BOARD CERTIFICATION EXAM STUDY GUIDES Lower Extremity Trauma
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“The staggering increase in methamphetamine-related deaths in the United States is largely now driven by the co-involvement of street opioids.”—Rachel Hoopsick, an assistant professor of epidemiology at the University of Illinois at Urbana-Champaign and lead researcher on a 20-year study (US News and World Report)
New medicines launched by US drug makers reached a median price of $222,003 last year, according to Reuters. These astronomical prices were fueled by three very-expensive gene therapies approved by the FDA. In fact, one of them, from Hemgenix, costs $3.5 million, making it the most expensive drug ever.
Congress did cap annual drug price increases via the Inflation Reduction Act, but that doesn’t cover the cost of new medications. Drug-makers, meanwhile, say the cost of their drugs doesn’t reflect what patients pay out-of-pocket for them.
According to the White House, “Americans pay two to three times as much as people in other countries for prescription drugs, and one in four Americans who take prescription drugs struggle to afford their medications. Nearly 3 in 10 American adults who take prescription drugs say that they have skipped doses, cut pills in half, or not filled prescriptions due to cost.” In an effort to combat this growing crisis, both the federal government and private companies have taken a number of steps over the past year aiming to lower drug prices. This Health Capital Topics article will review those actions and the potential unintended consequences of these actions.
CVS, Walgreens, and Walmart agree to pay $13 billion over opioids
The pharmacy chains have reached a tentative deal to settle thousands of lawsuits brought by state and local governments that accuse them of contributing to the opioid epidemic.
If the deal goes through, CVS and Walgreens will each cough up around $5 billion, and Walmart will reportedly be on the hook for $3 billion.
Traditional medicinal agents come in a variety of ways, known as dispensing vehicles. Drugs may be in liquid, pill or inject able form, they may be compounded in capsules, caplets, gelatin tablets, powders or suppositories, or they may come in creams or ointments for the eye, anus and vagina. They may be ingested into the stomach, placed and dissolved under the tongue, put into the eyes, popped, injected or smeared and transported through the human skin from patches.
A valid drug prescription is a written order, by a doctor, to a pharmacist. In this country, prescriptions are written by physicians, podiatrists, osteopaths, dentists. and some optometrists, physician assistants and nurse practitioners. In addition to the name of the patient and that of the medical prescriber, the prescription contains the name of the drug (not necessarily a narcotic), its quantity, instructions to the pharmacist, and directions to the patient. Narcotic prescriptions may not be prescribed to a drug addict to prevent withdrawal symptoms, as there must be some other therapeutic purpose for such an order.
The art of medicinal prescription writing, and pharmaceutical compounding, has declined in modern medicine for several reasons. Most drugs are made by pharmaceutical companies, and the role of the pharmacist, in most cases, consists only of compounding and error prevention. Many drugs are even automatically dispensed, and tracked, in the hospital setting with bar coding technology and modern inventory tracking mechanisms. Also, the practice of writing long and complicated prescriptions, containing many active ingredients, adjuvants, correctives, and elegant vehicles, has been abandoned in favor of using pure compounds.
Drugs may be prescribed by their official names, which were first given by the United States Pharmacopeia (USP), in 1920, or by the National Formulary (NF), since 1906. Unofficial or generic names may be used, known as New and Non-Official Drugs (NND) or by the United States Adopted Names (USAN), or by the manufactures trade name. For example, the generic narcotic meperidine or pithidine, is also known by the trade named, demerol. The designation USAN does not imply endorsement by the American Medical Association (AMA) Council on Drugs (CODs), or by the USP.
Of course, there is an advantage and disadvantages to prescribing drugs by their trade name, or generic names. Advantages of generics include economies of scale for both the patient and pharmacist, and although the active ingredient in generics are identical to trade drugs, they are often less expensive since research and development costs are absent, and various binders, colorizing agents, preservatives or dispersing agents are of an inferior quality, and hence cheaper for the patient. Appearance, size and taste issues are common. For the pharmacist, generics are cheaper since a multiplicity of very similar drugs need not be shelved.
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For example, the tablet or capsular form of many drugs contains inactive ingredients, such as: ammonio methacrylate copolymer, hydroxypropyl methylcellulose, lactose, magnesium stearate, povidone, redironoxide, stearyl alcohol, talc, titanium dioxide, triacetin, yellowironoxide, yellowironoxide with FD&C blue No.2 (80 mgstrengthtablet only), FD&C blue No.2 and other ingredients. And yes, I’ve seen an addict do into shock, or die from acute anaphylaxis, after taking drugs containing ingredient he was highly allergic to.
Shock is a life-threatening condition where blood pressure falls too low to sustain life. It occurs when low blood volume (due to severe bleeding, excessive fluid loss or inadequate fluid uptake), inadequate pumping action of the heart or excessive dilation of the blood vessel walls (vasodilation) causes low blood pressure. This in turn results in inadequate blood supply to body cells, which can quickly die or be irreversibly damaged.
Anaphylactic shock is the severest form of allergy that is a medical emergency. It is a Type I reaction according to the Gell and Coombs medical classification, and is often severe and sometimes fatal systemic reaction in a susceptible individual upon exposure to a specific antigen (such as wasp venom or penicillin) following previous sensitization, or drug use. Characterized especially by respiratory symptoms, fainting, itching, itching and swelling of the throat or other mucous membranes and a sudden decline in blood pressure! The victim literally cannot breathe and drowns in its own congested and fluid filled lungs
So, patients in need of routine drugs for acute or chronic conditions like arthritis, high blood pressure, asthma, acne, hay fever, performance enhancing steroids or, so called life style drugs, like Viagra for a limp woody, or hair growth stimulator Rogaine, may get a good deal by going to Canada or Mexico for generics. But for important drugs, like nitroglycerine fro your heart, blood thinner coumadin, birth control pills or various anti-cancer agents, stick with brand names.
The main disadvantage of trade drugs is increased cost, due to R & D, patents, trademarks, marketing and company advertising expenses. Of course, trade drug are first to market, and hence may be beneficial as a new treatment modality, or injurious if significant side affects or other complications arise.
Today, the prime source for drug information is probably the well known, Physicians Desk Reference (PDR). Now, in its 58th edition, the PDR® provides the latest information on prescription, but not illegal street drugs. It is considered the standard reference that can be found in virtually every physician’s office, hospital and pharmacy in the United States. The current edition is over 3,000 pages long, and is where you can find data on more than 4,000 drugs, by brand and generic name, manufacturer and product categories. The PDR also provides usage information and warnings, drug interactions, plus full-size, full-color photos cross-referenced to specific drugs. For the layman, it also includes: phonetic spelling for each listing, a key to controlled substances, adverse reactions and contraindications, pregnancy ratings, dosages and all other FDA-required information. Of course, on the street, or in Mexico, none of this information matters.
Latin abbreviations, sometimes still used by doctors on prescription blanks include:
Rx = take thou (receipe)
po = by mouth (para orbis)
prn = as needed (pro re’nata)
hs = at bed time (hora somnae)
BID = twice daily
TID = three times daily
QID = four times daily
M = Mix
Traditionally, a medical prescription is written in a certain order, well known to drug abusers, and DEA agents, and consist of six basic parts:
Superscription: This is the Rx, or recipe. In Latin it means take thou.
Inscription: Represents the ingredients and amounts.
Subscription: Represent the description for drug dispensing, and may be represented by the letter M, for mix.
Signature: Often abbreviated as Sig, and contains the directions for patient use.
Refill Status: Indicates the number of refills allowed.
DEA Number: This is nine-character alpha-numeric sequence, used by all licensed physicians who prescribe narcotic agents. An example is AM2685591. The second letter is the first letter of the doctor’s last name, (ie, Marcinko) and the first two digits add up to the third (ie, 2+6=8).
Finally, in addition to the basic parts of a prescription, it should have the patient’s name, and physician signature written in ink, followed by degree designation, such as MD, DPM, DO or DDS, etc.
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Perhaps the most egregious narcotic prescribing habits recently encountered by DEA agents have been by doctors of all degrees and medical designations. Reasons are generally two-fold. First, the doctor may become a drug addict himself, either by accident or through initial legitimate therapeutic use, and over-prescribe the narcotics. Or, increasing office costs, and decreased reimbursement fee reductions of many managed medical care have so economically destabilized the medical community, that economically impoverished doctors desperately sell prescriptions to finance their personal lifestyles, automobiles, clothes, fancy vacations or own addictions.
For example, a staggering medical student loan debt burden of $100,000-$250,000 is not unusual for new practitioners. In fact, the federal Health Education Assistance Loan (HEAL) program reported that for the Year 2001, it squeezed significant repayment settlements from its Top 5 list of deadbeat doctor debtors. This included a $303,000 settlement from a New York dentist, $186,000 from a Florida osteopath, $158,000 from a New Jersey podiatrist, $128,000 from a Virginia podiatrist, and $120 from a Virginia dentist. The agency also excluded 303 practitioners from Medicare, Medicaid and other federal healthcare programs and had their cases referred for non-payment of debt.
These facts indicate that the current healthcare reimbursement climate has caused more pain and tumult to doctors than the pubic realizes. Older medical practitioners are retiring prematurely, mature providers are frustrated and in despair, and young physicians have no concept of the economic servitude to which they are about to be subjected. Frustration is high and physician suicides have been documented. Many doctors get divorced at the start of their careers. Even the U.S. Inspector General has declared healthcare providers to be public enemy #2,behind international narco-traffickers, for their federal drug, fraud and abuse initiatives. Still, the statistic above lends itself to narcotic drug prescription abuse, either on the part of the doctor or patient, since only these two parties that can directly alter a prescription for illicit drug use, as illustrated by this poorly written prescription for a narcotic pain killer, vicodin.
Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved.
What is the difference between a regular pharmacy and a compounding pharmacy?
Both types of pharmacies prepare medications prescribed for a patient by a doctor. The main difference is that a regular pharmacy provides commercial medications in standardized dosages, while a compounding pharmacy can customize medication based on a patient’s specific needs.
Are compounded drugs FDA approved?
Compounded drugs are not FDA approved. And what this means is FDA does not verify the safety effectiveness or quality of compounded drugs before they’re marketed.
• 56% of the U.S. adult population report no recent occurrences of being unable to afford care or prescribed medicine. • 36% of the U.S. adult population report recent occurrences of being unable to pay for care or medicine or lack easy access. • 8% of the U.S. adult population report recent occurrences of being unable to pay for household care, being unable to pay for prescribed medicine and feeling that they would not have access to affordable quality care if needed today.
According to FOX News, a New York physician was charged in an unsealed indictment on Thursday over an alleged $10 million health care fraud scheme. The Department of Justice announced that Elemer Raffai, 56, was charged with health care fraud for his alleged involvement in an alleged scheme between July 2016 and June 2017, signing prescriptions and other order forms for services that weren’t medically necessary, the Department of Justice states.
Raffai allegedly signed prescriptions and other order forms through telemedicine services for durable medical equipment that the Department of Justice claims were not medically necessary.
Justice says that Raffai was partially convinced to make the prescriptions and orders due by the payments of bribes and kickbacks. The indictment also alleges that Raffai and other individuals either submitted or caused $10 million in false and fraudulent claims to be submitted to Medicare, which paid more than $4 million on the claims.
If convicted, the physician faces a maximum of 10 years in prison
StockMarkets: The major equity indexes staged a thrilling comeback to close solidly in positive territory. At one point, the NASDAQ was down nearly 5% and the S&P entered correction territory.
Mark Cuban: The billionaire owner of the Dallas Mavericks just launched an online pharmacy for generic drugs that looks to cut out middlemen and combat pharmaceutical industry price gouging by offering steep discounts. Set up as CostPlusDrugs.com with 100 generic drugs to treat conditions like diabetes and asthma. Cost Plus will not accept health insurance but claims its prices will still be lower than what people would typically pay at a pharmacy. “All drugs are priced at cost plus 15%!” Cuban tweeted.
Mark Cuban, not Congress, will give Americans cheaper prescription drugs
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When universal health care fails to pass in Congress, there’s always Mark Cuban to fall back on. The billionaire and Dallas Mavericks owner launched an online pharmacy this week in order to combat the price gouging of prescription drugs by large pharmaceutical companies.
The Mark Cuban Cost Plus Drug Co. (MCCPDC) will offer more than 100 generic drugs that will be purchased directly from the manufacturers and sold online with a 15 percent markup across the board and a small pharmacist fee. For context, pharmaceutical companies generally mark prices up at least 100 percent and up to 1000 percent in some cases.
On November 30, 2021, the U.S. Supreme Court heard oral arguments regarding the challenges arising from the cuts made by the Centers of Medicare & Medicaid Services (CMS) to the 340B Drug Pricing Program.
The 340B Drug Pricing Program allows hospitals and clinics that treat low-income, medically underserved patients to purchase certain “specified covered outpatient drugs” at discounted prices (applying a ceiling to what drug manufacturers may charge certain healthcare facilities) – 25% to 50% of what providers would typically pay – and then receive reimbursement pursuant to the rates set forth in the Outpatient Prospective Payment System (OPPS) at the same rate as all other providers. (Read more…)
1) Prior Authorization – Approval Must Be Given by the Health Insurance Company/PBM Before They Agree to Pay for a Medication.
2) Step Therapy – Certain Less Expensive Generic Medications Have to Be ‘Tried’ First and Fail Before a Doctor Can Prescribe a More Expensive Brand-Name Medication.
3) Mandatory Generics – If a Brand Name Medication Has A Direct Generic Equivalent, Then the Insurance May Only Agree to Pay for the Generic and Not the Brand.
4) Mandatory Mail Order – Certain Chronic Medications That Are Filled for 90 Day Supplies Must Be Filled via Mail Order and Not at the Retail Pharmacy.
A recent Gallup survey asked “Thinking about the last 12 months, have you or a family member skipped a prescribed pill, dose, or other type of medication in order to save money?”. The amount of prescriptions in the household of those who answered yes varied as follows:
• 8+: 25% • 5-7: 22% • 1-4: 17% • 0: 8% • Total that answered yes: 18%
The pharma industry has taken a big swung into digital transformation. All participants invest in digital health topics.
But as with all trending issues, and there is a lot of fuss that is hard to see through. As the medical community increasingly acknowledges the importance of digital health, the cultural shift we so often talk about is still a way to go. To change that, the first step is always getting to know what’s coming.
In this article, with podcast, Bert collected the trends changing the pharmaceutical industry.
The New York Times Had an Excellent Article on the FDA on September 2, 2021.
The Article Described How the FDA Began Receiving Funding from the Pharmaceutical Industry Itself to Pay for FDA Employee Salaries in 1992–a Potential Conflict-of-Interest. Subsequently, a Study Found that 1/3 of Drugs Approved by the FDA Were Found to Have Safety Problems from 2000 -2010. Another Potential Conflict-of-Interest is Number of FDA Regulators Who Leave Their Positions to Take High-Paying Jobs at Pharmaceutical Companies.
Submit your innovative solution in patient health management to the Pharmacy Benefit Management Institute (PBMI) Innovation Challenge by August 6, 2021 for the chance to be among one of the 5 finalists selected to pitch their ideas before a panel of judges at the PBMI 2021 Annual Meeting!
Be sure to submit your idea by August 6, 2021 for the chance to be featured in an upcoming issue of Managed Healthcare Executive with a full-year integrated marketing program valued at over $100K, in addition to formal acknowledgment at this year’s PBMI Conference.
Administration Announces Prescription Drug Payment Model
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By staff reporters
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HHS Secretary Alex Azar has announced a drug payment model through the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services that will lower Medicare Part B payments for certain drugs to the lowest price for similar countries and save American taxpayers and beneficiaries more than $85 billion over seven years.
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Starting in January, the model, known as the Most Favored Nation (MFN) Model, will test an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries.
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Following the President’s recent Executive Orders to lower drug prices and improve access to life-saving medications, the MFN Model will protect current beneficiary access to Medicare Part B drugs, make them more affordable, and address the disparity of drug costs between the U.S. and other countries.
On June 19, 2020 the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding Medicaid Drug Rebate Program (MDRP) regulations, with the aim of lowering drug prices, increasing patient access, and encouraging innovation in the insurance and pharmaceutical industries.
This proposal is consistent with the Trump Administration’s Blueprint to Lower Drug Prices (Blueprint) released in May 2018, in which the administration highlighted its goal to “avoid excessive pricing by relying more on value-based pricing by expanding outcome-based payments in Medicare and Medicaid” and to “speed access to and lower the cost of new drugs by clarifying policies for sharing information between insurers and drug makers.”
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The proposed rule seeks to accomplish the Blueprint’s goals by reducing regulatory barriers that have previously prevented commercial plans and states from entering into value-based purchasing (VBP) arrangements with drug manufacturers.
Colleagues from Health Capital Consultants, LLC; explain.
These pharnacy stocks are good businesses. In general they have solid balance sheets, above-average returns on capital, and they generate a lot of cash, which is used to pay dividends and buy back stock.
But, these defensive features have not mattered much lately, as we are entering the 10th year of uninterrupted economic expansion.
Accordingly, these companies are significantly undervalued. How under valued? Let’s answer that question by examining two stocks in our portfolio in closer detail.
I don’t know anyone personally who has been affected by the opioid epidemic in the US. And I truly hope I never will. I don’t know if I would be able to maintain objectivity in my analysis of drug distributors and their involvement in this epidemic if I had experienced getting a call at night informing me that my loved one had died from a drug overdose. Drug overdoses killed 70,237 Americans in 2017. Of these deaths, 47,600 (67.8%) involved opioids and 17,000 involved prescription opioids (24% of total overdose deaths). Legally prescribed opioids are killing 47 of us every day.
How did we get here?
According to the National Institute on Drug Abuse:“In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.”
Today pharma distributors are used as scapegoats for the opioid epidemic – not because they are guilty but because they have money and they are “drug distributors.” They are dragged through the same mud as the tobacco companies and British Petroleum (after it spilled millions of gallons of oil in the Gulf of Mexico). Despite negative headlines, we own drug distributors.
Here is why:
They distribute legally prescribed medicine to pharmacies that are approved by several government agencies, including the DEA. Doctors write scripts; pharma distributors order medicine from pharma manufacturers and deliver them to pharmacies. The sad truth about the opioid epidemic is that 21-29% of patients who were prescribed them for chronic pain misused them, and 8-12% of those who received an opioid prescription developed an opioid use disorder.
However, just as truck drivers cannot be held liable for delivering cigarettes to convenience stores, pharma distributors are not manufacturers of drugs and cannot be held liable for the addictive properties of the drugs they distribute or the fact that doctors overprescribe them and patients misuse them.
Also, the DEA should be responsible for limiting the illegal use of opioids. That is its job – DEA stands for Drug Enforcement Agency. It has legal and enforcement resources that distributors lack. And it has a lot more data and tools. Drug distributors do their part and provide data to the ARCOS database that DEA manages.
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However, each individual distributor has data only for the drugs it distributes, while DEA has data (which it doesn’t share with distributors) for all opioid sales to pharmacies. The DEA is in a much better position to spot suspicious activity in orders than distributors. The DEA controls how much legal opioid is manufactured in the US every year and has been increasing quotas of opioids produced.
Opioids constitute only a very small percentage of the $450 billion in drugs distributed in the US, and thus incentives for distributors to overdistribute opioids are very limited. Though lawyers and the media keep saying that distributors are some of the largest companies in the S&P 500 by sales, they forget to mention that distributors operate on razor thin margins of less than 2%. Comparing the distributors (not even the makers) of legal medicine, that helps millions of people cope with excruciating pain, to cigarette companies that have a 40% pretax profit margin on a product that doesn’t have a societal benefit, and is almost guaranteed to cause cancer if you use it long enough, creates awesome headlines but has little substance.
What if DEA was the one distributing all the opioid drugs to pharmacies instead of McKesson, Cardinal Health, and Amerisource Bergen?
Would fewer people get addicted to opioids?
Would opioids be less accessible? Remember, DEA sets the production targets every year.
Maybe DEA would catch a few bad actors sooner – it has more data than distributors and a specific skillset and mindset aimed at catching criminals.
But in the big scheme of things, even if DEA distributed opioids nothing would really change. Doctors would still prescribe them; some patients would still get addicted to them … and so on. Distributors will likely settle lawsuits for two reasons:
Second, McKesson and other drug distributors don’t want to be involved in costly and protracted litigation. We don’t know how much the settlement will be, but it is very unlikely to be in the hundreds of billions of dollars and likely (see reasons above) to be hundreds of millions or a few billion dollars.
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Assessment
Today McKessonʻs market capitalization is $25 billion. We think the company is worth at least $50 billion (at 15 times earnings), thus there is a $25 billion of margin of safety. If the lawsuit costs the company less than $25 billion, McKesson will be a profitable investment; if not, then the market is right and we are wrong.
Conclusion
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Regulatory capture is a form of government failure that occurs when a regulatory agency created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating and introduced in an article by George J. Stigler in 1971 entitled The Theory of Economic Regulation. The main idea of the article can be summarized in Stigler’s (1971: 3) affirmation that:
“…as a rule, regulation is acquired by the industry and is designed and operated primarily for its benefits.”
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A Picture of Poor Health and Opportunity for Retail Pharmacy and Pharmacy Benefits Managers [PBMs]
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Conclusion
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According to the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary, overall national health expenditures grew at an annual rate of 3.7 percent in 2012, marking the fourth consecutive year of low growth. Health spending as a share of gross domestic product fell slightly from 17.3 percent in 2011 to 17.2 percent in 2012.
Private Insurance
Private health insurance spending growth remained low. Private health insurance spending continued to grow at a low rate, increasing 3.2 percent in 2012 compared to 3.4 percent growth in 2011. Medicare spending growth continued to be low. Despite a large uptick in Medicare enrollment, Medicare spending growth slowed slightly in 2012, increasing by 4.8 percent compared to 5.0 percent growth in 2011.
The Totals for MC/MD
Total Medicare spending per enrollee grew by only 0.7 percent in 2012. Medicaid spending continued to grow at a historically low rate. Total Medicaid spending grew 3.3 percent in 2012. While an increase over 2011, this increase still represents historically low overall growth rates tied to improved economic conditions, as well as efforts by states to control costs.
Rx Drugs
Prescription drug spending growth was low. Retail prescription drug spending slowed in 2012, growing only 0.4 percent as the result of numerous drugs losing their patent protection, leading to increased sales of lower-cost generics. Nursing home spending growth slowed.
Assessment
Spending for freestanding nursing care facilities and continuing care retirement communities increased by only 1.6 percent in 2012, down from 4.3 percent growth in 2011, due to a one-time Medicare rate adjustment for skilled nursing facilities.
Conclusion
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Turn in your used or expired medication for safe disposal on September 25th.
Assessment
This novel program is actually available, anytime.
Conclusion
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What does it cost to send a drug addict to jail? Far more than it needs to as demonstrated by this infographic.
War on Drugs
Thanks in part to the War on Drugs, more than half of the inmates in the federal prisons are there because of drug-related offenses.
It’s a staggering statistic, one that helps explain the explosive growth of the prison system over the past thirty years, as officials struggle to keep up with the influx of inmates convicted of, in many cases, minor drug possession.
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This ME-P comes to us from Appature, a Seattle based company that provides a cloud based healthcare marketing tool.
Upon submission of this infographic, the folks at Appature had the following to say:
Appature Inc, a Seattle-based software company that makes marketing tools for the healthcare industry, just launched its first infographic about Prescriptions Most Marketed to Doctors in the healthcare industry! Our infographic breaks down the ins and outs of which prescriptions are most marketed to doctors, to which prescriptions have the greatest sales ($5.3 Billion!) and even patient sentiments regarding a doctor’s prescribing habits. By reading this infographic, we hope that readers will get a little peek inside the intricate inner-workings of the infamous pharmaceutical industry! As TIME magazine highlights, “…the pharmaceutical industry is – and has been for years – the most profitable of all businesses in the U .S.”
Conclusion
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Increasing in costs each year, prescription pills are one of the most profitable and dominating industries in the nation, with annual sales in the hundreds of billions. Prescribed medications constitute a significant bulk of work that medical coders must transcribe.
Shockingly, the prescription pill industry has questionable practices to increase their bottom line, and in turn, increase coding workload through unnecessary prescriptions.
Though pharmaceutical companies have long-earned a reputation for wooing doctors with gifts, bribes, and incentives, it was only revealed in recent years that they’ve also been paying doctors huge sums of money to promote certain products – and doctors are taking up these offers. These pre-selected medications are not only violating a conflict of interest, they can be largely responsible for increases in patient and insurance costs: a doctor may feel obligated to prescribe an expensive “sponsored” medication over a cheaper alternative.
This in turn, is reflected on the overall rising cost of healthcare, which unfortunately, is exactly what the doctor ordered.
And so, your thoughts and comments on this ME-P are appreciated. Feel free to review our top-left column, and top-right sidebar materials, links, URLs and related websites, too. Then, subscribe to the ME-P. It is fast, free and secure.
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By Marian Wang ProPublica, November, 14th, 2011, 2:41 pm
Pharmaceutical companies have sought for years to protect their expensive brand-name drugs by paying generic rivals [1] handsome sums of money to put off efforts to introduce cheaper, generic alternatives that could steal market share.
Pay for Delay
The controversial practice, known as “pay for delay,” occurs as part of patent litigation settlements and typically buys a brand-name drug company more time to sell its blockbuster drug exclusively until its patent on the drug expires. Federal Trade Commission regulators have said the practice costs consumers an estimated $3.5 billion each year [2], and have pushed for a ban.
But now it appears the drug company Pfizer is adding yet another twist to its efforts to delay generic competitors. As The New York Times reports, the company seems to have struck a deal with certain pharmacy benefit managers — the middlemen in the pharmaceutical industry — to block generic versions [3] of Lipitor.
The Block Buster
Lipitor, Pfizer’s blockbuster cholesterol-lowering drug, is among the world’s best-selling pharmaceuticals, and this isn’t Pfizer’s first attempt to protect it.
In 2008, the company settled patent litigation [4] with Ranbaxy, an Indian generic manufacturer, striking a deal that guaranteed that Pfizer would not have to face challenges [5] from Ranbaxy’s generic version of Lipitor until the end of November 2011. Pfizer granted Ranbaxy some incentives [6] as part of the bargain but said it made no payments. Nonetheless, a group of pharmacies filed suit [7] against Pfizer and Ranbaxy last week over the deal, calling it “an extraordinary ripoff” and alleging price-fixing between the two companies.
Big Discounts
Now that it’s November 2011, Ranbaxy and other drugmakers are gearing up to offer cheaper versions of Lipitor. As The Timesreports [3], Pfizer has tried to counter this competition by offering big discounts on Lipitor to the middlemen that process prescriptions [8] for pharmacies and other buyers, giving them discounts in exchange for having them block generic versions of Lipitor for another six months. Here’s The Times:
Many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins.
Medco Health Solutions, among the nation’s largest pharmacy benefit managers, is one of the companies issuing instructions, seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor for six months.
See some of those instructions [9] sent to pharmacies by the pharma middlemen. The documents were released by Pharmacists United for Truth and Transparency, a group of independent pharmacists. (We first noticed them posted at the blog Pharmalot [10].)
According to the group, Pfizer’s plan would mean that customers at the pharmacies serviced by these middlemen would receive Lipitor even when they’ve been prescribed a generic version. Because Lipitor co-pays would also be reduced to the level of generic co-pays, customers might not notice, but employers and Medicare Part D would pay the same amount as before, despite the availability of a cheaper alternative.
Assessment
A Pfizer spokesman gave The Times a statement saying that the company was committed to ensuring that customers had access to Lipitor but declined to answer additional questions. We’ve also asked Pfizer for comment and will update when we hear back.
Conclusion
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Did you know that in January 2010, New Jersey became the 14th state in the nation to legalize marijuana use for certain chronic illnesses?
Other states where the use of medical marijuana is permitted include Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington; around a dozen more states are weighing pending bills.
Jersey is Toughest State
The New Jersey law is the most restrictive in the nation and authorizes prescribed marijuana for only a handful of chronic illnesses, such as multiple sclerosis, cancer, glaucoma, epilepsy, Crohn’s disease, AIDS, muscular dystrophy and Lou Gehrig’s disease. Unlike other states, physicians in New Jersey will not be able to prescribe medical marijuana for anxiety, headaches, or chronic pain.
Dispensaries
According to reports, the state of New Jersey plans to authorize six dispensaries, and patients will receive identification cards authorizing them to purchase the drug. They will not be able to grow their own marijuana or use it in public, however. And, individuals without a prescription will still be subject to criminal prosecution if caught in possession of marijuana.
Do you support the use of medical marijuana? If you are a doctor that lives in a state where medical marijuana is legalized, have you prescribed it to any patients? If you live in a state where medical marijuana is not legalized, do you want it to be? What about you patients, out there?
Conclusion
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Allow me to begin this post by making the unusual disclosure that I was the Editor-in-Chief of a print guide in healthcare finance and economics [aka periodical or journal].
Formally, the title was: Healthcare Organizations [Financial Management Strategies]. At 2 volumes, and more than 1,200 pages, it was quite a job to update it quarterly. And, with more than two dozen contributing authors, it was a labor of love indeed. Alas … no more!
Varying Levels of Credibility
Now, we doctors know that medical journals are not all alike. There are different levels of “credibility.” Some are peer-reviewed, others not. Some are trade magazines. Frankly, some “real” journals are better, and more respected than others. Some entrenched journals are in decline, while other emerging journals are leading-edge in the health 2.0 space. Still others, like the formerly esteemed Journal of the American Medical Association [JAMA], have been accused of outright censorship.
Of course, doctors also know that pharmaceutical companies routinely offer us reprints of articles from medical journals that are favorable to their products. But, news of a Merck-sponsored publication for doctors in Australia has come to light in a personal injury lawsuit over Vioxx. It raised more than a few eyebrows in international medical publishing circles. It may have even crossed the line of journalistic, not to mention medical, ethics.
Read: Merck Paid for Medical ‘Journal’ Without Disclosure; by Natasha Singer, May 13, 2009.
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A report in Bloomberg News, January 13, says that drug regulators haven’t done enough to force disclosure of financial conflicts among the researchers who conduct clinical trials of medications and medical devices.
Quid-pro-Quo
Financial connections between companies that make drugs and devices, and the doctors and other researchers who test them on humans, may compromise the safety of patients in studies and the integrity of the results.
According to the report, lawmakers led by Senator Charles Grassley [Republican from Iowa] have raised concern that conflicts of interest among doctors and manufacturers may influence prescribing decisions.
Assessment
Furthermore, the report said the “FDA should ensure that sponsors submit complete financial information for all clinical investigators.” Is this a new or novel idea?
Conclusion
And so, your thoughts and comments on this Medical Executive-Post are appreciated. Is this entire “pay-2-play” or “quid-pro-quo” idea another dark-alley of drug research and development; or not?
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Did you know that the US Supreme Court just ruled that makers of medical devices – like implantable defibrillators or breast implants – are immune from liability for personal injuries as long as the Food and Drug Administration [FDA] approved the device before it was marketed and it meets the agency’s specifications?
Background
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law, but because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards, according to the New York Times.
The Ruling
The decision does not foreclose lawsuits claiming that a device was made improperly, in violation of Food and Drug Administration [FDA] specifications, while cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.
Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced and expensive, while examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.
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Assessment
The Bush administration plans to continue its push for pre-emption from personal injury suits in another FDA case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits.
And so, is this ruling a boon for trial lawyers or patients; both or neither?
Conclusion
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