Disruptive Women in Health Care » Pharmacists

Why Did They Do That? Unraveling The Actions of the FDA

Archelle Georgiou, MD — Fri, 14 May 2010 11:57:24 +0000

By Archelle Georgiou. On Wednesday, the FDA suddenly decided to impose their regulatory authority on personalized genetic test kits after Walgreens and Pathway Genomics announced they’d be selling them in local pharmacies. But, what triggered this response from the FDA?

Are they new? No. These kits have been available to consumers via the Web for 3 years.

Have they been off the regulatory radar screen? No. As far back as 2008, the rapid emergence of genetic testing fueled the passage of GINA, a federal law prohibiting health insurers and employers from discriminating on the basis of genetic information.

Have these companies been quietly launching their strategy and staying invisible? No. They have made major investments in marketing with an abundant amount of media coverage in women’s magazines and news shows.

So, why did the FDA choose to take a stand now?

Maybe the Agency was dealing with higher priority issues. The FDA is busy and constantly putting out other fires, resources are limited, and the number of people buying these kits off the Web has been relatively small. But, with the announcement that kits would available in 6000 local pharmacies, they may have been concerned about a surge in use and the need to fulfill their responsibility to protect the public. A “noble” act, I am sure.

But, were there other underlying forces? Who was nudging the FDA? And, why?

The American Medical Association recommends that “genetic testing only be made available under the supervision of a qualified health care professional.”

Hmmm… the most powerful lobbying organization within the traditional medical establishment believes that only clinicians should be the keeper of the keys to our personal DNA information. By the way, does “qualified” include mean nurses, pharmacists, and licensed genetic counselors…or is it really just a code word for “doctors?”

Is the AMA advocating for better health and the rights of consumers, OR…

….Are they trying to maintain a paternalistic status quo?
….Do they feel that doctors are relatively uninformed about the science behind genetic testing and trying to protect them from feeling unqualified to respond to questions when their patients come in with a 77 page report?
….Do they simply want to protect doctors’ revenue stream?

I am not picking on doctors…merely the lobbying group that positions itself as a voice for doctors. We should remember that the AMA only represents 29% of US physicians. So, maybe we should listen to the voices of other professional organizations including the American Society of Clinical Oncology (ASCO), the National Comprehensive Cancer Network (NCCN), the Society of Gynecologic Oncologists (SGO), the National Society of Genetic Counselors (NSGC) and the Oncology Nursing Society (ONS) that have more patient-centric positions regarding direct to consumer genetic testing. While all are similar, ONS specifically advocates for pretest education, counseling, and informed consent, with post-test disclosure and follow-up. I would even go further and mandate a telephonic/web based discussion with the certified genetic counselors that are already on staff part of the support team of the genetic testing companies. (FYI, only 10-20% of people currently take advantage of the ready access to genetic counselors. Even as a physician, I found this an important and valuable part of my experience.)

This type of solution would entail a few more steps than the current process which simply requires a credit card and some spit, but it would help assure that people are fully informed. At the same time, it allows the consumer to stay in control and eliminates the additional cost (or profit, depending on what perspective you have) that mandatory physician visits and consultations would incur. In addition, the big 3–Pathway Genomics, Navigenics, and 23andMe–should be able to integrate online education into the patient experience process since each already has elaborate consumer web capabilities.

The managed care industry eliminated doctors as gatekeepers to health care services in 1999. It is now 2010. We don’t need doctors as gatekeepers to our own health information.

Create Health,
Archelle

This blog entry was originally posted in Archelle On Health on May 13, 2010.

Genetic Test Kits for Sale Over the Counter: Good or Bad Idea? Take our Poll

Hygeia — Tue, 11 May 2010 17:03:05 +0000

NOTE: Disruptive Woman Sharon Terry is quoted in TheWashington Post article linked below. If you haven’t already done so, take a look at Disruptive Woman Dr. Archelle Georgiou’s post entitled Stop the Drama and Spit in which she shares her personal experience with genetic testing.

“Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer’s disease, breast cancer, diabetes and other ailments. ” Click here to read the rest of The Washington Post article.

Note: There is a poll embedded within this post, please visit the site to participate in this post's poll.

Improving Adherence with the Help of Pharmacies

Hygeia — Tue, 03 Nov 2009 15:59:02 +0000

The following post – part of Disruptive Women’s Drug Adherence Series – is by Stacey Irving of McKesson Patient Relationship Solutions.

Poor medication adherence affects all of us in healthcare — it’s a problem that our entire industry is trying to tackle. By many estimates, more than 50% of patients aren’t taking their medications as prescribed. And that’s a real problem: it’s adding $177 billion in additional healthcare costs and contributing to sicker patients. Reports associate lack of adherence with 10% of hospital visits and 40% of nursing home admissions.

At McKesson, we’re trying a new approach. We’ve partnered with pharmaceutical manufacturers to sponsor programs that get community pharmacists involved in promoting medication adherence. Independent and small-chain pharmacies, including McKesson’s chain of Health Mart pharmacies, have a reputation for building strong relationships with their customers and delivering excellent service. By getting pharmacists to spend time counseling patients about their medications, we’re helping patients become more informed, more confident, and more motivated to adhere to their medication regimens.

In one of our first programs, the Pharmacy Intervention Program, we’ve trained hundreds of pharmacies in motivational interviewing and other key health behavior change techniques — asking patients open-ended questions and having a true discussion about the patient’s knowledge, feelings, beliefs, goals and expectations. This patient-centered approach to counseling helps pharmacists be as effective as possible in providing education and support to patients.

Here’s how it works: when patients come to pick up their prescription for one of the sponsored medications, the pharmacy’s computer system alerts the pharmacist or pharmacy technician that the prescription is eligible for counseling. Before the patient leaves the pharmacy, a pharmacist begins a conversation with him or her about the medication and provides the patient with literature to take home. Pharmacists are reimbursed financially for the 5 minute counseling time — something they ordinarily do for free — further encouraging them to take the time to promote patient adherence.

We’re already seeing incredible results from the program. In our pilot program this summer for two products, our pharmacists achieved a 24% increase in adherence (the number of patients returning for refills) for a smoking cessation therapy medication, and an average 38 % increase in adherence rates for a COPD medication. These are mind-blowing results, and the manufacturers with whom we’re working have taken notice. We’re all excited about the impact of this program and the results that community pharmacies may be able to achieve in driving medication adherence.

So many times in our healthcare system, a patient’s different care providers work in isolation to promote better outcomes. But programs like the one we’ve introduced at McKesson suggest that more collaboration and coordination — reinforcing common messages about conditions and medications from the physician to the pharmacy counter — can make a huge difference. We’re also seeing the real difference that strong relationships and quality, patient-centered discussions can have on a patient’s understanding of and loyalty to a therapy. These are things to keep in mind as we ponder how to address this very large issue our healthcare system faces with medication adherence.

Drug Adherence Throwdown: Analyzing America’s Other Drug Problem

Robin Strongin — Sun, 18 Oct 2009 20:55:04 +0000

As I mentioned in my post last week, Disruptive Women in Health Care is tackling the issue of drug adherence, often referred to as America’s other drug problem. From a health policy standpoint, the issues cross financial, clinical, behavioral, and cultural boundaries.

Over the next two weeks, Disruptive Women and guest bloggers, all experts in their respective field–each representing a different perspective — patient, physician, nurse, pharmacist, researcher, behaviorist, policy analyst, distributor, to name a few–will share their analyses, opinions, and solutions.

At the completion of this series, we will compile an e-book as we did when we tackled the issue of Comparative Effectiveness Research.

THE SCOPE OF THE PROBLEM

A new report, Thinking Outside the Pillbox: A System-wide Approach to Improving Patient Medication Adherence for Chronic Disease, issued by the New England Healthcare Institute (NEHI) found that patients who do not take their medications as prescribed pay a price in poorer health, more frequent hospitalizations and a higher risk of death.

Collectively, noncompliant patients incur up to $290 billion annually in increased medical costs–that’s $290 billion in avoidable medical spending every year, according to the NEHI report.

This is not a new problem, nor is it unique to the US. In 2003, the World Health Organization (WHO) issued a landmark report entitled Adherence to Long-Term Therapies in which it noted:

Adherence to therapies is a primary determinant of treatment success. Poor adherence attenuates optimum clinical benefits and therefore reduces the overall effectiveness of health systems.

“Medicines will not work if you do not take them.” Medicines will not be effective if patients do not follow prescribed treatment, yet in developed countries only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In developing countries, when taken together with poor access to health care, lack of appropriate diagnosis and limited access to medicines, poor adherence is threatening to render futile any effort to tackle chronic conditions, such as diabetes, depression and HIV/AIDS.
This report is based on an exhaustive review of the published literature on the definitions, measurements, epidemiology, economics and interventions applied to nine chronic conditions and their risk factors. These are asthma, cancer (palliative care), depression, diabetes, epilepsy, HIV/AIDS, hypertension, tobacco smoking and tuberculosis.

In the intervening years since the WHO issued its report, adherence has become more problematic. Numerous reports highlight the ongoing challenges, which are especially critical in the mental health arena.

A study in the American Journal of Psychiatry found that close to 60% of schizophrenics who were prescribed anti-psychotic drugs did not take the medication as prescribed by their physicians. “We looked at adherence to anti-psychotic medication because they form the backbone of treatment for schizophrenics,” said Dr. Dilip Jesete, co-author of the study. “These medications are good, but only work when taken properly.”

The study found that psychiatric hospitalizations were higher for people who did not take their medication as prescribed.

When schizophrenics, a disease which affects over 2 million Americans, do not take their medication, they are at risk for dying by suicide. Four out of ten people who suffer from schizophrenia attempt suicide and one in ten die by suicide.

SOLUTIONS

Despite the complexity of adherence related challenges, a number of promising solutions, innovative responses and well-researched efforts are underway. Many of these will be described in greater detail in our Drug Adherence series.

Some of these include:

Text message alerts to remind patients
Greater use of health care teams
Integration of health information technology
Creation of online and offline medication management systems, reminders
Health e-games
Insurance reforms
Public awareness campaigns
Patient education
Mobile phone applications
Research in gender-based barriers

We look forward to your comments and input as we shed light on this critical policy issue.

Drug Adherence Throwdown: Disruptive Women Take on America’s Other Drug Problem

Robin Strongin — Mon, 12 Oct 2009 13:21:41 +0000

It has been estimated that 3 out of 4 people report that they do not take their medications as directed, resulting in hundreds of billions of dollars annually in related medical costs and an enormous number of hospital admissions and readmissions.

The reasons for this are complex and varied. This is a particularly vexing challenge for young, chronically ill patients, for people with mental health diagnoses and for the elderly who may suffer from memory impairment. Anyone on a complicated drug regimen knows how committed one must be to remain adherent.

For some, cost is an issue while for others side effects can be unpleasant, travelling can compromise the best of intentions as can the need for refrigeration when none is available. Some patients must take some drugs on an empty stomach and others on a full stomach. Some patients are simply not ready to accept they have a serious, or lifelong illness. It is complicated.

Because the implications, both clinical as well as financial, are significant, we have invited a number of our Disruptive Women bloggers, as well as some other experts in the field, to join us in a series of policy posts on this critically important issue.

Beginning next week, on October 19th, we will launch our Drug Adherence series which will analyze this challenge from a number of perspectives: patients, providers, researchers. In addition, we will also offer innovative solutions.

At the completion of this series, we will compile all the posts into an e-book, just as we did when we tackled the issue of Comparative Effectiveness Research and created our Comparative Effectiveness Research e-book.

If you or someone you help care for has experiences you would like to share, or you have research, solutions and other thoughts on this topic, I hope you will share them with us.

Prescribing Pharmacists: A Boon for Physicians?

Glenna Crooks — Thu, 09 Oct 2008 13:00:40 +0000

Will pharmacist prescribing be good for physicians? Yes.

The practice of medicine has never been more complex or demanding. It’s a perfect storm, especially in primary care. The number of primary care providers is dwindling as older physicians retire, those not at retirement age leave the profession and younger people do not replace them. Even those who do choose primary care are less likely to work long hours. And why should they? They’ll not be paid commensurate with their value and the love of their work is not something they can use to negotiate a mortgage or pay the kids’ tuition.

Meanwhile the population is aging and requires more care. Far too many people – including the young – have multiple chronic conditions. Payment pressures increase paperwork burdens and limit visit times and the consequences of making mistakes are serious.

Pharmacist prescribing and medication management will allow physicians to focus on the arena that is uniquely theirs – creating the relationships that allow for making the best, most accurate diagnoses in the increasingly complex patient circumstances they see. It will give them the time to consider non-medication alternatives and discuss life-style changes to improve health.

When physicians determine medications are necessary, just as they did during their training when they practiced in teams with pharmacists, they can refer the patients to community pharmacists to address medication selection, counseling and follow-up.

As they make that referral, they can be reassured that though patients see other physicians, they tend to visit the same pharmacy. Even if they do not, medication records are much more likely to be linked than medical records and unsafe combinations of drugs will more likely be avoided.

Pharmacists are not prescribing medications, but they are demonstrating – today – that they can be trusted to assume the other aspects of care management. There’s no better example than the American Pharmacists Association Ten City Challenge.

Employers are convinced and they’re investing in pharmacist management of diabetes and the results are good.

Savings of nearly $918 per employee in total health care costs for the initial year, with a even greater savings in subsequent years.
Return on Investment (ROI) of at least 4:1 beginning in the second year.
A 50% reduction in absenteeism and fewer workers’ compensation claims.
High employee satisfaction – 95% approval for pharmacist care – and improved quality of life.

That’s good for patients, for payers and for all of us who support health care systems and what they cost. What physician wouldn’t call that good for them, too?

The Best Hope for Health Reform is Pharmacists

Glenna Crooks — Thu, 25 Sep 2008 15:00:45 +0000

A “new” profession of pharmacy is about to be born in the US. There are those who will pace nervously awaiting its arrival. Like expectant fathers they’ll anticipate – but also fear – the consequences of the blessed event. It will change their lives forever. Though at this point there won’t be any turning back, perhaps they’ll wonder if it was such a good idea after all to allow pharmacists to be direct providers of health care, with independent prescribing authorities.

Mr. President, you can help midwife this innovation in health care by keeping those expectant fathers – and especially those in the federal government – out of the way.

What will this baby look like?

The “new” profession of pharmacy in the US will be the younger sibling of the one born at the start of healing traditions created in ancient worlds.

In ancient times the profession was a separate, distinct, third branch of medicine. Patients selected a pharmacist, a physician or a surgeon to treat their condition. I predict that patients in the US will be able to make a similar choice.

It won’t be long now, perhaps even within your term in office. The “new” profession of pharmacy in the US will likewise become independent healers of the sick and enablers of health and wellness, and yes, with totally independent prescribing authorities.

Why do I say that? Everywhere, I see signs of this impending birth.

Pharmacists are trained, skilled and ready:

All graduates today have Pharm.D. degrees, supplying the country with the best trained pharmacists the world has ever known.
Their information on medications is superior to all other clinicians.
They are the best trained clinicians in the interpersonal skills required to manage patients and the problems they encounter with their diseases and lives.

Pharmacists are equipped for the job:

Their computerized information systems help manage increasing numbers of prescribed medicines and increasingly complex combinations prescribed by separate clinicians.
Their medication use and disease management infrastructures are among the best in the world.

Pharmacists are needed to assure access and quality care:

Clinicians have abdicated medication management under reimbursement stress.
Pharmacy hours and locations make them the most accessible professionally-managed health care settings in the nation.

Pharmacists are preferred professionals:

Consumers trust pharmacists and want the convenience, quality and care they deliver.
Payers are looking for effective alternatives to traditional care.

Pharmacists can be held accountable:

Their information systems are already in place and enable them to be held accountable for pharmaceutical care to a much greater degree than in traditional medical and nursing clinical care.

As you see, Mr. President, when this sibling arrives, it will not be an infant or even a toddler. Nor will it be a weak sister to medicine or surgery.

Perhaps your own clinicians, after they have diagnosed some condition, will refer you to a pharmacist who will take over any pharmaceutical care you need, identify the right doses and combinations of medicines you need, counsel you on how to take them, encourage you to embrace healthy practices (and even give you stress management tips!), monitor your progress and adjust the regimen accordingly.

Will this be good for patients, clinicians, payers and even you, Mr. President?

I have some ideas about how to make it so, and since it’s starting to happen as states expand practice authorities, we need to be sure to “get it right.”

“Getting it right” means that you should not meddle in this. Pharmacy is a profession that is evolving into what patients and health care reform need. Let it happen. Don’t stand in the way and stop this progress.

Pharmacists like my own terrific pharmacist team – Andrew and Greg – are ready. The right question is this: are the rest of us?

That will be the subject of my next blog.