Thursday, January 1, 2015

Third Question of the Day January 1, 2015 The Washington Post Article linked below mentioned states that were cracking down on compounding pharmacies. How many state boards of pharmacy followed up and disciplined compounding pharmacies that were resident pharmacies who haave been disciplined by other states? If readers know of examples where a compounding pharmacy was disciplined in one state such as Colorado but a resident of another states such as Arizona or Texas and the resident state board of pharmacy took no action please comment. Are these states lacking in authority, resources, both, or just on willing to take action?

A Law Review: The Pharmacist's Duty to Warn in Texas

Passing synthetic drug law priority for East Texas legislators

http://www.news-journal.com/news/local/passing-synthetic-drug-law-priority-for-east-texas-l...
Dec 14, 2014 ... Rusk County's state representative said he plans to lead the House charge against synthetic drugs in the legislative session that begins next ...

Lawmakers seek solutions to prescription drug epidemic

Lawmakers seek solutions to prescription drug epidemic

Texas legislators seeking an antidote for prescription drug abuse are expected to propose that doctors be encouraged — but not required, as some have urged — to use an online database that can identify patients who are “doctor shopping” for drugs.

Second Question of the Day January 1, 2015 Aren't the advertisements and notices stating there is a "right" or "entitlement" to compounded medications totally contrary to the law that says compounded medications are based on need? If we have a "right" or "entitlement" to drugs of choice what does this do to the laws regarding illegal substances? If there are no or should be no federal regulations of compounded drugs and we have a "right" to them according to these advertisements then does that "individual right" trump the health and safety of the public? Where do compounders draw the line or is there any line at all in their opinion? Are is it simply their right as compounders to make compounded medications and our right at US citizens to use compounded medications if we choose--even if untested, ineffective, and could cause harm to pets or humans? Will the new group of compounding pharmacist emerging who do not like the current messages advocated and who want compounding to based solely on legitimate need and not on entitlement theory be able to change the profession?


Question of the Day January 1, 2015 IACP and others continue to advocate that the DQSA and the FDA have hindered treatment options because traditional compounding pharmacies cannot provide office use compounding. Very few states allow office use compounding. How have all the states that do not allow office use compounding been able to function for all the years prior to the DQSA? Why hasn't the focus been on changing all these state laws in the past? And why haven't states changed these laws if compounded office use is so essential?


Another Incident Involving Compounding Pharmacy: Endophthalmitis Outbreak Associated with Repackaged Bevacizumab - Volume 21, Number 1—January 2015 - Emerging Infectious Disease journal - CDC

Endophthalmitis Outbreak Associated with Repackaged Bevacizumab - Volume 21, Number 1—January 2015 - Emerging Infectious Disease journal - CDC

Washington State Health Care Authority Policy on Compounded Drugs Effective January 1, 2015

Prescription Drug Program Provider Guide - Health Care ...  

www.hca.wa.gov/medicaid/billing/.../prescription_drug_program_bi.pdf

8 hours ago - Compounded Prescriptions .........................................................................................................26. What is ......Compounding – The act of combining two or more active ...

Recalls, Market Withdrawals, & Safety Alerts Valeant Pharmaceutical North America LLC Issues Voluntary Nationwide Recall Of Virazole (Ribavirin Powder For Solution) Due To Microbial Contamination

Recalls, Market Withdrawals, & Safety Alerts Valeant Pharmaceutical North America LLC Issues Voluntary Nationwide Recall Of Virazole (Ribavirin Powder For Solution) Due To Microbial Contamination

Important Comment from Reader Regarding DQSA working....

Anonymous said...
The DQSA is not perfect, but it is working, especially indirectly, to reshape the compounded drug market, making those products easier for FDA to oversee. Many pharmacies, particularly the smaller ones, have ceased sterile compounding, rather than (a) make the investments required to comply with cGMPs, and (b) subject themselves to FDA regulation. This will tend to centralize production in the larger, less numerous outsourcing facilities that are directly overseen by FDA.

A regulatory framework is only as effective as the agency enforcing it. Practically all of the nation's 50,000+ community pharmacies, together with the thousands more hospital and clinic pharmacies, engage in some level of compounding, at least occasionally. FDA simply lacks the personnel, infrastructure, and institutional expertise to operate at this level.

Further, FDA oversight is not a panacea. FDA's track record, even with commercially manufactured drugs, is ... mixed: Thalidimide, Vioxx, Heparin, Crestor, Duract, Pisocor, Rezulin, Baycol, Accutane, to name a few.

And state enforcement is not "less" these days. Many states have tightened regulations and more importantly, practically every state has gotten more serious about enforcement and (especially) inspections. Why? Mostly because state pharmacy boards understand FDA's limited front-line capabilities.