Usability of Medicine Package Inserts for Chronic Diseases: A Survey of the Pharmaceutical Market in Jos, Nigeria

Joseph, Benjamin; Asiegbu, U; Aya, B. M.; Nyam, Mary Azumi; Umar, David Mohammed; Jimam, Nanloh S; Dapar, M. L. P.

doi:10.9734/jpri/2017/34603

Cited by 4 publications

(12 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Terminology, language and font size were described as problematic in this latter study, which also assessed readability of 23 PILs using the Flesch Reading Ease (FRE) score, 21 of which had scores requiring college or tertiary education reading ability [ 26 ]. Readability was not assessed in a further Ghanaian study that examined the language used in PILs [ 28 ], but three studies from other countries did assess readability [ 30 , 31 , 37 ]. One covered 107 ART products available in five countries (Burkina Faso, Democratic Republic of the Congo, Rwanda, Nigeria and Zambia) [ 37 ], only 28 of which (26%) included a PIL, none of which met standard criteria for layout, all had small font and only 12 were written in easily understood language.…”

Section: Resultsmentioning

confidence: 99%

“…One covered 107 ART products available in five countries (Burkina Faso, Democratic Republic of the Congo, Rwanda, Nigeria and Zambia) [ 37 ], only 28 of which (26%) included a PIL, none of which met standard criteria for layout, all had small font and only 12 were written in easily understood language. Small font size was also problematic in two Nigerian studies, one assessing 45 leaflets for malaria medicines [ 30 ] and the other assessing 66 medicine leaflets for a range of conditions [ 31 ]. Readability scores in both studies indicated a college or tertiary education level was required.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

View full text Add to dashboard Cite

Published reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers from Africa and 99 from Asia. Most African studies (n = 20) involved patients in the development of PILs, in the assessment of the effectiveness of PILs or in surveys. In contrast, the highest proportion of Asian studies concerned the content of WMI (n = 42). WMI is desired, but needs to be in local languages, and there needs to be more use made of pre-tested pictograms. Existing WMI frequently does not meet local regulatory requirements, particularly locally manufactured products. A number of studies reported potentially positive impacts of providing WMI on knowledge and medicine use behaviours. Provision of medicine information is essential for safe use of medicines in all countries. Internationally agreed guidelines, incorporating good design principles, are needed to ensure the optimal content and design of WMI. The World Health Organization should support African and Asian regulatory bodies to share best practice in relation to WMI for patients/consumers and to develop and implement pan-continental guidelines that take into account consumer needs and preferences.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

2021

View full text Add to dashboard Cite

show abstract

“…Patients require accurate and reliable information to help them use their medications safely and effectively [ 1 , 2 ]. However, inadequate information provided by healthcare providers is common because of heavy workloads, many patients unable to retain verbal information they have been told for a long time [ 3 ], and misunderstanding of verbal information [ 4 ]. Insufficiency of pharmacological knowledge and communication skill by health professionals might also contribute [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

“…MPIs are leaflets that are packed with both over-the-counter and prescription medicines to provide specific information about their indication, administration, precautions during use, dose/dosage, potential side effects, and contraindications [ 5 , 9 ]. MPIs, which are also called patient package inserts or prescription drug labels, are provided by the medicine's manufacturer based on regulatory guidelines [ 2 , 4 ]. It is an important source of medication information to both healthcare providers and patients especially in developing countries where access to contemporary medical information is limited [ 3 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Medication Package Inserts in Ethiopia

Hailu

Gobezie

Tuem

et al. 2022

Journal of Environmental and Public Health

View full text Add to dashboard Cite

Background. Patients require accurate and reliable information to help them use their medications safely and effectively. Inadequate patient knowledge may contribute to medication nonadherence which could negatively affect treatment outcomes. The purpose of this study was to evaluate the presentation and completeness of medication package inserts (MPIs) which are available in the Ethiopian market. Methods. A cross-sectional document review was performed in February and March of 2019. All MPIs which were authorized by EFDA to sell in the Ethiopian market and available during the data collection period were considered. Results. The mean overall completeness score of 200 MPIs was 18.39 ± 4.30. Of the 200 MPIs, only 20% were from domestic pharmaceutical companies. Antimicrobials represented 24% of the total MPIs. Topical preparations, cardiovascular drugs, gastrointestinal drugs, and nonsteroidal anti-inflammatory drugs, accounted for 12.5%,12.5%, 11%, and 9% of the MPIs, respectively. The majority of the MPIs presented information about the drug’s use during pregnancy and lactation, 77.0% and 74.0%, respectively. However, only half of the MPIs, 49.5%, gave information about special warnings and precautions. Only a few of the MPIs provided information about instructions to convert tablets or capsules into liquid forms and the possibility of tablet splitting, 4.8% and 8.7%, respectively. Furthermore, only 1.0% had local language translation. Conclusion. The MPIs available in Ethiopia provide inadequate information including about the safety of drug products and local language translation. Regulatory authorities should implement stringent regulations to ensure the provision of vital information which extends beyond checking the mere presence of an MPI. They should also act to the possible standardization of MPIs.

show abstract

“…Information missed by the health professionals should be accessible in MPIs by the patients, however, several studies have shown that MPIs are froth with omission of vital information for the patients. [6][7][8] A study conducted in East Africa reported that some of the medication package inserts circulating in the East African Community Partner States market did not conform to regulatory requirement and lack some vital information for the patient. 7 Medication package inserts should contain all necessary drug information needed by patients for optimal use of their medications.…”

Section: Introductionmentioning

confidence: 99%

Readability of Medication Package Inserts Accompanying Prescription Drugs and Conformity of the Package Inserts Information with Regulatory Requirements

Showande¹,

Babalola²

2022

IJOPP

View full text Add to dashboard Cite

Background: Medication package inserts (MPIs) provides patients with appropriate information on the rational use of drugs. This study evaluated the level of conformity of MPIs with the regulatory drug labelling requirements and determined the readability of selected prescription MPIs. Methods: One hundred and fifty-six MPIs of commonly used and prescribed antilipidemics, anticonvulsants, anti-diabetes, antiarthritis and antihypertensives in Nigeria were retrieved from four pharmacies. The MPIs were evaluated on the availability of 20 items drug labelling requirements for prescription drugs by the National Agency for Food and Drug Administration and Control (NAFDAC). The readability of 31 randomly selected MPIs was assessed with seven readability measures. Primary outcomes were percentage conformity with the labelling requirements and reading grade level of the MPIs. Secondary outcomes were the MPIs sentence characteristics. Results: The percentage conformity with NAFDAC drug requirements of the MPIs ranged from 82.9% to 89.6%. All the MPIs included information on active ingredient(s), adverse drug reactions, and indications. Few MPIs, 46.8% had section on product net content and 53 (34.0%) omitted information on overdose. The reading grade level for the MPIs was 14.55 ± 1.71 (undergraduate level). Most of the MPIs, 25 (80.6%), were very difficult to read. Conclusion: The percentage conformity of the MPIs with NAFDAC drug labelling requirements was high though few vital information were missing in some MPIs. Majority of the MPIs were very difficult to read. The regulatory authority may need to optimize MPIs readability and conformity of content with drug labelling requirements prior to marketing.

show abstract

Usability of Medicine Package Inserts for Chronic Diseases: A Survey of the Pharmaceutical Market in Jos, Nigeria

Cited by 4 publications

References 0 publications

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature

Evaluation of Medication Package Inserts in Ethiopia

Readability of Medication Package Inserts Accompanying Prescription Drugs and Conformity of the Package Inserts Information with Regulatory Requirements

Contact Info

Product

Resources

About