AAFP Says No to Safe Use Class of Drugs

AAFP Says No to 'Safe Use' Class of DrugsBy Emily P. Walker, Washington Correspondent, MedPage Today Published: May 01, 2012

WASHINGTON -- The American Academy of Family Physicians (AAFP) has voiced its opposition to an FDA proposal that would allow pharmacists to dispense some drugs without a prescription.

Currently, the FDA approves drugs either as prescription or nonprescription, but the agency is considering adding a third class of drugs called "safe use" drugs, which would be regulated much as over-the-counter drugs are now, but with extra controls.

"The AAFP recognizes the important role of pharmacists in the provision of high quality healthcare; however, this proposed new paradigm would allow patients to receive powerful prescription drugs without the input of a physician," Roland Goertz, MD, chairman of AAFP board, wrote in an April 30 letter to FDA Commissioner Margaret Hamburg.

In a notice published in February, the FDA said it is considering a "new paradigm" where drugs that would normally require a prescription could be available without one if they met certain "conditions of safe use."

Those conditions could include restricting them to sale behind the counter at a pharmacy, or requiring an initial prescription but allowing refills at the patient's request.

Examples cited by Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, might be EpiPens or glucagon -- both of which are prescribed for possibly life-threatening conditions and which patients can easily find themselves without when they're needed.

Moving some prescription drugs into safe use status could allow patients to skip visits to the doctor, which the AAFP opposes.

"Only licensed doctors of medicine, osteopathy, dentistry, and podiatry have the statutory authority to prescribe drugs ... . Allowing the pharmacist authority to dispense medication without consulting with the patient's physician first could seriously compromise the physician's ability to coordinate the care of multiple problems of many patients," Goertz wrote in the letter to Hamburg.

In March, the FDA held a public meeting on its proposed plan and heard from stakeholders such as the AAFP, the AMA, which is also opposed to the safe use category, and the American Pharmacists Association (APhA), which is in favor of adding this third category of drugs.

Thomas Menighan, CEO of the APhA, said creating a safe use category could greatly improve access to drugs because pharmacists are the most easily accessed healthcare provider for many patients.

In addition to improving access for patients, reducing routine doctor's visits could free up physicians to spend more time with sicker patients, "reduce the burdens on the already overburdened healthcare system, and reduce healthcare costs," the February FDA notice read.

When nicotine replacement therapy changed from requiring a prescription to being over-the-counter, tens of thousands of people quit smoking, which represented a $2 billion annual "societal benefit," Scott Melville, CEO of the Consumer Healthcare Products Association, a trade group for over-the-counter drugmakers, said during the FDA's public meeting.

In addition, making heartburn medicines available without a prescription saves the healthcare system $757 million each year, according to Melville.

In order for the FDA to consider switching a drug from prescription to nonprescription, it must meet certain criteria, including that it must not be addictive; it must not have significant toxicity if overdosed; and users must be able to self-diagnose conditions for appropriate use and be able to safely take the medication without a physician's screening.

Presumably some of those same requirements would apply to drugs moved from prescription status to the new safe use status.

During the March public meeting, an ob/gyn argued that birth control pills -- especially progestin-only pills -- meet those criteria and should be available without a prescription.

The FDA is seeking comments on the proposal.

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My take? We have more drug training than physicians. It's all about the $.

Publication Bias - Antidepressants and Autism

Publication bias: It has long been a problem with medical studies. Studies with outcomes that are positive are more likely to be published than those that are negative.  As a result, the medical literature that establish how diseases and disorders are treated often provides doctors and other healthcare providers a flawed picture of the evidence presented.

Antidepressants are not FDA approved for treating some of autism's symptoms:  hoarding, tapping, head banging and strict adherence to routine.

Read more here.

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5 Reasons Why You Should Take Up Running

I finished my last half marathon on Saturday at 2:13.  I am still on the quest to break the two hour mark.  I know that if I actually trained for a race, I would probably be a lot faster.  I still show up at the starting line in the early hours of the morning with all the other runners and beat my body into submission.

Why do I run?

I remember one of the first exercises running years and years ago.  Let us flash back to about 1988.  I was in ninth grade and on the basketball team.  We didn't win a single game that season, but I do remember running.  Lots and lots of running and the reason why was because we NEVER won a game.  I loved running.  Back then I was the fastest on the team.  I was small.  Fast.  Couldn't shoot a basket to save my life but I could almost fly.

I remember running with my dad and sprinting.  Freedom.

I did a little jaunt in college with the cross country team.  I was the slowest.

What ended up happening is that running became something more than I ever thought, and when it was almost taken from my life due to chronic back pain (degenerative disc disease and facet arthropathy with spondylosis).  During the time of the most pain, I could not run.  During that time, I was quite depressed about it.

So you can imagine, the joy I feel when I run today.  Radio frequency lesioning (RFL) found me, and I'm back to running again.  It's different though.  Now when I run, there is an elation that I did not experience before.  There was a moment Saturday when I was running through a shaded area.  The trees were shading the road very heavily and there were tiny flowers floating through the air landing in front of me.  Very ethereal.  I'm just saying the appreciating is way above what it could ever have been otherwise.

1.  I run because I can.

2.  I run because I want my heart and lungs to be stronger.

3.  I run because I desperately need ME time.  I can't pull out my iPhone and fill every void moment with texting or tweeting.  It's a time that I completely check out.

4.  I run because I do some of my best thinking while running.  Have a problem at work?  I tend to work through them mentally.

5.  I run because the runner's high exists, and it is truly better than any drug.

I have had runs that absolutely sucked.  Just keep trying.  Just put one foot in front of the other.

It will change your life!

Whooping Cough Reaching Record Levels

I remember how I felt about vaccines prior to becoming a mother. They were effective. They were needed. They saved lives. However, my thinking changed the first time I stared at my newborn son seconds after birth, and the reports of the possibility of a link between autism and vaccines and the higher rate in males vs females really challenged my thinking. I ran to the bookstore buying all of Dr. Sears' books, scoured the Internet for information, and joined forums where it was cool to be a home birthing, baby wearing, baby led weaning, crunchy, baby food making, raw milk drinking and cloth diapering momma. I suddenly felt like the worst mother in the world, and all my sense about science left as the prolactin levels rose.

I declined hepatitis B vaccine for my infant. Hell, he was not a IV drug user and wasn't having sex yet.

Over time, he is finally up-to-date, and my daughter received all as scheduled (though I did delay hepatitis B with her as well until she reached three months, I believe. I have definitely been more laid back this time. And I have also seen the stories of the prevalence of diseases previously almost eradicated making a huge comeback. Unfortunately herd immunity is only good if all subscribe. Sporadic cases are becoming more normal... and with that deaths.

Last month, Washington state had 640 confirmed cases of whooping cough (or pertussis) compared to only 94 in the same period last year.

The connection between autism and vaccines have never been confirmed. I cannot think of anything more responsible as a parent than getting your kids vaccinated. I guess you can say my thinking was challenged, but I have reached full circle.

Meet Mr. MRSA

I thought I would introduce you to an infectious organism every week!  Today, the lucky "bug" as they are referred to in the medical community is methicillin resistant staphylococcus aureus (MRSA). If I was a common layperson in the field of medicine, I would view this microorganism as a very nasty flesh eating entity.  I thought I would shed some light about MRSA.  Whether you are dealing with a soft tissue infection, pneumonia, central nervous system infection, endocarditis (heart), or bone and joint, the treatment differs.

Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium that causes infections in different parts of the body. It's tougher to treat than most strains of staphylococcus aureus -- or staph -- because it's resistant to some commonly used antibiotics.

The symptoms of MRSA depend on where you're infected. Most often, it causes mild infections on the skin, causing sores or boils. But it can also cause more serious skin infections or infect surgical wounds, the bloodstream, the lungs, or the urinary tract.

Though most MRSA infections aren't serious, some can be life-threatening. Many public health experts are alarmed by the spread of tough strains of MRSA. Because it's hard to treat, MRSA is sometimes called a "super bug."  Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterium that causes infections in different parts of the body. It's tougher to treat than most strains of staphylococcus aureus -- or staph -- because it's resistant to some commonly used antibiotics.

The symptoms of MRSA depend on where you're infected. Most often, it causes mild infections on the skin, causing sores or boils. But it can also cause more serious skin infections or infect surgical wounds, the bloodstream, the lungs, or the urinary tract.

Though most MRSA infections aren't serious, some can be life-threatening.  Many public health experts are alarmed by the spread of tough strains of MRSA.  Because it's hard to treat, MRSA is sometimes called a "super bug." 

Also just news today... an almost instant test in detecting MRSA.

Skin and soft-tissue infections

1.  Abscess  - incision and drainage
2. Purulent cellulitis
   • Clindamycin 300-450 mg PO TID (C diff)
   • Bactrim 1-2 DS tablets BID (pregnancy category C/D)
   • Doxycycline 100 mg BID (pg category D and not recommend for children under 8)
   • Minocycline 200 mg x 1, then 100 mg PO BID
   • Linezolid 600 mg BID (expensive)
3.  Nonpurulent cellultis
   • Beta lactam (cephalexin and dicloxacillin) 500 mg QID
   • Clindamycin 300-450 mg TID
   • Beta lactam and/or Bactrim or a tetracycline – amoxicillin 500 mg TID
   • Linezolid 600 mg BID
4. Complicated SSTI
   • Vancomycin 15-20 mg/kg/dose IV every 8-12 hours
   • Linezolid 600 mg PO/IV BID
   • Daptomycin (cubicin) 4 mg/kg/dse IV QD
   • Telavancin 10 mg/kg/dose IV QD
   • Clindamycin 600 mg PO/IV TID
5. Bacteremia
   • Vancomycin 15-20 mg/kg/dose IV every 8-12 hours
   • Daptomycin 6 mg/kg/dose IV QD
6. Infective endocarditis, native valve – same as bacteremia
7. Infective endocarditis prosthetic valve
   • Vancomycin and gentamicin and rifampin – 15-20 mg/kg/dose IV every 8-12 hrs,                                          i.      1 mg/kg/dose IV every 8 h,  300 mg PO/IV every 8 h
8.  Persistant bacteremia
9. Pneumonia
   • Vancomycin 15-20 mg/kg/dose IV every 8-12 hours        
   • Linezolid 600 mg PO/IV BID
   • Clindamycin 600 mg PO/IV TID
10. Osteomyelitis (Bone and Joint Infections)
    • Vancomycin 15-20 mg/kig/dose IV every 8-12 hours
    • Daptomycin 6 mg/kg/day IV QD
    • Linezolid 600 mg PO/IV BID
    • Clindamycin 600 mg PO/IV TID
    • TMP-SMX and rifampin – 3.5-4.0 mg/kg/dose PO/IV every 8-12 h
11. Septic arthritis
    • Vancomycin 15-20 mg/kg every 8-12 hours
    • Daptomycin 6 mg/kg/day IV QD
    • Linezolid 600 mg PO/IV BID
    • Clindamycin 600 mg PO/IV TID
    • Bactrim 3.5-4.0 mg/kg/dose PO/IV every 8-12 hours
12. Meningitis
    • Vancomycin 15-20 mg/kg/dose IV every 8-12 hours
    • Linezolid 600 mg PO/IV BID
    • Bactrim 5 mg/kg/dose PO/IV every 8-12 hours
13. Brain abscess, subdural empyema, spinal epidural abcess
    • Vancomycin 15-20 mg/kg/dose every 8-12 hours
    • Linezolid 600 mg po/iv BID
    • Bactrim 5 mg/kg/dose PO/IV every 8-12 hours
14. Septic thrombosis of cavernous or dural venous sinus
    • Vanc same
    • Zyvox
    • Bactrim same

Pharmacy Perfection

One of the biggest things I struggle with as a pharmacist is the idea of a profession that requires absolute perfection in everything you do; yet I am human. There is not a lot of room for error because it can detrimentally affect a patient. I remember back when I was as green as the spring grass freshly graduated from pharmacy school in 1999. I landed my first job with K-Mart, not exactly the job that I had dreamed of while I was attending pharmacy school, but they paid for my relocation from one city to another. They also did not do a lot of volume in the particular store where I was assigned. I do not remember the name of the pharmacist that worked there opposite from me initially. What I do remember about her is the words that came out of her mouth almost at her introduction, “I have never made an error while being a pharmacist.” I was too naïve at the time to realize that there was no way she was telling the truth. We are human; we will make mistakes. And at the time K-Mart did not have any mandates in place on flow or any bar-coding scanning to ensure more safety as Walgreens and CVS had. They were way behind the times as far as technological advances go.

I believe one of my first errors was dispensing Adalat CC 30 mg when the prescriptions called for 60 mg. Yes, I felt SICK. But over time I have come to realize that there are things you can do as a pharmacist to be more accurate whether it be hospital, retail, or anything in between.

According to a 2006 report by the Institute of Medicine, medication errors cause harm to roughly 1.5 million patients annually.5 Millions more are caught prior to administration, before they reach the patient. Not only do medication errors adversely impact the patient population, they are estimated to cost billions of dollars in additional treatment costs. Read more: http://www.uspharmacist.com/content/c/31431/

Here are some tips to help you become more accurate

1. Concentrate. Don’t allow distractions to stop your flow of thinking. If a technician comes up to you and needs something right away, go ahead, but realize when you start back on the order, you need to continue the exact same flow from beginning to end. Don’t try to “pick up where you left off.”

2. Do the same thing every single time. Consistency.

3. Do a second double check after you are finished checking. If that means pulling up the profile on the computer screen and holding up the order or pulling it back up electronically, just double check at the very end.

4. Any time you are going outside the usual, there is a higher incidence for errors. For example, if you have to build something from scratch in the computer on a new medication, you can be sure you are more likely to mess up on something else within the order than normal.

5. If you work retail, utilize every program they have to improve accuracy. In the hospital, just do another last review of MAR prior to moving to the next order. If in doubt; ask. It’s always better to phone the office if you work in retail or phone the nurse if you work in hospital to bounce off what you are seeing.

The most important thing is to make sure you have enough staff to safely fill medications and orders.

Vegetarian Atkins... Are You Serious?

If the plain Atkins diet weren't disgusting enough with what I call a greasy tongue from all the butter, meats, fats, etc... now there is something called a vegetarian version that lowers heart risks. Can you think of any other diet you'd rather do? (Pun intended) A small, month-long study of the so-called Eco-Atkins diet, which stresses plant proteins, worked better than a high-carb diet at reducing levels of low-density lipoprotein or LDL, which raises the risks of heart attacks and strokes.

Swine Flu Continues

...though the media has dropped the story from their front page headlines. Perhaps there weren't enough people dying from it as originally was feared, but having the flu in the summer (for Americans now) is very strange!

There are 25,288 confirmed cases worldwide, according to the World Health Organization’s latest briefing Monday, with 73 countries having at least one case. There have been 139 deaths confirmed caused by Swine Flu worldwide, according to the WHO. Mexico, where the illness is believed to have originated, has 5,717 cases and 106 deaths, according to the WHO.

The U.S. has the most cases, with 13,217 confirmed and probable — up from just more than 10,000 last week. There are cases now in all 50 states plus Washington, D.C., as of 11 a.m. Monday, according to the Federal Centers for Disease Control and Prevention. There have been 27 confirmed deaths in the U.S., with three in Texas, five in Illinois, four in Arizona, two in Utah, eight in New York and one in Connecticut, Missouri, Michigan, Virginia and Washington.

Vacinatons and the Trend Grows to "Opt Out"

If you are tempted to delay any vaccinations for your children, it’s critical that you educate yourself about the diseases those vaccinations are intended to prevent. As an increasing number of parents are delaying or forgoing certain vaccinations, it’s no longer possible to simply assume these diseases will remain so rare that they are not a threat. Exit herd immunity. Find out about the diseases themselves.... tetanus not spread person to person but spores in dirt as a source. Mumps can cause issues with males later on.

Swine Flu

Oh, sorry... I meant to say H1N1. I wouldn't want the farmers to have to slaughter their swine since people aren't eating swine with the thoughts of pigs passing this disease to us. Stop the presses. You mean farmers are killing pigs because of the Swine Flu?

And you are upset?

Aren't the pigs going to get slaughtered anyway? *sigh*

Here we are in the middle of a mild case of the flu hitting the US in the spring. Glad it didn't hit in the fall.

Underlying conditions like asthma, diabetes, heart disease or tuberculosis appear to put swine flu victims at greater risk of hospitalization or death, doctors from the World Health Organization and the Centers for Disease Control and Prevention said Friday.

** so does the regular flu **

Swine flu tally reaches 3,440 in 29 countries: from the World Health Organization.