CPhT CONNECT™ Magazine - Jan/Feb 2021


vaccine administration: ASSURING SAFETY


Business “safety” seems illogical at first. It is easy to under- stand keeping people safe, but the ability to keep the business safe is also important. Sister Irene Kraus, the CEO of the Daughters of Charity National Health System, famously stated, “If there is no margin, there is no mission.” This statement implies that if the business cannot make money, it cannot carry out any mission it aspires to achieve. Likewise, if a pharmacy is at financial risk from failure to follow laws and regulations regarding vaccines, it will not be able to continue to provide vaccines or other pharmacist services. The pharmacy techni- cian can help ensure that the business is safe by learning the requirements for vaccination that go beyond administration. Documentation Vaccination programs are accompanied by documenta- tion requirements. Pharmacy technicians have been trusted with maintaining pharmacy documentation for years. This talent can be valuable in protecting the patient and the busi- ness of the facility. Knowing what documentation is required is essential in legally and correctly providing vaccines. The law requires that patients or caregivers be provided with a VIS form before being vaccinated. The VIS may be viewed on a screen, read from a posted copy, or provided to the patient on paper. Following the vaccination, the patient or caregiver must be provided a copy of the VIS if requested. Pharmacy technicians who are administering vaccinations need to ask the patient if they have been provided a copy of the VIS before administering the vaccine. Pharmacy technicians can also assure that the vaccine information statements are available for all vaccines in the facility. This preparation and organiza- tion can protect the facility, but more importantly guarantees that patients and caregivers have access to the information necessary for making decisions about receiving a vaccination. Like the VIS, screening questions must be provided to the patient before a vaccine is administered. While screening questions may not be explicitly required by law, professional credentialing requirements require that practitioners meet the prevailing standard of care. Therefore, since screening for danger is considered to be pro- spective drug use review, and prospective drug use review is a standard of care in pharmacy, administering the proper screening questions and evaluating a patient’s answers is required. While pharmacy technicians may not have sufficient clinical training to evaluate all dangers to patients, a pharmacy technician can assure that screening questions are com- pletely answered. Pharmacy technicians can also review the answers for unexpected information. The pharmacy techni- cian administering the vaccine must review the answers to the screening questions as a safety check to assure that no unusual answers were overlooked during the verification process. The vaccine administration record is the evidence that the vaccine was provided. The vaccine administration record con- tains the following patient information: the patient’s name, the

patient’s birthdate, and identifying information such as address or medical record number. The administration record contains information about the vaccine including the manufacturer, the lot number, and the expiration date. The administration record, as the name implies, also includes information about the admin- istration itself: the date of administration, the dose administered (usually 0.5cc), the site of administration (e.g., right or left del- toid), the route (intramuscular, subcutaneous, nasal), the date on the VIS and the date the VIS was provided to the patient, the name of the person administering the vaccine, and that per- son’s signature. All of this information will be required if a report needs to be made to the Vaccine Adverse Event Reporting System (VAERS). Many jurisdictions have vaccine registries. Reporting to the vaccine registry is mandatory in some jurisdic- tions and voluntary in others. As previously discussed, adhering to prevailing standards of care may be mandatory, and thus the duty to report to the registry may be mandatory through that requirement. In either case, reporting to the registry allows for safer patient care and for monitoring for necessary vaccinations. When the report is mandatory for a facility, properly reporting will also protect the facility. Robust vaccine registries are useful in promoting public health and improving communication about needed vaccines. Pharmacy technicians can be the key to improving vaccine reporting and to populating vaccine regis- tries with essential information regarding patient vaccine status. Records Retention Health care facilities are well aware of the need to retain and quickly access medical records. Most federal requirements for record-keeping require that all records be retained for a mini- mum of 2 years. Many states, however, require that records be maintained for a longer duration. Vaccination records, how- ever, should be maintained for 10 years or for 2 years after the age of majority is reached, whichever is longer. The pharmacy technician can assist in developing and maintaining the records retention process as this will be a process that is longer than most records retention in the facility. Failure to maintain proper records can adversely impact the license of the facility, the licenses of any supervising pharmacists, and potentially the credentials of the pharmacy technician on the vaccination team. HIPAA As with all health care services, vaccinations are subject to the Health Insurance Portability and Accountability Act (HIPAA) and the privacy protections that are a part of that law. Reporting to the vaccine registry is not a violation of HIPAA privacy protections, in fact, it is important to protecting the patient and, in some cases, as previously discussed, to pro- tecting the facility and the members of the vaccination team. All members of a health care team involved in vaccinations need to protect patient records and maintain patient privacy to the best of their ability. Yes, a patient may be seen receiv- ing a vaccination in a facility, but this alone is not a violation of the privacy protections of HIPAA. As a general rule, all the

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