The opioid epidemic: What was the Joint Commission's role?

Last year the Joint Commission issued a statement written by its Executive VP for Healthcare Quality Evaluation, Dr. David W. Baker, explaining why it was not to blame for the opioid epidemic. If you haven’t already read it, you should. Here is the first paragraph of that document:

“In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame. We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.”

With the help of an anonymous colleague, I looked at some of the historical context.

In December 2001, the Joint Commission and the National Pharmaceutical Council (founded in 1953 and supported by the nation’s major research-based biopharmaceutical companies) combined to issue a 101-page monograph entitled “Pain: Current understanding of assessment, management, and treatments.”

Here in italics are some excerpts from it. My emphasis is added in bold.

Narcotic addicts can sue doctors and pharmacies for "enabling" them

In a 3-2 decision, the Supreme Court of West Virginia ruled that narcotic addicts may sue pharmacies and physicians for facilitating their addictions.

A suit was brought on behalf of 29 pain center patients who had been treated with narcotics for various injuries and became addicted. One article quoted the Chief Justice's explanation: "A plaintiff’s wrongful or immoral conduct does not prohibit them from seeking damages as the result of the actions of others."

The court recognized that most of the plaintiffs "admitted their abuse of controlled substances occurred before they sought help "at the pain clinic.

Another story said, "The justices paved the way for people to claim damages for allegedly causing or contributing to their addictions of controlled substances—even if they broke the law by doctor shopping."

In a dissenting opinion, one justice wrote that the decision “requires hardworking West Virginians to immerse themselves in the sordid details of the parties’ enterprise in an attempt to determine who is the least culpable—a drug addict or his dealer.”

In response to the ruling, the West Virginia Medical Association issued a statement: "It may cause some physicians to curb or stop treating pain altogether for fear of retribution should treatment lead to patient addiction and/or criminal behavior. It may create additional barriers for patients seeking treatment for legitimate chronic pain due to reduced access to physicians. It would allow criminals to potentially profit for their wrongful conduct by taking doctors and pharmacists to court."

A post on the American Pharmacists Association website explained that pharmacists were included in the ruling "because they were aware of the 'pill mill' activities of the medical providers. The plaintiffs said these pharmacies refilled the controlled substances too early, refilled them for excessive periods of time, filled contraindicated controlled substances, and filled 'synergistic' controlled substances."

One newspaper summarized the public reaction to the ruling in an editorial stating, "Those who are illegally abusing prescription narcotics should be prosecuted to the fullest extent of the law. The same goes for medical professionals who are found guilty of committing a criminal act. But telling a drug addict or someone who is illegally abusing prescription narcotics that it is OK to go to court and file what could very well be a frivolous lawsuit is both baffling and shameful. This ruling by the Supreme Court justices is a clear back eye for West Virginia. And it does nothing to help West Virginia’s rampant drug problem."

As I wrote last year, I think the prescription drug abuse epidemic all stems from a 15-year campaign that declared pain is the fifth vital sign—a concept which is both untrue and as we have come to learn, harmful.

I agree with the WVMA. If I were practicing in West Virginia, I would be very reluctant to prescribe narcotic pain medication to any patient.

What do you think?

Should every man over the age of 65 be on a statin?

If you believe the latest arteriosclerotic cardiovascular risk calculator, the answer is yes.



A previous version seemed to recommend statins for everyone over a certain age. I decided to plug in the optimal values, conveniently stated in a footnote beneath the data entry fields, for a 65-year-old man. Here is what the data entry looks like.



As you can see below, the risk calculator recommends "moderate to high-intensity statin therapy."



Below the recommendation, it says, "Adults 40 to 75 years of age with LDL-C 70 to 189 mg/dL with no diabetes and estimated 10-year ASCVD risk ≥7.5% should be treated with moderate to high-intensity statin therapy." This is a apparently high-level (A1) evidence-based recommendation.

What am I not understanding here?

I would very much appreciate it if some cardiologists would comment and explain to me how such a sweeping recommendation came to be.

Is this accepted as gospel? Do all cardiologists recommend statins in the above situation?

Overactive bladder: Is it a "disease"?

According to the Urology Care Foundation, the official foundation of the American Urological Association, 33 million Americans suffer from overactive bladder (OAB). That's 30% of all men and 40% of all women in the United States. The foundation estimates that the actual number is much larger because many people who have overactive bladder problems are embarrassed and do not seek care.

This represents a nearly twofold increase since 2001 when a paper written said 17 million people had the problem.

Its' not clear how either of the two sources cited above obtained their information.

Maybe you didn't know that there are two kinds of OAB. "Dry" is the one where the patient is able to get to the bathroom on time. "Wet" is the form that is accompanied by leakage of urine also known as the urge incontinence.

Here is something else you probably didn't know. The disease was virtually unknown before 1997.

Pain is not the "5th vital sign"

No, contrary to what you may  have heard, pain is not the 5th vital sign. It's not a sign at all.

Vital signs are the following: heart rate; blood pressure; respiratory rate; temperature.

What do those four signs have in common?

They can be measured.

A sign is defined as something that can be measured. On the other hand, pain is subjective. It can be felt by a patient. Despite efforts to quantify it with numbers and scales using smiley and frown faces, it is highly subjective. Pain is a symptom. Pain is not a vital sign, nor is it a disease.

How did pain come to be known as the 5th vital sign?

The concept originated in the VA hospital system in the late 1990s and became a Joint Commission standard in 2001 because pain was allegedly being undertreated. Hospitals were forced to emphasize the assessment of pain for all patients on every shift with the (mistaken) idea that all pain must be closely monitored and treated .

This is based on the (mistaken) idea that pain medication is capable of rendering patients completely pain free. This has now become an expectation of many patients who are incredulous and disappointed when that expectation is not met.

Talk about unintended consequences. The emphasis on pain, pain, pain has resulted in the following.

Diseases have been discovered that have no signs with pain as the only symptom.

Pain management clinics have sprung up all over the place.

People are dying. In 2010, 16,665 people died from opioid-related overdoses, a four-fold increase from 1999 when only 4,030 such deaths occurred. And the number of opioid prescriptions written has doubled from 109 million in 1998 to 219 million in 2011.

Meanwhile in the 10 years from 2000 to 2010, the population of the US increased by less than 10% from 281 million to 308 million.

Doctors are caught in the middle. If we don't alleviate pain, we are criticized. If we believe what patients tell us—that they are having uncontrolled severe pain—and we prescribe opioids, we can be sanctioned by a state medical board or even arrested and tried.

Some states now have websites where a doctor can search to see if a patient has been "doctor shopping." I once saw a patient with abdominal pain in an emergency room. After looking up her history on the prescription drug website, I noted that she had received 240 Vicodin tablets from various doctors in the four weeks preceding her visit.

That's a lot of Vicodin, not to mention a toxic amount of acetaminophen if she had taken them all herself during that month.

What is the solution to this problem?

I don't know, but as long as pain is touted as the fifth vital sign, I do not see it getting any better.

Choosing antibiotics for appendectomy and cholecystectomy: Are "big guns" needed?

An emergency medicine physician asked me to comment on the use of antibiotics in patients having surgery for acute appendicitis and acute cholecystitis. He said in hospitals where he has worked in three different areas—New York, Miami and San Francisco—surgeons are using Imipenem for cholecystitis and Zoysn for appendicitis.

He wondered why those drugs were chosen and offered a few theories. They are as follows:

1) Surgeons are trying to avoid resistant bugs, so they’re using bigger guns

2) There is more pressure to reduce post-op complication numbers, so they’re using bigger guns

3) It’s easier to give one antibiotic to cover multiple bacterial types, instead of, say, cipro/flagyl or cefoxitin/flagyl

4) Patients do better with these big gun antibiotics

5) Residents are being taught incorrectly, and are just developing bad habits

Yes, it is mandated that everyone needs a dose of prophylactic antibiotics within an hour of surgery for appendicitis and cholecystitis. Of course, there are nuances.
 
Appendicitis is a disease involving an inflamed, eventually infected appendix so the use of antibiotics is possibly therapeutic and not simply prophylactic.
 
For acute cholecystitis, a similar argument can be made. The problem here is that it is often difficult to tell acute cholecystitis (with possibly infected bile) from biliary colic (pain caused by a gallstone impacted in the neck of the GB) without infection. Sometimes the GB ultrasound says acute cholecystitis, the surgeon says acute cholecystitis and the path report says chronic cholecystitis. There are many other permutations of those three observations. (e.g., US-biliary colic, surgeon-biliary colic, path-acute cholecystitis, etc.)
 
Note: I do not routinely culture peritoneal fluid in appendicitis or bile in cholecystitis because by the time the culture report comes back, most patients have been home for two or three days. There is evidence to support not culturing either fluid.
 
Honestly, I’m not so sure that people with early acute appendicitis really need antibiotics. Unless the appendix is perforated, I use only one preop dose. There are also similar differences in the imaging reports, surgeon description and path reports for this disease too.

I doubt that patients with biliary colic benefit from antibiotics either. The problem is that one may not discover that acute cholecystitis is present until one is in the abdomen. The same issue occurs with appendicitis where an unsuspected perforation may be found at surgery.

At least for now, at least one pre-op dose of an appropriate antibiotic seems reasonable.
 
Where I practiced for the last few years, we did not use Imipenem for GBs and only occasionally is Zosyn used for appys. Most of us used Unasyn for both except in the penicillin-allergic patient. For that patient, we used Levaquin and Flagyl. The problem with the latter two drugs is that they each are supposed to be infused over an hour. This is not always possible because the surgery may be started within an hour in certain circumstances, such as when an operating room happens to be vacant and the patient is ready to go. It’s a rare event, but it does happen.
 
There is no evidence that patients with either disease, who usually present from home, have resistant bacteria, and postoperative complications, especially infections, are not common with either disease. There is no evidence that patients do better with “big gun” antibiotics. In fact, most of the evidence that prophylactic antibiotics are even needed in these two operations comes from the pre-laparoscopic era. Wound infections are extremely uncommon with laparoscopic appendectomies and cholecystectomies. This is probably due to the fact that the wounds are small and in most cases, the specimen is removed in a plastic bag so the infected organ does not touch the subcutaneous tissue.
 
If residents are being taught to use “big gun” antibiotics for these two diseases, I agree it’s incorrect. There is little hope of changing this.

It is similar to the unfounded practice of giving everyone who is NPO a proton pump inhibitor, which I wrote about here. There is no scientific rationale for it. Yet everyone does it, and no amount of discussion will convince people to stop.

[Note: A version of this post appeared on General Surgery News a few weeks ago. The version above is better because I thought about it more.]

Overuse of proton pump inhibitors is expensive & dangerous

Let’s talk about proton pump inhibitors [PPIs]. These drugs, successors to the innovative H2 blockers, have revolutionized the treatment of gastro-esophageal reflux disease [GERD] and peptic ulcers.

But like all good things, too much can be a problem, and that’s where we are today.

A new study shows that of 90 patients who were tested and found NOT to have GERD, 38 [42%] continued to take PPIs which had been prescribed prior to the testing. Some apparently were not always told to stop the medication and others continued it because they remained symptomatic.

Ambulatory patients are not the only ones overusing PPIs. According to UpToDate, the indications for stress ulcer prophylaxis in hospitalized patients are as follows:

Mechanical ventilation for more than 48 hours, coagulopathy, GI ulceration or bleeding within the past year, traumatic brain injury, traumatic spinal cord injury, severe burns, or two or more minor risk factors, including sepsis, ICU admission lasting >1 week, occult GI bleeding lasting ≥6 days, or high-dose glucocorticoid therapy.

But in most hospitals, intravenous PPIs are routinely ordered for any patient who is npo [not taking food or drink by mouth]. There is not one shred of evidence that PPIs are indicated in this setting. I am old enough to remember the days before PPIs and H2 blockers existed. I assure you that millions of patients were npo and did not develop gastritis or ulcers.

Of course, PPIs are available over the counter [OTC] now, and although they are meant to be taken for only 3 weeks at a time and for no more than 3 such courses per year, there is really no limit to the number of PPIs purchased and used.

In 2010, an estimated $11.4 billion of prescription PPIs alone were sold. The amount of OTC drugs sold is not included, but Consumer Reports noted that in 2009, Nexium OTC sales amounted to $6.3 billion.

Among the adverse effects associated with PPIs reported in a recent systematic literature review are these:

Clostridium difficile-associated diarrhea

Community-acquired pneumonia

Osteoporotic fracture

Vitamin B12 deficiency

Inhibition of antiplatelet therapy

Other studies show that hospital-acquired pneumonia may also be more frequent in patients on PPIs.

Many experts feel that the current epidemic of C. diff colitis is being fueled not only by the indiscriminate use of antibiotics, but also by the overuse of PPIs.

How can the overuse of PPIs be stopped? When I was teaching residents, I tried to confront them with the evidence of harm and lack of evidence of utility of PPIs for patients who were simply npo. It didn’t seem to matter. Someone or something had gotten into their heads, and I couldn’t convince them.

I can’t count the number of outpatients I see who say they are on PPIs for GERD or “gastritis” but have never had a proper workup to establish those diagnoses. I have no idea how to stop the wholesale use of PPIs by primary care MDs, gastroenterologists and people who self-medicate.

It may be hopeless.