|Action||Delivery of dispensed prescriptions; labeling|
|Comment Period||Ends 6/16/2020|
CVS Health’s comments on proposed amendments 18VAC110-20-275. Delivery of dispensed prescriptions
Dear Ms. Yeatts:
I am writing to you in my capacity as Sr Director of Regulatory Affairs for CVS Health and its family of pharmacies. CVS Health, the largest pharmacy health care provider in the United States, is uniquely positioned to provide diverse access points of care to patients in the state of Virginia through our integrated offerings across the spectrum of pharmacy care. CVS Health appreciates the opportunity to submit comments on the Virginia Board of Pharmacy proposed amendment to 18VAC110-20-275 Delivery of Dispensed Prescriptions. We would also like to thank the Board for their vigilance to continuously improve the laws and regulations that guide pharmacists, pharmacy interns and pharmacy technicians serving Virginia patients.
CVS Health appreciates the Board’s acceptance of our Petition for Rule-making and proposed language to amend 18VAC 110-20-275, which changes the policy and procedure requirements for delivery to another pharmacy, allowing for a unique identifier to be used in identifying all pharmacies utilized in filling and dispensing the prescription. Amendments also include the allowance for the unique identifier to not be placed on the label if the pharmacy solely holds the prescription for further pickup and delivery without being involved in the filling and dispensing. As we have mentioned previously, the Institute for Safe Medication Practices published industry guidelines for medication labels for community and mail order pharmacies in which they suggest maximizing the use of white space on a label to improve medication adherence and reduce inadvertent medication errors.1 The proposed language would assist in achieving maximum white space, while still providing an audit trail for the tracking of the prescription, as required, and providing the patient with one contact pharmacy (the dispensing pharmacy) to answer any questions or provide additional counseling.
CVS Health appreciates the opportunity to submit comments for this proposed rule amendment. If you have any questions, please contact me directly.
Lauren Paul, PharmD, MS
Sr Director, Pharmacy Regulatory Affairs
- Principles of Designing a Medication Label for Community Pharmacy and Mail Order Pharmacy Prescription Packages. Available from: https://www.ismp.org/recommendations/designing-medication-label-community-pharmacy (Accessed March 23, 2020).
First of all why we do need any changes in our labeling practices? It seems very logical to have the name and address of the pharmacy providing the medications to be clearly labeled on the medication label for questions from the patients or ease of finding information by law enforcement or caregivers.
The only reason I could see for not including this information would be to deceive the patient from the knowledge of who filled their prescription.
Why would large corporations start filling prescriptions in other states to ship to their local stores? They could be ashamed that they don't want their local pharmacist to fill the prescription. More likely they are trying to usurp the Virginia Board of Pharmacy to in order to not fill these prescriptions according to the standards set by our BOP. Another reason could be tax implications. Hiring workers and building closed doors pharmacies in other states, would not only prevent the Commonwealth from collecting taxes on these facilities and employees, but be a windfall in profit of these corporations over smaller independent pharmacies who don't have the option of filling prescriptions in a different state.
When independent pharmacies close (and they are closing) it hits the poorest areas of our state the worst. Making policies that only help certain large corporations make more money, without any benefit for our patients seems like a waste of paper and ink for this Board.
Would this regulation make our patients any safer? (these medications would be filled under the guidance of other states, do they know Virginians better than our BOP?)
Would this regulation bring in more revenue for the state to help more patients? (Tax dollars would go to other localities and wouldn't be here to help Virginians)
Would this regulation give some corporations advantages over other corportations? Only large companies (probably owned by PBMs) would benifit, making it harder for small business to keep up
Would this regulations make medications more accessible for our patients? There is no proof that this would make medications more accessible
Therefore please do not move forward with this regulation and spend more of your efforts on the current drug shortages and ways to make replacement medication easier to get paid for from these PBMs that won't less us substitute medications like generic albuterols when there is a shortage in the market
Steven C Hylton, PharmD
Unique Identifiers for Prescription Medications
I am writing as a graduate student of public health and resident of the Commonwealth of Virginia in response to the call for public comment for the Virginia Board of Pharmacy’s proposed amendment to 18VAC110-20-275 Delivery of Dispensed Prescriptions. Thank you for the opportunity to provide input regarding unique pharmacy identifiers that are required on prescription medication labels. There is a delicate balance regarding information that consumers need when it comes to their prescription medications. It is important to provide enough information so that consumers can safely understand how, when, and why to take their medications as well as who to contact and how to reach that contact when questions arise. Providing too much irrelevant information can overwhelm some consumers, leaving room for medication errors to occur. It is vital to find this delicate balance.
I write in support of the proposed amendment to 18VAC110-20-275 Delivery of Dispensed Prescriptions. Annually the FDA receives more than 100,000 reports concerning potential medication errors. The proposed amendment provides an opportunity to reduce potential medication errors. According to the US Food and Drug Administration’s (FDA) article, Working to Reduce Medication Errors, prescription drug labels play an important role in preventing medication errors. The FDA recommends that drug labels be designed so that consumers do not overlook important information1. Prescription drug labels will have more room for this important information by reducing the number of unique pharmacy identifiers that are required on prescription medication labels. The important information will be clearer and more easily identified by the consumer potentially leading to a reduction in medication errors.
It goes without saying that it is vital to be able to track the pharmacies that are involved in filling and dispensing prescription medications. By including the unique identifiers for all pharmacies that are involved in filling and dispensing a prescription medication, a paper trail would be maintained that would include the final pharmacy from which a consumer obtained the prescription in case that information is ever needed. This proposed amendment does not interfere in that system of checks and balances because it continues to require that the filling and dispensing pharmacies’ unique identifiers remain on the prescription label. The consumer continues to have access to the contact information for the pharmacy in case any questions or needs arise.
Lastly, by omitting the unique identifier for pharmacies that are only holding prescription medications for consumer pick up or delivery, efforts are made to minimize the points of possible data breaches. Any time unique identifiers are required for maintaining records there is potential for those identifiers to be utilized in a data breach. By minimizing unique identifiers that are provided to the general public, the chances of those data breaches occurring from this avenue are reduced. The omission of these unique identifiers is one step closer to protecting personal health information.
As a graduate student in public health, I appreciate the opportunity to be involved in the process of amending prescription drug policies. It is encouraging that the Virginia Board of Pharmacy continuously works towards the safest possible medication administration while protecting the health care information. Thank you for the time and efforts regarding the proposed amendment to 18VAC110-20-275 Delivery of Dispensed Prescriptions. The risk of medication administration errors for those individuals filling prescriptions in the Commonwealth of Virginia will be reduced by eliminating the unique identifiers for pharmacies that are only holding prescription medications for a consumer to pick up or to be delivered to the consumer. This amendment moves toward the delicate balance of providing the correct amount of information.
Working to Reduce Medication Errors. Available from https://www.fda.gov/drugs/drug-information-consumers/working-reduce-medication-errors. Accessed May 25, 2020.
Focus on the SIG not the phone number
I am writing in against this change. By removing the identifying phone number of the pharmacy, it will hurt patient safety and reduce the ability to properly conduct a medication reconciliation. The amount of space a 10 digit pharmacy phone number takes up is extremely minor and would not lead to extra space for the most important part of the label, the directions.
At our pharmacy , our phone number is built into our logo and our label designs are completely customizable. Font sizes can be increased or shrunk and we always have extra room. Our directions will also fill the allowable space to maximize the dedicated directions space.
As a pharmacist at an independent with 2 locations, we get calls for each other’s locations all the time. It delays response from doctors and delays delivery to patients when the caller does not have the correct contact number. If we remove the pharmacy identifier, all chains become the same. It would begin a guessing game of who to call or where to send the prescription to.
If most patients are unaware of how to take their medications, how do we expect them to know the phone number of the pharmacy in which it was filled? With prescription transfers, the phone number IS the paper trail to transfer the prescription.
With poly-pharmacy becoming such a problem, between mail order and prescription shopping, imagine the struggle to conduct a medication reconciliation for a patient entering or leaving the hospital. If the tech had the bottle with the pharmacy phone number, they may reach out to get the last fill date or other clarification. Without it, they will not have the time to call all of the pharmacies of that chain in the area to get the information, leading to gaps in the record causing potential medication related complications resulting higher medical expense.
The focus of any change should be having a consistent sentence equation for the SIG, patient instructions. This has been studied over and over and found that even though a patient can read the directions, it differs from how they interpret them and take the medication. By changing the direction verbiage to a standard that has been studied and would be required to use for prescription directions, increasing consistency and clarity, this would reduce patient harm and errors.
I require all of my directions to be in the following order: Verb, # ( number not in words), dosage form, route, frequency, with indication if known. ( TAKE 1 TABLET BY MOUTH EVERY DAY FOR BLOOD PRESSURE).
I have transferred prescriptions from other pharmacies in which the sig was so poorly written, that I had to call the prescriber to understand how the patient was to take the medication or call the pharmacy back to request the original hard copy for clarity. (Ex: B12 injection - take 1ml every 90 days) This was an injection in which the prescription should have been inject 1 ml intramuscularly every 30 days. Without requiring a route, the patient may have taken this orally and been off track by 60 days. This to me would be more important. However, if there was not a phone number on the patients label for me to call to get the correct information, how would I be able to track down the chain pharmacy in which this prescription was poorly dispensed?
I challenge you to take a look at your own prescription label and see if the phone number should be the focus of change.
Jenni Helmke, PharmD
Please deny this amendment to help frontline pharmacist's do their job
I respectfully request that the proposed amendment 18VAC 110-20-275 be emphatically denied for several good reasons.
This amendment does nothing to help protect public safety and in fact does the opposite and causes public harm.
It will cause more stress to front line retail pharmacists due to negatively impacting their workflow procedures by increasing the time it takes them to perform routine prescription transfers. This added stress which can be at high levels as it is, will add more distraction and thus create a greater potential for errors than if this process would be left alone as it stands.
The implication that more white space on the label is safer by eliminating the pharmacy phone number is untrue and a poor attempt at justification of a bad change in the regulations. I feel if you check with ISMP, they will not advocate nor appreciate the comments by CVS Caremark in that regard.
This amendment is a blatant attempt by CVS to manipulate the board of pharmacy and if passed, will demonstrate that Corporate Pharmacy Benefit Manager profits outweigh the need for public safety.
This amendment is all about increasing the practice of central filling to the detriment of local pharmacies both chain and independent. CVS management is seeking to cut hours and staffing and further lower pharmacist and pharmacy staff wages with this kind of practice. Is this for public safety?
I would note that that this amendment will lead to more Virginia prescriptions being filled out of state by a large mail order type operations which are not inspected by the board to insure the regulations of Virginia are being complied with as is the case with local pharmacies.
Mailed prescriptions are subject to temperature fluctuations that are outside of the labeling for the product and could thus be adulterated. This seems to be a risk to Virginia patient’s lives that the board is not very concerned about. They have repeatedly denied regulations adding temperature-tracking devices to mailed prescriptions.
Let’s be open and honest about this amendment. It is a corporate manipulation of the board of pharmacy disguised, as something needed which it is not. Historically, many employees of CVS have worked for or held positions on the board, and the companies interests seem to be represented with higher regard than the public good at times.
I would hereby request it be denied.
Thank you for your considerations in this matter,
John W. Frye R.Ph.
Cedar Bluff, VA
Amendment of 18 VAC 110-20-275
Dear Board Members,
I am writing to you today in opposition to the proposed change to 18 VAC 110-20-275. This proposed change adds a layer of confusion to patients and ultimately could lead to delays in treatment and harm to patients. When a patient delivers and picks up a prescription medication from a pharmacy, they connect with that pharmacist. If that pharmacy is doing what it should be by law, that patient is seeing and talking to the providers of their care. When they get home and have a question, or are confused, or have a side effect from treatment and need to speak to their pharmacist they expect to talk to the person that was involved in their care at the pharmacy where they picked up their medication. The pharmacist that has been involved with and knows of all of their health issues.
With this proposed change you will effectively be taking that pharmacist out of the equation. The patient will no longer have the contact information readily available to them to speak to the pharmacist that just counseled them at the drug counter. And what happens when the information given at the drug counter at time of pick-up is different than the information given at some call in line in another state. Most patients I know will stop therapy until they can reach their Doctor, and what if that is over a weekend or holiday?
The patient deserves our best care. That best care is to provide them all of the information necessary to take their medication properly and to be able to contact THEIR pharmacist when there is a problem. If a pharmacy opts to conduct their business model in such a way as to move filling operations off site then they also bear the responsibility of insuring that the patient has access to ALL pertinent information related to the filling of that prescription and how to contact THEIR pharmacist. Where it was filled (address and phone number) and who filled it, as well as the information as to where the patient actually did business (address and phone number), was consulted by their pharmacist and where they can contact someone when help is needed all need to be provided to the patient.
I hope you will consider this a critical public health concern and do the right thing for our patients.
Opposition to amendment
Fellow Pharmacists and Citizen Members of the Board,
I am not in favor of the proposed amendment to [18 VAC 110-20-275]. This amendment screams of big business ways to cut costs at the expense of the citizens of this Commonwealth. The citizens that you are appointed to protect.
The citizens that will be most affected are our Seniors. Those that take lots of medications, that have limited resources, that have mental health or dementia conditions and that have no support system to help them navigate this most confusing labeling situation that will be created if you proceed with this change.
I urge you to do what is right for our citizens. Do not cave to the wishes of big business and pad their pockets with the health and welfare of the people of this Commonwealth.
Thank you for allowing me to comment,
John W Hasty, RPh
Past Executive Director Virginia Department of Health Professions
Opposition to amendment
I am opposed to amending the labelling requirements for prescription labels to delete the identification of the pharmacies involved with filling patient prescriptions.
When patients come into a pharmacy, they should be given information which properly identifies the pharmacies involved with processing their prescription. This critical information needs to be fully transparent.
Health care providers also need to have ready access to this information. Many caregivers and emergency services personel are trained to bring patient's prescription bottles to the point of care. Not having the complete information on the label can create a delay when that patient's healthcare provider calls the information on the label only to discover that pharmacy does not have the complete information. In this instance that provider may have to hang up and dial another pharmacy. Once that occurs with several encounters, that provider is less likely to call to verify what can be critical information in treating that patient.
We already have violations on these labelling requirements which seem to go unchecked particularity with certain mail order pharmacies. Since Humana began sending Medicare Part D prescriptions into our state they have a pharmacy address and phone number on their label which is not the pharmacy number. Instead they provide the contact number to their customer services line. When we call for prescription transfers we have to first, call the number on the label and provide all of our information as well at the information to the customer services representative who then will transfer our phone call to the actual pharmacy. Once the call finally gets to the pharmacy, we have to reverify the information once again only the be transferred to the pharmacist to verify a third time and finally provide the transfer. This process can easily take 15 - 20 minutes. Doing that several times a day is quite time consuming and frustrating for a pharmacist who has to multi-task to remain anywhere close to profitable. Unfortunately this frustration can then lead to patient safety issues as the now stressed pharmacist becomes tainted by the frustration of getting the transfer and is less focused on the task at hand.
Pharmacy regulations are there for a reason. That reason is patient safety. Not having the complete information about the pharmacies associated with filling each prescription is not transparent to the patient and can delay patient care activities with the provider. CVS is asking for a resolution to a problem that they have created. They need to figure out how to comply with the existing patient safety related regulations.
I wish to thank the Board of Pharmacy for allowing us to comment on these important matters.
Concerns with the proposed labeling amendments before the Board of Pharmacy
On behalf of the Virginia Breast Cancer Foundation (VBCF), I am writing to share our concerns with the proposed labeling amendments before the Board of Pharmacy. VBCF is a statewide, state-based organization that that is focused on education and advocacy for all Virginians affected by breast cancer. Medication plays an important role in the treatment of breast cancer and timely access to prescriptions and transparent labeling is vital. Patients should be able to easily identify the best person to contact if they have questions about a prescription. Therefore, attempts to alter pharmacy identifiers should be minimized. If breast cancer patients pick up products at a pharmacy that is serving as a depot for the products, they should be able to read the label information and contact the person who can help answer any related questions. There should be no questions about how a patient can speak with someone to obtain medical information. Please do not amend the current labeling system unless a change makes it easier, clearer, or more user-friendly to the patient.
Katy Sawyer, Executive Director, Virginia Breast Cancer Foundation
Opposition to proposed amendments affecting the labeling of prescription medications [18 VAC 110-20]
The Richmond Academy of Medicine (RAM) appreciates the opportunity to comment upon the proposed regulations affecting the labeling of prescription medications (18 VAC 110-20). The Academy represents more than 1900 physicians in the greater Richmond region.
While an initial reading of the proposed labeling changes sounds innocuous and could result in a less confusing label, the implications of this proposed change are significant, do not improve the health of Virginians, and have potentially devastating impacts upon not only our patients, but also pharmacies and physician practices.
First, we do not understand the rationale for the proposal. At a time when both citizens and legislators are asking for more transparency within the drug supply chain, it is inappropriate to decrease the ability of the prescription recipient to ask questions of or hold accountable the actual dispenser of the medication, not the final distribution point.
Second, anyone who has a question about a prescription would naturally call or speak with the person at the site where they picked up the prescription. If the pharmacist at the location did not actually fill the prescription, they may or may not be able to legitimately vouch for the information on the label, whether the prescription was actually filled correctly, or a number of other issues. If there is no data on the label to contact the actual dispenser to confirm the information, this places a potential significant liability on the distribution site employee and/or undue burden upon that person if they must then contact the pharmacy that actually filled the prescription. This creates additional unnecessary waste within our drug distribution system while creating an unfunded mandate upon the prescription distribution site.
Third, this proposed change opens the door for further limitation of prescription fulfillment from neighborhood and independent pharmacies to only chain pharmacies. We have seen in other states (i.e. Ohio) how national corporations have funneled business to their own pharmacies through spread pricing and other techniques. This business model has resulted in the closing of independent pharmacies. These closings are especially prevalent in areas where access to health care is already difficult - rural areas and inner cities. This proposal will allow national organizations to utilize their centralized pharmacies to fill prescriptions and have them delivered through their corporate network pharmacies, thereby cutting out neighborhood and independent pharmacies. We do not believe this will improve access to medications nor same money for the health care system. We fear it will result in profit mongering for these vertically integrated insurer/pharmacy benefit manager/pharmacy businesses at the expense of access to care.
Fourth, there is significant potential impact on physicians and their practices, especially those that prescribe specialty medications and/or infusion services. It will likely have a negative effect on independent infusion providers and hospital systems. This labeling proposal creates a means for insurers and/or pharmacy benefit managers to require that any medication that will be infused come from their national or specialty pharmacy. This so-called "white bagging" comes with a lack of validation by the infuser of how the medication was handled prior to being infused. It also creates an additional financial barrier to the provision by these localized infusion centers and/or a problem for the hospital if the infuser cannot "buy and bill" for these medications. The current financial strain on physician practices as well as hospital/regional health care systems means that this change in drug distribution/payment system could result in the closure of these providers. Again, the potential negative effects of this action would primarily affect the most vulnerable Virginians - those with chronic and/or disabling conditions as well as those who live in rural areas or inner cities.
Lastly, the Academy is concerned that the out-of-state filling of prescriptions could negatively affect to Commonwealth's revenue resulting in the loss of jobs and small businesses as an unintended consequence of this proposed regulation change.
For these reasons, on behalf of the 1,900+ physicians we represent and most importantly, the patients for whom they care, the Richmond Academy of Medicine respectfully opposes the proposed regulation changes to 18 VAC 110-20.
Concerns with the proposed labeling amendments before the Board of Pharmacy
As policy advocates for the Hemophilia Association of the Capital Area (HACA) and the Virginia Hemophilia Foundation (VHF), we are writing to express our concerns with the proposed labeling amendments before the Board of Pharmacy. Our members are individuals with inherited bleeding disorders and their family members. To achieve high quality of life, many individuals with inherited bleeding disorders receive clotting factor replacement therapy to treat bleeding episodes or prevent bleeding. The two main types of clotting factor concentrates are plasma-derived factor concentrates or recombinant factor concentrates. Other common treatment products include Hemlibra, DDAVP or Stimate, and Amicar.
Because medication is critically important in the treatment of inherited bleeding disorders, timely access to products is essential. And transparent labeling is vital. Persons should be able to determine who filled their prescriptions; therefore, attempts to alter pharmacy identifiers should be minimized. If we pick up products at a pharmacy that is serving as a depot for the products, we should be able to read the label information and contact the person who was responsible for filling the prescription. There should be minimal delays in obtaining this information, should we be obtaining a product that is to be used immediately to treat an emergent situation.
We recommend that you make no changes to current labeling requirements at this time.
Kelly Waters, MSW, LCSW
Virginia Hemophilia Foundation
Hemophilia Association of the Capital Area
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
Opposition to Proposed Change to Delivery of Dispense Prescriptions Labeling
Commenter: The Medical Society of Virginia
Opposition to the Proposed Change to Delivery of Dispense Prescriptions Labeling
The Medical Society of Virginia (MSV) serves as the voice for more than 10,000 physicians, residents, medical students, physician assistants, and physician assistant students, representing all medical specialties in all regions of the Commonwealth. On behalf of these clinicians, I am writing you in opposition to the proposed amendments to section 275 of Chapter 20 pertaining to the procedure for identifying all pharmacies involved in the filling and dispensing of a prescription.
MSV recently became aware of the proposed changes which would no longer require a unique identifier for a pharmacy to be listed on the prescription label when a pharmacy was not involved in filing or dispensing functions. Such changes to the regulations would result in many patients with prescriptions no longer having quick access to the contact information of their local pharmacist. To ensure patient safety, it is essential that patients are provided with the contact information of their local pharmacist who can help address the concerns or questions they may have regarding their prescriptions. Many patients have become accustomed to having this resource posted on their prescription label and to remove this critical information for patients is simply improper patient care and not the standard for which should be accepted.
In addition to the detrimental effects to a patient’s health, this change would further jeopardize independent pharmacies who have already been suffering, with many closing in our highest need communities. The proposal would essentially promote removing neighborhood and independent pharmacies from the pharmaceutical process by allowing national organizations to use their centralized pharmacies to fill prescriptions and their corporate network pharmacies to deliver prescription. Cutting out independent and community pharmacies that often reside in low-income and rural areas will do nothing to increase access or support affordability for patients. Rather, such proposal would put the profits of vertically integrated insurers, pharmacy benefit managers, and pharmacy corporations over patients.
Furthermore, MSV has concerns that such proposed changes could make it more difficult for physicians to identify a patient’s local pharmacist and thus coordinate care. During visits, patients often may bring in a prescription which would typically include the number and/or address of a local pharmacist. This information, while essential for patients, is also helpful for physicians so that they can easily identify the pharmacist with whom to communicate to in the need of determining what other medications a patient may be taking and/or to discuss special needs of that patient. It also raises concerns around patient safety, if the physician is unable to verify the safety of drug supply chain, particularly for those patients that require infusions of specialty medications.
In summary, MSV feels the proposed changes, while may seem harmless, could result in numerous negative effects to patients, independent pharmacies, and the health care system at large.
We thank you for the opportunity to provide feedback on the proposed regulation change. If you have any questions, please do not hesitate to reach out to Clark Barrineau at firstname.lastname@example.org or 704.609.4948.
Opposition to proposed Amendment of 18 VAC 110-20-275
I am writing to voice my opposition to proposed amendment of 18 VAC 110-20-275. Simply put, as pharmacists and patient advocates, we all took an oath to serve and protect our patients' well-being. Please take a moment to put yourself into the shoes of your 85 year old grandfather who has CHF, on dialysis, and can hardly see anymore. Will these proposed labeling changes better serve and protect him when he has a medication issue? Will your grandfather want to speak to some stranger on an 800 number about his health conditions? If the proposed changes would better serve and protect him, then we would not be writing in opposition to these proposed labeling changes.
Lastly, I remember some words of wisdom from a preceptor when I was a student pharmacist. When we are faced with tough decisions, think of that patient as your grandfather and how your decisions would affect him. If it will negatively impact him, then don't do it! DO NO HARM
Randall Cole, PharmD
Opposition to proposed Amendment of 18 VAC 110-20-275
From: Harry L Gewanter, MD, FAAP, MACR
Re: Opposition to proposed Amendment of 18 VAC 110-20-275
As a pediatrician and pediatric rheumatologist I am writing in opposition to the Board’s proposed amendments to 18 VAC 110-20-275. Beyond a lack of understanding for the concept of amending this regulation, I have serious and significant concerns regarding the proposed amendment’s implications.
This change has the potential to seriously impair access to services for Virginians through the deference provided to chain pharmacies as compared to independent ones. The ability of an insurer/pharmacy benefit manager/specialty pharmacy to limit access to its clients/patients to its own pharmacies may be in the corporation’s best interest, but it is not in the patient’s best interest. As has been seen in other states, this type of forced choice through other means such as spread pricing has led to the financial failure and closure of these small businesses, especially in rural and inner city areas.
The lack of transparency that results from “increasing the amount of white on the label” is another concern. The patient will assume that the pharmacy where the prescription is obtained is the pharmacy that filled the prescription, thereby placing an inappropriate burden upon that pharmacy should the patient have any questions or issues. Further, I could easily conceive of a potential liability issue for that pharmacy and pharmacist since they are now part of the distribution chain but cannot vouch for the prescription or its handling during shipment, etc.
As a physician who has infused specialty medications for my patients, I am especially concerned about Part C of the proposed amendment.
C. Delivery to a practitioner of the healing arts licensed by the board to practice pharmacy or to sell controlled substances or other authorized person or entity holding a controlled substances registration authorized for this purpose.
This amendment would allow an insurer/pharmacy benefit manager/specialty pharmacy to minimize my ability to provide my patients with the medications we have agreed are in their best interest. Similar to the distributing pharmacist, this places an undue burden and liability upon me to confirm and ensure the medication is as ordered, has been shipped and handled correctly, etc., with an inability to confirm these details. This “white bagging” system adds another layer of cost and complexity to an already overly complex and costly drug delivery system without adding any benefit to the patient, the ultimate payer.
While there are numerous other reasons to oppose this unnecessary amendment, I think these make the point that this proposal should be roundly defeated. It seems to only benefit the insurer/pharmacy benefit manager/specialty pharmacy component of the drug supply chain, but not the patient, pharmacist or any of the health care providers involved in the actual care of the patient.
Thank you for your consideration.
Harry L. Gewanter, MD, FAAP, MACR
Opposition to Proposed Change to Alternative Delivery Site Prescription Labeling
The American College of Rheumatology (ACR) represents rheumatology professionals across the United States. The College routinely comments on proposed policy changes that could impact our members or the patients that they treat. The Virginia Society of Rheumatologists (VSR) represents rheumatology professionals across the state of Virginia and routinely comments on policy changes that would negatively impact our members and the patients they treat. The ACR and VSR are concerned that the proposed rule will have negative impacts on drug transparency that is vital to patient safety. The ACR urges the Board of Pharmacy to withdraw this proposed rule.
The drug supply chain is a complex system. When a prescription makes its way into the hands of the consumer it has been touched numerous times by many other people and entities along the way. To ensure adequate pharmacovigilance, the chain of custody once it reaches the pharmacy must be clear and transparent. This proposed rule would allow prescriptions to be filled at a specialty pharmacy then shipped to an alternative site for pickup, without requiring anything on the label to identify the pickup location. This substantially diminishes the drug transparency that patients deserve and that safety demands.
The ACR and VSR are concerned that this rule would further open the door for “white bagging” and “brown bagging” of pharmaceuticals. “White bagging” policies require providers to purchase medications through a specialty pharmacy, typically owned by the PBM or payer. “Brown bagging” refers to policies that require the dispensing of a medication from a specialty pharmacy directly to a patient, who then transports the medication to the physician’s office for administration.
Our members frequently administer infusions. Increasingly payers are forcing patients to engage in the dubious practice of “brown bagging” to ensure that the payer’s own specialty pharmacy is utilized to fill a prescription, instead of using the “buy and bill” system. The reason “buy and bill” is predominantly used in infusions goes to the heart of patient safety and chain of custody. Once a medication is delivered to a clinic, storage and handling is no longer an issue. With “brown bagging” handling and storage is especially a concern. Once the patient picks up the medication from a pharmacy, ensuring proper handling and storage is impossible.
It is worth noting that Board of Pharmacy already has a proposed rule on “white bagging” and “brown bagging” in its final stage of consideration. It is also particularly worth noting that the rule would add subsections F-G to the same code sections being modified in this rule. [i] The sections contained in the other proposal prohibit the delivery of a dispensed drug to a patient’s residence that requires special storage, compounding or reconstitution, and is to be subsequently taken by the patient to a clinic for administration. However, it would allow these drugs to be delivered to “alternative delivery sites,” which includes another pharmacy. If this rule is adopted in conjunction with the other proposed rule, the pick-up pharmacy would not be on the drug label and would not just be hidden from the patient, but also from the administering physician.
In a “brown bagging” scenario, a physician must have as much information about the chain of custody as possible. Patient safety depends on the physician knowing how long the patient has had the drug, how it was stored, and where the drug was received from. The ACR and VSR do not endorse or condone “brown bagging.” However, if this rule should move forward, it must exclude “brown bagged’ medications from this label exemption, so that physicians have all the information necessary to determine the safety of the medication. That includes being able to contact the pharmacy where the prescription was picked up by the patient.
Finally, the ACR and VSR are a strong supporters of the rulemaking process and the transparency that it provides for physicians and patients. However, we strongly question the transparency of the rulemaking being undertaken here. While we do not question the Board’s authority, modifying the same code section simultaneously with two different rules effectively hides the ball from interested parties. At a minimum this current proposal should be withdrawn until the other rule has a final disposition and interested parties can submit comments on the full implications of the changes proposed in this rule. We do not believe that the Board has undertaken this new rule with any ill intent. We simply believe it is an oversight driven by a petition for rulemaking that does not take into full account the implications of the proposed rule on patient safety and provider liability. We respectfully ask the Board to withdraw this rule.
We appreciate the opportunity to comment. If you have any additional questions please reach out to Joseph Cantrell at email@example.com.