Antibody responses among adolescent females receiving the quadrivalent HPV vaccine series corresponding to standard or non-standard dosing intervals

An important privilege pharmacists have is to administer and counsel patients about vaccinations they should receive. A relatively new (new meaning it’s been on the market for roughly 10 years) but very important vaccine called Gardasil is a vaccine that protects patients against multiple strains of the human papillomavirus virus (HPV). HPV is an STD virus that can cause genital warts, cervical cancer (only in women), anal cancer, throat cancer, and penile cancer (only in men). HPV is spread through skin-to-skin contact, especially when mucous membranes come into contact with each other (e.g. kissing, intercourse, and oral sex). Most people in the United States contract some form of HPV in their lifetime, and a person usually contracts it by the age of 26 years. The Gardasil vaccine, also known as quadrivalent human papillomavirus vaccine (HPV4), is recommended as a 3-dose series administered at 0, 1–2, and 6 months. The vaccine is administered to both boys and girls, and it is recommended to be administered to children between the ages of 9 and 13 years. The reason for administering the vaccine to children at such a young age is because there is a high chance that they will contract some form of HPV during their teenage or young adult years through skin-to-skin contact. The vaccine can be administered to girls between the ages of 9 and 26 years, and it can be administered to boys between the ages of 11 and 21 years (boys between the ages of 21 and 26 years can be given the vaccine under the special circumstances of engaging in male-male sexual activity or if they have a suppressed immune system).

The purpose of this study was to asses if administering doses 2 and 3 of the Gardasil vaccine later than recommended would affect antibody titers. The reason for this study is that the Gardasil dosing schedule is often not followed, and children/adolescents often receive doses 2 and 3 later than recommended. The study assessed antibody titers to HPV4 when dose 2 and/or dose 3 were administered on schedule or delayed. 331 Healthy females aged 9–18 years were enrolled at the time of receipt of HPV4 dose 2 or 3. Participants were classified as belonging to one of four groups depending upon timing of receipt of HPV4: both doses on time; only dose 2 delayed later than 90 days; only dose 3 delayed later than 180 days; or both doses 2 and 3 delayed. Pre- and post-dose 3 blood samples were taken to test HPV antibody titers.

The results of the study were that post-dose 3 geometric mean titers (GMTs) for all HPV types were NOT significantly lower for any of the delayed dosing groups when compared to the on time group. When compared to the on time group, the post dose 3 GMTs in the delayed dose 3 group were actually significantly higher for HPV types 6, 11, and 16. These results suggest that delays of dose 2 or 3 do not interfere with immune responses to the vaccine after completion of the 3-dose series. These results are important because they support current recommendations to not administer additional doses of HPV4 vaccine if dose 2, dose 3, or both doses have been administered late.

I think this study highlights an important factor in vaccinations that we as pharmacists will have to be aware of, which is inappropriately administering a repeat vaccination. This study proves the importance of checking a patient’s antibody titer before administering a repeat dose of a vaccine. We should never assume that a patient’s antibody is low because the vaccine was not administered in the correct timeline or certain recommendations assert that vaccines given during a specific time period need to be readministered. As pharmacists, we will need to use our analysis skills to determine which vaccines our patients need and which vaccine antibodies should be tested via titers before readministering any vaccines.

My question posed to colleagues: How do you think this study applies to pharmacists administering and recommending vaccinations? Are the results of this study surprising to you?

Russel, K, Dunne, EF, Kemper, AR, et al. Antibody responses among adolescent females receiving the quadrivalent HPV vaccine series corresponding to standard or non-standard dosing intervals. Vaccine. 2015;33:1953-1958. 

Pharmacist Role in Counseling on Preconception Health

As accessible health care providers, pharmacists have a unique opportunity to improve preconception health in women which can lead to overall improved pregnancy outcomes. If women are thinking about conceiving a baby, it is important that they are counseled on prenatal supplementation and vaccinations. The information that a pharmacist can provide can help the woman make informed decisions about their lifestyle.

Screening for immunizations for measles, mumps, rubella, varicella, human papillomavirus, hepatitis A, and hepatitis B should all be recommended for women thinking about conceiving since they may have harmful effects on the developing fetus after conception. Not all vaccinations are off limits however. Inactivated influenza virus and tetanus, diphtheria, and pertussis vaccinations are recommended) even if the woman is pregnant (regardless of trimester) and should not pose a risk to the fetus. Moreover, contraction of influenza may cause problems for the baby. Influenza contraction in the first trimester gives rise to higher incidence of schizophrenia in the child. Contraction of the virus in the second and third trimesters poses more risk for the mother as breathing is impaired and the fetus is applying pressure on the mother’s diaphragm and lungs.

Counseling the woman on supplementation of folic acid may also lead to improved pregnancy outcomes as this B vitamin has been shown to improve optimal birth outcomes and neural tube development. Deficiency of this vitamin may result in spina bifida, a condition in which the spine does not close properly which can result in paralysis or mental retardation. It can also result in anencephaly or the case in which the brain does not form altogether. Since these events occur in the developing fetus within the first 28 days, it is important that the woman supplements this ahead of time.

Pharmacists have a role in helping educate people about medication day to day. However this role may be all the more important when discussing good preconception habits with women. This is a situation that there is a good chance that they have not been in before and since the development of the fetus is so fragile, it is important to make sure that they are getting all of the information correct in order to improve the likelihood of optimal birth outcomes.

Reference

El-Ibiary S, Raney E, Moos M. The pharmacist’s role in preconception health. J Am Pharm Assoc. 2014; 54(5): 288-303

J Am Pharm Assoc. 2014; 54(5): 288-303

Impact of the RxVaccinate program for pharmacy-based pneumococcal immunization

Pneumonia is a disease that is very prevalent within society and is one of the leading causes of death, particularly in adults aged 65 or older. A very easy way to prevent contraction and spread of pneumonia is to receive the appropriate vaccinations at the correct time in a patient’s life. Pharmacists are providing an increasingly higher proportion of these vaccines, and are projected to administer even more in the future. This study looked at the effectiveness of a program called RxVaccinate, created by APhA, which was designed to compare the effectiveness of two different types of education programs in increasing the amount of pneumococcal vaccines administered.

The two programs involved in the study were a series of self-directed training webinars and the webinars combined with expert coaching sessions. The webinar focused on the current pneumococcal immunization recommendations, benefits of getting the vaccine, how to identify high-risk patients and provide counseling to them. The coaching sessions involved outlining action plans for the pharmacists and how to implement them. One group of pharmacists received only the self-directed training on pneumococcal vaccines, while the other group received coaching sessions in addition to the self-directed webinars. This study found that while both programs significantly increased the number of pneumococcal vaccines administered at each community pharmacy, the pharmacists who received both the webinar and the coaching session trainings increased the amount of pneumococcal vaccines administered than the pharmacists who only received the webinar training, with a P value of 0.032.

This study is really interesting to me because at my work (in a community pharmacy), we are frequently assigned self-directing online learning modules to teach us about new programs or educate us on new compliance policies within the company. I know for the sake of efficiency it is easier to send us online modules, but it does make it easier for pharmacy team members to dismiss them or not take the training as seriously as they would if the same information was presented in an expert-led training session. However, for something as important as teaching pharmacists the proper methods to identify, counsel, and administer the vaccine to patients, it is definitely necessary to have an in-person training session. As more advanced technological methods of teaching emerges, how do you think the effectiveness of pharmacists’ training will be affected? Do you think these types of online learning modules will completely replace in-person training sessions, or do you think they will only be used as more of a supplement to these sessions?

Westrick SC, Owen J, Hagel H et al. Impact of the RxVaccinate program for pharmacy-based pneumococcal immunization: A cluster-randomized controlled trial. J Am Pharm Assoc. 2016; 56:29-36.

http://www.japha.org/article/S1544-3191(15)00011-4/abstract

 

Pharmacist Education and Inpatient Influenza and Pneumococcal Vaccination Acceptance Rates

The United States is vastly affected by pneumococcus pneumonia, invasive pneumococcal infections, and seasonal influenza each and every year. Although there are vaccines that prevent these diseases, approximately 70 million high-risk adults are vulnerable to pneumococcus by by remaining unvaccinated. The number of deaths related to influenza has been steadily increasing in the United States since 1990. If patients qualify, patients can receive both the influenza and pneumonia vaccinations to protect themselves from these disease, however, less than half of adults 18 years of older were vaccinated during the 2012 to 2013 flu season. It is apparent that pharmacists, as immunizers in the community setting, are increasing the current vaccination rates in the population today.

A study was conducted to determine just how effective pharmacist-driven education programs were at increasing vaccination rates. Patients in a small community hospital who initially rejected vaccinations upon admission were educated by pharmacists and pharmacy interns and reoccurred the vaccination. As a result, 39.2% of patients changed there minds and decided to receive the influence and pneumococcal pneumonia vaccines.

This study proves the importance of patient education. Pharmacists need to provide patients with all the available information in order for patients to make the right decisions in regards to their health care. I am proud to be going in to a profession that has such a big influence on its patient population.

Journal of Pharmacy Practice (2016): n. pag. Web.

Link to article

Controversy of Childhood Vaccinations

Childhood vaccinations have become a point of controversy among parents and physicians. Due to a more recent outbreak of measles and other childhood diseases in America, the American Academy of Pediatrics has urged parents to vaccinate their children more than in the past. Speculation about vaccinations was generated after a falsified report by Andrew Wakefield was published claiming there was a connection between the measles vaccine and autism. The paper was been withdrawn and Wakefield has been eliminated from the General Registrar, however the fabricated data still has a massive presence in the decision making process for parents. Because parents have sole decision-making power, physicians can only make recommendations through counseling in order to obtain informed consent.

In order to reverse the negative connotations surrounding childhood vaccinations, physicians and medical professionals must take on the role to educate the parents prior to their decision-making. They must emphasis the purpose of vaccinations, which is to prevent the child from diseases that may cause mortality or major morbidity. It is up to the physician to strongly recommend and urge the parents to approve vaccinations for their children. The American Academy of Pediatrics recommends that in addition to educating the parents, the physicians must call on their ethical responsibility to their children, which means emphasizing the clinical benefit to not only their children but also to the other children that will come in contact with their own child. In conclusion, it is up to medical professionals to remove the negative stigma of vaccines and reinforce the positive benefits to each parent and patient.

J Pediatr. 2016;169(305-309)

Less than half of U.S. kids under age two fully vaccinated against flu

Vaccination rates among children under the age of 2 years have been alarmingly low for the past decade, if not more. In the 2011-2012 flu season, only 45 percent of infants aged 7 to 23 months were vaccinated. While compared to the 5 percent rate in 2002-2003, this is step in the right direction, but more needs to be done to continue raising the vaccination rates among infants. In some states, the vaccination rate is as low as 24 percent, meaning that 3 in 4 babies are at risk to influenza. A contributing factor to these low vaccination rates is that for an infant’s first vaccination, they need two doses of the vaccine. Nearly 36 percent of children end up only receiving the first dose and end up not being fully vaccinated.

Pharmacists have already began seeing changes in immunization laws over the past couple years, especially in the restrictions on patient-age. At the beginning of 2015, only 27 states allowed pharmacists to vaccinate patients of any age, while there were 8 states where pharmacists could only vaccinate people older than the age of 18, Pennsylvania being one of them (until June 26th, where a bill was passed lowering the minimum age to 9). These changes can prove to be instrumental in raising vaccination rates across the country. Increasing the access to these immunization services can make a huge impact on the country’s health and encourage more people to stay current on their vaccinations. Hopefully in the near future, legislators will realize the potential of pharmacists immunizing and allow for them to do so all over the country, and not just in select states.

Pediatrics. 2016; 137(3): .