Note: This following report was just released, and we thought you might be interested. We will continue our series on Clinical Pharmaceutics next week.

Researchers have just reported that almost half of all prescriptions for menopausal hormone replacement therapy (HRT) in the U.S. are for compounded "bioidentical" hormones. The estimates from a survey of compounding pharmacists revealed about 26 to 33 million prescriptions each year for compounded HRT, which is about the same number written for FDA-approved HRT. The report by JoAnn Pinkerton, MD, of the University of Virginia Health System, and colleagues was presented at the Endocrine Society meeting. The reference is:

Pinkerton JV, Constantine GD. Menopausal hormone therapy (MHT) usage: FDA-approved Mht has decreased while compounded non-FDA approved Mht has increased. Presented at the Hyperandrogenic Disorders and Menopause Basic/Clinical 2015 Endocrine Society Meeting. ENDO 2015; Abstract FRI 102-126.

The report states that the popularity of compounded "bioidentical" hormones increased in the U.S. after the Women's Health Initiative found that HRT increased the risk of breast cancer and heart disease. About 18 million women used FDA-approved HRT before the WHI results were presented, but that number fell to 3.7 million in 2013 -- close to the estimated 2.5 million women who use compounded hormones.

Pinkerton and colleagues sent an online survey to 12,250 compounding pharmacists last fall (2014) and a total of 2,902 responded; 483 were used in the final analysis. From the study, they estimated that some 26 to 33 million prescriptions for compounded hormone therapy are filled annually; this figure parallels the number of prescriptions written for FDA-approved hormone therapy.

A comparison based on the average compounded price of $50 estimates that sales of compounded HRT are estimated to reach $1.3 to $1.7 billion annually; current sales for FDA-approved HRT is $4 billion per year. Participants in the survey said they expect to see continued growth by 5% to 25% over the next 2 years.

In her presentation, Dr. Pinkerton said there is a need for education for both patients and prescribers on compounded HRT preparations: they are not tested in rigorous clinical trials, they're not monitored or regulated by the FDA, they may contain contaminants, and there may be batch-to-batch variations in stability, among other concerns, she said.

(Note: Pinkerton is a consultant for Pfizer, TherapeuticsMD, Noven, and Shionogi.)

http://www.medpagetoday.com/MeetingCoverage/ENDO/50372

Announcement from IACP

"Do you ever feel like you're spending a lot of your time debunking the compounding myths out in the marketplace? We understand, and have tried to help make those myths vaporize. David Miller conducted an interview yesterday with Pharmacy Times specifically for that purpose. To help put to the bed the ridiculous untruths circulating in the media, and elsewhere. Please click here to view the article - Pharmacy Times: 3 Biggest Compounding Pharmacy Myths Debunked."

Please share this article!!!

http://www.pharmacytimes.com/news/3-Biggest-Compounding-Pharmacy-Myths-Debunked

News

FDA to Conduct Clinical Trial to Test Cannabis Oil
Lawmakers in Idaho are working on amendments to a bill that would legalize cannabis oil use on children with intractable seizure disorders. The drug used will be a pharmaceutical-grade cannabis oil or CBD oil known as Epidiolex. Some studies have been done but the FDA trials help to ensure there's a scientifically rigorous process, so it's not just anecdotal evidence. The clinical trial will take about 14 weeks and uses the CBD oil produced by a British pharmaceutical company, and administered with the cooperation of the Idaho Office on Drug Policy and a local neurologist. The study is open to all ages for patients that suffer from the uncontrollable seizures.
http://www.kboi2.com/news/local/fda_trial-295251641.html

FDA Cracking Down on CBD Companies
The FDA is cracking down on several companies selling products advertised as containing cannabidiol (CBD). In late February, the FDA notified seven companies that market CBD products for the treatment of health conditions that their products are not "generally recognized as safe and effective" and that the companies are engaging in illegal interstate commerce. Up to now, the FDA has not approved any drug product containing cannabidiol, for any indication.
http://www.usnews.com/news/articles/2015/03/11/fda-brings-down-hammer-on-cbd-companies

DEA Causing Some CDS Shortages
There has been a noticeable shortage of prescription CDSs, causing difficulties for both patients and physicians. A recent report finds the U.S. Drug Enforcement Agency has contributed to the problem. To prevent diversion, the DEA sets quotas that limit the amount of CDSs that can be produced and has not effectively managed the quota process; this has contributed to product shortages, according to the U.S. Government Accountability Office. To correct the situation, the GAO recommends that the DEA should institute metrics and policies and perform periodic data checks in order to better manage the quota process. They also suggest that the DEA and FDA should immediately update a memorandum of understanding, which has not been revised since the 1970s, so that information can be more easily shared and agreed-upon steps taken to combat shortages.
http://blogs.wsj.com/pharmalot/2015/03/11/dea-contributes-to-shortages-of-drugs-with-controlled-substances-report/

Specialty Compounding Receives Consent Decree
Specialty Compounding of Cedar Park, Texas, and the company's co-owners, Raymond L. Solano, III and William L. Swail, have received a consent decree of permanent injunction from U.S. District Judge Lee Yeakel. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination; the U.S. Department of Justice brought the action on behalf of the FDA. This action prohibits Specialty Compounding and its owners from manufacturing, holding, or distributing sterile drugs until they comply with the Federal Food, Drug, and Cosmetic Act and its regulations, in addition to other requirements.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437682.htm

Drug Companies to be Allowed to Undermine Official Safety Warnings?
The FDA is proposing to allow pharmaceutical companies to undermine official safety warnings in sales presentations to customers. This new proposal would allow companies to provide doctors, hospitals, and other customers with information that conflicts with official advice, which is typically developed after a rigorous scientific process.

The pharmaceutical manufacturers support the proposal and argue that the policy would allow them to provide doctors and hospitals with the latest research. Also of concern are the academic journals who publish the results of industry-funded studies that are trying to weed out error, but they are not always successful.
http://www.washingtonpost.com/blogs/wonkblog/wp/2015/03/11/how-the-first-amendment-is-undermining-the-fdas-power-to-regulate-drugs/

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Tip of the Week

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Looking Back

Violets are blue,
Roses are pink,
On graves of those,
Who drive and drink!
     Burma Shave