002 cholesterol guideline that recommended statin therapy only for individuals with a 10-year CV risk level above 20%. The old guideline did not take into account the risk for stroke, only the risk for heart disease, according to a American Heart Association report.

	“We’ve been undertreating people who need statin therapy in this country,” said AHA volunteer Donald Lloyd-Jones, MD, also a member of the expert panel. “Statins lower cholesterol levels, but what they really target is overall cardiovascular risk.”

	In addition to the cholesterol guideline, revised guidelines were released for diet/exercise, obesity, and risk assessment, according to the AHA.

 for individuals with elevated cholesterol and blood pressure recommends a diet that includes fruits, vegetables, whole grains, low-fat dairy products, poultry, fish, and nuts, but limits consumption of red meats and food/drinks with sugar. A diet that limits sodium to 2,400 mg daily should be considered for patients with hypertension. Exercise should consist of 40 minutes of moderate to vigorous aerobic exercise three to four times per week.

 patients will help clinicians identify patients who need to lose weight, will match treatment with risk profiles, offer diets for weight loss, lifestyle intervention, and counseling, as well as aid in the selection of candidates for bariatric surgery.

	Healthcare providers are advised to measure height and weight in order to calculate body mass index (BMI) during annual visits or more often. Overweight and obese patients are defined by a BMI of >25.0-29.9 kg/m2 or >30 kg/m2, respectively. Waist circumference also should be measured annually or more often in overweight and obese patients.

	“Advise adults that the greater the waist circumference, the greater the risk of CVD, type 2 diabetes, and all-cause mortality,” the obesity guideline stated.

	Patients should be counseled that lifestyle changes as modest as sustained weight loss of 3% to 5% can produce clinical health benefits in terms of reductions in triglycerides, blood glucose, hemoglobin A1C, and the risk of type 2 diabetes. Losing more weight will reduce blood pressure, improve cholesterol levels, and reduce the need for drugs to control blood pressure, cholesterol, and blood glucose.

	Bariatric surgery can be considered in adults with BMI >40 or >35 with obesity-related comorbid conditions who have not responded to behavioral treatment or pharmacotherapy to achieve sufficient weight loss. There is no sufficient evidence to recommend either for or against bariatric surgery for adults with a BMI <35.

	“The panel did not choose to deal with various aspects of pharmacotherapy … since at the time the CQs were chosen there was only one approved medication (orlistat) for weight loss,” the expert panel wrote.

 no longer follows the Framingham 10-year risk score estimates of coronary heart disease. New equations were developed to incorporate sex, race, age, treated/untreated systolic blood pressure level, total, and HDL-cholesterol levels, smoking status, and history of diabetes. 

Statin therapy is now recommended for approximately 33 million Americans who don’t have cardiovascular disease (CVD), but have an estimated 10-year CV risk of 7.5% or higher. These individuals also have LDL cholesterol between 70 mg/dL and 189 mg/dL, according to new guidelines issued Nov. 12 by the American College of Cardiology and the American Heart Association.

Statin use urged for 33 million Americans

	Mobile health (mHealth) technology has the potential to reach medically underserved populations and to positively influence behavior change among prediabetes and diabetes patients.

	Knowing this is possible, the Beacon Community Cooperative Agreement Program, developed through funds from the Office of the National Coordinator for Health Information Technology, was created to launch community-based mHealth programs in 17 diverse communities throughout the country. Each Beacon community received $12-$15 million over a 3-year period for its health information technology systems and for implementing them to improve population health, healthcare quality, and reduce costs.

	Three Beacon communities released their insights on the implementation of mHealth for diabetes risk reduction and disease management. They were the Louisiana Public Health Institute, Crescent City Beacon Community in New Orleans, La.; HealthInsight, Southeast Michigan Beacon Community, Detroit, Mich.; and HealthInsight, Utah Beacon Community, Salt Lake City, Utah, said study author Alison L. Rein, MS, of AcademyHealth, Washington, DC. The study was recently published in the 

	Two of these communities - the Crescent City and Southeast Michigan Beacon Communities - had at-risk populations of overweight or obese patients who had low incomes and/or no health insurance. The Utah Beacon Community targeted adults aged 18 and older who had type 2 diabetes.

	In the first group of at-risk individuals, the program used txt4health, a text message service that delivered health information. After enrollment, patients completed a risk assessment for diabetes and received 4 to 7 messages a week that were tailored to their risk stratification level. Patients could also track the progress of their weight loss and exercise by responding to text messages.

	In the second group, adults with type 2 diabetes, Care4Life, a two-way text messaging service, was used to help patients with self-management of their disease. It also provided coaching and an interactive support function, so patients could report monitoring levels for blood sugar and blood pressure, exercise, weight loss, and medication adherence.

	“Beacon communities encountered a number of barriers at each stage [of implementing mHealth], including issues related to developing tailored, culturally competent messages; designing comprehensive outreach strategies; enrolling participants; engaging providers in mHealth programs; evaluating mHealth programs; and sustaining and scaling pilots,” Rein and her colleagues wrote in the study.

	Factors that were critical to success included identification of community partners that could help to reach the targeted individuals, development of message content that could increase enrollment and engagement, and a budget for in-person engagement to increase enrollment. Other important elements are the need to engage providers in promoting mHealth among potential patients and a plan to evaluate the mHealth program strategy.

	The Crescent City and Southeast Michigan Beacon communities reached out to their target populations through advertisements in settings where individuals congregate, including bus shelters and buses, laundromats, and hair salons. Other outreach efforts included health fairs, retail stores, and church meetings, in which community partners were helpful. The Utah Beacon Community directed its outreach effort toward 19 primary care clinics, which identified potential candidates with type 2 diabetes from electronic health records. Patients were invited by mail to enroll online, and staff later helped to assist with patient enrollment.

	“These three Beacon Communities identified some key barriers to enrollment. First, although the txt4health and Care4Life programs were free, messaging rates applied for participants without unlimited texting plans, which proved cost-prohibitive for many,” Rein and colleagues wrote.

	“Limited technology proficiency and/or access to computers or the Internet presented additional barriers to online and text-based enrollment. During a follow-up telephone survey of 104 patients invited to participate in Care4Life, 35% reported limited or no access to a computer and 38% reported having trouble using a Web browser,” the authors noted.

	In-person engagement was helpful in driving enrollment numbers, but this is a more costly and labor-intensive option that needs to be budgeted, Rein said.

	While provider engagement is important for the success of mHealth initiatives with patients, the fee-for-service reimbursement model may be an impediment. With limited time for appointments and providers not being reimbursed for promotion of mHealth programs, this could have been a major problem for the Beacon communities.

	To get around this challenge, practice managers in Southeast Michigan helped enroll patients during check-in and check-out times. At the Utah Beacon program, pay-for-performance incentives to clinics helped drive enrollment with medical assistants enrolling patients as a strategy to achieve their hemoglobin A1c levels.

	“While new reimbursement structures may facilitate integration of mHealth into the primary care workflow, further advances in device interoperability and data integration will also be necessary to achieve this objective,” Rein noted.

	The Beacon communities had to find resources to help with evaluation of their programs, which included community partners. The primary sources of data were the txt4health and Care4Life systems data, electronic health records, and surveys delivered online, by mail, and by phone. Limitations to data collection included nonresponse to surveys, incomplete electronic health records, sampling bias, and landline survey method that could introduce selection bias. Another challenge was determining the impact of mHealth on health behaviors and outcomes, they said.

	“Those embarking on mHealth interventions should carefully consider their evaluation and research aims from the outset, as well as the resources they have at their disposal to achieve their desired outcomes,” Rein noted.

	“In all three Beacon Communities, building relationships with community organizations and leveraging local resources was critical to the success of their mHealth initiatives,” she said.

Technology-based messaging support for at-risk and diabetic patients is being tested in 17 communities across the country. Three of the participating programs have released their evaluations and conclusions.

mHealth for diabetes patients: Lessons learned

	The National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) have endorsed legislation that would restore the ability of consumers to purchase OTC medications using pre-tax dollars from flexible spending accounts (FSAs) and health savings accounts (HSAs) without obtaining a doctor’s endorsement.

	Sen. Mary Landrieu (D-La.) and Sen. Pat Roberts (R-Kan.) recently introduced Senate bill 1647, 

. The act is supported by the Health Choices Coalition, including groups representing consumers, pharmacists, pharmacies, physicians, health insurance companies, and employers.

	“This issue is critically important to the estimated 19 million working Americans who rely on voluntary contributions of pre-tax dollars to FSAs to help meet their basic health care needs, including the purchase of safe, affordable OTC medicines,” the coalition stated in a Nov. 5 letter to the senators.

	“These medicines save consumers billions of dollars annually through reducing unnecessary doctors’ visits, less time lost from work, and the cost advantage of OTC medicines,” according to the coalition.

	The Senate bill is similar to H.R. 2835 that was introduced earlier in the year by Rep. Lynn Jenkins (R-Kan.) and Rep. John Barrow (D-Ga.).

The National Association of Chain Drug Stores and the National Community Pharmacists Association have endorsed legislation that would restore the ability of consumers to purchase OTC medications using pre-tax dollars from flexible spending accounts and health savings accounts without obtaining a doctor’s endorsement.