Mortality after implantation of a transjugular intrahepatic portosystemic shunt (TIPS) is increased for patients aged 70 and older with cirrhosis, but creatinine and sodium levels can help with decision-making, according to a study published in Hepatology.

TIPS can improve survival in cirrhotic patients with refractory ascites or portal hypertensive bleeding, and age alone shouldn’t preclude older patients from receiving TIPS, wrote the researchers led by Francesco Vizzutti, MD, of the department of experimental and clinical medicine at the University of Florence in Italy.

“However, the indication for TIPS in older adult patients (70 years and over) is debated, and a specific prediction model developed in this particular setting is lacking,” they wrote.

JFalcetti / iStock / Getty Images

Dr. Vizzutti and colleagues aimed to develop and validate a multivariable model to accurately predict mortality in older adults. They prospectively enrolled 411 patients at four Italian referral centers with de novo TIPS implantation for refractory ascites or secondary prophylaxis of variceal bleeding between October 2020 and March 2021.

All patients underwent TIPS placement using Viatorr-covered stent grafts. All patients had follow-up outpatient appointments every 6 months until the end of the study or when clinically indicated, such as recurrence of portal hypertension complications or TIPS dysfunction.

The research team created a competing risks model to predict liver-related mortality attributable to liver failure, portal hypertensive bleeding, hepatorenal syndrome, or hepatocellular carcinoma, with orthotopic liver transplant and death from extrahepatic causes considered as competing events. In older adults, the only competing event was death from extrahepatic causes because this age group could not receive orthotopic liver transplant.

Alcohol use disorder was the most common etiology at 37%, followed by viral infection at 30%. At the time of TIPS placement, alcohol use disorder was present as a main or concomitant etiology of liver disease in 181 patients, including 36 with active alcohol consumption.

Compared with younger patients, older adults had significantly higher prevalence of viral etiology (at 41%) and lower prevalence of alcohol use disorder (at 18%). In terms of liver function, older adults had significantly less advanced liver disease based on international normalized ratio levels, likely “reflecting a more careful selection by physicians when managing older adults,” the study authors wrote. However, older adults had significantly higher creatinine levels than younger patients, “underlining the importance of the assessment of kidney function when selecting patients for TIPS placement,” the authors wrote.

During a median follow-up time of about 20 months after TIPS placement, 99 of 411 (or 24%) of patients died of liver-related causes, 49 underwent a transplant, and 17 died of extrahepatic causes. Among the 99 older adults, 44 (or 44%) died of liver-related causes, and 7 patients died of extrahepatic causes.

In the overall cohort, the probabilities of liver-related death were 13% after 1 year, 17% after 2 years, and 24% after 3 years. The probabilities were higher in older adults, at 19% after 1 year, 30% after 2 years, and 41% after 3 years.

According to the model, age, alcoholic etiology, creatinine levels, and international normalized ratio levels were independently associated with a higher risk of liver-related death. In older adults, creatinine and sodium levels were the only independent risk factors for death.

Notably, older adult patients with favorable creatinine and sodium levels (1.2 mg/dL and 140 mEq/L, respectively) had survival probabilities of liver-related death at 1, 2, and 3 years from TIPS placement of 14%, 26%, and 34%, respectively, the authors wrote. In contrast, older adults with creatinine levels of 2.5 mg/dL and sodium levels of 130 mEq/L had worse outcomes, with risks of liver-related death of 71%, 92%, and 96%, respectively.

“These results suggest that older adult patients with preserved renal function and normal sodium levels could obtain a survival outcome after TIPS placement similar to younger patients,” they wrote. “Moreover, the occurrence of [hepatic encephalopathy] and/or recurrence of ascites or bleeding was not significantly different comparing the two groups of patients according to age.”

Future research should update the prediction model with larger sample sizes, the study authors wrote.

“The decision for or against TIPS should be made only after carefully weighing the risks and benefits, taking into consideration the available literature,” said Bubu Banini, MD, PhD, an assistant professor of digestive diseases and translational research director of the Metabolic Health and Weight Loss Program at Yale University, New Haven, Conn.

Dr. Banini, who wasn’t involved with the study, said the prediction model could be a useful tool to guide the decision-making process.

“As is usually the case with management of portal hypertension–related complications, a multidisciplinary discussion with evaluation of a multitude of factors, including quality of life, comorbidities, risks, and benefits, should guide decision-making,” she said.

Dr. Banini highlighted the finding that alcohol etiology for cirrhosis was associated with higher mortality compared with viral etiology.

“This is important in the context of unfortunately increasing trends in alcohol consumption in the pre- and peri-COVID era and the increased prevalence of alcohol-associated liver disease, especially in women,” she said.

The study was supported by grants from the University of Florence and the University of Modena and Reggio Emilia. The study authors have received lecture fees from Gore Medical, which creates stent grafts. Dr. Banini reported no relevant disclosures.

Mortality after implantation of a transjugular intrahepatic portosystemic shunt (TIPS) is increased for patients aged 70 and older with cirrhosis, but creatinine and sodium levels can help with decision-making, according to a study published in Hepatology.

TIPS can improve survival in cirrhotic patients with refractory ascites or portal hypertensive bleeding, and age alone shouldn’t preclude older patients from receiving TIPS, wrote the researchers led by Francesco Vizzutti, MD, of the department of experimental and clinical medicine at the University of Florence in Italy.

“However, the indication for TIPS in older adult patients (70 years and over) is debated, and a specific prediction model developed in this particular setting is lacking,” they wrote.

JFalcetti / iStock / Getty Images

Dr. Vizzutti and colleagues aimed to develop and validate a multivariable model to accurately predict mortality in older adults. They prospectively enrolled 411 patients at four Italian referral centers with de novo TIPS implantation for refractory ascites or secondary prophylaxis of variceal bleeding between October 2020 and March 2021.

All patients underwent TIPS placement using Viatorr-covered stent grafts. All patients had follow-up outpatient appointments every 6 months until the end of the study or when clinically indicated, such as recurrence of portal hypertension complications or TIPS dysfunction.

The research team created a competing risks model to predict liver-related mortality attributable to liver failure, portal hypertensive bleeding, hepatorenal syndrome, or hepatocellular carcinoma, with orthotopic liver transplant and death from extrahepatic causes considered as competing events. In older adults, the only competing event was death from extrahepatic causes because this age group could not receive orthotopic liver transplant.

Alcohol use disorder was the most common etiology at 37%, followed by viral infection at 30%. At the time of TIPS placement, alcohol use disorder was present as a main or concomitant etiology of liver disease in 181 patients, including 36 with active alcohol consumption.

Compared with younger patients, older adults had significantly higher prevalence of viral etiology (at 41%) and lower prevalence of alcohol use disorder (at 18%). In terms of liver function, older adults had significantly less advanced liver disease based on international normalized ratio levels, likely “reflecting a more careful selection by physicians when managing older adults,” the study authors wrote. However, older adults had significantly higher creatinine levels than younger patients, “underlining the importance of the assessment of kidney function when selecting patients for TIPS placement,” the authors wrote.

During a median follow-up time of about 20 months after TIPS placement, 99 of 411 (or 24%) of patients died of liver-related causes, 49 underwent a transplant, and 17 died of extrahepatic causes. Among the 99 older adults, 44 (or 44%) died of liver-related causes, and 7 patients died of extrahepatic causes.

In the overall cohort, the probabilities of liver-related death were 13% after 1 year, 17% after 2 years, and 24% after 3 years. The probabilities were higher in older adults, at 19% after 1 year, 30% after 2 years, and 41% after 3 years.

According to the model, age, alcoholic etiology, creatinine levels, and international normalized ratio levels were independently associated with a higher risk of liver-related death. In older adults, creatinine and sodium levels were the only independent risk factors for death.

Notably, older adult patients with favorable creatinine and sodium levels (1.2 mg/dL and 140 mEq/L, respectively) had survival probabilities of liver-related death at 1, 2, and 3 years from TIPS placement of 14%, 26%, and 34%, respectively, the authors wrote. In contrast, older adults with creatinine levels of 2.5 mg/dL and sodium levels of 130 mEq/L had worse outcomes, with risks of liver-related death of 71%, 92%, and 96%, respectively.

“These results suggest that older adult patients with preserved renal function and normal sodium levels could obtain a survival outcome after TIPS placement similar to younger patients,” they wrote. “Moreover, the occurrence of [hepatic encephalopathy] and/or recurrence of ascites or bleeding was not significantly different comparing the two groups of patients according to age.”

Future research should update the prediction model with larger sample sizes, the study authors wrote.

“The decision for or against TIPS should be made only after carefully weighing the risks and benefits, taking into consideration the available literature,” said Bubu Banini, MD, PhD, an assistant professor of digestive diseases and translational research director of the Metabolic Health and Weight Loss Program at Yale University, New Haven, Conn.

Dr. Banini, who wasn’t involved with the study, said the prediction model could be a useful tool to guide the decision-making process.

“As is usually the case with management of portal hypertension–related complications, a multidisciplinary discussion with evaluation of a multitude of factors, including quality of life, comorbidities, risks, and benefits, should guide decision-making,” she said.

Dr. Banini highlighted the finding that alcohol etiology for cirrhosis was associated with higher mortality compared with viral etiology.

“This is important in the context of unfortunately increasing trends in alcohol consumption in the pre- and peri-COVID era and the increased prevalence of alcohol-associated liver disease, especially in women,” she said.

The study was supported by grants from the University of Florence and the University of Modena and Reggio Emilia. The study authors have received lecture fees from Gore Medical, which creates stent grafts. Dr. Banini reported no relevant disclosures.

Mortality after implantation of a transjugular intrahepatic portosystemic shunt (TIPS) is increased for patients aged 70 and older with cirrhosis, but creatinine and sodium levels can help with decision-making, according to a study published in Hepatology.

TIPS can improve survival in cirrhotic patients with refractory ascites or portal hypertensive bleeding, and age alone shouldn’t preclude older patients from receiving TIPS, wrote the researchers led by Francesco Vizzutti, MD, of the department of experimental and clinical medicine at the University of Florence in Italy.

“However, the indication for TIPS in older adult patients (70 years and over) is debated, and a specific prediction model developed in this particular setting is lacking,” they wrote.

JFalcetti / iStock / Getty Images

Dr. Vizzutti and colleagues aimed to develop and validate a multivariable model to accurately predict mortality in older adults. They prospectively enrolled 411 patients at four Italian referral centers with de novo TIPS implantation for refractory ascites or secondary prophylaxis of variceal bleeding between October 2020 and March 2021.

All patients underwent TIPS placement using Viatorr-covered stent grafts. All patients had follow-up outpatient appointments every 6 months until the end of the study or when clinically indicated, such as recurrence of portal hypertension complications or TIPS dysfunction.

The research team created a competing risks model to predict liver-related mortality attributable to liver failure, portal hypertensive bleeding, hepatorenal syndrome, or hepatocellular carcinoma, with orthotopic liver transplant and death from extrahepatic causes considered as competing events. In older adults, the only competing event was death from extrahepatic causes because this age group could not receive orthotopic liver transplant.

Alcohol use disorder was the most common etiology at 37%, followed by viral infection at 30%. At the time of TIPS placement, alcohol use disorder was present as a main or concomitant etiology of liver disease in 181 patients, including 36 with active alcohol consumption.

Compared with younger patients, older adults had significantly higher prevalence of viral etiology (at 41%) and lower prevalence of alcohol use disorder (at 18%). In terms of liver function, older adults had significantly less advanced liver disease based on international normalized ratio levels, likely “reflecting a more careful selection by physicians when managing older adults,” the study authors wrote. However, older adults had significantly higher creatinine levels than younger patients, “underlining the importance of the assessment of kidney function when selecting patients for TIPS placement,” the authors wrote.

During a median follow-up time of about 20 months after TIPS placement, 99 of 411 (or 24%) of patients died of liver-related causes, 49 underwent a transplant, and 17 died of extrahepatic causes. Among the 99 older adults, 44 (or 44%) died of liver-related causes, and 7 patients died of extrahepatic causes.

In the overall cohort, the probabilities of liver-related death were 13% after 1 year, 17% after 2 years, and 24% after 3 years. The probabilities were higher in older adults, at 19% after 1 year, 30% after 2 years, and 41% after 3 years.

According to the model, age, alcoholic etiology, creatinine levels, and international normalized ratio levels were independently associated with a higher risk of liver-related death. In older adults, creatinine and sodium levels were the only independent risk factors for death.

Notably, older adult patients with favorable creatinine and sodium levels (1.2 mg/dL and 140 mEq/L, respectively) had survival probabilities of liver-related death at 1, 2, and 3 years from TIPS placement of 14%, 26%, and 34%, respectively, the authors wrote. In contrast, older adults with creatinine levels of 2.5 mg/dL and sodium levels of 130 mEq/L had worse outcomes, with risks of liver-related death of 71%, 92%, and 96%, respectively.

“These results suggest that older adult patients with preserved renal function and normal sodium levels could obtain a survival outcome after TIPS placement similar to younger patients,” they wrote. “Moreover, the occurrence of [hepatic encephalopathy] and/or recurrence of ascites or bleeding was not significantly different comparing the two groups of patients according to age.”

Future research should update the prediction model with larger sample sizes, the study authors wrote.

“The decision for or against TIPS should be made only after carefully weighing the risks and benefits, taking into consideration the available literature,” said Bubu Banini, MD, PhD, an assistant professor of digestive diseases and translational research director of the Metabolic Health and Weight Loss Program at Yale University, New Haven, Conn.

Dr. Banini, who wasn’t involved with the study, said the prediction model could be a useful tool to guide the decision-making process.

“As is usually the case with management of portal hypertension–related complications, a multidisciplinary discussion with evaluation of a multitude of factors, including quality of life, comorbidities, risks, and benefits, should guide decision-making,” she said.

Dr. Banini highlighted the finding that alcohol etiology for cirrhosis was associated with higher mortality compared with viral etiology.

“This is important in the context of unfortunately increasing trends in alcohol consumption in the pre- and peri-COVID era and the increased prevalence of alcohol-associated liver disease, especially in women,” she said.

The study was supported by grants from the University of Florence and the University of Modena and Reggio Emilia. The study authors have received lecture fees from Gore Medical, which creates stent grafts. Dr. Banini reported no relevant disclosures.

Click to view more from Federal Health Care Data Trends 2022

Click to view more from Federal Health Care Data Trends 2022

Click to view more from Federal Health Care Data Trends 2022

Among women who took vitamin D supplements during pregnancy and who breastfed for more than 1 month, the likelihood of atopic eczema in the baby’s first year was reduced, according to results of a clinical trial.

“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.

“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.

The study also was published in the British Journal of Dermatology.

Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.

The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.

Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.

The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.

The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.

Infants appear to be protected up to 1 year of age

Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.

After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).

The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.

The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.

At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).

The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.

Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.

“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.

The results are mixed, though, she noted.

“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.

“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.

“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”

The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among women who took vitamin D supplements during pregnancy and who breastfed for more than 1 month, the likelihood of atopic eczema in the baby’s first year was reduced, according to results of a clinical trial.

“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.

“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.

The study also was published in the British Journal of Dermatology.

Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.

The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.

Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.

The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.

The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.

Infants appear to be protected up to 1 year of age

Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.

After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).

The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.

The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.

At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).

The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.

Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.

“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.

The results are mixed, though, she noted.

“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.

“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.

“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”

The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among women who took vitamin D supplements during pregnancy and who breastfed for more than 1 month, the likelihood of atopic eczema in the baby’s first year was reduced, according to results of a clinical trial.

“Our data provide the first randomized controlled trial evidence of a protective effect of antenatal cholecalciferol supplementation on risk of infantile atopic eczema, with the effect only seen in infants that were breastfed for more than 1 month,” lead study author Sarah El-Heis, MRCP, DM, and colleagues wrote.

“The findings support a developmental influence on infantile atopic eczema and point to gestational cholecalciferol supplementation as a preventive strategy to reduce the burden of atopic eczema during infancy,” Dr. El-Heis, an academic clinical lecturer in dermatology at the Medical Research Council Lifecourse Epidemiology Center of the University of Southampton (England), said in a presentation at the annual meeting of the Society for Investigative Dermatology.

The study also was published in the British Journal of Dermatology.

Dr. El-Heis and colleagues analyzed data from one of the three U.K. study sites involved in the double-blind Maternal Vitamin D Osteoporosis Study (MAVIDOS), which enrolled participants between 2008 and 2014.

The women enrolled at the University of Southampton site were of age 18 or older, and had a singleton pregnancy. Serum 25-hydroxy vitamin D (25[OH]D) levels were 25-100 nmol/L, and calcium levels were less than 2.75 mmol/L.

Those who had metabolic bone disease, kidney stones, hyperparathyroidism, or hypercalciuria or who were taking more than 400 IU/day of vitamin D supplements or medication known to interfere with fetal growth or whose fetus had a major anomaly were excluded.

The study included 1,134 women. Half of the participants were randomly assigned to receive cholecalciferol 1,000 IU/day from around 14 weeks’ gestation until delivery, and half were assigned to receive placebo. Their babies were assessed for atopic eczema at 12, 24, and 48 months of age.

The maternal and infant characteristics were similar in both groups, but the treatment group tended to breastfeed longer.

Infants appear to be protected up to 1 year of age

Using logistic regression, the researchers analyzed links between maternal cholecalciferol 1,000 IU/day supplements or placebo and atopic eczema risk in their offspring.

After adjustments for breastfeeding duration, among the 636 infants assessed at 12 months, those whose mothers received cholecalciferol had lower odds ratios of atopic eczema than those whose mothers received placebo (OR, 0.55; 95% confidence interval, 0.32-0.97).

The risk of atopic eczema at 12 months was reduced only for children in the treatment group who were breastfed longer than 1 month (OR, 0.48; 95% CI, 0.24-0.94), further analysis showed. Those who were breastfed for less than 1 month showed no reduced risk.

The combined effect of vitamin D and breastfeeding for longer than 1 month weakened after 1 year and was not statistically significant among the 611 children assessed at 24 months and the 450 children assessed at 48 months. The ORs of atopic eczema in the treatment group and in the control group increased to 0.76 (95% CI, 0.47-1.23) and 0.75 (95% CI, 0.37-1.52), respectively.

At baseline, the mean maternal serum 25(OH)D levels in the treatment group (46.0 nmol/L) and in the control group (44.7 nmol/L) were similar. But by late pregnancy, maternal serum 25(OH)D levels in the treatment group were higher (67.4 nmol/L) than in the control group (42.4 nmol/L).

The authors note that strengths of the study include its design, the uniformity of criteria used to diagnose atopic eczema, and the similarity of both pregnant groups in their intake of vitamin D during the study.

Limitations included the lack of ultraviolet B light exposure data, the lack of non-White women in the study, the lack of measurement of cord blood and offspring 25(OH)D levels, and the exclusion of women with baseline 25(OH)D concentrations less than 25 nmol/L.

“This is an interesting study that brings up the possibility that maternal factors during pregnancy may impact atopic dermatitis,” Kalyani S. Marathe, MD, MPH, the director of the division of dermatology at Cincinnati Children’s Hospital Medical Center, told this news organization.

The results are mixed, though, she noted.

“While some impact on the risk of eczema is seen at 1 year of age, that protective effect is gone by 2 years and 4 years,” Dr. Marathe, who was not involved in the study, said in an email. “So if maternal supplementation does improve eczema, the effect is not long-lasting.

“The other complicating factor is that the babies who showed reduction in eczema were also the ones who were breastfed longer than 1 month,” she added. “We know that breastfeeding is associated with several factors, including socioeconomic status, so it is difficult to tease out the relationships here.

“Vitamin D has become a very hot topic lately and seems to have protective effects in many areas of health care,” Dr. Marathe said. “These results may motivate pregnant women to be compliant with their prenatal vitamins that contain the amount of vitamin D studied here.”

The study received grant support. Several authors disclosed financial relationships with pharmaceutical and nutritional products industries. Dr. El-Heis and Dr. Marathe reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There is a growing body of evidence to show that air pollution is a major risk factor for lung cancer among never-smokers, although there is less certainty about the duration of exposure to fine particulate matter in ambient air as it relates to risk for lung cancer.

But as Canadian researchers now report, even 20 years of data on cumulative exposure to air pollution may underestimate the magnitude of the effect, especially among people diagnosed with lung cancer who have migrated from regions where heavy air pollution is the norm.

In a study of Canadian women with newly diagnosed lung cancer who never smoked, Renelle Myers, MD, FRCPC, from the University of British Columbia in Vancouver and colleagues found that shorter-term assessment of cumulative exposure to ambient air particles smaller than 2.5 microns (PM2.5) may underestimate the health effects of chronic exposure to pollution, especially among those patients who had migrated to Canada after living in areas of high PM2.5 exposure for long periods of time.

“Our study points to the importance of incorporating this long-term cumulative exposure to air pollutants in the assessment of individual lung cancer risk, of course in combination with traditional risk factors, and depending on the country of residence, I think that even a 20-year cumulative exposure may underestimate the effects of PM2.5, as we’re not capturing childhood or adolescent exposure when the lung is developing, and what effect that will have,” she said in an oral abstract presented at the World Conference on Lung Cancer.
 

Satellite data on local pollution

With the objective of comparing cumulative 3-year vs. 20-year exposure to PM2.5 in women who had never smoked and had a new diagnosis of lung cancer, Dr. Myers and colleagues conducted a cross-sectional study.

They recruited a total of 236 women and had them fill out a detailed residential history questionnaire, and demographic details including age, race, country of birth, arrival in Canada for those born out of the country, occupations, family history of lung cancer, and exposure to second-hand smoke.

The investigators linked local addresses or postal to satellite-derived data on local PM2.5 levels, which first became available in 1996.

The median age of participants was 66.1 years. Of the 236 participants, 190 (80.5%) were born outside of Canada, and came to the country at the median age of 45. About half of all participants came from mainland China or Hong Kong, and another one-third came from elsewhere in Asia.

Tumor histologies included adenocarcinomas in 219 patients, squamous cell carcinoma in 1, and other types in 16 patients. Slightly more than half of the patients (55.%) had stage III or IV disease at diagnosis. In all, 106 of 227 evaluable patients had EGFR mutations.

3 years not enough

Among the foreign-born patients, only 4 (2%) had 3-year cumulative PM2.5 exposure greater than 10 mcg/m³, but 38 (20%) had 20-year cumulative exposure greater than 10 mcg/m³ (P < .0001).

All of the patients had cumulative PM2.5 exposures greater than 5 mcg/m³.

Comparing patients with and without EGFR mutations, the investigators found that higher 3-year cumulative PM2.5 exposure was significantly associated with EGFR mutations compared with nonmutated cancers (P = .049), but there was no significant association with higher 20-year cumulative exposures.

“The significance of this study really captures that short term or at least less than 3-year cumulative exposure risk for PM2.5 will probably underestimate the adverse effects that chronic exposure to air pollution has, especially among patients who lived elsewhere that may have had higher exposure throughout their lifetime than where you actually meet them,” Dr. Myers said in a media briefing held prior to her presentation.
 

Lung cancer in female nonsmokers

During the oral abstract session, invited discussant Chang-Chuan Chan, ScD, National Taiwan University, Taipei, said that the study’s focus on female patients with lung cancer is important. He pointed to a 2019 study examining the relationship between air pollution and lung cancer among nonsmokers in Taiwan, in which the authors found that, although smoking levels among women remained low over time (about 5%), the incidence of lung adenocarcinomas among women increased from 7.05 per 100,000 in 1995, to 24.22 per 100,000 in 2015.

The authors of that study also found that changes in PM2.5 levels in Taiwan were predictive of fluctuations in lung cancer prevalence in never-smokers.

“We’re moving from 50-year studies of smoking to these new issues of air pollution, asbestos, and radon, and I think it’s better that these three factors can be combined together,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

The study was supported by the BC Cancer Foundation, Terry Fox Research Institute, and VGH-UBC Hospital Foundation. Dr. Myers and Dr. Chan reported having no financial conflicts of interest to disclose.

There is a growing body of evidence to show that air pollution is a major risk factor for lung cancer among never-smokers, although there is less certainty about the duration of exposure to fine particulate matter in ambient air as it relates to risk for lung cancer.

But as Canadian researchers now report, even 20 years of data on cumulative exposure to air pollution may underestimate the magnitude of the effect, especially among people diagnosed with lung cancer who have migrated from regions where heavy air pollution is the norm.

In a study of Canadian women with newly diagnosed lung cancer who never smoked, Renelle Myers, MD, FRCPC, from the University of British Columbia in Vancouver and colleagues found that shorter-term assessment of cumulative exposure to ambient air particles smaller than 2.5 microns (PM2.5) may underestimate the health effects of chronic exposure to pollution, especially among those patients who had migrated to Canada after living in areas of high PM2.5 exposure for long periods of time.

“Our study points to the importance of incorporating this long-term cumulative exposure to air pollutants in the assessment of individual lung cancer risk, of course in combination with traditional risk factors, and depending on the country of residence, I think that even a 20-year cumulative exposure may underestimate the effects of PM2.5, as we’re not capturing childhood or adolescent exposure when the lung is developing, and what effect that will have,” she said in an oral abstract presented at the World Conference on Lung Cancer.
 

Satellite data on local pollution

With the objective of comparing cumulative 3-year vs. 20-year exposure to PM2.5 in women who had never smoked and had a new diagnosis of lung cancer, Dr. Myers and colleagues conducted a cross-sectional study.

They recruited a total of 236 women and had them fill out a detailed residential history questionnaire, and demographic details including age, race, country of birth, arrival in Canada for those born out of the country, occupations, family history of lung cancer, and exposure to second-hand smoke.

The investigators linked local addresses or postal to satellite-derived data on local PM2.5 levels, which first became available in 1996.

The median age of participants was 66.1 years. Of the 236 participants, 190 (80.5%) were born outside of Canada, and came to the country at the median age of 45. About half of all participants came from mainland China or Hong Kong, and another one-third came from elsewhere in Asia.

Tumor histologies included adenocarcinomas in 219 patients, squamous cell carcinoma in 1, and other types in 16 patients. Slightly more than half of the patients (55.%) had stage III or IV disease at diagnosis. In all, 106 of 227 evaluable patients had EGFR mutations.

3 years not enough

Among the foreign-born patients, only 4 (2%) had 3-year cumulative PM2.5 exposure greater than 10 mcg/m³, but 38 (20%) had 20-year cumulative exposure greater than 10 mcg/m³ (P < .0001).

All of the patients had cumulative PM2.5 exposures greater than 5 mcg/m³.

Comparing patients with and without EGFR mutations, the investigators found that higher 3-year cumulative PM2.5 exposure was significantly associated with EGFR mutations compared with nonmutated cancers (P = .049), but there was no significant association with higher 20-year cumulative exposures.

“The significance of this study really captures that short term or at least less than 3-year cumulative exposure risk for PM2.5 will probably underestimate the adverse effects that chronic exposure to air pollution has, especially among patients who lived elsewhere that may have had higher exposure throughout their lifetime than where you actually meet them,” Dr. Myers said in a media briefing held prior to her presentation.
 

Lung cancer in female nonsmokers

During the oral abstract session, invited discussant Chang-Chuan Chan, ScD, National Taiwan University, Taipei, said that the study’s focus on female patients with lung cancer is important. He pointed to a 2019 study examining the relationship between air pollution and lung cancer among nonsmokers in Taiwan, in which the authors found that, although smoking levels among women remained low over time (about 5%), the incidence of lung adenocarcinomas among women increased from 7.05 per 100,000 in 1995, to 24.22 per 100,000 in 2015.

The authors of that study also found that changes in PM2.5 levels in Taiwan were predictive of fluctuations in lung cancer prevalence in never-smokers.

“We’re moving from 50-year studies of smoking to these new issues of air pollution, asbestos, and radon, and I think it’s better that these three factors can be combined together,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

The study was supported by the BC Cancer Foundation, Terry Fox Research Institute, and VGH-UBC Hospital Foundation. Dr. Myers and Dr. Chan reported having no financial conflicts of interest to disclose.

There is a growing body of evidence to show that air pollution is a major risk factor for lung cancer among never-smokers, although there is less certainty about the duration of exposure to fine particulate matter in ambient air as it relates to risk for lung cancer.

But as Canadian researchers now report, even 20 years of data on cumulative exposure to air pollution may underestimate the magnitude of the effect, especially among people diagnosed with lung cancer who have migrated from regions where heavy air pollution is the norm.

In a study of Canadian women with newly diagnosed lung cancer who never smoked, Renelle Myers, MD, FRCPC, from the University of British Columbia in Vancouver and colleagues found that shorter-term assessment of cumulative exposure to ambient air particles smaller than 2.5 microns (PM2.5) may underestimate the health effects of chronic exposure to pollution, especially among those patients who had migrated to Canada after living in areas of high PM2.5 exposure for long periods of time.

“Our study points to the importance of incorporating this long-term cumulative exposure to air pollutants in the assessment of individual lung cancer risk, of course in combination with traditional risk factors, and depending on the country of residence, I think that even a 20-year cumulative exposure may underestimate the effects of PM2.5, as we’re not capturing childhood or adolescent exposure when the lung is developing, and what effect that will have,” she said in an oral abstract presented at the World Conference on Lung Cancer.
 

Satellite data on local pollution

With the objective of comparing cumulative 3-year vs. 20-year exposure to PM2.5 in women who had never smoked and had a new diagnosis of lung cancer, Dr. Myers and colleagues conducted a cross-sectional study.

They recruited a total of 236 women and had them fill out a detailed residential history questionnaire, and demographic details including age, race, country of birth, arrival in Canada for those born out of the country, occupations, family history of lung cancer, and exposure to second-hand smoke.

The investigators linked local addresses or postal to satellite-derived data on local PM2.5 levels, which first became available in 1996.

The median age of participants was 66.1 years. Of the 236 participants, 190 (80.5%) were born outside of Canada, and came to the country at the median age of 45. About half of all participants came from mainland China or Hong Kong, and another one-third came from elsewhere in Asia.

Tumor histologies included adenocarcinomas in 219 patients, squamous cell carcinoma in 1, and other types in 16 patients. Slightly more than half of the patients (55.%) had stage III or IV disease at diagnosis. In all, 106 of 227 evaluable patients had EGFR mutations.

3 years not enough

Among the foreign-born patients, only 4 (2%) had 3-year cumulative PM2.5 exposure greater than 10 mcg/m³, but 38 (20%) had 20-year cumulative exposure greater than 10 mcg/m³ (P < .0001).

All of the patients had cumulative PM2.5 exposures greater than 5 mcg/m³.

Comparing patients with and without EGFR mutations, the investigators found that higher 3-year cumulative PM2.5 exposure was significantly associated with EGFR mutations compared with nonmutated cancers (P = .049), but there was no significant association with higher 20-year cumulative exposures.

“The significance of this study really captures that short term or at least less than 3-year cumulative exposure risk for PM2.5 will probably underestimate the adverse effects that chronic exposure to air pollution has, especially among patients who lived elsewhere that may have had higher exposure throughout their lifetime than where you actually meet them,” Dr. Myers said in a media briefing held prior to her presentation.
 

Lung cancer in female nonsmokers

During the oral abstract session, invited discussant Chang-Chuan Chan, ScD, National Taiwan University, Taipei, said that the study’s focus on female patients with lung cancer is important. He pointed to a 2019 study examining the relationship between air pollution and lung cancer among nonsmokers in Taiwan, in which the authors found that, although smoking levels among women remained low over time (about 5%), the incidence of lung adenocarcinomas among women increased from 7.05 per 100,000 in 1995, to 24.22 per 100,000 in 2015.

The authors of that study also found that changes in PM2.5 levels in Taiwan were predictive of fluctuations in lung cancer prevalence in never-smokers.

“We’re moving from 50-year studies of smoking to these new issues of air pollution, asbestos, and radon, and I think it’s better that these three factors can be combined together,” he said at the meeting sponsored by the International Association for the Study of Lung Cancer.

The study was supported by the BC Cancer Foundation, Terry Fox Research Institute, and VGH-UBC Hospital Foundation. Dr. Myers and Dr. Chan reported having no financial conflicts of interest to disclose.

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Managing type 1 diabetes is never easy. But if you ask 16-year-old climbing star Katie Bone, she’ll tell you that she will never let this disease get in the way of her goals.

“My motto is the same one as Bethany Hamilton’s – the surfer who lost her arm in a shark attack: ‘I don’t need easy, I just need possible,” said Ms. Bone, who lives in Albuquerque and has been a competitive rock climber since she was 8 years old. “That really stuck with me.”

Just watching her compete on NBC’s hit reality show American Ninja Warrior in June is proof of that. Not only did the nationally ranked climber fly through the obstacles with grace and grit, but she proudly showed off her two monitoring devices: a glucose monitor on one arm and a tubeless insulin pump on the other.

“I specifically decided to keep my devices visible when I went on the show,” she said. “It’s part of my life, and I wanted to show that I’m not ashamed to wear medical devices.”

Still, it has been a long journey since Bone was diagnosed in 2017. She was just 11 years old at the time and had recently done a climbing competition when she started feeling ill.

“I didn’t perform well,” she said. “I needed to go to the bathroom a lot and felt really nauseous. Three days later, we ended up in urgent care.”

When her doctor first told her she had diabetes, she started crying.

“My grandma had type 1 and was extremely sick and died from complications,” she said. “That was all I knew about diabetes, and it was scary to think my life could be like that.”

But her outlook brightened when her doctor assured her that she could keep climbing.

“When I was told that I could keep competing, a switch flipped for me and I made a decision that nothing would hold me back,” she says.

But every day isn’t easy.

“It’s sometimes really hard to manage my diabetes during competitions,” she said. “When we climb, for example, we’re not allowed to have our phones, and I manage my [glucose monitor] through my phone. This means accommodations have to be made for me.”

And managing her diabetes can be unpredictable at times.

“If my blood sugar is low or high, I might be put last in a competition,” she said. “That messes up my warm-up and my mental game. It’s a never-ending battle.”

Ultimately, Ms. Bone’s goal is to inspire others and advocate for diabetes awareness. She says she’s been overwhelmed by viewer responses to her appearance on the show.

“I heard from so many parents and kids,” she said. “I want the world to know that wearing a pump on your arm only makes you more amazing.”

She also draws inspiration from others with diabetes.

“Everyone with this disease is a role model for me, since everyone is fighting their own battles,” she said. “Diabetes is different for everyone, and seeing how people can do what they do despite the diagnosis has been incredibly inspiring.”

For now, the rising high school junior plans to continue training and competing.

“My goal is to make the 2024 Olympic climbing team in Paris,” she said. “I’ve always wanted to compete in the Olympics since I was a little kid. Nothing can stop me.”

A version of this article first appeared on WebMD.com.

Managing type 1 diabetes is never easy. But if you ask 16-year-old climbing star Katie Bone, she’ll tell you that she will never let this disease get in the way of her goals.

“My motto is the same one as Bethany Hamilton’s – the surfer who lost her arm in a shark attack: ‘I don’t need easy, I just need possible,” said Ms. Bone, who lives in Albuquerque and has been a competitive rock climber since she was 8 years old. “That really stuck with me.”

Just watching her compete on NBC’s hit reality show American Ninja Warrior in June is proof of that. Not only did the nationally ranked climber fly through the obstacles with grace and grit, but she proudly showed off her two monitoring devices: a glucose monitor on one arm and a tubeless insulin pump on the other.

“I specifically decided to keep my devices visible when I went on the show,” she said. “It’s part of my life, and I wanted to show that I’m not ashamed to wear medical devices.”

Still, it has been a long journey since Bone was diagnosed in 2017. She was just 11 years old at the time and had recently done a climbing competition when she started feeling ill.

“I didn’t perform well,” she said. “I needed to go to the bathroom a lot and felt really nauseous. Three days later, we ended up in urgent care.”

When her doctor first told her she had diabetes, she started crying.

“My grandma had type 1 and was extremely sick and died from complications,” she said. “That was all I knew about diabetes, and it was scary to think my life could be like that.”

But her outlook brightened when her doctor assured her that she could keep climbing.

“When I was told that I could keep competing, a switch flipped for me and I made a decision that nothing would hold me back,” she says.

But every day isn’t easy.

“It’s sometimes really hard to manage my diabetes during competitions,” she said. “When we climb, for example, we’re not allowed to have our phones, and I manage my [glucose monitor] through my phone. This means accommodations have to be made for me.”

And managing her diabetes can be unpredictable at times.

“If my blood sugar is low or high, I might be put last in a competition,” she said. “That messes up my warm-up and my mental game. It’s a never-ending battle.”

Ultimately, Ms. Bone’s goal is to inspire others and advocate for diabetes awareness. She says she’s been overwhelmed by viewer responses to her appearance on the show.

“I heard from so many parents and kids,” she said. “I want the world to know that wearing a pump on your arm only makes you more amazing.”

She also draws inspiration from others with diabetes.

“Everyone with this disease is a role model for me, since everyone is fighting their own battles,” she said. “Diabetes is different for everyone, and seeing how people can do what they do despite the diagnosis has been incredibly inspiring.”

For now, the rising high school junior plans to continue training and competing.

“My goal is to make the 2024 Olympic climbing team in Paris,” she said. “I’ve always wanted to compete in the Olympics since I was a little kid. Nothing can stop me.”

A version of this article first appeared on WebMD.com.

Managing type 1 diabetes is never easy. But if you ask 16-year-old climbing star Katie Bone, she’ll tell you that she will never let this disease get in the way of her goals.

“My motto is the same one as Bethany Hamilton’s – the surfer who lost her arm in a shark attack: ‘I don’t need easy, I just need possible,” said Ms. Bone, who lives in Albuquerque and has been a competitive rock climber since she was 8 years old. “That really stuck with me.”

Just watching her compete on NBC’s hit reality show American Ninja Warrior in June is proof of that. Not only did the nationally ranked climber fly through the obstacles with grace and grit, but she proudly showed off her two monitoring devices: a glucose monitor on one arm and a tubeless insulin pump on the other.

“I specifically decided to keep my devices visible when I went on the show,” she said. “It’s part of my life, and I wanted to show that I’m not ashamed to wear medical devices.”

Still, it has been a long journey since Bone was diagnosed in 2017. She was just 11 years old at the time and had recently done a climbing competition when she started feeling ill.

“I didn’t perform well,” she said. “I needed to go to the bathroom a lot and felt really nauseous. Three days later, we ended up in urgent care.”

When her doctor first told her she had diabetes, she started crying.

“My grandma had type 1 and was extremely sick and died from complications,” she said. “That was all I knew about diabetes, and it was scary to think my life could be like that.”

But her outlook brightened when her doctor assured her that she could keep climbing.

“When I was told that I could keep competing, a switch flipped for me and I made a decision that nothing would hold me back,” she says.

But every day isn’t easy.

“It’s sometimes really hard to manage my diabetes during competitions,” she said. “When we climb, for example, we’re not allowed to have our phones, and I manage my [glucose monitor] through my phone. This means accommodations have to be made for me.”

And managing her diabetes can be unpredictable at times.

“If my blood sugar is low or high, I might be put last in a competition,” she said. “That messes up my warm-up and my mental game. It’s a never-ending battle.”

Ultimately, Ms. Bone’s goal is to inspire others and advocate for diabetes awareness. She says she’s been overwhelmed by viewer responses to her appearance on the show.

“I heard from so many parents and kids,” she said. “I want the world to know that wearing a pump on your arm only makes you more amazing.”

She also draws inspiration from others with diabetes.

“Everyone with this disease is a role model for me, since everyone is fighting their own battles,” she said. “Diabetes is different for everyone, and seeing how people can do what they do despite the diagnosis has been incredibly inspiring.”

For now, the rising high school junior plans to continue training and competing.

“My goal is to make the 2024 Olympic climbing team in Paris,” she said. “I’ve always wanted to compete in the Olympics since I was a little kid. Nothing can stop me.”

A version of this article first appeared on WebMD.com.

Veterans’ access to medical care was expanded outside of US Department of Veterans Affairs (VA) facilities with the inception of the 2014 Veterans Access, Choice, and Accountability Act (Choice Act).¹ This legislation aimed to remove barriers some veterans were experiencing, specifically access to health care. In subsequent years, approximately 17% of veterans receiving care from the VA did so under the Choice Act.² The Choice Act positively impacted medical care access for veterans but presented new challenges for VA pharmacies processing community care (CC) prescriptions, including limited access to outside health records, lack of interface between CC prescribers and the VA order entry system, and limited awareness of the VA national formulary.^3,4 These factors made it difficult for VA pharmacies to assess prescriptions for clinical appropriateness, evaluate patient safety parameters, and manage expenditures.

In 2019, the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act, which expanded CC support and better defined which veterans are able to receive care outside the VA, updated the Choice Act.^4,5 However, VA pharmacies faced challenges in managing pharmacy drug costs and ensuring clinical appropriateness of prescription drug therapy. As a result, VA pharmacy departments have adjusted how they allocate workload, time, and funds.⁵

Pharmacists improve clinical outcomes and reduce health care costs by decreasing medication errors, unnecessary prescribing, and adverse drug events.^6-12 Pharmacist-driven formulary management through evaluation of prior authorization drug requests (PADRs) has shown economic value.^13,14 VA pharmacy review of community care PADRs is important because outside health care professionals (HCPs) might not be familiar with the VA formulary. This could lead to high volume of PADRs that do not meet criteria and could result in increased potential for medication misuse, adverse drug events, medication errors, and cost to the health system. It is imperative that CC orders are evaluated as critically as traditional orders.

The value of a centralized CC pharmacy team has not been assessed in the literature. The primary objective of this study was to assess the direct cost savings achieved through a centralized CC PADR process. Secondary objectives were to characterize the CC PADRs submitted to the site, including approval rate, reason for nonapproval, which medications were requested and by whom, and to compare CC prescriptions with other high-complexity (1a) VA facilities.

Community Care Pharmacy

VA health systems are stratified according to complexity, which reflects size, patient population, and services offered. This study was conducted at the Durham Veterans Affairs Health Care System (DVAHCS), North Carolina, a high-complexity, 251-bed, tertiary care referral, teaching, and research system. DVAHCS provides general and specialty medical, surgical, inpatient psychiatric, and ambulatory services, and serves as a major referral center.

DVAHCS created a centralized pharmacy team for processing CC prescriptions and managing customer service. This team’s goal is to increase CC prescription processing efficiency and transparency, ensure accountability of the health care team, and promote veteran-centric customer service. The pharmacy team includes a pharmacist program manager and a dedicated CC pharmacist with administrative support from a health benefits assistant and 4 pharmacy technicians. The CC pharmacy team assesses every new prescription to ensure the veteran is authorized to receive care in the community. Once eligibility is verified, a pharmacy technician or pharmacist evaluates the prescription to ensure it contains all required information, then contacts the prescriber for any missing data. If clinically appropriate, the pharmacist processes the prescription.

In 2020, the CC pharmacy team implemented a new process for reviewing and documenting CC prescriptions that require a PADR. The closed national VA formulary is set up so that all nonformulary medications and some formulary medications, including those that are restricted because of safety and/or cost, require a PADR.¹⁵ After a CC pharmacy technician confirms a veteran’s eligibility, the technician assesses whether the requested medication requires submitting a PADR to the VA internal electronic health record. The PADR is then adjudicated by a formulary management pharmacist, CC program manager, or CC pharmacist who reviews health records to determine whether the CC prescription meets VA medication use policy requirements.

If additional information is needed or an alternate medication is suggested, the pharmacist comments back on the PADR and a CC pharmacy technician contacts the prescriber. The PADR is canceled administratively then resubmitted once all information is obtained. While waiting for a response from the prescriber, the CC pharmacy technician contacts that veteran to give an update on the prescription status, as appropriate. Once there is sufficient information to adjudicate the PADR, the outcome is documented, and if approved, the order is processed.

Methods

The DVAHCS Institutional Review Board approved this retrospective review of CC PADRs submitted from June 1, 2020, through November 30, 2020. CC PADRs were excluded if they were duplicates or were reactivated administratively but had an initial submission date before the study period. Local data were collected for nonapproved CC PADRs including drug requested, dosage and directions, medication specialty, alternative drug recommended, drug acquisition cost, PADR submission date, PADR completion date, PADR nonapproval rationale, and documented time spent per PADR. Additional data was obtained for CC prescriptions at all 42 high-complexity VA facilities from the VA national CC prescription database for the study time interval and included total PADRs, PADR approval status, total CC prescription cost, and total CC fills.

Direct cost savings were calculated by assessing the cost of requested therapy that was not approved minus the cost of recommended therapy and cost to review all PADRs, as described by Britt and colleagues.¹³ The cost of the requested and recommended therapy was calculated based on VA drug acquisition cost at time of data collection and multiplied by the expected duration of therapy up to 1 year. For each CC prescription, duration of therapy was based on the duration limit in the prescription or annualized if no duration limit was documented. Cost of PADR review was calculated based on the total time pharmacists and pharmacy technicians documented for each step of the review process for a representative sample of 100 nonapproved PADRs and then multiplied by the salary plus benefits of an entry-level pharmacist and pharmacy technician.¹⁶ The eAppendix  describes specific equations used for determining direct cost savings. Descriptive statistics were used to evaluate study results.

Results

During the 6-month study period, 611 CC PADRs were submitted to the pharmacy and 526 met inclusion criteria (Figure 1). Of those, 243 (46.2%) were approved and 283 (53.8%) were not approved. The cost of requested therapies for nonapproved CC PADRs totaled $584,565.48 and the cost of all recommended therapies was $57,473.59. The mean time per CC PADR was 24 minutes; 16 minutes for pharmacists and 8 minutes for pharmacy technicians. Given an hourly wage (plus benefits) of $67.25 for a pharmacist and $25.53 for a pharmacy technician, the total cost of review per CC PADR was $21.33. After subtracting the costs of all recommended therapies and review of all included CC PADRs, the process generated $515,872.31 in direct cost savings. After factoring in administrative lag time, such as HCP communication, an average of 8 calendar days was needed to complete a nonapproved PADR.

The most common rationale for PADR nonapproval was that the formulary alternative was not exhausted. Ondansetron orally disintegrating tablets was the most commonly nonapproved medication and azelastine was the most commonly approved medication. Dulaglutide was the most expensive nonapproved and tafamidis was the most expensive approved PADR (Table 1). Gastroenterology, endocrinology, and neurology were the top specialties for nonapproved PADRs while neurology, pulmonology, and endocrinology were the top specialties for approved PADRs (Table 2).

Several high-complexity VA facilities had no reported data; we used the median for the analysis to account for these outliers (Figure 2). The median (IQR) adjudicated CC PADRs for all facilities was 97 (20-175), median (IQR) CC PADR approval rate was 80.9% (63.7%-96.8%), median (IQR) total CC prescriptions was 8440 (2464-14,466), and median (IQR) cost per fill was $136.05 ($76.27-$221.28).

Discussion

This study demonstrated direct cost savings of $515,872.31 over 6 months with theadjudication of CC PADRs by a centralized CC pharmacy team. This could result in > $1,000,000 of cost savings per fiscal year.

The CC PADRs observed at DVAHCS had a 46.2% approval rate; almost one-half the approval rate of 84.1% of all PADRs submitted to the study site by VA HCPs captured by Britt and colleagues.¹³ Results from this study showed that coordination of care for nonapproved CC PADRs between the VA pharmacy and non-VA prescriber took an average of 8 calendar days. The noted CC PADR approval rate and administrative burden might be because of lack of familiarity of non-VA providers regarding the VA national formulary. The National VA Pharmacy Benefits Management determines the formulary using cost-effectiveness criteria that considers the medical literature and VA-specific contract pricing and prepares extensive guidance for restricted medications via relevant criteria for use.¹⁵ HCPs outside the VA might not know this information is available online. Because gastroenterology, endocrinology, and neurology specialty medications were among the most frequently nonapproved PADRs, VA formulary education could begin with CC HCPs in these practice areas.

This study showed that the CC PADR process was not solely driven by cost, but also included patient safety. Nonapproval rationale for some requests included submission without an indication, submission by a prescriber that did not have the authority to prescribe a type of medication, or contraindication based on patient-specific factors.

Limitations

CC PADRs were assessed during the COVID-19 pandemic, which might have resulted in lower-than-normal CC prescription and PADR volumes, therefore underestimating the potential for direct cost savings. Entry-level salary was used to demonstrate cost savings potential from the perspective of a newly hired CC team; however, the cost savings might have been less if the actual salaries of site personnel were higher. National contract pricing data were gathered at the time of data collection and might have been different than at the time of PADR submission. Chronic medication prescriptions were annualized, which could overestimate cost savings if the medication was discontinued or changed to an alternative therapy within that time period.

The study’s exclusion criteria could only be applied locally and did not include data received from the VA CC prescription database. This can be seen by the discrepancy in CC PADR approval rates from the local and national data (46.2% vs 44.2%, respectively) and CC PADR volume. High-complexity VA facility data were captured without assessing the CC prescription process at each site. As a result, definitive conclusions cannot be made regarding the impact of a centralized CC pharmacy team compared with other facilities.

Conclusions

Adjudication of CC PADRs by a centralized CC pharmacy team over a 6-month period provided > $500,000 in direct cost savings to a VA health care system. Considering the CC PADR approval rate seen in this study, the VA could allocate resources to educate CC providers about the VA formulary to increase the PADR approval rate and reduce administrative burden for VA pharmacies and prescribers. Future research should evaluate CC prescription handling practices at other VA facilities to compare the effectiveness among varying approaches and develop recommendations for a nationally standardized process.

Acknowledgments

Concept and design (AJJ, JNB, RBB, LAM, MD, MGH); acquisition of data (AJJ, MGH); analysis and interpretation of data (AJJ, JNB, RBB, LAM, MD, MGH); drafting of the manuscript (AJJ); critical revision of the manuscript for important intellectual content (AJJ, JNB, RBB, LAM, MD, MGH); statistical analysis (AJJ); administrative, technical, or logistic support (LAM, MGH); and supervision (MGH).

Veterans’ access to medical care was expanded outside of US Department of Veterans Affairs (VA) facilities with the inception of the 2014 Veterans Access, Choice, and Accountability Act (Choice Act).¹ This legislation aimed to remove barriers some veterans were experiencing, specifically access to health care. In subsequent years, approximately 17% of veterans receiving care from the VA did so under the Choice Act.² The Choice Act positively impacted medical care access for veterans but presented new challenges for VA pharmacies processing community care (CC) prescriptions, including limited access to outside health records, lack of interface between CC prescribers and the VA order entry system, and limited awareness of the VA national formulary.^3,4 These factors made it difficult for VA pharmacies to assess prescriptions for clinical appropriateness, evaluate patient safety parameters, and manage expenditures.

In 2019, the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act, which expanded CC support and better defined which veterans are able to receive care outside the VA, updated the Choice Act.^4,5 However, VA pharmacies faced challenges in managing pharmacy drug costs and ensuring clinical appropriateness of prescription drug therapy. As a result, VA pharmacy departments have adjusted how they allocate workload, time, and funds.⁵

Pharmacists improve clinical outcomes and reduce health care costs by decreasing medication errors, unnecessary prescribing, and adverse drug events.^6-12 Pharmacist-driven formulary management through evaluation of prior authorization drug requests (PADRs) has shown economic value.^13,14 VA pharmacy review of community care PADRs is important because outside health care professionals (HCPs) might not be familiar with the VA formulary. This could lead to high volume of PADRs that do not meet criteria and could result in increased potential for medication misuse, adverse drug events, medication errors, and cost to the health system. It is imperative that CC orders are evaluated as critically as traditional orders.

The value of a centralized CC pharmacy team has not been assessed in the literature. The primary objective of this study was to assess the direct cost savings achieved through a centralized CC PADR process. Secondary objectives were to characterize the CC PADRs submitted to the site, including approval rate, reason for nonapproval, which medications were requested and by whom, and to compare CC prescriptions with other high-complexity (1a) VA facilities.

Community Care Pharmacy

VA health systems are stratified according to complexity, which reflects size, patient population, and services offered. This study was conducted at the Durham Veterans Affairs Health Care System (DVAHCS), North Carolina, a high-complexity, 251-bed, tertiary care referral, teaching, and research system. DVAHCS provides general and specialty medical, surgical, inpatient psychiatric, and ambulatory services, and serves as a major referral center.

DVAHCS created a centralized pharmacy team for processing CC prescriptions and managing customer service. This team’s goal is to increase CC prescription processing efficiency and transparency, ensure accountability of the health care team, and promote veteran-centric customer service. The pharmacy team includes a pharmacist program manager and a dedicated CC pharmacist with administrative support from a health benefits assistant and 4 pharmacy technicians. The CC pharmacy team assesses every new prescription to ensure the veteran is authorized to receive care in the community. Once eligibility is verified, a pharmacy technician or pharmacist evaluates the prescription to ensure it contains all required information, then contacts the prescriber for any missing data. If clinically appropriate, the pharmacist processes the prescription.

In 2020, the CC pharmacy team implemented a new process for reviewing and documenting CC prescriptions that require a PADR. The closed national VA formulary is set up so that all nonformulary medications and some formulary medications, including those that are restricted because of safety and/or cost, require a PADR.¹⁵ After a CC pharmacy technician confirms a veteran’s eligibility, the technician assesses whether the requested medication requires submitting a PADR to the VA internal electronic health record. The PADR is then adjudicated by a formulary management pharmacist, CC program manager, or CC pharmacist who reviews health records to determine whether the CC prescription meets VA medication use policy requirements.

If additional information is needed or an alternate medication is suggested, the pharmacist comments back on the PADR and a CC pharmacy technician contacts the prescriber. The PADR is canceled administratively then resubmitted once all information is obtained. While waiting for a response from the prescriber, the CC pharmacy technician contacts that veteran to give an update on the prescription status, as appropriate. Once there is sufficient information to adjudicate the PADR, the outcome is documented, and if approved, the order is processed.

Methods

The DVAHCS Institutional Review Board approved this retrospective review of CC PADRs submitted from June 1, 2020, through November 30, 2020. CC PADRs were excluded if they were duplicates or were reactivated administratively but had an initial submission date before the study period. Local data were collected for nonapproved CC PADRs including drug requested, dosage and directions, medication specialty, alternative drug recommended, drug acquisition cost, PADR submission date, PADR completion date, PADR nonapproval rationale, and documented time spent per PADR. Additional data was obtained for CC prescriptions at all 42 high-complexity VA facilities from the VA national CC prescription database for the study time interval and included total PADRs, PADR approval status, total CC prescription cost, and total CC fills.

Direct cost savings were calculated by assessing the cost of requested therapy that was not approved minus the cost of recommended therapy and cost to review all PADRs, as described by Britt and colleagues.¹³ The cost of the requested and recommended therapy was calculated based on VA drug acquisition cost at time of data collection and multiplied by the expected duration of therapy up to 1 year. For each CC prescription, duration of therapy was based on the duration limit in the prescription or annualized if no duration limit was documented. Cost of PADR review was calculated based on the total time pharmacists and pharmacy technicians documented for each step of the review process for a representative sample of 100 nonapproved PADRs and then multiplied by the salary plus benefits of an entry-level pharmacist and pharmacy technician.¹⁶ The eAppendix  describes specific equations used for determining direct cost savings. Descriptive statistics were used to evaluate study results.

Results

During the 6-month study period, 611 CC PADRs were submitted to the pharmacy and 526 met inclusion criteria (Figure 1). Of those, 243 (46.2%) were approved and 283 (53.8%) were not approved. The cost of requested therapies for nonapproved CC PADRs totaled $584,565.48 and the cost of all recommended therapies was $57,473.59. The mean time per CC PADR was 24 minutes; 16 minutes for pharmacists and 8 minutes for pharmacy technicians. Given an hourly wage (plus benefits) of $67.25 for a pharmacist and $25.53 for a pharmacy technician, the total cost of review per CC PADR was $21.33. After subtracting the costs of all recommended therapies and review of all included CC PADRs, the process generated $515,872.31 in direct cost savings. After factoring in administrative lag time, such as HCP communication, an average of 8 calendar days was needed to complete a nonapproved PADR.

The most common rationale for PADR nonapproval was that the formulary alternative was not exhausted. Ondansetron orally disintegrating tablets was the most commonly nonapproved medication and azelastine was the most commonly approved medication. Dulaglutide was the most expensive nonapproved and tafamidis was the most expensive approved PADR (Table 1). Gastroenterology, endocrinology, and neurology were the top specialties for nonapproved PADRs while neurology, pulmonology, and endocrinology were the top specialties for approved PADRs (Table 2).

Several high-complexity VA facilities had no reported data; we used the median for the analysis to account for these outliers (Figure 2). The median (IQR) adjudicated CC PADRs for all facilities was 97 (20-175), median (IQR) CC PADR approval rate was 80.9% (63.7%-96.8%), median (IQR) total CC prescriptions was 8440 (2464-14,466), and median (IQR) cost per fill was $136.05 ($76.27-$221.28).

Discussion

This study demonstrated direct cost savings of $515,872.31 over 6 months with theadjudication of CC PADRs by a centralized CC pharmacy team. This could result in > $1,000,000 of cost savings per fiscal year.

The CC PADRs observed at DVAHCS had a 46.2% approval rate; almost one-half the approval rate of 84.1% of all PADRs submitted to the study site by VA HCPs captured by Britt and colleagues.¹³ Results from this study showed that coordination of care for nonapproved CC PADRs between the VA pharmacy and non-VA prescriber took an average of 8 calendar days. The noted CC PADR approval rate and administrative burden might be because of lack of familiarity of non-VA providers regarding the VA national formulary. The National VA Pharmacy Benefits Management determines the formulary using cost-effectiveness criteria that considers the medical literature and VA-specific contract pricing and prepares extensive guidance for restricted medications via relevant criteria for use.¹⁵ HCPs outside the VA might not know this information is available online. Because gastroenterology, endocrinology, and neurology specialty medications were among the most frequently nonapproved PADRs, VA formulary education could begin with CC HCPs in these practice areas.

This study showed that the CC PADR process was not solely driven by cost, but also included patient safety. Nonapproval rationale for some requests included submission without an indication, submission by a prescriber that did not have the authority to prescribe a type of medication, or contraindication based on patient-specific factors.

Limitations

CC PADRs were assessed during the COVID-19 pandemic, which might have resulted in lower-than-normal CC prescription and PADR volumes, therefore underestimating the potential for direct cost savings. Entry-level salary was used to demonstrate cost savings potential from the perspective of a newly hired CC team; however, the cost savings might have been less if the actual salaries of site personnel were higher. National contract pricing data were gathered at the time of data collection and might have been different than at the time of PADR submission. Chronic medication prescriptions were annualized, which could overestimate cost savings if the medication was discontinued or changed to an alternative therapy within that time period.

The study’s exclusion criteria could only be applied locally and did not include data received from the VA CC prescription database. This can be seen by the discrepancy in CC PADR approval rates from the local and national data (46.2% vs 44.2%, respectively) and CC PADR volume. High-complexity VA facility data were captured without assessing the CC prescription process at each site. As a result, definitive conclusions cannot be made regarding the impact of a centralized CC pharmacy team compared with other facilities.

Conclusions

Adjudication of CC PADRs by a centralized CC pharmacy team over a 6-month period provided > $500,000 in direct cost savings to a VA health care system. Considering the CC PADR approval rate seen in this study, the VA could allocate resources to educate CC providers about the VA formulary to increase the PADR approval rate and reduce administrative burden for VA pharmacies and prescribers. Future research should evaluate CC prescription handling practices at other VA facilities to compare the effectiveness among varying approaches and develop recommendations for a nationally standardized process.

Acknowledgments

Concept and design (AJJ, JNB, RBB, LAM, MD, MGH); acquisition of data (AJJ, MGH); analysis and interpretation of data (AJJ, JNB, RBB, LAM, MD, MGH); drafting of the manuscript (AJJ); critical revision of the manuscript for important intellectual content (AJJ, JNB, RBB, LAM, MD, MGH); statistical analysis (AJJ); administrative, technical, or logistic support (LAM, MGH); and supervision (MGH).

Veterans’ access to medical care was expanded outside of US Department of Veterans Affairs (VA) facilities with the inception of the 2014 Veterans Access, Choice, and Accountability Act (Choice Act).¹ This legislation aimed to remove barriers some veterans were experiencing, specifically access to health care. In subsequent years, approximately 17% of veterans receiving care from the VA did so under the Choice Act.² The Choice Act positively impacted medical care access for veterans but presented new challenges for VA pharmacies processing community care (CC) prescriptions, including limited access to outside health records, lack of interface between CC prescribers and the VA order entry system, and limited awareness of the VA national formulary.^3,4 These factors made it difficult for VA pharmacies to assess prescriptions for clinical appropriateness, evaluate patient safety parameters, and manage expenditures.

In 2019, the Maintaining Internal Systems and Strengthening Integrated Outside Networks (MISSION) Act, which expanded CC support and better defined which veterans are able to receive care outside the VA, updated the Choice Act.^4,5 However, VA pharmacies faced challenges in managing pharmacy drug costs and ensuring clinical appropriateness of prescription drug therapy. As a result, VA pharmacy departments have adjusted how they allocate workload, time, and funds.⁵

Pharmacists improve clinical outcomes and reduce health care costs by decreasing medication errors, unnecessary prescribing, and adverse drug events.^6-12 Pharmacist-driven formulary management through evaluation of prior authorization drug requests (PADRs) has shown economic value.^13,14 VA pharmacy review of community care PADRs is important because outside health care professionals (HCPs) might not be familiar with the VA formulary. This could lead to high volume of PADRs that do not meet criteria and could result in increased potential for medication misuse, adverse drug events, medication errors, and cost to the health system. It is imperative that CC orders are evaluated as critically as traditional orders.

The value of a centralized CC pharmacy team has not been assessed in the literature. The primary objective of this study was to assess the direct cost savings achieved through a centralized CC PADR process. Secondary objectives were to characterize the CC PADRs submitted to the site, including approval rate, reason for nonapproval, which medications were requested and by whom, and to compare CC prescriptions with other high-complexity (1a) VA facilities.

Community Care Pharmacy

VA health systems are stratified according to complexity, which reflects size, patient population, and services offered. This study was conducted at the Durham Veterans Affairs Health Care System (DVAHCS), North Carolina, a high-complexity, 251-bed, tertiary care referral, teaching, and research system. DVAHCS provides general and specialty medical, surgical, inpatient psychiatric, and ambulatory services, and serves as a major referral center.

DVAHCS created a centralized pharmacy team for processing CC prescriptions and managing customer service. This team’s goal is to increase CC prescription processing efficiency and transparency, ensure accountability of the health care team, and promote veteran-centric customer service. The pharmacy team includes a pharmacist program manager and a dedicated CC pharmacist with administrative support from a health benefits assistant and 4 pharmacy technicians. The CC pharmacy team assesses every new prescription to ensure the veteran is authorized to receive care in the community. Once eligibility is verified, a pharmacy technician or pharmacist evaluates the prescription to ensure it contains all required information, then contacts the prescriber for any missing data. If clinically appropriate, the pharmacist processes the prescription.

In 2020, the CC pharmacy team implemented a new process for reviewing and documenting CC prescriptions that require a PADR. The closed national VA formulary is set up so that all nonformulary medications and some formulary medications, including those that are restricted because of safety and/or cost, require a PADR.¹⁵ After a CC pharmacy technician confirms a veteran’s eligibility, the technician assesses whether the requested medication requires submitting a PADR to the VA internal electronic health record. The PADR is then adjudicated by a formulary management pharmacist, CC program manager, or CC pharmacist who reviews health records to determine whether the CC prescription meets VA medication use policy requirements.

If additional information is needed or an alternate medication is suggested, the pharmacist comments back on the PADR and a CC pharmacy technician contacts the prescriber. The PADR is canceled administratively then resubmitted once all information is obtained. While waiting for a response from the prescriber, the CC pharmacy technician contacts that veteran to give an update on the prescription status, as appropriate. Once there is sufficient information to adjudicate the PADR, the outcome is documented, and if approved, the order is processed.

Methods

The DVAHCS Institutional Review Board approved this retrospective review of CC PADRs submitted from June 1, 2020, through November 30, 2020. CC PADRs were excluded if they were duplicates or were reactivated administratively but had an initial submission date before the study period. Local data were collected for nonapproved CC PADRs including drug requested, dosage and directions, medication specialty, alternative drug recommended, drug acquisition cost, PADR submission date, PADR completion date, PADR nonapproval rationale, and documented time spent per PADR. Additional data was obtained for CC prescriptions at all 42 high-complexity VA facilities from the VA national CC prescription database for the study time interval and included total PADRs, PADR approval status, total CC prescription cost, and total CC fills.

Direct cost savings were calculated by assessing the cost of requested therapy that was not approved minus the cost of recommended therapy and cost to review all PADRs, as described by Britt and colleagues.¹³ The cost of the requested and recommended therapy was calculated based on VA drug acquisition cost at time of data collection and multiplied by the expected duration of therapy up to 1 year. For each CC prescription, duration of therapy was based on the duration limit in the prescription or annualized if no duration limit was documented. Cost of PADR review was calculated based on the total time pharmacists and pharmacy technicians documented for each step of the review process for a representative sample of 100 nonapproved PADRs and then multiplied by the salary plus benefits of an entry-level pharmacist and pharmacy technician.¹⁶ The eAppendix  describes specific equations used for determining direct cost savings. Descriptive statistics were used to evaluate study results.

Results

During the 6-month study period, 611 CC PADRs were submitted to the pharmacy and 526 met inclusion criteria (Figure 1). Of those, 243 (46.2%) were approved and 283 (53.8%) were not approved. The cost of requested therapies for nonapproved CC PADRs totaled $584,565.48 and the cost of all recommended therapies was $57,473.59. The mean time per CC PADR was 24 minutes; 16 minutes for pharmacists and 8 minutes for pharmacy technicians. Given an hourly wage (plus benefits) of $67.25 for a pharmacist and $25.53 for a pharmacy technician, the total cost of review per CC PADR was $21.33. After subtracting the costs of all recommended therapies and review of all included CC PADRs, the process generated $515,872.31 in direct cost savings. After factoring in administrative lag time, such as HCP communication, an average of 8 calendar days was needed to complete a nonapproved PADR.

The most common rationale for PADR nonapproval was that the formulary alternative was not exhausted. Ondansetron orally disintegrating tablets was the most commonly nonapproved medication and azelastine was the most commonly approved medication. Dulaglutide was the most expensive nonapproved and tafamidis was the most expensive approved PADR (Table 1). Gastroenterology, endocrinology, and neurology were the top specialties for nonapproved PADRs while neurology, pulmonology, and endocrinology were the top specialties for approved PADRs (Table 2).

Several high-complexity VA facilities had no reported data; we used the median for the analysis to account for these outliers (Figure 2). The median (IQR) adjudicated CC PADRs for all facilities was 97 (20-175), median (IQR) CC PADR approval rate was 80.9% (63.7%-96.8%), median (IQR) total CC prescriptions was 8440 (2464-14,466), and median (IQR) cost per fill was $136.05 ($76.27-$221.28).

Discussion

This study demonstrated direct cost savings of $515,872.31 over 6 months with theadjudication of CC PADRs by a centralized CC pharmacy team. This could result in > $1,000,000 of cost savings per fiscal year.

The CC PADRs observed at DVAHCS had a 46.2% approval rate; almost one-half the approval rate of 84.1% of all PADRs submitted to the study site by VA HCPs captured by Britt and colleagues.¹³ Results from this study showed that coordination of care for nonapproved CC PADRs between the VA pharmacy and non-VA prescriber took an average of 8 calendar days. The noted CC PADR approval rate and administrative burden might be because of lack of familiarity of non-VA providers regarding the VA national formulary. The National VA Pharmacy Benefits Management determines the formulary using cost-effectiveness criteria that considers the medical literature and VA-specific contract pricing and prepares extensive guidance for restricted medications via relevant criteria for use.¹⁵ HCPs outside the VA might not know this information is available online. Because gastroenterology, endocrinology, and neurology specialty medications were among the most frequently nonapproved PADRs, VA formulary education could begin with CC HCPs in these practice areas.

This study showed that the CC PADR process was not solely driven by cost, but also included patient safety. Nonapproval rationale for some requests included submission without an indication, submission by a prescriber that did not have the authority to prescribe a type of medication, or contraindication based on patient-specific factors.

Limitations

CC PADRs were assessed during the COVID-19 pandemic, which might have resulted in lower-than-normal CC prescription and PADR volumes, therefore underestimating the potential for direct cost savings. Entry-level salary was used to demonstrate cost savings potential from the perspective of a newly hired CC team; however, the cost savings might have been less if the actual salaries of site personnel were higher. National contract pricing data were gathered at the time of data collection and might have been different than at the time of PADR submission. Chronic medication prescriptions were annualized, which could overestimate cost savings if the medication was discontinued or changed to an alternative therapy within that time period.

The study’s exclusion criteria could only be applied locally and did not include data received from the VA CC prescription database. This can be seen by the discrepancy in CC PADR approval rates from the local and national data (46.2% vs 44.2%, respectively) and CC PADR volume. High-complexity VA facility data were captured without assessing the CC prescription process at each site. As a result, definitive conclusions cannot be made regarding the impact of a centralized CC pharmacy team compared with other facilities.

Conclusions

Adjudication of CC PADRs by a centralized CC pharmacy team over a 6-month period provided > $500,000 in direct cost savings to a VA health care system. Considering the CC PADR approval rate seen in this study, the VA could allocate resources to educate CC providers about the VA formulary to increase the PADR approval rate and reduce administrative burden for VA pharmacies and prescribers. Future research should evaluate CC prescription handling practices at other VA facilities to compare the effectiveness among varying approaches and develop recommendations for a nationally standardized process.

Acknowledgments

Concept and design (AJJ, JNB, RBB, LAM, MD, MGH); acquisition of data (AJJ, MGH); analysis and interpretation of data (AJJ, JNB, RBB, LAM, MD, MGH); drafting of the manuscript (AJJ); critical revision of the manuscript for important intellectual content (AJJ, JNB, RBB, LAM, MD, MGH); statistical analysis (AJJ); administrative, technical, or logistic support (LAM, MGH); and supervision (MGH).

Click to view more from Federal Health Care Data Trends 2022

Click to view more from Federal Health Care Data Trends 2022

Click to view more from Federal Health Care Data Trends 2022