A new network will likely increase the volume of organ transplants, influencing how dental offices treat donors and recipients
by Kathryn Kupczyk, BS, BSDH, RDH
In 2015, the Food and Drug Administration (FDA) did something unprecedented in its 110-year history, approving 51 pharmaceuticals to market in the United States.1 Among these pharmaceuticals were three FDA-approved medications-Nulojix, Astagraf XL, and Envarsus XR-to treat patients who have undergone organ transplants.
Consequently, in 2015, the US Department of Health and Human Services reported there were 30,970 transplants in the US, the highest number ever.2 At the time of researching this article in 2016, 27,605 organ transplants were completed.3 The increase in organ transplant surgical procedures can be attributed in large part to advances in medical technology, immunosuppression pharmaceuticals, and an increase in technology-based transplant communication. This communication network allows a dispatch between health-care systems to ensure wait lists are actively monitored and managed in communities closest to the patient in need.
Recently, 19 transplant hospitals have been selected to participate in the pilot phase of COIIN (Collaborative Innovation and Improvement Network), a three-year project intended to increase kidney utilization and to study new methods of quality monitoring.4 They will participate in an alternative, collaborative quality improvement framework to drive improvements in organ offerings and acceptance, wait-list management, and care coordination. Training started in October 2016, and data collection and collaborative learning commenced in January 2017.4
These advances in organ transplants translate into an increased likelihood that the dental hygienist will encounter a patient who has received, or who possesses a live organ for an organ transplant. This substantial growth will be seen in all dental health-care settings across the United States, especially as the dental hygiene profession continues to expand in licensure and diversifies into other health-care settings.
It is the professional responsibility of dental hygienists to think critically at the chairside, continue to educate themselves and their patients on current research of multiple oral and systemic health linkages, work collectively within a multidisciplinary health-care team to ensure overall patient safety and health, and to note the possible short- and long-term side effects of patients taking new-to-the-market antirejection medications.
Chairside assessment
Dental hygienists should assess transplant patients for myriad of antirejection medication side effects. These include hyperglycemia, hypertension, hyperlipidemia, obesity, cataracts, muscle disease, bone metabolism alterations, and skin problems, as well as an increased risk for hernias, cancers and serious infections.8 All transplant patients are placed on immunosuppressant drugs postsurgery. There are two major types of immunosuppressant drugs: induction drugs used at the time of the transplant and maintenance drugs.
There are four subcategories of maintenance drugs: calcineurin inhibitors (tacrolimus and cyclosporine), antiproliferation agents (mycophenolate mofetil, mycophenolate sodium, and azathioprine), mTOR inhibitors (sirolimus), and steroids (prednisone).9 Among these advanced drugs are three medications for kidney transplant patients: Nulojix, Astagraf XL, and Envarsus XR. Therefore, patients taking Nulojix, Astagraf XL, or Envarsus XR will also be taking a steroid, such as prednisone, and an antirejection medication, such as mycophenolate.9
Nulojix is an injectable medication that was engineered with the hope it would replace two common antirejection medications, Prograf (tacrolimus) or Neoral (Gengraf, cyclosporine).10 A predosed injection of Nulojix is administered once a month for 30 minutes by a health-care provider. It is especially revolutionary for patients who normally take a daily cyclosporine or tacrolimus pill. Within the first three years of receiving Nulojix, patients reported they had better control of blood pressure, smaller increases in cholesterol, and avoided toxicity reactions to the kidney, heart, and nervous systems. However, patients taking this new antirejection injection are subject to more rejection episodes or post-transplant lymphoproliferative disorder (PTLD) and are at an increased risk of developing cancer. After three years, blood pressure may worsen and should be monitored carefully by all health-care providers. It should be noted that patients are only approved for Nulojix if they have been exposed to the Epstein-Barr virus (EBV).10
Astagraf XL is the first once-a-day version of oral tacrolimus that is now available in the US. According to clinical trials, Astagraf XL has shown to have the same effectiveness and side effects as twice-daily Prograf (also oral tacrolimus).10 Patients report Astagraf XL's convenience as they take only one pill a day that addresses the need for a calcineurin inhibitor. Health-care providers and patients should be aware that taking Astagraf XL may lead to increased blood pressure, hypertension, and increase cholesterol, which may put a patient at higher risk for other comorbidities.10 Possible reported side effects of Astagraf XL also include diarrhea, constipation, anemia, tremor, nerve toxicity, renal toxicity, and an increased risk of new-onset diabetes.10
Although Envarsus XR is not a novel medication since it is composed of previously prescribed tacrolimus, it is proprietary in its extended release dosing method. Envarsus XR is a prescription medicine used with other medications to help prevent organ rejection in patients who have had kidney transplants.11 Envarsus XR is an extended-release tablet and is not the same as tacrolimus extended-release capsules or tacrolimus immediate-release capsules. Serious side effects that have been reported include an increased risk of cancer, including skin and lymph gland cancer (lymphoma), and a significant risk of infection.11
Patients who are taking Envarsus XR are advised to avoid live vaccines, such as the flu vaccine through the nose, measles, mumps, rubella, polio by mouth, BCG (TB vaccine), yellow fever, chicken pox (varicella), and typhoid. Those taking this medication should avoid exposure to sunlight and UV light, including artificial sources of UV light such as tanning machines. These patients should always wear protective clothing in the sun and use a sunscreen.11
Chairside Implications
An in-depth awareness of the myriad of systemic issues that can impact the delivery of dental hygiene care to these patients is an imperative conversation between the dental hygienist and dental team. Dental hygienists should be aware first and foremost of a patient's change in blood pressure, especially for major dental procedures and for administering local anesthetic. Patients undergoing long appointments in the supine to semisupine position should be treated with a two-minute dismissal in which they are given time in an upright chair position to equilibrate blood pressure before they stand. Patients should also be monitored for low red blood cell count (anemia) and swelling in the legs.
Patients taking Nulojix, Astagraf XL, and Envarsus XR can also exhibit increased risk of cancer and infection, especially skin cancer if premalignant lesions are present. Dental hygienists should measure and note in the patient's chart any suspicious lesions or nodules on the skin during the oral cancer screening and head and neck exam. Patients should receive an oral cancer exam by both the dental hygienist and dentist, and a biopsy is recommended for any oral lesions that lack a clear etiology.12 Aggressive treatments when periodontal, oral, or systemic infection is suspected should be taken in conjunction with the patient's health-care team. Current trends in antibiotic prophylaxis are patient-specific and should be determined by the patient's primary health-care provider and transplant team.
For patients taking these novel antirejection medications, especially Astagraf XL, an increased risk of new-onset diabetes is possible. This is especially pertinent to dental hygienists as an increased risk of diabetes may exacerbate gingivitis and periodontal disease. Patients should be educated as to this oral-systemic health risk, and should be monitored more frequently and treated appropriately for periodontal disease.
Providers should exercise caution because many medications commonly used in the dental practice, including NSAIDS and some antimicrobials, are metabolized differently in the kidneys or liver of transplant patients and are not removed from circulation as quickly.12 Again, intervals and dosing should be confirmed with the patient's medical team.
Dental hygienists should watch for signs of adrenal insufficiency, especially in procedures that prompt stress for the patient. For some patients, this is all dental appointments. Preventive hydrocortisone replacement therapy at the time of the dental procedure may be required for these patients. Signs of adrenal insufficiency include but are not limited to hypertension, weakness, fever, and nausea, and patients with these symptoms should be transported to a hospital immediately for medical attention.12
Transplant patients taking tacrolimus sometimes have oral ulcerations and numbness or tingling, especially around the mouth.12 Steroids taken in conjunction with immunosuppressant drugs can increase the risk of oral and systemic infection while also masking typical signs of infection (such as periodontal disease, Candida albicans, and others) in the mouth. Therefore, dental hygienists should view these patients even more critically in their overall assessment and partner with the dentist to complete the most successful home-care routine, as well as prophylaxis and/or periodontal maintenance schedule for these patients.
As advances in immunosuppressant drugs progress and the number of successful transplant patients increases, it is imperative that dental hygienists remain informed and steadfast advocates for their patients. The role of interprofessional communication for these patients is critical as minute changes in periodontal, immune, cardiac, and kidney function response can affect the patient's oral and overall health. The patient's inclusive assessment and quality of life should always be at the center of care. A critical analysis of the patient's medications, risks, and side effects is an imperative part of the dental hygienist's personalized care plan for the patient.
Although the rate of organ transplants continues to increase, the need for transplants is as great as ever. As immunosuppression pharmaceuticals, medical technology, and an increase in technology-based transplant communication continue to improve, dental hygienists are always in a role of patient education, and may have the opportunity to encourage patients to think about registering to be organ donors. As pharmaceuticals improve, the dental hygienist's role as integral health-care provider to transplant patients will only increase in importance. RDH
Current trends in organ transplantation
The most common transplant procedures involve the heart, liver, kidneys, lungs, pancreas, and small intestines. However, it has become increasingly more common for tissues to be transplanted such as corneas, skin, veins, heart valves, tendons, ligaments, and bones.5 Some patients in need of transplants have comorbidities that would benefit from multiple organ transplants. For example, both Type I and Type II diabetic patients are more likely to be the recipient of multiple organ transplants-mainly kidney and pancreas organ transplants. This is especially true in the growing number of obese patients with type 2 diabetes.
Type 2 diabetes is the leading cause of kidney disease. Current trends in research show an increase in successful outcomes in patients receiving simultaneous pancreas/kidney (SPK) transplants, and patients with type 1 diabetes are the main recipients of this transplant procedure.6 This success is largely due to recipients receiving both organs from the same donor. About 75% of pancreas transplants are performed simultaneously with a kidney transplant from the same donor.7
SPK transplantation is typically offered to patients who have insulin-dependent diabetes mellitus, and in whom diabetic nephropathy has developed. Although suspected to also play an important role, more research is needed to explore the relationship between the establishment of normoglycemia in patients with long-term diabetes and a reduction in cardiovascular morbidity and mortality.7
Kathryn Kupczyk, BS, BSDH, RDH, attended DePaul University and completed her bachelor of science degree in biology with a concentration in biotechnology. She has presented at several research symposiums in Chicago. Kathryn graduated from the University of Michigan School of Dentistry with a bachelor of dental hygiene degree. She is an active member of ADHA, a member of Sigma Pi Alpha, and is currently working full-time in private practice.
References
1. Pharmaceutical Research and Manufacturers of America. 2015 biopharmaceutical research industry profile. Washington, DC: PhRMA; April 2015. Web. 15 Nov. 2016.
2. U.S. Government Information on Organ Donation and Transplantation. Organ Donations Statistics. U.S. Department of Health and Human Services, 2015. Web. 15 Nov. 2016.
3. U.S. Department of Health and Human Services. Organ Procurement and Transplantation Network: At a Glance. 11 Nov. 2015. Web 15 Nov. 2016.
4. U.S. Department of Health and Human Services. Hospitals chosen for initial phase of COIIN pilot-OPTN. Organ Procurement and Transplantation Network, 18 Oct. 2016. Web. 11 Dec. 2016.
5. U.S. Department of Health and Human Resources. Organ matching. http://www.organdonor.gov/about/organmatching.html. Web. 7 Sept. 2016.
6. FDA Approves Nulojix for Kidney Transplant Patients. Food and Drug Administration, 01 Apr. 2014. Web. 15 Nov. 2016.
7. Lerma EV. Kidney-Pancreas Transplantation: Overview, Technique, Periprocedural Care. MedScape, 03 Aug. 2015. Web. 29 Dec. 2016.
8. Vella J. Investigational Immunosuppressive Drugs and Approaches in Clinical Kidney Transplantation. www.uptodate.com. Wolters Kluwer, 15 Jan. 2016. Web. 07 Sept. 2016.
9. The National Kidney Foundation. What Are Immunosuppressants? 2016. Web. 10 Sept. 2016.
10. Paley D, Anderson-Haag T. New Anti-Rejection Medications: The Low Down. The National Kidney Foundation, 20 May 2015. Web. 10 Sept. 2016.
11. Envarasus XR (tacrolimus extended-release tablets) Once-daily dosing | ENVARSUS XR® (tacrolimus extended-release tablets) guidelines. N.p., 01 Oct. 2016. Web. 14 Dec. 2016.
12. NIDCR. Dental Management of the Organ or Stem Cell Transplant Patient. National Institutes of Health. U.S. Department of Health and Human Services, 162016 Sept. 2016. Web. 12 Dec. 2016.
