Florida Board of Pharmacy Meeting Update

August 12th and 13th

Orlando

Attached is the Rules report and summary from the last board of pharmacy meeting. Also included are some items presented to the Board.

Rules Report

I made notations on the margins on some of the discussions.

The title page shows the status and progression of each rule and the expected effective date.

As to the Control Substance Standard of Practice Guidelines, the discussion was that these are intended to be guidelines only. Several of the Board members now have expressed concern that some Pharmacists may see these as ‘rule mandates’ and may feel the need to refuse all prescriptions if not able to meet these standards in all instances. The attempt to repeal the ‘rule’ and change the communication format to a written newsletter published guideline died with a 4-4 tie (The board is currently short a consumer member, Stacy Wessinger has a statutory employment conflict that has led to her to resign). Helen Fong has immediately begun new rule making procedures to insert language to clarify mail, nursing home and institutional setting guidelines. The Senior Prosecuting Attorney for Dept of Health (DOH) indicated that in understanding these are guidelines, if used by his office the application would be to demonstrate the actual violation of 456 ‘practicing outside scope’ and would be similar to calling an expertise witness at a Dept of Administrative Hearing (DOAH) ‘trial’.

Certain Miss-fill events are also slated to become violations handled through the Citation process versus the administrative complaint process. It’s important to note though that there are specific conditions required for that to happen and it will still result in disciplinary action. These are reportable violations that will need to be disclosed for licensure renewal etc and will result in ‘out of state’ violation reporting by the NABP. It may be important to review possible ways to dispute an event if conditions or situational events appear to merit contesting the allegations. It does provide an efficient and less expensive way to deal with a clear cut, first time event.

The Internet Standard of Practice Filling rule has been legally challenged, as has the Osteopathic Prescribing Rule on standards for issuing prescriptions by United Mail Pharmacy Services and therefore stops rule progression at this moment.

The Sterile compounding rule has become effective. Its effect would be on community pharmacies that may be compounding sterile products like eye drops or other items using micropore filters etc. A rule adjustment has been started to provide an implementation period for those affected to obtain required items to obtain the permit.

Other topics that came up during the Rules Meeting:

Presentations, oral and written were made against any automation that allows for the pharmacist to be removed as the very last stop

Automation rule making will be noticed without text and if requested will have workshops over the next two meetings. (Rule chair requested workshops)

The Florida Health Systems Pharmacist Association offered to supply a working draft for a starting point. The Board has never officially accepted the draft attached to the general presenters’ written statements which contains the language that allows filling technology to count and package providing the pharmacist’s final product check is performed through oversight of the product handling, loading and packaging functions of the system.

The Board reiterated its intent that the CQI requirements applied to all permits, even if ‘dispensing’ did not occur.

A Task force was created to look at working with Jerry Hill at the Bureau of Pharmacy Services (Chapter 499 – Florida’s ‘FDA’) concerning manufacturer-discontinued specialty, hard to locate compounded items (Hyluronidase. emergency care items etc.)

Pharmacy Tech rule consolidation began with work to combine the 1:1 and 2:1 sections into one.

Confirmed previous discussion that ‘Direct and Immediate’ tech supervision would include ‘on the premise’ not meaning ‘standing next too’ and that ability to account for activity through process is acceptable.

Central Fill rules were moved into the rulemaking process and requested for workshoping.

William ‘Buck’ Stevens from PDX a ‘pharmacy software’ company spoke as to the need to allow the Central Fill site to be able to deliver medications at the patient’s request directly to the patient

He sited; the statute would allow this, this would allow the continuity of care at the community pharmacy with the records remaining there, and that even though his company had not intended to pursue incorporating control substances into the process, in discussion with the DEA, the DEA indicated CII handling would not only we workable but possibly a help because more community pharmacies are not stocking pain medications for security issues. He drew the picture of the community pharmacy entering the prescriptions, retaining records and the filling taking place at the central fill.

Rod Presnell spoke on behalf of Medco for to this allowance as well

The Board’s ensuing discussion covered items such as; concern that direct delivery was not the intent of the Statute versus the final verbiage and other items such as exemptions necessary for the central fill site from certain community permit requirements(signage etc), unalterable audit trails, recordkeeping issues and the similarly to existing hospital central IV units.

The Board initiated discussion on allowing ‘Temporary Closings’ in certain circumstances.

General Requests

Discussed and confirmed that Prescriber agents can call in control prescriptions on their behalf as allowed

Reaffirmed that a pharmacy cannot compound floor stock for another pharmacy without becoming a wholesaler per Chapter 499. They also referred this to the manufacturer discontinued specialty drug problem task force.

Reviewed correspondence from Esther Tingen (Target) looking for guidance on a system they would like to use that would allow for workload balancing by allowing DURs to be reviewed at an alternative site. They discussed patient consent, accountability, permitted locations and finally asked John Taylor to respond by suggesting she appear to discuss the topic.

Denied a Non-resident permit to a Canadian Pharmacy citing Statutory restriction of needing to be a US ‘State’.

Discussed the Bureau of Pharmacy Services Task force working on Pedigree Paper issues (Mike Stamitoles from the Board of Pharmacy represents the Board on this committee) He indicated organized crime and illegal drug syndicates have moved into this area because the profit margin versus penalties compared to the current anti-drug enforcement climate is making it less risky.

They also requested they get a summary of citations to review after the fact at least for a while, especially since they have moved more items, including some miss-fills into that category and would not see them otherwise.

David Herman the prosecuting attorney reported 233 active cases with 145 in probable cause

Disciplinary Action taken this meeting involved:

15 permit violation cases fines up to $2,500 and costs averaging $700 (Internet activity, inspection violations, record-keeping, outdates etc)

9 miss-fill cases Fines up to $2,000 with most around $250 to $500 and costs of $700 (incorrect strengths, drugs, switched labels and mixed meds -some deaths were also involved)

10 practice issues Fines up to $3,500 costs average $600 and some revocations (impaired pharmacist, diversion self and others, dispensing without prescription etc)

2 out of state disciplines for being disciplined in another state.

Discussed proposed statutory language on corporate disclosure requirements when applying for permit licensure. They continue to be concerned about corporation’s closing down one store and corporation and re-opening another under another name to avoid disciplinary action. They have a draft statute numbered 465.018 and have instructed John Taylor (Exec Dir) and Ed Bayo (Board Attorney) to continue to work on this and indicate to the Dept of Health they want this placed on the legislative agenda.

In light of some cases recently having disciplinary actions against people convicted of violent behavior and with members immediately receiving repeated harassing phone calls and abusive language on work and home numbers after denying a license application on Monday the board asked that armed security be looked into for the meetings

Items of Interest that came up in the proceedings:

Walgreens couldn’t produce records locally on a timely basis on a miss-fill case for items that should have fallen into the 2 years after last fill category. Concern was indicated over that and reflected in the fine.

Members, Barrad, Stamitoles and others discussed the increasing number of permit violations where it appears record-keeping responsibilities are getting loose or have become a low priority. (Daily refill logs, Pharmacist signatures, prescriptions records etc). They voiced concern over the Pharmacy Managers’ attention to these issues.

Concern was also expressed over the delicate balance of handling miss-fills and wanting a learning situation, but also needing to meet the public demand that punitive action be taken and that pharmacist must take responsibility in their workplace for what goes on. They also discussed seeing more cases of pharmacists trying to claim they didn’t remember or know and yet were the ‘pharmacist on duty’. They took several opportunities to verbally remind pharmacist of their accountability as opposed to the employer or anyone else.

Jim Powers, Ed Bayo and others discussed having the Prosecutor look to see and initiate more permit companion cases in areas such as miss-fills etc since more appear to be system related too.

Discussed the need to continue to see customer service issues, as an aggravating factor in complaints, for example syringe and needles being the wrong size is not real serious but then escalating up. The prosecutor indicated he has started and would also review his cases and settlements considering service handling by the defendant as aggravating or mitigating circumstances.

Bayo stated to be Board although frustrating and irritating to them that ‘failing to appear’ on a stipulation etc is not an actual violation as a defendant has the right not to testify. The Board had to waive the appearance requirement of several stipulations in order to take action and move on.

The Prosecuting attorney pointed out that if an employer or supervisor is a pharmacist and fails to report a violation of ‘fitness to practice’ as required they could have action taken against them

Discussed concern about the increase number of diversion cases involving techs and not having any licensing or tracking procedure in place to maintain a history or keep them out of a pharmacy.

During the Medco negative formulary case, several board members seemed to be believe local laws are binding on non-resident pharmacies. Discussion did not delve into that nor did the Staff, Board Attorney or the Prosecuting Attorney. Medco remained silent on that issue and just contested the motion to default.

Moved Automation into rule development

Requested Target to appear to explain their DUR offloading question.

Current Chair continues to move to have Community Service included in disciplinary stipulation settlements

Informal Discussions

I had discussion with John Taylor and Ed Bayo on the rumors of the Miccosukee Indian Reservation in Davie (near Weston) opening a mail pharmacy and John appeared to be aware of some talk of a pharmacy. Ed indicated his opinion is that as long as the dispensing in contained to the Indian Population and the reservation, the State does not have jurisdiction.

The Board also underwent training to use a new system of obtaining meeting material via CD-rom for view on laptops issued to them. This will affect ability to be able to view documents related to the meeting discussions.

Discussion was had at the meeting about this as well with members of the audience voicing similar thoughts and indicating the desire to be able to get information even if as the purchase of a CD. The Board attorney pointed out that the State does not have the responsibility to provide free copies of the material and that transcripts of the proceedings are available for purchase from the court reporter. Apparently for now a ‘public’ version (without probable cause) has not been developed by the company providing this new service nor has the State requested or looked into it. It would be extremely helpful to have visibility to the actual documents, requests and letters the board has in front of them to understand the questions, opinions and decisions made concerning these requests. My suggestion would be to break the CDs down to separate blocks Probable Cause, Disciplinary, and General Business with Rules Committee.