The F-Word. “Formulary!”

20021002Back when I worked in the Emergency Department of a large hospital, my medical staff assignment for many years was to the Pharmacy and Therapeutics Committee.  The P&T committee’s assignment was to develop a hospital Formulary and to establish guidelines and rules for medication use.   My hospital was not unusual.  In fact, every hospital has a drug formulary and a P&T committee to oversee it.

So when I got into correctional medicine, I was surprised to learn that “Formulary” is often considered to be a dirty word in corrections and many correctional facilities do not even have a formulary.

I have been told that one reason for this is that inmates, their attorneys and advocates (like the ACLU) sometimes define “Formulary” as a system that bans certain medications simply based on their cost without any consideration of the medical needs of the patient. “This is the best medication for my client and you denied it just because it cost too much.  As a result, my client suffered harm.”  So some facilities, I am told, are afraid to have a formulary because of its bad reputation.

But this is an incorrect definition of a formulary.  Formularies aren’t bad; to the contrary, a well-done formulary is good medical practice.  Every correctional facility should have a formulary and some mechanism for formulary oversight.  In fact, if you don’t have a formulary, you are practicing inferior medicine.

The first thing to understand about formularies is that having a drug formulary is the Standard of Care in your community.  Every hospital has a formulary. Nursing homes have formularies.  The VA has a formulary.  Your state’s Medicaid program has a formulary.  Why is this? Because formularies are good medicine.  Formularies have two basic functions.

Formularies and Drug Value

First, formularies do evaluate drug prices, but not to forbid medications based on cost alone but rather to evaluate drug Value.  “Value” in general is the benefit of a product, any product, divided by its cost.  The easiest way to assess value is by comparing prices of identical (or similar) items.  For example, if I want to purchase a new vacuum and the exact same model is sold at store A for  $50.00 less than store B, I usually will buy from store A because it is offering me a better deal, i.e. better value.

In pharmaceutical purchases, the value of a drug again is the benefit of that drug divided by its cost.  Since Value is easiest to assess when comparing similar drugs, my P&T committee spent a lot of time setting up lists of “Therapeutic Equivalents.”  This entailed reviewing the literature and making lists of drugs that had similar therapeutic properties.  A good example would be Proton Pump Inhibitors (PPIs).  The literature shows that the various Proton Pump Inhibitors are equivalent; there is no one PPI that is clearly better than any other.  So the preferred PPI for our hospital was the least expensive one.  This PPI was the best value.

Interestingly, the prices of similar models of vacuum cleaners don’t vary too much between stores.  The $50.00 cheaper price between store A and store B may represent only a 10% cost savings.  But the difference in pharmaceutical prices can often be mind-boggling.  For example, consider these two therapeutically equivalent PPIs:  as of January 2, 2013, the cost of Nexium was $6.15 per capsule.  But omeprazole costs 10 cents a capsule.  Is Nexium really 60 times better than omeprazole?  No!  They are therapeutically equivalent!

A formulary points these two facts out:  that the two drugs are therapeutically equivalent and that omeprazole is 60 times less expensive.  A formulary that absolutely forbids any physician to prescribe Nexium, ever, is called a “Closed Formulary.”  On the other hand, a formulary that allows Nexium to be prescribed in certain circumstances is called an “Open Formulary.”  In my hospital, if you wanted to prescribe Nexium rather than omeprazole, you would have to make a presentation to the P&T Committee as to why you thought Nexium (or any other non-formulary drug) was worth the extra cost.  Until then, the hospital pharmacy would not fill a Nexium prescription.  In fact, if you were to write an order for Nexium, the hospital pharmacy would automatically substitute omeprazole without even telling you—this is called “Automatic Substitution” and happens all the time in community hospitals.

Formularies Monitor Appropriate Drug Prescribing

The second main function of a formulary is to define and monitor appropriate prescribing within the facility.  As another example, we had one older physician who prescribed hydralazine as a first line agent for hypertension. The P&T Committee noted that this did not conform to any hypertension treatment guidelines (notably JCIS-7) and so did not permit the prescription to be filled until the physician explained himself.  Rather than come to a P&T Committee meeting, this physician chose, instead, to change his prescription to a standard agent. The reason, then, that hydralazine is non-formulary is not that it is expensive (hydralazine is, in fact, quite cheap); rather, it is because hydralazine has no indications as a first line antihypertensive.  There are other, better drugs that should be used yet before anyone thinks of using hydralazine.

Another way my P&T Committee’s formulary monitored prescribing was by making sure that specialty drugs were prescribed appropriately.  For example, the P&T Committee would not allow, say, an orthopedic surgeon to prescribe chemotherapy for leukemia without consulting an oncologist (don’t laugh, it really happens).  Some medications are so potentially toxic that their prescription should always be double-checked by someone:  a specialist, a P&T committee, or maybe just the facility medical director.  Thus, Peg-interferon for hepatitis C is non-formulary in my jails not because we do not want to use it, but because its prescription should be double-checked to make sure it is being used appropriately.

What’s in a Name?

The problem with the word “Formulary” is not with what a formulary does.  No one would object to monitoring appropriate drug usage within a facility or preferring the best value among equivalent drugs.  No, the problem with the word “Formulary” is that the word itself has taken on a negative connotation:  “Formulary” implies to some the denial of appropriate medical care based on cost alone.

One way to combat this notion is to use a different term for the processes of monitoring appropriate drug usage and preferentially using drugs with the best value.  This term should emphasize the “Open” nature of the process.  No drug is banned.  Any drug can be prescribed if the prescriber can justify the medical need for that particular drug over alternative therapies.  (That might be hard for a drug like hydralazine.  Or Nexium.  Or Ritalin in a county jail.  But it is not impossible!  In fact, I have allowed all three of those drugs to be dispensed in my jails in unusual but appropriate circumstances!)

“Pre-Approved” instead of “Formulary”

One term that works to convey this is “Preferred Drug List.”  My state’s Medicaid program uses that term.  But I think an even better term is this:  “Pre-approved Drug List.”  That term concisely conveys all of the important information:  the drugs on the list can be prescribed without obtaining outside approval.  Obviously, cancer chemotherapy is not going to be on that list.  Neither is Nexium.  But the term also implies that there is a mechanism to obtain approval for drugs not on that list.

Next:  A step-by-step guide on how to set up a “Pre-Approved Drug List.”

Has your facility had problems setting up a formulary?  Has your facility had particular success with your formulary program?  Please comment!

Interesting Article of the Week Plus Price Check!

An acquaintance complained to me recently that he was struggling to afford his medications, which cost him a couple of hundred dollars a month.  I looked at his medication list and saw (among other examples) that he had been prescribed the statin Crestor, which costs $5.00 a pill, even though generic simvastatin costs just 3 cents a pill!  He was prescribed the Angiotensin Receptor Blocker (ARB) Benicar ($4.26 a pill) even though the generic ARB losartan costs 7 cents a pill.

When I called the prescribing doctor on behalf of this patient, the doctor readily changed his prescriptions to the more affordable brands.  But why would he prescribe expensive stuff his patient couldn’t afford in the first place?  That is the subject of our interesting article of the week.

Ann Pharmacother. 2012 Feb;46(2):200-7. Epub 2012 Feb 7.

Assessment of prescribers’ knowledge of the cost of medications.

Cogdill BNappi JM.

(Click here to go to the PubMed citation)

This study assessed physician and medical students’ knowledge of drug prices. The prescribers in the study did amazingly poorly on a test of their knowledge of drug prices.  That didn’t surprise me.  What did surprise me, however, that the prescribers seemed not to care that they did not know drug prices! They didn’t seem to think it was important.  These prescribers also routinely prescribed medications without knowing or checking whether their patients had insurance that would cover the drug.

This attitude may be common (common?  Almost universal!) in the outside world of medicine, but it has no place in Correctional Medicine.  We prescribers who work in correctional facilities need to have an idea of what drugs cost.

  1. Most of our patients will eventually get out of our jails and prisons.  Most of them will not have medical insurance.  We need to prescribe medications that they will be able to afford.
  2. Besides being medical practitioners, we also are stewards of the money the county or state spends on medical care within our facility.  Every dollar that we spend needlessly is a dollar that cannot be used for something else.
  3. Besides looking for effective medications, we also need to look for medications with high value.  Value is a concept that seems to have been forgotten in modern medicine, as practiced in the United States at least.

What is the Value of a Drug?

The “Value” of a drug can be defined as the benefit of that drug divided by its cost.  If medication A and medication B both achieve the same result, but medication A is 20 times more expensive than medication B, then medication B has 20 times more value.

Sometimes, new and expensive drugs are touted by drug reps as having, say, “17% improved relative benefit” over the old, generic drug.  Almost always, these claims are unfounded or the difference is clinically meaningless.  But even if it is true, the generic drug  will still usually have more Value.  Nexium versus omeprazole is a good example.  AstraZenica, the maker of Nexium, claims that Nexium provides slightly better stomach acid control than does omeprazole.  Most experts do not believe this, but even if it is true, omeprazole costs 10 cents a pill, whereas Nexium costs $6.15 a pill.  Is Nexium 61 times more effective than omeprazole?  The answer is, of course, no.  Instead, omeprazole is 60 times more Valuable than is Nexium.

So why is Nexium one of the best selling drugs in the world?  The Interesting Article of the Week has the answer:  Because U.S. doctors don’t know how much Nexium costs and they don’t care.  Sad.

Let’s make sure that we Correctional Medical Specialists know the basic price of the drugs we use.  To do this, we need a source.  Your pharmacy is one source.  Have your pharmacy do a price comparison for you on a different category of drug every month.  You can also find the acquisition cost of most medications online.  Here is the one I use:  The Idaho Average Acquisition Cost Drug List.  It is published by Idaho Medicaid and is updated every two weeks.  You can find it here.

Price Comparisons

Here is the Average Acquisition Cost Drug List price for the medication classes I discussed in today’s post:

Angiotensin Receptor Blockers

Generic DrugsBrand Name DrugsPrice per Pill
Losartan (Cozaar)50mg$0.07
Irbesartan (Avapro)150mg$1.83
Atacand (candesartan) 4mg$2.79
Benicar (olmesartan) 40mg$4.26
Diovan (valsartan) 40mg$2.67
Micardis (telmisartan) 40mg$4.02

Comment:  If you have to use an ARB rather than an ACE inhibitor, why would you use anything other than losartan (at least until the price of irbesartan falls to comparable levels?)

Statins

Generic DrugsBrand Name DrugsPrice per Pill
Atorvastatin (Lipitor) 20mg$0.22
Simvastatin (Zocor) 20mg$0.03
Pravastatin (Pravachol) 20mg$0.07
Crestor (rosuvastatin)20mg$4.99
Livalo (pitavastatin)$4.14

Comment:  Note that atorvastatin is rapidly falling in price and will soon be comparable to simvastatin and pravastatin.  Lipitor was once the top selling drug in the world!

Proton Pump Inhibitors

Generic DrugsBrand Name DrugsPrice per Pill
Omeprazole (Prilosec) 20mg$0.10
Lansoprazole (Prevacid) 15mg$1.27
Pantoprazole (Protonix) 20mg$0.09
Nexium (esomeprazole) 20mg$6.15
Dexilant (dexlansoprazole) 30mg$4.67
Aciphex (rabeprazole) 20mg$8.61

Comment:  Note that pantoprazole (Protonix) is now even a little less expensive than is omeprazole!  And remember that omeprazole also has an OTC formulation, so you can put it on your commissary, so inmates won’t have to come to you to get it.

Do you track drug prices at your facility?  How do you do it?  Please Comment!

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Essential Pearls from Essentials

Essentials of Correctional Medicine was held last week in Salt Lake City, Utah and included some great talks.  Today’s post is a list of Pearls I gleaned from the conference speakers.

The definition of a “Pearl” is a bit of pithy and insightful information that can be communicated in one or two sentences. Hopefully, it is also something that you have not thought of yet and will change your practice for the better.

I ran into several Pearls at the Essentials conference. Here is a sampling (in no particular order): Continue reading

A Daring Plan for Discharge Meds!

One of the “systems” problems that all jails have to deal with is what to do with medications when a patient is released from jail.  Prisons deal with this issue as well but tend to have fewer headaches than jails, mainly because they know exactly when inmates are leaving the facility and can plan ahead.  In jails, often we don’t know exactly when a patient will leave.  Continue reading

Price Check! Antipsychotics.

It is a good idea to check on the current price of medications once in a while.  When I do this, I am invariably surprised by price changes since the last time I looked.  On the one hand, once a medication goes generic, the price will fall to a small fraction of what it used to cost.  This process can occur quickly, say over 6 months, or may take a couple of years until it hits bottom.  On the other hand, sometimes drugs that had been cheap, quickly and inexplicably become expensive.  The current prices for antipschotics show both trends. Continue reading

Obstacles to a Medical Commissary Program

Last week, I counted down the five most popular articles from JailMedicine’s first six months.  This week, I would like to revisit my own personal favorite post.  I don’t have very many really good ideas—but this is one of them:  You Need a Medical Commissary in Your Facility! Continue reading

Question of the Week: STD’s–Test or Just Treat?

Reader Question of the Week:

How do I go about convincing the management team to allow me to treat inmates for STI’s.  It is common practice to obtain a UA for c/o burning etc per protocol.  But, I am not allowed to move forward with determining if they have an STD if the UA is negative and s/s persist.  I am told there was previous funding for this, but was lost with budget cuts.  I am tempted to treat these inmates per WA State Department of Health Guidelines for STD management anyway.  Would this be wrong?  How would I know what to give them? I would be guessing.  I am thinking azithromycin 1 gm and flagyl 500 mg po bid x 7 days?  Comments? Continue reading

Interesting Article of the Week: Prostate Screening?

 

Mike, Nursing Supervisor, Ada Co. Jail in Boise. Should he be screened for prostate cancer?

SCREENING FOR PROSTATE CANCER: A REVIEW OF THE EVIDENCE FOR THE U.S. PREVENTIVE SERVICES TASK FORCE

Chou, R., et al, Ann Intern Med 155:762, 2011.

One of my hobbies is that I do Wellness-Fitness examinations of local firefighters.  They come in once a year and, for the most part, are quit fit and healthy.  As part of their wellness screen, I have been doing PSA tests on everyone over the age of 40.  One year, a certain 50ish year old firefighter’s PSA came back at 13.0.  Continue reading

Interesting Study of the Week and Updates

Janelle, Excellent Ada County Jail nurse!

Set your TiVos!

For those interested in the Bath Salts phenomenon that I wrote about in “Bath Salts,” A Review and Bath Salts Update, CNBC is airing an hour-long program tonight about the “Bath Salts” and “Incense” phenomenon entitled Crime Inc.: A Deadly High.  The program promises to explore in detail this marketing phenomenon, as well as the designer drug analogue issue, in which chemists make minor changes to the chemical structure of an illicit chemical, thus making it legal.  Who knew that bath salts and incense generate an estimated  $5 billion per year!

Crime Inc.: A Deadly High airs tonight, August 2nd, at 8:00, 9:00 and midnight on CNBC.

Interesting Study of the Week

Moyer VA, for the U.S. Preventive Services Task Force. Screening for cervical cancer: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med 2012;156:880-891.

This U.S. Preventative Services Task Force guideline replaces the one issued in 2003 and contains several important changes that will impact correctional facilities.

1.  Less than age 21.  No PAP smears before age 21.   No HPV (Human Papilloma Virus) screening.  Period.

2.  Age 21-30.  PAP smears every 3 years.  No HPV testing.

3.  Age 30-65.  PAP smears every 5 years.  HPV testing begins and is also done every five years.

4.  Age older than 65.  No PAP smears.

Implementing these official government guidelines will result in big changes in my facilities.  One of the facilities that I am the Medical Director for is the Idaho Juvenile Correctional Facility, which we call JCC and is the state juvenile prison.  Heretofore, we have done HPV testing and PAP smears on all of the girls entering the JCC.  According to these new guidelines, we should stop.  I need to discuss the matter with the medical administrator there (I’ll be calling, Mardi)!

The adult women in the state prison have been getting PAP smears as often as yearly and have come to expect them.  According to the new guidelines, we would only do them every 3 years from ages 21-30 and every five years thereafter until age 65.

On a personal note, a relative of mine (who prefers to not be identified) continues to dutifully report to her gynecologist for her annual “exam,” (including a PAP smear) even though she is well into her 80s.

The U.S. Preventative Services Task Force did not comment on the potential economic impact of this guideline, but it seems that it has the potential to save a lot of money in correctional facilities.  How much did your institution spend on PAP smears and HPV testing last year?  If you adopt these new guidelines, cut that in half.  At least.

Have you already implemented these guidelines at your facility?  How has it worked out?

Have you considered these new guidelines but have not implemented them?  Why not?

Please comment!

Essentials of Correctional Medicine is approved for CME credit!

Essentials of Correctional Medicine has been approved for 19.5 hours of Continuing Medical Education Credit by the American Academy of Family Physicians.  This conference should be a great learning experience as well as a good way to get Correctional Medicine specific CMEs!

 

Interesting Study of the Week–MRSA

Antibacterial drugs and the risk of community-associated methicillin-resistant Staphylococcus aureus in children. Schneider-Lindner, et.al., Arch Pedicatr Adolesc Med, 2011 Dec:165(12):1107-14.

This is a great study done in England, where a database of medical treatment for the whole country is available for research (unlike in the US).  These researchers asked the question, “If you are prescribed an antibiotic, does that increase your risk of subsequently contracting a MRSA infection?”  So the researchers reviewed records for children between 1994 and 2007, including ~300 MRSA cases and >9000 controls.

Not surprisingly, they found that a child who is prescribed an antibiotic does, in fact, have an increased risk of a subsequent MRSA infection.  The surprising thing is how much of an increased risk this represents.

If you receive one antibiotic prescription, your risk of MRSA infection within the next 6 months more than doubles. If you receive two antibiotic prescriptions within 150 days, your risk of MRSA more than triples.  Then the risk really goes up.  If your receive three antibiotic prescriptions within 150 days, your risk of subsequent MRSA infection goes up eleven fold.  Four antibiotic prescriptions and your risk for MRSA rises more than 18 fold.

Quinalones are particularly prone to increase the risk of subsequent MRSA infections.

These researchers had previously studied adults and found the same thing.  (Antimicrobial drugs and community-acquired methicillin-resistant Staphylococcus aureus, United Kingdom).

Perfect lawn

I’m going to prevent weeds by killing the grass.

This, of course, makes sense.  A great analogy that I like to use with inmates who want an antibiotic prescription for their viral syndrome is of a lawn of grass.  The grass itself prevents noxious weeds, like thistle, from sprouting.  The grass chokes them out.  But if I were to kill the grass by spraying Roundup, what are the odds that thistle will grow now?  The grass is like our normal, healthy colonies of bacteria.  They help us in many ways, including “choking out” noxious bacteria like MRSA. There has been some great recent research into the beneficial effects of our personal bacterial colonies, such as this report on the  Human Biome Project.

Using antibiotics is very like using grass killer.  Antibiotics are a great medical tool when used properly, but they also have the potential to cause great harm.  If you prescribe an antibiotic for a viral syndrome, like a typical case of sore throat or bronchitis, your potential for benefit is zero.  It’s a virus!  But your potential for harm is the same as it always is.  This study shows that one unnecessary prescription doubles your patient’s subsequent risk of MRSA.  If you prescribe Augmentin, the risk of diarrhea is one in six!  So you cannot help this patient with a virus by prescribing an antibiotic; you can only harm them.

The CDC has published excellent guidelines on the proper use of antibiotics for sore throats, bronchitis and sinusitis.  I have written about these guidelines previously here (Evidence-Based Use of Antibiotics Can Save Your Jail Money! and here (Don’t Use Antibiotics for Most Cases of Pharyngitis!, although my focus then was how inappropriate antibiotic prescribing wastes money.

The more important message is that inappropriate antibiotic prescribing harms your patients.  According to these studies, if you reduce your antibiotic prescribing by following these guidelines, you may find that your MRSA infection rate goes down, too! Bonus!

 

 

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