Prince Edward Island Department of Health

Prince Edward Island Department of Health Pharmaceutical Information Program Integration and Conformance Specification FINAL VOLUME 2(A): BUSINESS RULES (PHARMACY) VERSION: 1.4.1 PRINTED 2006-12-19

TABLE OF CONTENTS 1 INTRODUCTION... 1 1.1 Purpose/Audience... 1 1.2 Status of this Specification... 2 1.3 Relationship to pan-canadian Standards... 2 1.4 Volume Index... 3 1.5 Document Conventions... 5 1.6 Related Standards/Documents... 5 1.7 Disclaimer... 5 2 HIGH LEVEL USE CASES... 6 2.1 Use Case Process... 6 2.2 Use Case Index... 7 2.3 Use Case Actors... 7 2.4 Use Cases... 9 2.5 CP-UC4 Supporting Processes... 9 3 CP-UC1 Dispense Prescription... 10 3.1 CP-UC1-PS1 Refill Prescription (CASH)... 10 3.2 CP-UC1-SS1 Refill Prescription (Payor)... 12 3.3 CP-UC1-SS2 Existing Patient, New Prescription... 14 3.4 CP-UC1-SS3 New Patient, New Prescription... 16 3.5 CP-UC1-SS4 Receive Prescription from Prescriber... 18 3.6 CP-UC1-SS5 Receive Prescription via Transfer... 20 3.7 CP-UC1-SS6 Reversal of Transaction (CASH)... 22 3.8 CP-UC1-SS7 Reversal of Transaction (Payor)... 24 3.9 CP-UC1-SS8 View/Enter Patient Record... 26 4 CP-UC2 OTC, Counselling, Professional Service... 29 4.1 CP-UC2-PS1 Dispense Schedule II/III Product... 29 4.2 CP-UC2-SS1 Provide Medical/Medication Advice... 31 4.3 CP-UC2-SS2 Provide Professional Service... 33 5 CP-UC3 Assess/Record Allergy, Observation, ADR... 36 5.1 CP-UC3-PS1 Add Allergy/Intolerance... 36 5.2 CP-UC3-SS1 Update Allergy/Intolerance... 38 5.3 CP-UC3-SS2 Add Adverse Drug Reaction... 40 6 CP-UC4 Supporting Processes... 42 6.1 CP-UC4-SS1 - Identify Client... 42 6.2 CP-UC4-SS2 Client Data Masking... 45 6.3 CP-UC4-SS2-PE Client Keyword... 47 6.4 CP-UC4-SS3 Undo of Prior Action... 49 6.5 CP-UC4-SS4 Correct Clinical Data... 51 6.6 CP-UC4-SS5 Daily Fiscal Reconciliation... 53 6.7 CP-UC4-SS6 Transfer Prescription... 55 6.8 CP-UC4-SS7 Attach Note... 57 Volume 2(a): Business Rules (Pharmacy) ii

6.9 CP-UC4-SS8 Pre-determine or Request Authorization... 59 6.10 CP-UC4-SS9 Coverage Extension... 61 6.11 CP-UC4-S10 Determine Coverage... 63 7 BUSINESS RULES... 66 7.1 Patient or Agent Requests Refill... 66 7.2 Process Script... 66 7.3 Review Patient Drug Profile and Medical History... 67 7.4 View/Manage DUR... 67 7.5 Dispense (Rx) not Correct... 68 7.6 Prepare Medication... 69 7.7 Check Medication and Sign Dispense (Rx)... 69 7.8 Store Medication for Later Pickup... 70 7.9 Retrieve Stored Medication... 70 7.10 Offer Counselling to Patient... 71 7.11 Provide Counselling... 71 7.12 Provide Follow-up... 72 7.13 Pay for Script... 72 7.14 Enter/Update Third Party Payor (TPP) Information... 73 7.15 View/Manage DUR (TPP)... 73 7.16 Send Claim Information... 74 7.17 Assess Fiscal Adjudication... 74 7.18 Fiscal Adjudication Requires Management... 75 7.19 Call TPP Help Desk... 75 7.20 Request Manual Reversal from TPP Help Desk... 75 7.21 Enter/Download Prescription... 76 7.22 Import/Review Patient Medical History from DIS... 76 7.23 Prescriber Sends Prescription (Rx) via Phone/FAX... 77 7.24 Verify Prescriber Authority and Transmission Validity... 77 7.25 Document Prescription (Rx) if Received via Phone... 78 7.26 Enter and Save Prescription (Rx) Information... 78 7.27 Patient Requests Transfer of Prescription... 79 7.28 Contact Transferring Pharmacist via Phone... 79 7.29 Paper Copy must be Created... 80 7.30 Record Details of Prescription (Rx) Transfer... 80 7.31 Change Prescription (Rx) to Inactive... 81 7.32 Lookup Prescription or Transaction... 81 7.33 Send Reversal Request... 81 7.34 Acknowledge and Save Reversal... 82 7.35 Provide Refund to Patient... 82 7.36 Restock Medication... 83 7.37 Resend Reversal Request... 83 7.38 Call TPP Help Desk for Manual Reversal... 84 7.39 Send Manual Reversal if Item for System Reversal has Expired... 84 7.40 Lookup Patient Profile... 84 7.41 Collect and Enter Patient Profile Information... 85 7.42 Verify/Update Patient Profile Information... 86 7.43 Enter Reason for Viewing Profile... 86 7.44 Obtain/Confirm Patient Consent... 86 Volume 2(a): Business Rules (Pharmacy) iii

7.45 Patient Requests Product... 87 7.46 Obtain Information on Patient Current Illness... 87 7.47 Recommend Product... 88 7.48 Refer Patient to Other Health Care Provider... 88 7.49 Requests Medication/Medical Advice... 88 7.50 Obtain Information on Advice Sought... 89 7.51 Obtain Information from Other Sources... 90 7.52 Requests Professional Service... 90 7.53 Obtain Information on Services Requested... 90 7.54 Provide Professional Services... 91 7.55 Enter Information on Services Provided... 92 7.56 Patient Presents with Symptoms of Allergy/Intolerance... 92 7.57 Obtain Information on Reaction... 92 7.58 Make Clinical Determination... 93 7.59 Record Allergy/Intolerance Reaction... 93 7.60 Patient/Physician Presents with New Information on Allergy/Intolerance... 93 7.61 Clarify New Information with Patient/Physician... 94 7.62 Record Update to Patient Profile... 94 7.63 Delete (Deactivate) Allergy from Patient Profile... 95 7.64 Patient Presents with Symptoms of Adverse Reaction... 95 7.65 Obtain Information on Reaction... 95 7.66 File Adverse Reaction Report... 96 7.67 Request Identification... 96 7.68 Request Mask... 96 7.69 Locate Information to Mask... 97 7.70 Mask Data... 97 7.71 Request Keyword... 98 7.72 Provide Department Contact... 98 7.73 Locate Information to Undo... 98 7.74 Undo Action... 99 7.75 Request Helpdesk Support... 99 7.76 Locate Information to Correct... 100 7.77 Correct Information... 100 7.78 Run Daily Totals Reports... 101 7.79 Query TPP (SOFA)... 101 7.80 Identify Prescription... 101 7.81 Release Prescription... 102 7.82 Locate Entity... 102 7.83 Attach Note... 103 7.84 Enter Request (Pre-determination/Authorization)... 103 7.85 Transmit to TPP (Pre-determination/Authorization)... 103 7.86 Record Authorization... 104 7.87 Enter Request (Coverage Extension)... 104 7.88 Transmit to TPP (Coverage Extension)... 105 7.89 Update Coverage (see 7.14 Enter/Update Third Party Payor Information)... 105 7.90 Transmit to TPP (Determine Coverage)... 105 Volume 2(a): Business Rules (Pharmacy) iv

CHANGE LOG Date Version Notes April 30, 2006 0.1 Pre-draft template. May 15, 2006 0.2 In-progress draft. June 7, 2006 0.3 In-progress draft. June 19, 2006 1.0 First draft. June 23, 2006 1.1 FINAL. September 15, 2006 1.3 Corrections The following corrective actions were performed: October 25, 2006 1.4 Additions Section 7.8.4 Corrected an existing Jurisdictional Variation Additions This edition one addition was made: Section 3.8.3 Added Business Rule Removals This edition one item was deleted: Section 7.86.4 Deleted the Jurisdictional Variation December 18, 2006 Section 3.3 & 3.4 added new requirements for the Author in the Control Act. 1.4.1 Updated version number to 1.4.1 Volume 2(a): Business Rules (Pharmacy) v

1 INTRODUCTION The Prince Edward Island (PEI) Pharmaceutical Information Program (PhIP) Integration and Conformance Specification provides the necessary business and technical information required for application integration. This documentation set is composed of a series of volumes, which are intended for specific audiences. There is a common set of volumes required by all software vendors. Two sets of business and technical volumes have been produced; one is intended for the practice of pharmacy while the other is intended for the practice of medicine. Interested parties may contact Sherry McCourt, Project Manager via telephone at (902) 368-6723 or via e- mail at samccourt@ihis.org to inquire about this documentation set or to request the most current version, and any technical questions may be directed to Patricia Holland, Technical Analyst at (902) 368-6194 or via e-mail at pmholland@gov.pe.ca. 1.1 Purpose/Audience This specification is intended for software vendors, health care providers, health care professionals, and administrators who share responsibility for the implementation and operation of software that is capable of interacting with the PEI Pharmacy Network in a fully compliant manner. This document describes the minimum implementation standards required for third-party provider software (local software) to be considered compliant with the functional requirements of the PEI Pharmaceutical Information Program as established by the Department of Health. Local software applications must provide the ability for participating service providers (Providers) to perform the mandatory functions described herein. Communication by local software with the PhIP is conditional based on compliancy with the requirements described herein. In addition to the provision of complaint software, Providers must ensure the following principles are established prior to implementing a for production Pharmaceutical Information Program connection: All users are provided adequate training in operating the compliant software; Privacy and confidentiality policies and procedures as outlined in the legislation and/or regulations are adhered to at all times; Proper telecommunications services have been acquired and are in accordance with the security requirements defined herein; and Adequate hardware and software infrastructure has been provided to users of the system. Volume 2(a): Business Rules (Pharmacy) 1

1.2 Status of this Specification This status is in its final version. 1.3 Relationship to pan-canadian Standards The PEI Department of Health, in developing the PhIP, has endeavoured to adhere to nationally sponsored standards initiatives in all regards. Wherever possible, the standards, best practices, and processes agreed upon nationally have been adopted. Exceptions include where legislation, regulations, or mitigating factors have not made such possible. Instances where the Pharmacy Network has deviated from these standards are clearly identified. The PEI Department of Health has worked in partnership with Canada Health Infoway in developing the Pharmaceutical Information Program. Canada Health Infoway (CHI) is a not-for-profit organization made up of Canada's 14 federal, provincial, and territorial Deputy Ministers of Health. CHI was created in 2001 with the mandate to foster and accelerate the development and adoption of electronic health information systems in Canada. An important focus of CHI's investment strategy is to promote the creation and use of compatible standards and communication technologies on a pan-canadian basis to support the implementation of interoperable systems across the country. Canada Health Infoway's target is to have an interoperable electronic health record in place across 50 percent of Canada (by population) by the end of 2009. The route to this target is through the strategic investment of $1.2 billion. A client registry (CR) is an essential component of any electronic health information system. A CR is a single directory that contains current patient identification information including Provincial Health Number (PHN) and demographics (name, address, date of birth, and gender). The CR also retains historic demographic information (maiden name and former addresses) which is critical to maintaining the concept of a lifetime record. The collection and retention of this information provides unique identification, which enables the linking together of all of the pieces of information that make up a patient's electronic health record. CeRx is a pan-canadian Clinical Drug Messaging Standard. This standard supports the clinical drug information interchange between and among clinicians. CeRx enables the population of the drug portion of the Electronic Health Records (EHR) at a provincial, territorial or regional level. These messages will allow the establishment of drug profiles within the EHR, as well as putting in place the workflows necessary to enable electronic prescribing. The creation of a single pan-canadian standard messaging specification aims at reducing costs for individual jurisdictions, software vendors and independent health care professionals in an effort to encourage adoption of these solutions and gain anticipated benefits. Volume 2(a): Business Rules (Pharmacy) 2

NeCST is a National e-claims Standard initiative whose goal it is to facilitate and support the development of a national electronic claims messaging standard for exchanging electronic health claims information across Canada. It will be used for private and public sector payors and for health service providers. NeCST benefits to health care providers include: Ability to send electronic information to both private and public sector payors using the same message format. Efficiencies in electronic claims. Consistent format for all payors. Pan-Canadian standard across all jurisdictions. Faster turnaround of claims processing and payment. Benefits to the Pharmacy include: Ability to send more complete information, including compound components. Improved ability to bill for professional services against multiple plans from various insurers. Ability to send and receive more consistent messages and information from payors. Enhanced ability to electronically complete coordination of benefits (COB). Improved inventory control through the use of Universal Product Codes (UPC) and Global Product Identification Numbers (GPIN) and New messages allow pre-determination and electronic coverage extensions. NeCST has been designed to facilitate all major health care business processes used to authorize, compile, submit, adjudicate and pay health care invoices submitted by any provider to any payor in Canada In accordance with the jurisdictionally agreed collaboration process, this specification will be provided to the standards management groups and representatives from other Canadian jurisdictions to facilitate the highest level of consistency possible on a Pan- Canadian basis. 1.4 Volume Index This PhIP Integration and Conformance Specification is composed of seven (7) volumes, each of which is described below. Volume 2(a): Business Rules (Pharmacy) 3

1.4.1 Volume 1: Introduction Volume 1 provides contact information, document formatting rules, and a description of the remaining volumes. 1.4.2 Volume 2: Business Rules Volume 2 contains business rules based on the work processes that are to be supported within the practices of pharmacy and medicine. A separate document is provided for each practice area. It provides explicit business rules and implementation guidance as it will be supported within the jurisdictional PhIP. 1.4.3 Volume 3: Technical Rules Volume 3 contains rules, work processes, and message sequences that are to be supported within the practices of pharmacy and medicine. A separate document is provided for each practice area. It provides explicit technical rules and guidance to the intended jurisdictional Pharmacy Network implementation. 1.4.4 Volume 4: Message Catalogue Volume 4 contains the complete list of message interactions and content/structure rules. In cases where a supporting standard exists, it will reference the standard and provide per-jurisdiction restrictions/constraints. In the case that the message is non-standard, complete interaction details will be included within this document. This includes information regarding the following: Network transmission and responses; Client Registry standard messages; Provider Registry standard messages; CeRx standard messages; NeCST standard messages; CPhA v3 standard messages; Custom messages; and Message formats and data definitions. 1.4.5 Volume 5: Security Volume 5 contains a description of the security infrastructure, integration requirements, minimal security policies, and references to appropriate procedures and forms that must be completed as part of the integration process. 1.4.6 Volume 6: Glossary Volume 6 contains definitions for all terms and acronyms used throughout the specification. Volume 2(a): Business Rules (Pharmacy) 4

1.4.7 Volume 7: Supplementary Materials Catalogue Volume 7 contains references, pointers, and descriptions of supplementary materials and other information sources considered relevant. 1.5 Document Conventions The following conventions are used in each volume: Must, Shall, Required, Minimum, or Mandatory indicate a mandatory requirement. May, Should, Recommended, Optional, or Suggested indicate a functional ability that, while not required by a minimum implementation, should be considered. Acronyms are used throughout this document. The first use will typically include both the full name and the acronym. Volume 6: Glossary contains definitions of all acronyms used within the specification. Terms are used throughout this document. Volume 6: Glossary contains definitions of all terms used within the specification. 1.6 Related Standards/Documents Please refer to Volume 7: Supplementary Materials Catalogue. 1.7 Disclaimer All reasonable care has been taken by the PEI Department of Health to achieve accuracy throughout this specification. However, the PEI Department of Health cannot fully guarantee the accuracy of its contents. In reviewing this document, each party waives and releases the Province of Prince Edward Island to the full extent permitted by law from any and all claims related to the usage of material contained herein. In no event shall the Province of Prince Edward Island be liable for any incidental or consequential damages resulting from the use of these materials. Volume 2(a): Business Rules (Pharmacy) 5

2 HIGH LEVEL USE CASES 2.1 Use Case Process This use case analysis was intended to capture current and future community pharmacy business processes, and to analyze the gaps that exist between the two. To this end, use case modeling was applied to the business processes and mapped into flowcharts to clearly document the steps involved in each business process. The current business processes were validated through a series of workshops with representatives from community Pharmacists. The future business processes were then introduced, and the workgroup participants were led through a discussion of the gaps resulting from the implementation of the DIS system. Volume 2(a): Business Rules (Pharmacy) 6

2.2 Use Case Index 2.3 Use Case Actors 2.3.1 Actor Overview The actors (in terms of people) involved in the business processes of a community pharmacy include: Pharmacist (PhC); Pharmacy Technicians/Assistants (PA); Patients or their agents (Pt); Prescribers (Dr); and Other Allied Health Practitioners (HP). 2.3.2 Pharmacist The role of a Pharmacist is to provide accurate medication information to patients, physicians, and other healthcare professionals and accurate medication to patients. The major tasks of a Pharmacist include the following: Dispense prescriptions; Manage clinical and fiscal adjudication messages; Volume 2(a): Business Rules (Pharmacy) 7

Patient Rx counselling; Review patient profiles; Provide OTC counseling and other advice; Prepare prescriptions and compounds; Assess and/or report ADR and allergies; and Perform prescription transfers between pharmacies. 2.3.3 Pharmacy Technician/Assistant A Pharmacy Technician/Assistant assists the Pharmacist in the preparation of medications for patients. Their major tasks consist of the following duties: Collect and enter patient and prescription information in pharmacy software system; Manage Third Party Payor information (update numbers, call helpdesk when needed, handle manual claims); and Prepare prescriptions and compounds (manual preparation). 2.3.4 Prescriber A Prescriber role is to prescribe medications and other items requiring a prescription to patients. The Prescribing role also involves engaging in two way communication with the Pharmacist. The major functions of the Prescriber role are as follows: Provide prescriptions via paper, phone, fax; Seek information from the Pharmacist when requested; and Provide consultation to the Pharmacist when requested. 2.3.5 Other Health Professional Other Health Professionals are responsible for engaging in two way communication with the Pharmacist regarding specific patient issues. Volume 2(a): Business Rules (Pharmacy) 8

2.4 Use Cases The following are the primary use cases outlining the Community Pharmacy Business Process: Dispense prescriptions; Provide OTC counseling/advice/professional services; and Assess and/or report allergies, intolerances, and ADR s These are illustrated in the use case model in Figure 2. 2.5 CP-UC4 Supporting Processes Volume 2(a): Business Rules (Pharmacy) 9

3 CP-UC1 DISPENSE PRESCRIPTION The community pharmacy use case group one (CP-UC1) contains workflows and activities that are focused on the dispensing of a medication to the patient. ID CP-UC1-PS1 CP-UC1-SS1 CP-UC1-SS2 CP-UC1-SS3 CP-UC1-SS4 CP-UC1-SS5 CP-UC1-SS6 CP-UC1-SS7 CP-UC1-SS8 Name Refill Prescription (CASH) Refill Prescription (Payor) Existing Patient, New Prescription New Patient, New Prescription Receive Prescription from Prescriber Receive Prescription via Transfer Reversal of Transaction (CASH) Reversal of Transaction (Payor) View/Enter Patient Record 3.1 CP-UC1-PS1 Refill Prescription (CASH) 3.1.1 Business Overview Refilling a cash prescription involves first locating the client in the DIS, verifying their information for accuracy, and updating and/or confirming their allergies/intolerances. If the client has the prescription in hand (bottle or note), it can be located via the prescription number; otherwise the Pharmacist or Pharmacy Technician may review the prescription profile and/or the DIS, and identify which prescriptions have refills remaining and which prescription the client would like refilled. Once the prescription has been located, the worker can proceed in filling the prescription and having it signed off by the Pharmacist. The Pharmacist may then counsel the client on the prescription they are receiving. Volume 2(a): Business Rules (Pharmacy) 10

3.1.2 Workflow 3.1.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist must submit the dispense to the DIS for DUR processing; and 3. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. Volume 2(a): Business Rules (Pharmacy) 11

3.1.4 Jurisdictional Variations 3.2 CP-UC1-SS1 Refill Prescription (Payor) 3.2.1 Business Overview Refilling a prescription that involves a third party begins with first locating the client in the DIS, verifying their information for accuracy, updating and/or confirming their allergies/intolerances, and entering or updating their third party information if required. If the client has the prescription in hand (bottle or note), it can be located via the prescription number; otherwise the Pharmacist (PhC) or Pharmacy Assistant (PA) may review the prescription profile and/or the DIS, and identify which prescriptions have refills remaining and which prescription the client would like refilled. The PA (or PhC) continues to process the Rx on the DIS. The PhC views and manages the DUR from the DIS and continues to send the claim information to the Third Party Payor. The PhC views and manages the DUR from the Third Party Payor, assesses the fiscal adjudication from them and begins the manual preparation of the Rx. Once the prescription has been prepared, the PhC then checks the medication and signs the hardcopy of the Rx and stores the medication until the patient or agent comes to pick it up at which time the PhC may counsel the client on the prescription they are receiving and the patient pays the co-pay if one exists. Volume 2(a): Business Rules (Pharmacy) 12

3.2.2 Workflow 3.2.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist must first submit the claim to the DIS a single time to permit both DUR and Fiscal adjudication; 3. The Pharmacist should submit the dispense to third party payor for DUR and Fiscal adjudication; and Volume 2(a): Business Rules (Pharmacy) 13

4. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. 3.2.4 Jurisdictional Variations 3.3 CP-UC1-SS2 Existing Patient, New Prescription 3.3.1 Business Overview The process of dispensing a new prescription consists of first locating the client in the system, verifying their information for accuracy, updating and/or confirming their allergies/intolerances, reviewing the patient s medication profile/history, entering the prescription into the system and filling the prescription. Before the prescription is dispensed to the patient, it is signed off by the Pharmacist and the patient may be counselled by the Pharmacist on the medications they are receiving. Volume 2(a): Business Rules (Pharmacy) 14

3.3.2 Workflow 3.3.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist (or PA) must identify themselves as the Data Enterer and reference the Prescriber as the Author in the prescription; 3. The Pharmacist must submit the dispense to the DIS for DUR processing; and; 4. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. Volume 2(a): Business Rules (Pharmacy) 15

3.3.4 Jurisdictional Variations PE Updates to the Client Registry are not supported; PE Non-Residents cannot be allocated Health Numbers from pharmacies; and PE Non-Residents that visited a Provincial hospital or care facility will have a Health Number allocated. 3.4 CP-UC1-SS3 New Patient, New Prescription 3.4.1 Business Overview The process of dispensing a new prescription for a new patient begins with locating the patient within the DIS, updating and/or confirming the patient s allergies/intolerances, reviewing the patient s medical profile and medical history. Once the patient s profile has been created and updated, the PA (or PhC) can begin entering the prescription into the system and filling the prescription. Before the prescription is dispensed to the patient, it is signed off by the Pharmacist and the patient is counselled by the Pharmacist on the medications they are receiving. Volume 2(a): Business Rules (Pharmacy) 16

3.4.2 Workflow 3.4.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist (or PA) must identify themselves as the Data Enterer and reference the Prescriber as the Author in the prescription; 3. The Pharmacist must submit the dispense to the DIS for DUR processing; and Volume 2(a): Business Rules (Pharmacy) 17

4. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. 3.4.4 Jurisdictional Variations 3.5 CP-UC1-SS4 Receive Prescription from Prescriber 3.5.1 Business Overview The process of dispensing a prescription that is received directly from a Prescriber requires the Pharmacist to first verify the authority of the Prescriber and validity of the prescription, and if the prescription is received over the telephone, the PhC must document the details of the Rx (according to Pharmacy Guidelines). Once the details of the prescription are finalized, the PA (or PhC) can proceed by locating the client in the system, verifying their information for accuracy, updating and/or confirming their allergies/intolerances, reviewing the patient s medication profile/history, entering the prescription into the system and filling the prescription. Before the prescription is dispensed to the patient, it is signed off by the Pharmacist and the patient may be counselled by the Pharmacist on the medications they are receiving. Volume 2(a): Business Rules (Pharmacy) 18

3.5.2 Workflow 3.5.3 Business Rules 1. The Pharmacist should verify the authority of the prescriber and validate the prescription as is currently done in today s practice; 2. The Pharmacist must use one of the Find Candidates processes; Volume 2(a): Business Rules (Pharmacy) 19

3. The Pharmacist must submit the dispense to the DIS for DUR processing; and 4. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. 3.5.4 Jurisdictional Variations 3.6 CP-UC1-SS5 Receive Prescription via Transfer 3.6.1 Business Overview Receiving a prescription due to a transfer from another pharmacy requires the Pharmacist to first locate the client in the system, review their patient profile and then contact the transferring Pharmacist via telephone to record the details of the transfer on a paper hard copy. Once the Pharmacist has verified the details of the transferred Rx, they can continue to enter the prescription into the system and fill the prescription. Before the prescription is dispensed to the patient, it is signed off by the Pharmacist and the patient may be counselled by the Pharmacist on the medications they are receiving. It is important to note that the transferring Pharmacist must maintain a record of the transfer on their local system by either making use of their transfer function or by inactivating the transferred Rx. Volume 2(a): Business Rules (Pharmacy) 20

3.6.2 Workflow 3.6.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist must submit the dispense to the DIS for DUR processing; and Volume 2(a): Business Rules (Pharmacy) 21

3. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. 3.6.4 Jurisdictional Variations 3.7 CP-UC1-SS6 Reversal of Transaction (CASH) 3.7.1 Business Overview The process of reversing a cash transaction requires the PA (or PhC) to retrieve the Rx or transaction record on the local system. Once the Rx/transaction record is retrieved, the PA (or PhC) sends the reversal request to the DIS. The PA (or PhC) may provide a refund to the Pt/agent if required and may restock the medication if able based on the regulations of the local Pharmacy Board. Volume 2(a): Business Rules (Pharmacy) 22

3.7.2 Workflow 3.7.3 Business Rules 3.7.4 Jurisdictional Variations Volume 2(a): Business Rules (Pharmacy) 23

3.8 CP-UC1-SS7 Reversal of Transaction (Payor) 3.8.1 Business Overview The process of reversing a Third Party Payor prescription requires the PA (or PhC) to retrieve the Rx or transaction record on the local system. Once the Rx/transaction record is retrieved, the PA (or PhC) must send the reversal request to the Third Party Payor. If the reversal is accepted*, the PA (or PhC) can proceed to send the reversal request to the DIS. The PA (or PhC) may provide a refund to the Pt/agent if required and may restock the medication if able based on the regulations of the local Pharmacy Board. *It should be noted that in the case where a reversal is not accepted, the PA (or PhC) may be required to call the third party helpdesk for a manual reversal and then proceed with the local system and DIS reversal. Volume 2(a): Business Rules (Pharmacy) 24

3.8.2 Workflow 3.8.3 Business Rules 1. The user must indicate a dispense as DIS cancelled and/or TPP reversed in the event that a cancel/reverse was not electronically possible. Volume 2(a): Business Rules (Pharmacy) 25

3.8.4 Jurisdictional Variations 3.9 CP-UC1-SS8 View/Enter Patient Record 3.9.1 Business Overview Virtually all activities relating to providing the patient with service require that you first locate, and potentially create, a patient record within the system. Volume 2(a): Business Rules (Pharmacy) 26

3.9.2 Workflow 3.9.3 Business Rules 1. A patient record must exist for every patient that receives service; and 2. A patient must be identified by a PEI Provincial Health Number. 3.9.4 Jurisdictional Variations Volume 2(a): Business Rules (Pharmacy) 27

PE Prince Edward Island Non-Resident persons information is not presently recorded; and PE Prince Edward Island personal demographic updates may not be transmitted to PhIP. Volume 2(a): Business Rules (Pharmacy) 28

4 CP-UC2 OTC, COUNSELLING, PROFESSIONAL SERVICE The community pharmacy use case group two (CP-UC2) contains workflows and activities that are focused on the provision of Schedule II/III and/or professional services to the patient. ID Name Description CP-UC2-PS1 Dispense Schedule II/III Patient requests a Schedule II or Product Schedule III product (OTC) from a CP-UC2-SS1 Provide Medical/Medication Advice Pharmacist Patient, Physician, or Other Health Professional requests medical/medication advise from a Pharmacist CP-UC2-SS2 Provide Professional Service Patient, Physician, or Other Health Professional requests a Professional Service for a Patient from a Pharmacist 4.1 CP-UC2-PS1 Dispense Schedule II/III Product 4.1.1 Business Overview The process of dispensing a schedule II or III product to a patient requires the PA (or PhC) to first locate the patient in the DIS, update and/or confirm the patient s allergies/intolerances and review the patient s medical profile and medical history. Once the patient is located within the DIS and their profile is up-to-date, the PhC should gather a history of the present illness for which the patient is seeking treatment. The PhC then assesses the symptoms and recommends the proper treatment. Once the proper treatment has been established, the PhC should then update the DIS with the medication information. Provided there are no problems with the medication interacting with the patient s profile, the PhC offers patient counselling, establishes treatment goals, arranges for follow-up if needed, and if necessary refers the patient to a healthcare provider. Volume 2(a): Business Rules (Pharmacy) 29

4.1.2 Workflow 4.1.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist must submit the dispense to the DIS for DUR processing; and; Volume 2(a): Business Rules (Pharmacy) 30

3. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. 4.1.4 Jurisdictional Variations 4.2 CP-UC2-SS1 Provide Medical/Medication Advice 4.2.1 Business Overview Providing medical/medication advice involves first locating the patient in the DIS (if applicable), updating and/or confirming the patient s allergies/intolerances and reviewing the patient s medical profile and medical history. Once the patient is located within the DIS and their profile is up-to-date, the PhC gathers information from the requester pertaining to the advice being sought. If applicable, this information should be entered in to the DIS. If necessary, the PhC collects information from other sources of medication/medical information and provides a response to the question posed in oral or written form. *A note can be attached to the patient or the clinical record regarding the medical/medication advice given. Volume 2(a): Business Rules (Pharmacy) 31

4.2.2 Workflow 4.2.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes if the requester is a patient; 2. The Pharmacist should post the information gathered to the patient s profile if pertinent; Volume 2(a): Business Rules (Pharmacy) 32

3. The Pharmacist should respond according to established professional guidelines in response to any request for advice. 4.2.4 Jurisdictional Variations 4.3 CP-UC2-SS2 Provide Professional Service 4.3.1 Business Overview Providing a professional service involves first locating the patient in the DIS (if applicable), updating and/or confirming the patient s allergies/intolerances and reviewing the patient s medical profile and history. Once the patient is located within the DIS and their profile is up-to-date, the PhC gathers information from the requester relative to the service being sought. If necessary, the PhC collects information from other sources of medication/medical information and provides the professional service to the patient. Once the professional service is rendered, the PhC arranges for follow-up if needed, and if necessary refers the patient to a healthcare provider. If a call-back is necessary this information, along with the information on the type of service provided should be recorded in the DIS. Volume 2(a): Business Rules (Pharmacy) 33

4.3.2 Workflow 4.3.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist may post the professional service provided to the DIS; Volume 2(a): Business Rules (Pharmacy) 34

3. The Pharmacist should respond according to established professional guidelines in response to any request for advice. 4.3.4 Jurisdictional Variations Volume 2(a): Business Rules (Pharmacy) 35

5 CP-UC3 ASSESS/RECORD ALLERGY, OBSERVATION, ADR The community pharmacy use case group three (CP-UC3) contains workflows and activities that are focused on the recording of allergies, patient observations, and adverse drug reactions. ID Name Description CP-UC3-PS1 Add Allergy/Intolerance Record a new allergy or intolerance on the Patient record. CP-UC3-SS1 Update Allergy/Intolerance Revise an allergy or intolerance on the Patient record. CP-UC3-SS2 Add Adverse Drug Reaction Record the event of an Adverse Drug Reaction on the Patient record. 5.1 CP-UC3-PS1 Add Allergy/Intolerance 5.1.1 Business Overview Adding an allergy/intolerance to a patient s profile consists of first locating the patient in the DIS and verifying their information for accuracy. Before entering in the allergy/intolerance in to the system, the PhC questions the patient regarding their specific reaction and makes a clinical determination on whether the reaction is a suspected allergy or intolerance. If required, the PhC follows up with the patient s physician or arranges for follow-up. The PhC then proceeds to record the allergen, allergy, intolerance, and/or specific reaction information to the DIS. Once the data has been entered in to the system, the PhC may provide counselling to the patient on the allergy/intolerance management. Volume 2(a): Business Rules (Pharmacy) 36

5.1.2 Workflow 5.1.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; and 2. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. Volume 2(a): Business Rules (Pharmacy) 37

5.1.4 Jurisdictional Variations 5.2 CP-UC3-SS1 Update Allergy/Intolerance 5.2.1 Business Overview Updating an allergy/intolerance to a patient s profile consists of first locating the patient in the DIS and verifying their information for accuracy. Before updating the allergy/intolerance, the PhC questions the patient regarding their specific updates to the reaction. The PhC then proceeds to record the update to the allergen, allergy, intolerance, and/or specific reaction information to the DIS or deletes allergy or intolerance from the profile if necessary. Once the data has been entered in to the system, the PhC may provide counselling to the patient on the allergy/intolerance management. Volume 2(a): Business Rules (Pharmacy) 38

5.2.2 Workflow 5.2.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; and 2. The Pharmacist should respond according to established professional guidelines in response to any DUR alerts returned. Volume 2(a): Business Rules (Pharmacy) 39

5.2.4 Jurisdictional Variations 5.3 CP-UC3-SS2 Add Adverse Drug Reaction 5.3.1 Business Overview Adding an adverse drug reaction to a patient s profile consists of first locating the patient in the DIS and verifying their information for accuracy. Before entering in the adverse drug reaction in to the system, the PhC should question the patient regarding their specific reaction and makes a clinical determination regarding the suspected adverse reaction. If required, the PhC follows up with the patient s physician or arranges for follow-up. The PhC may then proceed to record the specific information regarding the adverse reaction on the DIS. Once the data has been entered in to the system, the PhC can provide counselling to the patient on the adverse reaction. The PhC may then send the Adverse Reaction reporting form to Health Canada, http://www.hc-sc.gc.ca/dhpmps/alt_formats/hpfb-dgpsa/pdf/medeff/ar-ei_form_e.pdf via phone or fax. Volume 2(a): Business Rules (Pharmacy) 40

5.3.2 Workflow 5.3.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes. 5.3.4 Jurisdictional Variations Volume 2(a): Business Rules (Pharmacy) 41

6 CP-UC4 SUPPORTING PROCESSES The community pharmacy use case group four (CP-UC4) contains workflows and activities that are not easily grouped into the primary use cases that are identified in any other use case. This may include use cases of the following types: Manual processes; Non-Client related processes; Fiscal only processes; and Legislative processes. CP-UC4-SS5 Daily Fiscal Reconciliation Process of reconciling financial transactions between the pharmacy and Jurisdictional payor. CP-UC4-SS6 Transfer Prescription Process of transferring a prescription from one pharmacy to another. CP-UC4-SS7 Attach Note Process of attaching a note to a client, prescription, or other Drug Information System entity. CP-UC4-SS8 Pre-determine or Request Authorization Process of pre-determining the coverage for a product/service or the request for authorization. CP-UC4-SS9 Coverage Extension Process of requesting an extension to an ID Name Description CP-UC4-SS1 Identify Client Process supporting the identification of the client. CP-UC4-SS2 Client Data Masking Process supporting masking of client data from retrieval. CP-UC4-SS2- PE Client Keyword The PEI supported process for masking client data. CP-UC4-SS3 Undo of Prior Action Process of removing recently added data that was incorrect. CP-UC4-SS4 Correct Clinical Data Process of correcting existing data within the Jurisdictional Drug Information System. CP-UC4- SS10 Determine Coverage 6.1 CP-UC4-SS1 - Identify Client 6.1.1 Business Overview existing coverage for a Patient. Process of requesting the coverage of a Patient. Volume 2(a): Business Rules (Pharmacy) 42

In order to process a claim for a Provincial Resident the user must determine the Provincial Health Number (PHN). This number is assigned by the Department due to a birth or as a result of a person making the Province their residence. Volume 2(a): Business Rules (Pharmacy) 43

6.1.2 Workflow Volume 2(a): Business Rules (Pharmacy) 44

6.1.3 Business Rules The PHN of a client may be acquired using the following methods: Swiping the client s Provincial Health Card; Request the PHN from the client; Request the PHN from the client s relatives or representatives; Searching local paper and electronic files; Searching the DIS using the Patient Profile query ; and Calling Medicare. 6.1.4 Jurisdictional Variations PE PEI Health Cards are supplied with a magnetic strip that can be used to retrieve the Health Number and vendors are encouraged to card-enable their software offerings. 6.2 CP-UC4-SS2 Client Data Masking 6.2.1 Business Overview All clients have the right to mask certain data contained within their patient profile. However, the client demographics can always be viewed regardless of whether the profile is masked or not. Control of the masking is possible based on the jurisdiction. Volume 2(a): Business Rules (Pharmacy) 45

6.2.2 Workflow Volume 2(a): Business Rules (Pharmacy) 46

6.2.3 Business Rules 6.2.4 Jurisdictional Variations PE PEI does not support the ability to allow external entities to adjust masking of the clinical profile through messaging. 6.3 CP-UC4-SS2-PE Client Keyword 6.3.1 Business Overview All clients have the right to apply a keyword to their profiles as a right of privacy. When a client has chosen to exercise this right, the Pharmacist can only access their client clinical profile upon entering the client s keyword into the system. Provision of the keyword is at the sole discretion of the client. Volume 2(a): Business Rules (Pharmacy) 47

6.3.2 Workflow Volume 2(a): Business Rules (Pharmacy) 48

6.3.3 Business Rules 1. The local software should provide a means to securely gather the keyword from the client. The Department recommends that a separate numeric pad for clients be provided to enter their keyword; 2. The staff must make all reasonable effort to ensure that the client keyword is not disclosed; and 3. In the event of a forgotten keyword, the client must contact the PhIP Director to retrieve their keyword through the help desk. After responding to a security clearance question, the client will be given the keyword. A follow-up form letter from the PhIP Director confirming the override should catch any instance of abuse. 6.3.4 Jurisdictional Variations PE PEI does not provide a message based solution for creating/changing/removing keywords. 6.4 CP-UC4-SS3 Undo of Prior Action 6.4.1 Business Overview An undo may be required to correct a mistake made during the course of dispensing or managing the clinical attributes of a patient. A PhC has a jurisdictionally allotted number of calendar days to perform an undo which will ultimately remove the mistake from the patient s profile. Volume 2(a): Business Rules (Pharmacy) 49

6.4.2 Workflow Volume 2(a): Business Rules (Pharmacy) 50

6.4.3 Business Rules 6.4.4 Jurisdictional Variations PE PEI has chosen a period of seven (7) calendar days for most undo events and (2) calendar days for other subsequent undo events; PE Undo events are not support for interactions that provide clearly established business processes for undoing (i.e. invoices must be reversed, not undone). 6.5 CP-UC4-SS4 Correct Clinical Data 6.5.1 Business Overview The health care provider may upon identifying an error in the clinical data perform a corrective action to remedy the data on the patient s profile. In the cases where this transaction is directly supported by an update action it can be conducted through the supported processes. In cases where existing messaging does not provide a means of correcting the information the provider may choose to attach a note and/or contact the DIS helpdesk to facilitate the corrective action to the profile. Volume 2(a): Business Rules (Pharmacy) 51

6.5.2 Workflow Volume 2(a): Business Rules (Pharmacy) 52

6.5.3 Business Rules 6.5.4 Jurisdictional Variations 6.6 CP-UC4-SS5 Daily Fiscal Reconciliation 6.6.1 Business Overview The Daily Fiscal Reconciliation Process is a tracking method used to ensure that the submitted scripts have been billed correctly. This is a daily comparison of the daily sales report against a report listing all electronic billings with the billing totals versus the amount that the Pharmacy was reimbursed and serves to ensure no errors. Volume 2(a): Business Rules (Pharmacy) 53

6.6.2 Workflow Volume 2(a): Business Rules (Pharmacy) 54

6.6.3 Business Rules 1. The Pharmacist should be able to generate a report from the local system that provides the daily transaction totals broken down by cost, markup, and fee categorized by each Provincially provided drug plan; 2. At the end of each day, Pharmacists may generate, from the local system, a daily sales report which tallies all sales onto a one-page report. The totals, broken down by cost, markup and fee for what was billed against each drug plan are listed including the amount the drug plan pays. The totals for each are listed at the bottom of the page; 3. A report that lists each plan on a separate page may then be generated by the Pharmacist. This report generates the individual script numbers with the totals of both the charged price and the amount the Pharmacy was reimbursed listed next to the script number. The totals for the particular plans are listed at the bottom of each page. At the end of the report a list of all electronic billings showing the amount that was billed versus the amount that was reimbursed to the Pharmacy is represented as well as the difference in the two amounts. These figures allow the Pharmacist to ensure that the scripts were billed correctly. A list of all scripts that were filled, but failed to get captured by the plan electronically, is also generated as another option for analysis; and 4. The local system may provide a facility in which the daily totals by program can be retrieved. The totals in the drug plan responses are compared against the local system generated reports to ensure no errors. 6.6.4 Jurisdictional Variations PE PEI is supporting only the summary SOFA query. 6.7 CP-UC4-SS6 Transfer Prescription 6.7.1 Business Overview The process of transferring a prescription can arise as a result of the patient requesting that the Pharmacist transfer the refill authority for a prescription(s) to another pharmacy. In this case, the transfer of this information will be sent to the DIS by the Pharmacist transferring the prescription and can be retrieved by the Pharmacist at the receiving pharmacy. Volume 2(a): Business Rules (Pharmacy) 55

6.7.2 Workflow Volume 2(a): Business Rules (Pharmacy) 56

6.7.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The transfer of refill authorizations to another pharmacy must be recorded on the DIS in compliance with existing Pharmacist guidelines and must also be recorded on hard copy by the receiving Pharmacist; 3. All refill authorizations remaining on the prescription must be transferred on previously filled prescriptions; 4. New, previously un-dispensed prescriptions may be transferred; and 5. Transfer of narcotic and controlled drugs is not permitted according to Pharmacy guidelines. 6.7.4 Jurisdictional Variations 6.8 CP-UC4-SS7 Attach Note 6.8.1 Business Overview A PA and/or PhC have the ability to attach a note to a number of different items within the DIS. Such items include: Patient Note; Prescription Note; Allergy Note; Immunization Note; Patient Observation Note; Medical Condition Note; Prescribing Indication Note; and Dispensing Note. Volume 2(a): Business Rules (Pharmacy) 57

6.8.2 Workflow Volume 2(a): Business Rules (Pharmacy) 58

6.8.3 Business Rules 6.8.4 Jurisdictional Variations 6.9 CP-UC4-SS8 Pre-determine or Request Authorization 6.9.1 Business Overview The pre-determination or request authorization process provides the Provider with the capability of assessing the clinical impacts of a chosen medication. The proposed prescription is submitted to the DIS and the DIS will respond with potential contraindications and issues with the use of the requested medication. This process allows the Provider to perform a complete DUR prior to choosing to commit to making a dispense claim. Volume 2(a): Business Rules (Pharmacy) 59

6.9.2 Workflow Volume 2(a): Business Rules (Pharmacy) 60

6.9.3 Business Rules 1. The Pharmacist must use one of the Find Candidates processes; 2. The Pharmacist should use this transaction rather than submitting a dispense claim and reversing it; 3. The Prescriber should use this transaction prior to writing a prescription; 4. The Provider must practice best judgement. This message is provided as an aid in the patient care. It is not a replacement for professional judgement; 5. The DIS may include indicators of whether the prescription would be covered by an existing Provincial Program; and 6. The host system may include indicators of alternative medications that are deemed suitable. 6.9.4 Jurisdictional Variations PE PEI will continue to support the common practice of submitting an invoice followed by a reversal until such a time as sufficient payors implement the required NeCST message support to fully support the coordination of benefits. 6.10 CP-UC4-SS9 Coverage Extension 6.10.1 Business Overview Situations may arise where the existing coverage for a patient does not adequately account for the nature of the drugs required to treat the patient. A coverage extension is a request to extend or modify the existing coverage. Volume 2(a): Business Rules (Pharmacy) 61

6.10.2 Workflow Volume 2(a): Business Rules (Pharmacy) 62

6.10.3 Business Rules 6.10.4 Jurisdictional Variations PE PEI is not supporting the use of a coverage extension. 6.11 CP-UC4-S10 Determine Coverage 6.11.1 Business Overview The client-eligibility business process is provided for the Pharmacist to interactively determine the present eligibility of a given client without incurring the overhead of submitting a claim followed by a subsequent reversal or rejection. The Pharmacist may use this feature to determine either general coverage under any Provincial program or specifically for a given program code. The Pharmacist and/or local system must provide the following to determine the eligibility: Client s Provincial Health Number (mandatory); Date of Service (mandatory); and Program Code (suggested). Volume 2(a): Business Rules (Pharmacy) 63

6.11.2 Workflow Volume 2(a): Business Rules (Pharmacy) 64