Marilyn N. Bulloch, PharmD, BCPS, FCCM

, recognizing a disease that can be both acute or chronic as well as infectious and non-infectious.

Hepatitis can have a widespread impact on the health

 and pharmaceutical needs of patients. It also carries a stigma that may make patients hesitant to seek treatment or disclose their condition.

As a result, providers may not be aware of unique pharmacotherapy requirements these patients may have. Prevention, optimal disease state management, and appropriate pharmacokinetic and therapeutic attention are all part of the holistic approach to hepatitis care.

Many of patients with hepatitis that pharmacists encounter have viral hepatitis, which can be easily remembered as the ABCs of hepatitis. Starting with the A for hepatitis A virus (HAV), the Centers for Disease Control and Prevention’s Division of Viral Hepatitis has noted an increasing number of HAV cases since March 2017.

This is thought to be linked to imported foods that had been contaminated, causing primary infection continuing to spread from person-to-person. HAV infection can be prevented through a vaccine, good hygiene, and patients decreasing their risk factors.

Promoting the HAV vaccine to patients, especially those at high risk of HAV infection, can be arguably the best preventative measure to ensure a patient’s safety, as HAV can result in cholestatic hepatitis, relapsing hepatitis, autoimmune hepatitis or even liver disease. Just one dose of inactivated HAV vaccine can provide protection from HAV for up to 11 years.

Risk factors for contracting HAV include illicit drug use, sexual contact with a person infected with HAV, contact with a person infected with HAV, homelessness, and travel to countries where HAV is prevalent including, Saudi Arabia, Syria, Turkey, and Eygpt.

 The spread of HAV can be reduced through good hand hygiene after using the restroom following contact with body fluids or stool, and through avoiding unsanitary food and water sources.

The role of the pharmacist has been highlighted in various HAV outbreaks across the United States. Once such pharmacist, Dr. Monica Payne, a pharmacist from Section, Alabama, was on the front lines of fighting HAV in her community during an outbreak in 2019.

“The hepatitis A outbreak in 2019 was a trying time for our community, but it was also an excellent opportunity for pharmacists to show what we can do as the most accessible healthcare providers,” Payne said

In late 2018, North Alabama, including Jackson County and Section, saw the start point of an outbreak that eventually made its way through the entire state by the end of 2020.

 Payne’s community pharmacy, Section Pharmacy, worked with the Alabama Department of Public Health to provide vaccine clinics in rural areas near Section where many patients did not have adequate transportation to a pharmacy or prescriber's clinic.

“We vaccinated hundreds of individuals across Jackson County to help control the outbreak, and we were proud to do our part in protecting the health of our community,” Payne said.

In contrast to HAV, there has been a steady decrease in hepatitis B virus (HBV) cases over the past 10 years. HBV prevalence has decreased in correlation with an increased vaccine prevalence. From 1999 to 2018, infection rates decreased from 5.7% to 4.3% with higher rates in men and non-Hispanic, Asian adults.

HBV can be contracted through sexual contact, contaminated blood, or be passed from mother to newborn. Due to this, vaccination was advocated for newborns and is correlated with today's decreased past and current cases of HBV.

It is important to continue to advocate for the HBV vaccine to all patients as severe complications can lead to cirrhosis, liver failure or kidney disease. During the years of 2015-2018, 25.2% of adults over 18 years of age had been vaccinated for HBV.

 Women had a higher prevalence of vaccination history, which would correlate with women having a lower prevalence for being infected.

These numbers and correlations of infections to vaccinations clearly depict a linear relationship of vaccinations lowering the number of infections and is why pharmacists should advocate for all patients to be fully vaccinated.

 A study published in 2020 showed clinically significant data that clinical pharmacists improved the attitude of patients living with HBV toward their infection and increased their knowledge about HBV through interviews.

During these interviews the pharmacists elicited what the patient currently knew about the disease, corrected any misinformation, and then further educated them about HBV. After the interviews, patients indicated that their attitudes toward HBV had improved now that they had gained more knowledge about the disease.

Also, as a rule, the better educated a patient is about their condition, the more likely they are to be adherent to their medication and non-pharmacological recommendations, improving patient outcomes.

Unlike HAV and HBV, hepatitis C virus (HCV) is more common in the United States. An estimated 2.4 million Americans are currently living with HCV.

In 2018, a conservative estimate of 14,242 deaths in the United States were reported as a result of chronic HCV.

Although this number continues to decline each year, pharmacists still need to promote the importance of risk reduction and frequent testing of those at high risk because complications of HCV can result in cirrhosis or liver cancer.

HCV is spread through contact with blood from an infected person and no vaccine is currently available for prevention. Pharmacists should encourage patients to get tested for HCV, because it often has no signs or symptoms and can lead to liver cancer if left untreated.

One population of high risk that pharmacists should recommend screening for are those born between the years 1946-1964, also known as the Baby Boomers. Risk reduction and early diagnosis are the best ways to increase the patient’s chances of a positive prognosis.

Talk with your peers about their comfortability level of performing point-of-care testing and providing basic education about HCV. A survey in 2019 was sent out to pharmacists in community settings that inquired about their comfortability level of performing point of care testing and patient education for HCV.

This survey concluded that the pharmacists surveyed were in support of the implementation of HCV point of care testing and that they would be willing to provide basic patient education.

 Having community pharmacists available for HCV testing could open the door for many patients who may feel more comfortable not going to a physician’s office and feel more comfortable with their pharmacist.

In the same mindset, National Hepatitis Testing Day is May 19. Use this day as an opportunity to discuss the importance of testing with patients to help protect themselves and others around them.

One study illustrated the impact clinical pharmacists have on the outcomes of patients with HCV and HIV coinfections. The most notable roles the pharmacist played within the study included HCV medication adherence counseling, HCV drug-drug interaction counseling and screening, HCV medication counseling regarding common adverse events (AEs), HCV counseling regarding HCV treatment outcomes and risk of reinfection, ordering laboratory tests, and interpreting the HCV laboratory values.

The study was conducted to compare AEs and outcomes between groups of patients who had contact with a clinical pharmacist versus those who did not. The results were in favor of a clinical pharmacist’s expertise as part of a multidisciplinary care team to decrease AEs, increase favorable outcomes, and have better drug management for patients living with HCV/HIV coinfections.

Studies such as these show the importance of pharmacists caring for patients with special pharmacokinetic indications, like hepatitis.

In addition to HAV, HBV, and HCV, there is also acute non-viral hepatitis. Acute non-viral hepatitis can stem from exposure to some medications, illegal drugs, alcohol overuse, and toxins.

Some autoimmune diseases can also lead to acute hepatitis, especially when they go uncontrolled for a prolonged period of time.

 These autoimmune diseases include thyroiditis, type 1 diabetes, hemolytic anemia, and celiac disease.

This illness results in inflammation of the liver that could progress to liver disease. In 2021, cases of acute non-viral hepatitis with unknown etiologies were suspected to have been derived from “Real Water” alkaline water, a brand that was recalled due to lack of compliance with the FDA.

Pharmacists can counsel patients to not consume products not approved by the FDA, help control any other comorbid conditions patients have, and to watch for signs and symptoms, such as fatigue, fever, abdominal pain, and joint pain.

Take time to educate patients on all-things hepatitis during the month of May. Educate patients on available vaccines, regular testing, and risk factors for contracting HAV, HBV, and HCV, as well as non-viral hepatitis.

Promote patient testing and immunizations, educate yourself on ways to promote hepatitis awareness, new testing procedures, and new treatment methods when available. Aside from educating patients, take the time to educate other health care professionals around you about the importance of hepatic dose adjustments for patients who have liver diseases.

It is instinct for many providers to double-check renal dose adjustments, but many may be unaware of the need for modifying the dose of drugs that are hepatic cleared to keep the patient safe and the drug at therapeutic concentrations. Overall, pharmacists hold a unique role in fighting hepatitis because of their extensive knowledge of pharmacokinetics and pharmacodynamics when treating hepatitis and preventing further liver damage.

Pharmacists are also the most easily accessible health care provider and can provide a safe and convenient space for patients to get tested and vaccinated against hepatitis.

“Widespread Outbreaks of Hepatitis A Across the U.S.” 

Centers for Disease Control and Prevention

, 2 May 2022, https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm.

Ott JJ, Wiersma ST. Single-dose administration of inactivated hepatitis A vaccination in the context of hepatitis A vaccine recommendations.

2013 Nov;17(11):e939-44. doi: 10.1016/j.ijid.2013.04.012. Epub 2013 Jun 21. PMID: 23791857.

McMahon BJ, Beller M, Williams J, Schloss M, Tanttila H, Bulkow L. A program to control an outbreak of hepatitis A in Alaska by using an inactivated hepatitis A vaccine. 

 Med. 1996 Jul;150(7):733-9. PubMed PMID: 8673200.

Ghasemian A. Prevalence of hepatitis A across various countries in the Middle East, African and Eastern European countries. 

Centers for Disease Control and Prevention. (2022, March 30). 

. Centers for Disease Control and Prevention. Retrieved April 7, 2022, from https://www.cdc.gov/hepatitis/hbv/bfaq.htm

. Alabama Public Health Immunization Division, 31 Mar. 2022, https://www.alabamapublichealth.gov/immunization/assets/hep_a_externalreport.pdf.

Office of Infectious Disease and HIV/AIDS Policy (OIDP). (2021, July 9). 

. HHS.gov. Retrieved April 7, 2022, from https://www.hhs.gov/hepatitis/awareness-months-and-days/hepatitis-awareness-month-may/index.html

Bahap, M., Kara, E., Cagla Sonmezer, M., Inkaya, A. C., Aydin-Hakli, D., Unal, S., & Demirkan, K. (2021). Pharmacist intervention to improve patients' knowledge and attitude towards hepatitis B infection. 

International journal of clinical practice

Centers for Disease Control and Prevention. (2021, June 14). 

Learn more about hepatitis C and about getting tested

. Centers for Disease Control and Prevention. Retrieved April 7, 2022, from https://www.cdc.gov/knowmorehepatitis/index.htm

Centers for Disease Control and Prevention. (2021, May 14). 

Table 3.7 of 2019 Viral Hepatitis Surveillance Report

. Centers for Disease Control and Prevention. Retrieved April 7, 2022, from https://www.cdc.gov/hepatitis/statistics/2019surveillance/Table3.7.htm

So E, Brands M, Suomala E, et al. Pharmacists’ opinions on the implementation of HIV and hepc point-of-care-testing in a U.S. pharmacy chain. 

. 2019;10(1):10. doi:10.24926/iip.v10i1.1425

Olea A Jr, Grochowski J, Luetkemeyer AF, Robb V, Saberi P. Role of a clinical pharmacist as part of a multidisciplinary care team in the treatment of HCV in patients living with HIV/HCV coinfection. 

. 2018;7:105-111. Published 2018 Aug 28. doi:10.2147/IPRP.S169282

Centers for Disease Control and Prevention. (2021, November 23). 

Investigation of Acute Non-Viral Hepatitis of Unknown Etiology Potentially Associated with an Alkaline Water Product. 

Centers for Disease Control and Prevention. Retrieved May 3rd, 2022, from https://www.cdc.gov/knowmorehepatitis/index.htm

, 19 Apr. 2022, https://www.hopkinsmedicine.org/health/conditions-and-diseases/hepatitis/autoimmune-hepatitis.

Articles

Many of patients with hepatitis that pharmacists encounter have viral hepatitis, which can be easily remembered as the ABCs of hepatitis.

Hepatitis Awareness Month: Help Your Patients Live(r) Longer

March is Bleeding Disorders Awareness Month, which gives pharmacists the opportunity to advocate for and honor patients with bleeding disorders. Having a bleeding disorder can put a patient at risk of a hemorrhage and death.

There are approximately 3 million people nationwide who are affected by bleeding disorders.

 Approximately 30,000 people in the United States are thought to have hemophilia, whereas approximately 1 in every 100 people are affected by von Willebrand disease.

One of the most important roles a pharmacist can play in the treatment of patients with bleeding disorders is counseling on the symptoms of bleeding, which include but are not limited to easy bruising, bleeding gums, heavy bleeding from small cuts, and nosebleeds. Making sure patients are aware of these signs can be lifesaving.

Another important role pharmacists can play in bleeding disorders is providing medication counseling and reconciliation for patients with bleeding disorders and individuals taking high bleed risk medications. Through medication counseling, pharmacists can warn these patients about the risk of using medications that may cause bleeding.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are found in most households and can pose the risk of bleeding when used inappropriately. Pharmacists can counsel patients on how to safely use NSAIDs and identify which patients should not use them.

In 2018, a study was done on the effect of a pharmacist-driven monitoring program and electronic health record on bleeding log completeness, documentation in an electronic health record (EHR) and pharmacist-driven clinical interventions.

 During this pharmacist-driven monitoring program, a pharmacist was placed in a hemophilia treatment center (HTC) 4 hours per week to provide patient education and help build interdisciplinary relationships with the care team.

While bleeding logs have been the standard of care for determining adherence in patients with bleeding disorders, the study showed that implementation of this program improved bleeding log completeness and documentation in the EHR among the HTC patients with bleeding disorders.

Another study developed by pharmacists focused on a Hemophilia Management Program. This program was designed to improve care, reduce spending, and expand clinical pharmacy services.

In total, implementation of the Hemophilia Management Program resulted in a net savings of 2.7 million for the fiscal year 2017. Some of this cost savings is attributed to the pharmacist’s early identification of patients needing clotting factors and use of the 340B Drug Pricing Program, which also effectively reduced the need for blood transfusions per patient.

Pharmacists can close the gap in care for patients with high-risk diseases, leading to better outcomes, patient education, and cost savings. As a pharmacist, whether in the clinical or the community setting, take the time to educate yourself and your patients on the risks of bleeding and early recognition of a possible bleed.

1. Bleeding Disorders. American Society of Hematology https://www.hematology.org/education/patients/bleeding-disorders Accessed February 7, 2022.

2. Shay B, Kennerly-Shah J, Neidecker M, et al. Effect of a Pharmacist-Driven Monitoring Program and Electronic Health Record on Bleeding Log Completeness and Documentation. 

. 2018;24(10):1034-1039. doi:10.18553/jmcp.2018.24.10.1034

3. Slocum, GW, Peksa, GD, Webb, TA, Lat, I. Implementation of a hemophilia management program improves clinical outcomes. 

. 2019; 2: 236– 242. https://doi.org/10.1002/jac5.1061

Pharmacists are an important part of the care team for patients with bleeding disorders, providing services such as medication counseling and reconciliation.

The Pharmacist’s Role in Bleeding Disorders

Birth defects affect approximately 3% of all babies born in the United States each year, affecting roughly 1 baby born every 4 and a half minutes, which makes birth defects the leading cause of infant death in the United States.

To raise awareness of this issue, March 3 was recognized as National Birth Defects Awareness Day. Because approximately 1 in 10 birth defects are caused by the use of teratogenic medications, pharmacists have multiple roles in prevention of these birth defects.

Roughly 6% of pregnancies in the United States are exposed to potentially teratogenic medications because of various reasons, such as 1 in 6 women being prescribed a teratogenic medication each year, approximately half of US pregnancies are unplanned, and there is a lack of pre-pregnancy health counseling.

Based on these statistics, it is essential that women are informed of these risks anytime they take a potentially teratogenic medication because most birth defects are likely to happen early in pregnancy before women become aware they are pregnant. Pharmacists are in a prime position to meet this education and counseling demand because they are the most accessible health care provider to aid in safe OTC therapy in the community as well in dispensing of medications.

More than 90% of women take at least 1 OTC or prescription medication while pregnant, and in the past 40 years, the number of women using 4 or more medications during pregnancy has more than doubled.

 Some examples of common teratogenic OTC medications are aspirin, guaifenesin, and pseudoephedrine.

In contrast, there are also certain vitamins and minerals necessary for appropriate fetal development, and if intake is not adequate, it can lead to birth defects. For example, inadequate folic acid intake during pregnancy increases the risk of neural-tube defects.

With the increasing amount and complexity of medication regimens of the general population, it is also necessary to increase access to preconception and pregnancy care, which pharmacists can do in all practice settings. For example, in the community setting, pharmacists can intervene when pregnant patients are selecting aspirin as a pain reliever when acetaminophen may be a safer option.

A prescription medication of current importance is molnupiravir because of its evolving role in COVID-19 treatment. Molnupiravir has been found to have fetal harm concerns based off findings from animal reproduction studies, including malformation of the eye, kidney, and axial skeleton, as well as rib variations.

 This risk is transmitted through both females and males of reproductive age.

Because COVID-19 treatment is constantly changing and management can be complex, pharmacists are in an ideal position to notify providers and patients of this risk and how to avoid potential harm. In an inpatient and ambulatory care setting, pharmacists can serve as essential managers of complex drug regimens directly. Pharmacists can also assist through the development of educational handouts on how to minimize medication-induced birth defects, conducting a periodic review of medications stocked on obstetrician floors, and using the most up-to-date information when developing or modifying order sets to make sure they align with recommended guidelines and pose the lowest risk of fetal harm.

A group of medications associated with birth defects that pharmacists have vast potential to address in the prevention of fetal harm are opioids. In 2019, the National Survey on Drug Use and Health documented that approximately 6.6% of pregnant women reported using a prescription opioid and 21% of them reported opioid misuse.

Furthermore, 31.9% of women reported that they never received information about how the use of opioids could affect a fetus. This gap could be addressed by pharmacists in community settings, office visits, and even discharge counseling from the hospital by providing education on opioids and their potential fetal effects, monitoring for substance misuse, and providing awareness for social support services.

A more unique role that pharmacists can be involved in for the prevention of birth defects is being aware of and informing other health care providers about rarer drug-induced birth defects, such as the association between lithium use early in pregnancy with an increased risk of Ebstein’s anomaly, as well as management of these medications during pregnancy.

For example, if a pharmacist was presented with a situation in which a pregnant patient was picking up a prescription for a psychotropic with minimal potential risk of fetal harm, such as olanzapine, and the patient was concerned about the switch from lithium, this is a prime opportunity to counsel on why it was necessary to switch medications, what other options may be needed in the future, as well as general pregnancy health education.

Lastly, it is important to note that vaccine hesitancy is a significant barrier in pregnant women receiving recommended 

 Tdap vaccines because the passive immunity significantly reduces the risk of influenza and pertussis illness among infants during the first few months.

 Pharmacists need to be familiar with these vaccines to appropriately address pregnant women's concerns, recommend necessary vaccines, and provide accurate counseling to help increase vaccination rates in pregnant women to help prevent infectious diseases that result in birth defects.

With nearly 120,000 babies born with birth defects each year in the United States, which has an unusually high infant mortality rate for a developed nation, it is imperative steps be taken to reduce the rate of these events.

 Although pharmacists have had a major role in counseling on common teratogenic medications and appropriate alternatives, their expertise and diverse positions in the community places them in a key position to fill in the counseling and education gap on potentially teratogenic medication to other health care members and the general population, assist in contraceptive needs, administer recommended vaccinations, and provide preconception and pregnancy care in order to reduce these risks.

Centers for Disease Control and Prevention. (2021, December 8). 

. Centers for Disease Control and Prevention. Retrieved December 13, 2021, from https://www.cdc.gov/ncbddd/birthdefects/index.html.

Drug-induced birth defects - teratogenic drugs - causes - effects - faqs

. Medindia. Retrieved December 13, 2021, from https://www.medindia.net/patients/patientinfo/drug-induced-birth-defects.htm.

Schwarz, E. B., Parisi, S. M., Handler, S. M., Koren, G., Shevchik, G., & Fischer, G. S. (2013). Counseling about medication-induced birth defects with clinical decision support in primary care. 

(10), 817–824. https://doi.org/10.1089/jwh.2013.4262

Joseph V. Etzel, P. D. A. D. for S. A. A. C. P. S. J. U. (2021, July 21). 

Pharmacist's role in prenatal care and safe medication use

. U.S. Pharmacist – The Leading Journal in Pharmacy. Retrieved December 13, 2021, from https://www.uspharmacist.com/article/pharmacists-role-in-prenatal-care-and-safe-medication-use.

Important Safety Information Regarding Use of Molnupiravir in Pregnancy and Individuals of Childbearing Potential

. FDA EAU108. Retrieved February 25, 2022, from https://www.fda.gov/media/155101/download#:~:text=Based%20on%20findings%20from%20animal,adverse%20maternal%20or%20fetal%20outcomes.

Williamson, J. D. M., Mager, N. D. P., Bright, D., & Cole, J. W. (2021, August 4). 

Opioid use disorder: Calling pharmacists to action for better preconception and pregnancy care

. Research in Social and Administrative Pharmacy. Retrieved December 14, 2021, from https://www.sciencedirect.com/science/article/pii/S1551741121002904?via%3Dihub.

Patorno, E., Huybrechts, K. F., Bateman, B. T., Cohen, J. M., Desai, R. J., Mogun, H., Cohen, L. S., & Hernandez-Diaz, S. (2017, June 8). 

Lithium use in pregnancy and the risk of cardiac malformations

. The New England journal of medicine. Retrieved December 14, 2021, from 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5667676/

Mood stabilizers in pregnancy and lactation

. Indian journal of psychiatry. Retrieved January 6, 2022, from 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4539876/#ref44

Joint position statement on vaccines from the society for ...

 (n.d.). Retrieved January 6, 2022, from https://birthdefectsresearch.org/pubs/bdr2_1674.pdf

It is essential that women are informed of the risks of potentially teratogenic medications because most birth defects are likely to happen early in pregnancy before women become aware they are pregnant.

How Pharmacists Can Help Lower Infants’ Leading Cause of Death 

Approximately 400,000 hospitalized patients experience some type of preventable harm each year, with one-fourth dying from these errors.

Medical errors cost roughly $20 billion a year, which makes preventable harm in health care both a leading cause of death and health expenditures in the United States.

Based on these statistics, the Institute for Healthcare Improvement has made March 13–19, 2022, Patient Safety Awareness Week to raise awareness of a major public health concern and attempt to improve the safety of the health care patients and workforce.

Pharmacists aid in minimizing the amount of preventable adverse events (AEs) in most health care settings through providing education and counseling, ensuring correct and safe medication use, as well as making sure health care settings are aware of and implementing practices shown to mitigate patient harm.

For the past several decades the mainstay of the pharmacist’s role in safety has revolved around ensuring safe prescribing, dispensing, and use of medications, as well as providing patients counseling to ensure they know how to use the medication appropriately.

 However, pharmacists’ expertise in medication use has expanded their role to a critical member of the multi-disciplinary care team, because their inclusion has been shown to reduce medication errors.

Pharmacists have a responsibility to provide education not only to patients, but other members of the health care team. This particularly important with complex medication management, adverse drug reaction prevention, drug interactions, pharmacokinetic and pharmacodynamic considerations, alternative treatment identification and evidence-based individualized treatment.

Pharmacists can ensure optimal safety practices are in place in many evolving ways, such as advancing medication stewardship.

 Medication stewardship in other areas ensures that medications are being used judiciously so that they provide the most benefit with the least harm, both to the patient and the community at large.

For example, antibiotic stewardship, which is now advocated in inpatient, long-term care, and community settings have routinely demonstrated improved clinical outcomes and reduced medication related harm and AEs in practice and in studies. A systemic review and meta-analysis from October 2021 illustrated that antimicrobial stewardship interventions in long-term care facilities improve antimicrobial use in this setting without increasing morbidity or mortality.

Although antimicrobial stewardship in hospitals is not a new concept, it is an emerging opportunity for pharmacists in the outpatient and long-term care settings. Stewardship programs do not have to be limited to infectious diseases. There is potential for pharmacists to develop or advance similar programs involving opioids, thrombotics, and glycemic control medications to improve patient outcomes and safety throughout multiple disease states.

In order to advance a culture of patient safety, it is essential that errors be acknowledged and reviewed so that any precipitating cause can be identified and actions can be put in place to minimize or prevent the likelihood of the error occurring again.

 Pharmacists should be encouraged to report medical errors without fear of punishment in a “blame-free” environment.

This environment and feedback process is shown to be an essential component of ensuring patient safety through necessary reporting and procedure development for prevention of these errors since multiple studies have identified that if error-prone situations are reported and managed by the modification of the system it will lead to a decrease in the frequency of the error and associated concomitant errors.

Pharmacist involvement in optimization of technology throughout the health care system is essential in the growing complexity of medication management. For example, it has been found when nursing staff is reduced, there is an increase in morality.

Although there are many options to take in response to the consequences of low staffing by the health care system overall, pharmacists can focus on technology advances that aid in medication dispensing while reducing errors in all areas of the patient care process, allow for increased direct patient care, and improve medication administration efficiency and safety.

A 2021 retrospective study that found a pharmacist-led prescription intervention system reduced prescribing errors and improved prescribing outcomes and patient safety.

 Because pharmacists in all areas of practice are critical users of patient safety technology, such as dispensing robots and clinical decision support systems, they can focus on individualized optimization of these in different health care settings to further safety improvement when faced with barriers, such as staffing concerns, that may impact optimal health care delivery.

Furthermore, use of these systems allows pharmacists to be more involved in patient care through the interprofessional team, which may reduce the workload of other health care professionals, depending on the setting.

With preventable health care errors being one of the leading cause of deaths in the United States, it is necessary for steps to be taken to reduce the rate of these events. Whereas pharmacists have had a role in preventing AEs in the past, they are now critical to help reduce these events further and in more health care settings through education and counseling of the community and other health care team members to ensure correct and safe medication use, as well as optimization of technology use across health care settings.

. StatPearls [Internet]. Retrieved February 10, 2022, from https://www.ncbi.nlm.nih.gov/books/NBK499956/

National Steering Committee for Patient Safety

. Institute for Healthcare Improvement. (n.d.). Retrieved February 10, 2022, from http://www.ihi.org/Engage/Initiatives/National-Steering-Committee-Patient-Safety/Pages/default.aspx

. Institute for Healthcare Improvement. (n.d.). Retrieved February 10, 2022, from http://www.ihi.org/Engage/Initiatives/Patient-Safety-Awareness-Week/Pages/default.aspx

. Patient Safety Network. (n.d.). Retrieved February 10, 2022, from 

https://psnet.ahrq.gov/perspective/pharmacist-role-patient-safety

Crespo-Rivas JC;Guisado-Gil AB;Peñalva G;Rodríguez-Villodres Á;Martín-Gandul C;Pachón-Ibáñez ME;Lepe JA;Cisneros JM; (n.d.). 

Are antimicrobial stewardship interventions effective and safe in long-term care facilities? A systematic review and meta-analysis

. Clinical microbiology and infection: the official publication of the European Society of Clinical Microbiology and Infectious Diseases. Retrieved February 28, 2022, from 

https://pubmed.ncbi.nlm.nih.gov/34118423/

Yang J;Zheng L;Guan YY;Song C;Liu YY;Li PB; (n.d.). 

Pharmacist-led, prescription intervention system-assisted feedback to reduce prescribing errors: A retrospective study

. Journal of clinical pharmacy and therapeutics. Retrieved February 28, 2022, from https://pubmed.ncbi.nlm.nih.gov/34312897/

Pharmacists’ expertise in medication use has expanded their role to a critical member of the multi-disciplinary care team.

Patient Safety Awareness: A Week Dedicated to Minimizing Preventable Harm in Health Care

On February 28, 2022, 106 countries will come together for Rare Disease Day. This global event has been observed since 2008 to increase awareness and advocate for those impacted by rare diseases.

Nationwide, rare diseases affect an estimated 30 million individuals, but what quite defines a disease as being rare? Unfortunately, it’s not a straightforward answer. Per the 1984 amendment to the Orphan Drug Act of 1983 (ODA), the United States classifies a disease as being rare when less than 200,000 people are affected.

Today, more than 7000 diseases fit this definition, ranging from more well-known conditions such as multiple sclerosis and cystic fibrosis, to diseases most people have never heard of, such as Prader-Willi syndrome and Friedreich’s ataxia.

 Patients with rare conditions have highly complex treatment needs, requiring a multi-disciplinary care team approach.

Pharmacists hold a vastly underrecognized role within this team—a role that offers a unique approach toward the therapeutic management of rare diseases.

The development and designation of orphan drugs has tremendously improved since the passage of the ODA, but progress is still to be made. The orphan drug market is expected to surpass $217 billion in sales by 2024, which is a staggering cost despite their utility in rare conditions. Today, only approximately 10% of rare diseases have FDA-approved therapies.

As a consequence, the remaining 90% of patients with a rare disease are left without standard treatment options and often have to rely on off-label drug use or no treatment at all. Although off-label prescribing of medications is not generally a preferred approach, it does play a pertinent role in rare conditions.

When faced with this situation, pharmacists must consult drug information resources, primary literature, and use their clinical knowledge to best assist prescribers. Thus, it’s important that pharmacists remain up to date on new drug approvals, drug safety warnings, and medical literature to properly partake in the care of rare disease patients.

Examples of rare diseases that currently require this approach include Alpers-Huttenlocher syndrome (AHS), aromatic L-amino acid decarboxylase (AADC) deficiency, and Rett syndrome.

 AHS, is a neurological disease characterized by seizures, hepatic insufficiency, and cognitive decline.

For seizure management in this population, it is well-documented that valproic acid should be avoided due to its hepatoxic effects accelerating the progress to liver failure. Pharmacists can recommend antiepileptics that are less reliant on hepatic metabolism, such as levetiracetam, topiramate, and lacosamide.

AADC deficiency is a genetic neurometabolic disorder that results in the improper synthesis of vital neurotransmitters—namely, serotonin, and dopamine. Because of the nature of this disease, pharmacists can offer guidance on medications to avoid. Limited reports exist, but central dopamine antagonists and serotonergic antagonists should be avoided because they can worsen symptoms.

A pharmacist can apply the same principle to Rett syndrome and other rare conditions, overall improving patient outcomes and enhancing the knowledge of the care team. Pharmacists serve as the final barrier between a patient and their medications and are the last step in the medication use process. 

Therefore, it’s important they remain up to date on new drug approvals, drug safety warnings, and medical literature to properly partake in the care of patients with a rare disease.

Orphan drugs that do gain FDA-approval also come with their own set of challenges. The FDA’s approval process of orphan drugs is rather complex.

In short, once a drug receives official designation as an orphan drug, its approval has the potential eligibility to undergo 1 of the FDA’s 4 expedited programs: Breakthrough Therapy, Priority Review, Fast Track, or Accelerated Approval. FDA-approved novel orphan drugs often result from clinical trials with small study populations.

Per the nature of the disorders that orphan drugs intend to treat, this is no surprise. In addition, the familiarity of rare diseases and their available treatments typically isn’t common knowledge—it requires experience.

In addition to monitoring for adverse reactions, and drug interactions, pharmacists can address patient-specific barriers. For instance, swallowing difficulties can majorly impact medication adherence.

Dysphagia can be due to age extremes, manifestations of the disease itself, or medications. Pharmacists can recommend appropriate strategies to aid rare disease patients in overcoming this barrier.

Rare conditions that include dysphagia in its clinical presentation include myasthenia gravis, eosinophilic esophagitis, and amyotrophic lateral sclerosis (ALS).

 Examples of orphan drugs that come in oral solution formulations include riluzole (Tiglutik) for ALS; nimodipine (Nymalize) for ischemic deficits in subarachnoid hemorrhage; and calcium, magnesium, potassium, and sodium oxybates (Xywav) for type I and type II narcolepsy in patients 7 years of age and older.

An additional barrier faced by patients with a rare disease is access to disease-specific care; however, 2 years ago, progression toward overcoming this barrier began. In 2020, URAC announced its new opportunity for specialty pharmacies to obtain the “Rare Disease Pharmacy Center of Excellence Designation.”

This special distinction solidifies the role that a pharmacist can have in the realm of rare disease, extending the definition of a specialty pharmacy to include patients with highly unmet needs. Currently, 8 states have this designation. Although still few in number, the presence of rare disease pharmacies as a whole is essential in improving care to the rare disease population.

Rare Disease Day allows individuals across the globe to reflect on how far we’ve come, and yet, how far we still must go to adequately serve this population. Each patient afflicted by a rare disease has a unique story—a story that led to a journey they never thought they would be a part of.

The dynamic role of the pharmacist in rare disease care is vital to recognize. As steadfast advocates for their patients, pharmacists are able to provide highly personable care that can be just as impactful as pharmacotherapy.

Rare Disease Day [Internet]. NORD (National Organization for Rare Disorders). NORD; 2022 [cited 2022 Jan 28]. Available from: 

Pharmacists hold a vastly underrecognized role within the care team—a role that offers a unique approach toward the therapeutic management of rare diseases. 