Polling Question # 3. DISCLOSURE STATEMENT Pharmacy Immunizations How to Stay Competitive and in Compliance LEARNING OBJECTIVES

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1 DISCLOSURE STATEMENT Pharmacy Immunizations How to Stay Competitive and in Compliance R. JEFFREY HEDGES President & CEO I, Jeff Hedges, disclose that I am employed as a consultant at R.J. Hedges & Associates. However, TPA staff and I are confident that this content of this program will exhibit fair content balance and be free of bias. If any participants feel otherwise, they should contact FIRST LAST ( ) immediately. LEARNING OBJECTIVES Recognize the governing organizations to perform immunizations Discuss Standing Orders & Emergency Protocols Discuss the need for a policy and procedure manual beyond Standing Orders Describe how Immunizations are considered a MTM Intervention Explain how Immunizations provides new revenue streams Polling Question # 1 What regulatory authority gives pharmacists the ability to give immunizations? a. U.S. Health and Human Services b. Centers for Disease Control and Prevention c. PA Board of Pharmacy d. OSHA Polling Question # 2 Are Standing Orders required to administer vaccines without a prescription? Yes No Not Sure Polling Question # 3 Why is an Emergency Protocol so important? a. Physician s order to treatment of an adverse reaction b. Provides legal authority to administer a drug c. Provides treatment instructions for EMT s d. None of the above e. Both [A] & [B] are correct 1

2 Polling Question # 4 Who requires Policies and Procedures for Immunizations? a. Health & Human c. Board of Pharmacy Services b. Liability Insurance companies d. Food and Drug Administration Recognize the governing organizations to perform immunizations CDC Centers for Disease Control and Prevention Establishes immunization Schedules Recommendations for influenza vaccines for the next year Provides Vaccination Coverage and Surveillance Centers for Disease Control and Prevention (CDC) Storage Requirements Centers for Disease Control and Prevention (CDC) Centers for Disease Control and Prevention (CDC) IAC Immunization Action Coalition Non Profit Arm of the CDC Provides worldwide immunization guidance Prepares templates for each vaccine standing order Provides Vaccine Information Sheets (VIS) Provides support materials including individual vaccine records 2

3 Federal Requirements No requirements for immunizations Health & Human Services Food and Drug Administration Drug Enforcement Agency OSHA Requirements Bloodborne Pathogens Bloodborne Pathogen Exposure Control Plan Establishes Personal Protective Equipment (PPE) Safety syringes for all immunizations Needle sticks procedures Texas State Immunization Requirements Texas requires the pharmacy to designate the primary and secondary location Primary location is the pharmacy s address Secondary Locations for Immunizations (examples): Businesses, Senior Centers and Assisted Living facilities Located in and around <CITY, STATE> Located in the county of <COUNTY> Texas State Immunization Requirements State law permits immunizations or vaccination that may be administered by a Pharmacist: 7 years Influenza only with protocol 14 years to 18 years all vaccines with a script 18 years and older all vaccines Insurance Requirements Insurance policies will state an immunization policy and procedure manual is required When an adverse reaction occurs, insurance company requires the immunization policy and procedure to be submitted What does your policy say? Standing Orders & Emergency Protocols Written Prescriptions Authority granted by state pharmacy law Physicians write prescriptions for specific vaccines they do not provide No standing order required Prescription is legal authority to administer vaccine 3

4 Standing Order Authority required by state pharmacy law Physician order authorizing the pharmacy/pharmacist to vaccinate under the physician s medical license Physician orders to administering vaccine Physician may accept the IAC s Standing Order Physician may edit IAC s Standing order or writer their own Emergency Protocols for administering medications Authority required by state pharmacy law Reactions can vary from trivial and inconvenient (e.g., soreness, itching) to severe and life threatening (e.g., anaphylaxis). Physician s protocol to treat a patient having an adverse reaction to a vaccine Provides treatment options: Reaction Symptoms Management Emergency Protocols for administering medications Establishes a list of supplies needed to treat an adverse reaction Establishes notification Requirements: Notify patient s Primary Care Physician (PCP) Report the adverse event to the Vaccine Adverse Event Reporting System (VAERS). The need for a policy and procedure manual beyond Standing Orders Is their a need for policies and procedures? The American Pharmacist Association recommends policies and procedures State Board of Pharmacy in PA does not require policies and procedures Liability insurance companies want the pharmacy s policy and procedure manual when an adverse reaction occurs Guidelines for a policy and procedure manual American Pharmacy Association has a guidebook to construct a policy and procedure manual Immunization Action Coalition provides tools CDC has recommendations for the FDA to add to a immunization policy and procedure manual CDC has recommended the following Establish a Vaccine Coordinator Staff training on the storage and handling of vaccines Site preparation How to construct a Standing order and Emergency Protocol Types of storage units for storage 4

5 Certification and Credentialing requirements Pharmacy Workflow Insurance companies and PSAO s are asking for policies and procedures Policies and procedures designate a specific workflow Designate who is responsible Designates the type of training required Designates who will be trained Best Practice for Workflow 1. Patient presents themselves for a vaccine 2. Clerk collects insurance cards 3. Clerk provides screening questionnaire to patient 4. Insurance cards are given to Pharmacy Technician to run claim to verify coverage 5. If there is no insurance coverage, the vaccine is a cash sell Best Practice for Workflow 6. Pharmacy Tech prints prescription label to run claim and determine co pay 7. Tech collects the Screening Questionnaire, pharmacy label and vaccine and gives to pharmacist 8. Pharmacist review questionnaire with patient and answers any questions 9. Pharmacist administers the vaccine 10. Patient remains under observation for 15 minutes Immunizations are considered MTM Intervention Mirixa and OutcomesMTM Assign MTM s to the pharmacy to complete Pharmacy has 30 days to complete During the MTM review with the patient, the patient is determined to need a immunizations If the pharmacy has a signed Standing Order, a vaccine can be provided during the MTM if on site or when the patient comes into the pharmacy What is Intervention? Any change in patient s health care plan qualifies Coordination with patient and their PCP 5

6 Types of Interventions Change of a BEERS list drug to a different drug Dispense a pair of diabetic shoes Recommend a change in drug therapy when there is a drug to drug reaction Administer a vaccine What Immunizations qualify for an Intervention? Influenza Pneumococcal ZosterVac Benefits of an intervention Provide additional needed health care services to the patient Paid for the MTM Paid for each Intervention Paid for the dispensed product and vaccination How Immunizations Can Provide New Revenue Streams Free Advertising Public Service Announcements Flu season and epidemics Health and Human Services State Department of Health Insurance Companies Immunizations provide a needed Service in the community Prevents local epidemics Provide vaccines to businesses, schools, churches, assisted living facilities, senior centers and staff Provide flu clinics Grow new patients by providing immunizations Market to vaccinated patients about pharmacy services Advertise immunizations within the pharmacy Signage at the front door Signs at the prescription pick up window Prescription bag stuffers Clerks asking if the patient needs a flu shot 6

7 Travel Vaccines Physicians and County Health Departments no longer provide travel vaccines because of the cost and shelf life of vaccines Pharmacies are the best solution for travel vaccines Market travel vaccines to: Local businesses who travel internationally Local Churches who are going on Mission Trips Local colleges and universities Travel Vaccines Travel vaccines are usually not covered by insurance, so they are cash sales Pharmacy is able to set their own pricing Generally there is no competition in the area SUMMARY Just because there is no regulatory requirement for an immunization policy manual, it is always requested when there is an adverse reaction Standing orders and emergency protocols are required for a pharmacist to administer a vaccine and treat an adverse reaction Immunizations provide value for EQuiPP scores through interventions New PA law permits pharmacists to give flu vaccines to children age 9 and older Immunizations marketed correctly can drive new patients to the pharmacy Polling Question # 1 What regulatory authority gives pharmacists the ability to give immunizations? Polling Question # 2 Are Standing Orders required to administer vaccines without a prescription? a. U.S. Health and Human Services b. Centers for Disease Control and Prevention c. PA Board of Pharmacy d. OSHA Yes No Not Sure 7

8 Polling Question # 3 Why is an Emergency Protocol so important? a. Physician s order to treatment of an adverse reaction b. Provides legal authority to administer a drug c. Provides treatment instructions for EMT s d. None of the above Both [A] & [B] e. are correct Polling Question # 4 Who requires Policies and Procedures for Immunizations? a. Health & Human Services c. Board of Pharmacy b. Liability Insurance companies d. Food and Drug Administration INFO@RJHEDGES.COM We re here to help you stay stress free and in compliance! 8

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