Continuous Quality Improvement
Continuous quality improvement (CQI) is an ongoing effort to improve products, services or processes. Starting a CQI program requires commitment, a culture of safety, policies, procedures and standardization; and a process for collection, analysis and improvement. The following resources will assist you with establishing a CQI program at your pharmacy or other practice site.

• Alliance for Patient Medication Safety
  The Alliance for Patient Medication Safety (APMS) encourages a culture of safety by providing recommendations on best practices and workflow processes designed to reduce medication errors, improve medication use and minimize patient risk. Visit www.MedicationSafety.org for additional information and resources.
  
  
• Pharmacy Quality Commitment
  Pharmacy Quality Commitment (PQC) is a CQI program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law and mandates for CQI programs under state law.
  
  Pharmacies, in order to be compliant with Centers for Medicare and Medicaid Services regulations and network contract requirements, must have a quality improvement program. Most contracts ask you to implement and maintain a verifiable, documented pharmacy quality assurance program (the wording varies from contract to contract):
  • a medication safe practices program
  • a utilization management and quality assurance program
  • establish an internal medication error identification program and a plan to reduce medication errors
  
  Easily implemented into your pharmacy’s daily routine PQC offers extensive toll free and online support to get your continuous quality improvement program started. Visit www.PQC.net to find out more about the program.

Drug Enforcement Administration
The Drug Enforcement Administration (DEA) is the premier drug enforcement organization in the world and the only single-mission federal agency dedicated to drug law enforcement. Follow the links below to access resources of value to pharmacists.

• Code of Federal Regulations: Title 21 - Food and Drugs
• Controlled Substances Act
• Drug Disposal
  The DEA holds National Prescription Drug Take-Back Days to encourage safe disposal of medications. Visit their Web site for more details on the program and upcoming dates.
• Drug Fact Sheets
• Drug Schedules
• Federal Trafficking Penalties
• Pharmacist’s Manual: An Informational Outline
  of the Controlled Substances Act

Provider Exclusion Lists
Federal regulations established by the Centers for Medicare and Medicaid Services (CMS) prohibit payment for any federal or state health care program services (prescriptions, durable medical equipment, labs, etc.) be made to any individuals or entities which are included on the Department of Health and Human Services Office of Inspector General (OIG) and General Services Administration (GSA) exclusions lists. Pharmacies and pharmacists must be aware of these regulations and ensure that all pharmacy personnel or contracted entities doing business with the pharmacy are not included on these exclusion lists to avoid payment recoupments as well as possible loss in the ability to participate in state or federal programs, including Medicare and Medicaid. Recent information provided by OIG is recommending that the provider exclusion lists be checked monthly since new data of excluded parties is added to these lists.

In addition to the OIG/GSA exclusion lists, providers also need to review the Data Bank to check for excluded individuals. The Data Bank is a clearinghouse created by Congress, which is comprised of the National Practitioner Data Bank and the Healthcare Integrity and Protection Data Bank. The Data Bank contains received and disclosed information on final actions taken against health care providers and entities. Access each of the lists at the links below.

• OIG Provider Exclusion List
• GSA Provider Exclusion List
• Data Bank

U.S. Food and Drug Administration
The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter medications, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED) and veterinary products. Visit www.FDA.gov for additional information or follow the links below to access additional resources.

• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) 
  Database of all FDA-approved prescription drugs, including new and generic drugs
• Drug Approvals and Databases
  Information on drug approvals and drug-related databases from the FDA
• FDA Drug Info Rounds 
  A series of training videos for practicing clinical and community pharmacists
• Drug Safety and Availability
  Medication guides, information on drug shortages, and safety communications and announcements
• Guidance, Compliance and Regulatory Information
  Guidance for industry, warning letters, rules and regulations and surveillance programs

Health Insurance Portability and Accountability Act of 1996

• Federal Trade Commission
  The Federal Trade Commission (FTC)'s principal mission is the promotion of consumer protection and the elimination and prevention of anti-competitive business practices. Visit www.FTC.gov for additional information or follow the links below to access additional resources.
  
  
  • Red Flags Rule - Identity Theft
    The Red Flags Rule requires many businesses and organizations to implement a written Identity Theft Prevention Program designed to detect the warning signs (or "red flags") of identity theft in their day-to-day operations. Pharmacies have been exempt from the FTC's Red Flags Rule, as of December 2010. Visit the FTC Web site for additional information.
    
    
  • FTC Breach Notification Form
    The FTC has designed a form to make it easier for anyone to report a breach of health information. For more on notifying the people whose information was breached, visit www.FTC.gov/healthbreach.
    
    
• Health Care Provider’s Guide to the HIPAA Privacy Rule
  This guide explains when a health care provider is allowed to share a patient’s health information with the patient’s family members, friends or others identified by the patient as involved in the patient’s care under the HIPAA Privacy Rule.
  
  
• HHS Health Information Privacy
  The Office for Civil Rights enforces the HIPAA Privacy Rule, which protects the privacy of individually identifiable health information. On this site, you can access information on understanding the Privacy Rule, how to file a complaint, frequently asked questions and more.
  
  
• HIPAA Training Resources
  Training materials are available to help you or your patients understand the HIPAA Privacy Rule, including an introduction, what types of entities are covered, health information that is protected, a summary of requirements related to research, and compliance and enforcement.
  

National Council on Patient Information and Education
The NCPIE Coalition offers resources focused on raising awareness about the role of communication in promoting safe, appropriate use of medications. A variety of research articles, recommendations for improving adherence geared toward specific types of health care providers and information on NCPIE initiative are available online.

Script Your Future
The tools provided on this Web site help patients keep track of their medications, including a wallet card, question builder, how-to videos about taking medications, and tips to assist them in talking with their pharmacist or physician about a health problem or medication.

Stick to the Script
This online resource center provides pharmacists and other health care professionals with tools and information to improve medication adherence. Adherence programs around the nation are identified, clinical tools are provided; research, education and outreach concepts and resources are addressed; and information about building an adherence toolkit is also shared. Below are some additional links on the Stick to the Script Web site that are valuable for pharmacy professionals.

• Adherence Estimator^®
  This one-minute, evidence-based survey designed by Merck to categorize patients into three groups—those who are at low, medium, or high risk for not adhering to a newly-prescribed medicine. After consumers answer three simple questions regarding their beliefs about a medicine, the tool provides easy to understand, personalized information which may address patient’s concerns about taking that medication. Once identified, the potential barriers of commitment, concern and cost may be addressed through effective dialogue between a consumer and his/her doctor, pharmacist, or other health care professional. Click here to access the Adherence Estimator^® online.
  
  
• Medication Matters
  Medication Matters is a simple medication compliance questionnaire (four questions) that can be given to patients and provides a quick assessment that helps patients find out if they take their medication correctly. A Spanish version as well as a patient commitment form are also available online.
  
  
• Outreach/Advocacy
  Various outreach tools are available, including an adherence presentation, a fact sheet, talking points, media training information for pharmacists and more.
  
  
• Your Medicine: Be Smart. Be Safe.
  This helpful medication guide was developed by the Agency for Healthcare Research and Quality (AHRQ) and the National Council on Patient Information and Education (NCPIE). It answers common questions about getting and taking medicines and has helpful forms to help patients keep track of this information.

Alliance for Patient Medication Safety
The Alliance for Patient Medication Safety (APMS) strives to foster a culture of quality within the profession of pharmacy that promotes a continuous systems analysis to develop best practices that will reduce medication errors,
improve medication use and enhance patient care. To learn more go
to www.MedicationSafety.org.

Institute for Patient Medication Safety and Pharmacist Peer Review
MPA, the Michigan Board of Pharmacy and the Michigan Bureau of Health Professions worked together to design a system that encourages voluntary pharmacist reporting of medication errors and their causes so data can be accumulated and analyzed and information disseminated to practitioners to help prevent errors of a similar nature in the future. This also provides the Board of Pharmacy with a way to move away from a punitive approach in dealing with pharmacists who make human errors.

MPA created the Institute for Patient Medication Safety and Pharmacist Peer Review, an organization that collects information on medication errors, while protecting the pharmacists who report them. No information regarding the identity of the patient or the pharmacist is retained in Institute files after an error has been reported.

Although MPA provided the initial funding, the Institute has been established as a Michigan nonprofit corporation and is classified by the IRS as a 501(c)(3) tax-exempt organization. Its operation is overseen by a seven-member Board of Directors. Each director is a pharmacist who brings expertise from a specific area of pharmacy practice (health-system, community, long-term care, etc.) Last month, MPA and the Institute sent a letter to all licensed pharmacists in the state providing them with an overview of the organization, as well as frequently asked questions and a medication error or accident reporting form. Additional copies of the form can be downloaded from the Institute Web site at MiInstitute.cphs.wayne.edu.

Medication Therapy Management
Medication therapy management (MTM) utilizes pharmacists knowledge-based and clinical skills to improve medication usage in patient care. MTM services vary based on practice area and can include formulary management, complex disease state management and medication therapy.

MTM was validated by its inclusion in the final regulations under the Medicare Modernization Act (MMA) of 2003 in addition to the creation of Medicare prescription drug benefit. While Medicare Part D plans are required to provide MTM services to beneficiaries who meet certain requirements, many other individuals can benefit from MTM programs.

MTM provides an excellent opportunity for pharmacists to make the most of their clinical expertise and in the process, help patients. It is now possible for pharmacists to be reimbursed for some of the services they have been providing for years.

• Humana
  Humana has contracted with Outcomes to deliver MTM services to eligible members in the community pharmacy setting. The Outcomes MTM provider network includes chain and independent pharmacies, as well as hospital-based clinical and consultant pharmacists. If you are a pharmacist interested in providing MTM services for Humana members, visit www.OutcomesMTM.com. Choose the "Pharmacy" link on the upper left and then click "GETTING STARTED" to find links that will allow you to execute a participating pharmacy agreement, complete training modules and view payment rates. Or, visit the Humana Web site for additional information.
  
  
• Mirixa
  Mirixa is a leading provider of MTM and targeted, pharmacist-delivered services to health plans. They have the largest and most comprehensive pharmacy services network in North America. Mirixa was founded by the National Community Pharmacists Association. Visit the Mirixa Web site for additional information.
  
  
• OutcomesMTM
  Outcomes is a national leader in the design, delivery and administration of MTM programs. The company has built a nationwide network of personal pharmacists that deliver MTM services to covered members. Outcomes has also worked with tens of thousands of pharmacies and dozens of MTM program sponsors, including Medicare Part D plans, states, employers, pharmaceutical manufacturers and others. Medicare is committed to the type of interactive, ongoing MTM services Outcomes has supported for more than 11 years. Pharmacy Services Inc., a for-profit subsidiary of MPA, and Well Street serve as a territory manager for Outcomes. Visit the OutcomesMTM Web site for additonal information.
  
  
• Road to Wellness: An MTM Resource Manual
  Well Street Care Management offers a comprehensive, educational MTM resource manual that includes a self-study module with clinical care guidelines for asthma diabetes, hypertension and hyperlipidemia; sample documentation forms; and automated slide presentations covering the MTM process. For additional information, please contact MPA at (517) 484-1466; visit the MPA Online Store; or access a printable order form. Well Street was created and commissioned by MPA and Pharmacy Services Inc. to address the emerging opportunity for Michigan pharmacists to provide medication management services.

Michigan Administrative Code
The Michigan Administrative Code is a compilation of all adopted rules and regulations that are in effect in the State of Michigan. Click here to view the Department of Community Health rules.

Michigan Automated Prescription System
The Michigan Automated Prescription System (MAPS) is the prescription monitoring program for the state of Michigan. Prescription monitoring programs are used to identify and prevent drug diversion at the prescriber, pharmacy and patient levels by collecting Schedule 2-5 controlled substances prescriptions dispensed by pharmacies and practitioners. Follow the links below to register to MAPS online or access important instructions. Or, visit the MAPS Web site for addtional information.

• Register to MAPS Online 
• Practitioner Registration to MAPS Online - Instructions 
• Practitioner Request a MAPS Report - Instructions

Michigan Board of Pharmacy
The Michigan Board of Pharmacy consists of 11 voting members: six pharmacists and five public members. As of Oct. 1, 2012, the Board oversees 14,734 pharmacists, 3,257 pharmacies and 1,742 manufacturer/wholesalers.

The Public Health Code, by Section 17722, grants authority to the Board of Pharmacy to regulate, control and inspect the character and standards of pharmacy practice and of drugs manufactured, distributed, prescribed, dispensed and administered or issued in this State and procure samples, and limit or prevent the sale of drugs that do not comply with this section's provisions; prescribe minimum criteria for the use of professional and technical equipment in reference to the compounding and dispensing of drugs; grant pharmacy licenses for each separate place of practice of a dispensing prescriber who meets requirements for drug control licensing; and granting licenses to manufacturer/wholesaler distributors of prescription drugs. The Board also has the obligation to discipline licensees who have adversely affected the public's health, safety and welfare.

Visit the Michigan Board of Pharmacy Web site to learn more about its role, current members and meeting days and locations.

Michigan Department of Licensing and Regulatory Affairs
The Health Professions Division in the Bureau of Health Care Services, in conjunction with state licensing boards, regulates more than 400,000 health professionals in Michigan who are licensed, registered or certified under Articles 7 and 15 of the Michigan Public Health Code and pharmacy related facilities. Utilize the links below to access important pharmacist licensure information online.

• Department of Licensing and Regulatory Affairs Web site
• Verify a License
• Renew Your License
• Check Your Application Status
• Frequently Asked Questions and Licensing Forms and Applications

Michigan Public Health Code
View the Michigan Public Health Code online.

Pay particular attention to the following sections:

• Article 7 - Controlled Substances
• Article 15 - Occupations
  • Part 161 - General Provisions
  • Part 177 - Pharmacy Practice and Drug Control

Other areas of the Public Health Code that impact prescribing:

• Part 170 – Medicine (specifically 333.17001 and 333.17076)
• Part 174 – Optometry (specifically 333.17435)
• Part 175 – Osteopathic Medicine and Surgery (specifically 333.17501 and 333.17548)

Pharmacy Audits

• AMCP Model Audit Guidelines for Pharmacy Claims
  The Academy of Managed Care Pharmacy (AMCP) Model Audit Guidelines for Pharmacy Claims are the result of over a year-long effort by a Task Force comprised of pharmacists in managed care organizations, community practice and law; auditing administration; third party management; and network administration. Visit the AMCP Web site to access a copy online.
  
  
• MAHP Pharmacy Audit Statement of Best Practices
  The Michigan Association of Health Plans (MAHP) developed pharmacy audit guidelines to promote an effective health plan compliance program. Their best practices statement seeks a reasonable balance between effective health plan compliance and equity in the pharmacy audit process. Click here to view the document.
  
  
• PAAS National
  PAAS National has been assisting pharmacies with contract reviews and provide audit assistance since 1993. PAAS is an expert resource on third-party audits, contracts and negotiating strategies. Visit www.PAASnational.com for additional information.
  

Combat Methamphetamine Epidemic Act 2005

• Training and Certification
  Before selling products containing ephedrine, pseudoephedrine or phenylpropanolamine, pharmacies must be self-certified and comply with all provisions of the CMEA relating to employee training, product placement, photo identification of customers, sales logbooks and other procedures listed in the law. The Drug Enforcement Administration (DEA) has provided detailed training instructions for use in explaining the obligations online. Self-certification must be done annually online. Only one certificate per retail store is required, and the date to recertify is determined by the date listed on the certificate.
  

National Precursor Log Exchange
The National Precursor Log Exchange (NPLEx) is a real-time electronic logging system used by pharmacies, retailers and law enforcement to track sales of over-the-counter (OTC) cold and allergy medications containing precursors to the illegal drug methamphetamine.

As of Jan. 1, 2012, in compliance with Public Act 86 of 2011, pharmacies are required to log pseudoephedrine (PSE) product sales in the NPLEx system. The provider of the NPLEx technology, Appriss, shared several resources with MPA that will assist members in utilizing the system, including a deployment guide and a complete NPLEx overview. If you have any questions, please contact Appriss by e-mail at MINPLEx@appriss.com. Be sure to include your pharmacy contact information and state license number.

Pseudoephedrine Logbook
Pharmacies are also required to maintain a logbook, written or electronic, to record sales of products containing ephedrine, pseudoephedrine or phenylpropanolamine. The seller must enter into the logbook the name of the product and quantity sold. The patient must write or enter into the logbook their name, address, date and time of sale. The customer must also sign the logbook.

Pharmacies with a point-of-sale (POS) system integrated to NPLEx that will electronically capture and submit purchaser, product and signature data do not need to utilize a manual logbook unless there is a mechanical or electronic failure with the electronic sales tracking system and the pharmacy is unable to comply with the electronic sales tracking requirement.

Pharmacies without the ability to electronically capture all the required elements (purchaser, product and signature) must maintain a manual logbook.   

Pharmacy Services Inc. (PSI), a for-profit subsidiary of MPA, offers several products to assist you with remaining in compliance with federal and state regulations, including a pseudoephedrine logbook. Click here to access an order form.

Discrepancy Reporting Form
This form was developed as a tool for pharmacies to report third party payment discrepancies. MPA requests that the form be submitted to MPA, as well as the third party payor, so these discrepancies may be recorded.

Price Discrepancy Complaint Form
This form was developed for the purpose of filing a complaint about incorrect information on the Department of Community Health Drug Pricing Web site.