Who’s Passing The Pills?

Despite warnings about borrowing medication prescribed to other people, many Americans say they have used someone else’s medication at least once in the past year. Stereotypically this practice was thought to be most widespread among low income, urban populations, due to a number of factors including a perceived lack of access to health care and higher rates of crime and drug abuse.  However, as with many stereotypes, it seems this just isn’t true.  A new study by researchers from Temple University Medical School has blown this urban myth wide open. Lead author, Lawrence Ward says “The perception was that those from a lower socioeconomic background would be more apt to use ill-gotten drugs, and we found that to not be the case.” Ward and his team surveyed patterns of borrowing prescription drugs among patients seeking outpatient, emergency or inpatient care. Most were African-American (75%), were high-school educated or less (71%) and lacked full-time employment (68%). However, the vast majority of this group (90%) reported having health insurance and about 75% had recently seen their primary health care provider.  Overall, only 18% reported ever taking a prescription medication originally meant for use by someone else. This rate is on par with the results of studies in other populations across the country. “I think this helps to break some stereotypes, particularly in the way doctors view their patients,” said Ward. “Just because patients are from a less affluent area, they are not more apt to borrow prescription medications than their more educated or more affluent counterparts.” The researchers also found that the most common reason for borrowing medicines was convenience. Most commonly they were obtained from a friend or family member, rather than via more illicit routes such as theft or from a dealer.  The most common drugs borrowed from others were:

Ward cautions that anyone borrowing medications from someone else can open themselves up to a host of health risks, including a delay in proper medical treatment, an increase in medication resistance and adverse drug to drug interactions. “We need to work towards better awareness of the problem,” said Ward. “Many patients might not realize the risk they take when using someone else’s medication. Doctors must recognize that at least 20 percent of their patients may be using another person’s medications, and should regularly inquire about medication use and stress the dangers of medication borrowing.” As someone who has been known to “share” medications (antibiotics, anti-inflammatories) with my dogs, I consider myself warned. Have you ever “borrowed” meds?  Share your stories with us and our readers.

Medicines Use(less) Reviews

SRxA’s Word on Health brings you news of a great idea gone bad!  Six years ago the UK National Health Service (NHS) introduced Medicine Use Reviews (MURs). Run by community pharmacists, MURs were designed to help patients understand how their medicines should be used and why they have to take them, identify any problems and, if required, provide feedback to the prescriber.

In addition, they were supposed to improve patient compliance and the clinical and cost effectiveness of medicines by reducing medicine wastage which is estimated to cost the NHS £100 million a year. However a damning new study by pharmacy researchers at the University of Nottingham found that they’d failed to achieve either clinical or cost effective improvements. And this failure didn’t come cheap.  1.7 million MURs were conducted between 2009 and 2010 at a cost of £28 ($44.63) per review.  In that period, the total cost to the NHS was £47.6m ($76 million).  Multiply that by the six years the scheme has been running and you’re talking close to $300 million. As part of the review, researchers carried out five weeks of observation in two retail pharmacies, during which 54 MURs were observed and 34 patients were interviewed about their experience of the MUR. Patients with any condition were invited for MURs rather than those with complex conditions and medicine regimes who may benefit most, the study found. They also found that pharmacists responded to pressures to complete the MURs quickly so that they could return to “routine” duties by adopting a scripted, formulaic approach. Complex medicine-related issues that did arise were circumvented by the pharmacist and so the opportunity to improve the clinical management of the patients’ medicines was lost. Moreover, most patients revealed that they already felt adequately informed about their medicines, and there was no evidence of a reduction in the wastage of unused medicines. Asam Latif, a researcher in pharmacy practice at the University of Nottingham, concluded: “There was little evidence that MURs in practice demonstrated improvements in the clinical or cost-effectiveness of patients’ medicine use or reduced waste.”  Ouch!

On this day, a child was born…

On this day in history, Bob Dylan was booed off stage at the Newport Folk Festival for using an electric guitar, Bob Lemon replaced Billy Martin as the manager of the Yankees and the Cerro Maravilla Incident occurred in Puerto Rico. Far away, in England an even more memorable event was taking place. On July 25th, 1978, Louise Joy Brown, the world’s first ‘test tube baby’ was born. Last month, Dr. Peter Brinsden, Director of the Bourn Clinic (Cambridge, England) paid a surprise visit to colleagues attending the Midwest Reproductive Symposium* to celebrate this very special birth.  Even after 33 years, Louise’s story continues to generate worldwide media interest. Her birth, through in-vitro fertilization (IVF), is still regarded as one of the most remarkable medical breakthroughs of the 20th Century. Her birthday also highlights the issue of millions of couples who try to have a baby only to find that they cannot. Infertility doesn’t discriminate.  It affects both men and women and all races. It can be hormonal, age-related, genetic, illness-related (think cancer), or anatomical in origin – as it was for Lesley Brown, Louise’s mother who suffered from blocked Fallopian tubes. Infertility is a disease, not an inconvenience and affects more than 7.3 million couples in the US alone. Fortunately, about 90% of cases can be treated with conventional medical therapies or surgery. IVF is the process of fertilization by manually combining an egg and sperm in a laboratory dish. When the IVF procedure is successful, the process is combined with a procedure known as embryo transfer, which is used to return the embryo to the uterus. Louise Brown’s birth was a culmination of over 10 years of work by Dr. Patrick Steptoe, a gynecologist at Oldham General Hospital, and Dr. Robert Edwards, a physiologist at Cambridge University. Dr. Brinsden, who worked closely with Dr. Edwards, paid homage to his colleagues while attendees at the MRS toasted Brinsden, the Bourn Clinic and its success. Success, as measured by the ‘take home baby rate’ has been increasing every year since Louise’s birth. About 1 in 100 babies born in the US are conceived using IVF or other forms of assisted reproduction and today, more than three million babies worldwide have been born thanks to IVF. Louise’s life has been an extraordinary one from the moment of birth. Every detail has been photographed and documented; every milestone celebrated. But mostly, she remains a symbol of this procedure’s success and the delight experienced by those touched by IVF. From all of us at SRxA’s Word on Health, Happy Birthday Louise!

* The MRS, an annual CME program for health care professionals in Reproductive Medicine, is hosted by Fertility Centers of Illinois and chaired by Angeline Beltsos, MD (Executive Chairperson), Barry Behr, PhD, HCLD, and William Kearns, PhD.  

What Matters More?

The doctor’s…or the patient’s perception of their treatment?  Interesting question!  Even more interesting, it is one that was posed in an editorial in the current edition of the New England Journal of Medicine.

The question arose after a new study showed that patients’ self-assessed outcomes in clinical trials can mask a real lack of an objective effect. The accompanying editorial took a completely different stance – asking, “What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception?”

The double-blind, crossover study in question was led by Michael Wechsler, MD, an SRxA Advisor.  It set out to determine whether responses to placebo differ from the physiological changes that occur without any intervention in patients with asthma. To address this, they compared the effects of an albuterol inhaler, two placebo interventions (an inert inhaler and sham acupuncture needle) versus “no treatment” in which patients were told to wait for several hours and then return home.

46 patients with stable asthma underwent each of four treatments over a series of visits. At each visit, lung function was measured by spirometry every 20 minutes for 2 hours.  Also at each visit, patients were asked to score any perceived improvements in asthma symptoms on a visual-analogue scale with scores ranging from 0 (no improvement) to 10 (complete improvement). Patients were also asked whether they thought they had received a genuine therapy or placebo.

Among the 39 patients who completed the study, improvement in maximum forced expiratory volume in 1 second (FEV1) was significant only after albuterol, however albuterol provided no incremental benefit with respect to the self-reported outcomes.

In other words… from the patients’ perspective all the interventions, except waiting, worked.

While the authors acknowledged that placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma, they argued that from a clinical-management and research-design perspective, patient self-reports can be unreliable.  They concluded: “Objective outcomes should be more heavily relied on for optimal asthma care.”

However an accompanying editorial in the same journal questions the authors interpretation.

In it, Daniel Moerman, Ph.D. asks: “Are patients wrong if they report improvement even if there is no evidence for this?” He argues that it is after all subjective symptoms such as wheezing, rather than reduced FEV1 that brings patients to seek medical attention in the first place.

Hence the question, What is the more important outcome in medicine: The objective or the subjective, the doctor’s or the patient’s perception?

All medical procedures whether active or placebo, he argues, are meaningful insofar that they represent something. These meanings create expectations that can dramatically modify the effectiveness of even the most powerful proven treatments. He gives an example of a recent experiment that showed the effects of an opioid drug were either doubled or extinguished by manipulating subject expectations and that  MRI scans showed brain mechanisms differed as a function of these expectations.

Moerman asks: “Do we need to control for all meaning in order to show that a treatment is specifically effective?” Maybe, he suggests, it is sufficient simply to show that a treatment yields significant improvement for the patients, has reasonable cost, and has no negative effects.

What do you think? Is perception reality?  We’d love to know.

Can I Cut You Open, Please?

I remember the day, almost 30 years ago, when as a nervous student, I handed an eminent neurosurgeon the wrong instrument by mistake. I recall even more clearly having to duck the bloody swab he threw in return and the ensuing stream of expletives that followed.

Such incidents were common place in the operating room (O.R.) back in those days. As students we all had our “war stories” and we vowed never to be as tyrannical, should we ever reach the dizzy heights of our learned mentors.

So, it was with interest, that I read a commentary in the July issue of Archives of Surgery showing that surgeon’s behavior in the O.R. affects patient outcomes, healthcare costs, medical errors and patient and staff satisfaction.  According to the article’s primary author, Andrew S. Klein, MD, MBA, a prominent liver surgeon and the director of the Cedars-Sinai Comprehensive Transplant Center, in our increasingly rude society where it is rare for a stranger to give up a bus seat to a senior citizen or a child to thank their parent for a meal, the lack of civility permeates even the surgical suite.

Often, surgeons get hired on the basis of their knowledge, training and technical accomplishments,” says Klein, “but operating rooms are social environments where everyone must work together for the patients’ benefit. When a surgeon, who is in the position of power, is rude and belittles the rest of the staff, it affects everything.”

Klein and co-author Pier M. Forni, PhD, cite numerous studies to demonstrate the links between rudeness in healthcare and how it affects patient care:

  • A study of 300 operations in which surgeons were ranked for their behavior shows a correlation between civility in the operating room and fewer post-operative deaths and complications.
  • Because co-workers tend to want to avoid a doctor who belittles them, 75% of hospital pharmacists and nurses say they try to avoid difficult physicians, even if they have a question about the doctors’ medication orders.
  • Hospitals with high nursing turnover generally have increased medical errors and poorer clinical outcomes.
  • One survey reports more than two-thirds of nurses are verbally abused by physicians at least once every three months.

During operations, surgeons cannot seek consensus on whether to employ staples or sutures. But it is bad medicine for them, for example, to berate a technician for wrongly handing them a clip if they, instead, have asked for a clamp, says Klein. Further, he states, once surgeons leave the operating room, they must understand the importance of relinquishing authority. By empowering others to lead, surgeons gain immeasurable respect among peers and subordinates; they create a culture of loyalty that surpasses what can be achieved via the strict, top-down management style that can be the typical persona of surgeons, Klein says.

Forni, founder of the Johns Hopkins Civility Project says two elements conspire to promote incivility – stress and anonymity. While surgery, by nature, is a stressful discipline, if surgeons took the time to know their co-workers better, it would help establish a positive workplace culture. That, he adds, translates into better patient care and outcomes, as well as higher job satisfaction for colleagues.

When people, especially team leaders, act rudely, Fomi says, “the stress response is activated, blood pressure increases and the body’s immune system is weakened. Studies show that incivility in the surgical workplace is associated with increased staff sick days and decreased nursing retention, both of which are associated with increased medication errors.”

Klein says that the steps to create a culture of civility in operating theaters must start early in surgeons’ formative years. The challenge for medical mentors of the next generation is how to nurture important traits in their charges of ego strength, confidence, focus, work ethic and dedication – without abandoning the practitioners’ commitment to civil behavior.

SRxA’s Word on Health could not agree more.  Thank you for reading!

Are ethics being left behind as drug trials go global?

The number of clinical trials being conducted in developing countries has surged in recent years but the legal and ethical frameworks to make them fair are often not in place. This was one of the key messages to emerge from the 7th World Conference of Science Journalists, held in Qatar, last month. In 2008 there were three times as many developing countries participating in clinical trials registered with the FDA than there were in the entire period between 1948 and 2000.  These figures included many “transitional” countries, such as Brazil, China, India, Mexico and South Africa. The attraction for the pharmaceutical industry of doing studies in such countries includes lower costs and the availability of “treatment-naive” patients, i.e. those who have not been previously exposed to other drugs or enrolled in other studies. For developing countries, the main incentive for involvement with clinical trials is the promise of advanced medical science and access to the latest medications. However, the process of establishing and enforcing a legal and ethical framework to protect study participants is not always keeping pace. While many countries have set ethical standards for clinical trials, they are not always being followed, by either the sponsor or the investigator. “Less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation make carrying out research in the developing world less demanding,” said Professor Ames Dhai, Director of the Steve Biko Centre for Bioethics, South Africa. The conference noted that in places such as South Africa, where it’s mostly poor people with low literacy levels and a culture to accept authority without question, there is the potential for ethical misconduct.  “The greatest challenge in moving to mutual benefit is balancing the needs of biomedical research with the full protection of research participants and communities,” said Dhai. If this can be achieved, clinical trials can be highly beneficial for developing countries.  Not only will patients get access to life-saving drugs, the research itself can be used as a platform to enhance local skills, build genuine partnerships with the pharmaceutical industry, and attract funds to develop appropriate programs. Have you sponsored or participated in clinical studies in the emerging world? Share your experience with us.

Pine Powder Puts an End to Sneezing

According to researchers at the University of Gothenburg, the end may be in sight for allergy sufferers.  Patients plagued by the misery of seasonal allergic rhinitis, better known as hay fever, can be cured, thanks to a powder derived from pine trees.

Cellulose nasal sprays like Nasaleze and Nasal Ease, have been on the market for years, but there wasn’t scientific evidence they worked – until now.

Now in this latest study, scientists found that the pine tree powder forms a barrier on the mucous membrane when puffed into the nose, filtering out allergens such as tree and flower pollen.

The cellulose powder has no adverse effects, and this fact makes it a particularly attractive treatment for children,” said study author Dr. Nils Aberg, Associate Professor in the Department of Pediatrics.

The double blind, placebo-controlled  study, was carried out during the birch pollen season and involved 53 children and adolescents aged 8 – 18 years with allergies to pollen. Participants puffed the pine-tree derived cellulose powder in the nose three times daily for four weeks. They also took a daily dose of an oral antihistamine.
Pollen levels were measured every day and were subsequently analyzed in relation to the symptoms reported by the children. Patients or their parents were reminded to report their symptom scores using daily SMS messages sent to their mobile phones.
Results showed a statistically significant reduction in total symptom scores from the nose.  Further data for the study, published in Pediatric Allergy and Immunology, came from past unpublished statistics of pollen levels collected for 31 years at the same location in Gothenburg, from 1979 to 2009.

Dr. Aberg added: “We showed that the nasal symptoms of the children were significantly reduced in those who used the cellulose powder. The best effect was obtained at low to moderate concentrations of pollen”.

Word on Health asked leading allergist, Dr. Bill Storms for his reaction to this study.  He told us, “It appears that the  waxy coat of the pine tree pollen might line the inside of the nose after sniffing it and  this might prevent other pollens from getting into the mucus membranes. However, I note that patients were asked to do this three times a day and I’m not sure how many will do this.  I also wonder if there are any long term effects of putting cellulose in the nose.”

As we’ve said so many times before, further studies are needed.

UCLA settles after Selling Secrets of the Stars

SRxA’s Word on Health brings you news of yet another big payout – only this time it’s not pharma that’s paying the price.  In a settlement reached with federal regulators last week, UCLA agreed to pay an $865,000 for potential violations of federal privacy laws after hospital employees were accused of snooping into the medical records of celebrity patients.

The investigation by the U.S. Department of Health and Human Services revealed that workers repeatedly accessed patients’ electronic health records between 2005 and 2008. In 2008, California Department of Public Health officials announced results of their own investigation into the privacy breaches and found that UCLA hospital workers inappropriately accessed records of 1,041 patients since 2003.

The hospital later disciplined 165 employees through firings, suspensions and warnings and at least two former UCLA employees have faced criminal charges for medical privacy violations.

Former administrative specialist Lawanda Jackson, 50, pleaded guilty to selling information to the National Enquirer from the files of Britney Spears, Farrah Fawcett and other high-profile celebrities. She died from complications of breast cancer before she could be sentenced.

Former medical school researcher Huping Zhou was sentenced to four months in federal prison and fined $2,000 for reading the confidential medical files of co-workers and celebrities such as Drew Barrymore, Arnold Schwarzenegger and Tom Hanks.  Zhou, a Chinese national, claimed he didn’t know it was a violation of U.S. law to peep into the files.

These headline-grabbing breaches led California legislators to pass a bill boosting the maximum fine for privacy breaches at health facilities from $25,000 to $250,000.

UCLA Hospital System which includes Ronald Reagan UCLA Medical CenterSanta Monica-UCLA Medical Center and Orthopedic Hospital, and the UCLA Medical Group, a network of primary and specialty care satellite offices, has agreed to report to a federal monitor on the implementation of its corrective plan over the next three years.

In a statement Thursday, UCLA said it has taken steps over the past three years to retrain staff and strengthen its computer systems.

Coming the same week that the British tabloid News of the World  was caught hacking into the phones of celebrities, government officials and murder victims, a scandal that has led to the demise of the popular Sunday newspaper and the public disgrace of media magnate Rupert Murdoch, UCLA should consider themselves lucky.

Exercise in a bottle

Can red wine offset the negative health effects of a sedentary lifestyle? Yes, says a new study, at least if you’re a rat!

The investigators set out to discover if resveratrol – an ingredient found in red wine, could help astronauts overcome some of the adverse effects of  zero gravity. Weightlessness in space makes physical activity almost impossible for astronauts, and results in a decrease in muscle and bone mass.

Scientists mimicked the inactivity astronauts experience by hanging rats by their back legs. Half the rats received a daily dose of resveratrol, and half did not. What happened? The rats not given resveratrol experienced reduced muscle mass and strength and bone density, and developed insulin resistance – which is considered a prelude to diabetes. The ones that took resveratol didn’t experience any of these negative health effects.

Earlier studies have shown that resveratrol can be good for health, because it lowers levels of “bad” cholesterol and protects the lining of heart blood vessels. Other studies have suggested that resveratrol can help stimulate estrogen production, prevent blood clots, boost the immune system and slow aging.

So how does it work? According to the French researchers resveratrol “flips a switch” for cell metabolism that lets the cells “breath internally” – counteracting the detrimental effects inactivity has on the body’s cells.

The results don’t just apply to astronauts, since a sedentary lifestyle also limits physical activity for us normal folks.  “For the earthbound, barriers to physical activity are equally challenging, whether they be disease, injury, or a desk job,” said Gerald Weissmann, editor-in-chief of the FASEB Journal where the study was published.

However, he cautions, it’ll take more than a glass or two of wine to reach the doses of resveratrol the rats received.   All of which is good news for the oenophiles amongst us.  We apologize for cutting this story short but we’re about to get our exercise in a bottle and while we’re at it, we’ll drink to your good health too!

Nurses are the Key to Reducing Revolving-Door Readmissions

Shockingly, one in five elderly patients discharged from a hospital is readmitted within a month. Seeking to address the substantial human and financial burden of revolving door hospital readmissions, the Affordable Care Act has proposed a number of initiatives to improve care and health outcomes and reduce costs for the growing population of chronically ill people in the U.S.

While transitional care is a central theme in these provisions, there is little information available to guide those responsible for implementing these important opportunities. To bridge the gap, researchers at the University of Pennsylvania School of Nursing reviewed existing programs in order to determine what works, for whom and for how long.

They discovered “a robust body of evidence” that transitional care can improve health outcomes and reduce hospital readmissions. Their paper published in a recent edition of Health Affairs, highlights a range of solutions to reduce avoidable hospitalizations and health care costs.

The team conducted a systematic review of the research literature and summarized twenty one randomized clinical trials of transitional care interventions targeting chronically ill adults. From these, they identified nine interventions that demonstrated positive effects on measures related to hospital readmissions. “All nine interventions that showed any positive impact on readmissions relied on nurses as the clinical leader or manager of care,” wrote lead author Mary Naylor, Ph.D., R.N.

The strategies they identified have been shown to result in short term benefits and effectively reduce all-cause hospital readmissions through six or 12 months. “If we capitalize on what we know, the real beneficiaries will those living with complex chronic conditions and their family caregivers,” explained Naylor.

This makes sense to us and is certainly a lot easier than trying to understand the Affordable Care Act.