Policy/Procedure Number: MPRP4034 (previously RP100434) / Lead Department: Health Services
Policy/Procedure Title: Pharmaceutical Patient Safety / ☒External Policy
☐Internal Policy
Original Date: 02/16/2005 / Next Review Date: 02/14/2019
Last Review Date: 02/14/2018
Applies to: / ☒ Medi-Cal / ☐ Employees
Policy/Procedure Number: MPRP4034 (previously RP100434) / Lead Department: Health Services
Policy/Procedure Title: Pharmaceutical Patient Safety / External Policy
Internal Policy
Original Date: 02/16/2005 / Next Review Date: 02/14/2019
Last Review Date: 02/14/2018
Applies to: / Medi-Cal / Employees
Reviewing Entities: / IQI / P & T / QUAC
OPerations / Executive / Compliance / Department
Approving Entities: / BOARD / COMPLIANCE / FINANCE / PAC
CEO / COO / Credentialing / DEPT. DIRECTOR/OFFICER
Approval Signature: Robert L. Moore, MD, MPH, MBA / Approval Date: 02/14/2018
  1. RELATED POLICIES:MPRP4020 - Restricted Status for Members Receiving Prescription Medications
  1. IMPACTED DEPTS.:

Pharmacy

  1. DEFINITIONS:

N/A

  1. ATTACHMENTS:
  2. Prescriber Letter
  3. Client Plan Advisory Letter
  4. Member Letter
  5. DUR Summary Example
  1. PURPOSE:

To describe Partnership HealthPlan of California’s (PHC’s) role in providing patient safety information to pharmacists, practitioners and patients.

  1. POLICY / PROCEDURE:
  2. Objectives:
  3. Identify, analyze, and notify dispensing providers of potential drug interactions, drug dose precautions, ingredient duplications, age precautions, pregnancy precautions, gender conflicts, and therapeutic duplications.
  4. 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.
  5. Identify and notify practitioners of other potential patient safety issues with regards to the use of prescription medications.
  6. Procedure:
  7. Drug Utilization Review (DUR): PHC’s Pharmacy Benefit Manager (PBM), MedImpact, performs POS (point of sale) DUR 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 DUR:
  8. Drug Interaction: Drugs which are categorized into the following three (3) severity levels are communicated to the dispensing pharmacy:
  9. 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 day’s supply submitted on the claim.
  10. Ingredient Duplication: The analysis is based on the claim submittal of two (2) or more drugs with the same active ingredient.
  11. 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.
  12. 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.
  13. Gender Conflict: This review checks for drugs that are used either exclusively in males or females.
  14. Therapeutic Duplication: This analysis notifies pharmacies if two (2) or more drugs in the same therapeutic class are being processed
  15. Reporting of DUR activity: Pharmacy will conduct quarterly DUR analysis, including MedImpact's DUR and FWA summaries and utilization report from Walgreens Specialty Pharmacy and MedImpact Direct, and present in quarterly Pharmacy Operation Report for evaluation and recommendations to assure drug utilization is medically appropriate and necessary.
  16. 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 thirty (30) calendar days of FDA notification
  17. Other potential drug safety issues: PHC identifies and notifies practitioners of drug safety issues which include but are not limited to the following:
  18. Members receiving excessive medications inappropriately. These members may bereviewed 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 being used excessively, and/or restricted to the use of one pharmacy provider.
  19. Members receiving high doses of acetaminophen and/or opioid use.
  1. REFERENCES:

N/A

  1. DISTRIBUTION:
  2. PHC Provider Manual
  3. PHC Department Directors
  1. POSITION RESPONSIBLE FOR IMPLEMENTING PROCEDURE:

Pharmacy Services Director

  1. REVISION DATES:

Medi-Cal

09/21/05; 07/24/08; 10/28/10; 01/16/14; 10/01/15; 04/07/16; 04/06/17, *02/14/18

*Through 2017, Approval Date reflective of the Pharmacy & Therapeutics Committee meeting date. Effective January 2018, Approval Date reflects that of the Physician Advisory Committee’s meeting date.

PREVIOUSLY APPLIED TO:

Healthy Families:

MPRP4034 - 10/28/2010 to 03/01/2013

Healthy Kids

07/24/2008; 10/28/10; 01/16/14; 10/01/15; 04/07/16 to 12/01/16 (Healthy Kids program ended 12/01/2016)

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.

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