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ACCREDITATION AND REGULATORY AFFAIRS

 

OUR SERVICES

Integrated Pharmacy Solutions (IPS); where an ounce of pre-emptive pharmacy risk management assessment yields superior business performance and regulatory peace of mind


In today’s highly evolving healthcare marketplace, pharmacies are subject to more regulatory risk than ever before. The ongoing enactment of federal and state legislation and regulation governing pharmacy practice acts, coupled with applicable civil and criminal regulatory non-conformance penalties, underscores the importance for organizations to partner with IPS’s Regulatory Affairs & Accreditation Services. IPS clients positively leverage our senior leadership team’s regulatory affairs expertise and operations experience and mutually benefit from the company’s diverse compliance service portfolio.


The adage to “Inspect what you expect” is crucial for any organization to reliably assess, achieve and maintain optimal regulatory compliance. A pharmacy’s commitment to truly embrace this hand-on approach is essential for continued organizational development and success and bolsters continuous quality improvement and quality assurance.


Now more than ever, pharmacy owners and staff members should take notice of potential significant adverse impacts (e.g., disciplinary licensing actions, fines) associated with any lapse and or failure to sustain compliance with mandated pharmacy practice acts. An effective solution to safeguard against this regulatory hazard, is to establish a confidential regulatory compliance evaluation arrangement with IPS.                                    

This partnership affords IPS the opportunity to collaborate with your organization to conduct a customized pharmacy operations regulatory compliance gap analysis. The comprehensive risk assessment designed by IPS metrically evaluates the regulatory fitness level of a particular pharmacy in an initiative-taking, responsible, and effective manner in comparison with applicable legislative and regulatory constructs and changes.                       

          

IPS’ Regulatory Affairs & Accreditation Service offerings, include but are not limited to, statutory and regulatory interpretive analysis; licensing and regulation guidance; national accreditation (e.g., specialty pharmacy) consulting, outcome-based regulatory conformance  risk management assessments; investigate audits; independent compliance monitoring; pilot project directive; Fraud Waste & Abuse (FWA) audit detection services; complaint resolution; credentialing reports; reporting writing assistance; and regulatory compliance mandated reporting.


IPS also provides pharmaceutical consulting services across the United States to clients in connection with regulatory, accreditation, and governmental affairs issues. IPS senior staff members pride themselves on remaining astute on regional and national legislative and regulatory issues and stand ready to collaborate with any client to understand and manage issues important to their business.

TYPICALLY IPS PERFORMS PHARMACEUTICAL CONSULTING ACTIVITIES FOR CLIENTS THAT INCLUDE:

Typically, IPS performs pharmaceutical consulting activities for clients that include:

  • Interpretive guidance with federal and state laws and regulations

  • Represent and support clients appearing before governmental regulatory agencies pertaining to:

  • Licensing matters

  • Complaint Resolution and Corrective Action Plan development, implementation, and on-going monitoring

  • Regulatory Compliance Risk Management Assessments

  • URAC®, ACHC® Accreditation consulting services

  • Provide regulatory guidance to clients, monitoring local and national regulatory affairs developments and presentations before regulatory agencies and professional associations; and   

Establishing and maintaining professional key contacts, including, but not limited to, agencies within the Department of Health and Human Services as well as organizations in the Department of Public Health.                 


Why IPS?

Eliminate Risk

In response to comprehensive statutory and regulatory pharmacy compliance requirements, has your pharmacy measured operational regulatory risk exposure? If yes, has the pharmacy formulated appropriate plans of correction and implementation strategies? If not, be informed that Integrated Pharmacy Solutions, Inc. (IPS) locally owned and operated in Melrose since 1992, is here to help. IPS consulting services are available to you on short notice to expertly quantify your pharmacies compliance readiness level with new and existing standards. Additionally, if desired, IPS can formulate a customized regulatory compliance remediation plan complete with prioritization of recommended compliance deliverables.  


Opportunity for internal improvement in collaboration with a non-governmental third party


IPS fully understands the complex and unorthodox environment of regulatory reform and can capably assist you to navigate your pharmacy to compliant safe harbors. For over thirty years, IPS has successfully partnered with pharmacies while operating as an industry recognized service leader in the fields of legislative and regulatory affairs, pharmacy data management and contract management.


Over the years, IPS has adeptly counseled clients to achieve sustainable operational performance improvements to enhance quality and patient safety and comply with transformational regulatory challenges. Simply positioned, partnering with IPS offers pharmacy owners and operators with peace of mind protection against the adverse impacts of unforeseen business disruption.                                                                        

                             

Quality is the result of high intention, sincere effort, and intelligent direction: which represents the wise choice of many alternatives (William A. Foster)

Leverage Regulatory Expertise & Experience                                                               

IPS associates are uniquely qualified by means of their education, experience, peer recognition and specialty knowledge bases to bridge any potential regulatory compliance gap. The IPS compliance team delivers exceptional pharmacy consulting services that strengthen client’s approach to measuring, managing and mitigating risk and responding properly to critical regulatory pressure points.


IPS clients resoundingly value the company’s steadfast commitment to continuous quality improvement, customizable regulatory audit design, technical information management excellence and customer satisfaction as evidenced by longstanding contractual relationships.

Reasons to contact IPS to Cure Pharmacy Regulatory Compliance Operating Risk:

  •   Integrated Quality First Focus: It is not what you dispense but how you dispense

  •   Peace of Mind: The regulatory landscape is complex and change is constant    

  •  Self and Business Preservation: Be informed, proactive and stay ahead of the curve   

  • Resilient Future: Opportunity to re-cast inspectional observations and findings   

  • Prevention: The U.S. Drug Enforcement Administration and particular state Boards of Pharmacy may assess a pharmacy a financial penalty for each violation of regulations or administrative rules governing the practice of pharmacy

  • Avoidance: Boards of Pharmacy may assess a pharmacy ordered to correct a violation of regulations or administrative rules, a financial penalty for each violation for each day the violation continues to exist beyond the date prescribed for correction

  • Fiscal: Board of Pharmacy violations including disciplinary actions and fines may    

  • Increase both your individual and business professional liability premiums 

  • Clear Conscience - Regret Free - External Survey to Validate Internal Sense of Regulatory Security: Be prepared for your next inspection “Pharmacy Inspection Serenity Now”

IPS offers unique pharmacy risk management assessment and other consulting service-based programs modeled after the following operating standards and functions:

  • IPS associates abide by strict standards for education, experience, professionalism, confidentiality and code of ethics

  • IPS utilizes experts in the company and industry that are highly specialized and offer consulting on a project basis to exceed clients’ organizational needs

  • Monitor risk factors including controlled substance diversion, pharmaceutical supply disruptions, quality failures, cyber intrusions, financial fraud and technology breakdowns

  • Conduct pharmacy field surveys and identification of potential risk points

  • Offer strategic planning and tactical implementation designed to help clients succeed and optimize regulatory compliance efficiencies

  • Provide leading edge, novel ideas, innovation and solutions for improving, modernizing, and advancing pharmacy practice, education, and/or policy                  

  • Assimilate quality review methodologies to assure for a commitment to continuous quality improvement   

  • Prepare recommendations for written plans of pharmacy corrective action

  • Perform external quality assessments and provide self-assessment tools that measure performance and achieve and sustain desired compliance outcomes

  • Assistance with quality assurance, independent verification and validation, and testing strategies regarding pharmacy program initiatives              

  • Deliver solutions to pharmacies considering how to better measure, report and govern quality metrics

  • Scrutinize expanding regulations and technology advances         

  • Explore best practices in internal auditing and state-of-the-art assessment techniques and practices for conducting a quality assessment review


We welcome you to contact IPS today by telephone (781 333 6040); e-mail info@integratedrx.net or visit our website at www.integratedrx.net to learn more about additional opportunities to utilize these innovative and evaluative consulting services to develop an efficient, customizable risk management audit tool solution for your pharmacy.           


We look forward to hearing from you to proficiently assist you to achieve and sustain superior regulatory audit performance results and commitment to quality and patient safety.