DUR: Prospective DUR Prospective Drug Use Review (DUR) is performed electronically at the time a drug is dispensed to a patient. This review is designed to identify potential problems such as drug-drug interactions, therapeutic duplication, inappropriate dosage, or duration of therapy. When a pharmacist is alerted to a potential problem, he or she is expected to use professional judgment to determine an appropriate intervention. In accordance with California Board of Pharmacy requirements and federal rules, Medi-Cal prospective DUR includes the following general requirements: • The pharmacist must maintain patient medication records. • The pharmacist must screen for potential therapeutic problems before the prescription is dispensed to the patient. • The pharmacist must counsel patients on all new or changed prescriptions and on refills when the pharmacist deems it warranted or the patient requests it.

California Board of Pharmacy regulations require these activities for all patients, including Medi-Cal. For Medi- Cal beneficiaries, as described in the Code of Federal Regulations, Title 42 Part 456, Subpart K – Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims, Section 456.705, 10-1-12 Edition, prospective DUR requires that all prescriptions must at least be screened by pharmacists for therapeutic duplication, drug-disease contraindications, adverse drug-drug interactions, incorrect drug dosage, incorrect duration of drug treatment, drug-allergy interactions, and clinical misuse/additive toxicity. In addition, the Medi-Cal Point of Service (POS) network screens prescriptions for targeted drugs for potential drug therapy problems due to ingredient duplication, overutilization, underutilization, drug-age conflicts, drug-gender conflicts, and drug-pregnancy conflicts.

Prospective DUR screening must use predetermined standards, which are based upon evidence-based practice guidelines, disease-specific health improvement programs developed by the State of California, peer- reviewed medical literature, and the following compendia: • American Hospital Formulary Service Drug Information • United States Pharmacopoeia Drug Information • American Medical Association Drug Evaluations

In accordance with the requirements of the California State Board of Pharmacy, California Code of Regulations (CCR), Title 16, Section 1707.3, conducting prospective DUR screening is the sole responsibility of the pharmacist. Pharmacies may use commercially available DUR database packages to assist with prospective DUR. Such database packages must be able to screen for therapeutic problems based on explicit standards. It is not expected that commercial databases will contain patient-specific diagnosis or allergy information. When, in the pharmacist’s professional judgment, obtaining such information is essential, he or she should consult the patient or the patient’s health care provider.

DUR: Prospective DUR 1 July 2020 Medi-Cal Prospective DUR Target Drugs Any drug paid for by the Medi-Cal program may be placed on a target drug list. Target drugs are subject to analysis and the target drug lists may be revised at any time, as directed by the Department of Health Care Services (DHCS).

Medi-Cal prospective DUR target drugs are selected based on the following overarching logical rules: 1. Therapeutic disease – Drugs that are grouped by therapeutic disease category, such as mental health, arthritis, asthma, infectious disease, etc., may be added to a target drug list. Medications that are recommended as part of nationally accepted, evidence-based guidelines will be monitored for adherence to such guidelines. Therapeutic disease categories may be included, especially if there is a Board member with sufficient expertise to guide the selection and review of these drugs. 2. Drugs with high risk or rare use – Drugs that have a narrow therapeutic range and potential for severe toxicity may be added to a target drug list. Along with these are drugs whose use is so infrequent that knowledge of common parameters might not be generally accessible. 3. Drugs with high cost and/or high risk for fraud, abuse or misuse – Drugs that hold or have demonstrated exceptionally high risk for fraud, abuse or misuse may be added to a target drug list, in support of the intent of the Omnibus Budget Reconciliation Act of 1990 (OBRA ’90) to directly address these issues. This will not preclude these drugs from appearing on a target drug list for therapeutic or high risk.

Automated DUR screening applies to prospective DUR target drugs billed to Medi-Cal through the POS network. If a DUR alert is generated, the pharmacist must respond with valid Professional Service Codes and Result of Service Codes when resubmitting the claim for payment. Note that although automated DUR will be performed on certain targeted drugs, it remains the pharmacist’s responsibility to review all prescriptions for potential problems regardless of the prescribed drug’s status as a target drug. For more information about automated DUR when submitting claims through the POS network, refer to your vendor-supplied user guide or contact the POS/Internet Help Desk at 1-800-427-1295. Pharmacies without computers, or that choose not to use the Medi-Cal automated claims adjudication system with its online DUR component, must undertake prospective DUR screening based on published DUR alert criteria.

There are three prospective DUR alerts that are currently active for all drugs: overutilization, drug-drug interactions flagged as Severity Level 1, and drug-pregnancy conflicts in which a drug is contraindicated or not recommended during pregnancy. All other alerts are active for selected prospective DUR target drugs only. Providers may refer to the Medi-Cal Fee-for-Service Prospective Drug Use Review (DUR) Target Drugs spreadsheet for more information.

DUR: Prospective DUR 2 July 2020 Role of the Global Medi-Cal DUR Board The Global Medi-Cal DUR Board (the “Board”) serves in an advisory capacity to DHCS on an ongoing basis in order to assess prospective DUR alert data against predetermined standards. As necessary, the Board may recommend remedial strategies in order to improve the quality of care. Noting that standards of care and practices change with time, the Board also serves in an advisory capacity to DHCS in the development and implementation of evidence-based methodology for determining standards to identify, classify, target, and act upon those drug interactions that pose the greatest risk for drug-induced illness.

Standard DUR Message The National Council for Prescription Drug Programs (NCPDP) has developed standardized pharmacy transactions for DUR to facilitate the transfer of information to Medi-Cal as well as other third-party payers. The data elements selected for standard DUR messages provide information for the pharmacist to use in determining a response to the DUR alert. The following data elements may be provided as part of the DUR message: • Clinical Significance – This indicates the clinical significance assigned to the DUR conflict. Medi-Cal notifies pharmacists only of DUR conflicts of major significance, which is noted as a significance level = 1. • Other Pharmacy Indicator – The value in this field indicates the dispensing location or source of the previous prescription that is in conflict with the prescription being submitted. A conflict at the same pharmacy = 1 and a conflict at another pharmacy = 3. • Previous Fill Date – This field indicates the fill date of the prescription that triggered the conflict with the submitted prescription. • Quantity of Previous Fill – This field indicates the quantity of the conflicting agent that was previously dispensed. • Other Prescriber Indicator – This field indicates whether the previously filled conflicting prescription and the current prescription were written by the same or different prescribers. The same prescriber = 1 and another prescriber = 2.

The procedure for responding to DUR alerts is as follows: • Pharmacist receives DUR alert message(s) on the computer screen; the claim is rejected for DUR • Pharmacist reviews and resolves identified DUR conflict(s) by contacting the prescriber, talking with the patient, and/or using other resources or professional judgment • Pharmacist resubmits claim with a six-character response in the DUR field • Pharmacist receives a paid response if the prescription was filled or a captured response if the claim was cancelled

If the eligibility verification system identifies more than three DUR conflicts, the overflow indicator is displayed. Pharmacists may call the POS Help Desk at 1-800-427-1295 to receive the additional alerts.

DUR: Prospective DUR 3 July 2020 Pharmacy DUR Reason for Service, Professional Service, and Result of Service Codes A DUR response includes three components. Reason for Service Codes reflect the type of potential therapeutic problem identified by the Medi-Cal eligibility verification system. Professional Service Codes consist of alphanumeric characters that identify the action the pharmacist took to resolve the DUR conflict. Result of Service Codes tell the Medi-Cal eligibility verification system if the prescription was dispensed and determine the payment status of the claim.

Reason for Service Codes

DA Drug-Allergy Conflict AT Additive Toxicity PG Drug-Pregnancy Conflict ID Ingredient Duplication MC Drug-Disease Conflict PA Drug-Age Alert DD Drug-Drug Interaction HD High Dose TD Therapeutic Duplication LD Low Dose ER Overutilization (Early Refill) MX Incorrect Duration of Therapy LR Underutilization (Late Refill) SX Drug-Gender Conflict

Professional Service Codes

M0 (M zero) Prescriber Consulted P0 (P zero) Patient Consulted R0 (R zero) Pharmacist Consulted Other Source

Result of Service Codes

1A Filled as is, false positive 1B Filled prescription as is 1C Filled with different dose 1D Filled with different directions 1E Filled with different drug 1F Filled with different quantity 1G Filled with prescriber approval 2A Prescription not filled 2B Prescription not filled, direction clarified

DUR: Prospective DUR 4 July 2020