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Physician Practice and Pono

On May 29, 2013, the Hawaii Prescription Drug Summit focused on the challenges Hawaii is facing with prescription drugs, particularly those associated with opioids and physician dispensing. Joe Paduda of Managed Care Matters was the keynote speaker – he was fabulous, as always. I was asked to do the closing session, titled “Physician Practice and Pono”. Although I am a “Haole” after a decade of being in Hawaii, I am (slowly) learning Hawaiian values, including that of Pono. Pono refers to balance or proper order, with the idea of righteousness being introduced after Western contact. The following are my remarks.

“Mahalo to each of you for participating in the Hawaii Prescription Drug Summit, to Kristy Kobayashi for her vision and leadership, to our knowledgeable speakers, and to our sponsors. I would like to take a few moments to share some insights, to explore just one example of physician drug dispensing, and to discuss some potential actions.

The underlying theme of the presentations and discussions is that we should each practice healthcare in a way that honors the Hawaiian concept of pono – our actions should be based on integrity and reflect what is right. The principles of pono and aloha must be honored. We should not tolerate physicians or other healthcare professionals violating these core values.

What should physicians be doing? Hippocrates, a Greek physician born in 460 BC, is the archetype of the ancient physician and often referred to as the father of western medicine. In accepting the Hippocratic Oath new physicians swear upon various healing gods that they will uphold a set of ethical standards. 98% of American medical students swear some form of the Hippocratic Oath. These oaths generally include the promise that:

I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.

Most physicians practice medicine in a pono fashion and honor their Hippocratic Oaths – but some do not.

What have we learned? What do we know?

1. In caring for our patients we need to focus on their wellbeing, on preventing illness and injury, and, when needed, on restoring health and function.
2. Evidence-based medicine – the conscientious and explicit use of current medical best-practices in making decisions about the care of individual patients – should be the foundation of all clinical practice. Unfortunately this is not always true.
3. Often the most important therapeutic interventions are providing support for personal empowerment, positive focus, activity and exercise, healthy diet – which generally means weight loss, and healthy lifestyle choices such as avoiding smoking, avoiding excessive alcohol and other drugs, and practicing safe behaviors.
4. Patients must be active engaged concerning our health – we each must assume personal responsibility for our wellbeing and our lives.
5. In the U.S. we have a society and a medical culture that over utilizes pharmaceuticals. This has been measured first by evidence-based medicine and again by contrasting U.S. drug use with that of the rest of the developed world.
6. The marketing and prescription of inappropriate drugs places the patient at risk, including the risk of death. Needless prescribing also promotes our perceptions of being ill, injured, and vulnerable. In pono and ethical healthcare the benefits of clinical interventions must always exceed the risks of such interventions.
7. The U.S. and New Zealand are the only two industrialized countries allowing direct-to-consumer drug advertising. Perhaps, rather than our drug advertisements telling us to “Ask your doctor if (Brand X) is right for you,” we should be reminded that the better question for our doctors would be “Do we really need any drugs? Would better lifestyle decisions, maybe improving our diet or exercise, answer our concern and leave us healthier?” Lifestyle changes can sometimes do more to improve our health, for far longer, than any drug.
8. The best interests of the patient must always take precedence over the self-interests of other stakeholders.
9. There are problems in the design of our workers’ compensation, automobile casualty, and medical-care systems when these systems generate incentives for actions that may harm our patients. Physicians are largely paid for doing “stuff,” such as procedures and dispensing. Most physicians are not adequately compensated for teaching better lifestyle choices and spending time with our patients.
10. Serious clinical issues include some patients not receiving adequate treatment for their pain while others receive excessive and harmful treatment.
11. The costs of bad care are enormous – and the human costs far exceed the financial costs.
12. Our failure to confront the issues discussed today has placed our patients at risk and has assuredly resulted in deaths.

My friend and colleague Joe Paduda discussed “repackaged medications and dispensing” and whether such practice can be win-win. From my perspective, and I may be wrong, when we weigh the risks versus the benefits from a realistic perspective my conclusion is that physicians should not dispense drugs. Dispensing drugs is inconsistent with our roles and competence.

To offer a specific example for our consideration, I would like to show what has happened with just one drug – Carisoprodol (Soma). This drug is a centrally acting muscle relaxant and is a modification of meprobamate, a Schedule IV drug. It may impair mental and physical activities and is known to result in abuse and dependence. Cochrane Database Systematic Reviews found “In subacute and chronic neck disorders, muscle relaxants, analgesics and NSAIDs had limited evidence and unclear benefits.” The drug is banned in Europe. In 2007 European Medicines Agency concluded risks outweigh benefits.

Carisoprodol is widely prescribed among physicians in dispense drugs. The typical charge seen by payers for this drug from third party billing companies is $558.42 for 60 tablets (Carisoprodol 350 mg). The original manufacturer established an Average Wholesale Price (AWP) of $0.56 per tablet and sold to a repackager for $0.056 per tablet. The repackager reestablished the AWP as $6.65 per tablet ($398.87 for 60 tablets) and sold the bottle of 60 tablets to the physician for $24.32. Therefore the original acquisition cost for 60 tablets was $3.36 and the final invoice was $558.42; this is a 166 fold increase. Clinically risks exceed benefits; however for the participants financially the benefits exceed the risks. The profit for the physician was $367, the biller $167, and the repackager $21. If the average patient had two prescriptions resulting in similar profit margins for the physician, the physician saw 20 such patients per day, and did this 210 days per year the resulting profiting is close to three million dollars per year. Even if 10% of this, it is unacceptable to place the patient at risk.

Joe Paduda spoke recently at the annual conference of the National Council on Compensation Insurance. His topic, “Thieves, Profiteers, and Enablers” further developed themes from my presentation three years earlier at the same conference. Joe provided a summary of physician dispensing; overprescribing of opioids; and the growth in the sales of compounded medications, physician-dispensed durable medical equipment, and physician-office-based drug testing. His discussion was physician-centric – but we all face significant challenges.

Most physicians are not bad; however a small number of bad physicians are causing the vast majority of the problems for our patients involving our state’s workers’ compensation, personal injury, legal, and social-welfare systems. Physician dispensing is the tip of the iceberg, what is below the surface is even more alarming.

Why are we seeing this pattern? Is it ignorance, ego, or greed or a combination of all three? It would be reassuring if we could attribute the behavior to ignorance; however my experience is that many of these problematic physicians are very smart. They are not ignorant of evidence-based medicine; rather they choose not to base their treatments on scientific data. The ego of many of these physicians is inflated. Simple financial greed would appear to, in large part, explain many of their actions. It is all about the money.

We should be outraged. Just because something is legal does not mean it is wise or ethical.

As patients we should be able to trust our healthcare providers. Unfortunately some are abusing both that trust and us for their own financial gain. This includes some physicians who claim to be advocates for injured workers. The actions of some supposed advocates are not beneficial for patients.
The systems in which we all function are far from perfect and are particularly difficult for our patients to navigate.

Core issues and problems go well beyond today’s focus on prescription drugs. Even if we were to ban physicians’ dispensing of prescriptions, the “thieves, profiteers and enablers” would not go away. They would simply seek profit opportunities in other areas – such as questionable non-pharmaceutical approaches or dispensing of devices not supported by evidence-based medicine.

Such healthcare practitioners will continue harm us with inaccurate clinical evaluations, faulty causation assessments, and by not supporting our focusing on our continuing or early return to work. I pray these physicians recognize their behaviors and make different choices.

We all need to recognize the broader questions:

• Why do people with the same problem have different outcomes even when they receive the same care? Our military-veteran Wounded Warriors – highly motivated individuals – may be contrasted with many others, both military and civilian, who become needless disabled.
• Do we actually have a healthcare system in the U.S. or do we just have fragmented, often self-serving, components?
• What is disability and how much of it is preventable?
• What is the impact of “needless disability” on the individual and society? What are the human and financial costs?
• How do our beliefs contribute to our living abled or our living disabled?
• How do compensation systems and our own actions contribute to needless disability?
• Are our workers’ compensation, disability, and other compensation systems fatally flawed?
• How do we best empower individuals to live full lives?
• What would our world be like if disability was the exception and we all lived full and productive lives?
• What actions can we take as individuals and as organizations to help empower our patients and stop needless disabling?
• Why do we tolerate medical disabling and dishonesty?

When we look at the medical issues affecting our well-being we find a complex web of stakeholders – each contributing positively or negatively to our outcomes.

What should we do? First we must recognize the problems. And second we must confront these problems.

Our faculty today provided insights into some of these problems and shared information on best practices. Patients need to be informed and empowered. Physicians need to be both compassionate and empowering.

All of our actions need to focus on improving our patient’s functions and be supported by evidence-based* medicine. Practice guidelines, reflective of most-current scientific evidence, should be followed – perhaps especially so in treating workers’ compensation and vehicle-accident casualties. We should demand zero tolerance of individuals or organizations harming our patients and our state – simply for profit.

Some may feel the issue of prescription dispensing can solved by adding constraints, after careful consideration of the benefits vs. risks from the perspective of the patient I believe the most practical solution is to ban physician dispensing. Other states have banned this practice, it has become a non-issue. However, there are still many reasonable physicians and there may be some circumstances that would support physician dispensing, such as practicing in a very remote area. Perhaps 1% of the time physician dispensing is reasonable. It could also be argued that a total ban is making rules based on the “lowest common denominator”. Those who financially gain from the current system will undoubtedly vigorously object to change. There is no scientific basis to support their assertions that it is beneficial. Based on your experiences and what you have learned today, I would appreciate your input about 3 options: 1) a ban, 2) restricting physician dispensing to specific circumstances, specifying payment will be based on the original manufacturers AWP plus a nominal dispensing fee, and requiring physicians to submit the prescription invoices electronically to the payers prescription benefits manager or 3) continue the current practice.

All the stakeholders would benefit from assuring that clinical practice and decisions are based on evidence-based medicine.

I encourage the active involvement of law enforcement in identifying and taking action against organized racketeering. I also encourage medical-malpractice carriers to exclude coverage for the consequences of physician dispensing – this will make physicians accountable for greedy actions. I encourage our elected officials, including those who have in the past received substantial funding from prescription-dispensing entities, to do what is right for Hawaii.

My final question is for all of us. What are we actually going to do now? Are we willing to take a stand? Mahalo.”