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Pharmacist Immunization Practices and OARRS Updates: Ohio Pharmacy Law

Introduction

One of modern medicine’s greatest successes may be the near eradication of many infectious diseases through vaccination. For instance, prior to the introduction of vaccines, data from Centers for Disease Control and Prevention (CDC) indicate that more than 15,000 Americans died from diphtheria in 1921, and more than 12 million Americans were infected with rubella from 1964 to 1965; only 9 cases of rubella were reported in the United States (US) in 2012.1 More than 600 cases of measles were reported in the US in 2014, which were predominantly linked to persons who refused vaccination for religious or philosophical reasons.2,3 Consequently, vaccine-preventable diseases are an ongoing health concern in the US. In addition to vaccine-preventable diseases, prescription opioid abuse has caused significant morbidity and mortality among Americans. This activity will discuss the current regulations for pharmacist/pharmacy intern administered immunizations in the state of Ohio.

Pharmacists are in a unique position mitigate prescription drug abuse through a variety of interventions, including patient education and prescription drug monitoring. The following activity will provide an overview of standards that have been established for the use of the Ohio Automated Rx Reporting System (OARRS) as well as regulatory updates to pharmacy immunization practices in the state of Ohio.

Pharmacist Immunizations

The pharmacist has always been recognized as one of the most accessible health care professionals. Over the past 3 decades, public health officials and state legislative bodies have recognized that pharmacists can be a valuable asset in making vaccines more accessible to the public. The Ohio General Assembly first granted pharmacists the authority to administer vaccines in 2003 when it adopted Section 4729.41 of the Ohio Revised Code (ORC 4729.41).4 This particular law, which has been amended several times over the years, permits a pharmacist or pharmacy intern (who is working under the supervision of a pharmacist) to administer immunizations under specified circumstances.

Up until 2015, immunizing pharmacists and qualified pharmacy interns have been permitted to administer influenza vaccines to persons who are aged 7 years or older without a prescription. Pharmacists and qualified pharmacy interns may also administer any vaccine that is included in the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended adult immunization schedule to persons aged 13 years or older (without a prescription).5 In addition, pharmacists and qualified pharmacy interns can administer any vaccine to persons aged 7 through 12 years, provided the individual presents a prescription for the vaccine and the vaccine is included in ACIP’s recommended immunization schedule for persons aged 0 through 18 years.6 No vaccine of any type may be administered to an individual under age 7, even with a prescription.

Effective October 5, 2015, Board of Pharmacy Rule Ohio Administrative Code (OAC) 4729-5-38 was amended to permit a pharmacist or pharmacy intern to also administer herpes zoster (shingles) vaccine according to the age criteria specified in the F.D.A. approved labeling; any immunization or vaccine recommended by the Advisory Committee on Immunization Practices (ACIP) if administered in accordance with the recommendations adopted by the committee, including travel vaccines.

This section of the OAC also permits a pharmacist or pharmacy to administer rabies vaccine. For post exposure rabies vaccine pharmacist or pharmacy intern may not administer the first dose of rabies vaccine but may administer the subsequent doses pursuant to a prescription. Pre-exposure rabies vaccine can be administered by a pharmacist or pharmacy intern in accordance with the recommendations adopted by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

Box 1. References for Vaccines and Vaccination Schedules, United States

Neither pharmacists nor pharmacy interns are authorized to administer other injectable medications, such as vitamin B12 or allergy shots, under this statute. However, qualified pharmacists are authorized to administer epinephrine and/or diphenhydramine to any person who experiences an adverse reaction to a vaccine that has been administered by a pharmacist or pharmacy intern.8

Immunization Requirements

Pharmacists and pharmacy interns who wish to administer immunizations must qualify to do so. First they must complete a board of pharmacy approved course that is focused on the administration of vaccines. The following website includes a current list of board approved programs: www.pharmacy.ohio.gov/immunizations. According to the Ohio Board of Pharmacy, an immunization program must be at least 5 hours in length and meet standards established by the CDC. For each vaccine the pharmacist or pharmacy intern wants or is required to administer at their place of employment, immunization training must cover the following topics9:

  1. Disease states associated with the immunization;
  2. Type or nature of activity of the immunization;
  3. Appropriate administration schedules;
  4. Appropriate routes of administration;
  5. Appropriate injection sites;
  6. Appropriate dosages;
  7. Appropriate monitoring and treatment of the patient for adverse reactions;
  8. Appropriate patient populations;
  9. Precautions and contraindications; and
  10. Proper storage requirements for the immunization.

Additionally, immunization programs must cover sterile preparation techniques, proper disposal of used needles and syringes, proper procedure for addressing accidental needle sticks, and at least one (1) hour of instruction and physical participation in vaccine administration techniques. Pharmacists and pharmacy interns are required to complete a cardiopulmonary resuscitation (CPR) program from either the American Red Cross or American Heart Association, and they must maintain this certification.10

Pharmacists and pharmacy interns may only administer immunizations under a physician established protocol that has been approved the Ohio Board of Pharmacy.11 The protocol must be signed and dated by the physician, maintained by the pharmacist, and renewed annually. The protocol must address the following for each vaccine the pharmacist or pharmacy intern is permitted to administer:

  1. Name and strength of each vaccine;
  2. Precautions and contraindications;
  3. Intended audience or patient population;
  4. Appropriate dosage;
  5. Appropriate administration schedules;
  6. Appropriate routes of administration;
  7. Appropriate injection sites.

The established protocol must also address the following: (1) the length of time the pharmacist or pharmacy intern must observe the patient for signs of an adverse reaction; (2) the procedure for handling emergency situations that may arise from an immunization, such as adverse or anaphylactic reactions or accidental needle sticks; (3) a procedure for the pharmacist to notify the patient’s physician or health board of the vaccination within 30 days; and (4) the location where the pharmacist or pharmacy intern may administer immunizations.12 In addition, prior to vaccinating persons under the age of 18 years, the pharmacist or pharmacy intern must obtain written signed consent from the minor’s parent or legal guardian.13

The Ohio State Board of Pharmacy requires a pharmacist to maintain records of vaccines for a period of no less than 3 years. The immunization records must contain at a minimum14:

  1. Full name and address of the patient;
  2. Patient's date of birth or age;
  3. Patient's gender;
  4. Patient's applicable allergy information;
  5. Date of administration;
  6. Name, strength, and dose of the immunization administered;
  7. Lot number and expiration date of the immunization;
  8. Route of administration;
  9. Location of the injection site;
  10. Positive identification of the administering pharmacist or the administering pharmacy intern and supervising pharmacist;
  11. Positive identification of the patient, parent, or legal guardian of the patient who gives informed consent to administer an immunization. Positive identification of the consent would require a hard copy signature of the parent or legal guardian under Ohio Board rules.15

Effective January 2015, the Ohio State Board of Pharmacy adopted a rule that permits pharmacists to document a vaccination that has been administered by a pharmacist or qualified pharmacy intern on a prescription form. The vaccination may be assigned a prescription number and kept in the pharmacy record keeping system, similar to a prescription for a medication.16 Also, records that show the successful completion of an Ohio Board of Pharmacy-approved immunization course and CPR certification must be kept for 3 years and remain readily available at the request of an agent of the Board of Pharmacy. Notably, the 3-year record keeping requirement has been established by the Ohio Board of Pharmacy. As with records of dispensing, third party payers may require longer periods of record retention.

The Ohio Automated Rx Reporting System (OARRS)

The abuse of prescription drugs has been a growing problem in the US. Several studies have shown that a significant amount of these drugs are obtained through prescriptions from legitimate prescribers. However, prescription drug abusers also resort to a variety of illegal methods to obtain prescription drugs, such as doctor shopping, prescription forging, and pharmacy robberies. Clinics where health care providers prescribe narcotics inappropriately, often referred to as pill mills, have been responsible for large quantities of controlled substances that are distributed on the streets. Although prescription drug abuse is a national concern, it has become an epidemic in the state of Ohio, particularly in the southern part of the state.

More than 3 decades ago, states began to establish prescription drug monitoring programs (PDMP). The initial monitoring programs collected data manually by mandating controlled substances be written on multiple copy forms. Then, the pharmacy was required to send a copy of the prescription to the state agency that was administering the program. The prescription drug monitoring process has become widespread in recent years, and many states have now adopted PDMPs that utilize electronic data collection.

The Ohio General Assembly enacted ORC 4729.75 in May 2005, which directed the Ohio Board of Pharmacy to establish and maintain an electronic drug database to monitor the misuse and diversion of controlled substances. It also granted Ohio Board of Pharmacy the authority to adopt rules for the collection and dissemination of information collected through the database. The program was eventually named the Ohio Automated Rx Reporting System (OARRS). As of the last update in May 2014, drugs that must be reported through OARRS include17:

All Schedule II through V controlled substances dispensed on prescription or personally furnished by a prescriber.

All Schedule II through V controlled substances sold to a pharmacy or a prescriber at wholesale.

Schedule V controlled substances that are sold over-the-counter as exempt narcotics under section ORC 3719.15 are not required to be reported.

All pharmacies in the state of Ohio who are licensed as terminal distributors of dangerous drugs (TDDD) must report required drugs dispensed to all outpatients to OARRS on a daily basis. Pharmacies located outside of the state of Ohio who are licensed in Ohio as a TDDD must report required drugs only to outpatients who reside in the state of Ohio. Thus, prescriptions filled at out-of-state mail order facilities are included in the OARRS database. Anyone licensed as a wholesale distributor of dangerous drugs must report transactions of required drugs sold at wholesale. Pharmacies that make a wholesale transaction to another pharmacy or to a prescriber are also required to report that as a wholesale transaction, even if they fall below the threshold where a wholesale license is required. In addition, all prescribers, except veterinarians located in the state of Ohio, must report required drugs that are provided directly to patients.18

Pharmacies and prescribers who have dispensed a scheduled drug within the last 3 years must submit dispensing activities at least daily to OARRS. If a pharmacy or prescriber does not dispense any required drugs on a particular day, they must submit a Zero Report.19 Many commercially available pharmacy record systems can be programmed to provide these reports automatically.

OARRS information may be obtained at the request of a prescriber or pharmacist (or an agent acting on behalf of a prescriber or pharmacist) as it pertains to a current or prospective patient for the purpose of providing professional service to that person. An individual may also request his or her own information directly from the Board of Pharmacy.20 However, anyone who attempts to obtain OARRS information for unauthorized use is subject to prosecution.21

Initially, OARRS was a voluntary service. Prescribers or pharmacists who had concerns about a particular patient could request a report. After the passage of HB 93 in 2011, the Ohio Board of Pharmacy adopted rules that made it mandatory for a pharmacist to obtain an OARRS report under certain circumstances. This rule was updated effective February 1, 2016 and mandates that a pharmacist, at a minimum, must obtain and review an OARRS report covering at least a one-year period if:

  1. A patient adds a different or new reported drug to their therapy that was not previously included;
  2. An OARRS report has not been reviewed for that patient during the preceding twelve months, as indicated in the patient profile;
  3. A prescriber is located outside the usual pharmacy geographic area;
  4. A patient is from outside the usual pharmacy geographic area;
  5. A pharmacist has reason to believe the patient has received prescriptions for reported drugs from more than one prescriber in the preceding 3 months, unless the prescriptions are from prescribers who practice at the same physical location;
  6. Patient is exhibiting signs of potential abuse or diversion. This includes, but is not limited to, over-utilization, early refills, appears overly sedated or intoxicated upon presenting a prescription for a reported drug, or an unfamiliar patient requesting a reported drug by specific name, street name, color, or identifying marks.22

The same section requires that a pharmacist practicing in a county bordering on a neighboring state must also obtain a report on the patient from that state when available.

Effective January 1 2015, any pharmacist who dispenses controlled substances or anticipates dispensing them is required by Ohio law (ORC 4729.12) to certify to the Board that he/she has a personal OARRS account when he/she renews his/her pharmacist license.25 This began with the 2016 renewal applications. A pharmacist may register for an account visiting the OARRS website at www.ohiopmp.gov. Pharmacy interns and technicians may register as a delegate of a pharmacist at that same site. Delegates must be electronically linked to their pharmacists before they will be able to make an OARRS request.

Section 4729-5-30 also states that a valid prescription must be for a legitimate medical purpose and be issued by an authorized prescriber in the course of his or her normal course of practice. The responsibility for the prescription being for a legitimate medical purpose rests with the prescriber. However, the pharmacist has a corresponding responsibility to ensure that the prescription has been issued for a legitimate medical purpose. All of the above-mentioned scenarios should alert a pharmacist to look further into select situations before dispensing a controlled substance. Obtaining an OARRS report is one method that a pharmacist may use to satisfy his/her corresponding responsibility. When requesting an OARRS report, the pharmacist should always document it in the dispensing record or patient profile that a report was requested.

In recent years, Morphine Equivalency Dosing (MED) was added to the OARRS report. MED equates potencies of different narcotic analgesics to a standard morphine equivalent. MED is found in the upper right hand corner of the OARRS report.22 The Ohio Medical Board cites an MED of 80 mg as a “press pause” in a patient’s therapy. It states: “The 80 mg MED trigger point” is an opportunity for a health care professional to review the patient’s plan of treatment, his or her response to treatment, and any modification to the plan of treatment that may be necessary to achieve a favorable risk-benefit ratio.23 Notably, MED should not preclude the dispensing process. Rather, a pharmacist should review the OARRS report, review the patient’s drug profile, use prior knowledge of the patient and physician, and use professional judgment during the dispensing process for all prescriptions. And the pharmacist should document steps taken to determine the legitimacy of the prescription. While OARRS can be a useful tool to monitor patient drug use and determine the legitimacy of prescriptions, it is not a substitute for professional judgement and diligence.

In mid-2015, a regional pharmacy chain integrated its prescription processing software with OARRS to provide instant, single sign-on access to a patient’s OARRS report. In autumn of 2015, the Governor of Ohio announced that the State of Ohio will invest $1.5 million to assist pharmacies and prescribers to integrate OARRS directly into their pharmacy systems and electronic medical record systems so they may obtain the reports systems they use in daily practice.26

Conclusion

The CDC updates vaccine guidelines each year, so it is important that pharmacists remain up-to-date with current recommended vaccine schedules. It is also critical that pharmacist administer vaccines in accordance with laws in the state of Ohio. Further, prescription drug abuse is a national health concern and PDMPs, such as OARRS, have shown to help mitigate this dilemma. It is important for pharmacists in the state of Ohio to understand the purpose and requirements of OAARS in order to help mitigate prescription drug abuse and avoid professional wrongdoing.

References

  1. What Would Happen if we Stopped Vaccinations? Centers for Disease Control and Prevention website, http://www.cdc.gov/vaccines/vac-gen/whatifstop.htm, Updated May 19, 2014. Accessed July 27, 2015.
  2. Measles Cases and Outbreaks. Centers for Disease Control and Prevention website. http://www.cdc.gov/measles/cases-outbreaks.html, Updated June 30, 2015, Accessed July 24, 2015.
  3. Gastañaduy, P.A., Redd, S.B., Fiebelkorn, AP, et al., Measles — United States, January 1–May 23, 2014, Morbidity and Mortality Weekly Report (MMWR), Center for Disease Control and Prevention, June 6, 2014 / 63(22);496-499
  4. The Ohio Revise Code (ORC) contains laws passed by the Ohio General Assembly. Section 4729 of the ORC is the Pharmacy Practice Statute Section 3719 is the Ohio controlled substances statutes. The Ohio Administrative Code (OAC) Section 4729 contains rules adopted by the Ohio Board of Pharmacy.
  5. ORC 4729.41, (A) (2) (a) (ii)
  6. ORC 4729.41, (A) (2) (a) (i)
  7. ORC 4729.41, (E) (3)
  8. ORC 4729.41, (A) (3)
  9. OAC 4729-5-36 (A) (3) (b)
  10. ORC 4729.41 (B) (1) (2)
  11. ORC 4729.41 (B) (3)
  12. OAC 4729-5-37 (A) (2) through (5)
  13. ORC 4729.41 (C) (3)
  14. OAC 4725-5-27 (O)
  15. OAC 4279-5-14 (N)
  16. OAC 4729-5-38
  17. OAC 4752-5-21 (K)
  18. OAC 4729-37-02
  19. OAC 2729-37-03
  20. OAC 4729-35-07
  21. ORC 4729.80
  22. OAC 4729-5-20 (D)
  23. Attention Pharmacists: Major Change in the OARRS Report to Address the MED Ohio Initiative, Newsletter, Ohio State Board of Pharmacy, November 2013.
  24. Guidelines for Prescribing Opioids for the Treatment of Chronic, Non-Terminal Pain 80 mg of a Morphine Equivalent Daily Dose (MED) “Trigger Point”, Your Report from the State Medical Board of Ohio, December 2013
  25. Mandatory OARRS Registration and Requests, Ohio Board of Pharmacy, updated 11/24/15
  26. Empowering Prescribers & Pharmacists to Prevent Opiate Abuse, Governor State of Ohio, Communication Department, October 2015

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