ABSTRACT
Introduction: Healthcare professionals' awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals' knowledge, practice, and potential barriers to pharmacovigilance-related practices and reporting adverse drug reaction. Methods: A cross-sectional investigation was conducted in government and private healthcare settings. The study included licensed physicians, pharmacists, and nurses. To examine knowledge, practice, and potential barriers to pharmacovigilance-related practices and adverse drug reaction reporting, a 22-item validated questionnaire was used. Results: The final analysis included 311 healthcare professionals. Most healthcare professionals, 59% (N = 182), mentioned encountering patients with adverse drug reactions during the last year. On the other hand, most healthcare professionals, 54% (n = 167), mentioned that they had not reported adverse drug reactions. A good proportion of respondents mentioned that it is essential to report adverse drug reactions (N = 288, 92.6%), availability of adverse drug reactions reporting forms in practice sites (N = 216, 69.5%), had awareness regarding how to report adverse drug reactions (N = 221, 71.1%), the necessity of reporting minor/less important adverse drug reactions (N = 265, 85.2%), and were trained on how to report adverse drug reactions (N = 201, 64.6%). Adverse drug reaction reporting program in the United Arab Emirates (N = 148, 47.6) was known to many healthcare professionals. Lack of time was the major impediment to reporting adverse drug reactions at 42.7% (N = 133). The predictor variable work experience does add to the model (p < 0.05) concerning association with filling of adverse drug reaction forms (Estimate = 0.380; SE = 0.452; p = 0.400), professional role (Estimate = 0.454; SE = 0.673; p = 0.500). In addition, the predictor variable practice setting adds to the model (p < 0.05) concerning the knowledge regarding the availability of adverse drug reaction reporting forms (Estimate = -1.229; SE = 0.298; p = 0.000), training on how to report adverse drug reactions (Estimate = -0.660; SE = 0.294; p = 0.025), and awareness regarding the adverse drug reaction reporting program in the United Arab Emirates (Estimate = -1.032; SE = 0.280; p = 0.000). Conclusion: Pharmacists had the most knowledge regarding adverse drug reaction reporting and pharmacovigilance. The underreporting of adverse drug reactions was documented among physicians and nurses. Lack of time was the most significant barrier to reporting adverse drug reactions, followed by uncertainty and complicated adverse drug reaction documentation forms.
ABSTRACT
Osteoarthritis (OA) is a degenerative joint disease that causes persistent joint pain and stiffness of mainly the large peripheral weight-bearing joints. It is a leading cause of functional disability and poor quality of life. Various modalities of therapy are recommended by different research organizations at different stages of OA including non-pharmacological, pharmacological, and surgical interventions. Intra-articular injections of hyaluronic acid (HA) is widely used for over three decades in the treatment of OA. However controversies exist regarding its safety and efficacy, the number of injections and courses, type of preparation, duration of its effects, and combining it with other drugs or molecules. This study aimed to review the most recent data available in the published literature to address these. Electronic databases like Medline, Embase, ProQuest, and Google Scholar were searched for articles using keywords, intraarticular injections, hyaluronic acid, and osteoarthritis knee. The review was carried out as per PRISMA guidelines. Thirty-eight randomized control trials (RCTs) investigating the efficacy and safety of intra-articular injection of HA were included in the systematic review. Out of the 38 studies, 22 (57.9%) were double-blind, eight (21%) single-blind, three (7.9%) non-blind, four (10%) with simple randomization, and one (2.7%) was open-labeled. Total 5,025 patients were included in these studies. The mean age of the patients was 60.28 years and the osteoarthritis grade of the knee joint was 1 to 3. HA was studied as a test preparation in 19 (50%) while in another 19 (50%) it was studied as a control. In 24 (63.2%) studies, HA was used as high molecular weight preparation in eight (21%) as low molecular weight preparation while in six studies the information was not available. HA was used as a standalone preparation in 31 studies, in two studies it was injected with platelet-rich plasma (PRP) and with either low-level laser therapy (LLLT), triamcinolone (TA), betamethasone (CS), poly deoxyribonucleotide (PDRN) or dexamethasone (DX) in one study each. In the majority of the studies, HA was given as a single injection (52.6% studies) or weekly three injections (28.9% studies). In 13.2 %, it was given as weekly 5 injections and in 5.3% as weekly two injections. IA-HA injections have a limited role in the treatment of knee osteoarthritis in those patients who do not have sufficient pain relief with topical or oral medication and physical therapy. It is safe and effective except for minor side effects such as local pain and swelling lasting for a few days. Severe allergic reactions are extremely rare. They provide adequate pain relief and functional improvement for up to six months irrespective of a number of injections and type of preparations used. The combination formulations with corticosteroids or PRP or MSCs show better results than HA alone. Combining HA with newer molecules such as peptides or diclofenac for sustained and disease-modifying effects requires more studies in the future.
ABSTRACT
OBJECTIVE: To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan. METHODS: In a multicenter, pragmatic, randomized study, patients with type 2 diabetes were recruited from clinical centers in India (n = 765) and Malaysia (n = 105). Eligible patients (age ≥ 18 yrs) expressed their intention to daytime fast during Ramadan, were treated with a stable dose of sulfonylurea with or without metformin for ≥3 months prior to screening visit, and had an HbA(1c) ≤ 10%. Patients were randomized in a 1:1 ratio to either switch to sitagliptin 100 mg q.d. or remain on their pre-study sulfonylurea. Daily diary cards were completed to document information on hypoglycemic symptoms and complications. The primary endpoint was the overall incidence of symptomatic hypoglycemia during Ramadan. RESULTS: Of the 870 patients randomized, 848 (n = 421 for sitagliptin and 427 for sulfonylurea) returned ≥1 completed diary card and were included in the analysis. The proportion of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan was lower with sitagliptin (3.8%) compared to sulfonylurea (7.3%). The risk of symptomatic hypoglycemia was significantly lower with sitagliptin (risk ratio [95% CI] = 0.52 [0.29, 0.94]; p = 0.028). By country, the proportions of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan were 4.1% vs. 7.7% in India and 1.9% vs. 3.8% in Malaysia for sitagliptin and sulfonylurea, respectively. No patient discontinued treatment due to a hypoglycemic event. One patient on sitagliptin and seven on sulfonylurea had an event that required non-medical assistance. No events required medical assistance. Both treatments were generally well tolerated. LIMITATIONS: Symptomatic hypoglycemic events did not require a confirmatory blood glucose measurement, which may have overestimated hypoglycemic events. Measures of glycemic control and body weight were not assessed. CONCLUSION: Switching antihyperglycemic treatment to sitagliptin from a sulfonylurea reduced the risk of symptomatic hypoglycemia by approximately 50% for Muslim patients with type 2 diabetes who fasted during Ramadan. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT01340768.
