Prospects of Establishing a Saudi Version of the United States Food and Drug Administration Orange Book

BackgroundThe recent incidents of generic drug recalls have shaken the public confidence in the quality of generic drugs in Saudi Arabia. Therefore, many clinicians and health policymakers are calling for the establishment of a national reference or formulary that rates different generic drugs based on their therapeutic equivalence to the listed reference drugs, such as the Orange Book of the United States Food and Drug Administration (USFDA).MethodTo explore the prospects of establishing a Saudi version of the USFDA Orange Book, the Saudi discussion group of the American Association of Pharmaceutical Scientists (AAPS) called for a group meeting to discuss the issue with stakeholders representing different sectors (regulatory, industry, purchasing and supply chain, and patient safety). The meeting was audio-recorded and transcribed verbatim. Thereafter, the text was reviewed and analyzed.ResultsThe participants agreed that there is no national guide or reference that can be used in generic substitution. Moreover, it was indicated that the Saudi Food and Drug Authority (SFDA) is working on establishing a Saudi version of the USFDA Orange Book, which will help in choosing the right generic drugs whenever medication substitution is performed to ensure patient safety.ConclusionThe establishment of a Saudi version of the USFDA Orange Book would help healthcare providers in choosing the right generic drug for their patients, which will hopefully improve health outcomes.     

Dietary Patterns and the Risk of Inflammatory Bowel Disease: Findings from a Case-Control Study

Scientific evidence shows that dietary patterns are associated with the risk of IBD, particularly among unhealthy and Western dietary patterns. However, Western dietary patterns are not exclusive to Western countries, as Jordanians are steadily moving towards a Western lifestyle, which includes an increased consumption of processed foods. This study aims to investigate the association between dietary patterns and the risk factors for IBD cases among Jordanian adults. This case-control study was conducted between November 2018 and December 2019 in the largest three hospitals in Jordan. Three hundred and thirty-five Jordanian adults aged between 18–68 years were enrolled in this study: one hundred and eighty-five IBD patients who were recently diagnosed with IBD (n = 100 for ulcerative colitis (UC) and n = 85 for Crohn’s disease (CD)) and 150 IBD-free controls. Participants were matched based on age and marital status. In addition, dietary data was collected from all participants using a validated food frequency questionnaire. Factor analysis and principal component analysis were used to determine the dietary patterns. Odds ratios (OR) and their 95% confidence interval (CI) were calculated using a multinomial logistic regression model. Two dietary patterns were identified among the study participants: high-vegetable and high-protein dietary patterns. There was a significantly higher risk of IBD with high-protein intake at the third (OR, CI: 2.196 (1.046–4.610)) and fourth (OR, CI: 4.391 (2.67–8.506)) quartiles in the non-adjusted model as well as the other two adjusted models. In contrast, the high-vegetable dietary pattern shows a significant protective effect on IBD in the third and fourth quartiles in all the models. Thus, a high-vegetable dietary pattern may be protective against the risk of IBD, while a high-protein dietary pattern is associated with an increased risk of IBD among a group of the Jordanian population.     

Persistent orofacial pain associated with nasopharyngeal extramedullary plasmacytoma

Orofacial pain (OFP) disorders affect the maxillofacial complex and typically involve other locations in the head and neck. Common etiologies of OFP disorders include odontogenic sources, temporomandibular disorders, neuropathic pain, chemosensory disorders, and headaches. Less commonly, benign and malignant neoplasms can be associated with OFP complaints. Patients with OFP symptoms require a thorough evaluation and are often referred to additional healthcare providers for interprofessional management. In those OFP patients whose symptoms do not respond to conventional treatment(s), whose symptoms change over time, or who report positive responses to review of systems questions that suggest more extensive involvement, further investigation is warranted. To the best of our knowledge, this is the first case report of nasopharyngeal extramedullary plasmacytoma, a localized malignant neoplasm, associated with persistent OFP.     

A PC-aided optical foetal heart rate detection system

Safe monitoring of foetal heart rate is a valuable tool for the healthy evolution and wellbeing of both foetus and mother. This paper presents a non-invasive optical technique that allows for foetal heart rate detection using a photovoltaic infrared (IR) detector placed on the mother’s abdomen. The system presented here consists of a photoplethysmography (PPG) circuit, abdomen circuit and a personal computer equipped with MATLAB. A near IR beam having a wavelength of 880?nm is transmitted through the mother’s abdomen and foetal tissue. The received abdominal signal that conveys information pertaining to the mother and foetal heart rate is sensed by a low noise photodetector. The PC receives the signal through the National Instrumentation Data Acquisition Card (NIDAQ). After synchronous detection of the abdominal and finger PPG signals, the designed MATLAB-based software saves, analyses and extracts information related to the foetal heart rate. Extraction is carried out using recursive least squares adaptive filtration. Measurements on eight pregnant women with gestational periods ranging from 35–39 weeks were performed using the proposed system and CTG. Results show a correlation coefficient of 0.978 and a correlation confidence interval between 88–99.6%. The t test results in a p value of 0.034, which is less than 0.05. Low power, low cost, high signal-to-noise ratio, reduction of ambient light effect and ease of use are the main characteristics of the proposed system.     

Correction: Effects of aluminum chloride and coenzyme Q10 on the molecular structure of lipids and the morphology of the brain hippocampus cells

Correction for ‘Effects of aluminum chloride and coenzyme Q10 on the molecular structure of lipids and the morphology of the brain hippocampus cells’ by Abdu Saeed et al., RSC Adv., 2021, 11, 29925–29933, DOI: 10.1039/D1RA03786B.

The authors regret that the name of one of the authors (Naeem F. Qusty) was shown incorrectly in the original article. In addition, the author contributions were incorrectly given. The corrected author list and contributions are as shown here.     

Men’s Knowledge of and Behavior toward Mammography Screening: A Cross-Sectional Study

Background: Breast cancer (BC) is a public health problem that affects many populations worldwide. Women’s health care behavior, including seeking mammography screening, might be affected by men, especially in conservative Arab societies. Few studies have investigated men’s behavior toward mammography for female relatives. The main aims of this study were (i) to evaluate men’s knowledge about mammography screening and (ii) to assess men’s behavior toward women regarding mammogram screening and the factors influencing their behavior. Methods: A cross-sectional study was conducted among male residents of the five main geographic areas of Saudi Arabia. Data were obtained with a self-administered questionnaire. In addition to sociodemographic data, the questionnaire assessed respondents’ general knowledge about mammograms, their behavior toward female family members who use mammography, and their perceptions about awareness campaigns. Results: A total of 9691 male respondents were included in the study. The majority (79%) recommended mammography to their female family members. Multiple factors were significantly associated with men recommending mammograms, including age (p <0.01), education (p <0.01), employment status (p <0.01), and region (p <0.01). Only 33.8% of the participants had a high knowledge score about mammography. Approximately 45% of respondents reported that BC awareness campaigns were weak, while 48% were not aware of BC screening programs. Conclusions: Despite their positive behavior in recommending mammograms to female relatives, men exhibited a notable lack of knowledge about mammography. Establishing national programs and educational campaigns for men to explain the benefits of screening and access to free mammography are essential.     

Physical and chemical screening of honey samples available in the Saudi market: An important aspect in the authentication process and quality assessment

Honey is becoming accepted as a reputable and effective therapeutic agent by practitioners of conventional medicine and by the general public. It has many biological activities and has been effectively used in the treatment of many diseases, e.g. gastrointestinal diseases, skin diseases, cancer, heart diseases, and neurological degeneration. Honey is an excellent source of energy containing mainly carbohydrates and water, as well as, small amounts of organic acids, vitamins, minerals, flavonoids, and enzymes. As a natural product with a relatively high price, honey has been for a long time a target for adulteration. The authenticity of honey is of great importance from commercial and health aspects. The study of the physical and chemical properties of honey has been increasingly applied as a certification process for the purpose of qualification of honey samples. The current work focusses on studying the authenticity of various types of honey sold in Riyadh market (24 samples). For this purpose, physical properties (pH, hydroxylmethylfurfural HMF, and pollen test) were measured. Besides, sugar composition was evaluated using Fehling test and an HPLC method. Elemental analysis was carried out using inductively coupled plasma (ICP). In addition, the presence of drug additives was assessed by means of GC–MS. The obtained results were compared with the Saudi Arabian standards, Codex Alimentarius Commission (2001), and harmonized methods of the international honey commission.