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Kentucky S.B. 250: An ACT Relating to Screening for Hepatitis C
Hepatitis C (HCV) is a chronic infection that attacks the liver and if not treated liver failure, cancer, and/or death can be the result. This infection is spread through contact with contaminated/infected blood and most individuals that are carriers of Hepatitis C have no symptoms. Typically, we know the most common spread of HCV is done through dirty needles, but what about spreading it inutero if an infected person was pregnant? According to the Centers for Disease Control and Prevention, a mother can transmit Hepatitis C to her baby via pregnancy, during delivery, and/or up to a month after the baby is born. On March 1, 2018 a bill was proposed in Kentucky to screen all pregnant women for HCV, where as previously only pregnant women who were high-risk were screened for HCV (Kentucky General Assembly, 2018). The bill also states that it is recommended babies get tested if their mother did in fact test positive for HCV. By testing every pregnant woman and the babies born to a positive tested mom for HCV we are able to help identify, treat, and slow down the spread of transmission. This bill, now a law, was passed in April of 2018. Kentucky is the first state to require HCV testing to all pregnant women and it will be done at their first prenatal appointment. As an advanced practice nurse (APN) this is something that is needed to be implemented in everyday practice. If you are an APN in an obstetric office you would need to screen every pregnant woman that you see, if it hasnt already been ordered. HCV antibodies can cross the placenta and be passed from the pregnant woman to the baby, therefore the presence of antibodies in the babys blood right after delivery is not enough to make a diagnosis for neonatal infection of HCV (Hughes, Page, & Kuller. 2017). The American Academy of Pediatrics and the CDC recommend for screening to be completed after the baby is 18 months of age (Hughes et al., 2017). I will be working in a Neonatal Intensive Care Unit (NICU) as an APN and it will be very important to always review the mothers HCV results and know whether follow-up testing for baby is needed. Education will need to be provided to the mother regarding possible transmission to baby, breastfeeding, the importance for follow up, and when and where the screening process for baby will take place.
Sociocultural Environment
There is a big opioid crisis happening right now in the United States. This epidemic is seeing a lot of individuals using drugs intravenously (IV) with a syringe and needle. When IV drug users share needles, they can spread HCV to other individuals. Sharing or reusing needles and syringes increases the chance of spreading the Hepatitis C virus. Syringes with detachable needles increase this risk even more because they can retain more blood after they are used than syringes with fixed-needles, (Centers for Disease Control and Prevention, n.d.). Because of the widespread opioid crisis where sharing needles is common the rates of HCV are increasing. According to the Centers for Disease Control and Prevention (CDC), HCV has increased by 400% from 2004-2014. While the onset of
Hepatitis C can last a few months, some people may not have any symptoms, thus mothers would not know they are infected and could pass it along to their baby. Originally, Kentuckys law was to only test women at risk for HCV but now have decided to test every pregnant woman, regardless of risk factors, so that treatment can be an option, and baby can be monitored throughout life. This overall will help to decrease the spread of HCV, despite the opioid crisis happening.
Ethical Environment
Pregnant women are among a population of vulnerable individuals. Prior to screening every pregnant woman, it was only women who were at risk for HCV. Women of childbearing age, the most common risk factor would be drug use. If a provider wasnt 100% sure the patient was an IV drug user and decided to test them for HCV, then that could make the patient feel stereotyped. The principle of justice comes into play by testing every single pregnant woman that seeks prenatal care. The principle of beneficence would be testing a pregnant woman who potentially could be infected with HCV in order to identify the infection and to provide treatment. Treatment decisions would be autonomous in the context of the doctor-patient relationship (Geppert, Arora, 2005).
Economic Environment
Screening every pregnant woman (universal screening) versus risk-based screening (only those who have risk factors) is more cost effective. While universal screening cost $308 more per patient, the associated incremental cost-effectiveness ratio was $18,139 for each active infection that was identified, with a quality-adjusted life year gained of $4662, which is below the willingness-to-pay cost-effectiveness threshold, (Dangi-Garimella, 2018). Dangi-Garimella explains that although there is an increase in cost with this screening the undiagnosed women will be able to be identified and able to receive care, thus offsetting the cost.
Political Environments
Amidst the major opioid crisis, we are experiencing in Kentucky, the rate of HCV births has drastically increased. We as a healthcare system have fallen short in attempting to prevent and control the disease. Experts say as many as 46,000 U.S. children are living with hep C, and research shows Kentucky fares much worse than other states because drug use among young women is so widespread. One federal study showed the disease rose 213 percent in four years among Kentucky women of childbearing age nearly 10 times the national rise of 22 percent, (Ungar, 2018). This Senate Bill was passed without discussion, it was evident that more needed to be done.
Legislative Environment
Senate Bill 250 was introduced in March of 2018 by Republican Senator, Julie Adams.
Passage and Progression
36 bill sponsors from the senate supported SB 250 to screen all pregnant women for Hepatitis C. The sponsors include these legislators by last name: Alvarado, Bowen, Buford Carpenter, Carroll D, Carroll J, Embry, Girdler, Givens, Harper Angel, Harris, Higdon, Hornnback, Humphries, Jones, McDaniel, McGarvey, Meredith, Neal, Parrett, Raque Adams, Ridley, Robinson, Schickel, Schroder, Seum, Smith, Stivers, Thayer, Thomas, Turner, Webb, West, Westerfield, Wilson, and Wise. There were 0 nays, 0 passes, and 2 legislators that did not vote. In the house of representatives there were 97 yeas (35 Democrats, 62 Republican), 0 nays, 0 abstained, and 3 who did not vote (Kentucky Legislature, 2018).
Stakeholders consists of the House of Representative and the Senate (133 legislators) that were all in favor of SB 250. There wasnt anyone who opposed the bill, although 5 legislators did not vote. It was said that there was no discussion for this bill because the outcome was unanimous therefore there werent any difficulties in the effort to pass the bill (Ungar, 2018). Healthcare consumers have seen a positive outcome resulting from this bill due to the opportunity for treatment and monitoring of their children for HCV. Healthcare providers benefit from screening each patient so that they can be properly treated and monitored (babies) all while being cost effective. I believe if this did not end up being cost effective albeit more testing, then difficulties would have been faced.
SB 250 was introduced by Senator Julie Adams in the Senate on March 1, 2018 and then to Health and Welfare on March 5. By the 14th the bill was reported favorably during its first reading and had its second reading the following day. On the 16th the bill passed the Senate 36-0 during its 3rd reading. On March 19 the bill moved along to be received by the House and then to Health and Family Services by March 21. On the 22nd the bill was reported favorably during its first reading. The second reading in the House was on the 27th and on March 29th the third reading took place, where it passed 97-0. The bill then went back to the Senate on the same day where it was signed by Bertram Robert Stivers II, President of the Senate, and David Osborne, Speaker of the House and then delivered to the Governor. On April 10, 2018 SB 250 was signed by the Governor, Matt Bevin (Legiscan, 2018; Kentucky, C.O, n.d.; Kentucky Senate Leadership, n.d.; Loftus, T. 2018).
Effects on Consumers and Providers
Overall there is mostly positive outcomes of this bill. Positive impacts this would have on consumers is early detection of HCV when pregnant, treatment plans, and testing for babies delivered to HCV positive mothers. Negative impacts would be cost of treatment, cost of screening your baby, cost of their treatment if positive, and the stigma of having such results. Positive effects for providers would be knowing if their patient is HCV positive so that they can adhere to proper precautions during examinations and delivery of the baby. Negative impacts on providers would be for more educational opportunities such as communication for the screening. Since testing is completed during the first antenatal visit it is important to provide the patient with effective communication in order to build a rapport (Oni, H., Buultjens, M., Abdel-Latif, M., Islam, M., 2018). Time constraints at the first antenatal appointment, the presence of family members during the visit, and a concern about anxiety and/or guilt of the patient are other negative impacts on providers (Oni, et al. 2018). Short-term negative effects would be getting into the habit of screening each and every pregnant patient. Long-term negative effects could possibly be the amount of treatment provided for HCV positive women depending on the cost for each patient. Short-term positive effects would be for patients to be able to seek treatment earlier and be knowledgeable about screening their baby at 18 months, if needed. Long term positive effects of SB 250 would be to decrease the overall number of persons infected with HCV and transmission rates.
Hepatitis Screening Among Pregnant Women in Egypt
Although Egypt is the worlds highest prevalence of HCV, it relies on risk-based screening instead of universal screening. A study was completed to determine how reliable the risk-based only screening is in Egypt. Prevalence of HCV infection in pregnant women in the US is estimated to range from 1 to 2.4% and in Egypt 15.7%19%, (El Kamary, et al, 2015). Despite having the highest rates of contracting HCV Egypt only practices risk-based screening which is insufficient. All these women may have no idea that they are even infected, have no symptoms, and no history of risk factors (El Kamary, et al, 2015). Waiting for women to develop long term complications from HCV before being diagnosed is worrisome, states El Kamary, et al (2015). Directly Acting antiviral medication (DAAs) have been approved and are highly effective in treating HCV and preventing the progression of liver disease. Although DAAs are effective in treating HCV the more prevalent the disease the higher the cost could become (Spengler, 2018). The Egyptian government was able to drive down the price initially and then even more once a generic form of medication became available from $900 to $84 per patient (Halter, 2018). Egypt is a country of limited resources, unlike the United States were resources are plentiful, so it is important to maintain cost effectiveness within HCV treatment. The HCV sustainable MOC in Egypt is considered a successful disease control programme serving up to 6 million patients. This model provides access to all HCVinfected individuals and an action plan and strategy for prevention of new infections. This control programme aims at elimination of HCV in Egypt in accordance with the WHO and global targets, (El-Akel, 2017). In 2017, the Egyptian Ministry of health also initiated a nationwide screening program through which more than 260 teams of community health workers go village to village testing people for the virus. So far, theyve screened more than 1,200 towns, cities and villages, targeting poor, rural communities. Meanwhile, less than 20 percent of those estimated to be living with chronic hepatitis C in the United States have received treatment, (Halter, 2018). Egypt is taking great strides by using their model of care and screening programs to decrease transmission of HCV, something the United States doesnt offer. According to the El-Kamary study (2015) All pregnant women accepted the universal screening instead of rosk-based. If risk-based screening was the screening of choice it would have missed 10% of pregnant women in the study with chronic HCV. With that being said I think it would be even beneficial for Egypt, the worlds highest level of HCV prevalence, to start implementing universal screening for pregnant women.
Options for Refinement and Change
Although there arent many ways to improve a great policy, the communication between the physicians and the consumers could be better. Communication about mandatory testing for HCV to the patients when making their first prenatal appointment to lessen any awkwardness, prepare for who would accompany you to the visit, and to overall just to be aware of the new law that has taken place would be helpful. Another improvement that can possibly be foreseen would be to go out into the community and target the population of women who typically do not seek prenatal care. I understand this could potentially be costly but having a representative of the delivering hospital reach out and test the women not seeking or has limited prenatal care. Although not everyone would be located this would help to somewhat fill in the gap for this population. Many young women may consistently seek medical care only during pregnancy. As has been previously noted for HIV and anecdotally by many HCV experts, the compliance of pregnant women for testing and follow-up is higher as they consider the future of unborn children. Studies have shown that after delivery, this compliance wanes, and reengaging these women in care can be difficult, (Jhaveri, 2018). There are several women that do not even seek medical treatment while pregnant until they come into the hospital to deliver the baby, so we would at least know the status of HCV in that patient so the opportunity is not missed.
References
- KY SB250. Regular Session. (2018, April 10). LegiScan. Retrieved March 06, 2019, from https://legiscan.com/KY/bill/SB250/2018
- Kentucky General Assembly. (n.d.). Retrieved from https://apps.legislature.ky.gov/lrcsearch#tabs-3
- HCV, Challenges, Pregnancy, NCHHSTP, CDC. (n.d.). Retrieved from https://www.cdc.gov/nchhstp/pregnancy/challenges/hcv.html
- Hughes, B., Page, C., Kuller, J. (2017). Hepatits C in pregnancy: screening, treatment, and management. American Journal of Obstetrics and Gynecology. 217(5). https://doi.org/10.1016/j.ajog.2017.07.039
- 2017 Increase in hepatitis C infections linked to worsening opioid epidemic | CDC. (n.d.). Retrieved from https://www.cdc.gov/nchhstp/newsroom/2017/hepatitis-c-and-opioid-injection-press-release.html
- Geppert, C., Arora, S. (2005). Ethical Issues in the Treatment of Hepatitis C. Clincial Gastroenterology and Hepatology. 3(10), 937-944. DOI: https://doi.org/10.1016/S1542-3565(05)00183-7
- Dangi-Garimella, S. (2018). Universal HCV Screening in Economical Over Risk-Based Screening in Pregnant Women. American Journal of Managed Care. Retrieved from: https://www.ajmc.com/newsroom/universal-hcv-screening-economical-over-riskbased-screening-in-pregnant-women-
- Ungar, L. (2018). Mandatory hepatitis C tests for all pregnant women approved by Kentucky lawmakers. Courier Journal. Retrieved from: https://www.courier-journal.com/story/news/2018/03/29/kentucky-general-assembly-mandates-hepatitis-c-tests-pregnant-women/469933002/
- Kentucky SB250 Regular Session. (2018). Retrieved from https://legiscan.com/KY/votes/SB250/2018
- Kentucky SB250 Regular Session (2018). Retrieved from https://legiscan.com/KY/bill/SB250/2018
- Kentucky, C. O. (n.d.). Governor Bevin’s Vision for Kentucky. Retrieved from https://governor.ky.gov/
- Hepatitis C and Injection Drug Use. (n.d.) Retrieved from: https://www.cdc.gov/hepatitis/hcv/pdfs/factsheet-pwid.pdf
- Loftus, T. (2018). Republican David Osborne elected as speaker of the Kentucky House. The
- Courier-Journal. Retrieved from: https://www.courierjournal.com/story/news/politics/2018/11/29/kentucky-house-republicans-elect-david-osborne-speaker/2147650002/
- Kentucky Senate Leadership (n.d). Retrieved from: https://votesmart.org/offices/leadership/KY/U#.XICUqS2ZM8Y
- Oni, H., Buultjens, M., Abdel-Latif, M., Islam, M. (2018). Barriers to screening pregnant women for alcohol or other drugs: a narrative synthesis. Women and Birth. Doi: https://doi-org.proxy.libraries.uc.edu/10.1016/j.wombi.2018.11.009
- El-Kamary, S. S., Hashem, M., Saleh, D. A., Ehab, M., Sharaf, S. A., El-Mougy, F., Abdelsalam, L., Jhaveri, R., Aboulnasr, A., El- Ghazaly, H. (2015). Reliability of risk-based screening for hepatitis C virus infection among pregnant women in Egypt. Journal of Infection,70(5), 512-519. doi:10.1016/j.jinf.2015.01.009
- Spengler, U. (2018). Direct antiviral agents (DAAs) – A new age in the treatment of hepatitis C virus infection. Pharmacology & Therapeutics,183, 118-126. doi:10.1016/j.pharmthera.2017.10.009
- El-Akel, W., El-Sayed, M. H., Kassas, M. E., El-Serafy, M., Khairy, M., Elsaeed, K., . . . Doss, W. (2017). A national treatment program of hepatitis C in Egypt: Hepatitis C virus model of care. Journal of Viral Hepatitis,24(4), 262-267. doi:10.1111/jvh.12668
- Halter, C. (2018). Egypt Could Eliminate Hepatitis C Among Its Population by 2023. Hep Mag. Retrieved from https://www.hepmag.com/article/egypt-eliminate-hepatitis-c-among- population-2023
- Jhaveri, R., Broder, T., Bhattacharya, D., Peters, M. G., Kim, A. Y., & Jonas, M. M. (2018). Universal Screening of Pregnant Women for Hepatitis C: The Time Is Now. Clinical Infectious Diseases,67(10), 1493-1497. doi:10.1093/cid/ciy586
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