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Review Article

Pharmacovigilance and Its Importance for Primary Health Care Professionals
Asma A’tiyah Abdul Hamid, Rashidah Rahim, Shyh Poh Teo
Korean J Fam Med 2022;43(5):290-295.   Published online September 20, 2022
DOI: https://doi.org/10.4082/kjfm.21.0193
Pharmacovigilance is used to detect, assess, understand, and prevent the adverse effects of medications. The need for safety monitoring has evolved around unfortunate incidents in history, with deaths caused by anesthesia and congenital malformations from thalidomide use. Reports from adverse drug reactions (ADRs) are stored in a global database and can be used to evaluate the associations between various medications and associated ADRs. Clinicians play an important role in the recognition and reporting of ADRs to national pharmacovigilance centers (NPCs). The purpose of NPCs is to make the clinicians understand their functions, including the monitoring, investigation, and assessment of ADR reports, along with periodical benefit-risk assessments of medications via multiple sources. A case study on NPCs and the types of safety issues evaluated by them are provided to illustrate their role in medicine safety surveillance. ADR monitoring was also combined with vaccine safety surveillance approaches. Overall, this study will provide insights to clinicians on the importance of pharmacovigilance in maintaining patient safety with the proper use of medications.

Citations

Citations to this article as recorded by  
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  • A common drug, an uncommon reaction: The combination of amoxicillin-clavulanic acid induced acute allergic reaction with urticaria and angioedema—A case study
    Aruna Kale, Avinash Khairnar, Anil Pardeshi, Vaishali Agrawal, Shweta Bora
    Medical Reports.2026; 15: 100401.     CrossRef
  • Long-Term Safety and Efficacy of Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid to Improve Skin Laxity of the Inner Upper Arms: A Single-Arm Study
    Adele Sparavigna, Clara Cigni, Laura Tanzini, Roberto Lualdi, Franco Grimolizzi
    Plastic and Aesthetic Nursing.2026; 46(1): 37.     CrossRef
  • Elevating Drug Safety Oversight: A Comprehensive Examination of Dynamic and Static Monitoring Systems across the United States, European Union, and India
    Deepika N, Robin George, Ravi Kumar Reddy Juturi, Baharul Islam Haidary, Prasiddhi Naik, Prakash Goudanavar
    Journal of Pharmaceutical Innovation.2026;[Epub]     CrossRef
  • Glutathione in Skin Aging and Tissue Regeneration: A Systematic Review of Molecular Mechanisms, Redox Modulation, and Biomedical Implications
    Cristina Stanescu, Iulia Chiscop, Monica Boev, Georgiana Daniela Stanescu, Madalina Nicoleta Matei
    Molecules.2026; 31(6): 981.     CrossRef
  • Pattern of Adverse Drug Reactions Reported from General Hospital Psychiatric Unit to Adverse Drug Reaction Monitoring Centre; A Retrospective Study
    Prakash Basgi, K. N. Karthik, Bidare Gangadharaiah Hemanthkumar, Anand Harshitha, V. G. Anusha, Narayana Keertish
    Journal of Psychiatry Spectrum.2026; 5(2): 114.     CrossRef
  • Carcinogenic Medications: A Review of Specific Agents and Molecular Mechanisms of Carcinogenesis
    Desta Seyoum Tadesse, Kalkidan Tekletsadik, Berhan Begashaw, Awgichew Shewasinad Yehualashet, Awol Mekonnen Ali, Kassahun Dires Ayenew
    Cancer Reports.2026;[Epub]     CrossRef
  • Ocular adverse events associated with aflibercept and faricimab: a population-based pharmacovigilance study
    Sara Kamali Zonouzi, Michael Balas, Parnian Arjmand
    Canadian Journal of Ophthalmology.2026; 61(4): 990.     CrossRef
  • BEYOND THERAPEUTIC BENEFITS: KAJIAN FARMAKOVIGILANS EFEK SAMPING KORTIKOSTEROID DI INDONESIA
    Senya Puteri Amalia, Farida Istiqamah, Nur Ainah, Desy Ayu Lestari
    Jurnal Insan Farmasi Indonesia.2026; 9(1): 259.     CrossRef
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    Chinwe Uzoma Chukwudi, Amadea Enwonwu, Oyetunde Timothy Oyeyemi, Ibrahim Malami, Ifeoluwa Temitayo Oyeyemi, Mohammed Auwal Ibrahim, Elijah Adegoke Adebayo, Mutiu Idowu Kazeem, Olayinka Atilola
    Clinical Phytoscience.2026;[Epub]     CrossRef
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    A. Sai Sachin, J. Karthikeyan
    Frontiers in Artificial Intelligence.2026;[Epub]     CrossRef
  • Analysis of literature-derived duplicate records in the FDA Adverse Event Reporting System (FAERS) database
    Weiru Han, Robert Morris, Kun Bu, Tianrui Zhu, Hong Huang, Feng Cheng
    Canadian Journal of Physiology and Pharmacology.2025; 103(2): 56.     CrossRef
  • Leveraging Natural Language Processing and Machine Learning Methods for Adverse Drug Event Detection in Electronic Health/Medical Records: A Scoping Review
    Su Golder, Dongfang Xu, Karen O’Connor, Yunwen Wang, Mahak Batra, Graciela Gonzalez Hernandez
    Drug Safety.2025; 48(4): 321.     CrossRef
  • Patient Experience Regarding Medication-Related Information Received in a Rural Private Polyclinic Setting in Vietnam
    Quang Loc Duyen Vo, Minh Trung Nguyen, Thi Ngoc Yen Dang, Thi Hong Dung Quach, Huynh Kim Ngoc Truong, Rebecca Susan Dewey, Thi Thu Tran, Van De Tran
    Journal of Patient Experience.2025;[Epub]     CrossRef
  • Interações Fármaco-fármaco em Prescrições de Pacientes em Unidade de Terapia Intensiva Adulto em Hospital Público de Montes Claros
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    Revista de Gestão e Secretariado.2025; 16(2): e4715.     CrossRef
  • A critical comparison of pharmacovigilance reporting forms in six countries with the WHO-UMC recommendations (form of the form)
    Saurav Misra, Manmeet Kaur, Jayant Kumar Kairi
    Journal of Basic and Clinical Physiology and Pharmacology.2025; 36(4): 285.     CrossRef
  • Glucocorticoid withdrawal syndrome: Disproportionality analysis of cases using VigiBase data
    Lütfi Mangal, Burcu Eda Arda, Hande Sipahi
    DARU Journal of Pharmaceutical Sciences.2025;[Epub]     CrossRef
  • Enhancing Public Health with Pharmacovigilance: Tools, Strategies, and Impacts
    Sujitha Pandian, Yashvanthan Vinjmur Ragavan, Angeline Grace Pandian, Ajith Kumar Kumaraguru, Kiran Kartheep Subramanian
    Biomedical and Pharmacology Journal.2025; 18(2): 1147.     CrossRef
  • Artificial Intelligence in Pharmacovigilance
    Dinesh Kumar, Amandeep Kaur, Shruti, Davender Kaur
    Current Computer Science.2025;[Epub]     CrossRef
  • Excipients in pharmaceuticals: mechanisms of hypersensitivity and the role of global pharmacovigilance
    Ruba Malkawi, Lora Altahrawi
    Saudi Pharmaceutical Journal.2025;[Epub]     CrossRef
  • Exploring pharmacovigilance awareness and attitudes among healthcare practitioners in Iraq: insights from a survey-based study
    Hussein Abdulmohsin Dabis, Ali Talib Hameed
    Jurnal Ners.2025; 20(1): 3.     CrossRef
  • A PHARMACOVIGILANCE STUDY TO ASSESS THE EFFECT OF ADVERSE DRUG REACTION ON PEDIATRIC HEALTH
    ARULRAJA S, THILIP KUMAR GNANADURAI, SUBBULAKSHMI RAMASAMY
    Asian Journal of Pharmaceutical and Clinical Research.2025; : 87.     CrossRef
  • Association between DPP4 inhibitor use and risk of skin cancer in type 2 diabetes: A real-world cohort study
    Zaryab Alam, Kevin T. Nguyen, Hamza Malick, Kyle C. Lauck, Stanislav N. Tolkachjov
    Journal of the American Academy of Dermatology.2025;[Epub]     CrossRef
  • Assessment of adverse drug reactions encountered in primary care settings
    Ki Dong Ko
    Korean Journal of Family Medicine.2025; 46(6): 458.     CrossRef
  • Pharmacovigilance and herbal medicines safety: a cross-sectional study of healthcare professionals’ knowledge, attitudes and practices in selected regions of Tanzania, 2021
    Alambo K. Mssusa, Godeliver Kagashe, Sheila Maregesi, Lone Holst
    BMC Complementary Medicine and Therapies.2025;[Epub]     CrossRef
  • Pharmacovigilance and adverse drug reaction reporting in primary, secondary, and tertiary healthcare: A review of practices, challenges, and recommendations
    Aleksandar Radlović, Elvis Mahmutović, Teodora Safiye
    Arhiv za farmaciju.2025; 75(6): 465.     CrossRef
  • Safety of COVID-19 Vaccination During Pregnancy and Lactation: A VigiBase Analysis
    Dayeon Kang, Ahhyung Choi, Suneun Park, Seung-Ah Choe, Ju-Young Shin
    Journal of Korean Medical Science.2024;[Epub]     CrossRef
  • Revolutionizing drug discovery: The impact of artificial intelligence on advancements in pharmacology and the pharmaceutical industry
    Seema Yadav, Abhishek Singh, Rishika Singhal, Jagat Pal Yadav
    Intelligent Pharmacy.2024; 2(3): 367.     CrossRef
  • Drug Repurposing Using FDA Adverse Event Reporting System (FAERS) Database
    Robert Morris, Rahinatu Ali, Feng Cheng
    Current Drug Targets.2024; 25(7): 454.     CrossRef
  • Drug-Related Glomerular Phenotypes: A Global Pharmacovigilance Perspective
    Alexandre Baptista, Ana M. Macedo, Ana Marreiros, André Coelho, Mark A. Perazella
    Journal of Clinical Medicine.2024; 13(16): 4869.     CrossRef
  • Postmarketing Surveillance: Review of Open Sources of Drug Safety Data
    E. V. Shubnikova
    Safety and Risk of Pharmacotherapy.2024; 12(3): 309.     CrossRef
  • Exploring the community pharmacist’s knowledge, attitude, and practices regarding adverse drug reactions and its reporting in the United Arab Emirates: a survey-based cross-sectional study
    Javedh Shareef, Sathvik Belagodu Sridhar, Mullaicharam Bhupathyraaj, Atiqulla Shariff, Sabin Thomas
    Therapeutic Advances in Drug Safety.2024;[Epub]     CrossRef
  • Pharmacovigilance: A Comprehensive Review of Drug Safety Monitoring Practices
    Aniket Anil Pawar, Aftab Imtiyaz Patel, Suhani Balu Jadhav, Harshavardhan T. Suryawanshi, Suhani Balu Jadhav
    International Journal of Advanced Research in Science, Communication and Technology.2024; : 314.     CrossRef
  • Drug Withdrawal from the Market: Causes and Consequences
    Rehan Haider, Asghar Mehdi, Geetha Kumari Das
    Dale View's Journal of Clinical Pharmacology and Pharmacotherapeutics.2024; 1(2): 8.     CrossRef
  • Explicit potentially inappropriate medications criteria for older population in Asian countries: A systematic review
    Chee Tao Chang, Siew Li Teoh, Philip Rajan, Shaun Wen Huey Lee
    Research in Social and Administrative Pharmacy.2023; 19(8): 1146.     CrossRef
  • A Real-World Data Driven Pharmacovigilance Investigation on Drug-Induced Arrhythmia Using KAERS DB, a Korean Nationwide Adverse Drug Reporting System
    Chaerin Go, Semi Kim, Yujin Kim, Yongjun Sunwoo, Sae Hyun Eom, Jiseong Yun, Sooyoung Shin, Yeo Jin Choi
    Pharmaceuticals.2023; 16(11): 1612.     CrossRef
  • 9,635 View
  • 196 Download
  • 21 Web of Science
  • 36 Crossref
Original Articles
Determining the Prevalence of and the Factors Associated with Antihypertensive Medication Non-Adherence in the Gaza Strip
Khalid Khadoura, Elham Shakibazadeh, Mohammad Ali Mansournia, Yousef Aljeesh, Akbar Fotouhi
Korean J Fam Med 2021;42(2):150-158.   Published online March 2, 2020
DOI: https://doi.org/10.4082/kjfm.19.0081
Background
This study aimed to estimate the prevalence of and determine the factors associated with antihypertensive medication (A-HTNM) non-adherence among hypertension care seekers attending primary health clinics in the Gaza Strip.
Methods
A cross-sectional survey was conducted as the recruitment phase of a clustered randomized controlled trial including 538 participants. The participants were randomly selected from 10 primary health care centers by two-stage cluster random sampling. A structured questionnaire was used to collect data through face-to-face interview. The questionnaire was developed based on the World Health Organization determinants for medication non-adherence and the Health Belief Model. The main outcomes of this study were the prevalences of A-HTNM non-adherence and its associated factors. Adherence status was assessed using the eight-item Morisky Self-Report Medication Adherence Scale. Data were analyzed by STATA ver. 14.0 (Stata Corp., College Station, TX, USA) using a standard complex survey, accounting for unresponsiveness and the clustering sampling approach.
Results
The overall prevalence of A-HTNM non-adherence was 65.8% (95% confidence interval [CI], 59.2–71.8). Among all studied predictors, only self-efficacy of participants (odds ratio [OR], 3.8; 95% CI, 1.79–2.84) and social support (OR, 2.26; 95% CI, 2.82–5.11) remained significantly associated with A-HTNM non-adherence after adjusting for age, education level, number and frequency of A-HTNM doses per day, and comorbidities.
Conclusion
The high prevalence of non-adherence highlights the need for serious intervention to enhance the adherence rate among hypertension patients. The associated factors can be considered when developing appropriate interventions.

Citations

Citations to this article as recorded by  
  • Psychological determinants of medication adherence in patients with hypertension: a systematic review and meta‑analysis
    Ziqiang Yao, Yu Wang, Shuangjiao Shi, Min Wang, Zhuqing Zhong
    Journal of Behavioral Medicine.2026; 49(4): 557.     CrossRef
  • Understanding the role of family social support in the medication adherence to hypertension treatment in Cambodia
    Savina Chham, Veerle Buffel, Por Ir, Grace Marie Ku, Srean Chhim, Wim van Damme, Josefien Van Olmen, Edwin Wouters
    BMC Public Health.2026;[Epub]     CrossRef
  • Factors Contributing to Anti-Hypertensive Medication Adherence Among Patients With Chronic Hypertension
    Brigit Reetha, Athira Abraham, Devina E Rodrigues, Priya Pereira
    Journal of Health and Allied Sciences NU.2026; 16: 253.     CrossRef
  • Exploration of Determinants of Adherence to Antihypertensive Medication: A Multilevel Analysis of the Fifth Wave of the Indonesia Family Life Survey
    Admin Admin, Mustara, Hartono2, Eti Poncorini PamungkasarI, Nur Hafidha Hikmayani
    Malaysian Journal of Medicine and Health Sciences.2026;[Epub]     CrossRef
  • Adherence to hypertension management at a rural hospital in Limpopo: A cross-sectional study
    Murendeni F. Sikhau, Mbuyisa J. Makhubu, Gert J.O. Marincowitz, Clara Marincowitz
    South African Family Practice.2025;[Epub]     CrossRef
  • ADHERENCE TO ANTIHYPERTENSIVE MEDICATION AND ITS DETERMINANTS IN A PRIMARY CARE SETTING OF KALABURAGI DISTRICT
    GEETHANJALI P, POONAM P SHINGADE, AMRUTA SWATI I, PRASHANT KUMAR
    Asian Journal of Pharmaceutical and Clinical Research.2024; : 15.     CrossRef
  • Prevalence of hypertension and its associated factors among healthcare workers in the Gaza Strip, Palestine: a cross-sectional study
    Joma Younis, Lina Wang, Kejing Zhang, Majed Jebril, Hong Jiang, Yahui Fan, Zhaofang Li, Mei Ma, Le Ma, Zhaozhao Hui, Mao Ma, Wei Zhang
    BMJ Open.2024; 14(12): e076577.     CrossRef
  • Blood Pressure Control and Its Determinants among Patients with Non-Dialysis Chronic Kidney Disease in Myanmar
    Ei Su Mon, Aurawamon Sriyuktasuth, Warunee Phligbua
    Nurse Media Journal of Nursing.2022; 12(1): 1.     CrossRef
  • Medication Adherence and Effective Management of Hypertension
    Seung-Won Oh
    Korean Journal of Family Medicine.2021; 42(2): 89.     CrossRef
  • 9,402 View
  • 153 Download
  • 7 Web of Science
  • 9 Crossref
Background

Non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen are widely used in the treatment of tension headache. The objective of this study was to evaluate and compare the efficacy and safety of single doses of acetaminophen and NSAIDs using meta-analysis of randomized placebo-controlled trial studies.

Methods

We searched MEDLINE, EMBASE, CINAHL, Cochrane, KMbase, KoreaMed, RiCH, National Assembly Library, Riss4u, and DBPIA for studies released through 27th July 2010. Two authors independently extracted the data. To assess the risk of bias, the Cochrane Collaborations risk of bias tool was used. Review Manager 5.0 was used for statistics.

Results

We identified 6 studies. The relative benefit of the NSAIDs group compared to the acetaminophen group for participants with at least 50% pain relief was 1.18 (95% confidence interval [CI], 0.99 to 1.39; I2 = 85%). We did subgroup analysis based on allocation concealment versus non-allocation concealment, and low-dose NSAIDs versus high-dose NSAIDs. The relative benefit of the low-dose NSAIDs subgroup to the acetaminophen group was 0.98 (95% CI, 0.91 to 1.06; I2 = 0%). However, the heterogeneity of other subgroup analysis was not settled. The relative risk for using rescue medication of the NSAIDs group compared to the acetaminophen group was 0.84 (95% CI, 0.64 to 1.12; I2 = 47%). The relative risk for adverse events was 1.31(95% CI, 0.96 to 1.80; I2 = 0%).

Conclusion

In this meta-analysis, there was no difference between low-dose NSAIDs and acetaminophen in the efficacy of the treatment for tension type headache. The results suggested that high-dose NSAIDs have more effect but also have more adverse events. The balance of benefit and harm needs to be considered when using high-dose NSAIDs for tension headache.

Citations

Citations to this article as recorded by  
  • Paracetamol versus ibuprofen in treating episodic tension-type headache: a systematic review and network meta-analysis
    Ammar Alnasser, Hassan Alhumrran, Mustafa Alfehaid, Mustafa Alhamoud, Nada Albunaian, Mazen Ferwana
    Scientific Reports.2023;[Epub]     CrossRef
  • Primaries non-migraine headaches treatment: a review
    Fabio Frediani, Gennaro Bussone
    Neurological Sciences.2020; 41(S2): 385.     CrossRef
  • Paracetamol for pain in adults
    Bruno T Saragiotto, Christina Abdel Shaheed, Chris G Maher
    BMJ.2019; : l6693.     CrossRef
  • Muscles and their role in episodic tension‐type headache: implications for treatment
    L. Bendtsen, S. Ashina, A. Moore, T. J. Steiner
    European Journal of Pain.2016; 20(2): 166.     CrossRef
  • Overview review: Comparative efficacy of oral ibuprofen and paracetamol (acetaminophen) across acute and chronic pain conditions
    R.A. Moore, S. Derry, P.J. Wiffen, S. Straube, D.J. Aldington
    European Journal of Pain.2015; 19(9): 1213.     CrossRef
  • Treatment of tension-type headache: from old myths to modern concepts
    P. Barbanti, G. Egeo, C. Aurilia, L. Fofi
    Neurological Sciences.2014; 35(S1): 17.     CrossRef
  • Medical Management of Adult Headache
    Frederick G. Freitag, Fallon Schloemer
    Otolaryngologic Clinics of North America.2014; 47(2): 221.     CrossRef
  • Protective Effects of Acetaminophen on Ibuprofen-Induced Gastric Mucosal Damage in Rats with Associated Suppression of Matrix Metalloproteinase
    Eriko Fukushima, Noriyuki Monoi, Shigeo Mikoshiba, Yutaka Hirayama, Tetsushi Serizawa, Kiyo Adachi, Misao Koide, Motoyasu Ohdera, Michiaki Murakoshi, Hisanori Kato
    The Journal of Pharmacology and Experimental Therapeutics.2014; 349(1): 165.     CrossRef
  • Managing and Treating Tension-type Headache
    Frederick Freitag
    Medical Clinics of North America.2013; 97(2): 281.     CrossRef
  • A Comparison of the Efficacy and Safety of Non-Steroidal Anti-Inflammatory Drugs versus Acetaminophen in Symptom Relief for the Common Cold: A Meta-Analysis of Randomized Controlled Trial Studies
    Il-Kwon Choi, Hyun-Keun Lee, Young-Jung Ji, In-Hong Hwang, Soo Young Kim
    Korean Journal of Family Medicine.2013; 34(4): 241.     CrossRef
  • Comments on Statistical Issues in November 2012
    Yong Gyu Park
    Korean Journal of Family Medicine.2012; 33(6): 410.     CrossRef
  • 11,464 View
  • 61 Download
  • 11 Crossref
How Many Hypertensive Patients Recognize the Name of Antihypertensive Drug That They Are Taking?.
Seung Yeon Lee, Seon Ho Min, Hong Jun Cho, Hong Geou Lee
J Korean Acad Fam Med 2003;24(5):437-443.   Published online May 10, 2003
Background
: Doctor shopping is common in Korea. Therefore, if patients are not familiar with the name of the antihypertensive drug they are taking, they may end up taking a drug that previously caused them side effects and may have to start on a new antihypertensive drug. This study was to clarify the factors related to patients' recognition of the name of their antihypertensive medications.

Methods : A questionnaire survey was done in June 2002 targeting 607 outpatients who were on antihypertensive medication seeking care at Asan Medical Center, Ulsan University Hospital and a clinic in Gyungju. Out of the 607 patients, 293 patients responded to the questionnaire.

Results : Ninety six of the 293 patients (32.8%) were able to accurately name at least one of the antihypertensive drugs they were taking. Women were more familiar with names of antihypertensive drugs than men (39.4% vs 23.6%, odds ratio [O.R], 2.69; 95% confidence interval [CI], 1.39∼5.22). The recognition of a drug was greater in subjects who had a higher education level (high school or university) compared to those with a lower education level (elementary school or less) by 4.2 fold (O.R, 4.20; CI, 1.64∼10.69). The type of concomitant drug intake was lower in subjects who could name their antihypertensive drugs than for subjects who could not (O.R, 0.78; CI, 0.63∼0.98). The patients who could name their antihypertensive drugs had both a lower mean systolic (133.2±11.6 mmHg: mean±standard deviation [S.D] vs 141.3±15.5 mmHg: mean±S.D) and diastolic blood pressure, compared to the patients who could not (84.5±7.2 mmHg: mean±S.D vs 86.8±9.5 mmHg: mean±S.D) when measured twice consecutively during a recent clinic visit.

Conclusion : The recognition of a medication was associated with patient's sex, education level and the number of concomitant drug intake. The patients, who could name the antihypertensive drugs they were taking, had a lower mean systolic and diastolic blood pressure.
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