Clinical pharmacy is currently not practised in Namibia. To introduce the concept and skills pert... more Clinical pharmacy is currently not practised in Namibia. To introduce the concept and skills pertinent to this area of practice, pharmacy undergraduates at Namibia's new School of Pharmacy are introduced to clinical pharmacy from their second year, and progress from theory to practical application on the wards. This approach has led to students having a greater understanding of clinical pharmacy and how it can be applied in practice. Introducing clinical pharmacy progressively at an undergraduate level may help to stimulate interest in the speciality for future career progression.
Expert review of pharmacoeconomics & outcomes research, Jan 14, 2015
The first Medicines Utilization Research in Africa group workshop and symposium brought researche... more The first Medicines Utilization Research in Africa group workshop and symposium brought researchers together from across Africa to improve their knowledge on drug utilization methodologies as well as exchange ideas. As a result, progress was made on drug utilization research and formulating future strategies to enhance the rational use of medicines in Africa. Anti-infectives were the principal theme for the 1-day symposium following the workshops. This included presentations on the inappropriate use of antibiotics as well as ways to address this. Concerns with adverse drug reactions and adherence to anti-retroviral medicines were also discussed, with poor adherence remaining a challenge. There were also concerns with the underutilization of generics. These discussions resulted in a number of agreed activities before the next conference in 2016.
Journal of Pharmaceutical Policy and Practice, 2016
Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based... more Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based antiretroviral therapy (ART) was initiated in female and male patients with baseline CD4 cell counts ≥250 and ≥400, respectively. Some studies reported no difference in risk between the high and low CD4 count groups. Consequently, the use of NVP-based ART in all patients with a CD4 cell count <350, was recommended. In 2011, the Pharmacovigilance Centre detected an increase in reports of grade III and IV reactions. The center was required to determine if there was an increase in NVP-related reactions. Automated dispensing records from January 2008 to November 2011 were accessed from the National Antiretroviral Dispensing Database (NDB). Records of patients who were initiated on NVP-based ART were selected, and records showing a replacement of NVP with protease inhibitor (PI) were identified. The proportions of grade III and IV reactions were calculated per quarter, and Odds Ratios (OR) were calculated, with the confidence interval set at 95 % and a p-value of <0.05. From 2008 to 2011 a total of 84,741 patients were started on ART. Of these 67,794 were initiated on NVP-containing ART. Of these, 211 females and 79 males were substituted from NVP to a PI. The OR for females was 2.4 (95 % confidence interval [CI] 1.8 - 3.1). For males the OR was 2.4 (OR 2.4; 95 % CI 1.4 - 3.8) which occurred nine months after the change observed in the females. The odds of a NVP-to-PI substitution in females compared to males before the launch of Namibia's 2010 ART guidelines was the same as the odds after the publication of the guidelines (before, OR 1.6; 95 % CI 1.1 - 2.5; after, OR 1.6; 95 % CI 1.2 - 2.2). There was an increase in substitutions of NVP with a PI following the increase in the CD4 threshold for initiating NVP-based HAART, meaning that there was an increase in grade III and IV reactions associated with NVP. Therefore the NVP-safety signal was confirmed to be a true signal, which contributed to the Ministry's decision to review the use of NVP.
Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug ev... more Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug events, in response to drug use tragedies such asphocomelia. As such, PhV has been long in existence in North America and Europe. However, in some countries the practice of PhV is relatively new. For example: In Namibia the Therapeutics Information and PhV Centre (TIPC) was established in 2008 by the Ministry of Health and Social Services (MoHSS), with technical support from Management Sciences for Health. Following the establishment of TIPC the MoHSS embarked on training in-service health care workers as a strategy to promote PhV. Training in-service HCW is a costly venture, and its continuous implementation may be interrupted. The training of medical, pharmacy, and nursing students is a more sustainable strategy for promoting PhV, by virtue of its long-term nature. In cognizance of the importance of PhV and the need to promote it, the School of Pharmacy (SoP), Faculty of Health Sciences at the University of Namibia included a module on PhV as part of the curriculum to train Bachelor of Pharmacy students. While didactic face to face training has been used to train PhV, the SoP utilised Self-Directed Learning. This report contains the aims of pharmacovigilance training at the SoP; how the module was structured; how the sessions were conducted; recommendations on how to make PhV training practical; and how to broaden student coverage on PhV training.
Background
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in fem... more Background Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity. Methods We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test. Results 1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP. Conclusion The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
Clinical pharmacy is currently not practised in Namibia. To introduce the concept and skills pert... more Clinical pharmacy is currently not practised in Namibia. To introduce the concept and skills pertinent to this area of practice, pharmacy undergraduates at Namibia's new School of Pharmacy are introduced to clinical pharmacy from their second year, and progress from theory to practical application on the wards. This approach has led to students having a greater understanding of clinical pharmacy and how it can be applied in practice. Introducing clinical pharmacy progressively at an undergraduate level may help to stimulate interest in the speciality for future career progression.
Expert review of pharmacoeconomics & outcomes research, Jan 14, 2015
The first Medicines Utilization Research in Africa group workshop and symposium brought researche... more The first Medicines Utilization Research in Africa group workshop and symposium brought researchers together from across Africa to improve their knowledge on drug utilization methodologies as well as exchange ideas. As a result, progress was made on drug utilization research and formulating future strategies to enhance the rational use of medicines in Africa. Anti-infectives were the principal theme for the 1-day symposium following the workshops. This included presentations on the inappropriate use of antibiotics as well as ways to address this. Concerns with adverse drug reactions and adherence to anti-retroviral medicines were also discussed, with poor adherence remaining a challenge. There were also concerns with the underutilization of generics. These discussions resulted in a number of agreed activities before the next conference in 2016.
Journal of Pharmaceutical Policy and Practice, 2016
Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based... more Clinical trials showed a higher risk of skin- and liver- related adverse reactions when NVP-based antiretroviral therapy (ART) was initiated in female and male patients with baseline CD4 cell counts ≥250 and ≥400, respectively. Some studies reported no difference in risk between the high and low CD4 count groups. Consequently, the use of NVP-based ART in all patients with a CD4 cell count &lt;350, was recommended. In 2011, the Pharmacovigilance Centre detected an increase in reports of grade III and IV reactions. The center was required to determine if there was an increase in NVP-related reactions. Automated dispensing records from January 2008 to November 2011 were accessed from the National Antiretroviral Dispensing Database (NDB). Records of patients who were initiated on NVP-based ART were selected, and records showing a replacement of NVP with protease inhibitor (PI) were identified. The proportions of grade III and IV reactions were calculated per quarter, and Odds Ratios (OR) were calculated, with the confidence interval set at 95 % and a p-value of &lt;0.05. From 2008 to 2011 a total of 84,741 patients were started on ART. Of these 67,794 were initiated on NVP-containing ART. Of these, 211 females and 79 males were substituted from NVP to a PI. The OR for females was 2.4 (95 % confidence interval [CI] 1.8 - 3.1). For males the OR was 2.4 (OR 2.4; 95 % CI 1.4 - 3.8) which occurred nine months after the change observed in the females. The odds of a NVP-to-PI substitution in females compared to males before the launch of Namibia&#39;s 2010 ART guidelines was the same as the odds after the publication of the guidelines (before, OR 1.6; 95 % CI 1.1 - 2.5; after, OR 1.6; 95 % CI 1.2 - 2.2). There was an increase in substitutions of NVP with a PI following the increase in the CD4 threshold for initiating NVP-based HAART, meaning that there was an increase in grade III and IV reactions associated with NVP. Therefore the NVP-safety signal was confirmed to be a true signal, which contributed to the Ministry&#39;s decision to review the use of NVP.
Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug ev... more Pharmacovigilance (PhV) was initiated to prevent adverse drug reactions and other adverse drug events, in response to drug use tragedies such asphocomelia. As such, PhV has been long in existence in North America and Europe. However, in some countries the practice of PhV is relatively new. For example: In Namibia the Therapeutics Information and PhV Centre (TIPC) was established in 2008 by the Ministry of Health and Social Services (MoHSS), with technical support from Management Sciences for Health. Following the establishment of TIPC the MoHSS embarked on training in-service health care workers as a strategy to promote PhV. Training in-service HCW is a costly venture, and its continuous implementation may be interrupted. The training of medical, pharmacy, and nursing students is a more sustainable strategy for promoting PhV, by virtue of its long-term nature. In cognizance of the importance of PhV and the need to promote it, the School of Pharmacy (SoP), Faculty of Health Sciences at the University of Namibia included a module on PhV as part of the curriculum to train Bachelor of Pharmacy students. While didactic face to face training has been used to train PhV, the SoP utilised Self-Directed Learning. This report contains the aims of pharmacovigilance training at the SoP; how the module was structured; how the sessions were conducted; recommendations on how to make PhV training practical; and how to broaden student coverage on PhV training.
Background
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in fem... more Background Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity. Methods We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test. Results 1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP. Conclusion The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
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Papers by Francis Kalemeera
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity.
Methods
We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test.
Results
1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP.
Conclusion
The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.
Nevirapine’s (NVP) pharmaceutical manufacturer recommended the avoidance of NVP in females and males with baseline CD4 counts >250 and >400, respectively. This safety measure was challenged by research results that showed similar proportions of adverse events in high and low baseline CD4 count patients. WHO’s antiretroviral therapy guidelines recommended the use of NVP in patients with CD4 counts <350. Whether this recommendation would result in increase of NVP-related adverse reaction reports in Namibia was not known. Consequently, the pharmacovigilance centre monitored the NVP-related reaction reports for change in number and severity.
Methods
We accessed adverse reaction reports in VigiFlow®. NVP-related skin and liver adverse reaction reports received in 2011 were compared with those received in the Previous Years. Also, NVP-related reaction reports were compared with the same reactions associated with other medicines. The comparisons were made by using reporting ratio, proportional reporting ratio, and the Students T-Test.
Results
1,074 adverse reaction reports were accessed. NVP-related liver and skin reactions were 208 (2011) and 99 (Previous Years). The proportions of reports related to ARV in 2011 and Previous Years were comparable (RR=1; p=0.87). The NVP-related reactions were greater in 2011 than in the Previous Years (43.2% vs. 16.7%: RR = 2.6; p <0.0001). Grade3 and 4 reactions related to NVP were greater in 2011 than in the Previous Years (SKIN: 22.7% vs. 5.6%: RR = 4.1; p <0.0001; LIVER: 8.5% vs. 2.2%: RR = 3.9; p <0.0001), but not for grade1 & 2 reactions (SKIN: 8.5% vs. 6.2%; RR = 1.4; p =0.16; LIVER: 2.7% vs. 2.4%; RR = 1.1; p = 0.73).The increase in reports was observed for both female and male patients (p<0.01). The increase ingrade 3 and 4 reactions were unique to NVP.
Conclusion
The significant increase in proportions of grade3 and 4 liver and skin reaction reports in patients on NVP was detected as a safety signal after shifting ART initiation to higher CD4 counts. The Ministry of Health halted the plan of initiating NVP-based ART in pregnant females, and recommended the avoidance of NVP in ART-naïve patients with high baseline CD4 counts. Through locally derived data, pharmacovigilance centres can protect patients from drug-induced harm.