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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  
  • Teaching approaches to delivering pharmacy law content to pre-registration pharmacy students: a global systematic scoping review
    Helen Ibrahim, Bandana Saini, Jessica Pace
    Currents in Pharmacy Teaching and Learning.2026; 18(1): 102507.     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
    Anna Lívia Lima, Kelly Cristiane Lopes, Esther Alves Marinho , Flávio Júnior Figueredo , Cecília Paiva Duarte , Viviane de Oliveira Vasconcelos, Izabella Mendes Lima , Thiago Santos Monção, Guilherme Henrique Azevedo dos Reis , Yves André Rodrigues Gomes
    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
  • 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
  • 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
  • 6,416 View
  • 153 Download
  • 13 Web of Science
  • 22 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  
  • 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
  • 7,642 View
  • 138 Download
  • 4 Web of Science
  • 5 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
  • 6,401 View
  • 49 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.
  • 1,418 View
  • 20 Download
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