PCCA announces on Facebook that it does not support nor encourage the marketing activities in the recent CBS story, and echos and supports IACP's position statement

"PCCA does not support nor encourage these types of marketing activities. We echo and support our industry partner, IACP's, position statement on this subject: http://bit.ly/1DuxnOA" more at PCCA Facebook page found at https://www.facebook.com/pccarx

Flashback to 2006: FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams

2006 FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams

IACP Article: A brief survey on prescriber beliefs regarding compounded topical pain medications. Warner M, Tuder D. (Eleven prescribing practitioners participated in this survey with a response rate of 78%).

A brief survey on prescriber beliefs regarding compounded topical pain medications.

Warner M, Tuder D.

Abstract

Pain is extremely common in the U.S. It is estimated that 116 million Americans suffer from chronic pain. Narcotics and opioid medications are heavily relied upon for the treatment of pain. Currently, there is an epidemic of opioid abuse and misuse in the U.S. and alternative methods for the treatment of pain are required. Topical compounded pain creams are thought to be one such alternative. The purpose of this study was to establish a baseline regarding the beliefs of community physicians on the safety and efficacy of these compounds. A survey was sent to practicing physicians in the U.S. regarding their prescribing behaviors for topical compounds, as well as their beliefs about the efficacy and safety of these medications. Eleven prescribing practitioners participated in this survey with a response rate of 78%. The results were compiled with basic statistical work (Excel). This survey demonstrated that at the time of the study, topical compound creams for the treatment of pain were commonly used in clinical practice; these creams were used for musculoskeletal pain and for neuropathic pain. It was also determined that the vast majority of practicing prescribers felt that compounded pain creams were more efficacious than mass-produced, U.S. Food and Drug Administration-approved creams marketed by large multi-national pharmaceutical companies. Most of the respondents felt that these compounds allowed them to reduce their narcotic prescriptions overall. In addition, the results demonstrated that the prescribers felt these compounds were safe for their patients. In this small survey of practicing prescribing providers regarding the use of topical compounds, we found that these medications were not only effective but also safe.

source here

Designer pain creams and ointments are profitable for compounding pharmacies but risky for patients and children; Here are some of the dangers you may not be aware of

Certain pharmacies, known as compounding pharmacies, can mix different ingredients together to produce a patient-specific product. Popular compounded products include pain creams and ointments that contain a combination of multiple potent medications. Many include drugs that can cause central nervous system depression or cardiac effects that result in slow breathing, a low heart rate or irregular beat, and drowsiness or a loss of consciousness. These drugs may include:

• Ketamine—a powerful pain reliever that can cause deep drowsiness
• Baclofen and cyclobenzaprine—powerful muscle relaxants that cause drowsiness
• Lidocaine and bupivacaine—local anesthetics that can cause heart rate and rhythm changes
• Tricyclic antidepressants—depression medicines used to treat pain that can cause heart or blood pressure abnormalities
• Gabapentin, clonidine, and nifedipine—pain relievers that are primarily used to control seizures or high blood pressure

Combinations of these and other drugs manufactured by compounding pharmacies are not approved by the US Food and Drug Administration (FDA).

Compounding pharmacies are largely profitable and growing rapidly. Consumers are charged per ingredient even though there is really no proof that more drugs together make the product better. Many compounding pharmacies have a large sales force that conducts an elaborate marketing campaign and will provide doctors with prescriptions that only require their signature to make prescribing of these creams easier. Prospective patients are often receiving unsolicited calls at home, with a promise that the cream can be prescribed after an arranged telephone consultation with a physician. Some compounding pharmacies are even enticing doctors with financial incentives to prescribe these creams, despite an Anti-Kickback Statute. In one high-profile case, the Federal Bureau of Investigation (FBI) recently announced the arrest of one pharmacist with a compounding pharmacy who paid tens of thousands of dollars in cash bribes to physicians for providing patients with pain cream prescriptions. more

APha: Fighting for fair PBM auditing practices, state by state March 1, 2015

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British Journal of Clinical Pharmacology: Ketamine analgesia is limited by low intrinsic efficacy compounded by large interindividual variability in drug responses, possibly due to the heterogeneity in drug concentration.

4. CYP2B6*6 allele and age substantially reduce steady‐state ketamine clearance in chronic pain patients: impact on adverse effects

Date: Feb 23, 2015

Abstract Aim Ketamine analgesia is limited by low intrinsic efficacy compounded by large interindividual variability in drug responses, possibly due to the heterogeneity in drug concentration. The CYP2B6*6 allele is associated with substantially reduced ketamine metabolism in vitro, and therefore, may affect ketamine clearance. Our aims were to examine the impact of the CYP2B6*6 allele on ketamine plasma clearance, and on adverse...more

Teaching NY Veterinarians About Legal vs. Illegal Compounding

HVVMS CE Session: Pharmaceutical Compounding Regulations for Practicing Veterinarians in NY 3/11/2015 When: 3/11/2015 7 to 9 p.m. Where: Map this event » Ramada Fishkill 542 Route 9 Fishkill, NY 12524 Presenter: Marc Gustas and Rosella Menta, Rye Beach Pharmacy Contact: Keith Sobel, DVM, DACVIM keithsobel@gmail.com Phone: 301.518.3859 Details Veterinary attendees will learn the specific regulations that control the compounding industry. These regulations address, among other things: Manufacturing vs. office use Shipments from out of state Injectables Factors that dictate why a medication can or cannot be compounded more information

Sterile compounding: Pharmacy profession should take back control: author notes accountability is not something you can outsource!

APha March 1, 2015 Sterile compounding: Pharmacy profession should take back control

Second Question of the Day March 1, 2015 What exactly would it take not to be granted a pharmacy licence from the Texas Board of Pharmacy

APPLICANTS FOR PHARMACY LICENSE Concierge Compounding Pharmaceuticals, Inc., Applicant for Pharmacy License, Henderson, NV. Alleged violation: corporate officer convicted (in 2001) of the felony offense of Conspiracy to Commit Securities Fraud. Agreed Board Order accepted by applicant and entered by the Board on 08-06-13: pharmacy license granted and placed on 1-year probation with conditions. University Medical Center East Pharmacy, Applicant for Pharmacy License, El Paso, TX. Alleged violation: failure to disclose criminal history of a corporate officer on pharmacy licensure application. Agreed Board Order accepted by applicant and entered by Board on 03- 01-13: pharmacist license granted and fined $1,000. Wylie Pharmacy, Applicant for Pharmacy License, Wylie, TX. Alleged violation: failure to disclose criminal history of a corporate officer on pharmacy licensure application. Agreed Board Order accepted by applicant and entered by Board on 03- 06-13: pharmacy license granted and fined $1,000. Cardinal Health 414, LLC, Applicant for Pharmacy License, Denver, CO. Alleged violation: disciplinary action taken by the Colorado State Board of Pharmacy. Agreed Board Order accepted by applicant and entered by Board on 04-12-13: pharmacy license granted and reprimanded.

quoted from Texas Board of Pharmacy Winter 2014 Disciplinary Newsletter

Texas Board of Pharmacy November 2014 Meeting Minutes Finally Posted in February 2015

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