Prescriptions, Physicians, Patients and Payers: Let the battle commence!

Last week the FDA announced that it wants to remove obstacles to America’s most commonly used drug treatments.  If the Agency gets its way, some drugs used to control chronic conditions, such as high cholesterol, diabetes and asthma may soon be available without prescription.  But in doing so, they have reopened a  big can of worms. One that brings into question the very nature of health reforms, preventative medicine and improved access to healthcare.

Here’s the proposal: The FDA would create a new class of “safe use” drugs. While consumers would not need a prescription, they would still need to get clearance from a pharmacist or from specially designed websites to purchase them.

Battle lines are being drawn! With physicians on one side, and patients, pharmacists, pharma and payers on the other.

Doctors are most definitely not thrilled by the idea. Removing the prescription requirement for an inhaler refill, for example, doctors fear they would be taken out of the loop on everyday care decisions.

Insurers, on the other hand are embracing the move. They recognize that they could save big bucks if physician visits weren’t required for run-of-the-mill complaints and ongoing medication monitoring. They might even save on the costs of the drugs themselves because, depending upon how they’re classified, most health plans don’t pay for over-the-counter treatments.

Pharmacists see it as validation of their expertise and pivotal role in primary healthcare and the pharmaceutical industry, who has repeatedly asked for permission to sell such drugs over-the-counter, must surely be cautiously optimistic.

Even normally conservative regulators are supporting the move. “Greater over-the-counter and behind-the-counter access will lower costs and make healthcare more accessible to consumers,” former FDA commissioner Scott Gottlieb said via Twitter. “It’s a good idea, long overdue.”

Even so, the FDA will have a fight on its hands as it moves to turn its proposal into reality. The American Medical Association lambasted the idea in USA Today, saying that patients need guidance from doctors. The doctors’ association also points out that giving patients more control could complicate coordinating care, such as, tracking all the drugs a patient uses to prevent interactions.

But, as The Washington Post points out, FDA sees the doctor’s visit as a hindrance to care; some patients don’t seek treatment if they have to see a physician first. “Obviously, it’s much easier for you to go to your drug store and pick up an item than it is to make an appointment, take a prescription, drop it off and get it filled,” says Nancy Chockley, president of the National Institute for Health Care Management.

About 20% of prescriptions written in the United States currently go unfilled. Removing obstacles that keep Americans from managing their own health care is, according to one patient, namely me, a good thing.

The FDA contends, and I agree, that some consumers may not even go as far as getting a prescription because of the “cost and time required to visit a health-care practitioner.  Earlier this month, I stood in line at my local pharmacy for thirty minutes to pick up a refill prescription for blood pressure meds. On reaching the end of the line I was told that there was no prescription. The pharmacist called my doctor and the lack of prescription was confirmed. I called my doctor and was told I would need to make an appointment to have the prescription renewed. I pointed out that I had done that one month earlier and that nothing had changed regarding my health. I was then informed that it was a new policy to issue prescriptions on a month-by-month basis rather than provide automatic refills. Even when I pointed out that I have a chronic condition that I’m doing my best to manage and part of that management is the medicine I have been taking for years, they wouldn’t sway. No doctors visit, no prescription.  And the kicker, I couldn’t get an appointment to see my doctor for a week…meaning, I had to go 7 days without blood pressure meds, all so my doctor could better manage my care!

Practicing medication adherence is very hard when your doctor won’t give you medication…and leaves me wondering if this policy change had more to do with revenue generation than improving chronic disease management.

My personal experience aside, at the heart of this discussion is a fundamental disagreement over what role doctors play in managing patient care. The FDA proposal views a trip to the physician as a hindrance to care, whereas doctors see that visit as crucial, especially as chronic conditions become increasingly prevalent.

The FDA proposal is still in formative stages, meaning there’s still a lot of space for this debate to evolve. Where the discussion heads on this particular issue could end up guiding health policy on what role doctors play in managing patient care – and, at what point, the patient takes charge.

I, for one, can’t wait to see how it plays out, assuming of course that I’m not dead from uncontrolled hypertension!

The Whys and Wherefore’s of White-Coat Hypertension

Yesterday was Mother’s Day for our readers who live in the US.  I do, but my mother doesn’t, so rather than treat her to lunch or chocolate, I’m dedicating this blog to her instead.

Let me start by saying that hypertension runs in our family.  My grandmother and her mother before her had it, my mother has it and even though I was an ultra-fit marathon runner at the time, I also developed high blood pressure around the time I turned 40.

But that’s where the family trait ends. We manage our disease very differently.  I take my meds, try to eat healthily, avoid stress and exercise whenever I can. I also avoid taking my blood pressure.  If I don’t know it’s high, it’s one less thing I have to worry about!  My mom, on the other hand is a much more compliant patient and goes for regular check-ups.

The problem with that, is she worries so much about having her blood pressure taken that it’s always high when she sees her doctor.  She can’t explain why she worries about this, she knows it’s not rational, but still she worries.  And she’s not alone.

For many patients, blood pressure measurements taken in a physician’s office may not correctly characterize their typical blood pressure. Up to 25% of patients evaluated by their doctors, have blood pressure measurements higher than their typical levels. This phenomena is known as white-coat hypertension and is thought to result from anxiety related to examination by a health care professional.

So I was really interested to read a new study from the UK where, incidentally, my mom lives.  It showed that by swapping a doctor for a nurse you can eradicate white-coat hypertension.

The meta-analysis of 14 studies found that mean blood pressures measured by nurses were 8.5/4.2mmHg lower than readings from doctors. When studies with a high risk of bias were removed from the analysis, the gap was reduced but remained, with a mean difference of 4.8mmHg in systolic blood pressure (the top number) and 1.5mmHg for diastolic (the bottom number).

The study concluded that blood pressure measurements taken by primary care doctors might be ‘unreliable for clinical decisions’, and that all measurements should be delegated to nurses.

Study leader Dr Chris Clark, clinical academic fellow at the Peninsula Medical School and a GP in Witheridge, Devon, said: “The difference could affect treatment decisions, especially when the measurement is marginal, between one course of treatment and another.”

Such a recommendation also has wide-ranging implications for how medical practices organize their services.  Researchers told the European Society of Hypertension Congress that the findings meant practices should move to nurse-only or home blood pressure monitoring.

The rationale for the different blood pressure values obtained by doctors and nurses?  The researchers speculate that nurses are better at relaxing patients.

Would you be more relaxed seeing a nurse rather than a doctor?  My mom says yes!

How do you talk when physicians won’t listen?

In general those who have nothing to say contrive to spend the longest time in doing it” said American poet, James Russell Lowell

But when it comes to the  pharmaceutical industry,  companies have plenty to say but less and less time and opportunity to convey or control the message.  Amid news this week that Pfizer is providing a $3 million grant to Stanford University for CME  programs, with no strings attached, it is clear that drug companies are facing some of the greatest challenges in their history.

Although there are pockets of real growth and development, worldwide revenues are dropping.  After a series of public relations disasters, the industry’s reputation is tarnished.  And despite an estimated $70 billion worth of drugs going off patent globally by 2012, pipelines hold fewer and fewer truly innovative new products.

Then there’s diminishing physician interactions due to an increasingly restrictive regulatory environment, along with the increasing power payers have over the market’s access to drugs. The ever-growing number of  “no see” doctors is a challenge for every pharmaceutical company’s sales and marketing departments.  Even those doctors who would like to see reps find themselves unable to do so either due to lack of time or strict institutional policies. With lunches, dinners and other forms of hospitality now all but banned, the question is: How do you talk when physicians won’t or can’t listen?