We are all aware that pharmaceutical compounding is "patient centered." The "TRIAD" includes the physician-patient-pharmacist relationship and how successful compounding for individual patients is heavily dependent upon the pharmacist. The physician and patient both rely on the pharmacist to integrate the prescribed medication into a safe and effective dosage form that will contribute to patient compliance and successful pharmacotherapy.

As we are all aware, the education of a pharmacist was formerly very heavily "product oriented," where the graduates were extremely well versed in the sciences and technology associated with the drug product. Today, the education pendulum of a pharmacist has swung the opposite direction where it is heavily oriented on the disease states with significantly less in the sciences involved with the drug product. We need to "moderate the pendulum" back to the middle where the graduate can intelligently discuss and evaluate all the scientific aspects of the drug product and how it can affect patient therapy. Some therapeutic failures are due to "drug product concerns" rather than just "drug concerns."

A subject that has been evolving over the years and one that we will begin discussing in detail over the next several newsletters and International Journal of Pharmaceutical Compounding (IJPC) articles is that of "Clinical Pharmaceutics." Clinical pharmaceutics involves applying basic scientific facts to solving problems in medication therapy. Where pharmaceutics has been looked at as being important primarily to those going into pharmaceutical industry—teaching and compounding—it is now becoming more apparent that therapeutic regimens can be effective or ineffective based upon pharmaceutics and the relationship with the patient. More to come!

New 503A Guidance Released

The FDA has released the new Guidance for 503A compounding. It may be obtained at:
http://www.fda.gov/downloads/drugs/guidancecompliance
regulatoryinformation/guidances/ucm377052.pdf

More than 150 doctors, nurses, patients, pharmacists, pharmacies, patient advocacy organizations, and others have formed a new coalition named Patients and Physicians for Rx Access. The Coalition seeks to stop or reverse unprecedented cuts in prescription coverage by Pharmacy Benefit Managers (PBMs) and some insurance plans. The cuts will impact millions of patients who rely on compounded medications to address conditions not satisfied by commercially available medications. The financial burden related to this loss of coverage will cause many patients to forego compounded medications altogether, thus leading physicians to prescribe less effective treatments. The coalition (Patients and Physicians for Rx Access) is working to educate and empower individuals and organizations to stop PBMs from making intended coverage cuts. Patients, pharmacists, and other supporters may learn more by visiting saverxaccess.org. They can take action to protect patient access to compounded medications by:

• Joining Patients and Physicians for Rx Access
• Asking impacted customers to share their stories
• Donating to this important cause
• Signing up for updates on the issue
• Downloading a free educational toolkit with:
  • Educational posters, flyers, fact sheets, and website content
  • An Rx Stuffer to include with filled prescriptions
  • Scripts pharmacists and support staff may use when answering patient questions regarding cuts to prescription benefits

News

Express Scripts Dropping Combo Meds?
Rising drug prices do not mean rising sales when PBMs step in to control costs—and that's exactly what they've been doing. The latest: Express Scripts and CVS Caremark are kicking two Horizon Pharma drugs off their formularies as of August 1—and plan to exclude them completely next year. The move to exclude Duexis and Vimovo could cut the drugs' prescriptions by 20% to 30%; and the exclusions may not end there. If other healthcare plans follow this action, there could possibly be other prescriptions affected.
http://www.fiercepharma.com/story/doom-combo-meds-express-scripts-cvs-dump-horizon-pharma-two-one-drugs/2014-07-30

Drug Companies Oppose Off-label Medicine Reimbursement When it Affects Their Sales
Pharmaceutical companies are "pushing back" against decisions by European governments to reimburse patients for drugs being used "off-label," specifically involving Avastin and Lucentis. Paying for off-label drugs, which are often cheaper than their approved rivals, is necessary to cut national healthcare bills. Avastin typically sells for about �40 ($53.90) per injection in Europe, while Lucentis sells for around �900 ($1212.75) per injection.

Pharmaceutical companies argue that encouraging doctors to prescribe medicines beyond their approved usage could harm patients and may violate European Union law. Prescribing medications off-label is neither illegal nor uncommon in Europe.

Roche said it is "our obligation to inform the medical community including physicians and patients about the known risks associated with the off-label uses of our medicines."

Italian antitrust authorities ruled that Roche and Novartis were colluding to push doctors to prescribe Lucentis rather than Avastin and decided to seek �1.2 billion in damages from the two companies. The companies presented Avastin as riskier than Lucentis to increase prescriptions for the more expensive approved drug.
http://online.wsj.com/articles/drug-companies-oppose-moves-to-reimburse-off-label-medicine-1406287000?cb=logged0.012428702286287785

IJPC Now on Facebook and Youtube

Become a fan of the IJPC Facebook page and share ideas, photos, and keep up to date with the latest compounding information - http://www.facebook.com/IJPCompounding

Learn about the Journal's new multi-media features and view our growing collection of educational and training videos at www.ijpc.com/videos or by subscribing to our Youtube channel at https://www.youtube.com/user/IJPCompounding.

Did You Know ...

�that the IJPC was the first pharmacy journal to incorporate augmented reality (AR) in its journal a year ago? Now, the American Journal of Health-Systems Pharmacy appears to be following IJPC's lead in using this new technology.

Tip of the Week

Some people make things happen; some people watch things happen; some people wonder "what happened?"

Looking Back

No matter the price,
No matter how new,
The best Safety Device,
In the car IS YOU!
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