Pharmacovigilance articles list

India is a country of immense diversity. It is home to people of many different racial, languages, ethnic, religious, and national backgrounds. Groups of people in India differ from each other not only in physical or demographic characteristics but also in distinctive patterns of behavior and these patterns are determined by social and cultural factors like language, region, religion, and caste. Apart from behaviour, economic development, level of education and political culture of the people in various social segments differ from region to region. More you can say that economy and cultures have been enriched by the contributions of migrants from round the globe. In an increasingly globalised world, migratory movements is continuously shaping the countries all over the world. Some countries like India and Ireland, which set the example of economic development and social integration, have the positive impact of the migration by globalisation and some countries like USA, which recently witness racism, xenophobia and discrimination have the negative impact on the migrants. It does not mean India do not face fragmentation and USA do not have cohesion. USA have many stories which show successful integration process, that facilitated the lives of immigrant communities, but being a developed country it still suffers from cultural alienation. In these countries, borders are built within borders to create cultural divides that do not allow people to integrate. Recently, this problem has become more prominent due to the rise of terrorism, clash of cultures in the world, leading to the glorification of stereotypes. People are becoming less accepting towards anyone who does not belong to their region. Migration does not stop after people move from one place to another place. The main question start after that ‘now what’ they will do. That is why this topic needs to be discussed thoroughly in order to find better solutions. This paper will begin with an analysis of different approaches to Migration, discuss the target groups for integration policies, provide indicators of the current situation of migrants and proceed to an analysis of integration tools: legislation, social policies and participatory processes. It will focus not only on the impact of migration but also on social integration, mix culture like indo-western culture in a comparative basis.

Ekta Meena

India is a country of immense diversity. It is home to people of many different racial, languages, ethnic, religious, and national backgrounds. Groups of people in India differ from each other not only in physical or demographic characteristics but also in distinctive patterns of behavior and these patterns are determined by social and cultural factors like language, region, religion, and caste. Apart from behaviour, economic development, level of education and political culture of the people in various social segments differ from region to region. More you can say that economy and cultures have been enriched by the contributions of migrants from round the globe. In an increasingly globalised world, migratory movements is continuously shaping the countries all over the world. Some countries like India and Ireland, which set the example of economic development and social integration, have the positive impact of the migration by globalisation and some countries like USA, which recently witness racism, xenophobia and discrimination have the negative impact on the migrants. It does not mean India do not face fragmentation and USA do not have cohesion. USA have many stories which show successful integration process, that facilitated the lives of immigrant communities, but being a developed country it still suffers from cultural alienation. In these countries, borders are built within borders to create cultural divides that do not allow people to integrate. Recently, this problem has become more prominent due to the rise of terrorism, clash of cultures in the world, leading to the glorification of stereotypes. People are becoming less accepting towards anyone who does not belong to their region. Migration does not stop after people move from one place to another place. The main question start after that ‘now what’ they will do. That is why this topic needs to be discussed thoroughly in order to find better solutions. This paper will begin with an analysis of different approaches to Migration, discuss the target groups for integration policies, provide indicators of the current situation of migrants and proceed to an analysis of integration tools: legislation, social policies and participatory processes. It will focus not only on the impact of migration but also on social integration, mix culture like indo-western culture in a comparative basis.

Ekta Meena

In this paper, investigations are made to analyze the human body temperature during wound healing process due to surgery. Wound is considered after the skin graft. Skin graft is a technique used in plastic surgery. Skin is the first line of defense between the human and environment, it is very susceptible to damage. Internal body or core temperature (Tb) is one of the clinical vital signs along with pulse and respiratory rates. Any disturbance in body temperature will drive complexities in wound healing process. These studies are important in the mechanism of establishing the limits of thermal regulation of human body during the healing process in different situations and conditions. The Finite element method is used to analyze tissues temperature for normal tissues (donor site) and abnormal tissues (tissues after surgery). Appropriate boundary conditions have been framed. Numerical results are obtained using Crank Nicolson Method.

Manisha Jain

Physically unclonable function (PUF) is a hardware security module preferred for hardware feature based random number and secret key generation. Security of a cryptographic system relies on the quality of the challenge-response pair, it is necessary that the key generation mechanism must unpredictable and its response should constant under different operating condition. Metastable state in CMOS latch is undesirable since it response becomes unpredictable, this feature used in this work to generate a unique response. A feedback mechanism is developed which forces the latch into the metastable region; after metastable state, latch settle to high or state depends on circuit internal condition and noise which cannot be predicted. Obtained inter hamming variation for 8 PUF is 51% and average intra hamming distance is 99.76% with supply voltage variation and 96.22% with temperature variation.

Abhishek Kumar

One of the unique features of Indian society is prevalence of caste system which was originated thousands of years back to demarcate the people engaged in different occupation or jobs. Initially it was not much rigid but gradually people belonging to upper castes for their own selfish means to maintain their monopoly made this arrangement hereditary and started treating people of lower castes disgracefully. For preservation of this system, people started controlling their women to prevent inter-caste marriages and the concept of endogamy came up. This robbed away many types of freedom from women. For women belonging to lower castes, this situation is worse as they are doubly subjugated on the basis on caste as well as gender. Men belonging to their own caste treat them as secondary beings. This paper throws light on this intersection. How intersection of these two kinds of inequalities place them at the lowest position in Indian society. Dr. B.R. Ambedkar rises as their leader who all his life worked for empowerment of downtrodden section of society. He argues that education is the primary tool for evading these differences among people. He further emphasizes to adopt the concept of exogamy to break the backbone of Indian caste system and to immediately leave a religion or culture which legitimizes such system of inequality among people of the same land.

Swati sharma

One of the unique features of Indian society is prevalence of caste system which was originated thousands of years back to demarcate the people engaged in different occupation or jobs. Initially it was not much rigid but gradually people belonging to upper castes for their own selfish means to maintain their monopoly made this arrangement hereditary and started treating people of lower castes disgracefully. For preservation of this system, people started controlling their women to prevent inter-caste marriages and the concept of endogamy came up. This robbed away many types of freedom from women. For women belonging to lower castes, this situation is worse as they are doubly subjugated on the basis on caste as well as gender. Men belonging to their own caste treat them as secondary beings. This paper throws light on this intersection. How intersection of these two kinds of inequalities place them at the lowest position in Indian society. Dr. B.R. Ambedkar rises as their leader who all his life worked for empowerment of downtrodden section of society. He argues that education is the primary tool for evading these differences among people. He further emphasizes to adopt the concept of exogamy to break the backbone of Indian caste system and to immediately leave a religion or culture which legitimizes such system of inequality among people of the same land.

Swati sharma

Rasa aushadhis are known for their uniqueness in curing the diseases with a very low dosage. These formulations are divided into two types based on their mode of preparation i.e., Single drug and Compound drug formulations. Based on their origin, the drugs are divided into three types, Herbal, Mineral and Animal. Any of these two or three together is combined to make a compound formulation. Apart from these, the other major factor which is needed for a formulation is the Rasa Panchaka of a Drug. Many of the formulations are being prepared based on their availability, keeping their Rasa Panchaka and Samprapti vighatana in mind. These formulations are designed in such a way that two or more drugs will be having one common quality, or Opposite Qualities or an Antidote of a particular Vishadravya, which can help in curing the disease. So an attempt is made to Review Tribhuvanakeerti Rasa with its Probable mode of action.

Suri abhiram

The aim of this study was to evaluate the knowledge, attitude, and practice of pharmacovigilance by healthcare professionals in Benghazi. A structured questionnaire adapted from a previous validated study. One hundred questionnaires were distributed in August 2019 and filled by healthcare providers working at different hospitals in Benghazi, Libya. Participants were 57% physicians and 43% pharmacists (age average 31-40 years). 47% had correctly defined Pharmacovigilance while 19% know what is meant by adverse drug reactions. Moreover, 61% of the participants did not share information about raising adverse drug reactions in some patients with other healthcare professionals. 35% of them did not know about the adverse drug reactions reporting system in Libya. Whereas, 42% have strongly agreed that reporting adverse drug reactions is essential. 41% and 45% of participants believed that reporting adverse drug reactions is not time-consuming and increases patient safety, respectively. In conclusion, educational programs and training courses about the importance of Pharmacovigilance for physicians and pharmacists in Benghazi are needed.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

AIM: The present cross-sectional questionnaire survey was conducted to assess the knowledge, and perception related to pharmacovigilance and ADR reporting among the B.pharm Final year students. MATERIALS AND METHODS: To assess the demographic details of the pharmacy students, their knowledge and perception toward pharmacovigilance and ADR reporting; a validated pretested questionnaire was used which comprises 11 knowledge-based closed-ended questions and 14 perceptions based agree/disagree questions. RESULT: The questionnaire was distributed to the 150 respondents of B. Pharm final year students who were willing to participate in the study. A response rate of 75% was recorded. The number of female respondents 53.3% was comparatively higher than the male respondents 46.6%. Most of the respondents were between 20 -22 years of age and only 4.7% were of 25 years of age. The average positive response for the knowledge-related statements was found to be 86.5% and the average positive response for the perception-related statements was found to be 70.67%. CONCLUSION: The findings showed adequate knowledge among pharmacy students and positive perception towards pharmacovigilance and ADRs reporting. This survey strongly suggests that there is a great need for increasing knowledge in clinical pharmacy courses and practical exposure to cases in the hospitals through internship programs which are meant to provide a unique opportunity for the pharmacy students that they must learn and practice the skills required for quality ADR reporting

Zeenath Banu

Aminopyrine (AM) has been used as a model substrate for investigation of drug metabolism. The major metabolic route is N-demethylation that was confirmed in liver microsomes. The aim of the present study was to identify the human cytochrome P-450 enzyme (CYP) mediating the N-demethylation of 4-di-methylaminoantipyrine (4-DMAA) to 4-methylaminoantipyrine (4-MAA). The contribution of human CYP to the metabolism of (4-DMAA) to (4-MAA) in human was investigated using virus expressed human CYP, human liver microsomes with chemical inhibition studies. The substrate of 4-dimethylaminantipyrine was employed at different concentrations (11.5, 23, 46, 115 and 230 µmol per l) with varying concentrations of selective inhibitors of CYP (CYP1A2), (CYP3A4), (CYP2C8),(CYP2A6), (CYP2D6), (CYP2C19) and (CYP1A1). 4-DMAA and 4-MAA were analysed by HPLC and enzyme kinetic parameters (Km and Vmax) were calculated from the concentration data. The transformation of 4-dimethylaminoantipyrine to 4-methyaminoantipyrine by microsomes prepared from baculovirus-expressed human CYP was pronounced with CYP2D6. The metabolism of 4-dimethylaminoantipyrine was inhibited by 60.0% and 55.17% by a concentration of 100 µmo per l of the known CYP2D6 inhibitors quinidine and moclobemide. The corresponding Ki values were 0.050 and 0.11 mM, respectively. The corresponding IC50 values were 0.06 and 0.13 mM, respectively. The enzyme CYP2D6 apparently has an important role in N-demethyl-ation of 4-dimethylaminoantipyrine.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Metamizole or Novalgin® is a widely used well tolerated analgesic drug which is however compromised by agranulocytosis as adverse effect. Subsequent to nonenzymatic hydrolysis, the primary metabolic step is N-demethylation of 4-methylaminoantipyrine (4-MAA) to 4-aminoantipyrine (4-AA). The aim of the present study was to identify the human cytochrome P-450 enzyme (CYP) mediating this reaction. This study identified the relevant CYP using virus expressed isolated human CYP, human liver microsomes and rat liver microsomes with chemical inhibition studies. The substrate of 4-methylaminantipyrine was employed at six different concentrations (25, 50, 100, 400, 800 and 1200 µmol per l) with varying concentrations of selective inhibitors of CYP1A2 (furafylline, fluvoxamine), CYP3A4 (ketoconazole), CYP2A6 (coumarin), CYP2D6 (quinidine), CYP2C19 (omeprazole, fluvoxamine, tranylcypromine), CYP2C9 (sulphaphenazole) and CYP1A1 (alpha-naphthoflavone). 4-MAA and 4-AA were analyzed by HPLC and enzyme kinetic parameters (Km and Vmax) were determined by regression (Sigma plot 9.0). The N-demethylation of 4-MAA by microsomes prepared from baculovirus expressing human CYP was pronounced with CYP2C19. Intrinsic clearance of the most active enzymes were 0.092, 0.027 and 0.026 for the CYP enzymes 2C19, 2D6 and 1A2, respectively. Metabolism by human liver microsomes was strongly inhibited by fluvoxamin, omeprazole and tranylcypromine (IC50 of 0.07, 0.07 and 0.18, respectively) but with coumarin, sulphaphenazole, ketoconazole, moclobemid, quinidine alpha-naphthoflavone and furafylline were 0.79, 1.20, 1.36, 1.44, 3.46, 4.68 and 8.41, respectively. The enzyme CYP2C19 apparently has an important role in N-demethylation of 4-methylaminoantipyrine which should be further analyzed in clinical studies and which may also be interesting concerning the agranulocytosis.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Although, antibiotics play a fundamental role in control of infectious diseases still the injudicious prescription of antibacterial agents and antibiotic resistance are a global problem. This study aims to assess prescribing pattern of antibiotics and to provide a baseline data about behaviors of physicians prescribing antibiotics during pediatric consultations. In this study, a total of 316 pediatric patients of both genders were receiving different antimicrobial therapy were evaluated during 2021 in pediatric health care services in Bayda, Libya. Data revealed that the average of drugs prescribed was 4.10 per patient while the average of antimicrobials was 2.30 per prescription. Most of the antibiotics were prescribed for the respiratory tract infections (34.0%) and followed by the urinary tract infections (29.0%). Cephalosporins and penicillins were the most common antibiotics prescribed in this study. In conclusion, these findings show the presence of polypharmacy and inappropriate prescribing pattern. To improve and minimize the unnecessary prescribing of antimicrobial agents, a continuous training program for physicians, as well as engaged pharmacists in health care services are needed.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Community pharmacist plays an essential role in educating the epileptic patients about their disease and medications. Improving the patient’s awareness may lead to improve their compliance and decrease drug-drug interaction and ultimately improve their quality of life. Pharmacist can detect the emergence of health problems and can help prevent progression of comorbidities. Considering the complexity of treating epilepsy and the lack of information about pharmacists’ contributions to epilepsy management, pharmacist performed pharmaceutical counselling, pharmaco-therapeutic follow-up and systematic measurement and evaluation of findings and increase medication adherence of patient with epilepsy. This study was aimed to assess the community pharmacist's knowledge about epilepsy and their treatment by antiepileptic drugs in Libya. The design of the study is a cross sectional study. The knowledge was collected through a questionnaire which included 35 questions divided into three sections: demographic data, general information about epilepsy and information about epilepsy and antiepileptic drugs. The questionnaire was prepared and validated by consultant training in Ali Omer Asker Hospital in Tripoli for two months. The findings indicate that over 200 patients are altered viewed, of whom, only epileptic patients were observed. The majority of the participants were female, qualification degree BSc and years of experience from one to five years. Unfortunately, some of the participants (40.0%) had poor knowledge and about 60.0% of them had good knowledge. This study indicates that the importance of community pharmacist in Libya requires more improvement to achieve the existing function and that the impact of continuous study of everything related to diseases and medicines is important to obtain a qualified pharmacist who can become an effective agent for a change.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

The diversity of reactogenicity and its variation in terms of risk and prevalence among populations had raised the need to study and evaluate the reactogenicity of different COVID-19 vaccines in our region. Thus, this study aimed to estimate the prevalence of reactogenicity of COVID-19 vaccines and compare the three vaccines (AstraZeneca-Oxford, Sinovac and sputnik V). An analytical cross-sectional study was conducted using a semi-structured telephonic interview with a sample size of 430 individuals who received one of the included COVID-19 vaccines (AstraZeneca, Sinovac or sputnik V) and were recorded at one of the vaccination centers' records that were affiliated with Aljamail Department of the National Centre for Disease Control, Libya. 410 Libyan participants met the inclusion criteria and were enrolled in the final analysis. The study has shown that 57.3% (CI 52.7-62) of the participants had at least one reactogenic event. Pyrexia (40.7%), headache (27.3%) and fatigue (19.5%) were the most common reactogenic events. In conclusion: the study found that reactogenic events were mild to moderate and the COVID-19 vaccines were safe and encouraged our community to be vaccinated. However, prospective studies with larger sample sizes, longer follow-up and inclusion of important laboratory parameters such as IgG and IgM immunoglobulins are recommended to better understand the relationship between the reactogenicities of COVID-19 vaccines with immunity system development and the factors associated with it.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

On January 2021, cases affected by coronavirus epidemic are constantly increasing, Libyan Ministry of Health provides the vaccine to the people those who are most at risk. The purpose of this study was to assess and verify the adverse effects of the first dose of the AstraZeneca COVID-19 vaccine. The study conducted at the Aljmail city, west region of Libya. The study was cross-sectional study during the period of August 31st and November 5th, 2021. The method involved 133 adult Libyan participants of both gender ageing more than 18 years old. The preliminary data were 54.0% who developed post-vaccination symptoms. The participant's aged 60 years and more with chronic diseases were more likely to have adverse effects after receiving the first dose of vaccine. In conclusion, AstraZeneca vaccine was good and effective but this study indicates a need for a large and long period study to confirm the safety of the vaccine use in the adult people.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Worldwide, the threat created by antibiotic resistance to public health calls for immediate action. Antibiotic resistance is one of the main causes of the emergence and spread of dispensing of antibiotics without a prescription. This study aims to investigate the dispensing of antibiotics without a prescription and the reason behind that in the community pharmacy in Libya. The study was randomized analytical conducted between March and April 2023 among pharmacists and assistant pharmacists employed by community pharmacies in various Libyan areas Tripoli, Zawia, and Sabratha. The data were analyzed by Fisher's exact and Chi-square tests to predict the determinations of dispensing antibiotics without prescriptions. In this study, a total of 293 participants were included, 63 had been excluded because they did not meet the inclusion of the study. The remaining 230 were enrolled for final analysis, most of them were female subjects (70.7%). Findings showed that 78.7% of the participants consulted with patients about the reason for requesting a specific type of antibiotic, while 68.7% dispensed antibiotics with probiotics. Study participants with 2 - 4 years' work experience were 76.6% higher toward dispensing of antibiotics without a prescription (P=0.683). The major reason for dispensing antibiotics without prescriptions were pharmacists knowledgeable enough to give a patient antibiotics without a prescription (68.3%). In Libya, misuse of antibiotics by the public is widespread. People can purchase antibiotics without prescription. Thus, dispensing of antibiotics without a prescription in community pharmacies is an alarming issue in Libya which can increase antibiotics resistance. Pharmacists' knowledgeable is high in dispensing patients antibiotics without a prescription, but patient pressure and financial issues are the major reasons behind dispensing antibiotics without a prescription. It can be recommended that the importance of antimicrobial stewardship and the need for ongoing education support for community pharmacy professionals is of importance.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Acenocoumarol is the only oral antivitamin K anticoagulant prescribed and marketed in Algeria for the prevention and treatment of thromboembolic diseases. Nevertheless, the difficulty of handling this drug linked to a narrow therapeutic index and to great inter- and intra- individual variabilities of the response to the treatment poses a major public health issue because of its iatrogenic risk. To improve the management of patients on acenocoumarol and optimize its dosage adjustment and reduce iatrogenic secondary to vitamin K antagonists, our main objective work is to assess the knowledge, attitude and practice of health care professionals regarding this anticoagulant agent. We conducted a multicenter descriptive cross-sectional study from April to May 2021. We interrogated 152 health professionals of all ages, all sexes and all grades from different health departments in Oran City (Algeria) prescribing anticoagulants, through a validated questionnaire made up of 26 questions. Statistical analysis was achieved by SPSS version 20 software. Thus, 59.9% were women with a sex ratio of 0.67, 92.8% knew that acenocoumarol belongs to the antivitamin K class, 45.0% chose INR and PT as follow-up parameters, 36.0% chose INR alone and 78.9% were unaware of acenocoumarol dose adjustment algorithms as well as 82.0% were unaware of the existence of pharmacogenetics testing. 54.0% use the recommendations of the HAS for dosage adjustment of patients on acenocoumarol. 07.9% suggested using pharmacogenetic tests to improve the dosage adjustment of acenocoumarol, 06.6% suggested patient follow-up and 05.9% suggested therapeutic patient education as well as 74.3%, wanted to do training on. Therefore, this study highlighted gaps in the medical practice of physicians in terms of dosage adjustment, pharmacogenetics and its impact on dosage optimization. However, the evaluation of their knowledge was considered unsatisfactory. To overcome this lack of knowledge, it seems necessary to make physicians aware of the contribution of pharmacogenetics of acenocoumarol in Algeria.

Mediterranean Journal of Pharmacy and Pharmaceutical Sciences

Standardization of crude drugs is a code of conduct and an essential need of the time. Substitution and adulteration now become a widespread practice, which makes the global crude drug market unsafe for crude drugs depending on the world population. Moreover, crude drug evaluation is not easy because numerous influential factors affect the bio-efficacy and reproducibility of therapeutic effects. The broad spectrum of standardization ensures the correct substance in the proper amount for desired therapeutic effects. It also provides all possible careful measures taken from collection and manufacturing to drug dispensing for clinical application. The authors have tried to cover precise tools for crude drug standardization in the present review.

Dr. Salman Ahmed