MINISTRY OF HEALTH

PHARMACY AND POISONS BOARD

Pharmacovigilance Summary Report: July 1st to September 30th 2023 (Q1)

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.
PPB has 4 directorates and the directorate of product safety (PDS) is responsible for
Pharmacovigilance, Post-Market 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.
Since the introduction of PV in Kenya, a total of 16,698 individual case safety reports
have been submitted to the global data reports 36,447,123 (0.05%).

SADRs (Suspected Adverse Drug Reactions)

Age group (n=307)

Product Count Proportion (%) 84.7%
Medicinal product 284 92.51%

Therapeutic 18 5.86%
Ineffectiveness
Others 6 1.95%

Herbal product 1 0.33%

9.4%
Cosmeceuticals 0 0.00% 2.3% 2.9% 0.7%

Adolescent Adult (18- Child (1-12 Elderly Infant

Blood products 0 0.00% (12-17 yrs) 17 yrs) yrs) (>65 yrs) (1month-1
yr)

Most of the reports on suspected ADRs in The incidence of SADRs was highest (84.7%,
the 1st quarter were suspected to be 260) amongst the adult age group (18-64) in
caused by medicinal products (92.51%). comparison to the others. The elderly age
All the 18 reports on therapeutic group made up 9.4% (29) while the
effectiveness were for medicinal products. adolescent age group made up 2.3% (7) of
Out of the 6 SADRs reported as others, 4 the reported SADRs in this quarter. There
were caused by a contrast media while 2 were 9 SADRs reported in children aged
reports were on medicinal products. between 1 and 11 years in this quarter

Page 1 of 19
 Gender (n=307) Pregnancy status (n=188)
Female Male Unknown
59.6%

5%

34%
15.4% 17.6%
61%

2.1% 4.3%
1.1%

1st 2nd 3rd Not Not Not

Trimester Trimester Trimester Applicable pregnant indicated

Out of the 188 Females with reported

The frequency of reported SADRs was SADRs, 2 (1.1%) SADRs were reported
higher in female (61%, 188) compared to among female patients who were in the 1st
male (34%, 104). A total of 15 SADR trimester of pregnancy while 8 (4.3%) were
reports indicated the gender as unknown reported in female patients who were in the
(5%) 3rd trimester. Majority of the affected
females (59.6%, 112) were not pregnant. A
total of 33 (17.6%) SADR reports in female
patients did not indicate the pregnancy
status. Twenty-nine (15.4%) reports
indicated pregnancy status as not
applicable.

Allergy type(n=22) Count Proportion

Known allergy (n=307)
Sulfur based drugs 5 22.7%
No yes Not indicated Not indicated 5 22.7%
Dust and Pollen 2 9.1%
Eggs 2 9.1%
Pollen and perfumes 1 4.5%
Dolutegravir 1 4.5%
19%
BcG 1 4.5%
7% Amoxicillin clavulanate 1 4.5%
Lactose intolerance 1 4.5%
Sulphur and tenofovir, 1 4.5%
74%
lamivudine, zidovudine
Co-trimoxazole 1 4.5%
NSAIDS 1 4.5%
Grand Total 22

The frequency of reported SADRs was Out of the 22 SADR reports with known
higher in patients with no history of allergies, 5 (22.7%) did not indicate the
known allergies (74%, 227) compared to allergy type. Allergy to Sulphur containing
those with known allergies (7%, 22). A products was reported in 22.7% of patients
total of 58 reports (19%) did not indicate with known allergies.
history of known allergy

Page 2 of 19
Generic name (n=307)
No Brand Count % No Brand Count %
1 TLD 59 19.22% 18 Metronidazole 500mg 2 0.65%
2 RHZE 25 8.14% 19 Rifampicin 150mg 2 0.65%
3 Not Indicated 16 5.21% 20 Metronidazole 200mg 2 0.65%
4 Ritonavir 100mg 14 4.56% 21 Ibuprofen 200 mg 2 0.65%
5 Tenofovir 300mg 14 4.56% 22 Ethambutol 100mg 2 0.65%
6 TDF/3TC 12 3.91% 23 Doxycycline 100mg 2 0.65%
7 Dolutegravir 50mg 11 3.58% 24 Ranibizumab 2 0.65%
8 RH 10 3.26% 25 Iron/Folic Acid 2 0.65%
9 Nifedipine Er 20 Mg 9 2.93% 26 Doxycycline 100mg 2 0.65%
10 Co-Trimoxazole 960mg 9 2.93% 27 Levofloxacin 500mg 2 0.65%
11 Ceftriaxone 1000mg 7 2.28% 28 Cefuroxime 500mg 2 0.65%
12 Diclofenac 75mg 6 1.95% 29 Bupivacaine 2 0.65%
Atazanavir/Ritonavir Amoxicillin/Clavulanate
13 (300mg/100mg) 4 1.30% 30 (500mg/125mg) 2 0.65%
14 FTC/TDF 4 1.30% 31 Glimepiride 4mg 2 0.65%
15 Iodixanol 4 1.30% 32 Fluorouracil 500mg 2 0.65%
16 Enalapril 5mg 3 0.98% 33 Isoniazid 300mg 2 0.65%
17 Cotrimoxazole 480mg 2 0.65%
Key:
TLD: Tenofovir/Lamivudine/Dolutegravir (300mg/300mg/50mg)
RHZE: Rifampicin/Isoniazid/Pyrazinamide/Ethambutol (150mg/75mg/400mg/275mg)
TDF/3TC: Tenofovir/Lamivudine (300/300mg)
RH: Rifapentine/Isoniazid (300mg/300mg)
FTC/TDF: Emtricitabine/Tenofovir (200/300mg)

A total of 99 Generic names were reported as suspected medicines in this quarter, with
only 33 generic names being reported in at least 2 SADR reports and above.
Tenofovir/Lamivudine/Dolutegravir FDC was the most reported suspected generic name
among SADRs in this quarter with 59 reports (19.22%). Other most reported generic
names were Rifampicin/Isoniazid/Pyrazinamide/ Ethambutol with 25 reports (8.14%),
Ritonavir 100mg and Tenofovir 300mg each with 14 reports (4.56%) and
Tenofovir/Lamivudine FDC with 12 reports (3.91%). Above is a list of most reported
generic names with at least 2 SADR reports.

Brand name

No Brand Count % No Brand Count %

1 Not Indicated 175 57.00% 12 Doxan 3 0.98%
2 Forecox Trac 12 3.91% 13 Diapride-4 2 0.65%
3 Nicardin SR Tablets 5 1.63% 14 NURABUCAINE 2 0.65%
4 Sulfran-DS. 5 1.63% 15 DICLOVITA 2 0.65%
5 Cefzed 4 1.30% 16 Patizra 2 0.65%
6 Acriptega 4 1.30% 17 Oncofluor 500 2 0.65%
7 Voltfast Powder 50mg 4 1.30% 18 AUROBINDO 2 0.65%
8 Visipaque 4 1.30% 19 Powercef Injection 1 Gm 2 0.65%
9 Atazor-R 3 0.98% 20 Ibucos-200 2 0.65%
10 Nefin 20 Er 3 0.98% 21 Rihide Tablets 2 0.65%
11 Cardace 5mg 3 0.98%

Page 3 of 19
In this 1st quarter, 84 suspected brands were reported in the 307 SADR reports received
by the National Pharmacovigilance Centre. Only 3 brands were reported in at least 5
reports and above. The most reported brands were Forecox Trac with 12 reports (3.91%),
Nicardin SR and Sulfran DS each with 5 reports (1.63%). Other reported brands were
Cefzed, Acriptega, Voltfast and Visipaque each with 4 reports (1.30%). A total of 175
(57%) SADR reports did not indicate the brand names. Above is a list of top 21 suspected
brands that were reported in at least 2 reports and above
Rechallenge (n=307) Rechallenge reappear (n=114)
37.13%
50.00%

18.57% 17.59% 17.92%

14.91% 14.91%
10.53% 9.65%
8.79%

No Not Not Unknown Yes

No Unknown Yes Not Not applicable indicated
applicable indicated

Of the 307 SADR reports received in Q1, In the 114 SADR reports in which a
37.13% (114) reported that a re-challenge rechallenge was done, the suspected ADR
was done while 8.79% (27) reported that a reappeared in only 11 reports (9.65%) and
re-challenge was not done. 17.92% (55) of did not reappear in 17 reports (14.91%). 17
the reports did not indicate if a re- of the 114 reports did not indicate if the
challenge was done or not. suspected ADR reappeared or not.
Reactions
Of the SADRs reported in this quarter, itchiness was the most reported with 55 reports
(10.48%). Other most reported reactions were rash with 53 reports (10.10%), swelling
with 33 reports (6.29%) and nausea with 20 reports (3.81%). The most reported SADRs
in at least 4 reports are listed below

No Event Count % No Event Count %

1 Itchiness 55 10.48% 16 Limb Oedema 8 1.52%

2 Rash 53 10.10% 17 Body Malaise 8 1.52%
3 Swelling 33 6.29% 18 Pain 7 1.33%

4 Nausea 20 3.81% 19 Fever 7 1.33%

5 Impaired Kidney Function 20 3.81% 20 Jaundice 7 1.33%

6 Joint Pain 19 3.62% 21 Insomnia 7 1.33%
7 Headache 18 3.43% 22 Chills 6 1.14%
8 Vomiting 18 3.43% 23 Skin Discoloration 6 1.14%
9 Virologic Failure 14 2.67% 24 Diarrhoea 6 1.14%
10 Dizziness 13 2.48% 25 Skin Peeling 6 1.14%
Therapeutic
11 Neuropathy 12 2.29% 26 ineffectiveness 5 0.95%
12 Numbness 12 2.29% 27 Arrythmia 5 0.95%
Mucosal
13 Malaise 11 2.10% 28 Ulceration 5 0.95%
14 Blisters 10 1.90% 29 Lipodystrophy 5 0.95%
15 Fatigue 9 1.71% 30 Blurred Vision 4 0.76%

Page 4 of 19
 Severity (n=307)
Of the 307 suspected adverse drug reaction
Unknown
reports received between 1st April 2023 and
1.95%
1st July to September 30th 2023, 19.87%
Severe 19.87%
(61) were classified as severe while 3.26% (9)
Not indicated 10.75% were classified as fatal and 10.75% (33) of
Moderate 34.85% the reports did not indicate severity. Most of
Mild 29.32% the reports (34.85%, 107) were graded as
Fatal
being of moderate severity
3.26%

Reaction serious (n=307) Reason for seriousness (n=101)

No Not indicated Yes
Not indicated 26.73%

Life threatening 11.88%

Hospitalization/ Prolonged
40.59%
33% Hospitalization

Disability 10.89%
1% 66%
Death 8.91%

Congenital anomality 0.99%

Out of the 101 serious SADR reports

Of the 307 SADR reports received in Q1, received, hospitalization/ prolonged
33% (101) were classified as serious while hospitalization was the major reason for
1% of the reports (2) did not indicate if the seriousness (40.59%, 41). A total of 27
reaction was serious or not. Most of the (26.73%) out of the 101 serious reactions
received reports (66%, 204) were not reported did not indicate the reason for
serious seriousness. A total of 9 reports (8.91%)
intimated death as the reason for
seriousness
Actions taken
Outcome (n=307)

Action taken Count Proportion Unknown 19.87%

Drug withdrawn 198 64.50% recovering/resolving

37.13%
Dose not changed 72 23.45% recovered/resolved with
0.98%
sequelae
Not applicable 17 5.54%
recovered/resolved 27.36%
Unknown 11 3.58%
not recovered/not resolved 11.73%
Dose increased 5 1.63%
fatal 2.93%
Dose reduced 4 1.30%
Grand Total 307

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Actions taken by the health care workers Out of the 307 SADR reports received in Q1,
included withdrawal of the offending drug 2.93% (9) were reported as fatal. Other
64.50% (198), dose reduction 4 (1.3%) outcomes reported included recovering with
and dose increase 5 (1.63%). A total of 72 114 reports (37.13%), recovered with 84
reports (23.45%) indicated that the dose reports (27.36%) and unknown with 61
of the suspect medicine was not changed. reports (19.87%).

Diagnosis (n=307)
Diagnosis
No Action taken Count Proportion
The incidence of SADRs in the
period between 1st July 2023 and
1 HIV/AIDS 144 46.91%
30th September 2023 was highest
2 Tuberculosis 42 13.68% among patients with HIV/AIDS
3 HIV/AIDS/TB 18 5.86% (46.91%), followed by patients with
Tuberculosis (13.68%), patients
4 Hypertension 13 4.23%
with coinfection with Tuberculosis
5 URTI 12 3.91% and HIV/AIDs (5.86%) and patients
6 Cancer 10 3.26% on antihypertensives 13 (4.23%).
7 Bacterial Infection 5 1.63% Overall, SADRs in this period were
reported among patients with 42
8 Eclampsia 5 1.63%
diagnoses. A list of top 48 diagnoses
9 CT 4 1.30% with at least 2 and above SADR
10 Epilepsy 3 0.98% reports is shown on the left.
11 UTI 3 0.98%
Key:
12 Abdominal Cramps 2 0.65% CT: Computerized Tomography
DME: (Diabetic Retinal Oedema)
13 SLE 2 0.65% URTI: upper respiratory tract infections
14 Iron Supplementation 2 0.65% UTI: Urinary tract infections
SLE: Systemic Lupus Erythematosus
15 Diabetes Mellitus Type 2 2 0.65% TB: Tuberculosis
16 DME 2 0.65%
17 Labor At Term 2 0.65%

Reporter designation Reporter designation

Majority of the SADR reports received by the

Reporter designation (n=307)
national pharmacovigilance center in the
46.6% period between 1st July 2023 and 30th
Pharmacist September 2023 were submitted by
Pharmacists (46%, 143).
Pharmaceutical technologist 41.0%
Pharmaceutical technologists submitted
Nurse 2.6% 41% of the reports (126) followed by Clinical
officers who submitted 9.4% (29) of the total
Medical officer 0.3% reports

Clinical officer 9.4%

Page 6 of 19
Institution
In this Quarter, only 137 facilities out of the 9,000 facilities listed in the Kenya Master
facility reported SADRs. 16 facilities reported at least 5 reports and above. The top
leading facilities were University of Nairobi with 12 reports (3.96%) followed by Norvatis
Kenya with 10 reports (3.3%) and Kenyatta National Hospital with 8 reports (2.64%).
Below is a list of top 21 facilities with at least 4 reports and above
No. Institution Count % No. Institution Count %
Coast Province General
1 University Of Nairobi 12 3.96% 12 Hospital 5 1.65%
2 Novartis Kenya 10 3.30% 13 Aga Khan Hospital 5 1.65%
Consolata Hospital
3 Kenyatta National Hospital 8 2.64% 14 (Nkubu) 5 1.65%
4 Maua Methodist Hospital 7 2.31% 15 Murang'a District Hospital 5 1.65%
5 Kiambu District Hospital 7 2.31% 16 Mbagathi District Hospital 5 1.65%
Nyanza Provincial General
6 Makueni District Hospital 7 2.31% 17 Hospital (Pgh) 4 1.32%
Butere Sub County
7 Port Reitz District Hospital 6 1.98% 18 Hospital 4 1.32%
8 Chogoria (Pcea) Hospital 6 1.98% 19 Akala Health Centre 4 1.32%
The Mater Hospital
9 Mukuru 6 1.98% 20 Webuye Hospital 4 1.32%
10 Masaba District Hospital 6 1.98% 21 Wananchi Nursing Home 4 1.32%
11 Bungoma District Hospital 5 1.65%

County
SADR reports were received from 36 of the 47 counties. Nairobi county submitted the
highest number of SADR reports (71, 23.13%) followed by Mombasa (32, 10.42%) and
Makueni (15, 4.89%). Below is a table of the counties that submitted SADR reports in
quarter 1.

No Name of County Count Proportion No Name of County Count Proportion

1 Nairobi County 71 23.13% 19 Busia 4 1.30%
2 Mombasa 32 10.42% 20 Taita Taveta 4 1.30%
3 Makueni 15 4.89% 21 Machakos 4 1.30%
4 Kisumu 15 4.89% 22 Laikipia 3 0.98%
5 Kiambu 14 4.56% 23 Nyeri 3 0.98%
6 Kirinyaga 14 4.56% 24 Baringo 3 0.98%
7 Meru 14 4.56% 25 West Pokot 3 0.98%
8 Kakamega 13 4.23% 26 Migori 2 0.65%
9 Bung'oma 13 4.23% 27 Samburu 2 0.65%
10 Kilifi 13 4.23% 28 Embu 2 0.65%
11 Tharaka Nithi 8 2.61% 29 Kericho 2 0.65%
12 Kisii 8 2.61% 30 Narok 2 0.65%
13 Homa Bay 7 2.28% 31 Bomet 2 0.65%
14 Nyamira 6 1.95% 32 Vihiga 1 0.33%
15 Siaya 6 1.95% 33 Uasin Gishu 1 0.33%
16 Kitui 6 1.95% 34 Kajiado 1 0.33%
17 Murang'a 6 1.95% 35 Turkana 1 0.33%
18 Nakuru 5 1.63% 36 Nyandarua 1 0.33%

Page 7 of 19
ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI)
Vaccine Type Count Proportion
Type of Report (n=204)
COVID-19 Vaccine - 95 57.58%
Followup Initial JANSSEN
COVID-19 Vaccine - 31 18.79%
PFIZER/BioNTech
Malaria (RTSS)Vaccine 10 6.06%
Oral Cholera 8 4.85%
vaccine(Euvichol
Measles Rubella Vaccine 7 4.24%
23%
Pentavalent Vaccine (DTP- 4 2.42%
HepB-Hib)
Human Papiloma virus 3 1.82%
vaccine
Novela oral polio type 2 3 1.82%
vaccine
77% Hepatitis B Vaccine 1 0.61%
Inactivated polio vaccine 1 0.61%
Pneumococcal conjugate 1 0.61%
vaccine
Tetanus Diptheria Vaccine 1 0.61%

A total of 204 AEFI reports were received Of the total AEFI reports received, most
by the NPC in the period between 1st July events were caused by Covid-19 vaccines
2023 and 30th September 2023. 77% (158) (126). Johnson and Johnson’s Janssen
of the reports received in this quarter were vaccine was the most suspected vaccine at
initial reports with only 23% (46) of the 57.58% (95) followed by Pfizer/BioNTech at
total being follow-up reports. 18.79% (31) with the least reports received
Of the 46 follow up reports, 2 of the from the Pneumococcal conjugate vaccine,
reports do no have their initial reports Tetanus Diphtheria Vaccine, Inactivated
within the interval analyzed. polio Vaccine and Hepatitis B vaccines at
one (1) report each.
Gender (n=160) Outcome (n=204)

Unknown 2

Fatal 2
39% Female Not recovered/Not
15
Male resolved/Ongoing
61%
Recovered/Resolved 87

Recovering/Resolving 98

Of the initial AEFI reports received in this Of the total AEFI reports (initial and follow-
quarter, it was noted that females were up) received, 48.04% indicated the outcome
affected 61% (98) more than males 39% as either recovering/resolving with 98
(62). reports. 42.65% of the reported cases (87)
were noted to have recovered/resolved with
7.35% (15) of the outcomes reported as not
recovered/not resolved/ongoing. Two (2)
reports were received whose outcome was
unknown while two (2) reports were fatal.

Page 8 of 19
 Reaction Serious (n=204) Reason For Seriousness (n=10)
No Yes
PERSISTENT OR SIGNIFICANT
DISABILITY 1

LIFE THREATENING 2
5%
HOSPITALIZATION OR
2
PROLONGATION OF EXISTING…

DEATH 2
95%
OTHER IMPORTANT MEDICAL
3
EVENT

Majority of the AEFI reports 95% (194) Of the AEFI reports noted to be serious 30%
received in this quarter were reported as (3) were due to other medical important
not serious, with 5% (10) reported as event, 20% were due to hospitalization or
serious. prolonged hospitalization, 20% were due to
death, and 20% were categorized as life
threatening. 10% of the cases were marked
as serious due to persistent or serious
disability.

Reporter Designation (n=204) Age Group (n=160)

140
PHYSICIAN 1 122
120
HEALTH RECORDS AND
INFORMATION OFFICER 1 100
PHARMACEUTICAL
3 80
TECHNOLOGIST
60
CLINICAL OFFICER 4
40
PHARMACIST 7 17
20 9 9
3
NURSE 17 0
Infant (1m- Child (1yr - Adolescent Adult (18 Elderly (65
RESEARCH ASSISTANT 171 1Yr) 11yrs) (12 yrs - 17 yrs - 65 yrs) Yrs +)
yrs)

Majority of the AEFIs in this quarter were Majority of the AEFIs reported in this
reported by research assistants who quarter affected the adult age group (122)
submitted 171 (83.82%) reports. Nurses and children (17). The least affected age
submitted 17 (8.33%) reports, group in this quarter were the elderly with
Pharmacists submitted 7 (3.43), while only (3) reports.
pharmaceutical technologist submitted 3
(1.96) reports. It was noted that the least
reporting cadres were physicians and
Health Records and Information Officers
each with one (1) report.

Page 9 of 19
Reporting institution (n=33)
No Facility Count % No Facility Count %
1. Kitengela Health 67 32.84% 17. Cherangany Health 1 0.49%
Centre Centre
2. Giaki Sub-District 27 13.24% 18. Gatundu Level 5 1 0.49%
Hospital Hospital
3. Homa Bay District 17 8.33% 19. International 1 0.49%
Hospital organisation for
migration (IOM)
4. Mama Lucy Kibaki 16 7.84% 20. Janeiro Nursing Home 1 0.49%
Hospital -
Embakasi
5. Nyabondo Mission 14 6.86% 21. Jomvu Model Health 1 0.49%
Hospital Centre
6. Webuye Hospital 11 5.39% 22. Kabula Dispensary 1 0.49%
7. Masimba Sub- 8 3.92% 23. Kajiado District 1 0.49%
District Hospital Hospital
8. Transmara District 5 2.45% 24. Kegoye dispensary 1 0.49%
Hospital
9. Kayole I Health 4 1.96% 25. Kendu Sub-District 1 0.49%
Centre Hospital
10. Huruma District 3 1.47% 26. Kimaeti Health Centre 1 0.49%
Hospital
11. Kariobangi South 3 1.47% 27. Kuoyo Kaila Health 1 0.49%
Dispensary Centre
12. Kathiani District 3 1.47% 28. Mtito Andei Health 1 0.49%
Hospital Centre
13. Kayole II Sub- 3 1.47% 29. Nairobi South 1 0.49%
District Hospital DISPENSARY
14. Live Well Health 2 0.98% 30. Ngiluni Dispensary 1 0.49%
Clinic (Kibwezi)
15. Rangwe Sub- 2 0.98% 31. Siboti Model Health 1 0.49%
District Hospital Centre
16. Vihiga District 2 0.98% 32. Umoja Health Centre 1 0.49%
Hosptial
33. Wangige Sub County 1 0.49%
Hospital

In this Quarter, only 33 facilities out of the 9,000 facilities listed in the Kenya Master
facility reported AEFIs. The top leading facility was Kitengela Health Centre with 67
reports followed by Giaki Sub-District Hospital with 27 reports. Seventeen (17) facilities
had one (1) report each.
Reporting counties
No County Count % No County Count %
1. Kajiado 68 33.33% 9. Machakos 3 1.47%
2. Nairobi 31 15.20% 10. Uasin Gishu 3 1.47%
County
3. Meru 27 13.24% 11. Vihiga 3 1.47%
4. Homa Bay 21 10.29% 12. Kiambu 2 0.98%
5. Kisumu 15 7.35% 13. Makueni 2 0.98%
6. Bung'oma 14 6.86% 14. Mombasa 1 0.49%
7. Kisii 8 3.92% 15. Trans Nzoia 1 0.49%
8. Narok 5 2.45%
Additionally, AEFI reports were received from 15 of the 47 counties. Kajiado and Nairobi
counties submitted the highest number of AEFIs reports (68) and (31) respectively. Two
counties submitted 1 report each including Mombasa and Trans Nzoia counties.

Page 10 of 19
Adverse Events
No Event Count % No Event Count %
1. Pain at the injection 60 24. Anxiety 1 0.41%
site 24.90%
2. Headache 38 15.77% 25. Blurry vision 1 0.41%
3. General Body Malaise 21 26. Cerebrovascular 1 0.41%
8.71% Accident
4. Fever 16 27. Coldness at the 1 0.41%
6.64% injection site
5. Numbness of the 19 28. Diarrhea 1 0.41%
injection site 7.88%
6. Dizziness 8 3.32% 29. Discomforts 1 0.41%
7. Hand pain 6 2.49% 30. Dysuria 1 0.41%
8. Flu 6 31. Early onset of 1 0.41%
2.49% Menstruation
9. Shoulder pain 5 2.07% 32. Heavy arm 1 0.41%
10. Loss of appetite 4 1.66% 33. High fever 1 0.41%
11. Back Pains 3 1.24% 34. Hypersomnia 1 0.41%
12. Cough 3 1.24% 35. Irritability 1 0.41%
13. Fatigue 3 36. Painful left upper 1 0.41%
1.24% arm
14. Drowsiness 3 1.24% 37. Poor feeding 1 0.41%
15. Chest Pains 3 1.24% 38. Redness 1 0.41%
16. Joint pains 3 1.24% 39. Restless 1 0.41%
17. Vomiting 3 1.24% 40. Abdominal Pain 1 0.41%
18. Whole body pains 3 41. Swelling at the site 1 0.41%
1.24% of injection
19. Stomachache 2 0.83% 42. Swollen left eye 1 0.41%
20. Running nose 2 43. Swollen and Painful 1 0.41%
0.83% upper arm
21. Rashes 2 0.83% 44. Tearing 1 0.41%
22. Fast breathing 2 0.83% 45. Tonsils 1 0.41%
23. Death 2 46. Weakness of the left 1 0.41%
0.83% limb

Of the AEFIs reported in this quarter, injection site pain was the most reported with an
incidence of 24.9%. Other most reported AEFIs were headache (15.77%), general body
malaise (8.71%), numbness of the injection site (7.88) fever (6.64%) and dizziness
(3.32%). The most reported AEFIs are listed above

Medication errors
Medication Errors Reported per Institution
No. of Reported Percentage of Reported Cases
Institution Cases

Kenyatta National Hospital 34 40%

Savani Medical Centre 17 20%

Kiambu Level 5 Hospital 15 17.64%

Ukwala Sub County Hospital 3 3.52%

Nanyuki District Hospital 3 3.52%

Page 11 of 19
Mariakani District Hospital 2 2.35%

Thika Level 5 Hospital 2 2.35%

Mrima Likoni 2 2.35%

SIMENYA HEALTH CENTRE 1 1.17%

Masaba District Hospital 1 1.17%

Likoni District Hospital 1 1.17%

Vipingo Rural 1.17%

Demonstration Health
Centre 1

Port Reitz District Hospital 1 1.17%

Murang'a District Hospital 1 1.17%

Ruiru Sub-County Hospital 1 1.17%

Grand Total 85 100%

Of the 85 Medication error reports received, Kenyatta national hospital submitted the
highest number of reports (34), followed by Savani Medical Centre with 17 reports, and
Kiambu Level 5 Hospital at 15. The number of other medication errors that were
reported is captured in the table above.

Gender (n=85) Reporter Designation (n=85)

9% Pharmaceutical
technologist
28, 33%
Female Pharmacist
52%
Male 39%
57, 67% Other Health Care
Professional

In Q1, 67% (57) of the medication errors From the reported cases, pharmaceutical
occurred in females patients while 33% technologists reported 44 (51.76%) cases,
(28) occurred in male patients. pharmacists 33 (38.82%) cases while other
healthcare provders reported 8 (9.41%)
cases.

Page 12 of 19
 Where the Medication Error Occured

DAYCARE 1

MATERNITY 1

DENTAL 1

INPATIENT 6

ONCOLOGY CLINIC 6

CCC 10

OPD 20

NOT INDICATED 40

0 5 10 15 20 25 30 35 40 45

Most of the medication errors reported occurred in the OPD (20), followed by CCC (10),
Oncology clinic (6) and the inpatient wards (6). However, a total of 40 reports did not
indicate where the error occurred.

Age Group (n=85)

Process Error Occurred (n=85)

68

Elderly 4

Neonate 4

Adolescent 7

Infant 8

Child 17 8 7
2
Adult 42
Prescribing Administration Dispensing Others
0 20 40 60
(includes filling)

The incidences of medication errors In this Quarter, most of the medication

was highest amongst the adult age errors occurred during the prescribing
group at 49.41% (42) and Children 20% process 68 (80%), followed by administration
(17), and infants 9.41% (8) in 9% (8) cases, dispensing 7 (8.23%), and other
comparison to the others. 2 (2.36%).

Medication Error Outcome

Error Error of Outcome Percentage of error outcomes

Actual error-did not reach 45.88%

patient 39

Not Indicated 14 16.5%

Actual error-caused no harm 10 11.76%

Page 13 of 19
Potential error, 10.6%
circumstances/events have
potential to cause incident 9

Treatment /intervention 7.05%

required-caused temporary
harm 6

Additional monitoring 3.53%

required-caused no harm 3

Initial/prolonged 3.53%
hospitalization-caused
temporary harm 3

Death 1 1.12%

Grand Total 85 100%

Most of the medication errors did not reach the patient 39(45.88%) and for medication
errors that actually reached the patient ,they did not cause actal harm to the patient
15 (17.64%).14 reporters did not indicate the outcome of the medication error. Three
(3) errors were serious as they caused prolonged hospitalization and one (1) error was
fatal.

Error per County (n=85) Did Error reach the patient

(n=85)
34

21
18

26, 31%
No
4 3 3
1 1 Yes
59, 69%
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Most of the reports submitted were Overall, 69.4% (59) cases of the medication
from Nairobi County 40% (34), followed error reports received in quarter 1 by the
by Mombasa County at 24.7% (21) and national pharmacovigilance center indicated
the least received was from Nyamira that the medication errors committed did not
and Murang’a whose contribution was reach the patient. However, 30.59% (26)
1.17% (1) respectively. cases reached the patient.
Errors Committed by
Error Description No. of errors committed Percentage

Prescribed an overdose 15 17.65%

Prescribed an underdose 14 16.47%

Prescribed wrong regimen 13 15.29%
Prescribed wrong drug 6 7.06%

Prescribed wrong dose 4 4.70%

Page 14 of 19
 Wrong drug dispensed 3 3.53%

Prescribed wrong dosing frequency 2 2.35%

Drug not dispensed 2 2.35%

Prescribed an allergic drug 2 2.35%

Wrong prescription duration 2 2.35%

Dispensed wrong regimen 2 2.35%

Wrong drug prescribed 2 2.35%

Of the reports received, the most frequent errors were prescription errors of overdosing
15 (17.65%), followed by prescription underdose 14 (16.47%), and wrong regimen
prescription 13 (15.29%). Other errors are as tabulated.

Contributing Factors
Contributing Factor No. Of errors Percentage of errors per factor

Inexperienced personnel 20 23.53%

Heavy workload 8 9.41%

Inadequate knowledge 5 5.88%

Distraction 3 3.53%

Peak Hours 3 3.53%

Sound alike 1 1.18%

Look alike packaging 1 1.18%

Stock arrangements 1 1.18%

work procedure 1 1.18%

Illegible prescriptions 1 1.18%

Inaccurate information 1 1.18%

Wrong labelling 1 1.18%

Others 1 1.18%

In quarter 1(Q1), most medication errors were due to inexperienced personnel 20

(23.52%), followed by heavy workload 8 (9.41%), inadequate knowledge 5 (5.88%),
distraction 3 (3.53%), and peak working hours 3 (3.53%). Other contributing factors
are as indicated in the table.

Blood Transfusion Reactions

Seven (7) reports of blood transfusion reactions were received in quarter 1(Q1). A total of
4 reports were submitted by pharmaceutical technologists while 3 reports were submitted
by Pharmacists.

The incidence of Blood transfusion reactions was highest (57%) amongst the adult age
group (18-64 year) in comparison to the elderly age group at 43% (>65 years). The
frequency of reported reactions was higher in females (57%,4) compared to (43%,3) males.

Page 15 of 19
Two of the patients had received a blood transfusion due to low Hemoglobin (Hb) levels
while three due to anemia and one was not indicated for the reason for transfusion.
Only one patient who had previously received a blood transfusion had a previous reaction.

Of the blood transfusion reactions reported during this quarter; Rigors and chills was the
most reported with 5 reports (20%) each. The other most reported reactions were fever
with 4 reports (16%), Tachycardia 3 reports (12%) and chest pain 2 reports (8%). The
other reported reactions were coughing, difficulty in breathing, flushing, intense itching
and severe backpain.

The most reported Blood Transfusion reactions are listed below;

No Event Count % No Event Count %

1 Rigors 5 20% 6 Coughing 1 4%

2 Chills 5 20% 7 Difficulty in breathing 1 4%

3 Fever 4 16% 8 Flushing 1 4%

4 Tachycardia 3 12% 9 Intense itching 1 4%

5 Chest pain 2 8% 10 Severe backpain 1 4%

Medical Device Incidence Reports

A total of 6 medical device incidents (MDI) were reported in the 1st Quarter. Two (2) of
these reports were received from Kakamega County, One (1) from Kilifi County, Two (2)
from Nairobi County and One (1) from Nakuru County.

Of the 6 Medical Device Incidents; 4 occurred in females and 2 in males. From the MDI
reports it was indicated that 3 of the problems had been noted prior by the reporters.

The reported medical device incidents are as tabled below:

Medical Device Manufacturer Incident (Event)

Vega R58 Microport Crm S.R.L. Duration of implantation-4 months.

The patient experienced dizziness with
regular fainting episodes.

This event was classified as a serious

event that led to the hospitalization of
the patient.

Infusion Set with Flow Qingdao Luckmed The infusion set flow regulator is not
Regulator Supplies Co., Ltd working

Sterile Latex Powdered Ideal Medical Industries Hole in the pair of gloves
Gynecological Gloves Co.Ltd

Infusion Set Not Vented Trident Mediquip Infusion set is made by polyvinyl
Limited chloride material and is leaking and
reacting with chemotherapy

Page 16 of 19
 Infusion Set Vented Angel Products The infusion set is leaking and is poly
vinyl chloride made thus not suitable
for chemotherapy administration

IUD Corporate Channels Patients had frequent complaints of

India Private Limited vaginal discharge and itchiness. On
removal, the copper T device had signs
of rusting.

This event was classified as a serious

event but lacked the reason for
seriousness.

Of the 6 MDI, the devices were handled by healthcare professionals (Pharmaceutical

Technologist (1 incidence), Pharmacist (4 incidences) and Other Health Care
Professional (1 incidence).

The event classification was (1) mild, (2) serious and (3) unknown. Only one (1) of the
reports indicated the reason for seriousness as Hospitalization or prolongation of
existing hospitalization. The indicated outcomes were (3) recovered (1) recovering and
(2) unknown

PUBLIC ADVERSE DRUG REPORTING (PADRS)

Age Group (n=32) Count of Gender (n=32)
35
30
25 29
20%
20 Female

15
47% Male

10 Unknown
33%
5
1 1 1
0
Adolescent Adult Child Elderly

The incidence of PADRs was highest The incidences of PADRs were highest
among adults (90.63%) with adolescents, amongst males (33%). Female reporters
child, and elderly at 3.13% each. constituted 20%. However, 47% (14) of the
reports did not have an assigned gender.

Page 17 of 19
Suspect medicine
Medicine Count Percentage

Unknown 19 59.38%
The most commonly reported medicine
causing adverse drug reactions is the
TDF/3TC/DTG 6 18.75% fixed dose combination of
RHZE 2 6.25%
Tenofovir/Lamivudine/Dolutegravir at
18.75% (6) followed by RHZE at 6.25%
3HP 1 3.13% (2). The rest of the suspected drugs were
Aqueous Cream 1 3.13%
reported only once below table. It is also
key to note that 19 out of 32 reports did
Cotrimoxazole 1 3.13% not have a suspected drug indicated.
TDF/FTC 1 3.13%

Vitamin K 1 3.13%

Reaction
Count Percentage
Event Most commonly reported event was rash
Unknown 20 47.62%
at 21.43%, followed by stomach pain,
Rash 9 21.43% diarrhea and vomiting at 7.14% each. All
the other events reported were fatigue,
Stomach pain 3 7.14% headache, insomnia and joint and
Diarrhea 3 7.14% muscle pain at 2.38% each. It is
important to note that 47.62% of the
Vomiting 3 7.14% reported event was unknown.
Fatigue 1 2.38%

Headache 1 2.38%

Insomnia 1 2.38%

Joint and muscle

pain 1 2.38%

County

Count Percentage PADRs were received from 9 of the 47

County counties. Nairobi County submitted the
Nairobi County 15 46.88%
highest number of PADRs (15) followed
Nakuru 4 12.50% by Nakuru County (4), Siaya and Kisii
Counties submitted 3 reports each.
Kisii 3 9.38% Counties that reported 2 cases or less
Siaya 3 9.38% included Kiambu, Mombasa, Embu,
Marsabit and Nandi Counties.
Kiambu 2 6.25%

Mombasa 2 6.25%

Embu 1 3.13%

Marsabit 1 3.13%

Nandi 1 3.13%

Page 18 of 19
 Abbreviations: PPB = Pharmacy & Poisons Board

PV = Pharmacovigilance

NPC = National Pharmacovigilance Centre

sADR = suspected Adverse Drug Reaction

PQMP = Poor Quality Medicinal Product

PVERS = PV Electronic Reporting System, SOC = System Organ Classification

For any queries please contact PV department on [email protected] or call

0795743049.

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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