MEDICATION MANAGEMENT IN NUCLEAR MEDICINE

MEDICATION MANAGEMENT IN NUCLEAR MEDICINE OBJECTIVES At the conclusion of this program, the nuclear medicine technologist will be able to do the following: Describe the purpose of Conditions of Participation (CoPs) defined by Centers for Medicaid and Medicare Services (CMS) Compare and contrast the three CMS deemed hospital accreditation agencies Explain why radiopharmaceuticals are subject to medication management standards and the role of hospital formulary Explain the oversight role of the pharmacy director within nuclear medicine State successful strategies for collaborating on medication management standards with the pharmacy director Note: Although this CE program frequently references The Joint Commission, the Pharmacy Director s oversight responsibility for medication use in nuclear medicine is applicable for all deemed accrediting agencies including the American Osteopathic Association and Det Norske Veritas. THE IMPORTANCE OF ACCREDITATION Accreditation is a process by which non-governmental organizations, such as The Joint Commission (TJC), assess hospitals, clinics and other health care providers to determine if they meet the requirements designed to improve the quality of patient care. In short, the accreditation process helps to verify the quality of service that is performed. In addition, a hospital that participates or intends to participate in the Medicare or Medicaid reimbursement programs must meet specific eligibility requirements such as being accredited by an agency that has received deeming authority by the Centers for Medicare and Medicaid Services (CMS). Accreditation is a voluntary process but is an important element of a hospital s efforts to meet all standards and requirements of the CMS Conditions of Participation (CoPs), which assures ongoing federal payment for health care services. 2013 Omnipath, Inc. All rights reserved. 1

In addition, accreditation can play a critical role in ensuring an enhanced quality of patient care, providing a higher degree of safety for hospital staff and patients, improving the ability to recruit highly qualified employees, and demonstrating the hospital s high level of accountability. CENTERS FOR MEDICARE AND MEDICAID SERVICES To execute the Medicare reimbursement program, CMS established minimum health and safety standards called Conditions of Participation (CoPs) for Hospitals. The CoPs were established to improve the quality of health care and protect the health and safety of CMS beneficiaries which are hospital patients. The CoPs are federal regulations found in the Code of Federal Regulations 42 CFR Part 482. As federal regulations, an act of Congress is required for any changes to be made to CoPs. Hospitals may be eligible to receive Medicare reimbursement in one of two ways: Hospitals must meet CoPs verified through a survey conducted by a state agency on behalf of CMS, or Hospitals must meet standards that are deemed to be equivalent to the CoPs. This can be done through participation in an accrediting organization that has received deeming status from CMS. In the second option, accreditation agencies develop standards that govern their program that must meet or exceed the CMS CoPs. There are currently three accreditation organizations that have received deemed status from CMS. They are listed here. The Joint Commission (TJC) Healthcare Facilities Accreditation Program (HFAP) offered by the American Osteopathic Organization (AOA) National Integrated Accreditation for Healthcare Organizations (NIAHO) offered by Det Norske Veritas (DNV) CMS conducts routine validation surveys to confirm that the survey processes of accreditation agencies (TJC, DNV, and AOA) are equivalent in determination to a survey performed by CMS. Validation surveys are conducted on a representative sample, are unannounced and include document review, observation, staff interviews and patient record reviews. Each year, approximately 5% of hospitals that undergo a survey by their accreditation agency will have a CMS validation survey performed. Other types of surveys that CMS may conduct on Medicare/Medicaid certified providers include those listed here: Complaint surveys in response to complaints and reported incidents of non compliance with CoPs For-cause surveys to validate compliance with CoPs due to cause that indicates possible noncompliance and may lead to termination within the Medicare/Medicaid programs MERP surveys specific to California to validate hospital Medication Error Reduction 2013 Omnipath, Inc. All rights reserved. 2

Untoward survey results can lead to significant monetary fines to the organization and to individuals and could lead to: Immediate Jeopardy (IJ) status Loss of Medicare/Medicaid reimbursement Additional surveys by other agencies and organizations Perception of poor patient care by the public Significant cost to the hospital due to fines, corrective measures, etc. ACCREDITATION AGENCIES: ACUTE CARE THE JOINT COMMISSION (TJC) Founded in 1951, TJC is an independent, not for profit organization that accredits more than 4,600 U.S. hospitals of different types. 12 TJC is the nation s oldest and largest standards-setting and accrediting body in health care. Since the inception of CMS in 1965, it has been deemed as a CMS accreditation authority. In addition, in 2002, TJC established National Patient Safety Goals (NPSGs) to help accredited organizations address specific areas of concern in regards to patient safety. In 2008, a change in the Medicare law now requires that the Joint Commission as well as all other accrediting organizations apply to CMS for its continued hospital deeming authority. In November 2009 the Joint Commission s current hospital deeming authority was extended through July 15, 2014. For more information: http://www.jointcommission.org/facts_about_the_joint_commission/ AMERICAN OSTEOPATHIC ASSOCIATION (AOA) AOA offers the Healthcare Facilities Accreditation Program (HFAP) that was originally created in 1945 to conduct an objective review of services provided by osteopathic hospitals. Since the inception of CMS in 1965, it has been deemed as a CMS accreditation authority. AOA supports hospitals, additional healthcare facilities and laboratories. 5 The program emphasizes CMS CoPs in addition to the National Quality Forum Endorsed Set of 34 Safe Practices. For more information: http://www.hfap.org/about/overview.aspx DET NORSKE VERITAS (DNV) National Integrated Accreditation for Healthcare Organizations (NIAHO) is the hospital accreditation program provided by DNV that integrates CMS CoPs with ISO 9001 Standards and applies to any size hospital. DNV was deemed an accreditation authority by CMS in September 2008. Their standards and survey processes support CMS quality initiatives, focus on continual improvement prioritized by the organization, and allow organization innovation to determine the most effective means for compliance using best practices. 5 2013 Omnipath, Inc. All rights reserved. 3

For more information: http://dnvaccreditation.com/pr/dnv/default.aspx Each program established by the various accreditation agencies varies in design and implementation. However, each has a series of standards that govern the program and that meet or exceed the CoPs established by CMS. Shown here is a brief overview of each deemed accreditation agency: TJC AOA DNV Has been accrediting Has been accrediting Worldwide reputation of organizations over 50 healthcare facilities quality and integrity in years and deemed an more than 60 years certification, standards Organization accreditation authority and under CMS since development in a wide range under CMS since CMS CMS inception in of industries. Received inception in 1965. 1965. deeming authority for hospitals from CMS on September 2008. Healthcare practice Standards include Standards are directly related standards and National CMS and other to CMS CoPs. Survey process Patient Safety Goals are nationally recognized supports CMS quality developed in concert with standards as well as initiatives, focuses on Accreditation requirements healthcare professionals, public & key stakeholders. Standards exceed CMS evidence-based best practice and selected patient safety continual improvement prioritized by the organization, and allows organizational CoPs. initiatives. innovation to determine the most effective means for compliance using best practices. TJC performs on-site AOA performs on-site DNV performs an annual on- surveys every 3 years. An surveys every 3 site survey Survey frequency annual self-assessment, the Periodic Performance years. Review, is prepared by the hospital. Table 1. Comparison Matrix (Adapted from: "The Big Three: A Side by Side Matrix Comparing Hospital Accrediting Agencies" by Diane Meldi, Faith Rhoades, and Annette Gippe) 2013 Omnipath, Inc. All rights reserved. 4

ACCREDITATION STANDARDS As stated earlier, all three accrediting bodies have very specific overall standards that correspond to the CMS Conditions of Participation and include more information and requirements than the law mandates. The Joint Commission, for example, has over 250 standards in areas such as Environment of Care, Human Resources, Infection Prevention and Control, and other topics. Unlike CMS CoPs, which are federal regulations, accreditation standards are continuously being reviewed and appropriate changes are made based on existing health care challenges. MEDICATION MANAGEMENT STANDARDS Each accrediting body has a series of standards designed to improve the safe use of medications in the hospital with an overall goal to increase patient safety. Both Joint Commission and DNV refer to them as medication management standards while the AOA refers to them as pharmaceutical standards. These standards include all stages of medication use, as shown here: Selection Storage Ordering Dispensing Administration, and Monitoring In 2004, Joint Commission mandated that contrast agents and radiopharmaceuticals be treated as medications subject to the scrutiny of medication management standards and medication related National Patient Safety Goals (NPSGs). All accreditation bodies classify radiopharmaceuticals as medications. Initially, hospitals concentrated on modifying existing policies and procedures to ensure the compliant use of contrast media within radiology. Focus is now shifting to the use of radiopharmaceuticals within nuclear medicine to ensure medication management compliance. Historically, decisions regarding the use of radiopharmaceuticals have been made solely within the imaging or nuclear medicine departments by the nuclear medicine physician and/or radiology director. However, medication management standards set forth by all accrediting bodies and corresponding to CMS CoPs, apply to all medications including radiopharmaceuticals and fall under the purview of the hospital pharmacy director. Contrary to a common misperception that radiopharmaceuticals are simply dyes they carry the prescription legend and are designated as drugs by the Food and Drug Administration (FDA); thus all medication management standards apply As a result these standards hold pharmacy directors and the hospital s pharmacy and therapeutics (P&T) committee responsible for overseeing radiopharmaceuticals as part of the organization s medication management system. 2 As a result, this change will ensure that the same controls that exist for other medications within the organization in regards to prescribing, dispensing, storage, security, administration, and monitoring must also be in place for contrast agents and radiopharmaceuticals Ensuring compliance with the standards also necessitates a closer 2013 Omnipath, Inc. All rights reserved. 5

working relationship between the departments of pharmacy and imaging, a collaboration that has not previously existed in many health care organizations. 11 This change in the status of radiopharmaceuticals introduced a new role for the hospital pharmacy director within nuclear medicine. It is important to understand the role of the pharmacy director in nuclear medicine and their specific oversight areas to ensure effective collaboration between the hospital pharmacy and nuclear medicine departments. ROLE OF THE HOSPITAL PHARMACY DIRECTOR Pharmacy directors have the ultimate responsibility for all medication use within the hospital. They are responsible for the development of all drug-use control policies in consultation with other appropriate professionals, departments, and committees. Pharmacy directors play a principal role in the development and maintenance of hospital formulary in association with the Pharmacy and Therapeutics (P&T) committee. Their responsibility extends throughout the hospital and their purview extends to satellite locations such as the emergency department, surgical suites, anesthesiology, radiology, and nuclear medicine. 1 The pharmacy director will likely become more actively involved in overseeing the management of medications including diagnostic and therapeutic radiopharmaceuticals, and adjunct pharmaceuticals. It is important to understand that the pharmacy director will not likely be involved in the day to day management aspects of drug use within nuclear medicine. Rather, they will most likely work collaboratively with the radiology director and nuclear medicine team to establish processes that will help ensure compliance with medication management standards. For example, nuclear medicine imaging and therapy protocols have historically been reviewed by the radiology director in collaboration with the nuclear medicine staff. The pharmacy director may play a complimentary role reviewing the drug aspects of these same protocols: the drug name, indication, procurement process, receipt, storage, disposal, etc. ROLE OF THE HOSPITAL PHARMACY DIRECTOR Some areas that may be of interest to the pharmacy director regarding radiopharmaceutical use include those listed here: Formulary: Are radiopharmaceuticals on the hospital formulary? FDA-approved radiopharmaceuticals: Are only FDA-approved radiopharmaceuticals being administered? (i.e. drugs sourced from manufacturers that have an approved New Drug Application (NDA) or Abbreviated New Drug Application (anda)) Procurement process: How are radiopharmaceuticals ordered, delivered and stored? Drug preparation: Are any drugs prepared in-house? What written standard operating procedures (SOPs) are in place to ensure patient safety and optimal patient outcomes, i.e. compliance with USP<797> standards, quality control (QC) of drugs prepared and immediate use provisions. 2013 Omnipath, Inc. All rights reserved. 6

Adjunct pharmaceuticals: How are adjunct pharmaceuticals (adenosine, furosemide, etc.) handled, stored, administered? This must be consistent with the storage and administration of these agents in other areas of the hospital. Drug-use protocols: Are drug-use protocols on file and do they include the name of the radiopharmaceutical, dosage, strength, and route of administration? Have they been approved by a medical staff committee, such as the Pharmacy and Therapeutics Committee? Hot lab access: Who has access to the hot lab? How are radiopharmaceuticals delivered to the hot lab? Has a written SOP been established that permits the contracted radiopharmacy access to the hot lab to make deliveries? THE ROLE OF FORMULARY IN MEDICATION MANAGEMENT Many hospitals have a robust procedure in place that requires the Pharmacy and Therapeutics (P&T) committee to conduct drug reviews and maintain a facility or system-wide drug formulary. The P&T committee develops an evidenced-based formulary of medications and medication-associated products accepted for use in the organization. 1 This process has been the standard of practice for many years and is done to help manage medication use and comply with applicable standards. For example, TJC Medication Management Standard 02.01.01 states The hospital selects and procures medications. This standard and its associated elements of performance explain the processes involved in the development of an approved list of medications for use in the hospital. The Joint Commission s medication management standards require organizations to use criteria to develop and maintain a formulary of medications to be available for dispensing and administration. The formulary must list all medications used in the organization, including those that may not be handled by the pharmacy (e.g. contrast media, radiopharmaceuticals, anesthetic gases, and blood derivatives. 12 The P&T Committee takes a broad approach to reviewing medications and through this comprehensive and thoughtful assessment, recommendations are made not only as to whether the product should be used, but also what safeguards should be implemented to optimize safety and what usage guidelines should be deployed to optimize value. 2 Historically, radiopharmaceuticals were not treated as medications under the purview of the pharmacy director; therefore they likely did not undergo formal P&T committee review and were not on the hospital formulary. Since formulary is an important function in the successful management of medications, collaboration with the pharmacy director will be needed to evaluate the status of radiopharmaceutical use. The pharmacy director may likely ask nuclear medicine to identify which medications (both radiopharmaceuticals and adjunct pharmaceuticals) are currently being used in the nuclear medicine department to initiate the formulary process. The drug formulary is typically evaluated and updated annually. New radiopharmaceuticals or new indications can be discussed with the pharmacy director during this time. 2013 Omnipath, Inc. All rights reserved. 7

POTENTIAL MEDICATION MANAGEMENT COMPLIANCE RISKS To help ensure safety and efficacy, drugs used within the hospital should be sourced from FDA-approved manufacturers, which include radiopharmaceuticals. An FDA-approved, commercially available radiopharmaceutical, like any approved drug, must go through the lengthy and rigorous FDA approval process to ensure that these drugs are safe and effective. This process includes the aspects listed here: Approval by the FDA of a New Drug Application (NDA) or Abbreviated New Drug Application (anda). Approved drugs can only be manufactured in facilities registered with the FDA (per 21 U.S.C. 360). Approved drugs must be listed with the FDA (per 21 U.S.C. 360(j)). Approved drugs must be manufactured in conformance with FDA Current Good Manufacturing Practices (cgmp) regulations (per 21 C.F.R. Parts 210 and 211). Failure to have approved drugs manufactured in appropriate facilities and drug listed causes them to be misbranded (per 21 U.S.C. 352(o). Some nuclear medicine departments may unknowingly administer radiopharmaceuticals that do not originate from an FDA-approved manufacturer. Unfortunately, some licensed nuclear pharmacies may use non-fda approved source ingredients to compound copies of FDA approved drugs rather than dispensing the commercially available FDA-approved radiopharmaceutical. These non-fda approved radiopharmaceuticals do not have an NDA or anda on file with the FDA validating safety and efficacy. There are several radiopharmaceuticals that may potentially have unapproved copies of FDA-approved commercially available radiopharmaceuticals in the market place. Some examples are shown here: Radiopharmaceutical Cr-51 sodium chromate In-111 chloride I-123 iobenguane (mibg) I-131 sodium iodide FDA-approved Manufacturer(s) Bracco Diagnostics Covidien GE Healthcare GE Healthcare Covidien Draximage Chromotope -------- Indiclor AdreView -------- HICON Trade Name Source: Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm If a nuclear medicine department is administering radiopharmaceuticals that do not originate from the approved manufacturer, the facility is likely administering a non-fda approved drug. In addition to potential patient safety concerns, the SNM compounding guidelines, which will be reviewed later in this section, indicate that the use of non-fda approved drugs may: Pose a regulatory or accreditation risk to the hospital, and/or Conflict with receiving CMS reimbursement through the Medicare or Medicaid programs 2013 Omnipath, Inc. All rights reserved. 8

As of March 2012, there are forty-four FDA-approved radiopharmaceuticals. Your contracted nuclear pharmacy should be able to provide a current list of all FDA-approved radiopharmaceuticals and the approved manufacturers. This list can be shared with the pharmacy director to initiate the P&T committee review and approval process to include radiopharmaceuticals on hospital formulary. It is also a good reference to confirm if your licensed nuclear pharmacy is dispensing FDA-approved radiopharmaceuticals. Manufacturers of FDAapproved drugs, including radiopharmaceuticals, can be located by searching the Orange Book. The list of drugs in the Orange Book is approved by the FDA based on safety and effectiveness under the Food Drug and Cosmetic Act. (Link to: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm) This issue of compounding non-fda approved radiopharmaceuticals has been recognized and addressed by the National Association of Nuclear Pharmacies (NANP), a trade organization of nuclear pharmacies similar to the Society of Nuclear Medicine. In the NANP Position Statement on Appropriate Compounding it specifically states that the NANP does not support: Making copies of commercially available pharmaceuticals, including radiopharmaceuticals, a practice which has been deemed illegal by the FDA. Claims that using the same supplier of raw materials as a licensed FDA manufacturer, one produces an FDA-approved product. Making small, clinically insignificant changes to a preparation that is otherwise a copy of commercially available product, in order to claim uniqueness. The use of non-fda approved ingredients when FDA-approved ingredients are available. 6 In addition, the Society of Nuclear Medicine has developed a position statement addressing the use of compounded radiopharmaceuticals that identifies several issues to consider: Is the drug available as a commercial product? Is the compounded preparation to be used in a hospital or health-system facility? If so, the pharmacy department should be involved. Will the patient s health insurance provider be charged for the compounded preparation? If so, the facility s compliance and billing department should be involved. Misrepresentation, either intentional or unintentional, of the compounded preparation as a commercially available (i.e., FDA-approved) product may be construed as fraud. Is the compounded preparation to be used in a healthcare facility accredited by The Joint Commission? If so, compliance with Medication Management standards must be achieved. 10 The SNM Positions Statement is available on the SNM website at http://interactive.snm.org/docs/use_of_compounded_radiopharmaceuticals.pdf ADJUNCT PHARMACEUTICAL USE IN NUCLEAR MEDICINE In addition to radiopharmaceuticals, there are other medications routinely used in nuclear medicine procedures: In some situations, the pharmacy director may request that these adjunct pharmaceuticals be dispensed from the hospital pharmacy. However, there is no provision within the medication management standards that precludes the nuclear medicine department from obtaining these medications from their contracted nuclear pharmacy. This ordering process should be outlined in an approved written standard operating procedure that specifies the use of FDA-approved adjunct pharmaceuticals. 2013 Omnipath, Inc. All rights reserved. 9

Adjunct pharmaceuticals used in the nuclear medicine department should be reviewed with the pharmacy director to verify if they are listed on the hospital formulary. If these medications are listed on the formulary, the nuclear medicine department should use the specified drugs and from an FDA-approved manufacturer. If adjunct pharmaceuticals are not on hospital formulary, this is an opportunity to collaborate with your pharmacy and radiology director to add these drugs to the hospital formulary. Listed here are other medications routinely used in nuclear medicine procedures: adenosine aminophylline diypridamole dobutamine esmolol furosemide regadenoson sincalide normal saline PROTOCOL REVIEW Ensuring compliance with the medication management standards will likely necessitate a closer working relationship between the hospital pharmacy and nuclear medicine departments A new area of collaboration would include the review of all nuclear medicine protocols. Historically, this process has been performed by nuclear medicine department team and the director of radiology. To help comply with medication management standards, the pharmacy director must participate in review of protocols containing medications The director of radiology would review the protocols for: Imaging or therapeutic procedures Delay interval between administration and imaging Type of images to obtain Image processing and display parameters The pharmacy director would review protocols for: Drug and dosage Route of administration Source of the drug FDA-approved? Compounded appropriately? Indicated use Formulary status 2013 Omnipath, Inc. All rights reserved. 10

PROCUREMENT OF RADIOPHARMACEUTICALS Another area of oversight responsibility for pharmacy directors is the procurement of medications. When medication sourcing is performed directly by the nuclear medicine department and no mechanism is in place for communication with the pharmacy director, the oversight function can not be fulfilled. An approach needs to be deployed that ensures a comprehensive, evidence-based formulary review, FDA-approval of the medication, availability of quality product, and sourcing from appropriately licensed suppliers A pharmacy director may satisfy this procurement oversight by establishing mechanisms to periodically review supplier license status, quarterly quality control reports, invoices, and other appropriate reports and logs. Some radiopharmaceutical vendors provide software to nuclear medicine departments to track orders and deliveries for their use in meeting regulatory and audit needs. Access to this resource can be a rich source of information for the pharmacy director. 2 SUMMARY Compliance with accreditation standards is critically important for a hospital to actively participate within the CMS Medicare/Medicaid programs and to ensure high quality patient care and patient safety. The standards set forth in CMS CoPs apply to radiopharmaceuticals as well as traditional medications used within the hospital. In many organizations, the practice of nuclear medicine has evolved over decades with these departments making management decisions for radiopharmaceutical use without any oversight from pharmacy. 2 The change to the status of radiopharmaceuticals, now defined as medications subject to medication management standards, has resulted in the pharmacy director being responsible for the safe use of radiopharmaceuticals. This in turn will require collaboration between pharmacy and nuclear medicine departments to ensure appropriate policies and procedures are in place. An important part of a hospital medication management system is the review and approval by the P&T committee for all drugs used in the hospital and the establishment and maintenance of a formulary. An important first step in complying with medication management standards is ensuring that the radiopharmaceuticals and adjunct medications used in the nuclear medicine department are FDA-approved and included on the hospital formulary. The ultimate goal of complying with these new processes and standards is to ensure the optimal patient safety in health care today. This can best be accomplished through a collaborative approach between the pharmacy and nuclear medicine departments. 2013 Omnipath, Inc. All rights reserved. 11

REFERENCES: 1. American Society of Health-System Pharmacists, ASHP Statement of Pharmacists Responsibility for Distribution and Control of Drug Products, 2005. 2. Beach TA, A Collaborative Approach to Radiopharmaceutical Management, Pharmacy Purchasing & Products, September 2011, Vol. 8 No. 9. 3. Centers for Medicare and Medicaid Conditions of Participation and Conditions for Coverage, https://www.cms.gov/cfcsandcops/ Code of Federal Regulations 42 CFR Part 482, ecfr.gpo.access.gov. 4. Compliance Policy Guidance for FDA Staff and Industry, Sec. 460.200 Pharmacy Compounding, http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074398.htm. 5. Meldi, Diane et al. The Big Three: A Side by Side Matrix Comparing Hospital Accrediting Agencies, Synergy, January/February 2009, http://www.hfap.org/mediacenter/namss%20synergy%20janfeb09_accreditation%20grid.pdf. 6. National Association of Nuclear Pharmacies, NANP Position Statement Appropriate Compounding, November 3, 2009, http://www.nanp.net/sites/nanp/home.nsf/nanp-position-statement-on- Compounding.pdf. 7. Norenberg, JP; Managing Radiopharmaceuticals, Pharmacy Purchasing & Products, April 2011 Vol. 8 No. 4. 8. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm 9. Phillion, Matt; CMS Validation Surveys: On the rise?, Health Leaders Media, April 2009 (www.healthleadersmedia.com/content/qua-2317441/cms_validation_surveys_on_the-rise.html 10. Society of Nuclear Medicine, SNM Use of Compounded Radiopharmaceuticals and Adjunct Drug Preparations, http://interactive.snm.org/docs/use_of_compounded_radiopharmaceuticals.pdf. 11. University HealthSystem Consortium Best Practice Recommendation, Safe Use of Imaging Contrast Agents and Radiopharmaceuticals, September 2008, Revised March 2009. 12. Uselton JP, Kienle PC, Lee MB; Assuring Continuous Compliance with Joint Commission Standards: A Pharmacy Guide 8 th Edition, American Society of Health-System Pharmacists, 2010. GLOSSARY anda: Abbreviated New Drug Application Deeming: Approval process used by CMS to ensure that the standards of accrediting organizations recognized by CMS meet or exceed the Medicare standards set forth in the CoPs Formulary: a listing of prescription drugs approved for use in a hospital by medical staff such as the pharmacy director and the Pharmacy and Therapeutics committee ISO 9001 Standards: an internationally recognised standard for the quality management of businesses Legend drug: A drug that is regulated by legislation to require a medical prescription before it can be obtained to distinguish it from over-the-counter drugs which can be obtained without a prescription NDA: New Drug Application Pharmacy and Therapeutics Committee: a medical staff committee that is responsible for the development and maintenance of hospital formulary through the review and approval of all medications to be used within the hospital 2013 Omnipath, Inc. All rights reserved. 12

EXAM: QUESTION #1 Accreditation agencies develop standards that meet or exceed minimum requirements defined by the Centers of Medicare and Medicaid as: ISO 9001 standards Conditions of Participation National Patient Safety Goals Quality Form Safe Practices QUESTION #2 Routine surveys conducted by CMS to ensure that the results of surveys conducted by accrediting bodies are equivalent to CMS conducted surveys are called: Compliant surveys For-cause surveys MERP surveys Validation Surveys QUESTION #3 The accrediting agency that integrates ISO 9001 Standards with CMS Conditions of Participation is: Det Norske Veritas American Osteopathic Association The Joint Commission Healthcare Facilities Accreditation Program 2013 Omnipath, Inc. All rights reserved. 13

QUESTION #4 It takes an act of Congress to make any changes to the standards established by accrediting agencies. True False QUESTION #5 The Joint Commission mandated that radiopharmaceuticals be treated as medications subject to medication management standards in: 2011 1965 2004 2008 QUESTION #6 The establishment of a hospital formulary is the mechanism used by hospitals to ensure compliance with: Third-party reimbursement Medication management standards National Patient Safety Goals Continuous quality improvement QUESTION #7 The pharmacy director and the_( ) are responsible for overseeing radiopharmaceutical use as part of the organization s medication management system: Risk manager Licensed independent practioneer Pharmacy and Therapeutics Committee National Association of Nuclear Pharmacies 2013 Omnipath, Inc. All rights reserved. 14

QUESTION #8 Any radiopharmaceutical used in nuclear imaging studies should be sourced from an FDA-approved manufacturer that has an approved ( ) for the drug: NDA or anda License USP equivalency Trade name QUESTION #9 Per the SNM position statement on the use of compounded radiopharmaceuticals, misrepresenting, either intentionally or unintentionally, a compounded drug as commercially available (FDA-approved) may be construed as: USP equivalent Reimbursement fraud Acceptable for reimbursement Not complying with National Patient Safety Goals QUESTION #10 In addition to ensuring radiopharmaceuticals are on formulary another area where the pharmacy director may collaborate with the nuclear medicine department includes: Protocol review Day to day operational efficiency Type of images to obtain Equipment calibration requirements 2013 Omnipath, Inc. All rights reserved. 15