Includes bibliographical references.

The Impact of a Community Pharmacy Diabetes Self-Management Education Program on Diabetes Distress -- Vulvodynia: A Review of the Literature -- Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability -- Hepatotoxicity With Elevated Bilirubin Secondary to Prophylactic Doses of Unfractionated Heparin: A Case Report and Review of Heparin-Induced Hepatotoxicity -- Oncology Drug Shortages—What We Have Versus What We Expect to Have? A Critical Scenario of Pakistan.

[Article Title: The Impact of a Community Pharmacy Diabetes Self-Management Education Program on Diabetes Distress / Morgan L. Machen, Hamilton C. Borden and Kenneth C. Hohmeier, p. 3-10]

Abstract:

Background: Negative psychosocial implications stemming from the presence of diabetes, known as diabetes distress, place people with diabetes at twice the likelihood of having clinical depression than those who do not have the disease. While many community pharmacies have incorporated diabetes self-management education (DSME) programs into their practices, there are no known studies that evaluate the impact that this model may have on diabetes distress.

Objective: The purpose of this study is to evaluate the impact that a community pharmacy DSME program has on diabetes distress.

Methods: Retrospective chart review for pre- and post-DSME Problem Areas in Diabetes scale scores, pertinent health history (type and duration of diabetes, A1C, and medications), and demographic information (age, gender) of patients who completed Blount Discount Pharmacy’s DSME program. Data were analyzed using descriptive and inferential statistics.

Results: Of the 17 charts that were reviewed, there was an overall decrease in Problem Areas in Diabetes scale scores from baseline (P = .029). Greater reduction was observed in patients with a long-standing history of diabetes compared with those who were diagnosed with diabetes within the previous 12 months of DSME.

Conclusions: The findings suggest that a community pharmacy DSME program may reduce diabetes distress and warrant future study.

https://doi.org/10.1177/8755122518805429

[Article Title: Vulvodynia: A Review of the Literature / Bobbi Jo Loflin, Kearsten Westmoreland and Nancy Toedter Williams, p. 11-24]

Abstract:

Objective: To evaluate the literature and educate the pharmacy community about the different treatment options for vulvodynia.

Data Sources: Searches were performed through MEDLINE (1946-May 2018) using OVID and EBSCOhost, and Excerpta Medica (1974-May 2018) using EMBASE. Search terms included vulvar vestibulitis syndrome, vestibulodynia, vulvodynia, vulvar pain, provoked vulvar vestibulitis, and vulvodynia treatment. References of all relevant articles were then used to find additional applicable articles.

Study Selection and Data Extraction: This review includes articles in the English language and human trial literature. Twenty-five trials explored the use of oral and topical medications in the treatment of vulvodynia.

Data Synthesis: Vulvodynia is a poorly understood disease with an unknown etiology. Oral tricyclic antidepressants and gabapentin continue to be the most commonly used treatments for vulvodynia pain. This is due to their ease of use and patient preference. Topical treatments that have efficacy data are amitriptyline, gabapentin, lidocaine, baclofen, and hormones. This route of administration avoids systemic adverse effects and interpatient variability that accompanies oral administration. Alternative therapies more commonly used include physiotherapy, psychotherapy, and surgery. Treatment length may vary due to dose titrations and potential changes in medication therapy.

Conclusions: Several medication and alternative therapies may be effective in treating vulvodynia. Current studies used wide dosing ranges, making it difficult to standardize therapy. No consistent method of assessing pain was used between studies, as well as a limited number being randomized and placebo controlled. Additional research is needed to increase knowledge and further develop vulvodynia treatments.

https://doi.org/10.1177/8755122518793256

[Article Title: Biosimilar and Follow-on Insulin: The Ins, Outs, and Interchangeability / John White and Jennifer Goldman, p. 25-35]

Abstract:

Objective: To provide an overview of the differences between biosimilars and generics, and to summarize regulatory requirements and outstanding issues related to biosimilar insulins in the United States, including the issue of interchangeability.

Data Sources: References were obtained using MEDLINE searches, the bibliographies of articles identified during the searches, review articles, and general Internet searches. Key words included the following: diabetes, insulin, biosimilar, regulatory, follow-on, and interchangeability.

Study Selection and Data Extraction: Articles, studies, regulatory documents, and opinion pieces that addressed issues around biosimilar/follow-on insulins and interchangeability of insulins in people with diabetes were selected for inclusion in this narrative review.

Data Synthesis: There is understandable interest in the potential for new copies of existing insulins—termed biosimilar insulins or follow-on insulins—to reduce the substantial and growing costs associated with managing the diabetes epidemic and to improve access, as has been achieved with conventional generic drugs. However, biosimilars or follow-on insulins are not generics. There are critical differences between biologic products and conventional chemical drugs, which present specific challenges to manufacturers, regulators, and clinicians.

Conclusions: Health care providers and payers need to be aware of the issues surrounding biosimilar and follow-on insulins as they become more widely available in the coming years. In particular, in the face of limited data on comparative safety and efficacy, careful consideration needs to be given when interchanging between originator and biosimilar drugs, when switching patients from one biosimilar drug to the other.

https://doi.org/10.1177/8755122518802268

[Article Title: Hepatotoxicity With Elevated Bilirubin Secondary to Prophylactic Doses of Unfractionated Heparin: A Case Report and Review of Heparin-Induced Hepatotoxicity / Michael Bosco and Troy Kish, p. 36-40]

Abstract:

Objective: To report a case of heparin-induced hepatotoxicity in a patient without prior liver dysfunction who received prophylactic doses of unfractionated heparin (UFH).

Case Summary: A 70-year-old man with no prior liver dysfunction was admitted to the hospital for presyncope, secondary to dehydration, and new-onset congestive heart failure. Prophylactic UFH was initiated for deep vein thrombosis prophylaxis. Within 2 days, he developed increases in aspartate aminotransferase and alanine aminotransferase. By day 4, aspartate aminotransferase and alanine aminotransferase were greater than 5 and 9 times the upper limit of normal, respectively. Alkaline phosphatase and bilirubin were markedly elevated as well. UFH was discontinued on day 4, and liver enzymes subsequently normalized.

Discussion: Hepatotoxicity, defined as increases in transaminases greater than 3 times the upper limit of normal, is relatively rare—estimated to occur in only 5% of those receiving therapy with UFH. Concurrent elevations in bilirubin have rarely been reported. Enzymes typically begin to rise after 4 to 5 days of UFH use and return to normal within 2 weeks of discontinuation. Previously published case reports of heparin-induced hepatotoxicity have occurred with therapeutic doses of either UFH or low-molecular-weight heparins.

Conclusions: Heparin-induced hepatotoxicity may occur more rapidly than previously described, and even with the use of prophylactic doses of UFH. Given their widespread use, it is important for clinicians to consider heparins in their differential as a potential cause of hepatotoxicity especially in patients without underlying hepatic disease.

https://doi.org/10.1177/8755122518803363

[Article Title: Oncology Drug Shortages—What We Have Versus What We Expect to Have? A Critical Scenario of Pakistan / Ehsan Elahi and Sidrah Andleeb, p. 41-42]

Abstract: Drug shortages in tertiary care hospitals always limit the health system’s ability to provide quality care to the patients. Immediately following the existing shortage of 5 different oncology drugs in Pakistan, numerous patients are finding themselves in a desperate state of no cure for their illness. Cardinal factors responsible for this unfortunate situation include interruption in vendor supplies and regulatory authorities’ issues related to approval and pricing. Effective review of policies by regulatory authorities for availability of drugs will certainly avoid this miserable condition in the future and ensure continuation of high-quality care to patients by health care systems.

https://doi.org/10.1177/8755122518810853