Acute abdominal pain is a chief complaint in emergency departments and represents 7%–10% of emergency room (ER) visits. Acute appendicitis represents 15% of the causes of abdominal pain and 62% of the causes that require surgical treatment. Opioid analgesia has been evaluated in clinical trials, and they have determined it does not impact diagnostic accuracy. Despite evidence, withholding analgesia is still a common practice. Pain severely impacts quality of life and analgesia has become essential in humanised medicine. We aim to determine the safety and effectiveness of different opioid regimens for adult patients that present to the ER with acute suspected appendicitis.
We will search MEDLINE and Embase via Ovid, and the Cochrane Central Register of Controlled Trials without restrictions on the study publication date. Screening, extraction and risk of bias assessment will be performed in duplicate. We will use the Cochrane Risk of Bias Assessment Tool. We will perform both pairwise meta-analysis and network meta-analysis (NMA) if transitivity and coherence principles are met. Heterogeneity will be evaluated using the I² and ² and using the thresholds recommended by Cochrane. We will perform sensitivity analysis based on the pre-established potential effect modifiers, risk of bias and data that required transformation or imputation. Publication bias will be addressed by using funnel plots on a pairwise level. We will assess the strength of the body of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) per outcome, and evidence from the NMA will be assessed using the GRADE approach for NMA.
Approval by an ethics committee is not required for this study since no personal information will be handled. Information will be disseminated by publication on a peer-reviewed journal.
CRD42024583804.
In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.
We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).
The quality of 183 antibiotics including amoxicillin tablets (148/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.
Almost all samples produced in Indonesia (182/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125 mg dry syrup (6/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500 mg tablet (5/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4/12, 95% CI 12.5% to 61.2%) of amoxicillin 125 mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.
While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.