Background: The pharmacovigilance system in the Philippines aims to ensure the safe use of medicines, including herbal products. However, there is a lack of reporting on adverse events related to herbal products, indicating a need for an improved monitoring system. Objectives: This study seeks to develop a community-based adverse event reporting system for herbal products in Calamba and Los Baños Laguna to enhance pharmacovigilance practices in the Philippines. The primary objectives include assessing consumer knowledge, willingness to report adverse events, and evaluating the feasibility of implementing such a system in community pharmacies. Methodology: A mixed-methods approach was employed, involving surveys with herbal product consumers and focus group discussions with community pharmacists. Data analysis utilized Likert scaling for surveys and thematic analysis for discussions, providing a comprehensive understanding of consumer perceptions and pharmacist experiences. Results: The study revealed limited consumer awareness of herbal safety risks but with a positive attitude towards reporting adverse events through community pharmacies. The developed algorithm, tailored to consumer and pharmacist preferences, demonstrated potential benefits in enhancing pharmacovigilance and promoting the rational use of herbal products. Conclusion The proposed community-based adverse event reporting system for herbal products in the Philippines offers a practical and accessible solution to improve pharmacovigilance, empower consumers, and ensure the safe utilization of herbal products. Implementation of this system has the potential to significantly enhance public health outcomes and contribute to the overall well-being of the Filipino population.
Pharmacovigilance ; Pharmacies ; Pharmacists

Humans ; Pharmacies ; Singapore ; Patient Safety ; Safety Management

Background: The incidence of hypertension and its complications continue to increase in the Philippine Army due to non-adherence resulting in poor health outcomes. Objective: This study implemented a Medication Counseling Program (MCP) for hypertensive soldiers, and assessed the effects of the program on knowledge of disease and treatment (Knowledge), attitude towards medication (Attitude), adherence to treatment (Adherence), and blood pressure (BP). It identified and categorized pharmacist interventions applied during the counseling sessions. The perceptions of patients and physicians on pharmacist's clinical roles were also determined. Methodology: The program was implemented from March to October 2015 in a government hospital for the Philippine Army. Knowledge, attitude, adherence, and BP (converted as mean arterial pressure or MAP) were measured at baseline, 30, 60, and 90th day after initial counseling. Data for pharmacist interventions were collected from patient's documentary form. The interview was conducted to patients after their 90-day counseling period and physicians after the 8-month duration of the program. Results: A total of 20 patients were enrolled in the program, but only 13 patients completed the study. Of the 62 counseling sessions conducted by the pharmacist for the 8-month period, a total of 252 pharmacist interventions were administered. Knowledge, attitude, adherence, and MAP scores improved, and 100 % of the patients achieved normal/controlled BP after the 90-day counseling period. Conclusion A pharmacist MCP intervention may improve a patient's knowledge, attitude, adherence, and BP. The program enabled the pharmacist to apply pharmacist interventions to identified drug-therapy problems of the patients and resolved these through collaboration with the physicians and cooperation of the patients.
Pharmacists ; Military Personnel ; Pharmaceutical Services ; Medication Adherence ; Pharmacies ; Hypertension ; Counseling

Oseltamivir is an antiviral medication prescribed to prevent and treat influenza A and B. A case from a community pharmacy in Korea was reported for an adverse event associated with oseltamivir administration. A 20-month-old boy had psychiatric symptoms after receiving 2 doses of oseltamivir. Therefore, an evaluation of whether the psychiatric symptoms were caused by oseltamivir was required. To determine whether the adverse event resulted from the administrated medication or other factors, three tools were used: the Naranjo scale, the Korean causality assessment algorithm (Ver.2), and the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria. The psychiatric symptoms occurred after oseltamivir administration, and were attenuated after oseltamivir termination. A possible cause of the psychiatric symptoms is high fever, but information on the body temperature of the patient was not sufficient. Therefore, it was unclear whether there were other nonpharmacological causes of adverse drug reaction. For these reasons, in terms of causality, the results evaluated by the three tools represented, “possible”, “probable”, and “probable/likely”, respectively.
Body Temperature ; Child ; Drug-Related Side Effects and Adverse Reactions ; Fever ; Global Health ; Humans ; Infant ; Influenza, Human ; Korea ; Male ; Oseltamivir ; Pharmacies

Atorvastatin is one of the most widely prescribed medications for dyslipidemia treatment. In Korea, post combined therapy with ezetimibe, a 73-year-old woman was reported by a community pharmacy to have experienced visual field defect, which recovered after drug discontinuation. She had never experienced this symptom before, and several studies have reported an association between use of statins and visual disorders such as blurred vision, diplopia, and cataract. Blockage of cholesterol accumulation, oxidative stress, or myopathy is expected to be a cause of this symptom. Naranjo scale, Korean causality assessment algorithm (Ver.2), and World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria were the three tools used to determine causality between the visual disorder and atorvastatin. The results represent ‘probable’, ‘certain’, and ‘probable/likely’ causality, respectively. Our results, in combination with a review of literature, indicate that ocular adverse effects are highly likely related to atorvastatin.
Aged ; Atorvastatin Calcium ; Cataract ; Cholesterol ; Diplopia ; Drug-Related Side Effects and Adverse Reactions ; Dyslipidemias ; Ezetimibe ; Female ; Global Health ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Korea ; Muscular Diseases ; Oxidative Stress ; Pharmacies ; Vision Disorders ; Visual Fields

OBJECTIVES: The aim of this study was to examine whether coordination between healthcare providers at an inpatient rehabilitation facility and healthcare providers in a community setting improves osteoporosis medication use in the community. METHODS: In 2012, a coordination project between an inpatient geriatric rehabilitation facility located in north-central Israel and general practitioners in the community setting was initiated. In this retrospective pseudo-experimental study, we compared osteoporosis medication use among patients who were hospitalized at the facility following an osteoporotic fracture during 2011–2012, and who constituted the control group (n=20), and patients who were hospitalized at the facility during 2013–2015, and who constituted the trial group (n=129). Data were collected from the patients' records and from records of the health maintenance organization concerning medications issued to the patients by pharmacies. RESULTS: Differences were observed between the trial and the control group in osteoporosis medication management by healthcare providers, both at the inpatient rehabilitation facility and in the community, suggesting favorable trends. However, osteoporosis medication use in the community was slightly lower in the trial group, then in the control group (32.8% vs. 34.2%, respectively). A regression analysis indicated that the only variable predicting use of osteoporosis medications in the community was a previous diagnosis of osteoporosis in the community. CONCLUSIONS: The study results indicate that mere coordination between the healthcare settings is insufficient in order to ensure continued care in the community, emphasizing the need for an osteoporosis coordinator.
Delivery of Health Care ; Diagnosis ; General Practitioners ; Health Maintenance Organizations ; Health Personnel ; Humans ; Inpatients ; Israel ; Osteoporosis ; Osteoporotic Fractures ; Pharmacies ; Rehabilitation ; Retrospective Studies

Levosulpiride is one of the most frequently prescribed medicines in Korea. An adverse drug reaction (ADR) after taking levosulpiride was reported at a community pharmacy in Korea. A 31-year-old woman reported the symptoms of lactation and amenorrhea after taking levosulpiride; an evaluation of whether these symptoms were caused by the medication was therefore necessary. Several tools can be used to determine if the ADR resulted from the administered drug or other factors, including the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria, the Naranjo scale, and the Korean causality assessment algorithm (Ver. 2). The causality was evaluated as “possible” by the WHO-UMC and Naranjo scales, but as “probable” by the Korean causality assessment algorithm (Ver. 2). In conclusion, the information provided did not indicate definite causality and there were slight differences in the results obtained from each assessment method.
Adult ; Amenorrhea ; Drug-Related Side Effects and Adverse Reactions ; Female ; Global Health ; Humans ; Hyperprolactinemia* ; Korea ; Lactation ; Methods ; Pharmacies* ; Weights and Measures

When stenting is applied to treat myocardial infarction, antiplatelet agents are administered to prevent thrombosis, which increases the risk of bleeding. Patients with myocardial infarction are also more likely to have osteoarthritis simultaneously, because both diseases occur frequently in elderly patients. Patients with osteoarthritis often use analgesics, especially nonsteroidal anti-inflammatory drugs (NSAIDs); hence, patients with both diseases use analgesics and antiplatelet agents simultaneously. The risk of bleeding increases with the use of antiplatelet agents and this is further increased when NSAIDs are added. We would like to report a case that reflects this situation. A 60-year-old man underwent stenting after ST-elevation myocardial infarction, and was treated with aspirin and clopidogrel. This patient also received a pelubiprofen prescription from another physician to treat osteoarthritis. After the patient took pelubiprofen twice, he found a bruise on his wrist and reported it to the pharmacist. It is unlikely that this is rare in community pharmacies, so pharmacists should pay careful attention to the concomitant administration of analgesics to patients receiving antiplatelet agents and should provide appropriate education to patients.
Aged ; Analgesics ; Anti-Inflammatory Agents, Non-Steroidal ; Aspirin ; Contusions ; Education ; Hemorrhage* ; Humans ; Middle Aged ; Myocardial Infarction ; Osteoarthritis ; Pharmacies ; Pharmacists ; Platelet Aggregation Inhibitors ; Prescriptions ; Stents ; Thrombosis ; Wrist

OBJECTIVE: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. METHODS: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-thecounter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. RESULTS: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, “possible” (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while “possible” (44.0%) and “unlikely” (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-thecounter and over-the-counter drugs. CONCLUSION: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.
Female ; Global Health ; Humans ; Metabolism ; Nonprescription Drugs* ; Outpatients ; Pharmacies* ; Pharmacovigilance ; Prescription Drugs ; Respiratory System

BACKGROUND: Patients with acne are at risk of using various over-the-counter drugs (OTCs). In addition, several OTCs are introduced in pharmacies in Korea. However, only few drugs are supported by well-established data. Among the treatments, acne patches are easy to purchase and use. Thus, they are widely used by patients. OBJECTIVE: This study aimed to investigate the patient's perception and usage of acne patches. METHODS: A questionnaire survey was conducted on 80 patients with acne who visited the outpatient department of the National Medical Center for 2 months. RESULTS: A total of 42 (52.5%) patients answered that they had used acne patches, and 38 (47.5%) patients stated that they had never used patches. Moreover, 27 (64.29%) patients responded that they used the patches on inflammatory lesions. Moreover, several patients were using acne patches after pricking themselves. There was only one response to confirm the ingredient when purchasing acne patch. Moreover, 14 (33.33%) participants responded that they noted side effects after using acne patches. Overall, the satisfaction score for the use of acne patches was 5.05. CONCLUSION: Patients often use acne patches because they can be easily purchased and used. However, they do not know how to properly choose and use the product that fits their skin. Therefore, doctors must educate patients on how to properly select and use the products.
Acne Vulgaris* ; Bandages ; Colloids ; Humans ; Korea ; Nonprescription Drugs ; Outpatients ; Pharmacies ; Skin