PostHeaderIcon Why Your Doctor Is Either Depressed or Retiring

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Why Your Doctor Is Burned Out or Retiring

There is a growing litany of acronyms and alphabet soup organizations and algorithms that are designed to confuse, obfuscate and subordinate physician discretionary thinking. Funneling physician thinking into more pre-defined and standardized patterns. With the notion that these patterns are always superior, more efficient and accurate.  More than traditional physician discretionary thought, observation and formulation of diagnosis and treatment plans.

This dizzying array is one of the many reasons why virtually every physician over the age of 65 is retiring. You are losing an entire generation of extremely well educated and experienced physicians. The ones who cared.  Who were trained to observe.  Who were taught to exhaust all testing means. To use deductive and inductive logic.

We have entered the era of economic zero sum medicine.  Simple agents of health insurance reimbursement schemes. A world in which medicine becomes thoroughly and inexhaustibly politicized. That is what is being played out in Washington today.

Do you care?

  • ACO = Accountable Care Organization
  • MA = Medicare Advantage, original Medicare + choice
  • ACA (aka PPACA, patient protection and affordable care act) – disastrously branded as ObamaCare
  • MSSP = Medicare Shared Savings Programs (built into the ACA).
  • MUHIT = Meaningful Use of health information technology
  • GPRO = Group Practice Reporting Option (CMS provider value modifier, 2010 present
  • MACRA = Medicare Access and CHIP Reauthorization (an acronym within an acronym)
    • MIPS = Merit Incentive Payment Systems (has 4 components)
      • ACI = Advancing care information (replaces MUA’s IT).
      • CPI = Clinical practice improvement activities
      • TCoC = Total cost of care (usually expressed as annual cost per beneficiary)
      • Quality = replaces the PQRS (physician quality reporting system)
    • APM = Alternative payment models
  • SGR = Sustained growth rate physician formula (1997 ‚Äď 2016)
  • RAF = Risk adjustment factor (adjustment used for and a payments)
  • HCC = Hierarchical condition category (codes that derive the RAF)
  • TIN = Taxpayer identification number
  • CMS = Center for Medicare Services — formerly HCFA (Healthcare Financing Administration)
  • CPC+ = Comprehensive primary care plus (a CMS driven Advance Primary Care Medical Home Model)
  • CPT = Current procedural terminology (procedure or billing codes)
  • ICD-10 = Diagnosis coding module currently used in the United States (supersedes the ICD-9)
  • VM or PVBM = Value Modifier or physicians value-based modifier
  • CAHPS = Consumer assessment of healthcare providers and systems (HCAHPS, CGCAHPS, HHCAHPS, OASCAPS, etc.)
  • HiTECH = Health Information Technology for Economic and Clinical Health Act (HITECH Act)

Makes your head spin. ¬†Doesn’t it? ¬†My mission is and has been the development of a new HealthCare paradigm. ¬†Health and Well Being for the next twenty years. ¬†Enhancing your healthspan. Enhancing cognitive function (smarter brains). You are going to need it in these times.

PostHeaderIcon Compounding pharmacies – a vanishing breed

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Compounding Pharmacies – Service like it used to be

Why are my  prescription medication prices increasing and not reimbursed?

Compounding pharmacies and the individualization of specific formulations is an integral part of antiaging, age management, functional medicine and similar holistic practices. There was a time in the distant past when most formulations were compounded. That is the source of the mortar and pestle that was so ubiquitous in all pharmacies. I think that symbol has vanished.

Mortar and pestle ‚Äď universal sign of pharmacy

The advantage of compounding is preparation of very specific formulations, combinations and dosages. There are many nonstandard dosages that are not commercially available. Compounding pharmacies is a very dedicated group of highly professional caliber. Really good people. The old-fashioned pharmacist is rapidly vanishing. Maybe the same with solo private practices.

Stifling regulation and pressure from Big Pharma has contributed to the steady decline of compounding pharmacists throughout the Bay area and probably across the state of California. This is not a healthy trend. Furthermore, you have seen most of the major insurance carriers are progressively denying all your compounded medications. Under the ruse of FDA non-approval. That is not the reason. They want you to buy prescription medications from large pharmacies.  At a very high premium.

The one constant is an accelerating increase in the cost of all medications. I have never been an advocate of insurance coverage of medications. I know this a losing proposition. But it contributes to the subsidization of ever-increasing price increases. Medication prices are out of sight. And now that the major carriers are denying more and more coverage.  So you are left with high prices without the subsidies. You are then forced into generic formulations. Generic drugs do not have the same degree of quality assurance and consistency as proprietary medications. I do not recommend generic preparations.

Stifling and onerous regulations – USP 800

Image result for usp 800Here is a very personal summary of the onerous regulations in the state of California that will contribute to a manifest decline in the number of compounding pharmacists.  And further price increases because of the costs of preparation.   This is a direct quote from my good friend, Dana Gordon of CAPRx. One of the best pharmacists in the business. A Pharm.D. A doctor of pharmacy with an advanced degree.

 

 

Well, ‚ÄúD-Day‚ÄĚ or ‚ÄúUSP 800-Enforcement Day‚ÄĚ has arrived. Effective Jan 1, many substances that were commonly compounded under normal environmental/exposure conditions must now be handled/manipulated under specific environmental areas (dedicated, externally vented, negative pressure room with a minimum 13 air changes per minute . Also externally vented source capture units/hoods within the room).

Let me be clear, the drugs/substances have ALWAYS been considered ‚Äúhazardous‚ÄĚ if an individual was exposed to them at certain levels and under certain exposure routes (i.e. respiration, mucous membranes). ¬†Although the list is quite extensive (see NIOSH link attached), some of the ones you are familiar with are: Progesterone, Estrogen, Testosterone, Thyroid, Anastrazol, Retinoic Acid, Fluconazole to name a few.

Understand, the language in USP 800 was pretty much already in existence for many years. What occurred is the renumbering of the chapter to an ‚Äúenforceable‚ÄĚ chapter. Prior to this, the chapter was only ‚Äúvoluntary‚ÄĚ. Now, in addition to our 3 (three) accreditations for compounding that hold us accountable to this chapter, we now are potentially subject to FDA oversight should we be in violation of USP 800. Very few pharmacies are as decorated as we are. ¬†Our choice, our standards, our commitment to our patients, our providers and ourselves.

Although I have previously communicated with you the significance of this new law, its broad and extensive effects it will have on the compounding industry, and the enormous economic/cost impact it will have on those that have decided and/or are able to comply with the newly implemented regulations, both its repercussions and effects will now become quite evident.

In a nutshell and in summary

1)      California version of USP Chapter 800 becomes effective Jan 1, 2017 (All California pharmacies must be compliant on this date)

2)      Official version of  USP Chapter 800 becomes effective July 1, 2018 (California Pharmacies still must be compliant Jan 1, 2017)

3)¬†¬†¬†¬†¬† Hazardous Drug-Definition: See attached definition. Really, nothing has changed and nothing new has been discovered about the handling of all of these drugs. The purpose of USP 800 is to protect the individuals handling and manipulating such substances. How this will be translated to patients will require some delicacy and discretion. Regardless, literature will be provided with each drug categorized on the NIOSH list. This is a requirement. Also, such substances will be dispensed separately in a plastic back titled ‚ÄúHazardous‚ÄĚ. Also a requirement.

4)      CAPRx has been painfully, expensively (over $200K and still counting) invested in preparing for this eminent enforcement date for over a year. Also taxing was the BUD (Beyond-Use-Date) limitations that USP (795 and 797) has determined and now the California State Board of Pharmacy will enforce. All of this at the detriment of causing delays in the production and provision of compounded drugs.

PostHeaderIcon Minivelle Vivelle Shortages Explained

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Minivelle and Vivelle continue to be in short supply in most pharmacies across the country.  Initially, I was not able to determine any reason. Nothing revealed by simple Google searches.  No FDA drug recalls.  Not evident from FDA drug shortage surveillance lists.

Now, one of my astute and persistent patients was able to track down the reason.   The FDA has been very critical of testing and quality assurance methods for this product.  Adherence to CGMP.  Current Good Manufacturing Practices.  The reasons seem sound but are not technically safety related.

Here is the full FDA warning letter which is long and tedious.  It is illuminating for you.

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PostHeaderIcon Minivelle Vivelle Short Supply

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Minivelle 17 beta estradiol system

Minivelle and Vivelle are severely backordered. We have not been able to determine the source of this short supply. It emanates from the manufacturer. This is not a local pharmacy problem it is not a distribution problem. For obscure reasons it is not being manufactured. We have not seen any recalls.

The 0.1 mg dose is in most demand and in short supply. Many of you have been dispensed a generic form of estradiol patches. Mylan is the leading generic house. Generic patches are not the same as the proprietary drug — Minivelle or Vivelle dot.

Estrogen patches are not about the drug which is bioidentical. It is 17-beta-estradiol. That is bioidentical.  Biologically identical to your own internally produced hormones.  The FDA prohibits the manufacturer labeling this as bioidentical.    That is a legal-political issue.  Not a medical issue.

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PostHeaderIcon Vitamin K, Calcification and GLA Proteins

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Vitamin K2 is a potent anti-calcification nutrient via GLA protein carboxylation. ¬†Let’s look at this process of calcification and the potency of these various forms of vitamin K2. ¬† Then talk about the MK-4 vs Mk-7. ¬† ¬†Which is best for you? ¬† And why?

Vitamin K2 forms

There are currently three forms of vitamin K available. Vitamin K1 (phylloquinone) has been extensively studied. It is not the most potent form. Vitamin K2 is currently available in two forms. MK-4 also known as menaquinone-4 or menatetranone. MK-7 (menaquinone-7) is currently advocated as the most potent form of vitamin K2. You can see in fig 1 that the MK-4 and MK-7 have long “tails” with multiple (poly unsaturated) double bonds. ¬†This increases lipid solubility.¬† These are fat soluble as opposed to water vitamins.

Vitamin K1 and vitamin K2 MK-4 MK7

fig 1

So what is the connection between Vitamin K2 and tissue calcification? Why do we petrify as we grow older? Why do we grow stiffer? This is a combination of calcification and glycation.  Glycation is secondary to excess carbohydrates, rising hemoglobin A1c (>5.6%), and impaired fasting blood sugars (>100 mg).

Calcification is an impaired healing process. Arterial injuries initiate a process of calcium deposition as a repair mechanism. Calcification is the end result of chronic inflammatory processes.   This is a key concept.

How can we prevent or reverse this ossification process?

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PostHeaderIcon Your Personal Supplement Prescription for Optimal Health

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Supplementation Regimen Can Optimize Your Health

Personal supplement daily regimen for your health and vitality

Patients often ask how do you maintain your health and youthfulness? What do you personally take? I need to walk the walk and practice what I preach.  I need to set an example for you.

You can do this.  You may need our help and motivation.  There are many variations of this rigorous approach.  You do not need to follow this implicitly.   But the closer you can approximate this, the better your results.

For 20 years I have advocated the same routine. The basic approach is consistent. Variations on a theme. The Paleo diet. Low Carb. Modified Atkins diet. Basically high protein low carbohydrate.  You can read the classic Protein Power by Michael and Mary Eades.

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PostHeaderIcon Anticoagulant Natural Alternative

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Novel anticoagulant regimen to prevent strokes and heart attacks

Natural Anticoagulant Regimen

A natural anticoagulant routine. How could this benefit you? How can you implement this? Why is this a time-proven alternative to conventional approaches?

Hopefully, you have read part1, part2, and part 3 of this 4 part series. Primers on coagulation and thrombosis. I have carefully explained the process of coagulation resulting in heart attacks and strokes. We have talked about platelet aggregation. Which then leads to fibrin aggregation. Which leads to the final clot. All clots cause obstruction. Obstruction causes heart attacks and strokes. How can we prevent this?

I have alluded to the most powerful natural anticoagulants. These include the following:

  • Nattokinase — 100 mg twice daily
  • Ginkgo biloba — 120mg daily
  • High-dose fish oils — 1 tablespoon (10 grams) daily
  • Vitamin E — 800-1200 units daily
  • Adequate hydration — many glasses of pure water daily

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PostHeaderIcon AntiPlatelet AntiCoagulant Drugs

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Coagulation and Anticoagulatant Therapy

Read part I and part II of this series for background.  So you will have a basic understanding of coagulation pathways. Yes, it is complex.

Remember, coagulation or clotting starts with platelet aggregation.  That initiates the complex coagulation cascade. This causes the mature thrombus or blood clot. Aggregated platelets with a thick fibrin mesh causes the thrombus.  The thrombus causes heart attacks, strokes or thrombophlebitis.  Here is the final complete picture:

injury activates platelets causing thrombus formation

fig 1- click for full size

So let’s discuss anticoagulant therapy medications.

Antiplatelet Agents – Aspirin and Plavix are first line of defense

Figure 2 shows how we prevent platelet aggregation and activation at various stages.  Look at figure 1.  Aspirin has been the mainstay of antiplatelet therapy. There has been a succession of drugs over the last three decades. Newer antiplatelet drugs supersede older ones.  Are these true advances or simply marketing campaigns?

antiplatelet drugs classified by site of action. Aspirin and Plavix are the most common platelet inhibitors

fig 2 – click for full size

Aspirin has been well studied in the literature.  A full 325 mg dose will prevent platelet aggregation.  Over time, aspirin has significant adverse reactions. These are direct and indirect reactions. It can cause tinnitus (ringing or buzzing noises in the ear).   It can cause major gastrointestinal bleeding.   This is a significant problem.

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PostHeaderIcon Coagulation Heart Attack and Stroke ‚Äď Part 2

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It is necessary to understand the interaction of fibrin coagulation pathways and platelet aggregation. Once we understand these interactions we can then discuss current treatment modalities. My goal is to show you a more creative and natural approach to anti-coagulation.

Initial Platelet Aggregation

activated platelet aggregation

fig 1

In part one I emphasized the importance of platelet aggregation as the initial step. ¬†There is an initial injury to an arterial or venous wall.¬† As a response, activated platelets cause a clumping reaction to repair the injury. ¬†Somewhat like Hans Brinker’s “finger in the dike.”

This injury could be a laceration. It could be a rupture of a atheromatous plaque. It could simply be a tear in an arterial wall.   Or simply from low-flow stasis.  Atrial fibrillation is an example.

 

platelet activating factor PAF

fig 2

You can see from fig 2 above that the platelets initiate an array of reactions.  I will elaborate even more detail in the next post.  This is ever-increasing overview.

Aspirin is the most common drug to prevent platelet aggregation.  We will look at an array of  drugs that have been used over the years. But there is a more creative approach.

Once the initial platelet plug has formed the long-term fibrin coagulation pathway is initiated.¬† Read the rest of this entry »

PostHeaderIcon Coagulation Stroke Heart Attack Part 1

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Heart Attack and Stroke Coagulation Basics

Let’s talk about heart attack and stroke causes and the complexity of the underlying coagulation (clotting) pathways. ¬† ¬†What a heady subject. ¬† ¬†You need a PhD in medical hematology, just to fully understand the complexities of coagulation. ¬† So let’s work through this step by step. ¬†This will be a multi part series. ¬†I will help you achieve a clearer understanding. None of us wants to suffer a heart attack or stroke!

What causes these these catastrophic vascular events? What are the risks?  What medications are commonly used?    Why are they not necessarily the best or even the healthiest choice?   Can we assess risk benefit ratios?   And what are the natural herbal-based alternatives?  Ones that can be just as effective with fewer side effects and less costly.   This is what you will not hear from your personal internist, cardiologist or even family physician.

Blood Clot is a Thrombus or Embolus

A thrombus totally blocks (occludes) blood flow from activated coagulation factors

fig 1

A blood clot usually starts with an injury to a vascular wall.  This could be one of your arteries or veins.  An intricate series of reparative or reactive events is set in motion.   Your body tries to rapidly repair injury to the vascular wall.   Atrial fibrillation is an alternative source of thrombus formation.  In this instance, stasis and not injury, initiates the reaction.

Fig 1  above shows you a representation of the well formed blood clot. It has the potential for blocking blood flow (vascular occlusion) which deprives tissues distal to the block of vital cell oxygenation. The medical term is myocardial infarction or cerebral infarction. Cells die from lack of oxygen.

The initial early phase begins with activation and aggregation of platelets.

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