Exploratory Findings of Prescribing Unlicensed and Off-Label Medicines Among Children and Neonates.

OBJECTIVE: A cross-sectional study was carried out to evaluate the practice of unlicensed and off-label drug prescribing/dispensing in children and neonates by physicians and clinical pharmacists in the metropolitan city of Karachi. METHODS: The study was conducted for the duration of 5 months - November 2018 to March 2019 - in different clinics and tertiary care hospitals of Karachi, Pakistan. Respondents were interviewed by our researchers using 30 items questionnaire. Descriptive statistics were used to evaluate the answers of respondents to survey items. Pearson correlation and independent sample t-test were employed to recognize the association between the responses of participants and independent variables. P values less than 0.05 were considered statistically significant. RESULTS: A total of 421 questionnaires were completed by physicians and clinical pharmacists. The mean age of the study participants was 49.5 years. Around 98% of pharmacists and 93.5% of physicians were well conversant with the definition of unlicensed and off-label drugs. Around 68% of physicians and 77% of pharmacists reported that they were more concerned about the efficacy of such drugs as compared to that of licensed medicines in children. The most frequent off-label categories observed in the study were dose (65.21%) and indication (17.52%). A vast majority (>80%) thought that approving new drugs by regulatory authorities will drop the occurrence of medication errors due to incorrect dosing. The British National Formulary (BNF) for children was used as the best reliable source of information among respondents. CONCLUSION: The present study highlighted the common practice of unlicensed and off-label drug prescribing in pediatrics; however, respondents showed their concern towards decreasing such practice and are likely to welcome initiatives intended to assure medication safety in children.

Limited Fibrosis Progression but Significant Mortality in Patients Ineligible for Interferon-Based Hepatitis C Therapy.

BACKGROUND: Individuals ineligible for interferon-based hepatitis C therapy may have a worse prognosis than patients who have failed or not received treatment. AIMS: To provide information about the limitations of medical treatment of hepatitis C in real-world patients. METHODS: We studied 969 treatment-ineligible patients and 403 treated patients enrolled between 1/1/01 and 6/30/06; data were collected until 3/31/13. Treatment barriers were grouped into five categories and classified as health-related or health-unrelated. Fibrosis stage was assessed initially and at the end of follow-up. Mortality was determined by search of the Social Security database. Death certificates of treatment-ineligible patients were reviewed. RESULTS: Initially, 288 individuals had advanced fibrosis and compensated disease; 87 untreated patients developed advanced fibrosis during follow-up. Health-related treatment barriers were more commonly associated with fibrosis progression and worse survival. During follow-up, 247 untreated patients died: 47% of liver-related and 53% of liver-unrelated causes. Patients with significant comorbid illness had the worst five- (70%) and ten-year (50.5%) survival. Despite high mortality (47%) in persons with decompensated liver disease, no treatment barrier was associated with a greater incidence of liver-related death. Only significant comorbid medical illness was an independent predictor of disease progression; however, it was not associated with a greater incidence of liver-related death. Furthermore, treated patients had better 10-year survival than untreated patients on Kaplan-Meier analysis (80.3% vs. 74.5%, P = 0.005). CONCLUSION: Many patients with hepatitis C will die of non-liver-related causes and may not be helped by anti-viral treatment.

Successful Treatment of a Persistent Esophageal Lichen Planus Stricture With a Fully Covered Metal Stent.

We report a case of a 51-year-old woman with an esophageal lichen planus (ELP) stricture refractory to medical therapy and endoscopic stricture dilation. A multidisciplinary decision was made to place an esophageal fully covered metal stent. The stent was removed 6 weeks later and the patient is doing well on 3-month follow up. We show that a removable esophageal stent is an option after standard medical therapy and endoscopic dilations fail. This is the first reported use of an esophageal stent for therapy of an ELP stricture.

Risk of New or Recurrent Cancer in Patients With Inflammatory Bowel Disease and Previous Cancer Exposed to Immunosuppressive and Anti-Tumor Necrosis Factor Agents.

BACKGROUND & AIMS: Our understanding of malignancy associated with immunosuppression in patients with inflammatory bowel disease (IBD) comes from studies of individuals with no history of cancer. We investigated whether patients with IBD and a history of cancer who were subsequently immunosuppressed have an increased risk of developing incident cancer. METHODS: We performed a retrospective analysis of data from 333 patients with IBD treated at 8 academic medical centers who developed cancer and subsequently received treatment with anti-tumor necrosis factor (TNF), anti-TNF with an antimetabolite (thiopurines, methotrexate), antimetabolites, or no subsequent exposure to immunosuppressive agents (controls). We collected data on their primary outcomes of incident cancers (new or recurrent). Hazard ratios (HRs) were calculated by using Cox proportional hazards and Kaplan-Meier survival curves; study groups were compared by using the log-rank test. RESULTS: During the follow-up period, 90 patients (27%) developed an incident cancer. Patient characteristics between groups differed, but matching was not possible because of the relatively small sample sizes. There was no difference in time to incident cancer (P = .14) or type of incident cancer (P = .61) among the 4 groups. After adjusting for recurrence risk for type of prior cancer, there was no difference in risk of incident cancer (HR for anti-TNF, 0.32; 95% confidence interval [CI], 0.09-1.09; HR for anti-TNF with an antimetabolite, 0.64; 95% CI, 0.26-1.59; HR for an antimetabolite, 1.08; 95% CI, 0.54-2.15) or time to subsequent cancer between study arms (P = .22). CONCLUSION: On the basis of a retrospective study, in patients with IBD and a history of cancer, exposure to an anti-TNF agent or an antimetabolite after cancer was not associated with an increased risk of incident cancer, compared with patients who did not receive immunosuppression. Larger, matched, prospective studies are needed to confirm these findings.