To:  Members and staff of the Virginia Board of Pharmacy

From:  H. Otto Wachsmann, Jr

Subject:  Comment period for proposed regulatory changes.

Date:  August 10, 2016

At this time I would like to express some concerns with the background document I received as a member of the Virginia Pharmacists Association.  I regret my comments are at the very end of the comment period however my scheduled vacation and an inability to discuss with the document further with VPhA as their telephone lines were impacted by a storm, I am just now able to provide some hastily prepared thoughts on the document.

In reading the document, I find it is difficult to respond.  While it provides subject material under consideration, it is difficult for me to have a full understanding on which direction many of these proposals are going.

An area that I initially agreed with was siting the CDC vaccine storage recommendations as the new guidelines for pharmacy refrigerators.  I have googled CDC Vaccine Storage and discovered a CDC web page which provided various discussions on the subject but wasn’t necessarily clear.  For example, it discussed how dorm refrigeration units were less than ideal, but didn’t exclude their use except for the freezer compartment.  It discussed advantages and disadvantages of traditional household refrigerators vs especially made units but didn’t necessarily exclude either one.  When discussing certified recording thermometers I wasn’t certain if there was a specific certification.  In attempting to conduct an internet search for these devices, I saw prices ranging from $800.00 to $1800.00 for the thermometer.  I am aware of one doctor’s office that recent purchased a specialty refrigeration that cost thousands of dollars.  I question with today’s reimbursements how a small business such as a family owned pharmacy might be able to purchase something of this magnitude without adequate notice.  It is also possible that I may have read a CDC recommendation/guideline page that was different than what the Board of Pharmacy is referencing.  I also question the validity of using vaccine storage requirements and how they may or may not relate to a pharmacy such as mine that does not store vaccines.  Then there is the question if we would need to have a complaint freezer if we do not stock zostavax? 

In reading the section on the physical barrier for the pharmacy department and the front door, I am hopeful this will not require a complete barrier for the pharmacy floor to ceiling in the event the pharmacy department which is already secured and separately alarmed is only open when the rest of the building is open.  The cost associated with constructing these barriers will be burdensome for family owned pharmacies.  I anticipate this remodel will also require the pharmacy to pay for a re-inspection which further creates a financial burden. 

Regarding the landline security system.  This appears to be going backwards from the Board of Pharmacy requiring cell phone systems.  I wonder how may alarm companies deactivated the old hard line phone system when pharmacies were required to install cell phone systems a few years ago.  For pharmacies that fall into this category, this will require these small businesses to pay to have the alarm companies come back into the pharmacy to reattach the landline.  I expect since this would be a change to the security system, will this not also require the pharmacy owner to have the pharmacy department re-inspected at an additional fee which may well be two inspections and two fees for those who will not be able to coordinate the alarm company at the same time period as the contractor installing the security barrier.  Has the Board of Pharmacy seen a substantial number of cases where these items were an issue?  My experience has been the existing alarm systems work effectively but the police response times cannot keep up with the professional burglars committing the crimes.  Making it too difficult to gain access to a pharmacy after hours is also likely to create a more dangerous situation where the criminals increase the amount of armed robberies occur.  This will results in pharmacy staff and our patients being placed in harms way.

I do not wish to complain about areas in which the Board of Pharmacy promotes to increase patient safety.  That is certainly an important and complex task.  I only wish to provide the perspective of a practicing community pharmacist of some unintended consequences that some of these areas may create.  If I might suggest, it may be helpful to provide some discussion in the Board’s quarterly newletter for additional thoughts and suggestions while providing a better understanding of the issues for practicing pharmacists.  It's quickly becoming quite impossible to keep up with all the state/federal/PBM requirement changes that are going which practitioners are forced to keep up with.  Add to that we are doing these at our expense in a market where stores are closing due to reimbursement issues.  There is less and less time/resources left to actually take care of the patient.

Thanks

Otto Wachsmann