PHARMACY AND POISONS BOARD

Pharmacovigilance Summary Report: 1st October to 31st December 2023 (Q2)

The Pharmacy and Poisons Board is the National Regulatory Authority established under
the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates
the Practice of Pharmacy and the manufacture and trade of drugs and poisons.
The PPB has 4 directorates of which the Directorate of Product Safety (PDS) is responsible
for Pharmacovigilance, Post-Marketing Surveillance, Clinical Trials & Medicines
Information activities. PDS shares quarterly pharmacovigilance reports with stakeholders
to serve as a feedback mechanism and also encourage all stakeholders to report adverse
events.
Since the introduction of PV in Kenya, a total of 19,754 individual case safety reports
(ICSRs) have been submitted to the global database representing 2.7% of the total ICSRs
submitted by African countries.

Suspected Adverse Drug Reactions (SADRs)

There were 294 suspected adverse drug reaction (SADR) reports submitted to the
National Pharmacovigilance Centre within Quarter 2 (1st Oct -31st Dec 2023). Out of the
294 reports submitted, 289 reports were on suspected adverse drug reactions while 5
reports were on suspected therapeutic ineffectiveness of medicinal products.
Of the 294 reports, 286 (97.28%) reports were initial reports while 8 (2.72%) reports
were follow-up reports.

Product Count Proportion Age group Count Proportion

Medicinal 271 92.18% adult 227 79.09%
product
elderly 27 9.41%
Therapeutic 5 1.70% child 18 6.27%
Ineffectiveness
adolescent 8 2.79%
Not indicated 18 6.12% infant 4 1.39%
neonate 3 1.05%

Most of the ADR cases reported were due to
medicinal products (92.18%).
There were 5 reports on suspected
therapeutic ineffectiveness (1.70%).
In 18 reports (6.12%), the product category
was not indicated by the reporter.
The prevalence of SADRs was highest
(79.1%) amongst the adults (18-64) in
comparison to the other age groups. This
followed by the elderly age group (9.41%)
and the children (6.27%).
The rest of the reports included the
adolescent, infant and neonate age
groups as shown above.

Page 1 of 16
 Gender
Pregnancy Status
(n= 287) (n=175)

1st Trimester 1

2nd Trimester 1

39% 3rd Trimester 7

Female
61% Male Not Indicated 25

Not Applicable 42

Not pregnant 99

Out of the 175 females with reported

The frequency of reported SADRs was higher SADRs, 56.6% were not pregnant at the
in female (61%, 175) as compared to male time of reporting. However, 4% were in
(39%, 112). their 3rd trimester, while 1.2% were in the
1st and 2nd trimesters of pregnancy. A
total of 25 (14.3%) female cases reported
did not indicate the pregnancy status
while 42 (24%) reports indicated
pregnancy status as
not applicable

Reported Count Proportion

Known Allergy allergens
n=287 Sulphur 7 31.82%
9% Containing Drugs
Aspirin 3 13.64%
Proteins 2 9.09%
16% Cotrimoxazole 2 9.09%
Honey 1 4.55%
Cefuroxime 1 4.55%
Cold Allergy 1 4.55%
75%
RHZE 1 4.55%
Strong 1 4.55%
Scents/Perfumes
Aspirin 1 4.55%
No Not Indicated yes Efavirenz 1 4.55%
Diclofenac 1 4.55%
The frequency of reported SADRs was higher
Out of the 25 SADR reports with known
in patients with no history of known allergies
allergies, 3 (12%) did not indicate the
(75%, 215) compared to those with knownallergy type. Allergy to Sulphur
allergies (8.71%, 25). containing products was reported in
A total of 47 reports (16.38%) did not 31.82% (7) of patients with indicated
indicate history of known allergy known allergens.
The table above shows the known
allergens documented in the SADR
reports.

Page 2 of 16
 Suspected medicines
(n=312)
No Suspected medicines (INN) Count Proportion
1. TLD 41 13.14%
2. RHZE 38 12.18%
3. Tenofovir 300mg 19 6.09%
4. Cotrimoxazole 960mg 12 3.85%
5. Tenofovir/Lamivudine (300/300mg) 10 3.21%
6. Nifedipine 8 2.56%
7. Rifapentine/Isoniazid 8 2.56%
(300mg/300mg)
8. Metronidazole 8 2.56%
9. Isoniazid 300 mg 8 2.56%
10. Dolutegravir 50mg 6 1.92%
11. Flucloxacillin 6 1.92%
12. Atazanavir/Ritonavir 5 1.60%
(300mg/100mg)
13. Enalapril 5mg 4 1.28%
14. Ciprofloxacin 4 1.28%
15. Amoxicillin/Clavulanate 4 1.28%
16. Ceftriaxone 4 1.28%
17. Methadone hydrochloride 4 1.28%
18. Abacavir/Lamivudine 4 1.28%
(600mg/300mg)
19. Diclofenac Sodium 4 1.28%
20. Isoniazid/Rifampicin 4 1.28%
(300mg/300mg)

Key:
TLD: Tenofovir/Lamivudine/Dolutegravir (300mg/300mg/50mg)
RHZE: Rifampicin/Isoniazid/Pyrazinamide/Ethambutol (150mg/75mg/400mg/275mg)

A total of 104 generic names/fixed dose combinations (FDC) were reported as suspected
medicines in this quarter. Tenofovir/Lamivudine/Dolutegravir (300mg/300mg/50mg)
FDC was the most frequently reported (13.14%).
The Rifampicin/Isoniazid/Pyrazinamide/Ethambutol (150mg/75mg/400mg/275mg)
regimen was reported in 38 cases (12.18%), while Tenofovir 300mg as single molecule
with 19 cases (6.09%) followed by Cotrimoxazole 960mg in 12 cases (3.85%). The table
above consists of a list of the most reported medicines.

Page 3 of 16
 Did the Count Proportion
Rechallenge reaction
(n=287) reappear?
N/A 45 45.92%
Not Indicated 27
Yes 21 21.43%
No 30
Unknown 12 12.24%
Unknown 55
No 12 12.24%
Not Applicable 77
Not 8 8.16%
Yes 98
Indicated
Grand 98 100.00%
Total
Rechallenge was conducted in 34.15% of the The suspected ADR reappeared in only
287 cases reported. 9.41% (27) of the reports 21.43% of the cases where a rechallenge
did not indicate if a re-challenge was done or was done. However, in 8.16% of the cases,
not. there was no indication whether the
suspected ADR reappeared or not.
Commonly reported adverse reactions
The following adverse drug reactions were commonly reported in Quarter 2: itchiness
(12.80%), rash (9.14%), headache (4.94%) and acute kidney injury (3.47%).

Malaise 6
Insomnia 6
Skin Darkening 6
Blisters 7
Fatigue 7
Pain 7
Weakness 7
Numbness 8
Fever 10
Swelling 10
Joint Pain 11
Lower Limb Swelling 11
Dizziness 12
Jaundice 13
Headache 27
Rash 50
Vomiting 16
Erythema 10
Acute Kidney Injury 19
Itchiness 70

0 10 20 30 40 50 60 70 80

Page 4 of 16
 Severity
Of the 287 suspected adverse drug
(n=287)
reaction reports received between 1st Oct
2023 and 31st Dec 2023, 15.33% (44)
135
were classified as severe, 1.39% (4) were
classified as fatal while 4.88% (14) of the
90 reports did not indicate severity. Most of
the reports (47.04%, 135) were graded as
44 being of moderate severity whereas
31.36% (90) of the reports were graded as
4
14 mild.

Fatal Mild Moderate Severe Not

Indicated

Was the reaction serious? Reason for Seriousness

n=287 (n=287)

Congenital anomality 1

Death 6

36%
No Disability 15
Yes
64%
Life threatening 19

Hospitalization/
Prolonged 63
Hospitalization

Out of the 104 serious SADR reports

Of the 287 SADR reports received in Q2, received, hospitalization/ prolonged
36% (104) were classified as serious while hospitalization was the major reason for
most of the received reports (64%, 183) were seriousness (60.58%, 63) followed by life
classified as not serious. threatening with 19 reports (18.27%). A
total of 6 reports (5.77%) were fatal. The
other reasons for seriousness marked by
the reporters were disability and
congenital anomaly as shown in the table
above.

Page 5 of 16
Actions taken
Outcome
Action Taken Count Proportion
(n=287)
Drug withdrawn 171 59.58% Recovered/Resolved… 6

Dose not changed 78 27.18% Fatal 7

Not applicable 15 5.23% Not recovered/Not… 34

Unknown 13 4.53% Unknown 53

Dose reduced 7 2.44% Recovered/Resolved 67

Dose increased 3 1.05% Recovering/Resolving 120

Grand Total 287 100.00%

Among the actions taken by the health care
workers following the occurrence of the
adverse drug reaction included withdrawal
of the offending drug in 59.58% cases, dose
reduction (2.44%) and dose increased
(1.05%). A total of 78 reports (27.18%)
indicated that the dose of the suspect
medicine was not changed.
Out of the 287 SADR reports received in
Q2, 2.44% (7) were reported as fatal.
65.1% reported to have either recovered
or were recovering at the time of
reporting.
The outcome was unknown in 18.47% of
the cases reported.

Diagnosis (n=307)
The prevalence of SADRs in the
No Diagnosis Count Proportion period between 1st October 2023
1 HIV/AIDS 77 21.88% and 31st December 2023 was
2 Tuberculosis 33 9.38% highest among patients with
3 Not Indicated 20 5.68% HIV/AIDS (21.88%), followed by
4 Hypertension 19 5.40% patients with Tuberculosis (9.38%),
5 Kidney Disease 14 3.98% patients on antihypertensives 19
6 HIV/AIDS/TB 13 3.69% (5.40%). and patients with kidney
disease (3.98%). Overall, SADRs in
7 HIV/AIDS/TB 12 3.41%
Prophylaxis this period were reported among
8 Tonsillitis 8 2.27% patients with 89 diagnoses.
9 HIV/AIDS 7 1.99% A total of 20 reports (5.68%) lacked
Prophylaxis a diagnosis
(PREP/PEP) A list of diagnoses with at least 5
10 Gastroenteritis/ 6 1.70% and above SADR reports is shown
Gastritis
on the left.
11 Diabetes 6 1.70%
12 URTI/ Flu 6 1.70% Key:
13 Rash 5 1.42% URTI: upper respiratory tract infections
14 Epilepsy 5 1.42% TB: Tuberculosis
15 Amoebic cyst 4 1.14% HIV/AIDS: Human Immunodeficiency
Virus/ Acquired Immunodeficiency
16 PID/ Vaginal 4 1.14%
Syndrome
candidiasis
SAM: Severe Acute Malnutrition
17 SAM 4 1.14%
PID: Pelvic Inflammatory Disease
18 Meningitis 4 1.14%
19 Opioid Use 4 1.14%
disorder

Page 6 of 16
 Reporter Designation Reporter designation
(n=287)
Majority of the SADR reports received by
Medical officer 1 the national pharmacovigilance center in
the period between 1st October 2023 and
Physician 2 31st December 2023 were submitted by
Other Health Care Pharmacists (45.99%, 132).
3
Professional
Nurse 11 Pharmaceutical technologists submitted
33.45% of the reports (96) followed by
Clinical officer 42 Clinical officers who submitted 14.63%
Pharmaceutical (42) of the total reports
96
technologist
Pharmacist 132

Institution
In this Quarter, only 132 facilities out of the 9,000 facilities listed in the Kenya Master
facility reported SADRs. 16 facilities reported at least 4 reports and above. The top
leading facilities were Port Reitz District Hospital with 13 reports (4.55%) followed by
Nanyuki District Hospital with 10 reports (3.50%) and The Mater Hospital - Mukuru
with 8 reports (2.80%). Below is a list of top 22 facilities with at least 4 reports and
above.

No Institution Count % No Institution Count %

1 Port Reitz District 13 4.55 12 Got Agulu Sub-District 5 1.75
Hospital Hospital
2 Nanyuki District 10 3.50 13 Tudor District Hospital 5 1.75
Hospital (Mombasa)
3 The Mater Hospital 8 2.80 14 Lumumba Sub County 5 1.75
Mukuru Hospital
4 Kaluo Health Centre 8 2.80 15 Kijauri Sub District 4 1.40
Hospital
5 Novartis Kenya 7 2.45 16 Karuri Health Centre 4 1.40
6 Ukwala Sub County 6 2.10 17 Marereni Dispensary 4 1.40
Hospital
7 Oresi hospital 6 2.10 18 Aga Khan Hospital 4 1.40
8 Moi Teaching Referral 6 2.10 19 Dreams Center 4 1.40
Hospital Dispensary (Lang'ata)
9 Reuben Health Centre 5 1.75 20 Our Lady of Lourdes 4 1.40
(GOK) Mutomo Hospital
10 Kenyatta National 5 1.75 21 Consolata Mission 4 1.40
Hospital Hospital (Mathari)
11 Ekerenyo sub county 5 1.75 22 Likii Dispensary 4 1.40
hospital

County
SADR reports were received from 33 of the 47 counties. Nairobi county submitted the
highest number of SADR reports (46, 16.03%) followed by Kirinyaga County (32, 11.15%)
and Mombasa (28, 9.76%). Below is a table of the counties that submitted SADR reports
in quarter 2.

No County Count Proportion No County Count Proportion

1 Nairobi 46 16.03% 18 Trans Nzoia 4 1.39%
2 Kirinyaga 32 11.15% 19 Bungoma 4 1.39%

Page 7 of 16
 3 Mombasa 28 9.76% 20 Baringo 3 1.05%
4 Siaya 26 9.06% 21 Nandi 3 1.05%
5 Kisumu 15 5.23% 22 Taita Taveta 2 0.70%
6 Laikipia 14 4.88% 23 Nakuru 2 0.70%
7 Nyeri 13 4.53% 24 Turkana 1 0.35%
8 Kisii 12 4.18% 25 Tharaka Nithi 1 0.35%
9 Nyamira 11 3.83% 26 Embu 1 0.35%
10 Kiambu 11 3.83% 27 Kajiado 1 0.35%
11 Kitui 9 3.14% 28 Garissa 1 0.35%
12 Kakamega 9 3.14% 29 Elgeyo/Marakwet 1 0.35%
13 Kilifi 9 3.14% 30 Isiolo 1 0.35%
14 Meru 7 2.44% 31 Homa Bay 1 0.35%
15 Makueni 6 2.09% 32 Vihiga 1 0.35%
16 Uasin Gishu 6 2.09% 33 Machakos 1 0.35%
17 Murang'a 5 1.74%

Adverse Events Following Immunization (AEFI)

Vaccine Type Count Proportion
Type of Report (n=51)
Novel oral polio vaccine 22 39.29%
type 2 (nOPV2)
Inactivated polio vaccine 10 17.86%
Malaria (RTSS)Vaccine 7 12.50%
Pentavalent Vaccine 5 8.93%
2%
(DTP-HepB-Hib)
Bivalent oral Polio 3 5.36%
vaccine
Measles Rubella Vaccine 3 5.36%
BCG 2 3.57%
Pneumococcal conjugate 2 3.57%
98% vaccine
Followup COVID-19 Vaccine - 1 1.79%
(JOHNSON&JOHNSONS)
Initial JANSSEN
Tetanus Diptheria 1 1.79%
Vaccine
The National Pharmacovigilance Centre Of the total AEFI reports received, most
received a total of 51 AEFI reports in the events were caused by the Novel oral polio
period between 1st October 2023 and 31st vaccine type 2 (nOPV2) (22), Inactivated
December 2023. 98% (50) of the reports polio vaccine at 17.86% (10), Malaria
received in this quarter were initial (RTSS)Vaccine at 12.50% (7), Pentavalent
reports with only 2% (1) of the total being Vaccine (DTP-HepB-Hib) 8.93% (5) followed
a follow-up report. by Bivalent oral Polio vaccine and Measles
Rubella Vaccine with 5.36% (3) reports each.
The other reports received with BCG and
Pneumococcal conjugate vaccine with 3.57%
(2) reports each, COVID-19 Vaccine -
(JOHNSON&JOHNSONS) JANSSEN and
Tetanus Diphtheria Vaccine with one (1)
report each.

Page 8 of 16
 Gender (n=51) Outcome Count Proportion

Recovering/Resolving 25 49.02%

Recovered/Resolved 17 33.33%

Not recovered/Not 5 9.80%

45%
55% Female resolved/Ongoing
Male Unknown 2 3.92%

Fatal 2 3.92%

Of the AEFI reports received in this Of the 51 AEFI reports (initial and follow-up)
quarter, it was noted that males affected received, 25 indicated the outcome as either
were 55% (28) more than females 45% recovering/resolving. 17 cases recovered
(23). while 5 cases had not recovered at the time
of reporting. 2 cases were fatal.
Reason for Count Proportion
Reaction serious seriousness
(n=51) Other important 4 33.33%
medical event
Hospitalization or 3 25.00%
prolongation of existing
hospitalization
24% Death 2 16.67%
No Yes
Life threatening 2 16.67%

76% Persistent or significant 1 8.33%

disability

Majority of the AEFI reports 76% (39) Of the AEFI reports noted to be serious 33%
received in this quarter were reported as (4) were due to other medical important
not serious, with 24% (12) reported as event, 25% (3) were due to hospitalization or
serious. prolonged hospitalization, 17% (2) were due
to death, and 17% (2) were categorized as life
threatening. 8% (1) of the cases were marked
as serious due to persistent or significant
disability.
Reporter Count Proportion
Designation
Pharmacist 20 39.22%
Nurse 15 29.41%
Pharmaceutical 11 21.57%
technologist
Clinical officer 3 5.88%
Dentist 1 1.96%
Health Records and 1 1.96%
Information Officer

Page 9 of 16
Majority of the AEFIs were reported by
Pharmacists (39.22%). Nurses submitted
29.41% of the reports, pharmaceutical
technologist (21.57%), while Clinical
Officer (5.88%) . It was noted that the least
reporting cadres were Dentists and Health
Records and Information Officers each
with one (1) report.
Majority of the AEFIs reported in this
quarter affected the Child age group (1-11
years) (29) and Infant (<1 year) (20). The
least affected age group in this quarter were
the adult (18-65 years) with only (2) reports.

Reporting institutions
No. Reporting Institution Count Proportion
1 Tigoni Sub County Hospital 8 15.69%
2 Chandaria Health Centre 5 9.80%
3 Gikambura Health Centre 4 7.84%
4 Shalom Community Hospital (Athi River) 2 3.92%
5 Kimaeti Health Centre 2 3.92%
6 Mathare Police Depot 1 1.96%
7 Ushirika Dispensary (Dandora) 1 1.96%
8 Nyakach County Hospital 1 1.96%
9 Greatness dispensary 1 1.96%
10 Malaika Healthcare LTD 1 1.96%
In this Quarter, only 35 facilities out of the 9,000 facilities listed in the Kenya Master
facility reported AEFIs. The top leading facility was Tigoni Sub County Hospital with 8
reports followed by Chandaria Health Centre with 5 reports. Thirty (30) facilities had one
(1) report each.

Reporting Counties

No County Count Proportion No County Count Proportion

1. Kiambu 15 29.41% 8. Siaya 2 3.92%
2. Nairobi 14 27.45% 9. Bomet 1 1.96%
3. Bungoma 4 7.84% 10. Kajiado 1 1.96%
4. Machakos 4 7.84% 11. Kilifi 1 1.96%
5. Vihiga 3 5.88% 12. Laikipia 1 1.96%
6. Kisumu 2 3.92% 13. Nyeri 1 1.96%
7. Mombasa 2 3.92%

Additionally, AEFI reports were received from 13 of the 47 counties. Kiambu and Nairobi
counties submitted the highest number of AEFIs reports (15) and (14) respectively. Five
counties submitted 1 report each whereas six counties submitted more than 2 reports
as detailed in the above table.

Page 10 of 16
Commonly reported AEFIs

No Event Count Proportion

1. 1 Fever 22 32.83%
2. Diarrhea 7 10.45%
3. Generalized urticaria 5 7.46%
4. Vomiting 5 7.46%
5. Rash 4 5.97%
6. Convulsion 3 4.48%
7. Injection site abscess 3 4.48%
8. Lesions on skin and legs 3 4.48%
9. Anaphylaxis 2 2.99%
10. Bleeding at injection site 1 1.49%

Of the AEFIs reported in this quarter, fever was the most reported (32.83%) followed by
diarrhea (10.45%), generalized urticaria and vomiting with a prevalence of (7.46%) each
and rash (5.97%). The other reported AEFIs include; difficulty in breathing, impotence,
left upper arm atrophy, pain, paralysis, severe local reaction and swelling at site of
injection

Medication Errors
Medication Errors Reported per Institution

In quarter 2, a total of 125 medication errors were received. Of this, Kenyatta National
Hospital (KNH) submitted the highest reports 61 (48.8%), followed by Tudor District
Hospital (Mombasa) 26 (20.8%), Savani Medical Centre 10 (8%). The number of other
medication errors that were reported is captured in the table below.

S/N Institution Count Proportion (%)

1 Kenyatta National Hospital 61 48.8
2 Tudor District Hospital (Mombasa) 26 20.8
3 Savani Medical Centre 10 8
4 Nanyuki District Hospital 6 4.8
5 Ukwala Sub County Hospital 4 3.2
6 Coast General Teaching and Referral 4 3.2
Hospital
7 Meru District Hospital 3 2.4
8 Kiambu County Referral Hospital 2 1.6
9 Kisumu District Hospital 2 1.6
10 Port Reitz District Hospital 2 1.6
11 Siaya District Hospital 2 1.6
12 Likoni District Hospital 1 0.8
13 Vihiga County Referral Hospital 1 0.8
14 Kijauri Sub District Hospital 1 0.8
Grand Total 125 100

Page 11 of 16
 Reporter Designation (n=125)
(Gender n=125) 80
70
70
60 52
50
40
30
54, 43% Female 20
71, 57% Male 10 2 1
0

In Q2, 57% (71) of the medication From the reported cases, pharmacists 70
errors occurred in females patients (56%) cases pharmaceutical technologists
while 43% (54) occurred in male reported 52 (41.6%) cases, while clinical
patients. officers reported 2 (1.6%) cases.

Where error occurred (n=125)

Clinic Count Proportion (%)
Outpatient 56 44.8
Not Indicated 46 36.8
CLINIC 18 13 10.4
CCC 4 3.2
Maternity 3 2.4
Pediatric 1 0.8
Oncology 1 0.8
Obs/Gyn 1 0.8
Grand Total 125 100
Most of the medication errors reported occurred in the Outpatient 56 (44.8%), followed
by Clinic 18 in KNH 13 (10.4%). The number of other medication errors that were
reported is captured in the table above. However, a total of 46 reporters did not indicate
where the error occurred.

Age Group (n=125) Process error occurred (n=125)

Age group Count Proportion Process error Count Proportion

(%) occurred (%)
Adult 77 61.6 Prescribing 102 81.6
Child 18 14.4
Dispensing 14 11.2
Infant 14 11.2 (includes filling)
Elderly 7 5.6 Transcribing 4 3.2
Not 5 4
Indicated Administration 3 2.4
Adolescent 3 2.4
Others 2 1.6
Neonate 1 0.8
Grand 125 100 Grand Total 125 100
Total

Page 12 of 16
The incidences of medication errors In Q2, most of the medication errors occurred
was highest amongst the adult age during the prescribing process 102 (81.6%),
group at 77 (61.6%) and Children 18 followed by dispensing 14 (11.2%),
(14.4%), and infants 14 (11.2%) in transcribing 4 (3.2%), and administration 3
comparison to the others. (2.4%).

Medication error outcome (n=125)

Error Outcome Count Proportion (%)
Actual error-did not reach patient 95 76
Actual error-caused no harm 13 10.4
Potential error, circumstances/events have potential 5 4
to cause incident
Treatment /intervention required-caused temporary 4 3.2
harm
Additional monitoring required-caused no harm 4 3.2
Not indicated 3 2.4
Initial/prolonged hospitalization-caused temporary 1 0.8
harm
Grand Total 125 100

Most of the medication errors did not reach the patient 95(76%) and for medication
errors that actually reached the patient ,they did not cause actal harm to the patient
13 (10.4%).Three 5 (4%)errors had the potential to cause harm.

No. of errors per county Did error reach patient

(n=125) (n=125)
County Count Proportion (%) 120
Nairobi 61 48.8 103
Mombasa 43 34.4 100
Siaya 6 4.8
80
Laikipia 6 4.8
Meru 3 2.4 60
Kiambu 2 1.6
Kisumu 2 1.6 40

Vihiga 1 0.8 22
20
Nyamira 1 0.8
Grand Total 125 100 0
No Yes
Most of the reports submitted were Overall, 103 (82.4%) cases of the medication
from Nairobi County 34 (48.8%), error reports received indicated that the
followed by Mombasa County at 43 medication errors committed did not reach the
(34.4%) and the least received was patient. However, 22 (17.6%) cases reached
from Nyamira and Vihiga whose the patient.
contribution was 1 (0.8%) respectively.

Page 13 of 16
 Error Description
Proportion (%)
Error Description Count
Prescribed overdose 31 24.8
Prescribed underdose 13 10.4
Prescribed wrong dose 10 8
Prescribed wrong drug 8 6.4
Look alike medications 8 6.4
Prescribed wrong regimen 6 4.8
Dispensed wrong drug 5 4
Prescribed wrong strength 5 4
Prescribed wrong route 4 3.2
Wrong formulation prepared 2 1.6
Prescribed wrong formulation 2 1.6
Administered wrong drug 2 1.6
Prescribed wrong duration 2 1.6
Prescribed without route of 1.6
administration 2
Prescribed without strength 2 1.6
Prescribed without duration 2 1.6

Of the reports received in Q2, the most frequent errors were prescription errors of
overdosing 31(24.8%), followed by prescription underdose 13 (10.4%), and wrong dose
during prescription 10 (8%). Other error descriptions are as tabulated.

Contributing Factors
Contributing Factor Count Proportion (%)
Inexperienced personnel 50 40
Inadequate knowledge 41 32.8
Distraction 28 22.4
Look alike medications 8 6.4
Look alike packaging 6 4.8
Heavy workload 6 4.8
Peak Hour 5 4
Sound alike medications 3 2.4
Illegible Prescriptions 3 2.4
Inaccurate information 3 2.4
Wrong labelling 2 1.6
Others 2 1.6
In Q2, most medication errors were due to inexperienced personnel 50 (40%), followed
by inadequate knowledge 41 (32.8%), distraction 28 (22.4%), and look alike medicines
8 (6.4%). Other contributing factors are as indicated in the table.

Page 14 of 16
Public Adverse Drug Reporting (PADR)

Age group n=24 Count of Gender n=24

18

Female
48% 52% Male

4
2

adult child infant

The incidence of PADRs was highest The incidences of PADRs were highest
amongst adults (75.00%) followed by amongst females 52.00%. Male reporters
children (16.67%) and infants (8.33%) constituted 48.00% of all the PADRs.

Suspected medicines
The most commonly reported medicine causing adverse drug reaction is the fixed-dose
combination of Tenofovir/Lamivudine/Dolutegravir at 17.86% (5) followed by nOPV
vaccine at 7.14% (2). The rest of the suspected drugs were reported only once as shown
in the above table. It is also key to note that 6 out of 24 reports did not have a suspected
drug indicated.
S/N Drug Count Proportion
1. TDF/3TC/DTG 5 21.74%
2. Nopv2 2 8.70%
3. Metformin 1 4.35%
4. Co-Trimoxazole 1 4.35%
5. Rifapentine 1 4.35%
6. Diracip-M tablets 1 4.35%
7. Viropil 1 4.35%
8. Fluconazole 1 4.35%
9. Nifedipine 1 4.35%
10. Fungiter cream 1 4.35%

Adverse reactions reported

S/N Reaction Count Proportion Most commonly reported
1. Dizziness 6 10.71% PADRs were dizziness, rash,
2. vomiting and drowsiness.
Rash 5 8.93%
Other minor PADRS were
3. Vomiting 5 8.93% diarrhea, nausea, joint pains
4. Drowsiness 5 8.93% and headache as shown in
5. Diarrhea 4 7.14% the table.
6. Nausea 3 5.36%
7. Headache 3 5.36%
8. Joint pains 3 5.36%
9. Red eyes 2 3.57%
10. Swollen face 2 3.57%

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Reporting Counties

PADRs were received from 14 of the 47 counties. Kisumu County submitted the highest
number of PADRs (4) followed by Nairobi County, Siaya County Tana River County and
Meru County (3 each). The rest of the counties submitted 2 or less reports as shown in
the table below.

No County Count Proportion

1 Kisumu 4 14.81%
2 Siaya 3 11.11%
3 Nairobi County 3 11.11%
4 Tana River 3 11.11%
5 Meru 3 11.11%
6 Narok 2 7.41%
7 Mombasa 2 7.41%
8 Kiambu 1 3.70%
9 Kisii 1 3.70%
10 Machakos 1 3.70%
11 Kitui 1 3.70%
12 Vihiga 1 3.70%
13 Laikipia 1 3.70%
14 Nyandarua 1 3.70%

There were no reports received at the National Pharmacovigilance Centre on Transfusion

reactions and medical devices incidences during the period of interest.

For any queries, please contact PV department on pv@pharmacyboardkenya.org or call

0795743049.

Please visit the PvERS web link at https://pv.pharmacyboardkenya.org/ under the summaries tab
for more information on the reports received at the National Pharmacovigilance Center.

This document is produced by the National Pharmacovigilance Center

Data sources: PPB PV Center

WHO VigiLyze Database (NB: the information does not represent the opinion of the World Health
Organization)

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