2017 Pharmacy Education Series

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1 Providing Continuing Education For Healthcare Professionals 2017 Pharmacy Education Series July 20, 2017 Radiopharmaceuticals in Health Systems: The Role and Responsibility of the Hospital Pharmacist Featured Speaker: Roxanne K. Wiley, RPh, BCNP Director, National Accounts Nuclear Pharmacy Services Cardinal Health Online Evaluation, Self-Assessment and CE Credit Submission of an online post test and evaluation is the only way to obtain CE credit for this webinar Go to Webinar attendees will also receive an with a direct link to the web page Print your CE statement of completion online Credit for live or enduring (not both) Deadline: August 18, 2017 CPE Monitor (applicable to pharmacists) CE credit automatically uploaded to NABP/CPE Monitor upon completion of post test and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity 2 1

throughout presentation Enter question Click No! Click 3 Accessing PDF Handout No!

2 How to Ask a Question Locate menu bar on your computer desktop Click orange arrow button to open menu box Type question into question box Click Send Do not close menu box This will disconnect you from the Webcast Please submit questions throughout presentation Enter question Click No! Click 3 Accessing PDF Handout No! Click the hyperlink that is located directly above the question box Do not close menu box This will disconnect you from the Webcast Click hyperlink 4 2

3 Update on Current Pharmacy Initiatives and Strategies B. Keith Yarde, R.Ph., M.S Pharmacy Operations Director QUORUM Health 5 Providing Continuing Education For Healthcare Professionals July 20, 2017 Radiopharmaceuticals in Health Systems: The Role and Responsibility of the Hospital Pharmacist Featured Speaker: Roxanne K. Wiley, RPh, BCNP Director, National Accounts Nuclear Pharmacy Services Cardinal Health It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Ms. Wiley is an employee of Cardinal Health. Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature

4 CE Activity Information & Accreditation (Pharmacist) 2.0 contact hours Funding: This activity is self funded through Quorum Health. 7 Radiopharmaceuticals in Health-Systems: Your Role and Responsibilities Presented by: Roxanne K. Wiley, RPh, BCNP 8 4

acknowledge the following subject matter experts for extensive input in slide development and

5 Disclosures and Acknowledgements Roxanne K. Wiley, RPh, BCNP Employed by Cardinal Health Nuclear Pharmacy Services I would like to acknowledge the following subject matter experts for extensive input in slide development and sharing their industry knowledge to develop this presentation. Patricia C. Kienle, MPA, FASHP Richard L. Green, RPh, BCNP 9 Roxanne and Annie

6 Objectives Understand what radiation is and the basic tenets of radiation safety Describe the function of a nuclear pharmacy and the five principle radiopharmaceuticals Identify key regulatory and accreditation standards related to radiopharmaceuticals and adjunct pharmaceuticals used in nuclear medicine Specify oversight responsibility of the pharmacy director in nuclear medicine as it relates to medication management Explain aspects of collaboration between pharmacy and nuclear medicine/radiology to help comply with medication management standards 11 Radiation: What is it? Ionizing radiation has enough energy to remove electrons from electrically neutral atoms Four basic types of ionizing radiation: Alpha particles, beta particles, neutrons, gamma rays Non-ionizing radiation does not have enough energy to remove an electron from an atom Types of non-ionizing radiation: Microwaves, radio waves, visible light, heat, infrared radiation

7 Radioactive Decay and Half-Life Radiation may decay by any one or a combination of six processes Spontaneous fission, alpha decay, beta minus decay, beta plus decay (positron emission), electron capture, and isomeric transition In all decay processes, the energy, mass, and charge of radionuclides must be conserved Every radionuclide is characterized by a unique half-life, which is defined as the time required to reduce its initial activity by one half (t 1/2 ) 13 Units of Radioactivity Curie or Becquerel 1 Curie (Ci) = 3.7 x disintegrations per second (dps) 1 Becquerel = 1 disintegration per second (dps) (SI unit) Patient doses are usually measured in millicuries (mci) The US is the only country in the world not using SI units??

8 Types of Radiation Different Types Are Utilized Differently (Penetrating) Gamma Rays and X-Rays No charge and mass Therefore have a much longer range in matter Diagnostic uses would include Most of regular nuclear medicine Heart scans, bone scans Positron emission tomography Primarily oncology 15 Types of Radiation Different Types Are Utilized Differently (Non-Penetrating) Alpha and Beta Particles Charge and mass Particles, shorter ranges Deposit more energy per unit path length Cause more damage Therapeutic uses would include: 131 I NaI for thyroid ablation 223 Ra for treatment of metastatic castration resistant prostate cancer (mcrpc)

9 Brachytherapy A form of radiotherapy that treats cancer by irradiation from a short distance (internal radiation therapy) Two different forms Permanent A small radioactive source or sources are implanted in the body Temporary The radioactive source is placed directly inside or close to the site of the tumor for a limited and defined period Example: Prostate cancer brachytherapy (seeds) 125 I, t 1/2 60 days 103 Pd, t 1/2 17 days 17 ALARA U.S. NRC (Nuclear Regulatory Commission) has instituted the ALARA (As Low As is Reasonably Achievable) concept in order to reduce radiation exposure to individuals Under the ALARA concept: Techniques, equipment, and procedures are all critically evaluated Modifications and improvements are made as indicated Radiation Safety Committee (RSC); Radiation Safety Officer (RSO); Environment, Health, and Safety Committee (EHS) ALARA is everyone s responsibility

10 Time, Distance, and Shielding Time: Total radiation exposure to an individual is directly proportional to the time the person is exposed to the radiation source. Longer the exposure, higher the radiation dose. Linear Reduction Distance: Varies inversely as the square of the distance from the source of radiation. Quadratic Reduction Shielding: Decreases or blocks radiation. Different types of shielding for different types of radiation (e.g. lead, tungsten, and plastic). Exponential Reduction 19 Annual Radiation Dose Limits rem: roentgen equivalent in man A unit of effective absorbed dose of ionizing radiation in human tissue, equivalent to one roentgen of X-rays Whole Body: 5 rem Lens of the Eye: 15 rem Extremities: 50 rem Dose limit to the fetus/embryo during the entire pregnancy due to occupational exposure of a declared pregnant woman: 0.5 rem Dose limit to a public member: 0.1 rem

Radiation Protection Program Anyone likely to receive more

dosimeter OSL badge usually worn on collar to get best eye

women TLD ring dosimeter(s) for handler, dispensers

Detection and Measurement Geiger Mueller Counters Dose

11 Radiation Protection Program Anyone likely to receive more than 10% of the annual occupational dose needs to wear a dosimeter OSL badge usually worn on collar to get best eye dose equivalent Fetal belly monitors for declared pregnant women TLD ring dosimeter(s) for handler, dispensers Exposures should be reviewed regularly 21 Radiation Detection and Measurement Geiger Mueller Counters Dose Calibrators Single and Multi Channel Analyzers Dosimeters, badges, monitors

12 Trivia Time! 23 Nuclear Pharmacy

Nuclear Pharmacy Development Centralized nuclear pharmacies emerged in 1972 Today over 95% of radiopharmaceuticals originate from a centralized nuclear pharmacy Most hospitals use a radiopharmacy

13 Nuclear Pharmacy Development Centralized nuclear pharmacies emerged in 1972 Today over 95% of radiopharmaceuticals originate from a centralized nuclear pharmacy Most hospitals use a radiopharmacy contracted by the Nuclear Medicine Department 25 Types of Radiopharmaceuticals Diagnostic: ~90% of procedures 43 different drugs Gamma emitters Positron emitters Therapeutic: ~ 10% of procedures 5 different drugs Alpha emitters Beta emitters Beta / Gamma emitters Dx images Tx uses

Boiled for 10 minutes Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate 99m Tc sestamibi 27 What is the most

14 Diagnostic Radiopharmaceuticals Short lived tracers have no pharmacologic effect: 85% are radiolabeled with nuclide 99m Tc (6 hour T 1/2 ) Not IV admixture preparation where chemistry occurs: chelation or precipitation 99m Tc NaTcO 4 Stannous reducing agent Boiled for 10 minutes Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate 99m Tc sestamibi 27 What is the most commonly used radiopharmaceutical in a hospital? 99m Tc sestamibi 99m Tc tetrofosmin 123 I Ioflupane I have no idea

$conditions: CAD Previous MI Gated wall motion Ejection fraction Prognostication 30$

15 Most Commonly Used 99m Tc sestamibi 99m Tc tetrofosmin 99m Tc medronate 18 F fludeoxyglucose 99m Tc mebrofenin 29 Myocardial Perfusion Imaging (MPI) 99m Tc sestamibi 99m Tc tetrofosmin Evaluation of coronary perfusion under Rest & Exercise conditions: CAD Previous MI Gated wall motion Ejection fraction Prognostication

$Skeletal Imaging 99m Tc medronate Evaluation of osteoblastic activity: Cancer metastatic to bone Stress fractures$ Evaluation of glucose metabolism Myocardial viability Dementia, Alzheimer s Disease Differentiation of benign and

Evaluation of glucose metabolism Myocardial viability Dementia, Alzheimer s Disease Differentiation of benign and

16 Skeletal Imaging 99m Tc medronate Evaluation of osteoblastic activity: Cancer metastatic to bone Stress fractures Avascular necrosis Osteomyelitis Musculoskeletal trauma Paget s disease 31 Glucose Metabolism 18 F fludeoxyglucose Evaluation of glucose metabolism Myocardial viability Dementia, Alzheimer s Disease Differentiation of benign and malignant lesions Cancer staging Multiple myeloma Evaluation of the effect of therapy on cancer

33 Key Radiopharmaceutical (RP) Concerns Formulary and FDA-approved radiopharmaceuticals (RPs) Sourcing vendor

17 Hepatobiliary Imaging 99m Tc mebrofenin Evaluation of biliary tract patency Acute cholecystitis Extrahepatic biliary tract obstruction Bile leaks Post surgical biliary tract evaluation Biliary atresia Liver transplants 33 Key Radiopharmaceutical (RP) Concerns Formulary and FDA-approved radiopharmaceuticals (RPs) Sourcing vendor review Protocol review Storage and security USP <797> compliance Adjunct pharmaceutical use

Non-FDA Approved RPs Your nuclear medicine department may unknowingly use non-fda approved radiopharmaceuticals Some licensed radiopharmacies may sell non-fda approved compounded products instead of

18 Non-FDA Approved RPs Your nuclear medicine department may unknowingly use non-fda approved radiopharmaceuticals Some licensed radiopharmacies may sell non-fda approved compounded products instead of commercially available FDA approved radiopharmaceuticals 35 Non-FDA-Approved RPs Some examples might include: 99m Tc RBC kit 99m Tc exametazime 99m Tc MAA 131 I NaI therapy capsules 123 I iobenguane (mibg) injection 201 Tl thallous chloride injection

stored Where RAM can be handled and stored Who may handle the materials 37 Sourcing Vendor Review Arrange a site visit or vendor

19 Nuclear Medicine Department Licensed by the U.S. Nuclear Regulatory Commission (NRC) or your state agency Radioactive Materials (RAM) license details: What nuclides can be received and stored Where RAM can be handled and stored Who may handle the materials 37 Sourcing Vendor Review Arrange a site visit or vendor qualification visit All nuclear pharmacies must comply with USP <795> and <797>: Statement of USP compliance Internal audit process All nuclear pharmacies should provide a statement of compliance upon request

20 Radiopharmaceuticals in Health Systems: The Role and Responsibility of the Hospital Pharmacist What is a Hot Lab? Area in nuclear medicine where RPs are stored and prepared Area in imaging where RPs are administered I have no idea 39 Hot Lab

RP Storage and Security Be familiar with the nuclear medicine hot lab

deliveries requires a written SOP that identifies authorized personnel Disposal decayed

in Nuclear Medicine Full USP <797> issues apply if on-site radiopharmaceutical

21 RP Storage and Security Be familiar with the nuclear medicine hot lab Radiopharmaceuticals are short-lived Hours / days / minutes Permission for early morning deliveries requires a written SOP that identifies authorized personnel Disposal decayed on site or returned to the vendor All radioactive materials must be secured 41 USP <797> in Nuclear Medicine Full USP <797> issues apply if on-site radiopharmaceutical compounding is performed 99 Mo generator used on site 99m Tc sodium pertechnetate used to compound CSPs

preparation of kits Fewer than 2 punctures into a septum outside ISO 5 Only one patient within

22 USP <797> in Nuclear Medicine Contracted unit dose service helps simplify USP <797> compliance Patient dosage administration is not part of USP <797> Immediate Use exemption can be used for preparation of kits Fewer than 2 punctures into a septum outside ISO 5 Only one patient within one hour and discard the remainder 43 BEYOND THE YELLOW SIGN: WHAT DO I NEED TO KNOW?

23 Trivia Time! 45 Trivia Time!

24 Trivia Time! 47 Traditional Roles Joint Commission added definition of medication to Medication Management standards Diagnostic / contrast agents Radiopharmaceuticals CMS and other accrediting organizations followed Imaging Department Contrast media Radiopharmaceuticals Other medications used in procedures

pharmacy standards to organization-wide scope Director of Pharmacy

25 Imaging Department Radiology CT MRI Nuclear Medicine Interventional Radiology 49 Oversight of Medication Management Changed from pharmacy standards to organization-wide scope Director of Pharmacy expected to oversee all areas of the medication use system

Oversight of in-house preparation of radiopharmaceuticals is included in the CMS Hospital Conditions of Participation. True False 51 Nuclear Pharmacy? Nuclear Medicine?

26 Oversight of in-house preparation of radiopharmaceuticals is included in the CMS Hospital Conditions of Participation. True False 51 Nuclear Pharmacy? Nuclear Medicine? Nuclear Pharmacy Licensed pharmacy Pharmacist in charge Nuclear Medicine Department Usually part of Imaging Oversight by Medical Director of Radiology Part of the health-system s regulatory and accreditation surveys

Role of the Radiology Director Department direction Medical director Administrative director Old days Physician controlled all policies for the department What changed? 53 What Changed?

27 Role of the Radiology Director Department direction Medical director Administrative director Old days Physician controlled all policies for the department What changed? 53 What Changed? Protocols must be approved by a medical staff committee, including pharmacy and nursing involvement Storage must meet federal, state, and accreditation requirements Compounding Sterile Preparations must comply with USP <797> Medication administration must comply with scope of practice and health-system policy

Medications Used Contrast Radiopharmaceuticals Adjunct medications in procedures Adenosine Dipyridamole Regadenoson Sincalide Others 55 Med Use System: Selection

28 Medications Used Contrast Radiopharmaceuticals Adjunct medications in procedures Adenosine Dipyridamole Regadenoson Sincalide Others 55 Med Use System: Selection Formulary Listing FDA approved products Approved indications Leadership knowledge and approval of use of contracted services CMS Accreditation organizations

29 Formulary Approval Include radiopharmaceuticals on formulary List of all FDA-approved RPs available Generic and brand names Manufacturer Indications Package inserts SDS 57 Can the nuclear pharmacy driver access the hospital hot lab? Yes, since certified by DOT to handle RPs Yes, if the hospital policy allows No, since they are not a hospital employee No, the RPs must be delivered to pharmacy

30 Med Use System: Storage Who can access medications? Nuclear medicine technologists Physicians Nurses Nuclear pharmacy driver What medications are in and out of scope? 59 Med Use System: Ordering Pharmacy reviews protocols for: Drug, dose, route Indications Formulary status Source of the drug (FDA-approved, compounded) Radiologist reviews protocols for: Procedure Delay interval between administration and imaging Images to be obtained Image processing and delay parameters

Med Use System: Dispensing State Board of Pharmacy regulations Health-system policy 61 Med Use System: Dispensing Pharmacist review of orders When required When not required In-house

31 Med Use System: Dispensing State Board of Pharmacy regulations Health-system policy 61 Med Use System: Dispensing Pharmacist review of orders When required When not required In-house preparation of radiopharmaceuticals CMS Hospital Conditions of Participation Compounding non-radiopharmaceuticals Cannot be compounded in department for convenience

Nuclear Medicine Technologists can administer meds provided Chief of Radiology approves Director of Pharmacy approves Hospital policy lists authorization No additional approval is needed

32 Nuclear Medicine Technologists can administer meds provided Chief of Radiology approves Director of Pharmacy approves Hospital policy lists authorization No additional approval is needed since it is within the scope of practice 63 Med Use System: Administration Licensing of nuclear medicine technologists Scope of practice Competence documentation LIP oversight

33 Med Use System: Monitoring CMS regulations and accreditation organization standards Medication errors Adverse drug reactions Incompatibilities 65 Collaboration Hospital Pharmacy Nuclear Pharmacy Nuclear Medicine

34 Key Takeaways Meet with your Nuclear Medicine Department Visit the Hot Lab Review the RAM license Be sure all suppliers meet your requirements Formulary FDA-approved drugs? Leadership approval of contracted services USP <795> & <797>

LUNCH AND LEARN. October 14, CE Activity Information & Accreditation

LUNCH AND LEARN. October 14, CE Activity Information & Accreditation LUNCH AND LEARN USP Chapter : What s on the Radar? October 14, 2016 Featured Speaker: Patricia C. Kienle, RPh, MPA, FASHP Director, Accreditation and Medication Safety Cardinal Health Innovative Delivery