Dear Healthcare Professional (DHP) letter is a risk minimization tool used to inform health workers about new and emerging safety information during the marketing period of medicinal products. DHP letters in some cases may not be effective because targeted audience may not be aware of these letters or even understand them. The objectives of this study were to assess the effectiveness and relevance of DHP letters as effective risk minimization tool and to seek opinion of health workers about the most effective way of communicating safety information. A descriptive correlational study of 913 health workers selected by convenient sampling through face-to-face interviews from Apr. to June, 2014 was conducted, with a response rate of 83.15%. The data was analyzed using descriptive analysis and Pearson-chi square test (χ 2 ) with STATA version 13. A p-value of < 0.05 was considered significant during the analysis. Of the 913 respondents only 350 (38.34%) were aware of at least one of the letters distributed in 2013 and 314 (89.71%) out of these admitted that these letters have influenced their way of prescribing, dispensing and administering the medicines involved. One hundred and ninety-two (54.82%) of the respondents rated the level of understanding of the language used as good and there was no significant difference in the health workers rating of the language used in the letters (p=0.40). Health workers suggested electronic methods such as short messaging service to their mobile phones 56.81% (438), e-mail 91 (85.85%) and posting the letters on the Food and Drugs Authority's website 26.85% (207). The results suggest that DHP letters issued by the Food and Drugs Authority (FDA) are effective in changing behavior of those who receive them but they are received late or not at all. The FDA should therefore explore other means of communicating safety information such as electronic means as suggested by the health workers.
Background: The novel coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There is limited information on the safety of drugs used for the treatment of COVID-19.Objective: Objective of this study is to describe the pattern of stimulated spontaneous adverse drug reaction (ADR) reports received from healthcare professionals for SARS-CoV-2 positive patients in Ghana and lessons learnt particularly for low- and middle-income countries.Methods: This is a study of individual case safety reports (ICSRs) received from healthcare professionals between 1st April 2020 to 31st July 2020 in SARS-CoV-2 positive patients in Ghana. The ICSRs were retrieved from the SafetyWatch System and descriptive statistics used to describe the ADRs by System Organ Classification and Preferred Term.Results: Information was received from 40 COVID-19 Treatment Centres across the country with 9 centres submitting a total of 53 ICSRs containing 101 ADRs; approximately two ADRs per ICSR. Females accounted for 29(54.7%) of the ICSRs and males 24(45.3%). Newly reported ADRs of interest were one report each of tremor for doxycycline; scrotal pain, dyspnoea, gait disturbances and dysgeusia for chloroquine; and dry throat, hyperhidrosis, restlessness and micturition frequency increased for hydroxychloroquine. A strong spontaneous system with the availability of focal persons at the Treatment Centres played a key role in reporting ADRs during the pandemic.Conclusion: This is the first experience with spontaneous reporting during COVID-19 pandemic in Ghana. The profile of most of the ADRs reported appears consistent with what is expected from the summary of product characteristics. A study with a larger sample size with well-defined denominator in future studies is paramount in determining the relative risk of these medications in SARS-CoV-2 positive patients.
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