Principles of “conservative prescribing" Gordy Schiff, MD Bill Galanter, MD/PhD & the FLIP group...

Principles of “conservative prescribing"

Gordy Schiff, MDBill Galanter, MD/PhD

&the FLIP group

This work was made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program which is funded by the

multi-state settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin.

Principles of Conservative Prescribing Confessions of a compulsive precriber Typical Galanter clinic

Principles of Conservative Prescribing

Seriously consider not starting a medication

After you start one, watch out, be careful

When you start one, choose wisely



-Seek and exhaust non-drug alternatives first-Lose weight or start metformin-Rest and ice or start celebrex

-Try to leave self-limited conditions alone-The Rx might be worse than the condition

-Try not to start a medication that the patient already has taken and did not like, did not tolerate, is allergic to or produced an adverse drug affect.

Principles of Conservative Prescribing Seriously consider not starting a medication

Reducing and Preventing Adverse Drug Events To Decrease Hospital Costs. Research in Action, Issue 1. AHRQ Publication Number 01-0020, March 2001. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/qual/aderia/aderia.htm

Try not to start a medication that the patient already has taken and did not

like, did not tolerate, is allergic to or produced an adverse drug affect.

Allergies: PCN (rash)

Medication List: …. “Subjective: 47 y/o w/m here for f/u. He was seen by urgent care multiple times since the last visit. He was diagnosed with bronchitis and was given augmentin although he is PCN allergic. He developed a rash and was switched to biaxin. The rash was severe and covered his entire body. He could not work for 2 weeks secondary to the uncomfortable feeling he experienced from the rash. He was given allegra to counteract the rash which did not help on 5/1. He went to Evanston Northwestern and was given a prednisone taper which helped. He also saw an outside internist who prescribed a steroid cream to the severe areas. The rash is now gone”

Principles of Conservative Prescribing Seriously consider not starting a medication

Try not to start a medication that the patient already has taken and did not

like, did not tolerate, is allergic to or produced an adverse drug affect.



-When possible, prevent disease instead of treating it

-Try to remove the underlying cause of a symptom, instead of giving a medicine for it.

-Try not to treat the side effects of one medication with another



Seven-year rule*: Do not be the first on your block to use a new drug. New drugs always appear to be safer because not enough time has passed or not enough patients have been exposed to identify more rare adverse effects.

Lasser et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA.2002 May 1;287(17):2215-20.

http://www.worstpills.org/

-Assume that new drugs are guilty until proven innocent. Innocent until proven guilty has been historically dangerous for patients!

i.e. The number of people in the trials may be smaller than the NNH



Maybe before your time

Baycol (Statin)Duract (NSAID)

Fenfluramine (Weight Loss)Grepafloxacin

Hismanal (Antisitamine)Lotronex (IBS) Lotronex (IBS)Posicor (CCB)

Propulsid(GERD/Gastroparesis) Raplon (Anesthestic)Redux (weight loss)

Rezulin (thiazoli dinediones)Seldane (Antihistamine)

*

*

*

Principles of Conservative Prescribing When you start one, choose wisely

Assume that new drugs are guilty until proven innocent.

“Luckily” Rezulin came onto the market!!!

What I had heard; -No GI side effects like Metformin-No hypoglycemia like sulfonyluria’s-No needles like insulin-Get’s to the root of the problem, insulin resistance-First of an exciting new class on drugs

I finished my residency in 1996. One of the most common diseases I treated was DM type II. The problems I had with DM;

-Patients did not lose weight, thus insulin resistence never improved-Most of my patients were not well controlled

P00-8 FOOD AND DRUG ADMINISTRATION FOR IMMEDIATE RELEASE Print Media: 301-827-6242 March 21, 2000 Consumer

Inquiries:888-INFO-FDA

REZULIN TO BE WITHDRAWN FROM THE MARKETFDA today asked the manufacturer of Rezulin (troglitazone) -- a drug used to treat type 2 diabetes mellitus-- to

remove the product from the market. The drug's manufacturer, Parke-Davis/Warner-Lambert, has agreed to FDA's request.

FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia and Actos, both approved in the past year, offer the same benefits as Rezulin without

the same risk. "When considered as a whole, the pre-marketing clinical data and post-marketing safety data from Rezulin as

compared to similar, alternative diabetes drugs indicate that continued use of Rezulin now poses an unacceptable risk to patients," said Dr. Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research. "We are

now confident that patients have safer alternatives in this important class of diabetes drugs," she added. Severe liver toxicity has been known to occur with Rezulin since 1997. In consultation with FDA, Parke-Davis has strengthened the drug's labeling several times and has recommended close monitoring of liver function in

patients taking Rezulin. In March 1999, FDA's Endocrine and Metabolic Drugs Advisory Committee reviewed the status of Rezulin and

its risk of liver toxicity and recommended continued availability of this drug in a select group of patients -- patients not well-controlled on other diabetes drugs.

Since then, FDA has continued to actively monitor adverse events associated with Rezulin, as well as Avandia and Actos. After up to nine months of marketing experience with these two newer drugs, it has now become

clear that these newer drugs have less risk of severe liver toxicity than Rezulin.



“Luckily” Januvia has come onto the market!!!

What I have heard; -No GI side effects like Metformin-No hypoglycemia like sulfonyluria’s-No weight gain-”Protects” beta cell function-First of an exciting new class on drugs;

DPP-4 inhibitor “Dipeptidyl peptidase-4”

It is now ~10 years later, 2007. One of the most common diseases I treat is DM type II. The problems I have with DM;

-Patients did not lose weight, thus insulin resistence never improved-Most of my patients were not well controlled-Americans are getting more and more obese



I think that I will take a pass for now.



Use only a few drugs and learn to use them well; become familiar with a limited number of drugs.

What makes a good drug in a class?

When Possible;-Generic:

-Less $$ for the patients, always on formulary & around longer

-No non-class SE’s or idiosyncratic side effects-Minimal DrugDrug Interactions (Keep away from P450!)-Most proven indications can broaden its evidenced based use-Daily



Are all drugs in a class about the same? Are they about as safe?

Simvastatin (Zocor) 1989Pravastatin (Pravachol) 1991Atorvostatin (Lipitor) 1996Ceruvosstatin (Baycol) 1998 (stronger) Rosuvastatin (Crestor) 2003 (stronger)

In 1998 should I have used Baycol? Should I use Crestor now?

Incidence of Hospitalized Rhabdomyolysis in Patients Treated With Lipid-Lowering Drugs JAMA. 292(21):2585-2590, December 1, 2004.



August 8, 2001

RE: Market withdrawal of Baycol (cerivastatin)

Dear Healthcare Professional:

I am writing to inform you of very important new safety information about Baycol (cerivastatin) and rhabdomyolysis. Rhabdomyolysis is a serious, potentially fatal, adverse effect of all statin drugs, including Baycol. It can occur with statin monotherapy, though the risk appears to be increased significantly by concomitant use of gemfibrozil (Lopid). Our ongoing scrutiny of post marketing reports of rhabdomyolysis, including fatalities, has revealed an increased reporting rate of rhabdomyolysis with Baycol relative to other statins, especially when gemfibrozil is co-prescribed. These data also suggest an increased reporting rate of rhabdomyolysis at the 0.8 mg dose of Baycol alone.

Bayer Corporation has already placed a contraindication in the Baycol product prescribing information sheet against co-prescription with gemfibrozil and issued letters to healthcare professionals warning against co-prescription of these two drugs. Despite these and other actions, Bayer has continued to receive reports of rhabdomyolysis when gemfibrozil is prescribed as a co-medication. Since the co-prescription of Baycol and gemfibrozil has continued despite communications by Bayer against this practice, the company has decided to take the following voluntary action to prevent further cases of rhabdomyolysis:

Effective immediately, Bayer has discontinued the marketing and distribution of all dosage strengths of Baycol. Patients who are currently taking Baycol should have their Baycol discontinued and be switched to an alternative therapy.

Bayer is taking this action as part of an ongoing commitment to patients and their healthcare providers to ensure patient safety.It is important to you forward any adverse event information associated with the use of Baycol to Bayer Corporation at 1-800-288-8371. You can also report the information directly to the FDA via the MedWatch system at 1-800-FDA-1088, by mail (using a postage paid form), or the Internet at www.fda.gov/medwatch.

If you have further questions regarding this action on Baycol, please contact Bayer customer service at 1-800-758-9794.Yours sincerely,

E. Paul Mac Carthy, MDVice President,Head U.S. Medical Science



-Don’t let surrogate physiologic/pharmacologic arguments win out over actual clinical results

-“vytorin goes after cholesterol in 2 ways”, “Alpha cells are important in diabetes”, “our ACE is a “tissue ACE”, “this is a new class of macrolide”, “our bioavailability is 30% better”, “The T calcium channel is different”, “We provide broader coverage” etc,etc, etc, etc…

-Learn about drugs from credible sources, not from free lunches, advertisements, patients or questionable “experts”.

Don’t let big pharma and nice reps with good food trick you



Beware of indication creep!!!!Beware of indication creep!!!!

Lyrica® Diabetic neuropathy

Partial Seizures adjunct

Post-herpatic Neuralgia

HIV neuropathy

Sciatica

Partial Seizures primary

Fibromyalgia

migraines

Back Pain

DJD

HeadachesAny Pain

Headaches

any neuropathy

Likely little or no data

Some data


-After you start one, watch out, be careful

-Know the potential adverse effects of the drugs that you use

-Explain to your patients the potential adverse drug effects that are serious or less serious, but likely

-Have a high index of suspicion for adverse drug effects when patients have complaints.

↓ Adverse Drug Events (ADE)Adverse Drug Events (ADE)


-After you start one, watch out, be careful

-Find out if your patient is actually compliant with a medication before you go up on a dose.

-For a given patient, use as few drugs as possible and discontinue as many drugs as possible, as often as possible.

↓ Adverse Drug Events (ADE)Adverse Drug Events (ADE)

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Principles of “conservative prescribing" Gordy Schiff, MD Bill Galanter, MD/PhD & the FLIP group...

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