Substandard medicines: a greater problem than counterfeit medicines?

Substandard medicines are medicines which have failed to pass the quality measurements and standards set for them.1 They should be distinguished from counterfeit (falsified) medicines which are deliberately and fraudulently mislabelled. Combining the two together however is not helpful. They are different problems that require different solutions. Substandard and counterfeit medicines are a widespread problem in low-income and lower–middle-income countries. A systematic review showed that the median prevalence of substandard and counterfeit medicines was 28.5%.1 This ranged from 11% to 48% in individual studies. The 15 studies were all limited to antimicrobial drugs, with the majority (13) including antimalarials. Only 2 of the 15 studies within the systematic review differentiated between substandard and counterfeit medicines. Both studies involved antimalarial drugs in South East Asia. They both found that counterfeit medicines were a greater problem than substandard medicines. The biggest problem in relation to the quality of the medicines tested was an inadequate amount of the active ingredient

The Interplay of Hypoxia and Autophagy in Epithelial-Derived Ameloblastoma Cell Survival: A Pilot Study

Ameloblastoma is the most clinically-significant benign odontogenic jaw tumor with a locally-aggressive growth pattern and high malignant transformation rate. Epithelial-derived ameloblastoma cells (EPAMCs) demonstrate enhanced basal autophagy but the etiopathogenesis of ameloblastoma and the roles of hypoxia and autophagy in EPAMCs survival and recurrence are still unknown. The goals of this study were to assess expression of ameloblastoma-specific markers and the roles of hypoxia and autophagy on EPAMC survival. Primary and recurrent ameloblastoma tissues from two patients were immunostained with pan-cytokeratin, vimentin and SQSTM1/p62. Additionally, EPAMCs were subjected to severe hypoxia (0.1% O2) to define responsiveness to hypoxia based on expression of hypoxic and autophagic markers. Human odontoma-derived cells (HODCs) served as control. Both primary and recurrent tissue samples stained positive for pan-cytokeratin. Vimentin and SQSTM1/p62 were undetectable but the connective tissue stained positive for vimentin. Phosphorylated-40S ribosomal protein S6 (pS6) levels were decreased in EPAMC in both hypoxia and post-hypoxia. There were no significant changes among the remainder markers or between the EPAMC and HODCs. While the small sample size of this pilot study limited the statistical power several interesting trends were observed. In EPAMCs, canonical autophagy tended to be active at baseline, hypoxia, and re-oxygenation but did not increase when cells were subjected to hypoxia. Cells displayed reduced levels of pS6 and elevated levels of LC3ABII/LC3ABI and p62 24 hours following hypoxia. The vimentin expression and pan-cytokeratin pattern are consistent with an epithelial origin of ameloblastoma. Our data also suggests EPAMCs are using autophagy to survive severe hypoxia

Magnitude and Time Trend of Acute Respiratory Infections (Aris) Among Male School Students and Employees in Aleith

A setting-based descriptive study was conducted to study magnitude and time trend of acute respiratory infections (ARIs) among male school students and employees in Aleith. Data about Acute Respiratory Infections (ARIs) among school students and employees in Aleith during the last three years were collected by reviewing monthly and annual reports in school health units. The proportion of acute reparatory infections in the last three years among male student and employees in Aleith was high in year 1435 which was 50.2%, followed by the year 1437 which was 47% and 1436 was 43.3%. The time distribution of acute respiratory infections illustrates that the percentage of infection occurred during Jumada-Al-Thani (21.9%) in the year 1435, Moharam and Rabi-Al-Thani (17.3%) in the year 1436 and Jumada-Al-Awwal (18%) in the year 1437. In the year 1435, acute respiratory infection among student was 811(63.7%) and among employees was 462 (36.3%); in the year 1436, the disease was 1177 (71.4%) in students while in employees was 471 (28.6%) and in the year1437, the percentage was 747(64.7%) in students and 408(35.3%) in employees. The high percentages of Acute Respiratory Infections (ARIs) occurred among primary school students was high 35.6%, 45.5% and 48.1% in the years 1435, 1436 and 1437 respectively. The peak of ARIs occurred during the year 1435 and the minimum proportion rate of cases was found in 1436. The study concluded that ARIs were still high and more frequent in winter months

Substandard and counterfeit medicines: a systematic review of the literature

Objective: To explore the evidence available of poor quality (counterfeit and substandard) medicines in the literature. Design: Systematic review. Data sources: Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013. Eligibility criteria: Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines. Study appraisal and synthesis: Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income. Data extraction: Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines. Results: 44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (p<0.000; 95% CI 0.21 to 0.32). No individual data about the prevalence in upper middle-income countries and high-income countries were available. Limitations: Studies with strong methodology were few. The majority did not differentiate between substandard and counterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials. Conclusions: The prevalence of poor-quality antimicrobial medicines is widespread throughout Africa and Asia in lower income countries and lower middle-income countries . The main problem identified was inadequate amounts of the active ingredients

Substandard and falsified medicines in the UK: a retrospective review of drug alerts (2001-2011)

Objective: To determine the extent of substandard and falsified medicines in the UK. Design: A retrospective review of drug alerts and company-led recalls. Setting: The Medicines and Healthcare Products Regulatory Agency (MHRA) website search for drug alerts issued between 2001 and 2011. Eligibility criteria: Drug alerts related to quality defect in medicinal products. Main outcome measure: Relevant data about defective medicines reported in drug alerts and company-led recalls, including description of the defect, type of formulation, year of the alert and category of the alert. Results: There were 280 substandard medicines of which 222 were recalled. The two most frequent problems were contamination (74 incidents) and issues related to packaging (98 incidents). Formulations for parenteral administration (117 incidents) were the formulation most frequently affected. There were 11 falsified medicines, as defined by the MHRA, reported over the 11-year period. The number of defective medicines reported by the MHRA increased 10-fold from 5 in 2001 to 50 in 2011. Conclusions: Substandard medicines are a significant problem in the UK. It is uncertain whether the increasing number of reports relates to improved detection or an increase in the number of substandard medicine

Perception of Saudi Mothers about Maxillary Midline Diastemas among Children with Mixed Dentition- A Cross-sectional Study

Introduction: Maxillary anterior spacing or midline diastema is the most frequently seen aesthetic concern among children, which can be quite challenging for the clinician to manage. There can be a significant disparity in the aesthetic perception from person to person and is greatly influenced by their personal experience and social environment. Aim: This study investigated the aesthetic perceptions of Saudi mothers to various Maxillary Midline Diastemas (MMDs) in mixed dentition. Materials and Methods: A cross-sectional study using structured questionnaire was employed for Saudi mothers chosen by stratified-cluster random sampling technique over a period of eight months (November 2016 to June 2017). The questionnaire assessed their perception about various MMDs using photographs and the source of information about MMDs. Data were statistical analysed (SPSS version 20) using the Chi-square test, with the level of significance set at p-value <0.05. Results: The sample consisted of 300 Saudi mothers with a response rate of 86.2%. The maximum mean score was 4.80±0.20 for the MMD photograph showing central incisor tooth discrepancy which the mothers perceived to be the most unpleasant (81%). The very unpleasant perception from the mothers’ perception for group D and B showing ugly duckling stage was (55%) and thumb sucking habit (33%), respectively. The MMD photograph showing high frenum attachment was perceived by 51% of the mothers to be unpleasant and 7% as very unpleasant. Moreover, on comparison it showed the least mean score of 3.65±0.41. Conclusion: The perception of Saudi mothers to various types of MMDs was found to be aesthetically unpleasant. Early detection of the MMDs by the Saudi mothers and intervention by the dental specialist can reduce the progression of the prevailing condition to a severe malocclusion