Importance of labelling and patient knowledge to ensure proper care during drug dispensing: A case study from a tertiary hospital in Ethiopia

Mekonen, Seblework; Samuel, Wondimu; Ambelu, Argaw

doi:10.4236/ojpm.2014.41001

Cited by 5 publications

(3 citation statements)

References 8 publications

(9 reference statements)

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“…A data collection tool for the patient interview was developed from previously conducted studies. 6,16,[21][22][23] Questionnaires were translated to local language Afan Oromo and Amharic in collaboration with Afan Oromo and Amharic Departments of Ambo University, respectively. The newly translated and refined items were administered to small samples (10 participants) as with a typical set of participants.…”

Section: Data Collection Tools and Methodsmentioning

confidence: 99%

Exit-Knowledge About Dispensed Medications and Associated Factors Among Patients Attending the Outpatient Pharmacy of Ambo General Hospital, Western Ethiopia

Eticha

Gemechu

2021

PPA

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Section: Data Collection Tools and Methodsmentioning

confidence: 99%

Exit-Knowledge About Dispensed Medications and Associated Factors Among Patients Attending the Outpatient Pharmacy of Ambo General Hospital, Western Ethiopia

Eticha

Gemechu

2021

PPA

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“…However, the resulting percentage was not optimal. It is important to include the patient's name on the label so that the drug is not accidentally exchanged with family members in the same house and with other patients at the pharmacy if there are many patients on the same day (Mekonen et al, 2014).…”

Section: Profile Of Eye Drops Labelling Of Pharmacies' Prescription S...mentioning

confidence: 99%

Profile of eye drops labelling of pharmacies’ prescription service in Surabaya

Aryanto,

Syahrul Wahyudi,

Arie Sulistyarini

et al. 2023

Pharm Educ

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Background: Drug labelling in prescription services is a critical stage because it contains information about the use of medicines. Objective: This study aimed to discover the drug information listed on the label of the eye drops prescription service at pharmacies in Surabaya. Method: An observational study with a cross-sectional design was used to conduct this research. Data collection was performed with the simulated patient method. The information on the label was examined using a checklist based on the “FIP Guidelines for The Labels of Prescribed Medicines” and the Minister of Health Regulation No. 73 of 2016. Result: Of 138 pharmacies visited in this study, 105 (76%) pharmacies dispensed the drug, and 83 (79%) pharmacies placed a label on the drug. The information that appeared the most was the pharmacy name (100.0%), pharmacy address (95.2%), patient name (90.4%), individual dosage instructions (100.0%), and dispensing date (88.0%). Then, the indicators that appear the least include the product name (9.6%), dosage form (2.4%), amount of drug (4.8%), expiration date (1.2%), and storage instructions (2.4%). Conclusion: Eye drops need to be maintained for their safety and efficacy. Hence, the period after opening needs to be included in the label.

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“…Correct drug labeling is essential for ensuring proper drug dispensing and thus for patient safety. Labeling errors may result in adverse health outcomes …”

Section: Introductionmentioning

confidence: 99%

Discussion on statistical analysis of carcinogenicity studies with an early terminated treated group

Saul

Ashcroft‐Hawley

2019

Pharmaceutical Statistics

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High rates of mortality on long term carcinogenicity studies can often result in challenges when it comes to the statistical analysis of tumor incidence. The current regulatory advice often results in treated groups being terminated earlier than the control group. However, this advice rarely considers the impact of this action on the statistical analyses. The nature of these analyses means that groups terminated at different times may not be directly comparable due to age differences of the animals. Here we discuss the issues related to this and investigate several approaches of how to incorporate these groups within the statistical analyses. Although no single method appears to resolve these issues consistently, inclusion of the early terminated group is still informative.Depending on the timing of the early termination, either pooling of the groups into a single terminal kill (TK) interval or reassignment of intervals based purely on time of death (ie, no separate TK interval) appear preferable. However, to draw meaningful conclusions the time of onset of a given tumor must also be considered alongside incident rates and any statistical findings.The objectives of a carcinogenicity study are to identify a tumorigenic potential in animals and to assess the relevant risk in humans. In accordance with ICH guideline S1A 1 carcinogenicity studies should be performed for any pharmaceutical with an expected clinical use of at least 6 months. Since carcinogenicity studies are time consuming and resource intensive, we need to ensure that they are designed appropriately and that maximum information can be inferred from them. Current regulatory guidance 2 indicates that a typical study should include at least 50 animals per dose per sex, with three doses of test article (low, mid, and high) dosed daily over the expected lifetime of the species (generally 24 months). For statistical analysis, animals are stratified into predefined intervals based on time of death. Common intervals used are 0-52 weeks, 53-78 weeks, 79-92 weeks, 93-104 weeks, interim sacrifice (if any), and terminal sacrifice. Dose selection is particularly important, and the general goal should be to maximize rodent exposure by testing at maximum tolerated doses (MTD). 2 Design, analysis, and interpretation of carcinogenicity studies are all important topics as the findings in these studies that are not considered to be species related, will appear on the drug label. Correct drug labeling is essential for ensuring proper drug dispensing and thus for patient safety. Labeling errors may result in adverse health outcomes. 3

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Importance of labelling and patient knowledge to ensure proper care during drug dispensing: A case study from a tertiary hospital in Ethiopia

Cited by 5 publications

References 8 publications

Exit-Knowledge About Dispensed Medications and Associated Factors Among Patients Attending the Outpatient Pharmacy of Ambo General Hospital, Western Ethiopia

Exit-Knowledge About Dispensed Medications and Associated Factors Among Patients Attending the Outpatient Pharmacy of Ambo General Hospital, Western Ethiopia

Profile of eye drops labelling of pharmacies’ prescription service in Surabaya

Discussion on statistical analysis of carcinogenicity studies with an early terminated treated group

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