PARTNERSHIP HEALTHPLAN OF CALIFORNIA POLICY / PROCEDURE Policy/Procedure Number: MPRP4034 (previously RP100434) Lead Department: Health Services External Policy Policy/Procedure Title: Pharmaceutical Patient Safety Internal Policy Original Date: 02/16/2005 –Medi-Cal Next Review Date: 10/1/2016 07/24/2008 – Healthy Kids Last Review Date: 10/1/2015 Applies to: Medi-Cal Healthy Kids Employees Reviewing Entities: IQI P&T QUAC OPERATIONS EXECUTIVE COMPLIANCE DEPARTMENT Approving Entities: BOARD COMPLIANCE FINANCE PAC CEO COO Approval Signature: Robert L. Moore, MD, MPH CREDENTIALING DEPT. DIRECTOR/OFFICER Approval Date: 10/1/2015 I. RELATED POLICIES: A. MPRP4020 - Restricted Status for Members Receiving Prescription Medications II. IMPACTED DEPTS.: III. DEFINITIONS: IV. ATTACHMENTS: V. PURPOSE: To describe PHC’s role in providing patient safety information to pharmacists, practitioners and patients. VI. POLICY / PROCEDURE: A. Objectives: 1. Identify, analyze and notify dispensing providers of potential drug interactions, drug dose precautions, ingredient duplications, age precautions, pregnancy precautions, gender conflicts and therapeutic duplications. 2. Identify and notify practitioners and members of product withdrawals, which include voluntary withdrawals by the manufacturer or those under FDA requirement, for patient safety reasons or other reasons on a case by case basis. 3. Identify and notify practitioners of other potential patient safety issues with regards to the use of prescription medications. B. Procedure: 1. Drug Utilization Review: PHC’s Pharmacy Benefit Manager (PBM), MedImpact, performs POS (point of sale) Drug Utilization Review for claims submitted by contracted pharmacy providers. These reviews are based on data and algorithms provided by First DataBank and the results are returned to the pharmacy with the claim response. The following is a description of each Drug Utilization Review. a. Drug Interaction: Drugs which are categorized into the following 3 severity levels are communicated to the dispensing pharmacy: 1) Level 1 Contraindicated Drug Combination a) Action: This drug combination is clearly contraindicated in all cases and should not be dispensed or administered to the same patient Page 1 of 3 Policy/Procedure Number: MPRP4034 (previously RP100434) Lead Department: Health Services ☒External Policy ☐Internal Policy Original Date: 02/16/2005 –Medi-Cal Next Review Date: 10/1/2016 07/24/2008 – Healthy Kids Last Review Date: 10/1/2015 ☒ Healthy Kids ☐ Employees Applies to: ☒ Medi-Cal Policy/Procedure Title: Pharmaceutical Patient Safety 2) Level 2 Severe Interaction a) Action: Action is required to reduce risk of severe adverse interaction. 3) Level 3 Moderate Interaction a) Action: Assess risk to patient and take action as needed 2. Drug Dose: The drug dosage review is performed both for the minimum and maximum daily dosage, and is reviewed for each age category for appropriate dosing based on quantity and days supply submitted on the claim. Pediatric: Birth to 18th birthday Adult: 18 to 60th birthday Geriatric: 60 and over 3. Ingredient Duplication: The analysis is based on the claim submittal of 2 or more drugs with the same active ingredient. 4. Age Precaution: The age precaution is done for both pediatric and geriatric members. Some medications for example may be inappropriate for use in the geriatric population. 5. Pregnancy Precaution: The pregnancy precaution review is done for female members within the age range of 12 years to 55 years and notifies pharmacies of drugs contraindicated in pregnancy. 6. Gender Conflict: This review checks for drugs that are used either exclusively in males or females. 7. Therapeutic Duplication: This analysis notifies pharmacies if 2 or more drugs in the same therapeutic class are being processed C. Class II or III drug recall or voluntary withdrawals from the market: When a drug is withdrawn from the market due to patient safety reasons PHC identifies those members who have recently received the drug and those practitioners who have prescribed the drug. The members and practitioners are then both notified by mail of the drug withdrawal within 30 calendar days of FDA notification Class I drug recall or withdrawals: PHC identifies those members who have recently received the drug and those practitioners who have prescribed the drug. The members and practitioners are then both notified by mail of the drug withdrawal within 5 working days of FDA notification. D. Other potential drug safety issues: PHC identifies and notifies practitioners of drug safety issues which include but are not limited to the following: 1. Members receiving excessive medications inappropriately. These members may be reviewed by PHC Clinical Pharmacists, Director of Pharmacy, Medical Directors and Chief Medical Officer and may be placed on Restricted Status requiring a Treatment Authorization Request (TAR) for all medications and/or restricted to the use of one pharmacy provider. 2. Members receiving high doses of acetaminophen and/or opioid use. VII. REFERENCES: N/A VIII. DISTRIBUTION: A. Provider and Practitioner Manuals, B. PHC Department Directors, C. SharePoint IX. POSITION RESPONSIBLE FOR IMPLEMENTING PROCEDURE: A. Pharmacy Services Director Page 2 of 3 Policy/Procedure Number: MPRP4034 (previously RP100434) Lead Department: Health Services ☒External Policy ☐Internal Policy Original Date: 02/16/2005 –Medi-Cal Next Review Date: 10/1/2016 07/24/2008 – Healthy Kids Last Review Date: 10/1/2015 ☒ Healthy Kids ☐ Employees Applies to: ☒ Medi-Cal Policy/Procedure Title: Pharmaceutical Patient Safety X. REVISION DATES: Medi-Cal 09/21/05; 07/24/08; 10/28/10; 01/16/14; 10/1/15 Healthy Kids 07/24/08; 10/28/10; 01/16/14; 10/1/15 PREVIOUSLY APPLIED TO: Healthy Families: MPRP4034 - 10/28/2010 to 03/01/2013 XI. POLICY DISCLAIMER: A. In accordance with the California Health and Safety Code, Section 1363.5, this policy was developed with involvement from actively practicing health care providers and meets these provisions: 1. Consistent with sound clinical principles and processes; 2. Evaluated and updated at least annually; 3. If used as the basis of a decision to modify, delay or deny services in a specific case, the criteria will be disclosed to the provider and/or enrollee upon request. B. The materials provided are guidelines used by PHC to authorize, modify or deny services for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under PHC. Page 3 of 3