Kate H. Gamble, Senior Editor

From a mega-pharmacy benefit merger to pharmacy robberies to a blockbuster drug going off patent, 2011 featured a number of stories that either affected pharmacists a great deal, or to look have a huge impact in the near future. 

 has compiled a list of the top stories of the year—the ones we know our readers (and bloggers) will be talking about for quite some time.

1. The Proposed Merger of Medco and Express Scripts

Perhaps no piece of news generated as much coverage—and triggered as many reactions&mdash;as the news that Medco Health Solutions planned to acquire Express Scripts. Pharmacists, physicians, and politicians voiced serious their concerns about how the merger will impact the field. Stay tuned for more news on this in 2012.

Express Script-Medco Merger: The Beginning of the End?

Specialty Pharmacists Urge FTC to Block PBM Merger

The fact that there is a shortage of vital drugs may not have been news to some, but in 2011, a report from IMS Health shed light on the magnitude of the problem, raising awareness on a national level and prompting involvement from the federal government.

Obama Ordering FDA to Help Reduce Drug Shortages

Incidents of pharmacy violence mounted in 2011, with a number of fatal incidents making the headlines, most of which involved patients looking for controlled substances. On the positive side, awareness of how these crimes can be avoided took center stage.

America's Pharmacists: Doing the Right Thing

Although it was a move that the entire industry saw coming, when the most successful branded prescription products ever developed lost its patient protection, it still caused a flurry, and could set a precedent for other blockbuster drugs as they go generic.

Pfizer’s Big Problem: Lipitor Patent Expiration

Another hot-button issue during the past year has been the battle over mandatory mail-order pharmacy. As pharmacy benefit managers sought to produce data proving that mail-order prescriptions can improve medication adherence, retail pharmacies argued that it violates patient rights—and could threaten their businesses.

Can Mail-Order Pharmacy Improve Medication Adherence?

This past summer, an online pharmacy owner operating out of Texas was sentenced to 7 years in federal prison for trafficking a counterfeit version of a weight loss drug. And if the trends continue, more arrests will likely follow. A review of more than 8000 sites that sell prescription drugs found that 96% were operating in conflict with pharmacy laws and practice standards.

Exposing the Dangers of Illegal Online Pharmacies

Drug Spam Finds Easy Target in US Patients

7. Rite Aid Initiates 15-minute Rx Guarantee

At a time when the demands of pharmacists seem to keep increasing, the decision made by one national chain to improve customer service generated strong reactions from pharmacists about how the initiative could impact safety and compromise their ability to deliver quality care.

Do Speedy Prescription Guarantees Compromise Safety?

What made this such a hot topic is not necessary that the emergency contraceptive would no longer be available over the counter, but instead, the fact that the FDA was overruled by the Department of Health and Human Services on the decision.

9. New Dosing Announced for Acetaminophen

In the spring, the makers of OTC products unveiled an industry-wide initiative to standardize the acetaminophen dose to make it safer and easier for parents and caregivers to dispense the liquid medication. The initiative also includes education for providers to help prevent overdosing.

OTC Industry to Standardize Dosing in Pediatric Liquid Acetaminophen

From diabetes care to helping to reduce readmissions, pharmacists have begun to emerge as a key member of the health care team. And as healthcare reform continues to take shape, leaders from the pharmacy associations believe that pharmacists will continue to take on a larger role in patient care.

Study Highlights Emerging Role of Pharmacists in Patient Care

Team Effort Leads to Improved Cholesterol Levels in Patients with Diabetes

Measuring the Impact of Pharmacist Interventions on Heart Failure Outcomes

Articles

From a mega-pharmacy benefit merger to pharmacy robberies to a blockbuster drug going off patent, 2011 was a landmark year for the field of pharmacy.

Wrapping Up an Exciting Year for Pharmacy

Chronic pain suffered by one spouse can affect marital communication and influence the partner’s ability to cope with a chronic pain condition, according to 

Research has shown that how a spouse or partner responds to an individual’s behavior affects how and when emotions are expressed. For example, validation of a partner’s emotions by showing respect and acceptance promotes effective emotional regulation, trust, and closeness. Conversely, invalidation of emotions, demonstrated by hostility or ignoring, increases emotional distance and is correlated with poor marital adjustment and depression.

In the study, a team of researchers led by Laura Leong of Wayne State University in Detroit, Michigan, tested how the sequences and base rates of couples’ affective interactions were related to pain and emotional adjustment in both partners. They hypothesized that invalidating behavior followed by invalidation by either partner would be related to more severe pain, less marital satisfaction and depression. Conversely, invalidation followed by a validating or neutral remark would be associated with better adjustment. The researchers also expected that that the association of spousal behaviors and pain adjustment would be significantly stronger when the wife is the pain patient, based on previous research showing that women react more profoundly to pain and affective communication than men, according to a 

Couples for the study, who were recruited in a Midwestern US city through a newspaper ad, were eligible to participate if one spouse had a musculoskeletal pain condition lasting more than six months. The initial sample had 78 adults with chronic pain and their spouses. Women comprised 58% of the pain patients studied. Low back pain was the most frequently mentioned site of the worst pain and the leading diagnoses were osteoarthritis, disc problems, and fibromyalgia.

Study subjects participated in a 3-hour interview sessions in which the final 15 minutes were devoted discussing a disagreeable topic, such as family finances. Each partner was interviewed about their perspectives on the problem topic, and the couples were instructed to discuss and make progress toward resolving the issue.

Results of the analysis showed that husbands with pain are more likely to respond negatively to spousal invalidation. Contrary to the study’s hypothesis, men, either as patients or spouses, appeared to be more sensitive to their partners’ responses. This finding contradicts previous research showing that women are more likely to experience greater pain, distress and depression. The authors noted that perhaps pain is disruptive to a husband’s traditional roles, such as being the family provider, causing him to be more vulnerable for emotional upheaval from spousal invalidation behaviors.

The authors believe their research shows patient gender is an important factor when assessing and treating pain patients and couples. Interventions, therefore, should be aimed at the couple, not just the pain patients, in order to help reduce invalidating behaviors and remarks and disruptive responses to them.

Chronic pain suffered by one spouse can affect marital communication and influence the partner's ability to cope with pain, a new study suggests.

Communication Between Spouses Impacts Pain Coping

New research shows that although the percentage of Americans who had trouble affording prescription drugs remained level between 2007 and 2010, the number is still significantly higher than it was in 2003.

 from the Center for Studying Health System Change (HSC), more than 1 in 8 Americans went without a prescription drug in 2010, with economic hardships and a growing number of individuals without health insurance cited as key factors. The good news, however, is that the number has not continued to drop in the last 3 years.

The most vulnerable individuals—including those who are uninsured, have low incomes, are in fair or poor health, and have multiple chronic conditions&mdash;continued to face the most unmet prescription needs, according to findings from HSC’s 2010 Health Tracking Household Survey, a nationally representative survey with information on 17,000 people.

“About 1 out of 2 uninsured people in fair or poor health couldn’t afford a prescription drug in 2010, almost double the rate of insured people in the same health,” said Ellyn R. Boukus, MA, coauthor of the study, in a 

Although prescription drug access remained stable for most Americans in recent years, uninsured, working-age adults (aged 19 to 64) saw a significant decrease in unmet prescription drug needs, from 35.9% in 2007 to 29.4% in 2010, according to the study. Some portion of the decrease in access problems likely reflects the fact that fewer uninsured individuals reported visiting a health care provider in 2010 compared with 2007.

Likewise, elderly individuals eligible for both Medicare and Medicaid saw a sharp drop in prescription drug access problems. After doubling between 2003 and 2007, unmet prescription drug needs for dually eligible, elderly Medicare beneficiaries dropped from 21.7% in 2007 to 8.0% in 2010.

Given the large increase in the uninsured population—from 42.8 million in 2007 to 51.7 million in 2010&mdash;and financial pressures caused by the economy, the authors noted that it is somewhat surprising that drug affordability problems did not increase.

Other key findings from the study include:

		In 2010, two-thirds of all Americans—and nearly 90% of seniors&mdash;reported taking at least one prescription drug in the past year.

		The number and percentage of Americans reporting unmet prescription drug needs because of cost concerns remained significantly higher in 2010 compared to 2003 (13% vs. 10%), largely reflecting an increase in access problems for children and working-age adults (aged 19 to 64) between 2003 and 2007.

		Individuals with private insurance experienced relatively few problems, with only 9.8% of working-age adults and 4.2% of children reporting an unmet prescription need in 2010.

		Uninsured individuals continued to have the most problems affording prescription drugs. Overall, 27.4% of those who are uninsured reported prescription drug access problems in 2010, which is nearly 3 times the rate for insured people.

		69% of uninsured individuals with multiple chronic conditions reported an unmet prescription need because of cost in 2010, compared with 20% of insured people with multiple chronic conditions.

		In 2010, those with incomes below 200% of poverty—$44,100 for a family of four&mdash;were 3.4 times more likely to report drug access problems as those earning 400% of poverty or more (19.3% vs. 5.7%).

For more information on the study, which was funded by the Robert Wood Johnson Foundation, 

Although the number of Americans who have trouble purchasing drugs remained steady during the past 3 years, it is still much higher than it was in 2003.

Prescription Drug Access Still a Struggle for Many Patients

Among individuals who don’t currently have memory problems, those with smaller regions of the brain’s cortex may be more likely to develop symptoms consistent with very early Alzheimer’s disease, according to 

“The ability to identify people who are not showing memory problems and other symptoms but may be at a higher risk for cognitive decline is a very important step toward developing new ways for doctors to detect Alzheimer’s disease,” said Susan Resnick, PhD, with the National Institute on Aging in Baltimore, who wrote an accompanying editorial.

For the study, researchers used brain scans to measure the thickness of regions of the brain’s cortex in 159 individuals around the age of 76 who did not have dementia. The brain regions were chosen based on prior studies showing that they shrink in patients with Alzheimer’s dementia.

Of the 159 people, 19 were classified as at high risk for having early Alzheimer’s disease due to smaller size of particular regions known to be vulnerable to Alzheimer’s in the brain’s cortex, 116 were classified as average risk and 24 as low risk. At the beginning of the study and over the next 3 years, participants were also given tests that measured memory, problem solving, and ability to plan and pay attention.

The study found that 21% of those at high risk experienced cognitive decline during three years of follow-up after the MRI scan, compared to seven percent of those at average risk and none of those at low risk.

“Further research is needed on how using MRI scans to measure the size of different brain regions in combination with other tests may help identify people at the greatest risk of developing early Alzheimer’s as early as possible,” said study author Bradford Dickerson, MD, of Massachusetts General Hospital in Boston, in a 

The study also found 60% of the group considered most at risk for early Alzheimer’s disease had abnormal levels of proteins associated with the disease in cerebrospinal fluid, which is another marker for the disease, compared to 36% of those at average risk and 19% of those at low risk.

Findings could represent a significant step in the development of new ways for health care professionals to detect the debilitating disease.

Brain Size May Predict Risk for Early Alzheimer's

Elderly women who suffer from sleep apnea, a condition characterized by disrupted breathing and sleep and a reduction in the intake of oxygen, are about twice as likely to develop dementia in the next five years as those without the condition.

Journal of the American Medical Association

 demonstrated for the first time that sleep apnea, also known as sleep-disordered breathing (SDB), can deprive the brain and other organs of the oxygen and may trigger declines in cognitive ability over a long-term period.

“This is the first study to show that sleep apnea may lead to cognitive impairment,” said lead author Kristine Yaffe, MD, of the University of California, San Francisco, in a 

. “It suggests that there is a biological connection between sleep and cognition and also suggests that treatment of sleep apnea might help prevent or delay the onset of dementia in older adults.”

Although it can’t be definitively concluded that SDB causes cognitive impairment, the study results suggest that it may at least be a contributing factor, she noted.

In patients with sleep apnea, the airways leading from the lungs to the nose and mouth collapse during sleep, interfering with an individual’s ability to inhale. Although previous research had uncovered a link between sleep apnea and dementia, the studies weren’t structured to follow the impact of sleep apnea on individuals who had normal cognitive abilities at the onset. The strength of the new findings stems from the fact that the 298 subjects began the study without dementia or measurable cognitive impairments, allowing researchers to measure the relationship between sleep apnea and mental acuity.

The participants, who were drawn from a larger, ongoing study examining osteoporosis in more than 10,000 women over 65, were first examined at clinics in Pittsburgh and Minneapolis and given tests that assessed their mental and cognitive abilities. Those who were found to be suffering from dementia or mild cognitive impairment at the initial assessment weren’t included in the study.

About 4 years later, sleep specialists visited the study subjects’ homes and monitored them as they slept using equipment that measured brain activity, heart rhythm, leg movements, airflow, breathing activity in their chest and abdomen and the oxygen content of blood as it passed through their fingers. These instruments allowed researchers to track how often the women experienced apneas or hypopneas and how much time they spent in an oxygen-deprived state.

About 5 years after the initial first visit, the women returned to the clinics and were given a larger battery of tests that measured their cognitive abilities, memory, and verbal fluency. Women whose test results suggested they had dementia or mild cognitive impairment had their records reviewed by a panel of clinical experts who decided whether to confirm the diagnosis.

Dr. Yaffe and colleagues concluded that about one third (35.2%) of participants developed dementia or mild cognitive impairment, and that those with sleep apnea were almost twice as likely to become cognitively impaired.

Among the women found to suffer from sleep-disordered breathing, 44.8% developed dementia or mild cognitive impairment, compared with 31.1% of those who didn’t have impaired breathing and sleep.

The findings suggest that the key factor leading to diminished cognition was hypoxia. Women who had frequent episodes of low oxygen or spent a large portion of their sleep time in a state of hypoxia were more likely to develop cognitive impairment. By contrast, no independent connection was seen between dementia and the number of times patients were awakened in their struggle to breathe.

Providing oxygen therapy to elderly people with sleep apnea may reduce the chances of cognitively impairment or delay the onset of mental decline, the authors found.

New data suggest that providing oxygen therapy to elderly women with sleep apnea may reduce the chances of cognitively impairment.

Sleep Apnea Linked to Increased Risk of Dementia in Elderly Women

A method of classifying brain atrophy patterns in Alzheimer’s disease patients using MRIs can also detect cognitive decline in Parkinson’s disease, according to a 

Researchers from the Perelman School of Medicine at the University of Pennsylvania also found that higher baseline Alzheimer’s patterns of atrophy predicted long-term cognitive decline in cognitively normal Parkinson’s patients.

“On the basis of a simple neuroimaging study, we can now predict which patients with Parkinson’s disease will experience long-term cognitive decline or develop dementia in the future,” said the study’s lead author, Daniel Weintraub, MD, in a 

. “Diagnostic tests like this can help us determine which patients would benefit from future clinical trials of medications aiming to stave off or prevent dementia progression in Parkinson’s disease.”

This research raises the possibility that both Alzheimer’s disease and Parkinson’s disease pathology contribute to cognitive decline in Parkinson’s disease. Researchers are still uncertain whether the neurodegeneration seen in these patients is caused by primary Parkinson’s disease pathology, Alzheimer’s pathology, a combination of the two, or is a form of compensation.

As biomarkers for Alzheimer’s and Parkinson’s disease continue to emerge, the researchers suggest at least an overlap in regions undergoing neurodegeneration with cognitive decline, and point to the Spatial Pattern of Abnormalities for Recognition of Alzheimer’s disease (SPARE-AD) classification system to detect brain atrophy in Parkinson’s disease, to detect patients at imminent risk of cognitive decline before clinically identifiable symptoms emerge.

Approximately 80% of Parkinson’s patients become demented over the course of the illness. Some patients experience cognitive impairment relatively soon after the disease presents, while others won’t experience dementia until the very end of their disease. Duration and severity of the disease and advanced age are risk factors for dementia, while nearly 20% of patients never have dementia. More than half of Parkinson’s patients with dementia have significant signs of Alzheimer’s disease-related plaques and neurofribrillary tangles on autopsy, and similar brain regions, such as the hippocampus and medial temporal lobe, have been reported to be affected in both diseases.

The Penn research team applied a pattern classification individual-based score, the SPARE-AD score, to a cross-sectional cohort of 84 Parkinson’s patients including patients with dementia, mild cognitive impairment and no dementia. In the cross-sectional analyses, the SPARE-AD score correlated to cognitive impairment across all groups. From this group, 59 Parkinson’s patients without dementia were followed for an additional two years. Researchers determined that a higher baseline SPARE-AD score predicted worsening cognitive performance over time, even in those patients with normal cognition at baseline. 

New findings indicate that intertwined diseases may both contribute to cognitive decline in Parkinson's disease.