Safe to Stick

     September 11, 2001, changed the way we view our safety and security. Prior to that day, contingency planning for weapons of mass destruction and large-scale mass-casualty incidents was not a priority. Small drills were run and mock disasters planned, but mostly without a sense of urgency. Over the years, media attention waxed and waned as reports of influenza outbreaks occasionally surfaced, only to fall back into obscurity. But with the attacks of September 11 and the events of the next few years—including continuing terrorist attacks on foreign soils and large-scale natural disasters like the 2004 Indian Ocean tsunami and Hurricane Katrina—both the government and the population at large began to realize the need for comprehensive disaster preparedness.

     The MEDICVAX study, completed by a consortium of EMS agencies in Pennsylvania in 1997, showed that large-scale immunizations are feasible.¹ The administration of vaccine in that study occurred at a variety of locations and included 10-minute observation periods in which no adverse effects were reported. No feasible plan for the long-term following of subjects was discussed. The MEDICVAX study also included provision for pre-administration education and practice dosing of intramuscular injections.

     This article describes research by which the authors hoped to demonstrate that paramedics can be safely utilized to provide mass immunizations in the event of an epidemic, pandemic or biologic event requiring mass prophylaxis.

     To test this idea, four licensed paramedics from three different EMS agencies administered intramuscular injections of the influenza vaccine to 125 hospital employees who presented for their yearly influenza vaccinations. For four weeks after the injections, the recipients were observed for complications. Their complication rate was then compared to the rate resulting from 1,600 injections given by hospital occupational health nurses with subsequent four-week observation periods.

     After four weeks of observation, none of the 125 study participants reported complications to their health as a result of the paramedic-administered influenza vaccines. There were also zero adverse reactions reported among the 1,600 injections administered by nurses. Accordingly, we conclude that the study, although limited in size, demonstrates that paramedic IM injections of a vaccine do not have a higher rate of complications than nurse IM injections, and paramedics can safely administer vaccines if mass immunizations are required.

     For our project, four state-licensed paramedics with varying levels of experience in direct patient care volunteered to give hospital employee influenza vaccine injections over a consecutive two-day period. Three of the paramedics were from two different surrounding ALS-transporting fire departments, and one was from the hospital EMS education department. The study participants were all adult hospital employees or hospital volunteers who presented freely during the work day for free immunizations available to all hospital employees.

     To keep the scenario as true to real life as possible, the paramedics received no new instructions on proper technique for intramuscular injections. No vaccine administration classes or teaching sessions were held—we relied solely on their previous experience and state-directed education on administering proper and safe intramuscular injections. Paramedics are allowed to administer vaccines in our state (Michigan) based on their scope of practice; this paper is therefore applicable only to those states in which paramedics' scope of practice includes IM injections.

     The paramedics were advised of the following exclusion criteria to screen patients for influenza vaccination:

1. Previous allergic reaction or hypersensitivity to poultry or poultry products;
2. Recent illness with documented fever greater than 100.4°F;
3. Previous allergy to immunizations or immunization preservatives;
4. Pregnant females were excluded based on hospital influenza immunization protocols. At the time of the study, the hospital was referring pregnant patients back to their obstetricians or primary care physicians for clearance and immunizations;
5. History of Guillain-Barre syndrome.

     Prior to immunization, each subject reviewed and signed release and consent forms outlining the exclusion criteria and a listing of possible adverse reactions, including localized hypersensitivity reaction, vascular injury, localized ecchymosis, nerve injury, fever, muscle aches or pain at the injection site, and infection at the injection site.

     The consent form outlined the intent and purpose of the study and identified study investigators and their contact numbers. If a subject declined to participate in the study, an employee health nurse was available to provide their immunization. This was done so that no subject felt pressured to participate in the study.

     The release and consent forms, as well as study protocols and rationale, had all been reviewed and endorsed by the hospital Institutional Review Board prior to initiation of the study. Subjects were instructed to return to the Employee Health Services Department if they developed any adverse reactions, at which time a medical chart and National Vaccine Injury Compensation Program form would be completed and submitted.

     The paramedics were to rely on previous training as provided by their individual state licensing education courses and the standards set forth by their state governing body. Observation and constant attendance by the principal study investigators allowed oversight for subject safety and the answering of questions.

     Vaccination was with 0.5 ml of Fluvirin influenza virus vaccine, which satisfied all guidelines for the 2005–06 season as directed by the U.S. Public Health Service. Each 0.5 ml injection contained appropriate levels to adequately protect against the common strains of the virus. Each injection also contained standard thimerosal preservative (24.5 mcg mercury).

     Prior to injection, an alcohol swab was used to disinfect the skin surface at the site. Injection was done with a standard 1-cc syringe and 19-gauge 1-inch needle administered to either the left or right deltoid area (subject's choice). The injection site was then covered with a sterile superficial bandage, and the employee released back to their duties. Purposefully, no immediate observation time was built into the study design. The injections were administered over two consecutive days in a highly visible location within the hospital corridors. The Employee Health Services Department was monitored for a total of four weeks for study subject presentation for post-injection complications.

     Prior to the paramedic injections, employee health nurses administered a total of 1,600 vaccinations using the same techniques and vaccine serum. Their injections were also followed for four weeks, during which time medical charts and National Vaccine Injury Compensation Program forms were also to be completed and submitted for subjects with complications.

     After four weeks of monitoring Employee Health for reactions to both the nurse-administered and paramedic-administered injections, no test subjects returned with complaints of complications or adverse effects, and no forms were completed. We believe this shows that paramedics can safely give intramuscular immunizations with no greater risk of complications than traditional healthcare providers.

     Previous studies have documented that licensed EMS agencies can deliver influenza immunization injections on large scales based on established protocols and policies. None have specifically addressed the long-term complication and safety rate directly. We purposely relied on the prior education of the paramedics instead of having an educational meeting to discuss injections and augment training, as well as deciding not to incorporate a direct observation period immediately after the injection. We felt that should the instance ever arise where mass immunizations were needed, the goal would be to immunize as many people as quickly as possible. It would be feasible and prudent in such an instance to provide the necessary vaccine and release people immediately, rather than detaining them for observation. This would promote better patient flow through immunization stations, enable more personnel to be directly immunizing patients, and prevent congestion of vaccine administration sites.

     Tapping into the network of EMS providers and paramedics in the United States effectively increases your direct immunization power. It should not be necessary to hold an educational clinic prior to the vaccination process.

     Our study had some limitations. First, the number of injections provided by paramedics was unpredictably small. We anticipated a larger study turnout for the free influenza vaccine, but attribute the small numbers to the fact that the paramedic injections were postponed to the second week of December due to a delay in the second round of vaccines being available. We theorize that by this time, many healthcare workers had already received vaccinations from their primary care physicians or other sources.

     Second, we closely monitored employee health for an established period of four weeks, during which time no subjects presented with study-related complications. We anticipated and expected that some subjects with complications would follow up with their primary care physicians instead of reporting back to Employee Health. Although such instances might have occurred, we can only theorize that this number was exceedingly low.

     Third, the injections in this study were administered to volunteer adults in a relatively controlled environment. The rate of complications may increase if the injections are performed in a less controlled situation. Also, while we used standard influenza vaccine as the subject of administration, we are, to some extent, extrapolating that paramedics can safely administer all vaccines with no increased risk of complications when compared to other healthcare providers.

     The purpose of the project was not to study if paramedics can give vaccinations as part of a community outreach project, follow a set of standard protocols or identify people who meet criteria for a vaccination. Rather, it was to isolate and review the complication rates associated with paramedic-administered vaccinations. Our goal was to be able to safely include the large-scale mobilization and utilization of EMS professionals in planning for the quick dispersal and dissemination of medications to the masses.

1. Mosesso V, Packer C, McMahon J, Audle T, Paris P. Influenza immunizations provided by EMS agencies: The MEDICVAX project. Preh Emerg Care 7(1): 74–78, Jan–Mar 2003.

     Brandon R. Peters, DO, and Stuart Etengoff, DO, FACOEP, are emergency medicine physicians at Genesys Regional Medical Center in Grand Blanc, MI. Ina J. Golden, RN, BSN, CEN, EMT-P, is a quality improvement coordinator for emergency medicine physicians at Genesys.