Following the removal of restrictions on mifepristone—a pill to induce abortions—in Canada, abortions remained safe in the country, according to a study published in the 

. The study examined government health data on 315,000 abortions in Ontario between 2012 and 2020, finding no increase in abortion-related health complications following the removal of restrictions on mifepristone.

"Complications were already very rare, and we found that abortion continued to be safe and effective when mifepristone was prescribed without restrictions," said Laura Schummers, ScD, the study's lead author and a postdoctoral fellow in UBC's department of family practice, in a press release. “This is the strongest evidence yet that it is safe to provide the abortion pill like most other prescriptions—meaning any doctor or nurse practitioner can prescribe, any pharmacist can dispense, and patients can take the pills if, when and where they choose.”

The original restrictions, first put into place when the drug was approved in 2015, required that physicians observe patients taking the medication. Further, the drug could only be dispensed by specially trained physicians who registered with the manufacturer, and not pharmacists. Many of these restrictions remain in place throughout the world, including the United States.

“Our study is a signal to other countries that restrictions are not necessary to ensure patient safety,” said Wendy Norman, MD, CCFP, FCFP, DTM&H, MHSc, professor in UBC's department of family practice, in a press release. “There is no scientific justification for mifepristone restrictions, which only make it harder for people to access the care they need. Canada's experience offers a roadmap for other countries on how to safely improve access to family planning services.”

Following the availability of mifepristone, the percentage of abortions performed medically as opposed to surgically rose from 2.2% to 31.4% over 2 years after the drug became available as a normal prescription. During this same time period, the overall abortion rate continued to decline after restrictions were removed, decreasing from 11.9 to 11.3 abortions per 1000 female residents aged 15-49 years.

"We saw that patients and their health care providers rapidly began choosing medical abortion, which can sometimes be preferred over surgical methods by offering care closer to home and earlier in pregnancy," said Sheila Dunn, MD, MSC, CCFP (EM), FCFP, scientist and family physician at Women's College Hospital in Toronto, in a press release. "As other studies have shown, making abortion more accessible does not increase the number of people seeking abortion. We found that abortion rates continued to decrease after mifepristone's availability as a normal prescription."

Prescribing the abortion pill without restrictions is safe and effective, study finds [news release]. Science Daily; December 8, 2021. Accessed December 14, 2021. 

https://www.sciencedaily.com/releases/2021/12/211208182541.htm

The study examined government health data on 315,000 abortions in Ontario between 2012 and 2020, finding no increase in abortion-related health complications following the removal of restrictions on mifepristone.

Study: Abortions Remain Safe Following Lifted Restrictions on Mifepristone

Skylar Kenney, Assistant Editor

A new analysis found that the organizational performance during the COVID-19 pandemic may be reflected in the nursing workforce retention as the risk for workforce attrition appears high, according to a study published in 

The purpose of the study was to get a better glimpse of the perspective of nurses working in the United States on the frontlines during the COVID-19 pandemic’s first wave. The impact of the pandemic on nurses’ roles, professional relationships, and the organizational cultures of their employers were a focus as well.

The research team conducted an online qualitative study through social networking recruitment to find frontline nurses across the country to participate. The participants provided long form, text-based responses to 4 questions designed to capture their experiences between the first COVID-19 wave between May and July 2020.

In total, 318 nurses participated from 29 out of 50 states, with 242 nurses completing all of the questions. The findings from the study suggest that the place of work mattered significantly in terms of the frontline working experience. Role changes, risk assumption, interprofessional teamwork experiences, and likelihood to leave their jobs or the profession altogether were major influences.

Although it was known that the working conditions varied during the pandemic, nurses shared that they experienced high levels of occupational risk to their health and were observed to be seen as threats to patient outcomes.

The data emphasized that nurses showed several signals about the potential impact to the stability and sustainability of the United States nursing workforce that are now manifesting, including a massive loss to the frontline of the US nursing workforce stemming from high rates of burnout. 

A. Squires, M. Clark-Cutaia, M. Henderson, et al., "Should I stay or should I go?” Nurses’ Perspectives AboutWorking During the Covid-19 Pandemic in the United States: A Summative Content Analysis Combined with Topic Modelling (2022), 

https://doi.org/10.1016/j.ijnurstu.2022.104256

The purpose of the study was to get a better glimpse of the perspective of nurses working in the United States on the frontlines during the COVID-19 pandemic’s first wave. 

Study: Potential Threats to Stability, Sustainability for US Nursing Workforce

Jill Murphy, Associate Editor

Cerebral palsy (CP) is defined as a group of disorders that affect an individual’s motor function, including a movement, muscle tone and posture.

CP is caused by abnormal brain development or damage to the developing brain in early years. This can occur prenatally or during birth, known as congenital CP, or during the first few years of a child’s life as the brain is growing, known as acquired CP.

 There are 4 major types of CP: ataxic CP, dyskinetic CP (includes athetoid, choreoathetoid, and dystonic), mixed CP (includes spastic-dyskinetic), and spastic CP (includes spastic diplegia, spastic hemiplegia, and spastic quadriplegia).

 Classification is based on the clinical features of motor abnormalities.

Patients with CP can have many comorbid conditions. Epilepsy occurs in 25% to 45% of these patients.

 The brain damage that causes CP typically occurs in 1 part of the brain, so these patients are most susceptible to developing a focal epilepsy. Most patients with CP begin having seizures before aged 2 years.

 Focal seizures start in one part of the brain and either stay in that part or spread to other parts of the brain or the whole brain. The commonly used medication choices for patients with focal-onset epilepsy include: brivaracetam (Briviact), carbamazepine (Tegretol), cenobamate (Xcopri), eslicarbazepine (Aptiom), lacosamide (Vimpat), lamotrigine (Lamictal), oxcarbazepine (Trileptal), topiramate (Topamax), and zonisamide (Zonegran).

 Many children with severe CP can have multiple seizure types. For patients with generalized seizures, which affect both sides of the brain, the following medications may be considered: cannabidiol (Epidiolex), clobazam (Onfi), levetiracetam (Keppra), rufinamide (Banzel), and valproic acid (Depakote).

 Adverse effects profile, age of patient, comorbidities, formulation, and insurance coverage are all factors when choosing an anti-seizure medication. Other treatment options that may help in reducing seizure burden include the ketogenic or modified Atkins diets.

When a patient with CP continues to have seizures, despite having tried 2 anti-seizure medications, they should quickly be referred to an epileptologist, who is a neurologist with specific training in epilepsy. Epileptologists often work at hospitals with a comprehensive epilepsy program where patients whose seizures are intractable to medications can be evaluated for potential epilepsy surgery. Several pre-surgical tests can help localize where in the brain the seizures are starting. If all the seizures are starting in the same area, a resective surgery, where the epileptogenic tissue is ablated or removed, can be a good option to help decrease the seizure burden or in some cases provide the patient with seizure freedom. Depending on the seizure types and extent of early brain damage, other surgical options include a corpus callosotomy (cutting a band of fibers so that the nerves cannot send signals between the 2 halves of the brain) or functional hemispherectomy (disconnecting the damaged and seizure-causing part of the brain from the normal hemisphere). When the seizure onset zone cannot be determined, implanting a vagus nerve stimulation device under the skin in the chest can decrease the frequency and intensity of seizures.

Children with CP can have many medical problems throughout their lives that are often complicated for caregivers and health care professionals to manage. For the common comorbidity of epilepsy, it is important to recognize and diagnose seizures as early as possible. All medication and surgical options should be considered for these patients to provide them with the best chance of seizure freedom and thus improvement in quality of life.

Sula Gillespie, MSN, PNP; Jennifer Glenn, MSN, PNP; and Mallory Murphy, MSN, PNP are nurse practitioners at Children’s of Alabama Epilepsy Monitoring Unit in Birmingham, Alabama.

1. Glader L, Barkoudah E. Cerebral palsy: clinical features and classification. 

. Updated September 21, 2021. Accessed November 2, 2021. https://www.uptodate.com/contents/cerebral-palsy-clinical-features-and-classification

2. What is cerebral palsy. CDC. Updated September 2, 2021. Accessed November 2, 2021. 

3. Pavone P, Gulizia C, Le Pira A, et al. Cerebral palsy and epilepsy in children: clinical perspectives on a common comorbidity. 

4. Epilepsy. Epilepsy Foundation. Accessed November 2, 2021. https://www.epilepsy.com/

For the common comorbidity of epilepsy, it is important to recognize and diagnose seizures as early as possible.

Help Pediatric Patients With Cerebral Palsy

Mallory Murphy, MSN, PNP 

Starting that fateful week in March 2020 when everyone’s life changed, health care settings closed their doors en masse.

From primary care to ambulatory surgery, physical therapy to massage therapy, nearly every setting of care suspended operations, except for emergency departments connected to hospitals and pharmacies. Yes, pharmacies. More than 60,000 remained open to patients, and most pharmacists continued their role as a source for OTC products and the free-of-charge counseling that often goes with them.

Telemedicine grew at an unprecedented rate starting in April 2020, but it did not entirely fill the health care void. Individuals needing acute medications, dose adjustments, or treatment for chronic diseases lost direct access to practitioners, but pharmacies remaining open meant patients could still receive their lifesaving medications. Of course, foot traffic slowed, and the flu was practically nonexistent in 2020, but hundreds of millions of Americans had access to basic triage, care delivery, medications, and testing supplies.

More than 80% of adults use OTC products as first-line treatment for common ailments. With Americans making approximately 3 billion trips to purchase OTC products annually and 60 million Americans using them who would otherwise not seek treatment, patient access to these products is essential to a well-functioning health care system. It is inconceivable these days to schedule an office visit, procure a prescription, and have it adjudicated by insurance just to get ibuprofen for an ankle sprain. A prescription for loratadine? Laughable. Yet less than 2 decades ago, nonsedating antihistamines were deemed too unsafe to be sold over the counter.

Making products available without a prescription does not have to mean patients go without care. Pharmacists and other health care professionals can counsel patients on all types of accessible and affordable OTC products. Does an Apple Watch’s electrocardiograph or pulse oximetry app keep patients from seeing their cardiologists? Do pregnancy tests keep women from visiting their gynecologists? Do wetting drops prevent patients from going to their ophthalmologists?

Do niacin or omega oils keep patients from getting their cholesterol checked? The answer to all these questions is no. Pharmacists have multiple encounters with patients every day, and most are just as meaningful to a patient’s care as billable encounters.

Expanding Access Through OTCs and Testing

COVID-19 self-administered testing is approved and available. Health plans have picked up on the power of patient convenience. Waning resistance against self-empowerment, which the pandemic necessitated, has enlisted a host of home-based diagnostics providing accessible and affordable screening and rescreening directly to health plan members—without a prescription. Need to improve A1c testing and reporting? Why not look to pharmacies or even send the tests directly to patients’ residences?

Postpandemic Self-Care and OTC Product Use

We are only a summer away from what will likely be the first widely prevalent cough and cold season of asthma flare ups, influenza, middle-ear infections, and rhinovirus in nearly 2 years. As social distancing and masking disappear, we will again share microbes. Disease surveillance and patient care will still have a prime spot in the consciousness of the frontline pharmacist’s mind in all seasons. Education, triage, testing, and counseling have a greater meaning and purpose than ever before, and much of this purpose is enabled by access to OTC products.

Click here to view the OTC products that pharmacists recommend the most to their patients

is vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 2000 medical practices to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake University and a PhD in pharmaceutical outcomes and policy from the University of North Carolina. He also serves on the board of directors of the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.

OTC use statistics. Consumer Healthcare Products Association. Accessed May 24, 2021. https://www.chpa.org/about-consumer-healthcare/research-data/otc-use-statistics.

COVID-19 permanently changed how pharmacists recommend and sell nonprescription options.

OTC Products Are Accessible When Traditional Health Care Delivery Is Not

Troy Trygstad, PharmD, PhD, MBA

Mary Koslap-Petraco, DNP, PPCNP-BC, CPNP, FAANP, is a clinical assistant professor at Stony Brook University School of Nursing in New York.

The pandemic has changed life as we knew it, but COVID-19 vaccines are changing lives again, this time for the better.

Grandparents are once again able to hug their grandchildren, but those same grandchildren are still at risk for COVID-19 until we can get all of them who are medically able vaccinated. At press time, children accounted for the largest number of new cases of COVID-19, because most are still not vaccinated (AAP, 2021, April).1 Hospitalization rates for children with COVID-19 have also risen, and serious cases are being seen (AAP, 2021, June).2 From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals aged 11 to 17 years had been reported to the CDC (USFDA, 2021, May 10).3

Most children will return to classrooms for school in the fall, if they have not done so already (Parents, 2021, March).4 Although handwashing, masks, and social distancing are essential public health measures and have slowed the pandemic, the best and most long-lasting way to protect children is to vaccinate them. The number of COVID-19 cases among individuals aged 50 years and older has dropped dramatically. A large segment of this population is fully vaccinated (CDC, 2021, June 13).5 There is also a serious public health threat from other vaccine-preventable diseases, such as measles and pertussis, as the rates of routine immunizations took a precipitous drop during the pandemic (Santoli, et al. 2020).6 The CDC is recommending that children receive all regularly scheduled vaccines, along with the COVID-19 vaccine (CDC, 2021 April 6).7

The Pfizer-BioNTech COVID-19 vaccine, which is an mRNA vaccine, recently received FDA approval for adolescents aged 12 through 15 years (USFDA, 2021, May 10).3 This vaccine is administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart. The most common adverse effects are chills, fever, headache, joint and muscle pain, pain and redness at the injection site, and tiredness. Aside from pain at the injection site, more adolescents reported these adverse effects after the second dose than after the first dose, so it is important to advise adolescents and parents to expect that there may be some adverse effects after either dose but even more so after the second. The adverse effects in adolescents were consistent with those reported in clinical trial participants aged 16 years and older (USFDA, 2021, May 10).3

Pfizer also said that it plans to request authorization for BioNTech COVID vaccine use in children aged 2 through 11 years in September 2021 and for children younger than aged 2 years later in 2021 (Jenco, 2021, May 6).8

Recently, there have been reports of myocarditis and pericarditis following mRNA vaccines. These events occurred mostly in male adolescents and young adults aged 16 years and older. Myocarditis and pericarditis are seen more often after getting the second dose of either Moderna or Pfizer COVID-19 vaccines than after the first dose. The symptoms typically occur within 4 days after COVID-19 vaccination. As of press time, there have been 275 cases of either myocarditis or pericarditis of more than 600,000 doses administered to adolescents and children in the United States since Pfizer received its emergency use authorization on May 10, 2021 (CDC, 2021, May 18).9 Most patients who received care responded well to rest and treatment and quickly recovered. Patients can usually return to normal daily activities after their symptoms improve, and they should speak with health care providers about returning to exercise or sports. The CDC continues to monitor the situation and recommends COVID-19 vaccinations for everyone aged 12 years and older, given the greater risk of COVID-19 illness and related, possibly severe complications (CDC, 2021, May 27).10 Getting vaccinated is the best way to help protect individuals aged 12 years and older from COVID-19 illness and potential complications.

Another COVID-19 vaccine for adolescents is also moving toward approval. Moderna reported that its COVID-19 vaccine is 96% effective for adolescents aged 12 through 17 years after at least 1 dose and has no serious safety concerns (Jenco, 2021, May 6).8 The report did not provide additional details on a projected timeline for requesting FDA approval. Moderna is also continuing to study its vaccine in children aged 6 months to 11 years (Jenco, 2021, May 6).8

COVID-19 vaccines are becoming a reality for children. With the vaccines comes the return to birthday parties, in-classroom school, play dates, and sleepovers. But the COVID vaccine is not the only one children need. Routine vaccination is an essential preventive care service for adolescents, children, and adults, including pregnant women, that should not be delayed because of the COVID-19 pandemic. Parents have not been bringing their children into the offices of health care providers for well-child visits and vaccines. It is essential to assess the vaccination status of all adolescents and children at each patient visit to avoid missed opportunities for vaccination and ensure timely vaccine catch-up. All vaccines due or overdue should be administered according to the recommended CDC immunization schedules during each visit unless there is a specific contraindication. This will provide protection as soon as possible and minimize the number of health care visits needed to complete vaccination. Health care providers should identify children who have missed recommended vaccinations and/or well-child visits. Contact parents to schedule in-person appointments, starting with newborns, infants, and children up to aged 2 years, young children, and extending through adolescence. COVID-19 is still circulating, and cases among children can often be asymptomatic. Consequently, the importance of evidence-based infection prevention practices cannot be overemphasized for all patient encounters. These measures include hand and respiratory hygiene, physical distancing, source control, and surface decontamination (CDC, 2021, April 6).7

Because vaccine administration has decreased during the COVID-19 pandemic, under vaccinated or unvaccinated children are susceptible to preventable illness, such as measles, and communities are at risk for outbreaks. Strategies should be implemented to promote vaccination schedule adherence and ensure catch-up vaccination. Reminder and recall systems should be implemented to identify children who are due for or who have missed vaccine doses. Electronic health records and immunization information systems can be essential to tracking delinquent vaccine doses. In addition, the vaccination status of all children should be assessed at every health care visit to reduce missed opportunities for vaccination, including COVID-19 vaccination, and standing orders should be implemented (CDC, 2021, April 6).7

Health care providers who care for children must ensure that children receive not just COVID-19 vaccines but all age-appropriate vaccines that are due and catch up on any missed doses. It would be a travesty if children headed back to school without the vaccine-induced protection they need to stay healthy. Without all Advisory Committee on Immunization Practices (ACIP)-indicated vaccines, children could be headed back to school and out of the COVID-19 pandemic into a measles or pertussis epidemic.

1. Children and COVID-19: state data report. American Academy of Pediatrics. April 29, 2021. Accessed June 17, 2021. 

https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%204.29.21%20FINAL.pdf

2. Children and COVID-19: state data report. American Academy of Pediatrics. June 3, 2021. Accessed June 17, 2021. 

https://downloads.aap.org/AAP/PDF/AAP%20and%20CHA%20-%20Children%20and%20COVID-19%20State%20Data%20Report%206.3.21%20FINAL.pdf

3. United Stated Food and Drug Administration. (2021, May 10). Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic. Retrieved from 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use

4. Harris N. Will kids go back to school in the fall? Here’s what experts think and what it may look like. 

https://www.parents.com/kids/education/back-to-school/will-kids-go-back-to-school-in-the-fall-heres-what-experts-think-and-what-it-may-look-like/

5. Demographic characteristics of people receiving COVID-19 vaccinations in the United States. CDC. June 16, 2021. Accessed June 17, 2021. 

https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic

6. Santoli JM, Lindley MC, DeSilva MB, et al. Effects of the COVID-19 pandemic on routine pediatric vaccine ordering and administration — United States, 2020. 

 2020;69(19):591-593. doi:10.15585/mmwr.mm6919e2

7. Interim guidance for routine and influenza immunization services during the COVID-19 pandemic. CDC. April 6, 2021. Accessed June 17, 2021. 

https://www.cdc.gov/vaccines/pandemic-guidance/index.html

8. Jenco M. Moderna reports COVID-19 vaccine for teens safe, effective. 

https://www.aappublications.org/news/2021/05/06/moderna-covid-vaccine-teens-050621

9. Mendez R. CDC says 600,000 kids ages 12 to 15 have received Covid vaccine shots in last week. CDC. May 18, 2021. Accessed June 17, 2021. 

https://www.cnbc.com/2021/05/18/cdc-says-600000-kids-aged-12-to-15-have-received-covid-shots-in-last-week-.html

10. Myocarditis and pericarditis following mRNA COVID-19 vaccination. CDC. May 27, 2021. Accessed June 17, 2021. 

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html

Practitioners can help ensure that kids get these and all age-appropriate vaccinations before school starts in the fall.

COVID Vaccines for Children Are Becoming a Reality

Mary Koslap-Petraco, DNP, PPCNP-BC, CPNP, FAANP

Adults who failed to pay down student debt or took on new educational debt between young adulthood and early mid-life faced an elevated risk of cardiovascular (CV) illness, results of a study published in the 

Additionally, individuals who repaid their student debt had better or equivalent health than individuals who never faced student debt, which suggests that relieving the burden of student debt could improve population health.

“As the cost of college has increased, students and their families have taken on more debt to get to and stay in college. Consequently, student debt is a massive financial burden to so many in the United States, and yet we know little about the potential long-term health consequences of this debt,” Adam Lippert, PhD, from the Department of Sociology at University of Colorado Denver, said in a statement.

“Previous research showed that, in the short term, student debt burdens were associated with self-reported health and mental health, so we were interested in understanding whether student debt was associated with cardiovascular illness among adults in early mid-life,” Lippert said.

The study included data from the National Longitudinal Study of Adolescent to Adult Health, which is a panel of 20,745 adolescents in grades 7 to 12 who were first interviewed during the 1994-1995 school year.

Four subsequent waves of data were collected, which included wave 3, where the respondents were aged 18 to 26 years, and wave 5, where the respondents were aged 22 to 44 years, and were invited to in-home medical exams.

Investigators assessed biological measures of CV health of 4193 qualifying individuals using the 30-year Framingham cardiovascular disease (CVD) risk score, which considers age, antihypertensive treatment, body mass index, blood pressure, diabetes diagnosis, sex, and smoking status, to measure the likelihood of CVD over the next 30 years.

Additionally, investigators looked at levels of C-reactive protein (CRP), a biomarker of chronic or systemic inflammation.

Student debt was classified into categories that included consistently in debt, never had student debt, paid off debt between waves 3 and 5, and took on debt between waves.

The models were adjusted for respondent family and household characteristics, including education, income, and other demographics.

Investigators found that more than one-third of respondents did not report student debt in either wave, while 24% consistently had debt, 12% had paid off their loans, and 28% took on student debt.

Individuals who consistently had debt or took on debt had higher CVD risk scores than those who had never been in debt and those who paid off their debt. Additionally, individuals who paid off debt had significantly lower CVD risk scores than those never in debt.

Investigators also found clinically significant CRP value estimates for those who took on new debt and those who were consistently in debt between young adulthood and early mid-life, which exceeded those who never had debt or paid off debt.

Ethnicity and results had no impact on the results, according to investigators.

Student debt can impair your cardiovascular health into middle age. EurekAlert. News release. May 3, 2022. Accessed May 3, 2022. https://www.eurekalert.org/news-releases/951393

Individuals with college debt have a higher risk of cardiovascular illness, undermining the typical benefits of a post-secondary education, data indicate.

Student Loans Can Impair Heart Health into Middle Age, Study Results Show

Ashley Gallagher, Assistant Editor

Jennifer Glenn, MSN, PNP

Health care professionals regularly have to judge whether they can cure patients of a medical condition or manage the condition to enable them to live the best life they can. Many pharmaceutical interventions and treatment options are designed to manage people’s illnesses, however, they are not necessarily a cure.

There are many medical conditions that have been difficult to cure from a historical perspective, from diabetes to high blood pressure, for which a maintenance approach to treatment has been the only option. However, this is expensive and challenging, both in terms of medicine and clinical resources.

Curing a condition is better than management, because managing these conditions can result in an increased burden on the health care system. This is particularly applicable as people live longer and the proportion of illnesses that are manageable increase versus those that are curable.

New interdisciplinary approaches to treatment include rebalancing the scales and exploring non-pharmaceutical interventions, such as dietary changes, exercise, and medical devices, to work alongside or instead of traditional care management techniques.

An example of this would be in the treatment process for leg ulcers. According to the Wound Healing Society, 15% of older adults in the United States suffer from chronic wounds, including predominantly venous stasis ulcers, pressure ulcers, and diabetic foot ulcers.

Every year, up to 3 million more Americans are diagnosed with various types of chronic wounds, with the annual cost of treating venous ulcers alone to the US health care system estimated to be $2.5 to $3.5 billion, which highlights the sheer scale of the growing problem.

These wounds often take months of traditional treatment to heal, and for health care professionals, managing the condition and its symptoms is a huge therapeutic challenge. It may require regular visits from health care professionals, which is expensive and time consuming. As the incidence of ulceration rises due to the aging population, and increased risk factors such as smoking and diabetes, so does the cost of intervention.

New medical technology devices offer an alternative because many of these devices can not only maintain people’s wellbeing, but provide a permanent treatment to chronic medical conditions. This new breed of technology has the potential to deliver better patient outcomes at a lower cost.

Technology has been one of the most significant disruptors to society. From Amazon in retail to new competitors banks in financial services, technology-first businesses are aiming to achieve both cost reduction and improved efficiencies.

In health care systems, technology is increasingly being seen as the key to reducing financial pressure while enhancing patient outcomes simultaneously. Implementing new medical devices into health care systems is challenging, because it requires time, money, clinical data, regulatory approval, and support from clinicians within the system.

Using the example of leg ulcers, clinical data now demonstrates that by increasing blood circulation to wound surfaces to enhance oxygen and nutrient delivery,

 ulcers can be cured rather than simply managed, with wounds closing in a matter of weeks as opposed to months or not at all.

Managing the care of patients with these types of conditions is always complex, but after receiving regulatory approval from the FDA, bioelectronic medical devices that increase blood flow in the lower limbs are now being deployed by forward-thinking clinicians to treat patients with the condition.

 This has dramatically reduced the financial and staffing impact on the health care system while achieving improved results for the patients.

Instead of requiring nurses to attend people’s homes 3 times a week to assess and redress ulcers, connected devices have the potential to monitor patients remotely and provide feedback data to health care providers enabling them to manage treatment plans and focus resource where it is most needed.

The current challenge is reshaping how health care systems reward positive outcomes to allow new solutions to continue to be adopted effectively, which rewards innovation and risk without reducing the impact of what already exists.

The US health care system presents a unique landscape because the process of paying for health care products or services is managed by either private commercial health insurers or public government payers. Traditionally, health care providers operate a fee-for-service model, which means they are paid separately for each service they provide regardless of whether that service leads to a positive and lasting outcome. For patients suffering with chronic conditions that require long-term care, specifically in wound care, this can result in expensive medical bills over a long period of time.

The US government has already legislated for change, which has led to the Centers for Medicare and Medicaid Services starting an episode-based approach to treatment and payment. With episode-based payments, the cost for a patient’s care related to any single medical issue is predetermined versus having to pay separately for each service and provider.

Based on the projected costs, a single amount is issued to all health care providers and institutions working on the same case. This will include physicians, hospitals, nurses, medical equipment providers, and post-acute care operators. The more effectively health care providers control expenses and stay within the budgeted amount, the better they share in the savings generated.

This approach means it is in the interests of both the patient and the provider to adopt the best possible treatment plan using the most effective medical technologies in the attempt to cure the patient’s condition.

Medical technology is uniquely placed to help facilitate positive change in health care, especially in the United States. Instead of trying to ensure the adoption of new innovations within the confines of the previous system, the health care system is actively fostering adoption of new, innovative solutions.

The hope is that this important shift will not only enable more investment in the development of new medical technologies, but will help decrease the pressure on the entire health care operation, creating a brighter, more effective, and affordable system for all.

Jones NJ & Harding KG et al, Neuromuscular electrostimulation on lower limb wounds. British Journal of Nursing VOL. 27, No. 20. Published Online: 12 Nov 2018. 

https://doi.org/10.12968/bjon.2018.27.Sup20.S16

https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133638.pdf

. August 21, 2014. Accessed August 3, 2021.

NICE Guidance (MTG19) costing statement Implementing the NICE guidance on the geko™ device for reducing the risk of venous thromboembolism (MTG19). Published June 25, 2014. Accessed August 3, 2021. 

How Technology Can Improve Patient Outcomes While Reducing Financial Burdens

Sky Medical Technology

Osteoporosis is a systemic skeletal disease involving low bone mass and microarchitectural deterioration of bone tissue, resulting in increased bone fragility and fracture risk.

Bone density corresponds to the amount of mineral within a volume, and bone quality depends on architecture, bone matrix composition, bone turnover, damage accumulation, and mineralization.

 Osteoporosis develops silently over years before it becomes apparent through bone mineral density (BMD) screening or fractures. Fragility fractures are the main physical manifestation and occur at diverse sites, such as the distal radius, proximal femur, and vertebral bodies.

Recommend a dual-energy x-ray absorptiometry (DXA) to check BMD and screen for osteoporosis in the following patients at high risk

Adults on chronic glucocorticoid therapy, such as oral prednisone ≥5 mg/day for 3 or more months or an equivalent

Individuals aged 50 years and older with a recent low-trauma fracture

Other patients may also be good candidates for a DXA to check BMD, especially those with multiple risk factors. Assess risk factors to see if BMD testing is warranted with a thorough history in men aged 50 to 69 years or postmenopausal women younger than age 65 years with the following medical concerns

Excessive alcohol intake of 3 or more drinks per day

Radiographic osteopenia (DXA T-score between -1 and -2.5)

Taking medications that decrease BMD, such as aromatase inhibitors, glucocorticoids, GnRH agonists, phenobarbital, or phenytoin

There are 3 different categories of bone health for classification purposes:

: BMD 1 standard deviation or less below that of young white women reference mean (ie, T-score of −1 or greater)

: BMD between 1 and 2.5 standard deviations below that of young white women reference mean (ie, T-score between −1 and −2.5)

: BMD more than 2.5 standard deviations below that of young white women reference mean (ie, 

There are specific indications for pharmacotherapy:

T-score of −2.5 or less (ie, or worse) in distal third of radius, femoral neck, spine, or total hip

T-score from −1 down to −2.5 in distal third of radius, femoral neck, spine, or total hip, and fragility fracture of hip or spine

T-score from −1 down to −2.5 in distal third of radius, femoral neck, spine, or total hip, and FRAX score shows that that 10-year probability of hip fracture is 3% or greater or the 10-year probability of a major osteoporotic fracture is 20% or more

There are different approaches to screening. Some think that it is not necessary to check a DXA in patients who are receiving osteoporosis treatment because women receiving osteoporosis treatment may have reduced fractures, regardless of the impact on BMD. Others recommend continuing to check a DXA during treatment until BMD has stabilized or after 3 to 5 years of bisphosphonate therapy.

There are several pharmacotherapeutic options for osteoporosis treatment. Medications are classified mechanistically as antiresorptive agents that slow bone breakdown or anabolic “bone building” agents.

Antiresorptive medications include intravenous (IV) and oral bisphosphonates; selective estrogen receptor modulators (SERMs), specifically raloxifene and calcitonin nasal spray; and subcutaneous denosumab. Romosozumab-aqqg is a subcutaneously administered monoclonal antibody with anabolic/antiresorptive properties.

Anabolic agents are the subcutaneous parathyroid hormone analogs abaloparatide and teriparatide. Oral bisphosphonates, such as alendronate or risendronate, are generally preferred first-line agents for osteoporosis prevention and treatment in most patients. The choice of osteoporosis medication depends on multiple factors, including cost, osteoporosis fracture risk and severity, route of administration, and tolerability. The 

details the adverse effects (AEs), contraindications, and dosing of osteoporosis medications.

There are specific circumstances for which other osteoporosis medications may be considered.Raloxifene may be an option for women at high risk for breast cancer and in women who cannot tolerate bisphosphonates or denosumab.

 Calcitonin may be an option to reduce acute bone pain associated with vertebral fractures as well.

Patients with severe osteoporosis and very high fracture risk who cannot tolerate or respond poorly to IV and oral bisphosphonates may be candidates for anabolic agents abaloparatide or teriparatide or alternatively romosomuzab.

 Denosumab is an alternative to anabolic agents for high-risk older patients who cannot take or tolerate or respond poorly to bisphosphonates.

AE indicates adverse effect; BMD, bone mineral density; IV, intravenous; PTH, parathyroid hormone; PTHrP, parathyroid hormone-related protein; and SERM, selective estrogen receptor modulator.

Osteoporosis is a common medical condition that increases fracture risk and requires individualized screening and management. Lifestyle management includes adequate vitamin D and calcium intake, increased physical activity, and smoking cessation. Oral bisphosphonates are first line for most patients with osteoporosis. Other agents may be reserved for high-risk patients who are intolerant or poorly responsive to bisphosphonates. Follow-up BMD testing is recommended to monitor response to therapy.

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 is a clinical associate professor at Pace University’s College of Health Professions in New York, New York.

 is a clinical professor at a department chairperson at Pace University’s College of Health Professions.

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Osteoporosis is a common medical condition that increases fracture risk and may require patients to make lifestyle changes.


Osteoporosis Requires Individualized Screening and Management

Jennifer Hofmann, DMSc, MS, PA-C, and Jean Covino, DHSc, MPA, PA-C

The Advisory Committee on Immunization Practices (ACIP) recommends that all Americans 6 months and older who do not have contraindications receive the flu vaccine.

Health care providers should recommend the high-dose or adjuvanted flu vaccine for patients 65 and older. These 2 types of the vaccine are designed to spur a stronger immune response. The difference between adjuvanted and high-dose vaccines is that the adjuvanted vaccine is made with MF59 adjuvant, which is designed to enhance the immune response. The high-dose vaccine is designed for patients 65 and older and contains 4 times the amount of antigen as the regular flu vaccine. As such, it is associated with a stronger immune response, and patients who received the high-dose vaccine had 24% fewer influenza infections compared with those who received the standard-dose flu vaccine.

Children aged 6 months to 8 years who have never received the vaccine should receive 2 doses, the first as soon as it is available and the second about a month later.

showed that the vaccine significantly reduces a child’s risk of dying from the influenza virus. The study looked at data from 2010 to 2014 and found that the vaccine reduced the risk of flu-associated death by 51% among children with underlying high-risk medical conditions. Just 1 in 4 children who reportedly died from influenza had received the vaccine. As of March, 61 pediatric flu-related deaths had been reported in 2017.

The deferral of vaccination could result in a missed opportunity to vaccinate a patient or the patient becoming infected with the influenza virus prior to obtaining the vaccine.

Authors