The inadvertent consequences of drug recalls: A case study of a recall of pantoprazole generics from the markets.

Introduction: Drug recalls may impact treatment plans or access to suitable therapies. Thus, they inadvertently affect treatment outcomes. Objective: We aimed to examine the impact of recalls on patients' safety using pantoprazole-containing products recall as a case study in terms of the occurrence of potential drug-drug interactions (pDDIs). Methods: This retrospective study used de-identified electronic health records of adult patients who had a prescription for oral proton pump inhibitors (PPIs) including pantoprazole, esomeprazole, lansoprazole, or omeprazole from April 2020 through September 2021 from a large tertiary care hospital. The study outcome definition was the prevalence of pDDIs in PPIs users before and after the recall date (March 2021). Changes in the prevalence of pDDIs were modeled using interrupted time-series. The rate ratio of pDDIs in the 12 months before and 6 months after the recall was modeled using negative binomial regression. Results: A total of 1,826 pDDIs were identified, and the median monthly prevalence of pDDI before the recall was 102.5 which increased to 115.5 after the recall. A change in the level of pDDIs occurred immediately after the recall date, followed by a gradual decrease over time. The rate of pDDIs was 69% higher after the recall compared to the baseline (rate ratio 1.69; 95% confidence interval, 0.75-1.91). Discussion: Recall of pantoprazole-containing products was associated with a higher rate of pDDIs. However, the prevalence of pDDIs gradually decreased over time. We highlight the importance of planning of recall process and coordinating all potential stakeholders to avoid potential harms.Word count: 1450.

Inorganic Compounds as Remineralizing Fillers in Dental Restorative Materials: Narrative Review.

Secondary caries is one of the leading causes of resin-based dental restoration failure. It is initiated at the interface of an existing restoration and the restored tooth surface. It is mainly caused by an imbalance between two processes of mineral loss (demineralization) and mineral gain (remineralization). A plethora of evidence has explored incorporating several bioactive compounds into resin-based materials to prevent bacterial biofilm attachment and the onset of the disease. In this review, the most recent advances in the design of remineralizing compounds and their functionalization to different resin-based materials' formulations were overviewed. Inorganic compounds, such as nano-sized amorphous calcium phosphate (NACP), calcium fluoride (CaF2), bioactive glass (BAG), hydroxyapatite (HA), fluorapatite (FA), and boron nitride (BN), displayed promising results concerning remineralization, and direct and indirect impact on biofilm growth. The effects of these compounds varied based on these compounds' structure, the incorporated amount or percentage, and the intended clinical application. The remineralizing effects were presented as direct effects, such as an increase in the mineral content of the dental tissue, or indirect effects, such as an increase in the pH around the material. In some of the reported investigations, inorganic remineralizing compounds were combined with other bioactive agents, such as quaternary ammonium compounds (QACs), to maximize the remineralization outcomes and the antibacterial action against the cariogenic biofilms. The reviewed literature was mainly based on laboratory studies, highlighting the need to shift more toward testing the performance of these remineralizing compounds in clinical settings.

Public Knowledge of Osteoarthritis in Al-Qunfudah Governorate, Saudi Arabia.

BACKGROUND: Joint pain is one of the most frequent complaints among adults and older people in primary healthcare settings worldwide. There are many causes for joint pain, osteoarthritis (OA) is so far the most prevalent form of arthritis that causes joint pain. It can attack almost any joint, but the most frequently affected joints are the hands, knees, hips, and spine. This study aimed to identify public knowledge of OA and its associative variables in Al-Qunfudah governorate, Saudi Arabia. MATERIALS AND METHODS: A cross-sectional descriptive community-based study was carried out among the general population in the Al-Qunfudah governorate. The research data were collected over two months, from November to December 2022, via an Arabic version of a self-administrated online survey of 29 items. RESULTS: A total of 746 respondents were included in this study. The majority of them were females (78%). The age group 18-29 was predominant. In terms of education, 69.9% were holding university degrees. The overall participants' knowledge of OA was poor at 36.1%, fair at 36.8%, and good at 26.9%. The associative variables with better participants' knowledge were; holding university degrees (P=0.021), being a student (P<0.001) and living in urban areas (P=0.020), having normal BMI (P=0.018), and depending on the school topics as a source of information (P<0.001). Good knowledge was significantly higher among healthy individuals and non-smokers (P<0.001) for each variable. CONCLUSION:  This study reveals the lack of knowledge of osteoarthritis among the general population in Al-Qunfudah governorate, Saudi Arabia. Being a student, university educated, from urban areas, and having a normal BMI, all were associative factors with good knowledge. Therefore, this study highlights the necessity for providing awareness and educational campaigns for the public, focusing on the rural population.

Hypopharyngeal lipomatous hamartoma in piriform fossa: A case report and review of literature.

Most hypopharyngeal disease presentations involve tumours or growths of various cellular origin. These lesions may include choristomas, hamartomas, hyperplasia, and harmless or dangerous neoplasms. A hamartoma is a benign focal malformation of tissue at the site of origin that lacks specific distinguishing features and is often designated as a neoplasm without consideration of pathology or biological behaviour. Here, we discuss the case of a 56-year-old man who presented with gradual dysphagia for 4 months along with sleep apnoea and voice changes. No palpable neck masses or abnormal lymphadenopathy was found. A left-sided homogeneous cyst-like mass was seen in the piriform fossa on laryngoscopy. The vocal cords were visualized and mobile. A contrast-enhanced computed tomography scan showed the obliteration of the piriform sinus on the left side by a faintly enhanced heterogeneous soft tissue lesion. The lesion originated from the left aryepiglottic fold, and was approached via micro-laryngoscopy and excised. Histopathological analysis led to a diagnosis of lipomatous hamartoma.

Lymph node yield as a prognostic factor in clinically node negative oral cavity squamous cell carcinoma.

OBJECTIVES: To determine the prognostic significance of nodal yield in patients with clinically node-negative (cN0) oral cavity squamous cell carcinoma (OCSCC). METHODS: This retrospective observational study included 40 patients with cN0 OCSCC who underwent treatment with at least 6 months of follow-up data from November 2012 to April 2020. We recorded the variables, including patient demographics, cancer site, tumor-node-metastasis (TNM) staging, type of treatment, lymph node yield (LNY), histopathologic diagnosis, and recurrence. The recorded data were analyzed with descriptive and interferential statistics using specific tests. RESULTS: Our study cohort comprised of 27 males and 13 females with a mean age of 60.08+13.153 years. Tongue (55%) was the commonly affected site. Seventeen (42.5%) patients belonged to TNM stage II. The mean LNY in our study was 38.65±25.41 (range 7-98). Following surgery, 19 (47.5%) patients further received adjuvant therapies. Recurrence was reported only in 4 (10%) patients. There was no significant difference between LNY and recurrence rate (p=0.892). Factors including, age (p=0.121), gender (p=0.209), site (p=0.519), size of tumor (p=0.416) did not influence the LNY. CONCLUSION: There is no correlation between LNY and recurrence in cN0 OCSCC patients in our study. Meticulous neck dissection and thorough pathologic reporting prevents TNM under staging and improves the overall survival and prognosis.

Prevalence of Metastasis and Involvement of Level IV and V in Oral Squamous Cell Carcinoma: A Systematic Review.

The occurrence of occult metastases in oral cavity squamous cell carcinoma (OSCC) to lower levels in the neck (levels IV and V) or development of skip metastases that bypass the upper neck levels (levels I to III) and go directly to level IV or V is common. This challenges the efficacy of conventional neck dissection approaches in the treatment of OSCC. Therefore, the decision to include lower levels cervical nodes during elective neck dissection of OSCC remains controversial. This systematic review was designed to assess the prevalence of level IV and/or V involvement or skip metastases in patients with the clinically negative neck (cN0) or positive (cN+) oral squamous cell carcinoma (OSCC). We searched for studies published between December 2000 and December 2020. Potentially relevant abstracts and full-text articles were screened, and data from the studies were extracted. Quality was rated using the Newcastle Ottawa Scale (NOS) criteria. In total, 802 abstracts and 227 full-text articles were screened, and 32 studies were included in this analysis. The prevalence of metastasis ranged from 1.8% to 66.0%. The incidence for skip metastasis to level IV or V was low, reaching 8.5%. Evidence favored elective neck dissection, including levels I to III, in selected patients with OSCC and patients with cN0 or cN+ neck. The literature was non-conclusive on the recommendation for inclusion of lower levels.

Ceftolozane-tazobactam for the treatment of multidrug-resistant Pseudomonas aeruginosa pneumonia in a patient receiving intermittent hemodialysis.

PURPOSE: The safety and effectiveness of ceftolozane-tazobactam for the treatment of multidrug-resistant (MDR) Pseudomonas aeruginosa pneumonia in a patient receiving intermittent hemodialysis are reported. CASE REPORT: A 79-year-old African-American man arrived at an emergency trauma center from a nursing home via ambulance with shortness of breath and potential nasogastric tube misplacement. His medical history included end-stage renal disease (ESRD) for which he was receiving intermittent hemodialysis 3 times per week, hypertension, sacral ulcer, coronary artery bypass graft surgery, and P. aeruginosa colonization of his airway. His white blood cell count was elevated, and a chest radiograph revealed atelectasis or infiltrates. As a result, aspiration pneumonia was suggested, and empirical vancomycin and piperacillin-tazobactam were initiated. A few days later, his sputum culture grew MDR P. aeruginosa. Empirical antibiotics were then discontinued, and targeted therapy with ceftolozane-tazobactam i.v. was initiated. A loading dose of ceftolozane-tazobactam 1.5 g i.v. was administered, followed by a maintenance dosage of 300 mg every 8 hours. Following the fifth dose, random ceftolozane-tazobactam plasma concentrations were measured and noncompartmental pharmacokinetics were calculated. After completing a 13-day course of ceftolozane-tazobactam, the patient was discharged from the hospital in stable condition and did not experience any adverse events with ceftolozane-tazobactam. CONCLUSION: In a patient with ESRD receiving intermittent hemodialysis, a ceftolozane-tazobactam loading dose of 1.5 g i.v. followed by a maintenance dosage of 300 mg every 8 hours appeared to be safe and effective in the treatment of nosocomial pneumonia caused by MDR P. aeruginosa.

Late Presentation of Aggressive Fibromatosis Involving Head, Neck and Chest Wall.

Fibromatosis is a rare, benign, slow-growing and locally infiltrative tumour, caused by uncontrolled proliferation of fibrous tissue arising from muscles, connective tissue, fasciae and aponeurosis. It is also called desmoid tumour, which is very rare pathology representing only 0.03% of all neoplasms in human and around 3% of all soft tissue tumours. It is locally aggressive and usually invades the surrounding structures and has a high recurrence rate, even after surgical complete resection, which should be the first line of treatment. Here, we report a very rare case of extensive and disabling fibromatosis tumour in a 38-year male, involving three compartments of the right side of the head, neck and chest wall, which was completely excised surgically and had excellent postoperative results with no morbidity.

Rasburicase-Induced Methemoglobinemia in a Patient with Aggressive Non-Hodgkin's Lymphoma.

BACKGROUND: Rasburicase is a recombinant urate oxidase enzyme that converts uric acid to allantoin (an inactive and soluble metabolite that is readily excreted in urine). It is used for the management of tumor lysis syndrome (TLS) in cancer patients receiving chemotherapy. Although rasburicase is a generally safe and effective treatment, it can be associated with the rare and potentially severe complication of methemoglobinemia. Here, we report a case of rasburicase-induced methemoglobinemia in a patient who was diagnosed with aggressive non-Hodgkin's lymphoma. CASE REPORT: A 74-year-old man with aggressive non-Hodgkin's lymphoma was admitted for initiation of chemotherapy. Upon admission, the patient was found to have hyperkalemia, hyperuricemia, hyperphosphatemia, elevated LDH levels, and acute renal failure. As a result, he was diagnosed with TLS. Rasburicase 6 mg was administered intravenously over a period of 30 min to treat TLS. Later, methemoglobinemia developed, with requirements for oxygen supplementation. Multiple units of packed red blood cells were transfused for recurrent significant anemia secondary to his cancer co-morbidity. The patient was tested for glucose-6 phosphate dehydrogenase (G6PD) deficiency, which returned negative; therefore, methylene blue was considered. After transfusion, the methemoglobin level normalized over the course of a few days, and the oxygen saturation improved without the use of methylene blue. However, during his hospitalization, the patient also developed a pulmonary embolism and had evidence of acute coronary syndrome. Later, the patient died of multiple complications related to his cancer co-morbidity on day 12 of admission. CONCLUSIONS: Blood transfusion and supplemental oxygen, without the use of methylene blue, may be an appropriate therapeutic alternative in rasburicase-induced methemoglobinemia treatment.