What Would You Do? Scenarios In Pharmacy Law Kathryn Schultz, PharmD, BCPS, BCOP Scott A. Meyers, RPh, MS, FASHP Jim Owen, Legislative Consultant Disclosures Kathryn Schultz has no conflicts to disclose. Jim Owen and Scott Meyers work for ICHP and have a vested interest in ICHP s advocacy efforts. 1
Learning Objectives Upon completion of the program participants should be able to: Compare different approaches to patient counseling and HIPAA with the new counseling rules. Argue why pharmacy personnel should advocate for their patients and their profession. Prepare an argument to convince colleagues, legislators and the public that pharmacists are a necessary member of the health care team. Section 1330.30 Unprofessional and Unethical Conduct h) Failing to provide patient counseling in accordance with this Part, failing to respond to requests for patient counseling, attempting to circumvent patient counseling requirements, or otherwise discouraging patients from receiving patient counseling concerning their prescription medication. 2
Section 1330.700 Patient Counseling a) Upon receipt of a new or refill prescription, a prospective drug regimen review or drug utilization evaluation shall be performed. Prior to dispensing a prescription to a new patient, a new medication to an existing patient, or a medication that has had a change in the dose, strength, route of administration or directions for use, the pharmacist, or a student pharmacist directed and supervised by the pharmacist, shall provide verbal counseling to the patient or patient's agent on pertinent medication information. An offer to counsel shall be made on all other prescriptions.if the offer to counsel is accepted, the pharmacist or the student pharmacist, as directed and supervised by the pharmacist, shall counsel the patient or patient's agent using his or her professional judgment. Section 1330.700 Patient Counseling Prescription to a new patient New medication/prescription for an existing patient Mandatory counseling by a pharmacist Mandatory counseling by a pharmacist Any medication prescription where the following have changed: Dose and/or Strength Route of administration Directions for use Mandatory counseling by a pharmacist All other prescriptions where counseling is not mandated Offer to provide counsel 3
Section a) continued: Counsel shall include but is not limited to: a) Name and description of the medication; b) Dosage form and dosage; c) Route of administration; d) Duration of therapy; e) Techniques for self monitoring; f) Proper storage; g) Refill information; h) Actions to be taken in case of missed doses; i) Special directions and precautions for preparation, administration and use; j) Common severe side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action if they occur. b) If, in the pharmacist's professional judgment, oral counseling is not practicable for the patient or patient's agent, the pharmacist shall use alternative forms of patient information. When used in place of oral counseling, alternative forms of patient information shall advise the patient or agent that the pharmacist may be contacted for consultation in person at the pharmacy or by toll free or collect telephone service. 4
c) Every licensed pharmacy directly serving patients at a physical location must conspicuously post a sign provided by the Division containing a statement that the patient has the right to counseling, the Division s consumer hotline number, information on how to file a complaint for failure to counsel, and any other information the Division deems appropriate. c) cont. The sign must be printed in color ink or displayed electronically in color, measure at least 8½x11 inches in size, and be posted at either the cashier counter or waiting area clearly visible to patients. c) cont. Licensed pharmacies that do not maintain a physical location directly serving patients must include a copy of the sign within any dispensed prescriptions. The sign will be available to download on the Division s website. 5
Illinois New Counseling Rules f) A pharmacist at an on site or off site institutional pharmacy shall not be required to provide patient counseling as required in this Section unless when drugs are dispensed by the pharmacy upon a patient s discharge from the institution. g) Nothing in this Section shall be construed as requiring a pharmacist to provide counseling when a patient or patient s agent refuses such counseling. When a patient or patient s agent refuses to accept patient counseling as provided in this Section, that refusal shall be documented. The absence of any record of a refusal to accept the offer to counsel shall be presumed to signify that the offer was accepted and that counseling was provided. 6
Scenario #1 What would you do? You receive three new prescriptions for a local elementary school teacher for two anti depressants and one anxiolytic agent. The teacher asks a co worker to pick up their prescriptions for them since the co worker was going to the pharmacy anyway. What kind of issues do you see in this case? What if one of the prescriptions was an anti retroviral agent? Instead of a teacher, what if the prescriptions were for a police officer? What other issues do you see with the current new rules? In a recent survey. 7
ICHP s most valuable/important benefit? Percent Advocacy Statewide Conferences Up to date information on pharmacy issues Professional Development Free online CE programs Champion live aand home study programs Local CE programs KeePosted Regional affiliate networking events And from that survey: Most Responsible Pharmacy Associations Me General Assembly Empoloyer Colleges of Pharmacy Board of Pharmacy 0.00% 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 90.00% 100.00% Students Everyone 8
Scenario #2: What would you do? It s time to push for provider status in Illinois. The bills have been drafted and introduced. What can you do to help get these bills passed and signed by the Governor? Who can you talk to and seek help from besides your legislators? What kind of things shouldn t you do during this important effort? Who do you believe is most responsible for any advocacy effort on behalf of pharmacy? Now it s time for a Special Guest! Jim Owen, ICHP s Legislative Consultant 9
Questions??? Kathryn_Schultz@rush.edu scottm@ichpnet.org jowenconsulting@aol.com 10