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 $.

Healthcare Reimbursement

If insurance companies are now tying reimbursement with patient satisfaction survey scores, then the same should apply to other areas of life. That Walgreens tech was rude to me, so my prescription is discounted. The cashier at McDonalds was terribly immature and the damn coffee machine was broken yet again. Free meal. How can this happen?

A doctor's personality should have nothing to do with his payment. But we all know a doctor with better bedside manner would influence the patient to rate them higher.

I hate the direction that healthcare is turning.

My Response on Why Docs Should Profit

The blog post: "Why Doctors Should Profit From Dispensing Medications" Yes. You did enter dangerous territory in regards to physicians dispensing medications. Immediately as a pharmacist my first thought is the idea of checks and balances going to pot. Even the federal government knows that having three branches of government decreases the chance for one particular party or worse, person, taking over thus changing our whole democracy.

Why do you feel so strong about making things easier for the patient and sacrifice the safety of what is being prescribed? I cannot tell you how many times I've discovered the wrong drug written for a patient. The wrong strength. The wrong frequency.

PHARMACISTS are not just workers at McDonald's filling your order for a number four supersized value meal. We actually are saving lives.

It is quite humorous to me that 90% of your blog post were the reasons why NOT to do it. You answered your own question.

Does your idea include hiring a pharmacist to actually do the job?

I personally would not go to a physician who had this setup. It does scream profit, and better... would insurance companies reimburse you for that $300/day that you are looking for?

Why dangerous? For a number of reasons.

One, physicians still grapple with the perception that it is improper for a physician to make money from the delivery of care from business ventures.

Two, profit-making from prescription writing might induce physicians to write unnecessary prescriptions.

Three, prescriptions for profit might lead to conflict with pharmacists.

Four, Some states prohibit physician office dispensing, and more dispensing might lead to other states prohibiting the practice.

Five, there is also a fear that such a physician business venture carry significant risk relative to government regulation.

Then, there’s the other side of the issue. Writing prescriptions and ordering their refills takes a lot of physicians’ time. It also takes knowledge. It carries some malpractice risk, should the patient suffer an adverse reaction. Dispensing from the office would be convenient for patients. Since 30% of patients never fill their prescriptions, office dispensing is more likely to assure compliance. And prescriptions dispensed at the office are generally significantly less expensive than those filled at the local pharmacy.

I especially like "It also takes knowledge." Really? At first I was thinking this was approaching the concept with the ease of the fast food model in mind. Shouldn't patients at least take a little bit of responsibility for their own healthcare? Some malpractice risk? Look at the pharmacist that is in a jail for making one mistake on filling a chemo for a child who died as a result. Pharmacists carry a lot of risk, and the majority of complaining you hear is because the retail pharmacy model has catered to the patient's ease to make more money and putting patients at higher risk.

I will always stand by the banking model... a quiet environment where you expect to wait patiently with no other distractions like selling beer, cigarettes, food, etc... A pharmacy should be a place where health is FIRST and respect demanded just like in a bank. Doctors' offices are like this too though yes, the phone rings off the hook and people are waiting for long periods of time (I've personally waited 90 minutes before!!!).

I really believe adding the dispensing portion to the physicians' practice will turn it into a very unprofessional madhouse.

Good luck with that.

Diprivan and the Death of Michael Jackson

Milk of amnesia, propofol, diprivan, whatever you want to label it, diprivan has always been a medication that I put in the category of a medication that definitely needs hospital or long-term care support when administrating. Now because of the latest error a physician made in the case of Michael Jackson, the drug is propelled into the spotlight. Just recently:

Propofol: Limited Recall Due to Elevated Endotoxin Levels − July 2009

Teva Pharmaceuticals USA has announced a voluntary recall of certain lots of propofol injectable emulsion 10 mg/mL 100 mL vials. The lots identified are being recalled due to elevated endotoxin levels in some of the vials. Teva has received reports of 41 propofol treated patients experiencing postoperative fever, chills, and other flu-like symptoms; most cases reported appeared to be self-limiting. Possible adverse effects associated with elevated endotoxin exposure include fever, chills, and rigors. High endotoxin level exposure may be associated with more serious adverse effects including disseminated intravascular coagulopathy, acute respiratory distress syndrome, and death.

But, that only included certain lots. Sounds scary, huh?

High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Um, no brainer. It's a medication that is an intravenous infusion and has several pharmacological purposes includng induction of anesthesia in patients ≥3 years of age; maintenance of anesthesia in patients >2 months of age; in adults, for monitored anesthesia care sedation during procedures; sedation in intubated, mechanically-ventilated ICU patients.

And straight from the books:

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: May rarely cause hypersensitivity, anaphylaxis, anaphylactoid reactions, angioedema, bronchospasm, and erythema; medications for the treatment of hypersensitivity reactions should be available for immediate use.

• Hypertriglyceridemia: Because propofol is formulated within a 10% fat emulsion, hypertriglyceridemia is an expected side effect. Patients who develop hypertriglyceridemia (eg, >500 mg/dL) are at risk of developing pancreatitis. Serum triglyceride levels should be obtained prior to initiation of therapy and every 3-7 days thereafter. Monitoring of serum triglycerides should especially be considered with therapy >48 hours with doses exceeding 50 mcg/kg/minute (Devlin, 2005). An alternative sedative agent should be employed if significant hypertriglyceridemia occurs. Use with caution in patients with preexisting hyperlipidemia as evidenced by increased serum triglyceride levels or serum turbidity.

• Hypotension: The major cardiovascular effect of propofol is hypotension especially if patient is hypovolemic or if bolus dosing is used. Hypotension may be substantial with a reduction in mean arterial pressure occasionally exceeding 30%. Use with caution in patients who are hemodynamically unstable, hypovolemic, or have abnormally low vascular tone (eg, sepsis).

• Injection-site reaction: Transient local pain may occur during I.V. injection; lidocaine 1% solution may be administered prior to administration or may be added to propofol immediately prior to administration to reduce pain associated with injection (see Administration).

• Myoclonus: Perioperative myoclonus (eg, convulsions and opisthotonos) has occurred with administration.

• Propofol-related infusion syndrome (PRIS): PRIS is a serious side effect with a high mortality rate characterized by dysrhythmia (eg, bradycardia or tachycardia), heart failure, hyperkalemia, lipemia, metabolic acidosis, and/or rhabdomyolysis or myoglobinuria with subsequent renal failure. Risk factors include poor oxygen delivery, sepsis, serious cerebral injury, and the administration of high doses of propofol (usually doses >83 mcg/kg/minute or >5 mg/kg/hour for >48 hours), but has also been reported following large dose, short-term infusions during surgical anesthesia. The onset of the syndrome is rapid, occurring within 4 days of initiation. The mechanism of the syndrome has yet to be determined. Alternate sedative therapy should be considered for patients with escalating doses of vasopressors or inotropes, when cardiac failure occurs during high-dose propofol infusion, when metabolic acidosis is observed, or in whom lengthy and/or high-dose sedation is needed (Jacobi, 2002; Corbett, 2008).

Sound familiar???

Are You Kidding Me?

My mouth just dropped open.  It's obvious to me that physicians do NOT read medication reconciliation forms for home meds at all.  The ones that do, kudos, but the ones that don't make my job more interesting and at times really get to me. Case-in-point:  50-something presenting to the hospital with lower GI bleed.

The doctor signed off to CONTINUE HER HOME MED OF PHENTERMINE FOR WEIGHT LOSS.  Are you kidding me?

I guess the nurse could have written "Purina Dog Chow - take one cup by mouth daily" and the physician would have signed off on it.

Way to go Joint Commission on putting in a requirement with no means of adhering to any sort of THINKING for anyone involved.

Except for the pharmacist of course to wade through the BS and find what is really needed.

I really like the one where the physician wanted to continue the patient's viagra while in the hospital.  THAT should keep the nurses on the floor on their toes running from a man who is looking for some fun.  Not good.

Medication reconciliation forms.  The bane of my existence.

Home meds in a hospital

One of the most frustrating things about the job I have now (and there are NOT as many frustrating things as in retail, etc..., I can tell you that!) is that when a patient is admitted into the hospital, he/she has a list of all the meds they take at home.  This list can be quite long and cumbersome...  and the most annoying thing is the doctor will sign off on it without even taking a peek that one line says, "hydromorphone 2mg prn."  PRN as needed... every second would fall here.  Or "acetaminophen prn"  OK.  There is a limit our livers can handle per 24 hours.  The doctor does not care for the most part.  He's there to take care of what ails him/her now and not the continuation of medications or reteaching of something they are taking incorrectly that may have precipitated the entire hospital visit (or at least exacerbated it!). The list can include anything... meds made up, meds misspelled so badly you can tell if it's hydralazine or hydroxyzine...

Meds are meds regardless if they come from home or the hospital.

Brain Shivers... Brain Zaps... Brain Shocks...

I do not know if many in the medical community are aware of this term that is thrown out there for such offenders as venlafaxine (Effexor), duloxetine (Cymbalta), paroxetine (Paxil), fluoxetine (Prozac), sertraline (Zoloft), fluvoxamine (Luvox), citalopram (Celexa), and escitalopram (Lexapro), but it is a very real phenomenon. Unfortunately, though many in the medical community have not had to rely on any of these meds in their own personal lives, I had a 2-3 year stint with venlafaxine from 2002-03. Basically, I presented with the inability to sleep due to anxiety of some personal issues (which we all have from time to time), and did not want a controlled substance. I tried paroxetine first and absolutely despised the drug. I quit cold turkey. Very smart for a pharmacist, right? (You can't just stop cold turkey and expect to not endure some uncomfortable sensory disturbances.) I found venlafaxine, at 75 mg extended release, to be a very good drug for its purpose of 9 to 12 months. However, what I didn't expect was that weaning from the drug would be so uncomfortable. 75 mg in itself is not even a moderate dose, falling more into the lower dose category. I've seen higher doses much more than the lower doses.

To explain what I felt, I will do my best to try to break down into words the feelings. Initially, there was a sinking feeling in my brain. If you've ever been to the Grand Canyon or a very tall building and looked down, there is a falling feeling that your brain sometimes throws at you though you are not falling at all. That feeling would happen for very short bursts, 2-3 seconds, enough to disrupt my thoughts, my work, and my being. I would just think, "What was that?" If I tapered over the recommended taper schedule (usually a week at a time step down, but keep in mind there's only one strength lower than the 75 mg XR - the 37.5 mg XR. Then where do I go? Literally it didn't matter. The big divide between the 75 mg and the 37.5 mg was enough to cause the "shivers" in my brain - a disorientation, falling, weird, and uncomfortable feeling.

"Brain zaps" are said to defy description for whomever has not experienced them, but the most common themes are of a sudden "jolt," likened to an electric shock, apparently occurring or originating within the brain itself, with associated disorientation for a few seconds. The phenomenon is most often reported as a brief, wave-like electrical pulse that quickly travels across the surface of (or through) the brain. Some people experience these "waves" through the rest of their body, but the sensation dissipates quickly. They are sometimes accompanied by brief tinnitus and vertigo like feelings. Immediately following this shock is a light-headedness that may last for up to ten seconds. The sensation has also be described by many as a flashbulb going off inside the head or brain. Moving one's eyes from side to side quickly while open has also been known to trigger these zaps and sometimes causing them to come in rapid succession. It is thought to be a form of neuro-epileptiform activity.

As withdrawal time increases, the frequency of the shocks decreases. At their peak, brain zaps have been associated with severe headaches. They may last for a period of several weeks after the last dose and usually resolve completely within a month or two. However, anecdotal reports of "zaps" during a protracted withdrawal are known to last a year or longer.

My remedy was to open the capsule and to count the tiny beads and literally make capsules with less and less tapering over a 6 week period rather than the usual 2 - 3 weeks at this dose. It did eliminate the feeling, but it definitely helped. One could go as far as asking the physician for a 37.5 mg immediate release tablet and maybe breaking it up into pieces and tapering at the very end that way. Any way you dice it, venlafaxine was a pain and taught me right away a bigger lesson in remembering the side effects than any package insert ever could.

10/31/12 - update and fitting it is Halloween! Guess what? Add Cymbalta (duloxetine) to the list. It has been given approval for pain, both arthritic lower back and cancer. Withdrawal when you miss a dose.

I did take Vitamin B Complex, and maybe it helped.  Others have mentioned other vitamins.  Would love to hear remedies that worked if you can email me at theblondepharmacist@gmail.com