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Drug News

doi: 10.1097/01.NURSE.0000569756.50549.5f
Department: DRUG NEWS
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Reading clinical notes may improve adherence to prescribed medication regimens...new drug approved for cluster headaches in adults...dentists overprescribe antibiotics for infection prophylaxis...patch matches the pen for mealtime insulin delivery...breakthrough therapy for pancreatic cancer

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MEDICATION REGIMENS

Reading clinical notes may improve adherence

Patients who read clinician's visit notes may be more likely to understand and adhere to their prescribed medication regimen, according to a recent survey. In a pilot program, patients were given access to their clinicians' notes via an online portal. Surveyed patients had logged into the portal at least once in the previous 12 months. Most patients reported that reading the notes helped them understand why their medication was prescribed, helped them feel more comfortable with the regimen, and answered their questions. Very few said the notes left them feeling worried or confused. The researchers say that giving patients access to clinical notes may help them manage their medications and adhere to therapy.

Sources: DesRoches CM, Bell SK, Dong Z, et al. Patients managing medications and reading their visit notes: a survey of OpenNotes participants. Ann Intern Med. [e-pub May 28, 2019]. Reading visit notes may improve medication management. HealthDay News. May 29, 2019.

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EMGALITY

New FDA approval for cluster headaches

First approved in 2018 as preventive treatment for migraine in adults, Emgality (galcanezumab-gnlm) solution for subcutaneous injection is now also approved to treat episodic cluster headaches in adults. These extremely painful headaches tend to occur in clusters, often at the same time of the day, for several weeks to months. Attacks may occur several times a day and last up to 3 hours.

In a clinical trial of 106 patients who experience cluster headaches, those taking Emgality experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared with 5.2 fewer attacks for patients on placebo. The most common adverse reaction was injection site reaction, but serious hypersensitivity reactions are possible.

Emgality is given by patient self-injection. Teach patients to recognize signs and symptoms of a hypersensitivity reaction and tell them to immediately discontinue the drug and seek medical attention if these appear.

Source: US Food and Drug Administration. FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks. News release. June 4, 2019.

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DIABETES MANAGEMENT

Patch matches pen for mealtime insulin delivery

Adults with type 2 diabetes may face various barriers to self-administration of mealtime insulin injections, such as dislike of injections, stigma, and inconvenience. Use of an insulin patch is a more appealing option for many patients, but is it as effective at controlling diabetes? Recent research suggests that it is.

In a multicenter, randomized controlled trial, researchers evaluated efficacy, safety, and self-reported outcomes in 278 adults with type 2 diabetes whose diabetes was inadequately controlled on basal insulin. These patients were randomized to manage mealtime insulin with a patch (n = 139)or an insulin pen (n = 139) for 48 weeks, switching treatment methods at week 44 for the final 4 weeks. Participants self-monitored blood glucose levels and used this information along with an insulin adjustment algorithm to adjust their dosage as needed. They also documented adverse reactions.

The results showed that mealtime use of both the pen and the patch significantly improved patients' A1c levels, with no difference in adverse reactions or patient adherence rates. However, those using the patch reported higher levels of satisfaction with treatment. In addition, 90% of the healthcare providers involved in the study (n = 89) preferred the patch for mealtime insulin administration, reporting that it required less time for patient education. The researchers write that the patch “can potentially reduce patient and provider resistance to initiating mealtime insulin therapy and improve patient adherence and persistence.”

Source: Bergenstal RM, Peyrot M, Dreon DM, et al. Implementation of basal-bolus therapy in type 2 diabetes: a randomized controlled trial comparing bolus insulin delivery using an insulin patch with an insulin pen. Diabetes Technol Ther. 2019;21(5):273-285.

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PANCREATIC CANCER

Breakthrough therapy for a deadly disease

Metastatic pancreatic cancer is typically refractory to treatment. Even with current standard-of-care first-line treatments, the median progression-free survival is only about 6 months. In a major randomized, double-blind, placebo-controlled drug trial, described as “practice-changing” by the authors, progression-free survival was significantly extended in a selected group of patients with metastatic pancreatic cancer who had inherited mutations in the BRCA1 and 2 genes. The study evaluated the effectiveness of the poly (adenosine diphosphate–ribose) polymerase (PARP) inhibitor olaparib, a drug with antitumor activity in this population. The primary endpoint was progression-free survival.

Over 3,300 patients at 119 centers on 4 continents were screened for germline BRCA mutations and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. After 154 participants received at least 16 weeks of platinum-based chemotherapy, they were randomized to receive either olaparib or placebo. Treatment continued until radiologic exams detected disease progression.

The median progression-free survival was significantly longer in the olaparib group than in the placebo group: 7.4 months versus 3.8 months. No significant difference between the groups was found in health-related quality of life.

“About a quarter of these patients responded to olaparib for a median of 2 years, which is truly remarkable in a disease where most patients survive for less than a year,” said study coauthor Hedy L. Kindler in an interview. Olaparib is currently approved by the FDA for patients with ovarian cancer and germline BRCA-mutated breast cancer.

Sources: Golan T, Hammel P, Reni M, et al. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. [e-pub ahead of print, June 2, 2019]. University of Chicago Medicine. POLO trial for advanced pancreatic cancer: a new standard of care. News release. June 3, 2019.

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ANTIBIOTIC STEWARDSHIP

Dentists overprescribe for infection prophylaxis

Most antibiotic prophylaxis prescriptions issued before dental work are “discordant” with current guidelines, according to a cohort study of 91,438 patients who received antibiotic prophylaxis for 168,420 dental visits from 2011 to 2015. Under current guidelines, prophylactic antibiotics before invasive dental procedures are recommended only for patients with cardiac conditions at the highest risk of adverse outcome from infective endocarditis.

For this study, appropriate antibiotic prophylaxis was defined as a prescription dispensed before a dental visit with a procedure that manipulated the gingiva or tooth periapex in patients with an appropriate cardiac diagnosis. Analysis showed that over 80% of antibiotics prescribed for infection prophylaxis before dental visits were unnecessary. Factors associated with unnecessary antibiotic prophylaxis were prosthetic joint devices and tooth implant procedures.

Dentists are the top specialty prescriber of antibiotics in the US. The study authors say that “implementation of antimicrobial stewardship in dental practices is an opportunity to improve antibiotic prescribing for infection prophylaxis.”

Source: Suda KJ, Calip GS, Zhou J, et al. Assessment of the appropriateness of antibiotic prescriptions for infection prophylaxis before dental procedures, 2011 to 2015. JAMA Netw Open. 2019;2(5):e193909.

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