Addressing the Polypharmacy Conundrum

Can I get an amen for medication coordination?........

Polypharmacy, the simultaneous use of multiple medications by a single patient for one or more conditions, has become a staggering problem in the United States. From 2000 to 2008, the percentage of Americans using at least one, two, or five prescription medications in the past month increased from 44% to 48%, 25% to 31%, and 6% to 11%, respectively. Prescription-related medication problems result in an estimated 119,000 deaths annually. Polypharmacy is especially problematic for the elderly. Eight or more prescription medications are used by 30% of this population daily, with an average of 18 prescription medications taken per year. In any given year, >175,000 elderly patients will visit the emergency room because of an adverse reaction to a commonly prescribed medication.

Many patients take medications to manage multiple chronic disease states. Clinical guidelines for these chronic diseases, such as hypertension, diabetes mellitus, chronic obstructive pulmonary disease, and heart failure, frequently include recommendations for multiple medications added in a stepwise approach. Therefore, adherence to these guidelines can quickly lead to polypharmacy. An example of this may be seen in a patient being treated for type 2 diabetes, hypertension, and dyslipidemia, which are three common comorbid disease states. If this patient is prescribed three antihypertensives, two antidiabetics, and one lipid-lowering medication, as is often seen in management of these diseases, he or she may already have achieved polypharmacy. 

Use of multiple healthcare providers is common for the management of chronic diseases, including a primary care physician and various specialists. While each provider is responsible for completing a thorough assessment of the whole patient, a “silo effect” may occur in prescribing (i.e., concentrating only on one disease state). Additionally, patients may fill medications at multiple community pharmacies or through a mail-order pharmacy. This may cause pharmacists to fill prescriptions without knowing the patient’s entire medication regimen. Use of multiple providers and pharmacies to manage a patient without proper interprofessional communication can lead to therapeutic duplication or prescribing of medications with significant drug-drug interactions. If patients do not have at least one single provider who knows their complete medication regimen, the risk of polypharmacy increases greatly.

Therapeutic duplication can result from prescribing by multiple providers. Duplication of medications in the same pharmacologic class or use of medications in different pharmacologic classes with similar side effects can also occur. This situation can lead to cumulative effects, as well as increased risk of adverse effect severity. If patients experience adverse effects that are unrecognized or misinterpreted by the healthcare provider, a prescribing cascade can result. For example, another drug could be inappropriately prescribed to treat a side effect that would have been alleviated by discontinuing the causative medication.

Insurance pays little for caregiving of elderly at end of life

This is interesting because the end of life is so expensive for healthcare. Short-sighted?......

Unpaid family and friends provide the overwhelming majority of care to the elderly in their last year of life, according to a new study highlighting the need to expand supportive services to caregivers.

In 2011, 2.3 million caregivers tended to the needs of an estimated 905,000 older Americans in their final year of life, the report in Health Affairs found.

Nearly 9 in 10 of the caregivers were unpaid, and only 9 percent of dying older adults received money for caregiving from government or private insurance.

“Supporting caregivers is an urgent public health issue,” said lead author Dr. Katherine Ornstein, a professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai in New York City.

“We have a huge reliance on families throughout the course of serious illness, but especially at the end of life. It’s the most complex and challenging time, and it’s really the families who are involved,” she said in a phone interview.

In Senate Health Care Bill, A Few Hidden Surprises

A low-income person, eligible for Medicaid but not enrolled, is hit by a car or a bullet. Gravely injured, she arrives at the hospital unconscious. Thanks to expert, intensive care that lasts for days or weeks, she gradually recovers. Eventually, her health improves to the point where she can complete the paperwork needed to apply for Medicaid.

Such a hospital can be paid today, thanks to Medicaid’s “retroactive eligibility.” Even if the combination of medical problems and bureaucratic delays prevents an application from being filed and completed for several months, Medicaid will cover the care if the patient was eligible when services were provided.

The newest version of the Senate health bill—the Better Care and Reconciliation Act, or BCRA—would end this longstanding feature of the Medicaid program for beneficiaries who are neither elderly nor people with disabilities. If services are received in one calendar month and the application is completed the following month, the hospital would be denied all payment, even if the patient was eligible and the services were both essential and costly.

It does not matter if the state is led by a governor who understands the devastating impact of this change on hospital infrastructure, especially in rural areas where many hospitals are hanging on by a thread. Today, states have the flexibility to seek waivers that limit retroactive eligibility. Under the BCRA, that flexibility would disappear, as states are forced to end retroactive coverage, whether they like it or not.

Almost certainly, this provision would come as a surprise to most senators who are being asked to support the BCRA. It is only one of many unpleasant surprises lurking largely undiscovered throughout the bill. Following are other selected examples.

More People Are Making Mistakes With Medicines At Home

When people take medicine at home, mistakes happen.

Some people end up taking the wrong dose of a medication or the wrong pill. Sometimes, they don't wait long enough before taking a second dose.

Other times, it's a health professional who's at fault. A pharmacist might have dispensed a medication at the wrong concentration, for example.

These kinds of mistakes are on the rise, according to a study published Monday in the journal Clinical Toxicology.

The researchers looked at a small subset of the medication errors that happen in the U.S. every year. The FDA estimates that about 1.3 million people are injured by medication errors annually in the U.S.

The study analyzed data collected by poison control centers across the U.S. and counted only errors that happened outside health care facilities and resulted in serious medical outcomes. That's defined in the study as symptoms that typically require some treatment to life-threatening situations and even death.

They found that the number of these cases doubled, from 3,065 cases in 2000 to 6,855 cases in 2012. In the 13 years covered by the study, more than 67,000 such errors occurred, and 414 people died as a result. Most of the mistakes were preventable, the study finds.

"We know that a third of the cases in this study resulted in hospital admissions, so these aren't minor errors. These can be pretty significant," says Nichole Hodges, a research scientist at Nationwide Children's Hospital in Columbus, Ohio, and the study's lead author. She says errors at home represent a significant public health burden and are likely undercounted.

"Since we're only including those non-health care facility errors that are reported to poison control centers, it's an underestimate of the true number," she says.

Jay Schauben, a former president of the American Association of Poison Control Centers, points out that not everyone calls a poison control center when they experience one of these events. And he says there could be "minor inaccuracies" in the data from poison control, because the employees who answer calls are relying on what the caller tells them, and if a physician calls about a patient, that physician might not know exactly what happened to the patient.

Despite these limitations, he says the study's findings are still valid and useful. And he says he's glad to see this study draw attention to medication errors happening at home.

"We focus on medication errors in health care facilities, and we tend to forget that these types of errors do occur in the home scenario and potentially go uncorrected, maybe unrecognized," Schauben says.

F.D.A. Panel Recommends Approval for Gene-Altering Leukemia Treatment

A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease.

If the F.D.A. accepts the recommendation, which is likely, the treatment will be the first gene therapy ever to reach the market. Others are expected: Researchers and drug companies have been engaged in intense competition for decades to reach this milestone. Novartis is now poised to be the first. Its treatment is for a type of leukemia, and it is working on similar types of treatments in hundreds of patients for another form of the disease, as well as multiple myeloma and an aggressive brain tumor.

To use the technique, a separate treatment must be created for each patient — their cells removed at an approved medical center, frozen, shipped to a Novartis plant for thawing and processing, frozen again and shipped back to the treatment center.

A single dose of the resulting product has brought long remissions, and possibly cures, to scores of patients in studies who were facing death because every other treatment had failed. The panel recommended approving the treatment for B-cell acute lymphoblastic leukemia that has resisted treatment, or relapsed, in children and young adults aged 3 to 25.

Type 1 diabetes risk linked to intestinal viruses

Now, a new study led by Washington University School of Medicine in St. Louis has found that viruses in the intestines may affect a person’s chance of developing the disease. Children whose gut viral communities, or viromes, are less diverse are more likely to generate self-destructive antibodies that can lead to Type 1 diabetes. Further, children who carried a specific virus belonging to the Circoviridaefamily were less likely to head down the path toward diabetes than those who carried members of a different group of viruses.

“We identified one virus that was significantly associated with reduced risk, and another group of viruses that was associated with increased risk of developing antibodies against the children’s own cells,” said Herbert “Skip” Virgin IV, MD, PhD, the Edward Mallinckrodt Professor and head of Pathology and Immunology, and the study’s senior author. “It looks like the balance of these two groups of viruses may control the risk of developing the antibodies that can lead to Type 1 diabetes.”

The findings, published online the week of July 10 in Proceedings of the National Academy of Sciences, suggest a way to predict, and maybe even prevent, the life-altering diagnosis.

Research Offers Hope For NF2 Neuro-Tumor Patients

I worked with a number of people with NF in the 70's.....

Since all NF2 patients develop multiple schwannomas, the scientists have developed a human cell culture model for schwannoma, comprising of human schwannoma cells isolated from both patients and control normal healthy Schwann cells (which form the sheath that protects nerves). Using this model, the research team found for the first time that PrPC is over-produced in schwannoma compared with healthy Schwann cells. This overproduction is due to Merlin deficiency and strongly contributes to tumour growth and patient prognosis.

The research team have already identified a range of existing drugs which could manage this protein overproduction and that are used currently for other non-NF2-related conditions, such as Creutzfeldt-Jakob disease, multiple myeloma (a type of bone marrow cancer) and Acute Myeloid Leukaemia (AML). By repurposing existing drugs, an effective therapy could be made available to NF2 patients, based on the failure of Merlin tumour suppressor expression, relatively quickly. The safety testing process for human use has already taken place for the original purpose of these drugs, which means they could be fast-tracked into clinical studies for NF2.

Disparities in Diabetes and Hypertension Care for Individuals With Serious Mental Illness

Objectives. People with serious mental illnesses (SMI), including schizophrenia, bipolar disorder, and major depression, experience early mortality, partly due to comorbid physical health conditions such as diabetes and hypertension. This study examined the quality of diabetes and hypertension care for Medicaid and Medicare enrollees with SMI.

Results. Adults with SMI receive poor-quality care for diabetes and hypertension. Depending on the health plan, performance on the diabetes care and hypertension control HEDIS measures was 14 to 49 percentage points lower among the SMI population than the general Medicaid and Medicare populations. 

Conclusions. Findings highlight disparities in care for individuals with SMI compared with the general Medicaid and Medicare populations. Health plans demonstrated substantial room for improvement on almost all diabetes and hypertension HEDIS measures for the SMI population.

Multiple Recurring C. Diff Infections on the Rise: Researchers aren't sure why

Really? They aren't sure why?.....

In an analysis of a large, nationwide health insurance database, researcher's at the University of Pennsylvania's Perelman School of Medicine found that the annual incidence of multiple recurring Clostridium difficile (mrCDI) increased by almost 200% from 2001 to 2012. During the same period the incidence of ordinary CDI increased by only about 40%. The study results were published this week in the Annals of Internal Medicine.

The reasons for the sharp rise in mrCDI incidence is unknown. Researchers said the finding points to an increased burden on the healthcare system, including increased demand for new treatments for recurrent CDI. The most promising of these new treatments, fecal microbiota transplantation -- the infusion of beneficial intestinal bacteria into patients to compete with C. difficile -- has shown good results in small studies, but hasn't yet been thoroughly evaluated. 

(It hasn't been thoroughly evaluated because pharma makes more money from expensive antibiotics than from fecal transplants.)

FDA approves new treatment for sickle cell disease

L-glutamine is a naturally sweet tasting precursor to some important neurotransmitters that has been used since the 70's for a wide variety of brain-based symptoms because the precursor can cross the blood-brain barrier. The most common that I saw was for inability to fall asleep because of churning thoughts. Its effectiveness in sickle cell is very important as you can read in the article since it is only the second one available (Gee, I wonder why there isn't more research on Sickle Cell?).....

The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

"Endari is the first treatment approved for patients with sickle cell disease in almost 20 years," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. "Until now, only one other drug was approved for patients living with this serious, debilitating condition."

Sickle cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent, or "sickle," shape). This restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage. According to the National Institutes of Health, approximately 100,000 people in the United States have sickle cell disease. The disease occurs most often in African-Americans, Latinos and other minority groups. The average life expectancy for patients with sickle cell disease in the United States is approximately 40 to 60 years.

The safety and efficacy of Endari were studied in a randomized trial of patients ages five to 58 years old with sickle cell disease who had two or more painful crises within the 12 months prior to enrollment in the trial. Patients were assigned randomly to treatment with Endari or placebo, and the effect of treatment was evaluated over 48 weeks. Patients who were treated with Endari experienced fewer hospital visits for pain treated with a parenterally administered narcotic or ketorolac (sickle cell crises), on average, compared to patients who received a placebo (median 3 vs. median 4), fewer hospitalizations for sickle cell pain (median 2 vs. median 3), and fewer days in the hospital (median 6.5 days vs. median 11 days).  Patients who received Endari also had fewer occurrences of acute chest syndrome (a life-threatening complication of sickle cell disease) compared with patients who received a placebo (8.6 percent vs. 23.1 percent).

Common side effects of Endari include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.

Endari received Orphan Drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare diseases.  In addition, development of this drug was in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and/or effectiveness of products for use in rare diseases or conditions.