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Department: DRUG NEWS

Drug News

doi: 10.1097/
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EMR default settings curb overprescribing

Overprescribing of opioids is a significant factor in the ongoing opioid crisis, but guidelines and physician education have had mixed results in reducing opioid prescriptions. To investigate whether changes in default settings in the electronic medical record (EMR) would modify prescribing practices in the ED, researchers conducted a quality improvement study at two large urban EDs. During a series of five 4-week blocks, the prepopulated dispense quantities of discharge prescriptions for commonly prescribed opioids were randomly altered. Default quantities for opioids were changed from status quo quantities of 12 and 20 tablets to null, 5, 10, and 15 tablets according to a block randomization scheme. Regardless of the default quantity, each healthcare professional could modify the quantity prescribed without restriction.

These changes were made without announcement, and prescribers were not informed of the study. Participants included all healthcare professionals (physicians, NPs, and physician assistants) working clinically in either ED. Data were collected from November 28, 2016, through July 9, 2017. The primary outcome was the number of tablets of opioid-containing medications prescribed under each default setting.

Analysis of the data showed an increase of 0.19 tablets prescribed for each tablet increase in default quantity. When each of 15 pairwise comparisons of default quantities were assessed, a lower default was associated with a lower number of pills prescribed in more than half of the comparisons (8 of 15); a higher quantity was seen in 1 pairwise comparison; and no difference was seen in 6 comparisons.

Researchers concluded that changing default settings in the EMR may have a positive influence on the quantity of opioids prescribed. They write, “This low-cost, easily implementable, EMR-based intervention could have far-reaching implications for opioid prescribing and could be used as a tool to help combat the opioid epidemic.”

Source: Montoy JCC, Coralic Z, Herring AA, Clattenburg EJ, Raven MC. Association of default electronic medical record settings with health care professional patterns of opioid prescribing in emergency departments: a randomized quality improvement study. JAMA Intern Med. [e-pub Jan. 21, 2020]


Additional strategies needed for older adults

Current guidelines prioritize older adults for vaccination against seasonal influenza, but how effective is this strategy? A new study found that vaccination alone had only a modest impact on reducing hospitalization and mortality in this vulnerable population, suggesting that additional strategies are needed.

This study involved 170 million episodes of care and 7.6 million deaths in the United Kingdom (UK) among people ages 55 to 75 who lived in the study area from 2000 to 2014. Researchers used an observational research design that reduces the possibility of bias and confounding. A regression discontinuity design was applied to the sharp change in vaccination rate at age 65, which resulted from an age-based UK vaccination policy. Comparisons were limited to people near the age threshold (65). The measurements were hospitalization rates and mortality by month of age.

The study produced no evidence that vaccination significantly reduced hospitalization or mortality in older adults, although the researchers write that these findings “do not preclude modest effectiveness of the influenza vaccine against severe outcomes.” They conclude that these findings “raise questions about the overall effectiveness of a vaccination strategy that is limited to standard vaccines and focuses too much on elderly persons. Supplementary strategies, such as vaccinating children and others who are most likely to spread influenza, may also be necessary to address the high burden of influenza-related complications among older adults.”

Sources: Anderson ML, Dobkin C, Gorry D. The effect of influenza vaccination for the elderly on hospitalization and mortality: an observational study with a regression discontinuity design. Ann Intern Med. [e-pub March 3, 2020] Focus on vaccinating elderly may not be enough for flu protection. HealthDay News. March 2, 2020.


MAOI may be an option when cancer recurs

Because the monoamine oxidase A (MAOA) gene is thought to influence prostate cancer growth and metastasis, researchers conducted an open-label single arm pilot study to investigate whether phenelzine, an older monoamine oxidase inhibitor (MAOI), could be an effective alternative to hormone therapy in patients with biochemical recurrent castrate-sensitive prostate cancer. Hormone therapy, the standard treatment for recurrent prostate cancer, can cause significant adverse reactions affecting quality of life.

Patients in the trial received oral phenelzine twice a day. The primary endpoint was the proportion of patients who achieved a decline in prostate-specific antigen (PSA) of 50% or more from baseline. PSA is a biomarker for prostate cancer circulating in the blood.

After 12 days of twice-daily treatment, 11 of the 20 participants had a measurable decline in PSA levels. Five of these patients experienced declines in PSA of 30% or more and two experienced declines of 50% or more. Common adverse reactions were dizziness, hypertension, and edema. Treatment was discontinued in three patients due to syncope or hypertension. Mood symptoms assessed with a standard questionnaire revealed a significant decrease in anxiety but no change in depressive symptoms.

The authors concluded that therapies directed at MAOA may represent a new avenue for treatment in patients with recurrent prostate cancer. They noted that most treatment-related adverse reactions were mild but cautioned that “rare significant and reversible cardiovascular toxicities were observed.” More research is planned.

Sources: Gross ME, Agus DB, Dorff TB, et al. Phase 2 trial of monoamine oxidase inhibitor phenelzine in biochemical recurrent prostate cancer. Prostate Cancer Prostatic Dis. [e-pub March 3, 2020] Decades-old antidepressant may fend off prostate cancer's return. University of Southern California. News release. March 4, 2020.


New oral medication for Cushing disease

The FDA has approved osilodrostat (Isturisa) oral tablets for adults with Cushing disease who cannot undergo pituitary gland surgery or who still have the disease despite the surgery. In patients with Cushing disease, which is caused by a pituitary tumor, the adrenal glands make too much cortisol. This is the first FDA-approved drug to directly address cortisol overproduction by blocking the 11-beta-hydroxylase enzyme and preventing cortisol synthesis.

Cushing disease is most common among adults ages 30 to 50 and affects more women than men. It can cause significant health issues, such as hypertension, obesity, type 2 diabetes, thrombosis, bone loss and fractures, immunosuppression, and depression.

Osilodrostat's safety and effectiveness was evaluated in a study of 137 adults, about three-quarters of whom were women. At the end of the study, 86% of patients receiving the drug maintained cortisol levels within normal limits compared with 30% of those taking a placebo. The most common adverse reactions were adrenal insufficiency, headache, vomiting, nausea, fatigue, and edema.

Osilodrostat is taken twice a day in the morning and evening. Because it was developed to treat a rare disease, it received Orphan Drug Designation.

Source: US Food and Drug Administration. FDA approves new treatment for adults with Cushing's disease. News release. March 6, 2020.

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