D-PRESCRIBE: Pharmacist-Led Intervention Can Reduce Inappropriate Medications in Older Adults

MedicalResearch.com Interview with:
Cara Tannenbaum, MD, MSc Director | Directrice Canadian Deprescribing NetworkCara Tannenbaum, MD, MSc

Director | Directrice
Canadian Deprescribing Network

MedicalResearch.com: What is the background for this study? What are the main findings?

 Response: The D-Prescribe trial was driven by the need to show that seniors can cut down on their medication in a safe and effective manner. Pharmacists intervened in a proactive way to flag patients who were on potentially risky meds such as sleeping pills, NSAIDs and glyburide and to inform them of the risks, using an educational brochure. Pharmacists also communicated with their physician using an evidence-based pharmaceutical opinion to spark conversations about deprescribing. As a result, 43% of patients succeeded in discontinuing at least one medication over the next 6 months.
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Medical Record Doesn’t Always Reflect Medications Patient Actually Taking

MedicalResearch.com Interview with:
"Portable Information station, nurse, computer, hand wipes, 9th floor, Virginia Mason Hospital, Seattle, Washington, USA" by Wonderlane is licensed under CC BY 2.0Timothy Ryan PhD

This work was performed while Dr. Ryan was at
Precera Biosciences, 393 Nichol Mill Lane
Frankluin, Tennessee 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The study design is quite simple.  We measured medication concentrations in patients, then compared empirically detected medications with prescribed medications in each patient’s medical record.  We used this information to estimate how many prescribed medications patients had actually taken and how often they took medications that were not in their medical record.  The later comparison is a particularly novel measure of the number and types of medications taken by patients unbeknownst to healthcare providers who use the medical record as a guide to patient care.

Further, the test was performed in blood and not urine, so we could obtain an estimate of how often patients were in range for medications that they did take – at least for medications where the therapeutic range for blood concentrations are well established.

In sum, we found that patients do not take all of their medications, the medical records are not an accurate indicator of the medications that patients ingest, and that even when taken as prescribed, medications are often out of therapeutic range.  The majority of out-of-range medications were present at subtherapeutic levels.  Continue reading

Most Older Americans Willing To Discuss ‘De-Prescribing’ Some Medications

MedicalResearch.com Interview with:

Dr. Emily Reeve BPharm(Hons) PhD NHMRC-ARC Dementia Research Fellow Northern Clinical School University of Sydney

Dr. Reeve

Dr. Emily Reeve BPharm(Hons) PhD
NHMRC-ARC Dementia Research Fellow
Northern Clinical School
University of Sydney

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Older adults commonly take multiple medications. All medications carry the potential for both benefit and harm. When a medication is started a decision has been made between the healthcare professional and the patient that the likely benefits outweigh the potential risks. But over time the potential benefits and harms can change. So, part of good clinical care is discontinuation of medications when the benefit no longer outweighs the risks – for example when it is no longer needed or high risk. This is called “deprescribing”.

Previously we knew that older adults could have mixed feelings about their medications, that is, they believe that all their medications are necessary but also feel that they are a burden to them. Qualitative research has explored this further, finding that there are a number of barriers and enablers to deprescribing from the patient perspective. For example, someone might have fear of deprescribing because they are worried that their symptoms may come back. But if they know that deprescribing is a trial and they will be monitored and supported by their physician or other healthcare professional they might be more open to deprescribing.

From the physician perspective, there were concerns that older adults and their families were resistant to deprescribing and so there was fear that discussing possible medication discontinuation could damage the doctor-patient relationship.

In this study of almost 2000 older adults in the United States, we found that over 90% were willing to stop one of more of their medications if their doctor said it was possible. Additionally, one third of participants wanted to reduce the number of medications that they were taking.  Continue reading

Errors in Dementia Drugs Surprising Common in Parkinson’s Disease

MedicalResearch.com Interview with:

Allison W. Willis, MD, MS Assistant Professor of Neurology Assistant Professor of Biostatistics and Epidemiology Senior Fellow, Leonard Davis Institute Senior Scholar, Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine

Dr. Willis

Allison W. Willis, MD, MS
Assistant Professor of Neurology
Assistant Professor of Biostatistics and Epidemiology
Senior Fellow, Leonard Davis Institute
Senior Scholar, Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania School of Medicine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study was motivated by my own experiences as a neurologist-neuroscientist.

I care for Parkinson disease patients, and over the year, have had numerous instances in which a person was taking a medication that could interact with their Parkinson disease medications, or could worsen their PD symptoms.
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With Aging Comes Increasing Cost of Life-Extending Medications

MedicalResearch.com Interview with:

Jonathan H. Watanabe, PharmD, PhD, BCGP Associate Professor of Clinical Pharmacy National Academy of Medicine Anniversary Fellow in Pharmacy Division of Clinical Pharmacy | Skaggs School of Pharmacy and Pharmaceutical Sciences | University of California San Diego La Jolla, CA 

Jonathan H. Watanabe, PharmD, PhD, BCGP
Associate Professor of Clinical Pharmacy
National Academy of Medicine Anniversary Fellow in Pharmacy
Division of Clinical Pharmacy | Skaggs School of Pharmacy and Pharmaceutical Sciences | University of California San Diego
La Jolla, CA

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: As a clinician in older adult care and as a health economist, I’ve been following the news and research studies on older patients unable to pay for their medications and consequently not getting the treatment they require. Our goal was to measure how spending on the medications Part D spends the most on, has been increasing over time and to figure out what prices patients are facing out-of-pocket to get these medications.

In 2015 US dollars, Medicare Part D spent on the ten highest spend medications increased from $21.5 billion in 2011 to $28.4 billion in 2015.  The number of patients that received one of the ten highest spend medications dropped from 12,913,003 in 2011 to 8,818,471— a 32% drop in that period.

A trend of spending more tax dollars on fewer patients already presents societal challenges, but more troubling is that older adults are spending much more of their own money out-of-pocket on these medications.  For patients without a federal low income subsidy, the average out-of-pocket cost share for one of the ten highest spend medications increased from $375 in 2011 to $1,366 in 2015.  This represented a 264% increase and an average 66% increase per year.  For patients receiving the low income subsidy, the average out-of-pocket cost share grew from $29 in 2011 to $44 in 2015 an increase of 51% and an average increase of 12.7% per year.  This may not sound like much, but for those living close to the federal poverty level this can be the difference between foregoing necessities to afford your medications or choosing not to take your medications.   Continue reading

‘Deprescribing’ Can Reduce Harm of Medications in Elderly

MedicalResearch.com Interview with:
“Pills” by Victor is licensed under CC BY 2.0Khalid Ali, MBBS, FRCP, MD

Senior lecturer in Geriatrics
Brighton and Sussex Medical School, UK 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Older people are more like to have more than one chronic condition (multi-morbidity), and as such as are more likely to be prescribed several medications (poly pharmacy) to treat those conditions. At the point of hospital discharge, older people are given different / new medications in addition to their old ones, and this puts them at higher risk of harm related to medicines. Our study led by  Brighton and Sussex Medical School (BSMS) and King’s College London involved five hospitals and 1,280 patients (average age 82 years) in South England. Senior pharmacists interviewed patients and carers, reviewed GP records and analysed hospital readmission to determine medication-related harm.

The study found that more than one in three patients (37%) experienced harm from their medicines within two months of hospital discharge, and that this was potentially preventable in half of the cases. Medication-related harm was most commonly found to occur from the toxicity of the medicine itself and in a quarter of cases from poor adherence.  The medicines found to pose the highest risk were opiates, antibiotics and benzodiazepines. Patients suffered a range of side effects including serious kidney injury, psychological disturbance, irregular heart rhythms, confusion, dizziness, falls, diarrhoea, constipation and bleeding.

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Big Data Using Predictive Analytics Aims To Improve Medication Adherence

Neil Smiley

Neil Smiley

MedicalResearch.com Interview with:
Neil Smiley

Founder and CEO of Loopback Analytics

Editor’s note: Loopback Analytics mission is to “integrate data across a myriad of healthcare information systems to bridge the expanding gaps within the care continuum”. CEO Neil Smiley discusses the problem of medication adherence and possible means to address the issue.

MedicalResearch.com: What is meant by medication “adherence”? How big a problem does this represent in term of health care outcomes and costs?

Response: Medication adherence is the degree to which a patient is taking medications as prescribed. Poor medication adherence takes the lives of 125,000 Americans annually, and costs the health care system nearly $300 billion a year in additional doctor visits, emergency department visits and hospitalizations.

MedicalResearch.com: What can be done by health care providers, systems and pharmacists to improve medication adherence?

Response: There are many potential failure points after a prescription is written, that range from affordability, transportation, literacy, confusion over brand vs. generics, duplication of therapy. Many patients simply stop taking medications when they start feeling better or fail to refill chronic maintenance medications. Healthcare providers can improve adherence by anticipating and eliminating potential points of failure before they become problems. For example, high risk patients leaving the hospital are less likely to be readmitted if they get their prescriptions before they are discharged. Follow-up consultations by pharmacists can assist patients with side effects that may otherwise cause patients to abandon their treatment plan and provide patients with education on how to take medications correctly.

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Patients With Schizophrenia Often Discharged on Multiple Medications

MedicalResearch.com Interview with:

Glorimar Ortiz, MS Senior Researcher/Statistician NRI-National Association of State Mental Health Program Directors Research Institute Falls Church, VA 22042

Glorimar Ortiz

Glorimar Ortiz, MS
Senior Researcher/Statistician
NRI-National Association of State Mental Health Program Directors Research Institute
Falls Church, VA 22042

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Despite the lack of empirical evidence that antipsychotic polypharmacy produces greater outcomes to antipsychotic monotherapy, and that several clinical guidelines recommend against it, patients with a diagnosis of schizophrenia continue to being discharged on polypharmacy. Over the past few years, attempts have been made to lower the rate of antipsychotic polypharmacy throughout the country. Most of the existing literature on this topic are based on Medicaid claims data which exclude data for patients discharged from state psychiatric inpatient hospitals. Our study is very important because it is the first time that data on the use of antipsychotic medications are analyzed using a large sample of discharges from state psychiatric inpatient hospitals. These hospitals now have the opportunity to benchmark their antipsychotic medication use rate with national rates more accurately, and therefore, develop and implement performance improvement activities that are more precise. The study found that 12% of all discharges were prescribed two or more antipsychotic medications. Of those patients discharged on at least one antipsychotic medication, 18% were prescribed two or more antipsychotics. The study also found that patients with a schizophrenia diagnosis and an inpatient hospital stay of 3 months or longer are more likely of being discharged on polypharmacy, and that the main reason for this was to reduce patient’s symptoms. Antipsychotic polypharmacy affects nearly 10,000 patients with schizophrenia annually in state psychiatric inpatient hospitals.
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Prescription ReadyFill® Program Improved Medication Adherence and Reduced Waste

Dr. William H. Shrank, MD, MSHS Senior Vice President, Chief Scientific Officer and Chief Medical Officer Provider Innovation and Analytics, CVS Health

Dr. Shrank

MedicalResearch.com Interview with:
Dr. William H. Shrank, MD, MSHS
Senior Vice President, Chief Scientific Officer and Chief Medical Officer
Provider Innovation and Analytics
CVS Health

Medical Research: What is the background for this study?

Dr. Shrank: CVS Health launched, a prescription refill program available at all CVS/pharmacy locations and through CVS/caremark mail pharmacy, to coordinate refills for eligible maintenance prescriptions as a way to save customers time and help them stay on track with their medications. Concerns had previously been raised about the potential of these programs to produce drug waste by reducing a patient’s involvement in the dispensing process, which could result in prescription oversupply and unnecessary health care spending. 

Medical Research: What are the main findings?

Dr. Shrank: The CVS Health Research Institute found that ReadyFill® improved adherence to medications for common chronic conditions without contributing to drug oversupply.

In fact, those enrolled in the program receiving 30-day supplies of medication had a Medication Possession Ratio (MPR), a measurement for medication adherence, which was three points higher than the control group. For those patients receiving 90-day supplies of chronic medications, their MPR was 1.4 points higher than the control group. In addition, those enrolled in the refill program who received 30-day fills had 2.5 fewer days of oversupply than those in the control group, and those receiving 90-day fills had 2.18 fewer days of oversupply.

Medical Research: What should clinicians and patients take away from your report?

Dr. Shrank: Medication adherence is a very complex public health challenge, and there are many reasons why people don’t always take their medications as prescribed by their doctor. This research shows that prescription refill programs, like ReadyFill®, are helping to address one of the most common challenges of medication adherence by making the prescription refill process easier and more convenient without contributing to drug oversupply. Increasingly, clinicians are working with their patients to help address barriers to adherence and can suggest their patients inquire about this kind of program when filling their prescriptions to help make adherence easier and more convenient.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Shrank: This research is one of many studies led by the CVS Health Research Institute to better understand and improve medication adherence. Research like this helps ensure that the tools and programs we create are evidence-based and effective.

Citation:

Community Pharmacy Automatic Refill Program Improves Adherence to Maintenance Therapy and Reduces Wasted Medication – 

Olga S. Matlin, PhD; Steven M. Kymes, PhD; Alice Averbukh, MBA, MS; Niteesh K. Choudhry, MD, PhD; Troyen A. Brennan, MD, MPH; Andrew Bunton, MBA, CFA; Timothy A. Ducharme, MBA; Peter D. Simmons, RPh; and William H. Shrank, MD, MSHS

Published Online: November 13, 2015

Dr. William H. Shrank, MD, MSHS (2015). Prescription ReadyFill® Program Improved Medication Adherence and Reduced Waste

 

Superlative Terms May Be Overused When Describing Cancer Drugs

Vinay Prasad, MD MPH Assistant Professor of Medicine Division of Hematology Oncology in the Knight Cancer Institute Department of Public Health and Preventive Medicine Senior Scholar in the Center for Health Care Ethics Oregon Health and Sciences University Portland, Oregon 97239

Dr. Prasad

MedicalResearch.com Interview with:
Vinay Prasad, MD MPH
Assistant Professor of Medicine
Division of Hematology Oncology in the Knight Cancer Institute
Department of Public Health and Preventive Medicine
Senior Scholar in the Center for Health Care Ethics
Oregon Health and Sciences University
Portland, Oregon 97239

 

Medical Research: What is the background for this study? What are the main findings?

Dr. Prasad: We wanted to get some information about when and which cancer drugs were called “game changer” or “breakthrough” or “revolutionary”.  What we found was surprising.  The use of these grandiose terms, or superlatives, was common in news articles.  They occurred across many classes of medication, were used for approved and unapproved drugs, and some of the use was questionable.

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Drug Coverage Gap Wider For Older Blacks Than Whites

Louanne Bakk, Ph.D. Assistant Professor Director, Institute on Innovative Aging Policy and Practice School of Social Work The University at Buffalo Buffalo, NY 14260

MedicalResearch.com Interview with:
Louanne Bakk, Ph.D
Assistant Professor
Director, Institute on Innovative Aging Policy and Practice
School of Social Work
The University at Buffalo
Buffalo, NY  14260

Medical Research: What is the background for this study? What are the main findings?
Dr. Bakk: Medicare Part D reduces out-of-pocket health care costs and increases access to medications.  While overall the benefit has facilitated the purchase of medications, cost sharing exists and be particularly difficult for more vulnerable populations.  Racial and gender disparities in cost-related nonadherence (CRN)  exist under Medicare Part D plans.  However, it was unknown whether the impact of the coverage gap on older Blacks and females.  This study examined whether the Medicare Part D coverage gap directly and indirectly affects the relationship between race, gender, and CRN.

Racial differences in cost-related nonadherence were largely driven by reaching the coverage gap.  In other words, the gap appears to be more difficult for older Blacks than Whites.  Additionally, both reaching and not reaching the coverage gap, poorer health and having a lower income were associated with cost-related nonadherence .

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Some Adverse Events Not Reported in Regulated Time Frame To FDA

Dr. Pinar Karaca-Mandic Ph.D Associate Professor, Health Policy & Management School of Public Health Division of Health Policy & Management Minneapolis MN University of MinnesotaMedicalResearch.com Interview with:
Dr. Pinar Karaca-Mandic Ph.D
Associate Professor, Health Policy & Management
School of Public Health
Division of Health Policy & Management Minneapolis MN
University of Minnesota

Medical Research: What is the background for this study? What are the main findings?

Dr. Karaca-Mandic: Drug safety has received a lot of attention recently, and FDA’s post-marketing drug surveillance program (FAERS) offers and important opportunity to monitor drug safety and update drug warnings. There has been an increasing trend in reports to FAERS of serious adverse drug events and earlier studies suggested that these trends were primarily driven by increased manufacturer reports of serious and unexpected adverse events. While these studies highlighted the overall increase in adverse event rates, manufacturer timeliness in reporting and compliance with the 15 calendar day regulation for expedited reports was unknown, though some recent media coverage has offered anecdotal examples of delay. My co-authors and I were interested in studying not only the reporting of these events, by manufacturers to FDA, but also their timely reporting as required by the Federal regulation. Delays in reporting can have important public health consequences because the FDA uses this information to update drug warnings.

We found that about 10% of serious and unexpected adverse events that are subject to the 15-day regulation were not reported by 15 days. We also found that events that involved a patient death were more likely to be delayed. For example, we found that after adjusting for other characteristics of the report and the patient, about 12% of events that involved patient death, and 9% of those that did not involve patient death were delayed beyond 15 days.

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Evidence of Value of Orphan Drugs Inconsistent

Igho Onakpoya MD MSc Clarendon Scholar University of Oxford Centre for Evidence-Based Medicine Nuffield Department of Primary Care Health Sciences Oxford UKMedicalResearch.com Interview with:
Igho Onakpoya MD MSc

Clarendon Scholar
University of Oxford
Centre for Evidence-Based Medicine
Nuffield Department of Primary Care Health Sciences
Oxford UK

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Onakpoya: Several orphan drugs have been approved for use in Europe. However, the drugs are costly, and evidence for their clinical effectiveness are often sparse at the time of their approval.

We found inconsistencies in the quality of the evidence for approved orphan drugs. We could not identify a clear mechanism through which their prices drugs are determined. In addition, the costs of the branded drugs are much higher than their generic or unlicensed versions.

MedicalResearch: What should clinicians and patients take away from your report?

Dr. Onakpoya: Because of inconsistencies in the evidence regarding the benefit-to-harm balance of orphan medicines, coupled with their high prices, clinicians and patients should assess whether the orphan drugs provide real value for money before making a decision about their use for a medical condition.
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Concomitant Proton-Pump Inhibitors With Antiplatelet Drugs Requires Caution

MedicalResearch.com Interview with:
José C. Nicolau, MD, PhD, FACC
Professor -University of São Paulo Medical School
Director – Acute Coronary Disease Unit, Heart Institute

MedicalResearch: What is the background for this study?

Dr. Nicolau: Previous studies, mainly performed in patients undergoing percutaneous coronary intervention (PCI), have shown that concomitant use of proton-pump inhibitors (PPIs) diminishes the antiplatelet effect of the drug clopidogrel. This diminished response to clopidogrel has in turn been associated with an increased risk of stent thrombosis and ischemic events. Our paper presented results from a secondary analysis performed in patients enrolled in the TRILOGY ACS randomized clinical trial. Our study is the first to examine the influence of interactions between PPIs and clopidogrel or the newer, more potent antiplatelet drug prasugrel, as well as correlations with platelet reactivity and clinical outcomes in high-risk patients who were receiving medical management without revascularization following acute coronary syndrome (ACS).

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Blood Pressure Medication ARBs Should Be Resumed As Soon As Possible After Surgery

MedicalResearch.com Interview with:
Susan Ming Lee, MD, FRCPC, MAS (Clinical Research)

Clinical Instructor, Dept. of Anesthesia and Perioperative Care
University of California, San Francisco

Medical Research: What are the main findings?

Dr. Lee: Angiotensin receptor blockers (often referred to as ARBs) are common medications used to treat high blood pressure, heart disease, and kidney disease.  Doctors sometimes stop these medications briefly around the time of surgery, since they are known to cause low blood pressure under general anesthesia.  Doctors may hesitate to restart ARBs after surgery because they are worried about low blood pressure or kidney function.  Prior to our research, there was little information to guide the optimal timing of restarting ARBs after surgery.

Medical Research: What are the main findings?

Dr. Lee: Our study of over 30,000 veterans shows that nearly one third of veterans admitted to hospital for non-cardiac surgery are not restarted on their usual ARBs within two days of their operation.  This delay in resuming ARBs is associated with increased death rates in the first month after surgery.  In fact, even accounting for factors that might contribute to why doctors would withhold ARB (such as low blood pressure, kidney dysfunction, or other comorbidities), 30-day postoperative mortality was increased approximately 50% in those without resumption of ARBs, and this effect was even greater in younger patients under age 60.  Our findings of reduced rates of infections, pneumonia, heart failure, and kidney failure in those that resumed ARBs soon after surgery suggest that early resumption may also reduce complications after surgery.

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Antifungal Drug May Be Repurposed As An Anti-Cancer Agent

Pan Pantziarka, PhD Member of the ReDO project and the Anticancer Fund Research from the Repurposing Drugs in Oncology (ReDO) projectMedicalResearch.com Interview with:
Pan Pantziarka, PhD

Member of the ReDO project and the Anticancer Fund
Research from the Repurposing Drugs in Oncology (ReDO) project

MedicalResearch: What is the background for this study?

Dr. Pantziarka: This study is one of a number initiated by the Repurposing Drugs in Oncology (ReDO) project. ReDO is an international collaboration between the Belgian foundation the Anticancer Fund and the US not-for-profit GlobalCures. ReDO includes researchers based in the UK, Belgium and the US. The project aims to identify the most promising non-cancer drugs which have evidence that they may be effective additions to oncological treatments. Itraconazole, the subject of this study, is a well-characterised and commonly used anti-fungal agent that is available internationally and at relatively low cost.

MedicalResearch: What are the main findings?

Dr. Pantziarka: We have summarised a broad range of in vitro, in vivo and clinical evidence of anti-cancer activity in itraconazole. In particular there is strong evidence that itraconazole has activity against the Hedgehog signalling pathway, which is active in a variety of different cancer indications. Our study also includes details of a number of positive clinical trials which have reported, and includes details of some still in progress. The level of evidence is particularly striking in basal cell carcinoma, prostate and lung cancer.

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Benefits of Medication Therapy Management Remain Unclear

MedicalResearch.com Interview with:
Meera Viswanathan, PhD
RTI International, Research Triangle Park
North Carolina

Medical Research: What is the background for this study? What are the main findings?

Dr. Viswanathan: Medications, when used appropriately, can alleviate symptoms. Often, however, they result in side effects, interact with one another, are prescribed incorrectly, or are taken incorrectly. These problems are particularly pronounced for the elderly who may have multiple chronic conditions and may be on numerous medications. We evaluated a variety of research studies and program evaluations regarding a distinct type of health care service known as Medication Therapy Management or “MTM.” The goals of MTM services are to help patients and their clinicians to optimize prescription and nonprescription drug regimens, thereby achieving better health outcomes from drug therapy, and. at the same time to minimize the potential for harms, such as incorrect dosing and duplicate medications. Some have proposed that optimizing drug regimens and preventing adverse drug events may reduce health-care-related costs.

Medication Therapy Management services are most often provided directly to patients by pharmacists. Sometimes the same pharmacists who dispense medications to patients offer Medication Therapy Management services as well; in other models, pharmacists working in a nondispensing role within a health care system, health insurance plan administering a prescription drug benefit program, or a centralized pharmacy call center may offer such services Although Medication Therapy Management can vary quite substantially in specifics, Medication Therapy Management programs in general share common elements; these include medication therapy review of all prescription drugs, over-the-counter products, and herbal or dietary supplements; patient education and counseling to solve issues with the drug regimen that a patient may be experiencing, such as side effects or difficulty remembering to take medications; and coordination and communication with the prescribing provider. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 allowed Medicare to expand access to Medication Therapy Management services for selected patients through Medicare Part D prescription drug benefits.

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Acid Reducing Medications May Increase Risk of Clostridium Difficile Infection

MedicalResearch.com Interview with:
Cade M. Nylund, MD, MS, FAAP
Major, United States Air Force, Medical Corps
Assistant Professor of Pediatrics
F. Edward Hébert School of Medicine
Uniformed Services University
Bethesda, Maryland

Medical Research: What are the main findings of the study?

Dr. Nylund: The main findings of our study were that among children who were identified as having a diagnosis of Clostridium difficile infection (CDI), CDI was about twice as likely to occur during periods when the child was taking either a proton pump inhibitor or histamine-2 receptor antagonist.

In brief, we performed a type of observational study called a self-controlled case series. Our data source was the military health system database which contains billing records for patients seen in military and civilian facilities. We identified all cases of Clostridium difficile infections in children ages 2-18 over the period of October 2001 to July 2013. We also identified periods when children were prescribed both proton pump inhibitors and histamine-2 receptor antagonists over the same time period. We compared the incidence of CDI during periods prescribed acid suppression medications to periods not prescribed these medications.
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Intensive Blood Pressure Treatment Did Not Increase Falls or Fractures

Karen Margolis, M.D., M.P.H. Senior Investigator (Director of Clinical Research) HealthPartners Institute for Education and Research Minneapolis, MN, 55440-1524MedicalResearch.com Interview with
Karen Margolis, M.D., M.P.H.
Senior Investigator (Director of Clinical Research)
HealthPartners Institute for Education and Research
Minneapolis, MN, 55440-1524

Medical Research: What are the main findings of the study?

Dr. Margolis: The study compared falls and fractures in patients aged 40-79 with diabetes who were treated for high blood pressure.  One group received treatment that aimed at getting systolic blood pressure under 120, while the other group received treatment to achieve systolic blood pressure under 140. The results show that patients who received intensive blood pressure treatment did not fall more than less intensively treated patients, nor did they incur more fractures over an average follow-up of about five years.
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Psychiatric Medications Linked To High Number of ER Visits

MedicalResearch.com interview with:
Lee M. Hampton, MD, MSc:
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, Georgia

Medical Research: What are the main findings of the study?

Dr. Hampton: The study, which used CDC’s national outpatient adverse drug event surveillance system (NEISS-CADES), found that there are almost 90,000 estimated annual emergency department visits by adults for adverse drug events from therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants between 2009 and 2011. Almost one in five of those emergency department visits (19.3%) resulted in hospitalization. Sedatives and anxiolytics, antidepressants, and antipsychotics each caused 20,000 to 30,000 emergency department visits annually. However, relative to how often each of these types of medications was prescribed at outpatient visits, antipsychotics and lithium salts were more likely to cause emergency department visits for adverse drug events than were sedatives, stimulants, and antidepressants. Antipsychotics caused 3.3 times more emergency department visits for adverse drug events than sedatives, 4.0 times more emergency department visits than stimulants, and 4.9 times more emergency department visits than antidepressants relative to their outpatient use.

Out of the 83 specific drugs the study looked at, ten drugs were implicated in nearly 60% of the emergency department visits for ADEs from therapeutic use of antipsychotics, antidepressants, sedatives and anxiolytics, lithium salts or stimulants. Zolpidem was implicated in nearly 12% of all such emergency department visits and 21% of such emergency department visits involving adults aged 65 years or older, more than any other antipsychotic, antidepressant, sedative or anxiolytic, lithium salt or stimulant.
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FDA Study on Diabetes Medication Use In US Shows Marked Increase in Number of Prescriptions

Christian Hampp PhD Senior Staff Fellow/Epidemiologist at FDA Division of Epidemiology-I, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MDMedicalResearch.com Interview with:
Christian Hampp PhD
Senior Staff Fellow/Epidemiologist at FDA
Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD

MedicalResearch.com: What are the main findings of the study?

Dr. Hampp: Our study described U.S. market trends for antidiabetic drugs, focusing on newly approved drugs, concomitant use of antidiabetic drugs, and effects of safety concerns and restrictions on thiazolidinedione use.

We found that since 2003, the number of adult antidiabetic drug users increased by approximately 43% to 18.8 million in 2012.  During 2012, 154.5 million prescriptions for antidiabetic drugs were filled in outpatient retail pharmacies.  Since 2003, metformin use increased by 97% to 60.4 million prescriptions dispensed in 2012.  Among antidiabetic drugs newly approved for marketing between 2003 and 2012, the dipeptidyl-peptidase-4 (DPP-4) inhibitor sitagliptin had the largest share with 10.5 million prescriptions in 2012.

Possibly triggered by safety concerns, the use of pioglitazone declined in 2012 to approximately 52% of its peak in 2008, when 14.2 million prescriptions were dispensed in outpatient retail pharmacies and the use of rosiglitazone use decreased to fewer than 13,000 prescriptions dispensed in retail or mail-order pharmacies in 2012.

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