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Showing posts with the label Pharmaceutical Quality

Why Won't My Doctor Give Me A Medication Refill?

One of the perennial patient gripes I confront is why on some occasions I refuse to refill a patient’s medication that I have previously prescribed.  Usually, but not always, when I offer my explanation for this roadblock, the patient understands why I advise a face-to-face meeting. Here is a sampling of patient feedback I’ve received over the years. Why do I need to come in?  I’ve been on the same prescription for years? Why should I have to pay a copay when all I need is a refill? I live 45 minutes away. The doctor doesn’t have an appointment for 2 months and I only have 4 pills left! I don’t drive anymore and I can’t get a ride. This doesn’t happen with any of my other doctors. Here’s how I see it.  Of course, I understand the sentiments expressed above from the patients’ perspective.  Certainly, when a patient I know whom I have been in regular contact with asks for a refill, I send it right through.  If, however, I feel that too much time has lapsed since I’ve had

Step Therapy - Pharmacy Benefit Managers are at it again!

Among the many tools that insurance companies wield to save money is a technique called ‘step therapy’.  This is a technique that exasperates patients and physicians.  Here’s how it works.  A patients comes to his doctor with a medical issue.  The doctor, who presumably has a decent measure of medical training, experience and judgment, decides to prescribe a medication, in an effort to ameliorate the patient’s distress.  Let us call this magic elixir Pill A.  The doctor zaps this prescription to the pharmacy at the speed of light using the ever trustworthy electronic medical record.  The satisfied patient leaves with the mistaken impression that his cure is just around the corner. Here’s where the fun begins.  Of course, the patient may receive the typical denial as Pill A is not on the formulary.  Keep in mind that an insurance company’s denial doesn’t mean the patient can’t fill the prescription.  Insurance companies would never interfere with a physician’s medical judgment.

Insurance Company Denies Coverage for Drug - Part II

Last week, I related a vignette where a routine medication refill was denied by a patient's new insurance company.  The patient had developed symptoms 2 weeks after he ran out of the medication. I surmise that 100% of gastroenterologists surveyed would have agreed that refilling the medication was the next step. So, even though the best medical option was to refill the medicine that we know has worked, the new insurance company won’t cover it and the patient cannot afford to pay retail for the drug.  (As a separate point, I challenge anyone including those with PhD's in economics to explain retail drug pricing.)   The patient did his best to navigate the insurance company’s website and found a colitis medicine that is covered, but it is medically inferior.   Should we just cave and prescribe it to save money and a hassle?  Is this an issue that we want on our sick patients' agendas?  How would you like to face surgery and be told that the newer clamps and scalpels are o

Insurance Company Denies Coverage for Drug

A patient came to see me recently with a suspicion that his colitis was recurring.     In general terms, colitis describes a condition when the large intestine is inflamed or irritated.   Typical symptoms are diarrhea, abdominal cramping and rectal bleeding.   This patient was concerned as his last 3 bowel movements were diarrhea.   He had been on a medicine called mesalamine, a safe and effective treatment for colitis, but he ran out of it 2 weeks ago.   While he was taking the medicine, he felt perfectly well.   So, his bowel change developed 2 weeks after he ran out of his medicine.   For readers who like to play doctor, choose among the following options: Schedule an urgent colonoscopy to verify that nothing has changed since his colonoscopy 6 months ago. Observe the patient without any treatment to give him time to heal himself. Recommend probiotics to restore his digestive health. Refill the mesalamine at his usual dosage. Request a 2 nd opinion because the case is

The Risks of Drug Side Effects - A Case for Caution and Humility

I prescribe heartburn medicines every day.    There’s a gaggle of them now – Prilosec, Nexium, Prevacid, Protonix – to name a few.   As far as experts know, their primary effect is to reduce the production of stomach acid.   This is why they are so effective at putting out your heartburn fire.   In simple terms: no acid, no heartburn. I am quite sure that well-meaning physicians like myself do not understand or will ever know all of the unintended effects of tampering with a digestive process that took a few million years or so to evolve.   Are we so arrogant that we believe that these drugs only target gastric acid production?   They are absorbed into the blood stream and course through every organ of the body.   Is it not conceivable that certain tissues might be sensitive to these foreign invaders?   Might there be unintended consequences that occur far downstream well beyond our horizon similar to a butterfly effect.     Do we really think that gastric acid is present just

Doctors and the Opioid Epidemic

I am against all forms of bodily pain, both foreign and domestic.  I wish the world were pain free.  When I am suffering from even a routine headache, I want immediate relief just like everyone else.  The medical approach to pain control has changed dramatically even during my own career.  When I started practicing a few decades ago, the strategy was pain reduction.  We gave narcotics for very few indications such as kidney stones, heart attacks and severe abdominal pain after a surgeon evaluated the patient.  (The reason for this was so the surgeon could obtain an accurate assessment of the patient’s belly before pain medicine masked the findings.)  The new goal is pain elimination which I believe is one factor that has fueled the overconsumption of opioids, although there are other factors present.  I admit that I am opining on this as an individual who is blessed to be pain free.  I do not pretend or suggest that if I were afflicted with a painful condition, that I would not wa

Ohio Limits Opioid Precriptions - The Journey Begins

I have written previously about the raging opioid epidemic here in Ohio.   Attacking and reversing this tidal wave will require many weapons, resources and time.   Opioid addiction is a crafty and elusive adversary that will be difficult to vanquish.   Our battle plan will have to be nimble and adjusted over time, much as military leaders must do in actual armed conflict. Here in Ohio and elsewhere, physicians must abide by new prescribing restrictions.   Prior to prescribing a controlled pain medicine, doctors are required to check the patients OARRS report on line, which catalogues the patient’s prescription history.   This would alert us if the patient was receiving controlled medicines from various pharmacies that the patient might not disclose to us.   Physicians and the public are encouraged to seek non-narcotic alternatives for pain relief.   If opioids are prescribed for acute pain, there is now a limit on the length of opioid treatment that is permitted.   There are exc

Why I Now Treat Hepatitis C Patients

In a prior post , I shared my heretofore reluctance to prescribe medications to my Hepatitis C (HCV) patients.   In summary, after consideration of the risks and benefits of the available options, I could not persuade myself – or my patients – to pull the trigger.   These patients were made aware of my conservative philosophy of medical practice. I offered every one of them an opportunity to consult with another specialist who had a different view on the value of HCV treatment. I do believe that there is a medical industrial complex that is flowing across the country like hot steaming lava.   While I have evolved in many ways professionally over the years, I have remained steadfast that less medical care generally results in better outcomes.   A Scouting Patrol of the Medical Indutrial Complex There was an astonishing development in HCV treatment that caused me to reevaluate my calculus.   New treatment emerged that was extremely safe and amazingly effective.   Now, ne

Avoiding Drug Interactions and Side Effects - Be Warned!

Eons ago, there was a television show where a non-human character would yell out, ‘ Warning ’, Warning ’, when he sensed imminent danger.     The series was called Lost in Space where we were entertained by a set of quirky characters on a cheesy set.   We loved that stuff.   It’s hard to imagine today’s millennials and younger folks being transfixed, as we were, with the deep television dramas of our day.   Who could match the subtle allegory and nuance of shows such as Green Acres or Gomer Pyle?   Some superficial viewers regarded The Andy Griffith Show as a homespun, idyllic view of small town America.   In truth it was a biting satire on the excesses and abuses of law enforcement in the 1960’s. Robot and Dr. Smith I am overwhelmed with the warnings that I receive in my work and in my life.   It seems that warnings, caveats and disclaimers are so omnipresent that they have lost their impact.   As I write this, I am seated in McDonalds, sipping a cold beverage that doe

Hepatitis C - Silent Killer or Innocent Bystander?

For a few decades, I did not treat patients with Hepatitis C (HCV) infection, despite aggressive marketing by the pharmaceutical companies and cheerleading by academics.   I was an iconoclast as most of my gastroenterology colleagues were HCV treatment enthusiasts. They argued that if the virus could be eradicated, that there was evidence that these patients could avoid some horrendous HCV complications, such as cirrhosis, liver failure and cancer of the liver. I’m certainly against cancer and liver destruction, but I have thought that the evidence that HCV patients who vanquished the virus would be saved from these fates was somewhat murky.   Treatment proponents would argue that the medical evidence for thes claims is solid, but I wonder to what extent their favorable bias toward treatment influenced their judgment.  We physicians know that a doctor or a drug company will seize on  particularly studies that supports their views.  Studies that challenge their beliefs may be crit

Polypharmacy in the Elderly: Who's Responsible?

There's a common affliction that's rampant in my practice, but it's not a gastrointestinal condition.  It's called polypharmacy, and it refers to patients who are receiving a pile of prescription and other medications.  I see this daily in the office and in the hospital.   It's common enough to see patients who are receiving 10 or more medications, usually from 3 or 4 medical specialists.  Of course, every doctor feels that he is prescribing only what is truly necessary.  If an individual has an internist, a cardiologist, a gastroenterologist, a urologist and a dermatologist – which is not unusual - and each prescribes only 2 or 3 essential medicines, then polypharmacy is created.  Each day, the patient swallows a chemistry set. First of all, I don't know how these patients, who are often elderly, manage the logistics of taking various medicines throughout the day and evening, before meals, after meals and at bedtime.  Who can keep track of this?  Nurs

Why I Don't Prescribe Pain Medicines

It may seem strange that a gastroenterologist like me does not prescribe pain medicines.  Let me rephrase that.  I don’t prescribe opioids or narcotics.   I write prescriptions for so few controlled substances that I do not even know my own DEA number.  You might think that a gastroenterologist who cares for thousands of patients with abdominal pains would have a heavy foot on the opioid accelerator.  But, I don’t.  Here’s why. I truly do not know my DEA number. I believe that one person on the health care team should manage the pain control.  In my view, this should be the attending hospital physician or the primary care physician in the out-patient setting.  There should not be several consultants who are prescribing pain medicines or changing doses of medicine prescribed by another physician.   With one physician in charge, the patient’s pain is more likely to be managed skillfully while the risk of fostering drug dependency and addiction is lessened.  We all know add

Why My Patient Will Quit the Military

I had an interesting conversation with a patient in the office some time ago.  He was sent to me to evaluate abnormal liver blood tests, a common issue for gastroenterologists to unravel.  I did not think that these laboratory abnormalities portended an unfavorable medical outcome.  Beyond the medical issue he confided to me a harrowing personal tribulation.  Often, I find that a person’s personal story is more interesting and significant than the medical issue that led him to see me. I am taking care to de-identify him here, and I did secure his permission to chronicle this vignette.  He is active duty military and is suffering from attention deficit disorder (ADD).  He likes his job.  He was treated with several medications, which were either not effective or well tolerated.  Finally, he was prescribed Vyvanse, which was a wonder drug for him.  The ADD symptoms melted away.  This is when military madness kicked in.  He met with military medical officials who concurred that this

Medical Marijuana Use - Ready, Fire, Aim!

Promoting medical marijuana use is hot – smokin’ hot.  States are racing to legalize this product, both for recreational and medical use.  In my view, there’s a stronger case to be made for the former than the latter.  Presently, marijuana is a Schedule I drug, along with heroin, LSD and Ecstasy.  The Food and Drug Administration (FDA) defines this category as drugs with no acceptable medical use and a high potential risk of addiction.  Schedule I contains drugs that the FDA deems to be the least useful and most dangerous.  Schedule V includes cough medicine containing codeine. On its face, it is absurd that marijuana and heroin are Schedule I soulmates.  I expect that the FDA will demote marijuana to a more benign category where it belongs.  It will certainly have to if marijuana is going to be approved as a medicine.  There is no question that some advocates favoring medicalization of marijuana were using this as a more palatable route to legitimize recreational use.  Th

Why Are Drug Prices So High?

Why are the costs of prescription drugs so high?  While I have prescribed thousands of them, I can’t offer an intelligent answer to this inquiry.  Of course, all the players in this game – the pharmaceutical companies, Pharmacy Benefit Managers, insurance companies, consumer activists and the government- offer their respective bromides, where does the truth lie?  While I don’t fully understand it, and I don’t know how to fix it, we all know that the system is broken.  More than ever before in my career, I am seeing patients who cannot afford the medicines I prescribe for them.  In the last few weeks of this writing, 3 patients with colitis, a condition where the large bowel is inflamed, called me to complain about the cost of their new medicine.  The annual cost was in the $2,500 - $3,000 range, which is way out of range for normal folks.  While I was only focused on the colitis drug, many of these patients face prohibitive costs over multiple medicines.  All of these patients had

Insurance Company Helps Patients Who Don't Speak English

When I was a kid, it was fun to get mail.  Now, not so much.  My mailbox at home is a receptacle for junk mail, various solicitations for services I will never need, and bills.  Office mail is not much more fun.  Each day I look through the stack and separate them into 3 categories. Important stuff Garbagio Not sure The latter category is the most vexing.  Some stuff is cleverly designed to appear important when, in reality it is drivel and nonsense.  We’ve all seen this stuff.  Sometimes, the envelope will include a teaser label, such as ‘Time Sensitive Material’, or ‘Signature Required’.   Once I have been duped to open up the envelope, I’ve lost the game.  Then, I am forced to scan the printed page as fast as my retinas can process the image with the hope that in a few nanoseconds I can send the page sailing into the waste bin.  Sometimes, however, even after reading the entire page, I simply can’t determine if the document merits calling an office meeting to discuss th

Why I'm Against Medical Marijuana

I have already opined on my disapproval of a medical marijuana law recently passed in Ohio.  Once of my points in that piece is that I did not want legislators making medical decisions for us.  They can’t even do their own jobs. I am not against medical marijuana; I am for science.  The currency of determining the safety and efficacy of a medicine should be medical evidence, not faith, hope or belief. Marijuana is a Drug Enforcement Agency (DEA) Schedule 1 drug, alongside heroin, LSD and Ecstasy.  I realize this seems odd since most of us do not believe that marijuana has the health or addictive risks of the other agents on the list.  It doesn’t.  But, danger is not the only criteria used in determining which category a drug belongs in, a point often misunderstood or ignored by medical marijuana enthusiasts.  An important criterion of Schedule 1 drugs is that they are deemed to have no proven medical use. The federal government recently affirmed marijuana’s Schedule 1 status

Mylan Defends EpiPen Price Hike

Why do smart people often do dumb things?  Would you plagiarize a speech that you know is going to be carefully scrutinized?   Would you respond to a robocall that congratulates you on winning a free cruise?  Would you keep eating sushi that didn’t smell right?  I’m certainly not judging anyone here.  I’ve had plenty of my own misadventures and I periodically add to the list.  Our presidential candidates fall prey to human error and misjudgments surprisingly often.  Aren’t these folks supposed to be pros or at least managed by honed handlers?  Why would Donald Trump have insulted nearly every constituency and rival during the primary election process knowing that this might render him unelectable in the general election?  Why would Hillary Clinton demand unconscionable speaking fees from special interest groups when she knew that she would pursue the presidency and her payoffs would be publicized? I’ll leave it to readers to ponder their own responses to the above inquirie

Who is Responsible for Prescription Drug Abuse?

I have written about pain medicine previously on this blog, and it generated some spirited responses.  Let me be clear that I am completely against all forms of pain, whether foreign or domestic, physical, spiritual, psychic or even phantom.  The medical profession has superb tools to combat and relieve pain, and physicians should utilize them, within the boundaries of appropriate use.  We now have an actual specialty – pain management – who are physicians with special training on the science and treatment of all varieties of pain.  I utilize these specialists when necessary and I am grateful for the help they provide to my patients.  There are two forms of drug abuse in our society – legal and illegal.  The latter has become a health scourge that is shattering families across the country.  A few days before I wrote this, I read the stats of overdose deaths in my state of Ohio.  I was shocked to learn that in our state alone, we lose thousands of individuals every year to drug ov

Is Medical Marijuana Safe and Effective? Who Decides?

Medical marijuana is a smokin’ hot issue in Ohio.  Marijuana enthusiasts targeted our state constitution again this year with another amendment attempt, which failed.  Instead, our legislature passed House Bill 523, which will legalize medical marijuana use.  As a physician, with some training and experience in prescribing medicines to patients, these marijuana machinations are medical madness.  Is this how we want to bring new medicines to market? I think it is absurd that a specific medical treatment – or any medical treatment - should become a constitutional issue.  Do we want to establish a constitutional right to a specific medicine? Why stop at marijuana?  Why not start circulating petitions for constitutional amendments for screening colonoscopies, mammographies and MRI’s for back pain?  Patients with chronic lumbar disk issues have rights too!  The Ohio bill specifies an array of medical conditions that could be treated with marijuana, including AIDS, hepatitis C, i