Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR): A Look at Its Quantitative Contribution to Spontaneous Reporting in Nigeria from August 2012 to February 2017

Ogar, Comfort Kunak; Ibrahim, Ammar; Osakwe, Adeline; Jajere, Fatima; Kigbu-Adekunle, Ashega Ademulegun; Alonge, Kemi; Oni, Yetunde

doi:10.1007/s40290-018-0228-8

Cited by 10 publications

(8 citation statements)

References 34 publications

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“…Alternative means of spontaneous ADR reporting in Nigeria is through the Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR). 21 This system allows a consumer who uses a medicine and experiences an untoward or unexpected effect to send a prepaid short text message (SMS) containing the name of the medicine and the reaction to a short code (20543) on any of the four major mobile networks in Nigeria.…”

Section: Methodsmentioning

confidence: 99%

“…In the NPC database, the causalities were categorized as certain, probable, possible, unlikely, conditional/unclassified, or inaccessible/unclassifiable. 21 Severity rating was based on the intensity of the specific ADR, and is generally categorized as mild, moderate, severe, life threatening or disabling, and fatal or death (Grades 1–5) according to the Common Terminology Criteria for Adverse Events (CTCAE) scale. 59…”

Section: Methodsmentioning

confidence: 99%

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Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017

Oshikoya

Ogunyinka

Ogar

et al. 2020

Therapeutic Advances in Drug Safety

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Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions (SCARs). There is scant literature on the characteristics and causes of these conditions among the Nigerian population. Here, we describe the epidemiology, associated morbidity and mortality, and culpable drugs in SJS and TEN cases using the National Pharmacovigilance (NPC) database in Nigeria. Methods: A retrospective review of the NPC database was done to analyze SJS and TEN cases reported over a period of 14 years. Annual reports, age and sex of patients, type of reporter, suspects and concomitant drugs, time to onset (TTO) of the reactions, and outcome of SJS and TEN were evaluated. Results: The NPC received a total of 24,015 adverse drug reaction (ADR) reports. SJS and TEN accounted for 284 (0.1%) of the total reports, of which 254 (89.4%) were SJS and the remainder were TEN. Females ( n = 184, 64.8%) and individuals aged 19–40 years ( n = 181, 63.7%) were the most affected by SJS and TEN. Antiretrovirals, followed by antibiotics, were the most common drug classes reported to cause SJS and TEN, with nevirapine ( n = 174, 40.7%) and co-trimoxazole ( n = 143, 33.5%) being the most widely implicated drugs. Among patients with reported outcomes, 73 (28.7%) SJS and 3 (10.0%) TEN cases recovered without sequelae, at the time of reporting. Severity of the SCAR was reported for only 171 (69.0%) cases, of which 12 (4.7%) and 8 (26.7%) resulted in death (Grade 5) among SJS and TEN cases, respectively. Conclusions: Antiretroviral and antibiotics were the commonly reported offending group of drugs for SJS and TEN cases. Nevirapine and co-trimoxazole were the commonly reported suspect drugs. SJS and TEN were reported most frequently in females and in patients aged 19–40 years, indicating that drug surveillance and counseling in these groups of patients may be beneficial.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017

Oshikoya

Ogunyinka

Ogar

et al. 2020

Therapeutic Advances in Drug Safety

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“…The Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR) has been used successfully in Nigeria. Potential reporters are encouraged to send a text message to a specific number at Nigeria's National Agency for Food and Drug Administration and Control and are then contacted by phone 88 …”

Section: Technological Advances and Digital Pharmacovigilance Systemsmentioning

confidence: 99%

Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa

Kiguba

Olsson²,

Waitt

2022

Brit J Clinical Pharma

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Low‐ and middle‐income countries (LMIC) face unique challenges with regard to the establishment of robust pharmacovigilance systems capable of generating data to inform healthcare policy and practice. These include the limited integration and reliability of pharmacovigilance systems across LMIC despite recent efforts to harmonize pharmacovigilance rules and regulations in several regional economic communities. There are particular challenges relating to the need to translate reporting tools into numerous local languages and the low numbers of healthcare providers relative to number of patients, with very short consultation times. Additional factors frequent in LMIC include high uptake of herbal and traditional medication, mostly by self‐medication; disruptive political conflicts jeopardizing fragile systems; and little or no access to drug utilization data, which makes it difficult to reliably estimate the true risks of medicines use. Pharmacovigilance activities are hindered by the scarcity of well‐trained personnel with little or no budgetary support from national governments; high turnover of pharmacovigilance staff whose training involves a substantial amount of resources; and little awareness of pharmacovigilance among healthcare workers, decision makers and consumers. Furthermore, little collaboration between public health programmes and national medicines regulatory authorities coupled with limited investment in pharmacovigilance activities, especially during mass drug administration for neglected tropical diseases and mass vaccinations, produces major challenges in establishing a culture where pharmacovigilance is systematically embedded. Very low spontaneous reporting rates with poor quality reports hinders robust signal detection analyses. This review summarises the specific challenges and areas of progress in pharmacovigilance in LMIC with special focus on the situation in Africa.

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“…Some studies have also explored the use of mobile phones to aid consumer reporting of ADRs. A study assessed the impact of a system named Pharmacovigilance Raid Alert System for Consumer Reporting (PRASCOR) and implemented in Nigeria to improve ADR reporting by consumers using mobile phones, and found the system as having the potential to contribute to ADR reporting . In 2017, mobile apps were launched in Burkina Faso and Zambia to aid consumer reporting of suspected ADRs…”

Section: Introductionmentioning

confidence: 99%

“…A study assessed the impact of a system named Pharmacovigilance Raid Alert System for Consumer Reporting (PRASCOR) and implemented in Nigeria to improve ADR reporting by consumers using mobile phones, and found the system as having the potential to contribute to ADR reporting. [28] In 2017, mobile apps were launched in Burkina Faso and Zambia to aid consumer reporting of suspected ADRs. [29] Studies are needed to explore the design of mobile phone-based interventions to encourage consumer reporting of ADRs in LMICs.…”

Section: Introductionmentioning

confidence: 99%

Consumer reporting of suspected adverse drug reactions: modelling the acceptance of mobile phone caller tunes to raise awareness

Appiah

Yoshikawa

Asamoah‐Akuoko

et al. 2019

J Pharm Health Serv Res

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Objectives Our main aim was to identify the factors that may influence consumers’ acceptance of mobile phone caller tunes to increase awareness of consumer reporting of suspected adverse drug reactions (ADRs). Mobile phone caller tunes — the songs or messages callers hear — are popular in Africa and Asia but have not been used to aid reporting of adverse drug reactions (ADRs). We also aimed to evaluate the psychometric properties of a survey instrument adapted for caller tunes and ADRs. Methods A cross‐sectional survey based on the technology acceptance model (TAM) was conducted among 486 non‐ADR‐themed caller tune users and 470 mobile phone users with no caller tunes in Accra, Ghana. Participants were purposively recruited from voluntary blood donation sites. After testing the validity and reliability of TAM constructs, a structural equation modelling approach was used to evaluate the factors that could influence the acceptance of caller tunes for increasing awareness of consumer reporting of ADRs. Key findings Perceived usefulness and perceived ease of use had significant positive effects on consumers' acceptance of caller tunes for increasing awareness of consumer reporting of ADRs. However, whereas free of cost had significant positive effects on the acceptance of caller tunes among those with non‐ADR‐themed caller tunes (β = 0.15, P = 0.006), it was not so for those lacking caller tunes (β = 0.05, P = 0.229). The survey instrument met acceptable validity and reliability criteria. Conclusions Our findings show that consumers would generally accept caller tunes on ADRs — if created — to aid consumer reporting of suspected ADRs, but there are research and practice considerations.

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Pharmacovigilance Rapid Alert System for Consumer Reporting (PRASCOR): A Look at Its Quantitative Contribution to Spontaneous Reporting in Nigeria from August 2012 to February 2017

Cited by 10 publications

References 34 publications

Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017

Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017

Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa

Consumer reporting of suspected adverse drug reactions: modelling the acceptance of mobile phone caller tunes to raise awareness

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