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LifesaverThe
The Kenya National Medicine and Pharmacovigilance Newsletter | Ensuring Quallity and Efficacy of Medicine for Better Healthcare
A Publication of the Pharmacy and Poisons Board | 6th
Edition | September 2016
InsideInside
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Adverse Drug Reactions (ADRs) in
Kenya 2010 – 2015: How are we
doing?
Pharmacovigilance in a Modern
Day Setting
Kenya Medicines Information and
Pharmacovigilance Directorate
Revamped
Should I report ‘non-serious’
Adverse Drug Reactions to PPB?
PPB as a Regional Center of
Regulatory Excellence (RCORE)
hosts other Country National
Medicines Regulatory Agencies
Round Six Minilab Refresher
Training
Joint Post-Marketing Surveillance for
Antiretrovirals, Antibiotics and Anti
TB Medicines
Pharmacovigilance Training
for Kiambu County Health
Management Team
Pharmacovigilance gains more
ground in Kirinyaga and
surrounding counties
Vaccines: Quality and Safety
MIPV Newsletter Pictures Speak-
Regional and Global Initiatives
Introduction
K
enya has been a member of the WHO Program for International Drug Monitoring
since 4th May 2010 and has been submitting ADR reports to the Uppsala
Monitoring Center (UMC) since that year. A total of 8,852 reports had been
submitted as at 31st December 2015. The annual number of reports peaked in 2012
and has since declined each year. The decline can be partly explained by the withdrawal
of Stavudine, which was implicated in more than 60% of the ARV-related ADRs when it
was in use, from the ART guidelines in Kenya. However, even after taking into account
the impact of Stavudine withdrawal, there has been a decline in the reporting rates and
possible reasons for this include attrition of trained staff as well as systemic changes
brought about as the health sector adjusted to the devolved system of governance. It
should also be noted that the spike in number of reports in 2011 and 2012 was partly
due to entry of backlog ADR reports following Kenya’s subscription to VigiFlow.
Adverse Drug Reactions
(ADRs) in Kenya 2010 –
2015: How are we doing?
Pharmacovigilance in a
Modern Day Setting
MOH/FACES, Nyatike Sub-county, Migori County
Background
Monitoring, collection, assessing and evaluating information from healthcare providers
and patients on ADRs of medicines with the view to identifying new information about
hazards, and preventing harm to patients has been ongoing at Macalder Sub-county
Hospital. Sub-optimal identification and reporting of adverse drug reactions (ADRs) and
Poor Quality Medicinal Products (PQMP) is thought to be the main challenge hampering
pharmacovigilance (PV) at the facility. The facility team was also of the impression that
medication errors were not adequately monitored and followed up. The team was
however aware of the importance of monitoring ADRs, PQMP and medication errors
in improving treatment outcomes for patients and also preventing the financial burden
brought about by these challenges.
continued on page 3
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2. 2
Objectives
The facility team at Macalder sought to identify the commonly
reported ADRs associated with ART; to identify the effect
of ADRs and side-effects on social and financial positions
of clients; gauge awareness among healthcare workers on
ADR and PQMP detection and reporting and also document
outcomes of reported cases of PQMP.
Methods
The team conducted a retrospective follow-up in Macalder
Sub-county hospital to identify clients who had experienced
ADRs and were on HAART in 2014 and cost implications of
managing ADRs. They also assessed the regulatory actions
taken following the substandard drugs reported and the
medication errors identified and documented. Data from
the blue cards and prescription forms were abstracted and
identification of the errors done. Health workers awareness
on PV reporting was assessed.
Results
Of the 433 new initiations on HAART 15 ADR cases were
identified and documented.3 product recalls have been done
in the period for paracetamol (2) and metronidazole syrup (1).
Some medication errors were detected with ARV prescriptions
and involved prescribing wrong drug, dosing errors and poly
pharmacy. The cost implication on management of the ADRs
to client ranged from a minimum of Ksh 20 -500 on outpatient
and up to Ksh 5,000 for severe ADRs for inpatient cases.
Following adoption of the mobile app for PV reporting, prompt
reports can be made within 12 hours of identification using the
mobile PPB app for smart phones.
Conclusion
There are few incidences of documented ADRs (3.46%)
among clients on HAART, mostly occurring during the first 3
months of treatment signifying a pattern of acute and non-
specific events. Widening the scope of pharmacovigilance and
the standardization of ADRs in the new ART guidelines has
improved the recognition and management and prevention of
ADRs.
continued from page 1
In Kenya, pharmacovigilance
activities have historically
been conducted through a
passive approach, dependent
on health worker suspicions
and voluntary reporting of
potential adverse reactions to
medicines. Lessons learned
from other countries and the
World Health Organization
suggestthatactiveapproaches
and formal research methods
are also needed to evaluate
potential medicines safety and
provide measures on the level
of potential risk. This calls for
pharmacovigilance system to
incorporate active surveillance
methods, including the use of
registries, sentinel sites, and
follow-up of patient cohorts.
In order for the Kenyan
National Pharmacovigilance
Centre to operate effectively
and achieve the above, there
has been need to deploy
more personnel to work at the
center which is housed within
Kenya Medicines Information and
Pharmacovigilance Directorate
Revamped
the Medicines Information and
Pharmacovigilance Directorate.
The centre has grown from a
one-man department into a
twelve-person directorate with
three units namely, Clinical
Trials, Pharmacovigilance &
Post Marketing Surveillance and
Medicines information. Below is
the staff at the center as at August
2016.
This calls for
pharmacovigilance
system to incorporate
active surveillance
methods, including the
use of registries, sentinel
sites, and follow-up of
patient cohorts
Data Management
Miriam Achieng’

3. 3
ADRs Reported by Class of Drugs
Though ARVs still account for most of the ADRs reported, the proportion of ARV-related ARVs has fallen steadily from 90% in
2012 to 71% in 2015. Other drug classes with many suspected ADRs reported are antibiotics, anti-TBs, anti-malarials, anti-
hypertensives and anti-cancer agents.
Drug Class
Number (%) of ADR Reports by Year
Total
2010 2011 2012 2013 2014 2015
ARV 92 (63%) 1,894 (90%) 2,182 (90%) 1,852 (80%) 781 (78%) 610 (71%) 7,411 (84%)
Antibiotic 25 (17%) 70 (3%) 39 (2%) 123 (5%) 67 (7%) 86 (10%) 410 (5%)
Unknown 0 (0%) 50 (2%) 88 (4%) 178 8(%) 31 (3%) 15 (2%) 362 (4%)
Anti-TB 7 (5%) 22 (1%) 21 (1%) 48 (2%) 27 (3%) 37 (4%) 162 (2%)
Anti-Malarial 8 (6%) 16 (1%) 20 (1%) 21 (1%) 16 (2%) 18 (2%) 99 (1%)
Anti-hypertensive 1 (1%) 12 (1%) 14 (1%) 15 (1%) 10 (1%) 13 (2%) 65 (<1%)
Anti-cancer 0 (0%) 3 (0%) 2 (0%) 0 (0%) 19 (2%) 20 (2%) 44 (<1%)
Others 12 (8%) 24 (2%) 54 (2%) 87 (4%) 49 (5%) 56 (7%) 299 (3%)
Total 145
(100%)
2,108
(100%)
2,420
(100%)
2,324
(100%)
1,000
(100%)
855
(100%)
8,852
(100%)
Table 1: Number of ADR reports by Drug Class in Kenya
2010 2011 2012 2013 2014 2015
Total 145 2,108 2,420 2,324 1,000 855
D4T-Related 62 1,350 1,259 206 120 219
Year
Total D4T - Related
3,000
2,500
2,000
1,500
1,000
500
0
NumberofADRReports
Total Number of ADRs and Stavudine (D4T)-Related ADRs
Reported in Kenya: 2010 - 2015 (n=8,852 & 3,216)
ADRs Reported by Individual Drugs
The drugs with the highest number of ADR reports between 2010 and 2015 were Stavudine, Lamivudine, Efavirenz, Nevirapine
and Zidovudine respectively. The non-ARV drugs with the highest number of ADR reports were Co-trimoxazole, Isoniazid,
Artemether/ Lumefantrine, Enalapril and Imatinib.
Drug
No. of ADR Reports (Rank**)
Total Serious
Stavudine 3,181 (1) 123 (4)
Lamivudine 2,048 (2) 127 (2)
Efavirenz 970 (3) 133 (1)
Nevirapine 729 (4) 124 (3)
Zidovudine 227 (5) 41 (5)
Drug
No. of ADR Reports (Rank)
Total Serious
Cotrimoxazole 200 (6) 36 (6)
Isoniazid 58 (8) 8 (12)
AL* 50 (9) 16 (8)
Enalapril 35 (11) 4 (23)
Imatinib 31 (13) 20 (7)
* AL = Artemether-Lumefantrine combination; ** Rank = overall position with regard to number of ADR reports
Drugs with the most reported ADRs (excluding ARVs)Drugs with the most reported ADRs (overall)
Table 2: Number of ADR reports by Drug in Kenya
continued from page 1

4. 4
ADRs Reported by Seriousness
Of the 8,852 ADR reports submitted to PPB over the six year period, 891 (11%) were classified as serious. Serious ADRs are
those that result in death; are life-threatening; require hospitalization or result in prolongation of existing hospitalization; or result
in persistent or significant disability/ incapacity. Outcomes of suspected ADRs include a total of 49 deaths and 14 congenital
abnormalities as well as 39 cases of disability/ incapacitation and 584 cases of (prolonged) hospitalization.
Table 3: Number of ADR reports by Seriousness in Kenya
Seriousness criteria Number (%) of Serious ADRs by Year Total
2010 2011 2012 2013 2014 2015
Caused/ Prolonged
Hospitalization
15 (20%) 139 (87%) 118 (58%) 161 (90%) 81 (58%) 70 (52%) 584 (66%)
Life threatening 12 (16%) 1 (1%) 20 (10%) 10 (6%) 24 (17%) 36 (27%) 103 (12%)
Other 47 (63%) 3 (2%) 40 (20%) 1 (1%) 9 (6%) 2 (1%) 102 (11%)
Death 1 (1%) 13 (8%) 9 (4%) 2 (1%) 14 (10%) 10 (7%) 49 (5%)
Disabling/ Incapacitating 0 (0%) 2 (1%) 12 (6%) 2 (1%) 9 (6%) 14 (10%) 39 (4%)
Congenital anomaly/ Birth
defect
0 (0%) 2 (1%) 4 (2%) 3 (2%) 2 (1%) 3 (2%) 14 (2%)
Total 75 160 203 179 139 135 891
ADRs Reported by Reporter Qualification
Improving patient safety is a role for all members of the multi-disciplinary health care team and not restricted to any one or two
cadres of health workers. The bulk of reports (75%) has historically been submitted by clinical officers and nurses, with pharmacists
(17%) and physicians (8%) accounting for the rest. Only 10 reports (0.1%) have been submitted by non-health workers.
Figure 1: ADR reports by reporter qualification in Kenya
ADRs Reported by County and Facility
ADR reporting by county has been highly variable with 90% of all reports coming from just 18 (38%) of the counties. These
18 counties comprise 53% of the Kenyan population (Kenya National Bureau of Statistics, 2010). Five counties (Elgeyo
Marakwet, Lamu, Tana River, West Pokot and Wajir) have never reported any ADR. Table 4 provides a breakdown of ADR
reporting by County.
Table 4: ADR Reporting by County in Kenya
County
Number of Reports by Year Total
2010 2011 2012 2013 2014 2015
Nairobi 2 225 481 242 99 243 1,292 (15%)
Uasin Gishu 0 333 368 177 54 75 1,007 (11%)
Migori 52 337 149 162 199 50 949 (11%)
physician
pharmacist
other HCW
NumberofReports
Year
2010 2011 2012 2013 2014 2015
2,500
2,000
1,500
1,000
500
0
Number of ADR Reports by Reporter Qualification: 2010 - 2015 (n = 8,852)

5. 5
Green Fill denotes top 5 counties in number of reports submitted for the respective year
With regard to reporting by health facilities, over 320 facilities have submitted ADR reports. However, 50% of these reports have
been submitted by just 14 health facilities and 90% by 83 health facilities. There are over 6,000 health facilities in the public and
private sectors across the country. Table 5 provides a breakdown of reporting by health facilities.
Table 5: ADR Reporting by Health Facility in Kenya
Facility Name
Number of Reports by Year
Total
2010 2011 2012 2013 2014 2015
Moi Teaching and Referral 0 333 368 177 54 75 1,007
St Camillus Mission Hospital 51 271 126 94 88 22 652
Thika District Hospital 6 56 136 109 90 0 397
Kilifi District Hospital 0 0 20 296 0 0 316
Vihiga District Hospital 0 91 116 72 0 8 287
Coast PGH 9 145 86 25 0 4 269
St Monica Hospital 0 98 26 80 17 13 234
Kisii Level 5 Hospital 0 15 36 63 68 44 226
Mater Hospital 0 73 44 32 42 0 191
Maragua District Hospital 3 0 49 61 73 0 186
Liverpool Care & Treatment 0 0 137 28 1 15 181
Kenyatta National Hospital 0 0 136 22 4 12 174
Riruta Health Centre 0 0 55 56 9 45 165
Kiambu District Hospital 0 54 73 18 3 9 157
Mutomo Mission Hospital 0 100 15 0 15 0 130
Machakos District Hospital 2 5 53 68 2 0 130
Meru District Hospital 12 24 65 25 1 1 128
Asumbi Mission Hospital 0 10 33 81 0 0 124
Migori District Hospital 0 0 0 0 105 14 119
Nakuru PGH 3 0 1 38 0 76 118
Mbagathi DH 0 0 0 0 0 110 110
304 other health facilities 59 833 845 979 428 407 3,551
Total 145 2,108 2,420 2,324 1,000 855 8,852
Green Fill denotes top 5 health facilities in number of reports submitted for the respective year
The individuals with the highest number of reports submitted overall were Ng’etich of Moi Teaching and Referral Hospital with 331
reports between 2010 and 2015; and Nabongo, also of MTRH with 241 reports during the same period. Congratulations to these
two committed pharmacovigilantes and all others who have been submitting ADR reports.
All county health teams with low (or no) ADR reporting are urged to investigate the reasons for this and address them in order
to improve patient safety. Health facility multidisciplinary teams (e.g. the Medicines and Therapeutics Committees) should also
routinely review their ADR reports and institute any facility-specific actions as may be necessary.
County
Number of Reports by Year Total
2010 2011 2012 2013 2014 2015
Kiambu 6 137 282 168 102 17 712 (8%)
Kisumu 18 152 219 193 42 41 665 (8%)
Siaya 0 83 2 124 143 131 483 (5%)
Mombasa 20 167 121 74 37 17 436 (5%)
Murang’a 5 40 118 97 76 2 338 (4%)
Kisii 0 51 84 63 81 52 331 (4%)
Kilifi 0 0 20 296 0 0 316 (4%)
Vihiga 0 91 116 72 1 8 288 (3%)
Nyeri 1 49 37 72 43 21 223 (3%)
Homabay 0 11 50 138 0 4 203 (2%)
Meru 12 47 79 36 12 5 191 (2%)
Nakuru 3 14 7 54 4 85 167 (2%)
27 other counties 26 371 287 356 107 104 1,251 (14%)
Total 145 2,108 2,420 2,324 1,000 855 8,852 (100%)

6. 6
S
ince June 2009, Kenya has had
a formal pharmacovigilance (PV)
system that enables all health
care providers to suspect, identify,
and report medicine-related concerns
to the national PV center based at
the Pharmacy and Poisons Board.
Thousands of health workers have been
sensitized on PV and patient safety and
hard copy and electronic tools have
been provided to health facilities to
facilitate spontaneous reporting of ADRs
to PPB.
In the past two years, a rapid
downward trend in the reporting of
ADRs has been observed with facilities
that previously submitted a significant
number of ADR reports submitting
only a handful of reports over a span
Should I report ‘non-serious’
Adverse Drug Reactions to PPB?
of two years. Whereas there are a
number of reasons for the downward
trend (including discontinuation of one
ARV drug that was responsible to a
large proportion of ADRS reported),
Discussions with facility staff have
revealed that a number of health
professionals do no bother to report
‘non-serious’ ADRs e.g. mild skin rash
or nausea. It should also be noted that
the spike in number of reports in 2011
and 2012 was partly due to entry of
backlog ADR reports following Kenya’s
subscription to VigiFlow
The World Health Organization
(WHO) defines a serious adverse event
or reaction as “untoward medical
occurrence that at any dose results in
death, is life threatening, requires or
prolongs patient hospitalization, results
in persistent disability/incapacity, or is a
congenital anomaly/birth defect”. WHO
advocates for reporting of both serious
and non-serious events. It is important
to report non-serious events because:
they might indicate a serious problem
they might affect adherence, e.g.
nausea
if common, they might be more
important to public health than rare,
but serious problems
Health professionals are therefore
urged to continue documenting and
reporting all suspected ADRS to the
PPB. Remember: You need not be
certain, just suspicious!
M
ay 2014 marked another huge milestone for Kenya the integrated Kenya
pharmacovigilance system with Kenya Pharmacy and Poisons Board (PPB)
being recognized by New Partnership for Africa’s Development (NEPAD)
Agency as a Regional Centre of Regulatory Excellence (RCORE) in Pharmacovigilance
in Africa.
This has led to Kenya National PV Center being earmarked as an institution for
benchmarking on PV best practices. The Center hosted teams from the Tanzania
PPB as a Regional Center of Regulatory
Excellence (RCORE) hosts other Country
National Medicines Regulatory Agencies
Food and Drugs Authority (TFDA)
and the Medicines Control Authority
of Zimbabwe (MCAZ) in August and
October 2015 respectively. The teams
wanted to learn more about the
Pharmacovigilance Electronic Reporting
System as well as other PV best
practices in Kenya.
Officials from the MCAZ
pay a courtesy visit to the
Registrar of PPB during
their visit to the PV Center
in October 2015
This has led to Kenya
National PV Center being
earmarked as an institution
for benchmarking on PV best
practices

7. 7
T
he Pharmacy and Poisons Board
in its endevour to ensuring
quality, safety and efficacy
of medical products and health
technologies in Kenya has invested in
the mini-lab technology which helps
with checking and monitoring the
quality of medicines. The mini-labs are
effective in testing for Substandard,
Spurious, Falsely-labeled, Falsified,
Counterfeit (SSFFC’s) at Ports of
Entry and other Regional sites. The
minilab is used for carrying out basic
tests including Physical/Visual (P/V)
Inspection, Disintegration, and Thin
Layer Chromatography (TLC).
If a medicine is suspected to be
SSFFC, a sample of the medicine is
taken for a screening test to check for
its quality. The mini-labs are also used
to support Post Marketing Surveillance
activities, which test for quality of anti-
malarial, anti-TB, antibiotics and anti-
retroviral drugs. PPB has carried out
five previous minilabs screening of
medicines. These have been done
once a year since 2010. The activities
have been preceded by Mini-lab
training of the personnel carrying out
the activity to ensure that the staff is
well equipped and up to date with the
technology.
This year’s training was conducted
at National Quality Control Laboratory
(NQCL) and was opened by Deputy
Registrar, Dr. Fred Siyoi at PPB
Headquarters and the Director of
NQCL, Dr. Hezekiah Chepkwony. The
training which was conducted from
25th -29th January 2016, attracted
30 participants. These were 9 from
NQCL, 8 from the counties, 1 from
Round Six Minilab Refresher Training
Mission for Essential Drugs & Supplies
(MEDS) and 12 PPB staff. The training
was facilitated by one participant from
United States Pharmacopoeia (USP)
and one from Global Pharma Health
Fund (GPHF) who are the manufacturers
of the mini-labs.
During his opening remarks, Dr
Siyoi called for teamwork between
PPB, NQCL & Counties and urged
pharmacists in the counties to make
good use of the mini-labs. He noted that
the quality of anti-malarials in Kenya has
greatly improved since the first round
of testing in 2010 and that this was
attributed to the constant training. In
conclusion, he asked pharmacists in the
counties to be extra vigilant and ensure
that medicines bought in their respective
counties have been retained at the PPB.
Dr. Chepkwony reminded the
participants that they need to learn
as much as possible from the experts
during the training session so that they
get to apply what they have learnt. He
further mentioned that PPB and NQCL
need to work closely as they are serving
the public so as to ensure the quality
and safety of medicines in the country.
The portable mini-labs each worth
55,000 Euros were acquired with the
assistance of USAID and USP and have
been distributed to various Ports of Entry
and regional sites to carry out routine
screening of medicines. These are:-
Kericho, Kisii, Migori, Namanga, Kwale,
Busia, Nairobi, Eldoret, Kakamega,
Mombasa & Kisumu
The mini-lab uses Thin Layer
Chromatography (TLC) and
Disintegration method of testing
suspicious medicines. Disintegration
is a method used to test tablets and
capsules to assess whether solid
dosage forms will break up under
standard conditions. During testing,
the tablet should mimic what happens
in the stomach. If the tablet does not
dissolve within 30 minutes, then it is
deemed suspicious and should be
taken for further confirmatory testing.
On the other hand, the TLC is a method
for analyzing medicines by separating
the compounds in the mixture. TLC
can be used to help determine the
number of components in a mixture,
the identity of compounds, and the
purity of a medicine. TLC consists of
three steps - spotting, development,
and visualization
In the event that a substance
fails any of the above methods of
testing it is then referred to NQCL for
confirmatory testing that include tests
like assay which is done to assess the
amount of active ingredient present,
and expressed as a percentage of the
label claim.
It is also worth noting that
participants were trained on how to test
all anti-malarials that are currently in the
treatment guidelines.
The Global Pharma Health Fund’s
(GPHF) Minilab is low-cost, on the spot,
and is designed to help developing
countries detect substandard medicine.
This technology is cost effective and
also saves time as screening takes
only 30 minutes while laboratory testing
consumes time and is also expensive.
This particular training was
supported by PPB, USP & NQCL.
PPB Deputy Registrar
giving his opening
remarks during the
training
Dr. Latifa El-Hadri, Ph.D. Senior
Program Manager United States
Pharmacopoeia (USP) demonstrating
how to test medicines by use of the
mini-lab

8. 8
O
ne of the core duties of any National Medicines
Regulatory Authorities is to ensure that the medicines
its citizen are exposed to, meet the highest quality,
safety and efficacy standards. This it does through a number of
activities like monitoring the products during the development
phase (Clinical Trials), carrying out evaluation and registration
of the medicines before they are allowed into the market,
monitoring the products during production to ensure that the
manufacturing process is carried out according to the approved
processes. In addition, Pharmacy and Poisons Board also
approves all importation of these medicines into Kenya.
During the registration of medicines, the Board asks for
certificate of analysis of the product to be registered from
a WHO prequalified laboratory and this is also one of the
procedures put in place to ensure that only quality products
are registered in Kenya. To continuously monitor the quality
of the registered products, the board does routine Post
Marketing Surveillance (PMS) of these products. In the recent
past, the board has done PMS for Antimalarial medicines, Anti
TB Medicines, Cough Syrups, Reproductive Health Products,
ARVs.
To continue with this noble activity of PMS the board
together with other stakeholder namely; NASCOP, NLTP,
NQCL and MSH organized and carried out a joint PMS activity
for Antibiotics, Antiretrovirals and Anti TB medicines. This was
the first time that a joint PMS for different groups of medicines
was being carried out in the country. Previously, the different
organizations used to carry out independent PMS activities for
their products.
To note is also that this was also the first time that the
board was carrying out a PMS for antibiotics products and this
is going to act as a baseline study on the quality of antibiotic
products in the Kenyan market. For anti TBs, this was the
second time that a PMS was being carried out for this group
of medicines the first one having taken place in June 2009. A
total of 120 product samples were analyzed during the initial
study. Ten samples failed to comply with one or more of the
test parameters, representing a pass rate rate of 91.7%. All
the non-compliant products were two- component fixed dose
combination samples with RH combination accounting for
Joint Post-Marketing Surveillance for
Antiretrovirals, Antibiotics and Anti TB
Medicines
80% of non-compliance and the EH combination accounting
for the remaining 20% of failures.
For ARVs, this was also the second time that a nationwide
PMS was being carried out the first round having taken place
in August and September 2009. In total 99.63% (n=272) of the
samples analyzed passed laboratory tests in the first round.
The main objective of joint PMS was to establish the quality
and storage conditions of selected antiretroviral, antibiotics
and anti-tuberculosis medicines in Kenya. The PMS was
conducted countrywide targeting different tier of health facilities
and affiliations. Data and samples for the three products were
collected from the public, private and faith-based health
facilities at tier two to four. For antibiotics, data and samples
were collected from registered community pharmacies as well
as health facilities.
The joint survey was carried out for a period of two weeks
by ten teams of five members. In addition to data on medicine
samples, temperature and humidity of the storage area were
also measured and recorded.
A total of 3,740 samples were collected from 156 facilities
comprising hospitals, health centers and chemists in both
public and private health sector across the 47 counties of
Kenya.
Approximately 76% of the samples (93% of anti-TBs, 92%
of ARVs and 59% of antibiotics) were collected from public
health facilities and 24% from private facilities. The ARVs and
anti-TBs from the private sector were from health facilities run
by Faith-Based Organizations (FBOs).
Across the 47 counties 79% of the samples (96% for
anti-TBs, 95% for ARVs and 62% for antibiotics) came from
hospitals, 3% from health centers (4% for anti-TBs, 5% for
ARVs and 1% for antibiotics) and 18% from chemists (37% for
antibiotics, 1% for anti-TBs and 0% for ARVs).
The total number of different APIs collected for ARVs, anti-
TBs and antibiotics was 15, 7 and 19 respectively.
The samples were then secondarily sampled and sent for
compendia testing at the National Quality Control Laboratory
(NQCL) where and the results should be available soon.
8
During the registration of medicines, the Board asks for
certificate of analysis of the product to be registered from
a WHO prequalified laboratory and this is also one of the
procedures put in place to ensure that only quality products are
registered in Kenya. To continuously monitor the quality of the
registered products

9. 9
C
entral Province Response and Integration
Strengthening and Sustainability Project
(CRISSP) of University of Nairobi in conjunction
with Kiambu County Health Management Team
(CHMT) and Pharmacy and Poisons Board
(PPB) conducted a three day non-residential
Pharmacovigilance training course at Jumuia Resort,
Limuru from 19th to 21st January 2015.
The objective of the training was to appraise
and sensitize different cadres of health care workers
on Pharmacovigilance. There were thirty eight
participants drawn from various CRISSP supported
government health facilities. The overall course
evaluation indicated that the course objectives
on importance and goal of pharmacovigilance,
Identification, management and prevention of ADRs,
Processes of collection, reporting and analysis of
ADR and other medicine safety information and Use
of pharmacovigilance reporting tools were achieved.
In Conclusion, the training was successful
and timely. The participants highly appreciated the
opportunity to be trained by facilitators from PPB
and CRISSP for organizing the training.
Pharmacovigilance Training for Kiambu
County Health Management Team
The objective of
the training was to
appraise and sensitize
different cadres of
health care workers on
Pharmacovigilance.
There were thirty eight
participants drawn
from various CRISSP
supported government
health facilities.
at Jumuia Resort, Limuru
Kiambu County
healthcare providers
during the training session
Participants at the
training
Participants are all
ears as PPB facilitator
takes them through a
training session

10. 10
C
entral Province Response and Integration
Strengthening and Sustainability Project
CRISSP – University of Nairobi in
conjunction with Kirinyaga county CHMT and
Pharmacy and Poisons Board organized a three
day Pharmacovigilance training course. The
training was non-residential and took place at
Nice Digital City, Mwea from 26th to 28th January
2015. A total of 39 healthcare workers of different
cadres from varied health facilities from the county
and its environs successfully completed the course
and were issued with certificates. The participants
appreciated the training and committed to promote
PV reporting through implementing their action
plans.
Pharmacovigilance gains more ground in
Kirinyaga and surrounding counties
Participants in a
dicussion session
during the training
Pharmacovigilance awareness
enhanced in Central Rift Valley
39 healthcare workers
of different cadres from
the county and its environs
successfully completed the
course
F
our sites namely Kabarnet, Nakuru, Koibatek and Narok county
referral hospitals benefitted from a one day sensitizations each
in their respective counties between 15th-19th December 2014
where more than hundred health care workers were trained. Kabarnet
and Narok county which received their first residential training
appreciated the effort from the PPB team and promised to become
active pharmacovigilantes.

11. 11
V
accines are complex biological products that are
manufactured in a highly controlled process that ensures
quality, safety and efficacy.
Since vaccines are biologicals, there exists an inherent
potential for variability. To ensure quality, safety and efficacy,
vaccines undergo a process of lot release. This is an
independent review of critical data from each lot of vaccines to
assure the consistent quality of each manufactured lot.
Vaccine safety
Vaccines are held to a high safety standard. It has been
observed that as the prevalence of vaccine preventable
diseases declines, tolerance to any adverse events following
immunization decreases. This means that public is becoming
less and less likely to accept adverse reactions to vaccines.
This lower tolerance for risks from vaccines translates into a
greater need to detect and investigate any adverse event
following immunization (AEFI) than is generally expected for
other pharmaceutical products
Safety of marketed vaccines is monitored through detection
reporting and investigation of Adverse Events Following
Immunization.
Vaccines: Quality and Safety
Classification of AEFI
Every year more than 1 million children are vaccinated with
different vaccines such as Oral Polio, BCG, DPT, Haemophilus
Influenzae, Hepatitis B, Inactivated Polio, Pneumococcal and
Measles.
Vaccine safety monitoring is a collaborative process that
involves the Unit of Vaccines and Immunization Services, the
Pharmacy and Poisons Board, Health Workers, patients,
partners and other stakeholders. The public and healthcare
workers are encouraged to report any AEFI through the specific
AEFI reporting forms.
What is an adverse event following immunization
(AEFI)?
It is any untoward medical occurrence which follows
immunization and which may or may not be caused by
the usage of the vaccine. The adverse event may be any
unfavorable or unintended sign, abnormal laboratory finding,
symptom or disease.
Serious adverse events following immunization occur
rarely but have the potential to cause loss of public confidence
in the vaccination program
A serious AEFI is one that:
results in death,
is life-threatening,
requires in-patient hospitalization or prolongation of existing
hospitalization,
results in persistent or significant disability/incapacity,
is a congenital anomaly/birth defect,
requires intervention to prevent permanent impairment or
damage.
Type of AEFI Definition Example
Vaccine product-related
reaction
An event that is caused or precipitated by a vaccine due
to one or more of the inherent properties of the vaccine
product.
e.g. Fever after vaccination with Measles
Vaccine
Immunization error-related
reaction
An event that is caused by inappropriate vaccine handling,
prescribing or administration and thus by its nature is
preventable
Transmission of infection by contaminated multi-
dose vial leading to toxic shock syndrome
Immunization anxiety-
related reaction
An AEFI arising from anxiety about the immunization Fainting spell in a teenager after immunization
Coincidental event An AEFI that is caused by something other than the
vaccine product, immunization error or immunization
anxiety
A fever occurs at the time of the vaccination
(temporal association) but is in fact caused by
malaria.
Coincidental events reflect the natural
occurrence of health problems in the community
with common problems being frequently
reported
References
1. WHO Classification of AEFI available at http://vaccine-
safety-training.org/classification-of-aefis.html
2. WHO Policy Statement: Multi-dose Vial Policy
(MDVP) available at http://apps.who.int/iris/
bitstream/10665/135972/1/WHO_IVB_14.07_eng.pdf

12. 12
T
he Kenya, Pharmacy and Poisons Board Regional Centre of Regulatory Excellence (RCORE) in Pharmacovigilance continued
to lead the PV agenda in the East African Community and at the African continent.
Pictures Speak- Regional and Global Initiatives
1. Dr Christabel Khaemba - MOH/PPB
2. Dr Edward Abwao - MOH/PPB
3. George Muthuri - MOH/PPB
4. Mary Njeri - MOH/PPB
5. Dr Victor Sumbi - MSH/HCSM
6. Dr Ndinda Kusu - MSH/HCSM
7. Dr Fred Siyoi - MOH/ PPB
Down memory lane in 2015!
The Kenya team and
Pharmacovigilantes out-did
themselves during the 2015 African
Society of Pharmacovigilance
(ASOP) conference on 25-27
November in Accra-Ghana.
The team made several oral
presentations during plenary and
concurrent break-out sessions.
They held the Kenya Flag high
and will host ASOP 2016! The
theme of the conference was
“Pharmacovigilance in Africa: new
methods; new opportunities; new
challenges”
The EAC- Expert Working Group
on Pharmacovigilance meeting in
Nairobi, 9-13 November 2015.
The meeting focussed on developing
Harmonized Tools for Assessing
Pharmacovigilance Systems in EAC
Partner States and was supported by
USAID funded Systems for Improved
Access to Pharmaceuticals and
Services (SIAPS) Program.
1. 3rdAfricanSocietyofPharmacovigilance
(ASoP) Conference, December 2016
in Mombasa
2. Deployment of a web-based electronic
HIV Cohort Event Monitoring data
management tool at 8 hospitals in the
country
The Kenya Pharmacovigilantes
participated actively in the
2015 Pharmacovigilance Sans
Frontiers (PVSF) aka African
Pharmacovigilance Consultants
Network workshop in Accra-
Ghana on 23-25 November 2015.
The theme of the workshop was
Pharmacodiplomacy: Attaining high
impact for medicine safety.
Upcoming Events
3. Post marketing surveillance of anti-
malarias using minilabs
4. As a Regional Center of Regulatory
Excellence, RCORE), PPB shall be
hosting the Ethiopia Food Medicine
and Health Care, Administration and
Control Authority
Editorial Team
Contributors: Lucy Mecca, George Nyando, Miriam Achieng
EAC PV Technical working group meeting, 9th
- 13th November 2015, SarovaPanafric Hotel,
Nairobi-Kenya
Kenya delegates pose for a photo with delegates
from neighboring countries at the African Society
of Pharmacovigilance (ASoP) Conference in Accra
Ghana 2015
1. A doctor is to give a speech at
the local AMA dinner. He jots down
notes for his speech. Unfortunately,
when he stands in front of his
colleagues later that night, he finds
that he can’t read his notes. So he
asks, “Is there a pharmacist in the
house?”
2. A miracle drug is one that has now
the same price as last year.
3. Customer gets a topical cream.
Direction: apply locally two times a
day.
Customer says to the pharmacist:
“I can’t apply locally, I’m going
overseas.”
Jokes
4. Lady says to pharmacist: “Why does
my prescription medication have 40
side effects?”
Pharmacist replies: “Cause that’s all
we’ve documented so far.”
5. What do you call a pharmacist working
at a veterinary drug company... a
FARM-ASSIST
6. Boy Pharmacist: What do you want
this time, with coat or without coat?
Gal Pharmacist: with coating, because
I don’t want to release granules
earlier.
Boy Pharmacist: So, Shall I start
molding?
Gal Pharmacist: No, No... first close
the door and window and switch off,
because this work is light sensitive.
PVSF Workshop Accra Ghana_a moment of
consultation
PVSF Workshop Accra Ghana
PVSF Workshop Accra Ghana_at work