# Presentation: 075156

## Pharmacy Regulatory Issues The EnforcerSession #118

- Jeff Ramirez
- John Lowe
- Lynn Sanders

## PHARMACY REGULATORY ISSUES Session #118 The Enforcer

- Local Regulations (Facility and VISN level)
- Jeff Ramirez
- Enterprise Wide (VA National level)
- John Lowe
- Global (United States level)
- Lynn Sanders

**Notes:**
For this session we will view three approaches to regulations that affect VA Pharmacy Informatics
Local Regulations (Facility and VISN level), Enterprise Wide (VA National level), Global (United States level)

## The Joint Commission (JC)

- SOARS program reviews for readiness
- Patient Safety Goals
- Recent discussions on MM.4.10

## Patient Safety GoalsChanges for 2008

- Goal 3 Improve the safety of using Medications
- 3E Reduce the likelihood of patient harm associated with the use of anticoagulation therapy

## Patient Safety GoalsChanges for 2008

- Goal 7 reduce the risk of health care-associated Infections
- 7A Comply with current World Health Organization (WHO) Hand Hygiene Guidelines or Centers for Disease Control and Prevention (CDC) hand hygiene guides.

## Patient Safety GoalsChanges for 2008

- Goal 8 Accurately and Completely reconcile medications across the continuum of care reduce the risk of health care-associated infections
- No Change but still a HOT TOPIC

## Medication Management (MM 4.10)

- Pharmacist must review all orders prior to admission
- Emergency Department Interim Action
- Radiology Interim Action
- Revision expected late in 2007
- Potential Solution, Inpatient Medications for Outpatients & BCMA changes

## USP 797

- _[http://www.usp.org/pdf/EN/USPNF/PF797redline.pdf](http://www.usp.org/pdf/EN/USPNF/PF797redline.pdf)_
- Proposed changes to chapter
- Final version to be free on website by end of August
- _[http://www.usp.org/USPNF/pf/generalChapter797.html](http://www.usp.org/USPNF/pf/generalChapter797.html)_
-  USP main 797 site

## FDA Medication Guides

- Required on designated drugs
- To be provided by manufacturer
- Recent FDA Hearings pharmacist provision of med guides.
- _[http://www.fda.gov/cder/Offices/ODS/medication_guides.htm](http://www.fda.gov/cder/Offices/ODS/medication_guides.htm)_
- VA provided Comments to Open Hearing

## VHA Directive 98-020Drug Accountability 3.0

- March 31, 1998
- Mandatory use of Drug Accountability software
- Impact on E-pharmacy Claims
- Prime Vendor Invoices
- Updates NDC information
- Alternative to manual edits.

## PHARMACY REGULATORY ISSUES Session #118 

- Local Regulations (Facility and VISN level)
- Jeff Ramirez
- Enterprise Wide (VA National level)
- John Lowe
- Global (United States level)
- Lynn Sanders

**Notes:**
For this session we will view three approaches to regulations that affect VA Pharmacy Informatics
Local Regulations (Facility and VISN level), Enterprise Wide (VA National level), Global (United States level)

## External and Internal Review Programs

- Office of Inspector General Combined Assessment Program (OIG CAP)
- System-wide Ongoing Assessment & Review Strategy (SOARS)
- Joint Commission
- Government Accounting Office
- Drug Enforcement Agency

## OIG CAP REVIEW PROGRAM

- Combine knowledge and skill of all divisions of OIG (Audit, Inspection, Investigation)
- Cyclical review of all facilities every 2-3 years
- Ensure high quality healthcare is provided to veterans

## OIG CAP PURPOSE

- Evaluate how well VA’s are providing access to quality care
- Determine if management controls are in place to minimize vulnerability to fraud, waste and abuse
- Provide fraud and integrity awareness training to VA staff

## IG CAP FOCUS AREAS IN PHARMACY

- Environment of care
- Government purchase cards
- Controlled substances
- Physical security
- Inventory management (returns, stock levels)

## OIG Summary Report Oct 2006 – Mar 2007

- VA Pharmacist convicted of stealing $670,000 of medications
- VA nurse diverts 1050 doses of controlled substances
- Several patients medications mailed to incorrect patient resulting in privacy violations
- Pharmacy manager pled guilty to conflict of interest charges
- VA employee improperly accepted gift from prohibited source

## OIG CAP FOCUS AREAS IN PHARMACY

- Environment of care
- Government purchase cards
- Controlled substances
- Physical security
- Inventory management (returns, stock levels)

## ENVIRONMENT OF CARE 

- Med room entry codes posted on wall
- Pyxis discrepancy reports not resolved at end of shift
- Prescription pads not secured
- Temperature in med refrigerators not monitored daily

## GOV’T PURCHASE CARDS

- Cardholders not using FSS or national contracts
- Transactions not reconciled and/or approved within time limits
- Quarterly audits of cardholder activity not completed
- Cardholders exceeding spending limits

## CONTROLLED SUBSTANCES (CS)

- Random, unannounced inspections not completed in all areas monthly
- Returned drugs not secured properly
- CS in research not ordered by pharmacy
- Hard copy verification not completed during inspections

## CS (continued)

- Drugs for destruction not included in inspection or destroyed quarterly
- 72 hr checks not completed, resolved, and records maintained for 3 years
- Inspectors not appointed in writing by Director for terms up to 3 years
- Refresher training not provided to inspectors, and performance not monitored

## CS (continued)

- Losses of CS not reported via 1108.1
- Access to vault not limited by policy
- CS in refrigerators not included in change of shift counts
- Unsealed liquids not measured during inspection
- CS prescriptions not secured at window prior to pickup

## CS (continued)

- Vault inventory levels excessive
- Lack of accountability in mailroom for CS
- Lack of separation of duties in ordering and receiving medications
- AMM or designee not witnessing receipt of CS
- RX pads not secured or inventoried

## Pharmacy Physical Security

- Suspected theft, diversion or suspicious loss not reported to VA Police immediately
- Keypad shields not in place
- Alarms not tested monthly
- Electronic access systems not in compliance with standards (Card plus PIN for vault)
- Vault construction not meeting standards

## PHYSICAL SECURITY (continued)

- Outer vault door not locked when pharmacy closed
- Returned controlled substances not secured and stored in vault
- Dispensing windows not bulletproof
- Recommendations from annual physical security assessment not completed

## SUGGESTIONS FOR OIG CAP VISIT

- Obtain and review OIG Controlled Substances worksheet
- Complete self assessment with PBM worksheet 6 months in advance
- Review all requested data prior to mailing to IG
- Review data and procedures in vault to ensure practice conforms with policy

## New Focus Areas for OIG CAP

- Patients receiving early refills/duplicate CS prescriptions (potential staff or patient diversion)
- Accountability of high cost drugs such as epo, sildenafil, atorvastatin, etc.
- Inventory management system
- P&T Committee activities (DUE, patient safety, etc)
- Antipsychotic medications monitoring and 30 vs. 90 day fills
- Timely administration and discontinuing of antibiotics

## SOARS Program

- Provide assessment and educational consultation to VA facilities
- Support a continuous readiness culture
- Help provide quality health services
- Assist medical centers with meeting standards of care
- Identify and share strong practices

## Top Findings Related to Pharmacy

- Outdated medications and improper labeling and dating of multi-dose vials
- Refrigerator temperatures not monitored on a 24hr, 7 day basis
- Controlled substance inspection programs not effective
- Medication security outside pharmacy not sufficient
- Emergency drug cache not included in drills

## SOARS Assessment Guides for Pharmacy

- Controlled substance program
- Pharmacy review
- Physical security
- Vault procedures
- USP 797
- Emergency drug cache
- Medication reconciliation
- Self medication programs

## Government Accounting Office

- Recent reviews on drug inventory management
- Focused on drugs returned for credit
- Recommendations regarding security, accountability and trending

## PHARMACY REGULATORY ISSUES Session #118 

- Local Regulations (Facility and VISN level)
- Jeff Ramirez
- Enterprise Wide (VA National level)
- John Lowe
- Global (United States level)
- Lynn Sanders

**Notes:**
For this session we will view three approaches to regulations that affect VA Pharmacy Informatics
Local Regulations (Facility and VISN level), Enterprise Wide (VA National level), Global (United States level)

## Impact of Global Regulations on VA Pharmacy Systems

- This section will focus on current and emerging global regulations
- Systems requirements to implement those regulations
- VA’s efforts to participate on a global level to develop global requirements
- VA’s efforts to modify and develop its current system to meet global requirements.

## Global Regulations

- VA Informatics systems design and management are not just impacted by VA policies and regulations but also by the country’s move to develop and mandate technology standards.
- For this presentation the term global regulations will apply to those National and International regulations that impact VA Pharmacy Informatics.
- Through US Congressional mandates VA may be required to adopt and comply with Global Regulations.

**Notes:**
Global regulations are important to VA because:

## Global Regulating Agencies

- Department of Health and Human Services
- Clinical Care
- Financial Re-imbursements
- State Regulating Agencies
- Environmental Protection Agency
- Drug Enforcement Agency

## How have HHS Informatics Regulations Impacted VHA Pharmacy

**Notes:**
The Department of Health and Human Services plays a major role in establishing global regulations.  To date these global regualations have already begun to impact VA Pharmacy Programs

## The HIPPA Law

- Dept. of Health and Human Services:
**HIPPA:** The Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) required the Department of Health and Human Services (HHS) to establish national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. It also addressed the security and privacy of health data. As the industry adopts these standards for the efficiency and effectiveness of the nation's health care system will improve the use of electronic data interchange.

**Notes:**
WE are currently required to be compliant with HIPPA regulations:

HIPAA Goals
The goals of the HIPAA legislation are summarized as follows:
Enhance the flow of information by creating unique identifiers for the constituents in healthcare; patients, providers, payers and employers. 
Secure the healthcare environment and confidentiality of healthcare information by establishing security and privacy standards. 
Reduce administrative costs through standardization of transaction formats and code sets.
HIPAA opportunities include (1) automation of expensive, manual processes such as health plans’ telephone responses to providers’ claim status and eligibility inquires; (2) increased health plan access to cost-saving information related to coordination of benefits; and (3) improvement of health data quality and completeness.

One of HIPPA s major goals has been to implement President Bush’s plan for a National Interoperable Health Record – as such HIPPA will be setting standards and regulations in this regard.

## HIPAA Violations

- CMS will be responsible for enforcing the transaction and code set standards that are part of the Administrative Simplification provisions of HIPAA.  Violations will be tracked through a complaint-based process that is tracked through the CMS website at _[http://www.cms.gov/hipaa/hipaa2/enforcement/default.asp](http://www.cms.gov/hipaa/hipaa2/enforcement/default.asp)__.._

## HIPPA Penalties for non-compliance include:

- Monetary penalties for violations of the standards ranging from $50,000 to $250,000 and up to ten years in prison for violations of the proposed privacy standards.
- Monetary penalties of not more than $100 per violation on any person who fails to comply with a standard other than the privacy standard, except that the total amount imposed on any one person in each calendar year may not exceed $25,000 for violations of one requirement

**Notes:**
And with violations come penalties.  Currently penalities for violations range from $50,000 to $250,000.

## HIPPA and The President’s Vision

- 	President Bush’s vision for widespread adoption of interoperable electronic health records (EHRs) within ten (10) years.

**Notes:**
After the HIPPA laws were established President Bush determined that the agency should extend its reach and bring enhanced value to the US Healthcare system.

## National Data Sharing Initiative

- Federal agencies with health-related missions need to find a way to share their health information. This health data sharing will enable them to make significant strides towards improving patient safety, reducing error rates, lowering administrative costs, and strengthening national public health and disaster preparedness. To share health data, agencies need to adopt the same clinical vocabularies and the same ways of transmitting that information

**Notes:**
In moving to implement the President’s plan. Health and Human Services Department also thought that by establishing a national data sharing initiative, we could improve health care quality and reduce the costs.  

## What organizations under HHS develop policies and regulations that require compliance

**Notes:**
 HHS established organizational to direct this effort and extended invitations to private and public sector organizations to work with this national effort.  

## HHS Agencies

- Agency for Healthcare Quality and Research - AHQR
- Center for Medicare and Medicaid Services – CMS
- Food and Drug Administration - FDA

## ONCHIT

- “ONCHIT” is the Office of the National Coordinator for Health Information Technology. Its mission is to implement President Bush’s vision for widespread adoption of interoperable electronic health records (EHRs) within ten (10) years.

**Notes:**
The Office of the National Coordinator for Health Information Technology was established to Our Dr. Robert Kolodner currently is a ONC leader.

## ONC (Office of National Coordinator for Health Information Technology)

- Under the US  Department of Health and Human Services, ONC
- 		Adopts a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to “speak the same language” based on common enterprise-wide business and information technology architectures.

## CHI Standards – Consolidated Health Information Standards http://www.hhs.gov/healthit/chiinitiative.

- The Consolidated Health Informatics (CHI) initiative will establish a portfolio of existing clinical vocabularies and messaging standards enabling federal agencies to build interoperable federal health data systems.

**Notes:**
Under the US  Department of Health and Human Services
	Office of the National Coordinator for Health Information Technology (ONC)
	Adopts a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to “speak the same language” based on common enterprise-wide business and information technology architectures.
Federal agencies with health-related missions need to find a way to share their health information. This health data sharing will enable them to make significant strides towards improving patient safety, reducing error rates, lowering administrative costs, and strengthening national public health and disaster preparedness. To share health data, agencies need to adopt the same clinical vocabularies and the same ways of transmitting that information. For example, today "cold" can mean many different things (temperature, mood, illness, influenza, and so forth). With common vocabulary standards, agencies are able to understand what "cold" means; with common messaging standards, they are able to transmit that information in a way that maintains its meaning. This sharing information within and between agencies establishes "interoperability." Public and private groups have emphasized how interoperability through standards will enable us to share a common electronic patient medical record and in turn greatly improve the quality of US healthcare.
The Consolidated Health Informatics (CHI) initiative will establish a portfolio of existing clinical vocabularies and messaging standards enabling federal agencies to build interoperable federal health data systems. This commonality will enable all federal agencies to “speak the same language” and share that information without the high cost of translation or data re-entry. Federal agencies could then pursue projects meeting their individual business needs aimed at initiatives such as sharing electronic medical records and electronic patient identification. CHI standards will work in conjunction with the Health Insurance Portability and Accountability Act (HIPAA) transaction records and code sets and HIPAA security and privacy provisions.
About 20 department/agencies including HHS, VA, DOD, SSA, GSA, and NIST are active in the CHI governance process. Through the CHI governance process, all federal agencies will incorporate the adopted standards into their individual agency health data enterprise architecture used to build all new systems or modify existing ones. There is a Consolidated Health Informatics Work Group that leads the work and is one of the five established FHA Work Groups. CHI conducts outreach to the private sector through the National Committee on Vital and Health Statistics; records and schedules are available at www.ncvhs.hhs.gov.

## 508 Compliance

- Section 508 of the Rehabilitation Act Amendments of 1998 requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, they shall ensure that the electronic and information technology allows Federal employees with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

**Notes:**
We wouldn’t want to leave out 508 compliance regulations which affect font size, colors, etc.

## Organizations That Work to Provide Standards, and Regulations 

- ANSI - American National Standards Institute
- HITSP - Healthcare Information Technology Standards Panel (HITSP).
- FMT – Federal Medication Terminology

**Notes:**
We’ll discuss some of the organizations and committees that are working to establish health informatics standards. ANSI, HITSP, and FMT

## ANSI

- As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment

**Notes:**
ANSI is one of the organizations contracted with HIPPA/ONC to establish standards to support the Presidents plan.  As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment. The Institute oversees the creation, promulgation and use of thousands of norms and guidelines that directly impact businesses in nearly every sector: from acoustical devices to construction equipment, from dairy and livestock production to energy distribution, and many more. ANSI is also actively engaged in accrediting programs that assess conformance to standards – including globally-recognized cross-sector programs such as the ISO 9000 (quality) and ISO 14000 (environmental) management systems. Mission To enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity
Affiliations ANSI is the official U.S. representative to the International Organization for Standardization (ISO) 

## What is the Healthcare Information Technology Standards Panel?

- One of the recommendations submitted by the *Standards Harmonization Collaborative* in its response to the ONCHIT1 RFP was the establishment of a Healthcare Information Technology Standards Panel (HITSP). The Panel’s objective is to achieve widely accepted and readily-implemented consensus-based standards that will enable and support widespread interoperability among healthcare information technology, especially as they would interact in a Nationwide Health Information Network (NHIN) for the United States.

**Notes:**
What is HITSP? The Panel’s objective is to achieve widely accepted and readily-implemented consensus-based standards that will enable and support widespread interoperability among healthcare information technology, especially as they would interact in a Nationwide Health Information Network (NHIN) for the United States. 

## HITSP (Healthcare Information Technology Standards) www.ansi.org/hitsp/ 

**Notes:**
HITSP has taken the lead on trying to “harmonize” communications between US health care informatics systems.

## A National Health Information Network

**Notes:**
This slide depicts how HITSP’s proposed Global National Health Information Network will communicate.  Having a industry technology infrastructure that’s linked to the Healthcare industry will facilitate industry transformation and bring healthcare value to the consumer.

**Notes:**
Harmonization of data is based on nationally accepted standards.  So a requirement of national or global standards for clinical information would be that those standards allowed harmonization of data sharing.

## How will the National Health Information Network Be Developed?

- RHIOs – Regional Health Information Organizations
- HIEs – Health Information Interchanges

**Notes:**
Regional Health Information Organizations and Health Information Interchange programs can act as a conduit to share clinical information and support harmonization among participating organizations.

## What are the Global Standards that Pharmacy Must Comply With

**Notes:**
Organizations have been participating in developing standards to support HHS’s goal to develop compliance regulations for US Health care organizations.  Now we’ll discuss some of those standards developed to date that VA will be expected to comply with.  One of the most important requirements for these standards is interoperability.

## The CHI Standards (Highlights for Pharmacy)

- HL7 Messaging
- NCPDP for ordering retail pharmacy drugs
- DICOM for imaging
- LOINC for Laboratory results
- HIPPA codes for billing and administrative functions
- FDA for ingredient names and codes, dosage forms, drug products and packages
- RxNORM for describing clinical drugs
- VA National Drug File Reference Terminology for specific drug classifications.

**Notes:**
The most significant federal standards for compliance have come out of CHI.
The standards all federal agencies will adopt are:
Health Level 7 (HL7) messaging standards to ensure that each federal agency can share information that will improve coordinated care for patients such as entries of orders, scheduling appointments and tests and better coordination of the admittance, discharge and transfer of patients. 
National Council on Prescription Drug Programs (NCDCP) standards for ordering drugs from retail pharmacies to standardize information between health care providers and the pharmacies. These standards already have been adopted under the Health Insurance Portability and Accountability Act (HIPAA) of 1996, and ensures that parts of the three federal departments that aren’t covered by HIPAA will also use the same standards. 
The Institute of Electrical and Electronics Engineers 1073 (IEEE1073) series of standards that allow for health care providers to plug medical devices into information and computer systems that allow health care providers to monitor information from an ICU or through telehealth services on Indian reservations, and in other circumstances. 
Digital Imaging Communications in Medicine (DICOM) standards that enable images and associated diagnostic information to be retrieved and transferred from various manufacturers’ devices as well as medical staff workstations. 
Laboratory Logical Observation Identifier name Codes (LOINC) to standardize the electronic exchange of clinical laboratory results.
Full Reports:
Laboratory Result Names [PDF - 201KB] - adopted 
Messaging Standards: Includes scheduling, medical record/image management, patient administration, observation reporting, financial management, patient care [PDF - 126KB] - adopted 
Messaging Standards: Includes retail pharmacy transactions [PDF - 117KB] - adopted 
Messaging Standards: Connectivity [PDF - 124KB] - adopted 
Messaging Standards: Includes Image Information to Workstations [PDF - 119KB] - adopted 
Health Level 7 (HL7) vocabulary standards for demographic information, units of measure, immunizations, and clinical encounters, and HL7’s Clinical Document Architecture standard for text based reports. (Five standards) 
The College of American Pathologists Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) for laboratory result contents, non-laboratory interventions and procedures, anatomy, diagnosis and problems, and nursing. HHS is making SNOMED-CT available for use in the U.S. at no charge to users. (Five standards) 
Laboratory Logical Observation Identifier Name Codes (LOINC) to standardize the electronic exchange of laboratory test orders and drug label section headers. (One standard.) 
The Health Insurance Portability and Accountability Act (HIPAA) transactions and code sets for electronic exchange of health related information to perform billing or administrative functions. These are the same standards now required under HIPAA for health plans, health care clearinghouses and those health care providers who engage in certain electronic transactions. (One standard.) 
A set of federal terminologies related to medications, including 
the Food and Drug Administration’s names and codes for ingredients, manufactured dosage forms, drug products and medication packages, 
the National Library of Medicine’s RxNORM for describing clinical drugs, and the 
Veterans Administration’s National Drug File Reference Terminology (NDF-RT) for specific drug classifications. (One standard.) 
The Human Gene Nomenclature (HUGN) for exchanging information regarding the role of genes in biomedical research in the federal health sector. (One standard.) 
The Environmental Protection Agency’s Substance Registry System for non-medicinal chemicals of importance to health care. (One standard.) 
Digital Imaging Communications in Medicine (DICOM) standards to enable the exchange of multimedia information 
Health Level 7 (HL7), SNOMED, the FDA SRS and EPA SRS UNII Codes and RXNORM for the exchange of allergy information 
Health Level 7 (HL7), International Classification of Functioning and Disability (ICF) and related CHI endorsed vocabularies for the exchange of Clinical Assessments and Disability and Functional Status 
Medications: Summary report including Special Populations and Drug Classifications [PDF - 222KB] - adopted 
Medications: Structured Product Labeling Sections [PDF - 140KB] - adopted 
Medications: Drug Product [PDF - 115KB] - adopted 
Medications: Package [PDF - 112KB] - adopted 
Medications: Active Ingredients [PDF - 155KB] - adopted 
Medications: Clinical Drug [PDF - 122KB] - adopted 
Medications: Manufactured Dosage Form [PDF - 118KB] - adopted 
Anatomy [PDF - 241KB] - adopted 
Billing / Financial [PDF - 232KB] - adopted 
Chemicals [PDF - 148KB] - adopted 
Clinical Encounters [PDF - 196KB] - adopted 
Demographics [PDF - 222KB] - adopted 
Diagnosis and Problem Lists [PDF - 236KB] - adopted 
Genes [PDF - 209KB] - adopted 
Immunizations [PDF - 179KB] - adopted 
Interventions & Procedures Laboratory Test Order Names [PDF - 233KB] - adopted 
Interventions and Procedures, non-Laboratory [PDF - 305KB] - adopted 
Laboratory Result Contents [PDF - 292KB] - adopted 
Nursing [PDF - 340KB] - adopted 
Text Based Reports [PDF - 269KB] - adopted 
Units [PDF - 292KB] - adopted 
Multimedia [DOC - 266KB] - adopted 
Allergy [DOC - 497KB] - adopted 
Disability and Assessments Forms [ZIP - 267KB] - adopted 

## Drug Enforcement Agency -DEA

- DEA currently has regulations for electronically ordering of controlled substances
- And is developing regulations for electronically prescribing Controlled substances.  These regulations will be aligned with CMS regulations for e-prescribing. VA participated in the pilot project for these requirements.  These requirements should be in place in 2008.
**dea**.diversion.policy@usdoj.gov,

**Notes:**
The next major organization with compliance standards is the DEA.
DEA currently has regulations for electronically ordering of controlled substances
And is developing regulations for electronically prescribing Controlled substances.  These regulations will be aligned with CMS regulations for e-prescribing. VA participated in the pilot project for these requirements.  These requirements should be in place in 2008.

## Food and Drug Administration FDA

- Drug Codes (NDC)
- Patient Medication Instruction Sheets
- Structured Product Labels (SPL)/Daily Meds
- Med Guides:
-   http://www.fda.gov/cder/Offices/ODS/medication_guides.htm

**Notes:**
The Food and Drug Administration has been developing and mandating compliance standards for some time.  We are all familiar with NDC codes, and the requirement to distribute Patient Medication Instruction Sheets,
but some of the new work has been the development of the Structure Product Labels that manufacturers are required to comply with, and Medication Guides
We- Medication Guides
Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: 
certain information is necessary to prevent serious adverse effects 
patient decision-making should be informed by information about a known serious side effect with a product, or 
patient adherence to directions for the use of a product are essential to its effectiveness.
We’re all aware of some of the challenges that Med Guides are causing us today.

## FDA DailyMed

- DailyMed provides high quality information about marketed drugs. This information includes FDA approved labels (package inserts). This Web site provides health information providers and the public with a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts.
- http://dailymed.nlm.nih.gov.

**Notes:**
The VA has also been working with the National Library of medicine to develop guidance on FDA DailyMeds.

## Interoperable Standards Accepted by VA

- CHI Standards – NCPDP for e-Pharmacy Claims
- National Provider Indicator
- DEA Controlled Substances Ordering
- FDA – Drug Codes, ADR, Med Guides
*VA has several major projects that require use of these standards*

**Notes:**
The VA has already accepted and is in compliance with a number of the global standards, I’ve mentioned

## Electronic Health RecordsVA CPRS

- CPRS includes Pharmacy, Lab, Radiology, Allergy Tracking, Consults, Dietetics, Progress Notes, Problem List, Patient Administration, Vitals, PCE, TIU, ASU and Clinical Lexicon
- Require interoperable standardized terms
- Adhere to HHS,FDA, and DEA regulations
- Provider Credentials – NPI
- Messaging Services – HL7
- 508 Compliant
- .

**Notes:**
Our EHR/CPRS meets the current laws and standards, for medical record storage as well electronic prescribing

## E-Prescribing and e-PHARMACY BILLINGe-Pharmacy Claims Project

- Require interoperable standardized terms
- Adhere to HHS,FDA, and DEA regulations
- State regulations – transfer of prescriptions
- Provider Credentials – NPI
- Pharmacy Credentials – NCPDP
- Messaging Services – HL7

**Notes:**
Our e-prescribing system is not fully compliant, as we still need to incorporated NCPDP requirements for dispense units, and some billing information, but we’re making significant progress

## Personal Health Records (PHR) VA My HealtheVet

- Adhere to HHS regulations – HIPPA, Privacy and Security.
- 508 Compliant
- Challenges
- Allow non-VA medication documentation to populate medical record in CPRS

**Notes:**
And MyHealtheVet has been very successful, but we still have some challenges and opportunites

## National Provider Indicator

- The public database will include only a subset of information submitted on the NPI application (to the National Plan and Provider Enumeration System, NPPES).  In brief, the data elements will include:
- NPI
- Name (First, Last)
- Business address and business phone number
- Taxonomy code
- License number
- License number state code
- http://www.cms.hhs.gov/NationalProvIdentStand/Downloads/DataDisseminationNPI.pdf )

**Notes:**
VA has recently completed requires for the National Provider Indicator.

## VA and HIPPA

- The VHA HIPAA PMO, within the Chief Business Office, has been chartered by the Under Secretary for Health to ensure that VHA complies with HIPAA. The PMO provides education about HIPAA, monitors legislative changes, facilitates VHA implementation activities, and coordinates activities with the VHA Privacy Office, other VHA Program Offices, and the VA Enterprise Privacy Program. Contact HIPAA PMO.

**Notes:**
And in order to facilitate compliance VA has established an internal PMO office that can be used as a resource.

## VA Business Drivers for Data Standardization

- To support data exchange, comparison, aggregation and reporting among VHA sites
- To readily support clinical research efforts
- To support development of an integrated, longitudinal patient record
- To enable exchange of clinically relevant health data between VA, other agencies, and other health partners
- To enable decision support on patient’s complete medical record
- To reduce costs by eliminating redundant expenses

*VA IT STS*

**Notes:**
I borrowed this slide from VA IT STS, because it clearly expressed the reasons for VA to be actively engaged in establishing global standards.

## VA as a Standards Setting Organization

- VA NDF – National Drug File, Drug Interactions, Patient Medication Information Sheets (FDB)
- pbm.va.gov/druginteractions/didb.htm
- BCMA – Medication Administration -EHR
- CPRS – Electronic Health Record
- My HealtheVet – Personal Health Record
- VA NDFrt – MOA, PE, Therapeutic Class
- Allergies NTRT: Ntrt Allergies http://vista.med.va.gov/ntrt
- Adverse Drug Reaction Reporting-VADERS for FDA
- HDR, CHDR, RDI – Standardization and Interoperability

**Notes:**
VA has actually been doing much more than working to comply with global standards, but has been actively engaged in setting standards internally.  In addition to those already mentioned, VA has been recognized for many of its programs.

## VA NDF

**Notes:**
Our VA NDF has been providing drug classification information to the National Library of Medicine.  The PBM has recently released it’s new On-line product data base to view our NDF and its links to FDA products.

## CMOP Drug Product Pictures

**	****Generic Name:** Atenolol**Strength:** 25 mg**Manufacturer:** Sandoz**Trade Name:** N/A**Type:** Antihypertensive**Class:** RX**Size (mm):** Approx. 4 mm diameter**Comment:** Image courtesy of quahog. Imprint GGL7

**Notes:**
Our CMOP has also had an agreement with the National Library of Medicine to provide pictures of products.  These images meet all the NLM format requirements.

## VA NDF RT

- VA worked on a project with Apelon to identify a more efficient process to update the VA NDF through NDFrt

**Notes:**
VA NDFrt File used as CHI standard for Mechanism of Action and Physiologic Effect, and last year we attempted to use this system to update our local drug files.

## VA Patient Medication Inserts

- First Data Bank serves as the content data source
- PMIs are distributed to VHA facilities through the NDF process
- PMIs are stored and retrievable in the event of a litigation regarding the provision of warnings and instructions to patients.

**Notes:**
Working with First Data Bank to import their PMIs has been one of the few areas that VHA pharmacy data has incorporated information from a commercial drug file.  How 

## Pharmacy Re-engineering Pharmacy Enterprise Product System (PEPS)

- Draft Plan for FDB’s role in PRE

**Notes:**
The PRE system will be using First Data Bank’s drug file for drug interactions.  However VA will be able to customize fields associated with FDA files to better meet VHA needs for drug interaction.  So our drug interaction system will become more interoperable and will better support the use of global patient safety standards.
PRE V. 0.5 provides for the implementation of all order checks demonstrated in the 2006 PEPS Proof of Concept Demonstration. VistA enhancements include: enhanced drug-drug interactions to provide more clinical information to the clinician; enhanced duplicate drug order check to utilize ingredient components; enhanced duplicate class to utilize First Data Bank’s (FDB) Enhanced Therapeutic Classification (ETC) system which allows for multiple classes per drug; a new maximum single dose order check; a new daily dosage range check; general dosing guidelines and APIs to support the order check enhancements. HealtheVet (HeV) construction will include component's) to utilized services provided by a commercial drug database to support Legacy VistA order check changes.

## Regulations that govern HDR Data

| FIELD # & NAME | DESCRIPTION | Req'd HDR | Req'd CHDR | EXAMPLE VALUE | Req'd for Legal Health Record (Note standard or guideline) | Req'd in a national repository; ADR, HDR or Other (Note business need) |
| --- | --- | --- | --- | --- | --- | --- |
| .01       DATE/TIME OF EVENT (RDX) [0;1] | The date/time that this observed reaction occurred.Req'd to link observed reactions to severity. | RE * | N | AUG XX, 19XX | YES - Joint Commission; VHA Handbook 1907.01 HEALTH INFORMATION MANAGEMENT AND HEALTH RECORDS | YES - Public Health Reporting - Medwatch Form FDA 3500A (10/05) |
| .02       PATIENT (R*P2') [0;2] | This field is the patient to whom this observed reaction occurred.1/26/07: Changed from Not Required to Required.  See column I for explanation. | RE * | N | ARTpatient, One | YES - Joint Commission; VHA Handbook 1907.01 HEALTH INFORMATION MANAGEMENT AND HEALTH RECORDS | YES - Public Health Reporting - Medwatch Form FDA 3500A (10/05) |

**Notes:**
We’ve also worked standardize our data for storage in the HDR, and have done a thorough review of laws, regulations, and standards that determine why this information should be stored as a part of the electronic health record.

## Emerging Global Regulations

**Notes:**
We’ve talked about existing standards, but we need to be aware of the tremendous effort that is going on around the country to develop more standards and thus regulations that VA will need to comply with.  I want to share some information regarding organizations you may be familiar with.

## Organizations that Develop Standards and Codes for Interoperability

- SNOMED
- HL7
- National Cancer Institute
- NCPDP
- NDF RT AND VA NDF – Mechanism of Action, Physiologic Effect, Therapeutic Class
- FDA –NLM/RxNORM -
- NCMERRP

**Notes:**
Some of these we currently use their standards but these organizations are all working to develop new standards and regulations

## Federal Medication Terminology Standards

- Federal Medication Terminology Standards
- FDA SRS and eLIST
- National Drug Code (NDC)
- Unique Ingredient Identifier (UNII)
- NLM RxNorm
- Semantic Clinical Drug
- VA NDF-RT
- Mechanism of action
- Physiologic effect
- Structural class
- NCI NCIt (SPL subset)
- Pharmaceutical dose form
- Route of administration
- Unit of presentation
- Package type

**Notes:**
A major effort that VA is participating with is the development of a Federal Medication Terminology Standard.  Jim McCain a pharmacist working for OI, Dr. Mike Lincoln and Dr. Steve Brown have been prominent VA leaders in working on this project.

## FMT Sig Groups Standards Work

**DOSE SEGMENT**
**DOSE CALCULATION SEGMENT **
**VEHICLE SEGMENT **
**ROUTE SEGMENT **
**SITE SEGMENT**
**ADMINISTRATION TIMING SEGMENT**
**FREQUENCY SEGMENT**
**INTERVAL SEGMENT**
**DURATION SEGMENT**
**INDICATION SEGMENT**

**Notes:**
Just like VA is doing internally this group is struggling to develop interoperable standards for electronic health records and e prescribing.  Its making us all think about terms we’ve taken for granted for so long, but in this example when you start breaking down the elements of information to make a interoperable SIG for patient instructions, we have to realize that Latin was probably a lot easier than computer-ease.

## CHI Standards for Interoperability of Allergies for FMT

**Notes:**
For example just thinking of the elements of Allergy code required to meet CHI standards requires us to take a look on many levels.

## VA Involvement with FMT

- The use of Federal Medication Terminology System endorsed by CHI, supports VA’s Enterprise Wide Informatics System.
- E-Pharmacy Claims, Pharmacy Re-engineering, HDR, CHDR, CPRS, MyHealtheVet, Research and Outcomes, Patient Safety Initiatives, Performance Monitors, Finances (Drug Cost Management, Revenue), Clinical Management (Clinical Decision Support)

**Notes:**
Once these FMTs are developed VA will be able to apply them to many of our terminology systems.

## Developing Global Regulations Why Should VA Be Engaged 

- Global Interoperable standards support VA’s efforts to share local, National, and Global Communications - RDI
- Improve data sharing within the VA and with DoD- CHDR
- Support Revenue – e-Pharmacy Billing
- Support Healthcare Analysis, Research, and Outcomes
- Improve Patient Safety
- Improve Practice Efficiency
- Improve care to Veterans
- Act as leaders in design and implementation of the Presidents plan for a National Healthcare Information Network

**Notes:**
We’ve touched upon a lot of areas that fall under Global regulations and standards, and I want to take a moment to recap, why it’s important to VA.

## Conclusion

- Understanding local, National and Global regulations improves our ability to be compliant.
- Being compliant reduces risk
- Reducing risk
- Improves patient safety and reduces cost
- Improves efficiency
- Its good for America

**Notes:**
Finally, we thought it was important to give system users information on the reason for our many regulations and the direction regulatory bodies are taking in the future.

The PBM will be working to keep  VHA staff updated on regulations that impact informatics.  We’ve also tried to include a number of websites that you can search for additional information.  And we certainly hope that this presentation has helped you increase your knowledge of regulations for the following reasons:
Understanding local, National and Global regulations improves our ability to be compliant.
Being compliant reduces risk
Reducing risk
Improves patient safety and reduces cost
Improves effiencey