The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets

Sukkari, Sana R.; Humaidan, Abdullah S. Al; Sasich, Larry D.

doi:10.1016/j.jsps.2012.01.006

Cited by 12 publications

(11 citation statements)

References 5 publications

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“…Our results are concordant with other studies that have found a large degree of inconsistency in risk communication between healthcare professional and consumer audiences, both within and across countries . While other researchers considered the quantity or presence/absence of information overall and usefulness of information, this study is the first to our knowledge to focus on how professional and consumer labeling conveys risk information when the state of knowledge is incomplete, contradictory or inconclusive.…”

Section: Discussionsupporting

confidence: 91%

ADHD medications and cardiovascular adverse events in children and adolescents: cross‐national comparison of risk communication in drug labeling

Sieluk

Palasik

dosReis

et al. 2017

Pharmacoepidemiology and Drug

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Section: Discussionsupporting

confidence: 91%

ADHD medications and cardiovascular adverse events in children and adolescents: cross‐national comparison of risk communication in drug labeling

Sieluk

Palasik

dosReis

et al. 2017

Pharmacoepidemiology and Drug

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“…; Sukkari et al. ). Few articles have compared safety information listed in the PIs across countries and regulatory systems.…”

Section: Introductionmentioning

confidence: 97%

“…Drug information from different resources that is available to healthcare professionals has previously been studied (Dunne et al 1973;Silverman 1976;Alloza and Lasagna 1983;Bawazir et al 1991;Reggi et al 2003;Malinowski et al 2008;Sawalha et al 2008;Sasich et al 2009;Sukkari et al 2012). Few articles have compared safety information listed in the PIs across countries and regulatory systems.…”

Section: Introductionmentioning

confidence: 99%

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Eriksson

Aagaard

Jensen

et al. 2014

Pharmacology Res & Perspec

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Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type “gastrointestinal disorders” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

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“…Analysis of the findings of the current study showed that nearly 50% of cases met the standards; in previous studies, the overall compliance was less. For instance, Sukkari et al 24 investigated Arabic PIs with keystone criteria of the United States and found that only 30% of the PIs produced complied with the standard in question. A study published in Nepal on PIs advertising medicines revealed that the pharmaceutical and advertising PIs did not comply with the standards of the WHO; in most cases, the health profile of the medicine, such as side effects or adverse effects of medicine, precautions and drug interactions, were ignored.…”

Section: Discussionmentioning

confidence: 99%

Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients?

Eteraf-Oskouei

Abdollahpour

Najafi

et al. 2019

Health Promot Perspect

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Background: Drug package inserts (PIs) are the most accessible source of information for users and are designed to aid the safe use of medicines and avert adverse events. This study measured the conformity of PIs with the health communications standards of Iran’s Food and Drug Administration (FDA). Methods: This descriptive cross-sectional study evaluated 92 PIs related to 22 best-selling neurological and psychiatric drugs in Iran based on criteria approved by Iran’s FDA. Six categories of criteria were considered in evaluating the extent of conformity: I) writing and formatting, II) references, III) drug description, IV) warnings and precautions, V) interactions, and VI) side effects. Each PI was scored based on observation of standards; data was analyzed using Microsoft Excel pivot tables. Results: In total, 2929 items from 92 PIs were evaluated, of which 37 (40.2%) were related to antidepressants, 31 (33.7%) to sedatives and hypnotics, and 24 (26%) to anticonvulsant drugs. The PI content was insufficient in various aspects of conformity with standards in each category. Among the six categories, the best match was found in warnings and precautions with 667 items (72.5%), followed by writing and formatting with 663 (69.1%). The lowest conformity was found in the reference category with 194 (26.4%) items. Conclusion: The PIs of Iranian neurological drugs do not fully meet Iran’s FDA standards. It is strongly recommended that smart PIs be developed using mobile apps to overcome this problem.

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The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets

Cited by 12 publications

References 5 publications

ADHD medications and cardiovascular adverse events in children and adolescents: cross‐national comparison of risk communication in drug labeling

ADHD medications and cardiovascular adverse events in children and adolescents: cross‐national comparison of risk communication in drug labeling

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Do drug package inserts meet the rules and regulations of Iran’s Food and Drug Administration in terms of informing patients?

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