1. Proposal to Amend WAC 246-869-220 in an Effort to Improve Pharmaceutical Care in Washington State Group LUCKY 7 – Pharm 543 Beth Walter, Thang Tran, Geoff Kozu, Beth Walter, Thang Tran, Geoff Kozu, Robert Kahns, Erin Alldredge, Quynh-Anh Nguyen, Ruby Soleimani Robert Kahns, Erin Alldredge, Quynh-Anh Nguyen, Ruby Soleimani

2. Pharmacist’s Role Pharmaceutical care defined pharmacist’s role as patient-centered, outcomes- oriented, pharmacy practice Does mail-order pharmacy provide optimal care for our patient? Answer: We’ll let you decide it.

3. Why should you CARE ? Sentinel event concerning a mail-order prescription medication error that resulted in a non-diabetic patient having a near fatal episode from taking a sulfonylurea that was intended for someone else A 64-year-old-male was diagnosis of profound hypoglycemic Causes: –Wrong Patient, wrong drug –Lack of direct counseling –Ineffective form of counseling (written instructions and/or package insert) Consequences: –Lethargic, diaphoretic, and incontinent of urine –Admit to ICU –Cost of hospitalization

4. What is the PROBLEM ? Written forms of counseling are inadequate because patients do not gain a sense of security with therapy. A written drug information sheet with all possible side-effects and warnings, while educational, can work to frighten the patient out of compliance A survey of 351 elderly subjects living in 2 retirement communities in Arkansas reported that –73.8% stated that they felt most protected when they received either face-to-face consultation or face-to-face consultation as well as written drug information “Even with face-to-face counseling, establishing patient comprehension can be difficult; with mail order pharmacy, counseling becomes even more challenging.”

5. PROBLEM Continues to Grow…. Data about missed/inadequate/lack of counseling and med errors –Annually there are 777,000 of medication errors in the United States –44,000 to 98,000 Americans LIVES are LOST each year as a result of medical errors –25% of medication errors (194,250) are due to 1. Lack of patient information 2. Lack of patients’ understanding of their therapy –1-4% of all visits to the ER are due to inappropriate use of medications that is no fault of the patient’s.

6. THE PROBLEM is still growing…. Medication errors CANNOT be directly attributed to RXs sent by mail Counseling issued when prescriptions are sent through the mail is less than optimal, it is below the minimal allowed for an in-person prescription pick-up Currently there is NO published data on medication errors caused exclusively by mail-order pharmacies Data has shown mail-order pharmacies’ lack of counseling requirements are a potential source of adverse outcomes.

7. Why do People Choose Mail-Order Services? Patients who are unable to leave their home Those living in remote areas without access to newer, more expensive drug Patients who just don’t have time to come into their local pharmacy Reduced monthly co-pay

8. Our Current Law Our current law: WAC 246-869-220(1)(2), Patient counseling required: For patients who come into a pharmacy to get prescriptions filled, it is the duty of the pharmacist to directly counsel the patient on their medications, but for prescriptions mailed to the patient, counseling is only required to be given in the form of a standard drug information sheet with the pharmacy’s phone number in case the patient has any questions or concerns about their therapy. We believe that mail-order service doesn’t provide optimal pharmaceutical care for our patients That’s why we came up with our proposal

9. OUR awesome Proposed Law Patient counseling required. The purpose of this counseling requirement is to educate the public in the use of drugs and devices dispensed upon a prescription. (2) For prescriptions delivered outside of the pharmacy either by mail or hand delivery, the pharmacist shall make a reasonable attempt to contact the patient or patient’s agent via telephone, to provide direct counseling and information about the drug. Including information on how to contact the pharmacist. (a) For prescriptions delivered outside of the local calling area, the pharmacy or the pharmacist must provide a toll-free means for the patient or patient’s agent to contact the pharmacist. If the pharmacy chooses to provide a toll-free number, the pharmacy shall disclose this toll-free number on a label affixed to each container of drugs dispensed and delivered to patients.

10. Alternatives Do nothing to current law Make mail order prescriptions illegal Add yearly BOP inspection of mail order procedures (Board in favor, would like a standardized inspection procedure)

11. Technical feasibility Political Viability Political Operability Impact of positive therapeutic outcomes Do nothing (+) (+) (-) (-) Make mailing rx’s illegal (+) (+) (-) (-) Make yearly BOP inspections (-) (-) (+) (+) (-) (-) (~) (~) Alternatives (Continued)

12. How do we intend to TRACK outcomes for changes in Patient Safety and Education ? Two ways to evaluate impact of new law for Washington State Pharmacies: Establish an Experimental Site Monitor quality of care after law is implemented Evaluation Criteria

13. ANALYZE THIS………….. Experimental Site Experimental Site Interesting data to record & evaluate: Pharmacist intervention with patients using mail order pharmacies. Recording and monitoring the causes of Adverse Drug Reactions and Events.

14. The Stakeholders, Their two cents Patients – Favor it Pharmacists - (Private and Chain) Have mixed feelings, but are mostly in favor Have mixed feelings, but are mostly in favor AARP – Possible support, no opposition at this time

15. Oh yeah…… THE END By changing the law as it now stands, we hope to bring mail-order pharmacy, an important and emerging form of pharmacy practice, up to the standard of care that patients in Washington State deserve.

16. Thanks for Listening

17. Just a friendly reminder Finals start in just a day and a half from NOW! If you have not started, we are sure you are not alone! GOOD LUCK From Group “Lucky” 7