Thamir M. Alshammari

Health care professionals' awareness of, knowledge about and attitude to influenza vaccination.

OBJECTIVES Influenza vaccination is recommended to all health care professionals (HCPs). However, vaccination rate among HCPs is low and may be due to uncertainty about the effectiveness of the vaccine and fear of its adverse effects. Therefore, this study aimed to investigate the awareness, knowledge, and attitude of HCPs towards influenza vaccination and we ascertain reasons for not getting vaccinated. METHOD A cross-sectional conducted in 6 major hospitals in Saudi Arabia. 245 anonymous questionnaires were distributed to a convenient sample of staff during the 2012-2013 influenza season. The validated questionnaire consists of five sections that collect information about: demographics, attitude towards influenza vaccination, knowledge about influenza virus and vaccination, current practice and awareness of published guidelines. RESULTS 242 completed questionnaires were received, a response rate of 98%. 38% of HCPs reported getting vaccinated. The most common reasons given by HCPs for not getting vaccinated were: fear of contracting illness (16%), belief that they are not at risk from influenza because they are young and healthy (13%) and being unaware of vaccine availability (13%). Non-availability of vaccine (43%) was the highest barrier for not providing vaccine for patients and HCPs followed by safety concerns for the patients (35%) and the respondents (33%). Almost 75% of HCPs were not aware of the influenza immunization guidelines published by the Advisory Committee on Immunization Practices and Centre for Disease Control. CONCLUSION Despite the recommendations, only low percentage of HCPs in Saudi Arabian hospitals is vaccinated against influenza. The attention of health policy makers is needed to improve compliance of HCPs with guidelines on influenza vaccination.

A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia

Objectives: To explore the challenges facing pharmacovigilance in Saudi Arabia and formulate recommendations to improve it from the perspective of healthcare professionals in Saudi Arabia. Methods: This was a qualitative study of 4 focus group discussions with pharmacists, physicians, and academicians held under the auspices of the King Saud University School of Pharmacy and the Center for Medicine in the Public Interest, Riyadh, Saudi Arabia. A total of 29 eligible healthcare professionals were invited to participate in the discussion. The predefined themes of the study were the current practice and major challenges facing pharmacovigilance in regulatory bodies, hospitals, the community, and academia, as well as recommendations to improve pharmacovigilance practice. Result: Of the 29 participants invited, 27 attended the discussion. Challenges facing regulatory bodies included complicated adverse drug reactions (ADR) reporting forms, lack of feedback on ADRs submitted to the Saudi Food and Drug Authority, lack of decisions from the local authority to withdraw medications, and lack of data on pharmacovigilance. The challenges to pharmacovigilance in hospitals included the lack of knowledge of the significance of ADR reporting, workload, blaming culture, and lack of collaboration between regulatory bodies and hospitals. However, challenges facing pharmaceutical industries included the lack of drug manufacturers in Saudi Arabia and lack of interest in pharmacovigilance. Recommendations to improve pharmacovigilance included the need for communication, stronger regulatory requirements, the need for research, the need for unified ADRs reporting, and continuous education and training. Conclusion: The study has identified the challenges facing pharmacovigilance in Saudi Arabia and made certain recommendations to overcome them. These recommendations might be helpful for regulatory bodies to enhance spontaneous reporting and promote pharmacovigilance.

Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

Objectives: To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications. Methods: A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported. Result: There were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient’s demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%). Conclusion: Although the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports.

Synthesis and Characterization of Cefotaxime Conjugated Gold Nanoparticles and Their Use to Target Drug-Resistant CTX-M-Producing Bacterial Pathogens

Multidrug‐resistance due to “β lactamases having the expanded spectrum” (ESBLs) in members of Enterobacteriaceae is a matter of continued clinical concern. CTX‐M is among the most common ESBLs in Enterobacteriaceae family. In the present study, a nanoformulation of cefotaxime was prepared using gold nanoparticles to combat drug‐resistance in ESBL producing strains. Here, two CTX‐M‐15 positive cefotaxime resistant bacterial strains (i.e., one Escherichia coli and one Klebsiella pneumoniae strain) were used for testing the efficacy of “cefotaxime loaded gold‐nanoparticles.” Bromelain was used for both reduction and capping in the process of synthesis of gold‐nanoparticles. Thereafter, cefotaxime was conjugated onto it with the help of activator 1‐Ethyl‐3‐(3‐dimethylaminopropyl)‐carbodiimide. For characterization of both unconjugated and cefotaxime conjugated gold nanoparticles; UV‐Visible spectroscopy, Scanning, and Transmission type Electron Microscopy methods accompanied with Dynamic Light Scattering were used. We used agar diffusion method plus microbroth‐dilution method for the estimation of the antibacterial‐activity and determination of minimum inhibitory concentration or MIC values, respectively. MIC values of cefotaxime loaded gold nanoparticles against E. coli and K. pneumoniae were obtained as 1.009 and 2.018 mg/L, respectively. These bacterial strains were completely resistant to cefotaxime alone. These results reinforce the utility of conjugating an old unresponsive antibiotic with gold nanoparticles to restore its efficacy against otherwise resistant bacterial pathogens. J. Cell. Biochem. 118: 2802–2808, 2017.

Pharmacovigilance system in Saudi Arabia

Pharmacovigilance plays an important role in ensuring that patients are receiving safe drugs. In Saudi Arabia, Saudi Food and Drug Authority, health institutions, marketing authorization holders and healthcare professional are involved in pharmacovigilance activities regardless of the level of the involvement. Although pharmacovigilance is well established in developed nations and it is considered a new concept in Saudi Arabia. It is a collective effort from various stakeholders to make pharmacovigilance successful toward promoting safe and effective use of medicines among the population. However, the practice of pharmacovigilance still needs more attention especially from marketing authorization holders and healthcare professionals. The aim of this review was to describe the current situation of pharmacovigilance in Saudi Arabia and the activities that have been conducted by the stakeholders.

Drug safety: The concept, inception and its importance in patients' health.

Background Drug safety is one of the hottest topics in daily medical practice, particularly with regard to approving new medication or questioning the possibility of withdrawing a drug from the market. Aim The aim of this review is to highlight the importance of the drug safety concept and its impact on patients’ health. Methods A literature search was conducted using Pubmed®, EMBASE®, EBSCO and Medline in the period between 1980 and 2013. The terms used in the search included “Drug Safety”, “Medication Safety”, “Patient Safety”, “Drug Interaction”, “Drug Pharmacokinetic”, and “Adverse Drug Reaction”. All retrieved abstracts were evaluated within the context of the review objectives. The full texts of the selected articles were included in this review. Studies in non-English language were excluded in this review. Results Since the early days of the past century, many acts, laws, or amendments have been created to make sure that approved drugs are first safe and then effective. Furthermore, these regulations are continuing to change to make sure that these drugs have a positive benefit–risk balance. Personalized medicine should be considered when medications are given to patients because the pharmacokinetic process inside the body varies from patient to patient and from one specific disease state to another. However, adverse drug reactions can be minimized if more precautions are taken by healthcare professionals, especially including the patient as one pillar of the therapeutic plan and providing more patient counseling, which will improve drug safety. Conclusion The drug safety concept has earned a lot of attention during the past decade due to the fact it plays a major role in patients’ health. Recent laws stress this concept should be included in the process of new medications’ approval and continued conduct of post-marketing drug evaluations. Benefit–risk assessment should be considered by all health care professionals when they need to give specific drugs to specific groups of patients. Therefore, more care should be given to some patients, such as pregnant women, children and the elderly, since they are considered vulnerable populations.

Comparison of different serum sample extraction methods and their suitability for mass spectrometry analysis

Mass spectrometry has been widely used, particularly in pharmacokinetic investigations and for therapeutic drug monitoring purposes. Like any other analytical method some difficulties exist in employing mass spectrometry, mainly when it is used to test biological samples, such as to detect drug candidates in mammalian serum, which is rich in proteins, lipids and other contents that may interfere with the investigational drug. The complexity of the serum proteome presents challenges for efficient sample preparation and adequate sensitivity for mass spectrometry analysis of drugs. Enrichment procedures prior to the drug analysis are often needed and as a result, the study of serum or plasma components usually demands either methods of purification or depletion of one or more. Selection of the best combination of sample introduction method is a crucial determinant of the sensitivity and accuracy of mass spectrometry. The aim of this study was to determine the highest serum protein precipitation activity of five commonly used sample preparation methods and test their suitability for mass spectrometry. We spiked three small molecules into rabbit serum and applied different protein precipitation methods to determine their precipitation activity and applicability as a mass spectrometry introductory tool.

Silymarin: an insight to its formulation and analytical prospects

Silymarin, a potential phytochemical compound obtained from the seeds of Silybum marianum plant has been used as a hepatoprotective agent for more than a decade. So far, eight active components of silymarin flavonolignans have been identified, among which silibinin has been proven the most active. However, it had poor oral bioavailability due to extensive phase II metabolism, low permeability across intestinal epithelial cells, low aqueous solubility, and rapid excretion in bile and urine. Therefore it becomes necessary to understand all its formulation and analytical aspects from past to present, including all of its possible future prospects. In modern research scenario, nanotization strategies of drugs has served as a potential approach to enhance solubility, bioavailability and to develop a robust formulation. Several approaches have been utilized previously to enhance the solubility and bioavailability of silymarin to provide it a robust strength against physical, chemical, and environmental degradation. Nanoscale formulations such as nanoemulsion, nanosuspension, liposomes, and solid–lipid nanoparticles can be used to enhance solubility and to target them to desired cells with minimum harm to normal cells. However, many other approaches exist such as dendrimers, ceramic nanoparticles, and carbon nanotubes, which serve as a great vehicle in drug delivery to transport medicament at target sites. Therefore, the purpose of this review was to develop a better understanding of the problems associated with silymarin and approaches to overcome the difficulties to develop a better and stable formulation for food and pharmaceutical applications.

Use of an entacapone-containing drug combination and risk of death: Analysis of the FDA AERS (FAERS) database.

To assess the signal of death associated with the use of an entacapone-containing drug combination in the FDA Adverse Event Reporting System (FAERS) database. Reports of death events submitted between January 2004 and December 2010 were retrieved and analysed by the reporting odds ratio (ROR). The ROR of case/non-case reports of death associated with an entacapone-containing drug combination was compared with the levodopa/carbidopa combination using the FDA AERS database. Eighty-seven reports linked the entacapone-containing drug combination to death, compared to 27 reports of death linking the levodopa/carbidopa combination. The ROR was statistically significant for the association between deaths with the use of an entacapone-containing drug combination (1.86 [95% CI 1.50-2.31]). In contrast, the ROR of death associated with the combination of levodopa and carbidopa was not statistically significant (0.89 [95% CI 0.61-1.30)]. Based on analysing reports in the FAERS database, there is a risk of death with the use of an entacapone-containing drug combination. These results generated a signal of death with the use of this drug. However, epidemiological studies are required to confirm this association.

Patient's medicinal knowledge in Saudi Arabia: Are we doing well?

Patient education is one of the main factors of patient therapeutic plan and without it, the patient may not benefit from his/her medications. Several studies showed the effectiveness of educating patients about their disease(s) and their medication(s) which ultimately enhance their quality of life especially in chronic diseases such as diabetes mellitus and hypertension. Concept of patient education is well known and understood in the Western countries while in the Kingdom of Saudi Arabia it is not well established despite some efforts made by few big hospitals. In Saudi Arabia, different stakeholders such as hospitals, pharmaceutical companies, healthcare professionals, health societies and association and governmental agencies do not do their job as patient education. Aim of this paper was to throw some light about the current situation in Saudi Arabia.