Agencies | Governor
Virginia Regulatory Town Hall
Agency
Department of Health Professions
Board
Board of Pharmacy
chapter
Regulations Governing the Practice of Pharmacy [18 VAC 110 ‑ 20]
Action Delivery of dispensed prescriptions; labeling
Stage Proposed
Comment Period Ends 6/16/2020
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6/14/20  3:52 pm
Commenter: Al Roberts, Remington Drug Company

Opposition to proposed Amendment of 18 VAC 110-20-275
 

I would like to thank the Virginia Board of Pharmacy for taking the time to review my comments on the proposed amendment of 18 VAC 110-20-275. My opposition is on several levels including but not limited to transparency, complete details on final product prior to final determination, patient choice, increased workflow stress in the pharmacy day to day operations, tracking and accountability for the filling process start to finish, and most importantly patient safety.

I can see how a patient would be concerned when a prescription label has an address different from the pick up address.  Community pharmacists often get calls when product appearance changes even when the pharmacy has taken steps to alert the patient either in verbal or written form and this is also where the entire filling process took place. This could cause a patient to be concerned as to the accuracy of the finished product and potentially not take the medication. The amount of time and effort required to explain this in a fashion all patients, regardless of comprehension level, would be huge. It could not be accomplished with a piece of paper---what if they do not speak English or the document could not print in their native language. The bottom line is the patient believes the prescription has been filled where they are picking it up and that may not be the case and they may not know this if the amendment is accepted. Transparency is lost in this example.

I am confused to some degree as to what the label would look like if this amendment is accepted. Is the listed pharmacy on the label the flling pharmacy or the pharmacy where the pickup takes place or no pharmacy specific information at all on the label. The comment in the recent Virginia Pharmacists Association newsletter on this subject stated the following: "This means there would be no phone number or address on the label where the  prescription was sold to the patient". From re-reading several times, it appears only the initial pharmacy processing the prescription would be listed, but I am not sure that is correct. What happens on refills, will it always be the pharmacy which initally processed the prescription the very first time?

This proposed amendment affects the patient's choice of where to fill their prescription. The patient is presenting a written prescription or a refill of an existing prescription at a pharmacy of their choice and the expectation is the prescription will be filled in that pharmacy and also picked up in that very same pharmacy each and every time. This amendment removes that piece of information related to remote processing/filling. While this may be done routinely, patients should be aware. A patient may have a reason for choosing a particular pharmacy and knowledge that the prescription may not always be processed/filled 100% at that location could determine which pharmacy is selected.

Without full disclosure of all pharmacies involved in the process, it will increase workflow time and work stress when transferring prescriptions. It is hard enough when a pharmacist knows which pharmacy to call to complete a transfer. Add in the infinite steps associated with mail order transfers and one could see that time lag becoming routine. It truly has taken our pharmacy 20 minutes to complete a transfer from a mail order facility. The analogy is similiar to what this amendment proposes since we often times call a remote call center which then routes the call or gives the pharmacist another number to call to complete the transfer. The workflow disruption  and added stress on staff could affect how care is provided to the patient. This is assuming the patient can provide a starting point for the pharmacist and this is not always the case. It is sometimes challenging if we are just talking about two pharmacies in the same chain at different locations in the same community as in 2 Walgreens or 2 CVS ----- which one do we call when all we have is "Please call "?" and transfer my prescription".  Without all necessary information related to the filling of a prescription, simple transfers can sometimes be difficult and time consuming.

With the recently enacted "track and trace" requirements related to pharmaceuticals, it seems odd as well as inappropriate to decrease the traceability of a prescription from start to finish. When a pharmacist is presented with another pharmacy's prescription bottle, the phone number listed should be the only one necessary to complete the transfer but in the event there is a problem all pharmacies information should be available if needed to resolve the concern. In independent pharmacies this is never an issue because the prescription is handled 100% in that brick and mortar location from start to finish. Any issue related to the prescription can be traced from start to finish . The same should be true for chain, big box operations using offsite processing and filling.

I have saved the most important reason for opposing this amendment to discuss last and that reason is patient safety. What if the prescription is wrong---wrong drug, wrong strength, wrong person, or wrong directions. How is this potential harm caught , how is it corrected and at which pharmacy? If it is a new prescription, how is the patient to know? What if the directions are very complex and require detailed explanation? What if the prescription is for a device like an inhaler, an injectable insulin, or one of the new GLP-1 products like Ozempic. Who is responsible for being sure the patient has all the information necessary to properly and effectively use the medication? The proposed amendment reads like the final link in the process, the pharmacy holding the prescription for pick up, is only responsible for that which amounts to exchange of monies or the processing of a credit card and handing the prescription the the patient or authorized agent.  The Institute for Safe Medication Practices (ISMP) has been cited in one comment as evidence for accepting this amendment. ISMP, in the second edition of MEDICATION ERRORS, devotes a full chapter to the patient's role in preventing medication errors. In this chapter the author highlights the importance of concise and accurate interpretation of the provider's directions for use on the prescription. With this amendent in place, if the patient has a question on the written directions, which pharmacy should be called--the one which processed or the one that delivered the prescription or should they both be accessible? The author also shares the six steps recommended by the American Medical Association for improving commmunication with patients thereby decreasing opportunites for errors. None of those six can be done by just handing a bag to a person and taking money or processing a card. They require a knowledgeable healthcare professional----that means one on one with a pharmacist.

Of the 10 comments to this point only two have supported this amendment. One is a student and the other is an employee of CVS Health neither of which has recently been involved in the intense everyday workflow experienced by pharmacists and technicians every single day. If this statement is not accurate, I apologize for jumping to this conclusion. I am aware one of the main functions of the Boards of Pharmacy is to be sure patients, our patients, are not harmed or exposed to unsafe pharmacy practices/procedures. I believe this amendment, if enacted/accepted, has the potential to adversely affect patient safety. It has the potential to allow the large pharmacy corporations to further reduce staff, increase employee workload, increase job related employee stress, mislead patients on where there prescriptions are filled, and negatively impact small independent pharmacies through more aggressive business efforts resulting in less patient choice when the independent pharmacy is forced to cease operations. The other 8 comments oppose this amendment and for good reasons--some repeated in this comment. While I have mentioned some major concerns, there are other like gaps in therapy due formulary changes, step therapy requirements, prior authorizations, and expensive co-pays/coinsurance hurdles. Who handles those and when is the patient alerted? I am disappointed this amendment was even proposed and requiring valuable Board time when other items such as pharmacits scope of practice have the ability to positively affect patient care once addressed and guidelines enacted.

Thank you again for reviewing my comments and concerns

Al Roberts, Remington Drug Company

 

CommentID: 80273