Patient counseling by pharmacists has recently been the subject of various news reports and a topic that is being discussed by both patients and pharmacists on a national level. Being labeled as “Mandated Patient Counseling by Pharmacists”, new legislation and rules have been enacted by several states that are aimed at improving the patient counseling that pharmacists have been required to provide for their customers. The laws are an attempt to educate the public on their drugs by “mandating” that the pharmacist verbally communicate when dispensing medications to a patient in certain situations. The rules regarding “mandated counseling” are aimed at achieving better medication compliance, minimizing possible dangerous drug interactions, making patients aware of possible side effects and achieving better overall results for consumers from their prescription therapies and drug regimens.
Illinois’ New Pharmacy Patient Counseling Rules
Perhaps the most specific example to note is the new legislation in Illinois that took effect several months ago on August 18th of 2017. In a major attempt at improving consumer safety in their state, the Illinois Department of Financial and Professional Regulation (IDFPR) adopted new rules regarding the counseling of patients by a pharmacist that effectively mandates verbal interaction when a prescription is dispensed under certain conditions. The Illinois rule specifies that the RPh must provide verbal counseling in the following instances:
1. When the RPh dispenses any prescription to a new patient.
2. When the RPh dispenses any new medications to an existing patient.
3. When the RPh dispenses any prescriptions where something has been changed by the prescribing physician or doctor. This includes any changes of dosage, dosage form, strength, routes of administration and even cases where any change in the directions have occurred.
Several other requirements of the new rules are also of significance to take note of. In lieu of the “mandated” instances noted above, the pharmacist must still offer to provide the patient with counseling on every prescription that they dispense. In situations such as mail order pharmacies, where verbal counseling is obviously not feasible, the RPh must use “alternate” forms of patient information, plus must notify all their patients in writing that the RPh is available and that the patient is advised to contact the pharmacist for a consultation regarding their prescription medications.
It is important to note that the Illinois legislation came about after a major investigation last year was published by the Chicago Tribune. The report that was released by the newspaper involved reporters picking up prescriptions at over two-hundred and fifty (255) pharmacies located in the Chicago Metropolitan area for multiple medications that were know to be harmful or fatal if taken in combination with each other. The reporters stated that over fifty percent (52%) of the pharmacies that dispensed the prescriptions failed to offer adequate counseling, nor warned them of the potential for harm inherent in taking the combination of drugs together. The 255 pharmacies included both independent retail community pharmacies, plus major chain stores including Walgreens, CVS, Walmart, Kmart and Costco (as well as several local chain store operations such as Chicago based Mariano’s).
What the New Mandated Patient Counseling Really Means to YOU
Many pharmacists and pharmacy owners are asking “how does the mandated patient counseling affect us?”. The new rules are obviously a departure from the previous requirements that stated that a patient merely be offered counseling when prescriptions are dispensed. Everyone knows that the common dispensing scenario is in reality the following:
– In the majority of instances the patient does NOT actually ever talk with a pharmacist when getting a prescription filled. The prescription is dropped off at the counter to a technician (or called in from a doctor or the physicians office staff ) and picked up from the technician or cashier.
– The patient picks up the prescription at the checkout counter and is asked by the cashier or drugstore worker if they “have any questions for the pharmacist”.
– The customer most commonly (perhaps almost reflexively) says no, signs a log and then leaves.
Admittedly this system of counseling patients regarding their medications is very weak and leads to a situation where the RPh meets the legislative requirements, yet the consumer leaves without hearing about potential medication interactions, potential side effects and possible problems.
The intent of the new Illinois mandated patient counseling rules is commendable, but leads to many questions regarding a pharmacist’s routine and the documentation required to meet the new criteria. Several questions that will need to addressed and answered include:
1. How will the pharmacist document that the mandated verbal consultation actually took place? Will they need to keep separate logs for both the instances where the required consultation occurred versus the instances where counseling was merely offered when the mandated criteria did not come into play?
2. Does the patient need to acknowledge and sign for the mandated consultation? How do you document that it was offered and refused?
3. Will video-taping of the patient-pharmacist interaction actually be a good idea for documentation of what took place? If so, how do you store the huge files and for how long?
4. For mail-order pharmacies, do the new rules mean that they are required to have a pharmacist “on duty” 24 hours a day to provide patients with counseling? After all, if the patient is 2-3 hours ahead or behind the pharmacy’s time zone (and does not get to choose what mail-order pharmacy their insurance utilizes), this could lead to legal issues regarding accessibility required to meet the intent of the new rules.
The answers are not specified in the new IDFPR rules, but the real answer is to get ready now and be prepared. Don’t wait until you are forced to act. Some states are currently considering adopting similar rules regarding mandated pharmacy-patient counseling, while other states are watching what transpires in Illinois. Define and document a process now to meet the requirements that Illinois has instituted. Develop policies and procedures now that meet (or exceed) the most stringent rules to show that you care about your patients. Show your customers that you care about their safety and welfare above everything else, to the extent that you embraced the new rules regarding counseling BEFORE you were even mandated to do so!
Healthcare Consultants Pharmacy Staffing can help you. Our experienced consultants can help you and your staff define and document a process that will meet every state’s rules, plus we’ll update and modify your Policy and Procedure manual as required. HCC has over 28 years of experience in Policy and Procedure development and operational evaluation and can provide your pharmacy team with valuable insights and recommendations.
HCC is known to be a national leader in pharmacy consulting. Since 1989, our network of seasoned advisers and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations. Some of the services we most commonly provide include:
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From major hospitals and healthcare systems to individual community pharmacies, HCC has been the nationally renowned pharmacy consultant firm of choice for over 28 years now. HCC can assist with expert advice in any area of your pharmacy business or practice. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.