Seventh Question of the Day, September 22, 2013, In the interest of transparency why doesn't the FDA make all 483 inspection reports available on its website?

Question of the Day; May 7, 2013 Wouldn't One Very Easy Way to Make Compound Pharmacy Inspections More Transparent Be To Require Compounding Pharmacies To Keep a Folder Available and Accessible to the Public On Their Counter With The Last Ten Years of All Inspections Reports from Any State Board or Federal Agency?

In the state of Oklahoma for example, all daycares are required to maintain a folder for public to inspect.  Here is required for daycares in Oklahoma:

(f) Compliance file.  A compliance file accessible to staff, parents, and others contains:

• (1) the most recent child care licensing monitoring report provided by the licensing specialist;
• (2) the following documents issued by Licensing within the last 120 days:
• (A) child care licensing monitoring reports and licensing correspondence;
• (B) Form 07LC037E, Notice to Comply;
• (C) licensing complaints; and
• (D) Form 04CP004E, Child Welfare Investigative Summary Notification to Oklahoma Child Care Services, with findings of unconfirmed or unsubstantiated to include findings of services not needed, ruled out, or services recommended; and
• (3) Form 04CP004E, Child Welfare Investigative Summary Notification to Oklahoma Child Care Services, with findings ofconfirmed or substantiated, for one year from the completion of the investigation.

source found here.  Why could there not be similar laws, rules or regulations for compounding pharmacy, especially for those states who do not provide on-line access to the disciplinary records and inspection reports.   This file could also include information regarding all pharmacists involved in compounding in the pharmacy.  This would not cost the state anything to implement, it would make more records accessible to the public--including doctors, veterinarians, and the public.  It might also encourage some pharmacies and pharmacists to strive to keep a clean record.

Expert: Pharmacy overhaul not enough

Jan. 5, 2013
By 

Richard Weir / Boston Herald

 

Gov. Deval Patrick’s planned overhaul of the state Board of Pharmacy — a move aimed at boosting oversight of sterile compounding pharmacies after a deadly nationwide fungal meningitis outbreak — is a “great first step” but further action is needed, according to an expert on pharmaceutical compounding.

“I think it’s moving in the right 
direction,” said Sarah Sellers, a former U.S. Food and Drug Administration official who worked on compliance issues involving compounding and has become a crusader. “But (the measures) will not be enough to protect the public without additional 
efforts by the FDA.”

Until federal law changes, Sellers said, states like Massachusetts can help protect the public by posting the inspection findings of such pharmacies online.

 

“Transparency can be a very effective regulation tool … and an 
efficient way to rein in inappropriate practices,” she said.

Continue reading here

More Transparency in and Easier Access of Discipline Records Needed: Tennessee Case Fails to Name Pharmacy and Pharmacists

By Doletta Sue Tuck

Originally Posted July 12, 2012

Reposted December 27, 2012

More transparency of disciplinary records is needed regarding violations of compounding rules and regulations.  Right now one must go to each individual state board of pharmacy to determine if a pharmacy or pharmacist that compounds drugs has been disciplined.  In same states, the records are not available online.  In other states, one maybe able to see that a pharmacist or pharmacy has been disciplined but it cannot be seen what the discipline was for.  In most states, you can obtain the information by writing the state board.  Some states require the requestor of the information to pay to have the information copied.  In other states, you can see that a compounding pharmacy or pharmacist was disciplined but you cannot determine the name of either.  An example of this is found in the board minutes of the Tennessee Department of Health Board of Pharmacy for Jan. 2012.  The minutes contain the following enter: 

Jan. 2012--Tennessee

5. Case No.: L11-PHR-RBS-20100093

Complaint generated from period inspection of Respondent’s compounding pharmacy. Periodic inspection found 20 partially filled compounding drugs which had expiration dates going back to 2009 and a hood which had not been recertified since 2007. At time of initial inspection Respondent stated that routine checks are conducted relating to expiration dates, however the shelf where the expired medication were found was inadvertently missed. A subsequent inspection was conducted which found that all expired drugs had been removed and that the non sterile hood had been recertified.

Prior discipline: none

Recommendation: Letter of Warning

Dr. Stephens made the motion to issue a Letter of Instruction to the pharmacy for the expired drugs. Dr. Smothers seconded the motion. The motion carried.

While this entry lets the public know that Tennessee is taking disciplinary action against pharmacies and pharmacists who break the compounding regulations and rules, it is not helpful  to consumers who want  to make informed decisions about which  pharmacies and pharmacists to use.  Easier access to disciplinary actions is greatly needed in the compounding world.  Such public access could encourage more compliance with the rules and regulations.

Florida State suspends Boca Raton-based medical compounding pharmacy:Proposed State Legislative Fix for Compounding Pharmacies Regulations: More States Need to Be Pro-Active Like Florida If They Want to Retain Jurisdiction to Regulate Compound Pharmacies: Don't Forget to Make Transparency A Key Facotor

Florida Department of Health entered an emergency order shutting down or as the order states "suspensi[ing] [ ] Rejuvi's permit to operate as a community and sterile products and special — parenteral enteral compounding pharmacy in the State of Florida."  See order here.  This is a terrific pro-active approach that should have been done long ago by the states.  More states need to be taking this approach and shutting down dangerous, non-complaint compounding pharmacies.  This needs to be done not only for public health reasons but also,  if the states have any interest at all in retaining at least some of the authority to regulate compounding pharmacies.  While it is true that the United States Congress has plans to introduce legislation granting the FDA more authority to regulate these entities, that legislation has not been introduced, it is unclear at this point how broad the legislation will be, and there is always a question of which version, if any, of a draft piece of legislation will pass.  This leaves states a chance to take action as Florida has done.

States should be inspecting compounding pharmacies, noting  whether those compounding pharmacies have been previously written up for violations, and taking the strongest action allowed under the state law.  For example, if allowed under the state laws, state boards should issue orders shutting pharmacies down that are a public health risk; if closure is not allowed then state boards should impose the maximum fine allowed.  In any event state boards should require the pharmacies to become compliant within so many days before they can begin operating again.  Also state boards should make compounding pharmacies that have such violations recall all drugs linked to any possible contamination or public health risk.    

If states do not already have strict compounding laws and regulations,  they should promptly adopted and enact the needed laws and regulation to deal with the problems.  The laws need to give the state boards (i.e., inspectors)  authority to immediately shut down compounding pharmacies that pose a public heath risk.  They also need to give the state boards authority to impose significant fines.  The fines need to be significant enough that the bad compounders would rather comply with the rules than pay the fines.  When the fine is a dollar amount that is merely a slap on the wrist and cheaper than actually complying  with most rules and regulations, then the bad pharmacies opt to pay the fine and continue to operate in an unsafe manner.  This also penalizes and is unfair to the good compounding pharmacies, and yes, there are some, who spend the money required to comply the rules and regulations.

One other key to fixing the compounding world that I have repeatedly stressed on this blog, is TRANSPARENCY.  The inspection reports, the orders and the fines need to be made readily available to the public.  While putting them on the Internet cost money--it is well worth the lives it could save.  Doctors, Veterinarians, Hospitals, Clinics, Consumers, . . .everyone can then look up the compounding pharmacy to see if their inspection report contained any violations, what corrections to the violations were made, etc.  For example, it was great that I could immediately go to the Florida Department of Health and download and read the emergency order as could any member of the public.  Reporters are reporting on it. Bloggers are blogging about it.  The public is becoming aware of it.   Florida has done a good job of making their disciplinary records for compound pharmacies transparent. Other states should follow Florida's lead.