To establish factors influencing voluntary reporting of adverse drug reactions among health workers. A second objective was to establish the level of awareness on adverse drug reaction reporting and attitudes towards the voluntary adverse drug reaction reporting scheme.
Design: Cross sectional descriptive study.
Setting: Parirenyatwa Hospital, a major referral and teaching hospital in Harare, Zimbabwe.
Subjects: 200 health professionals randomly selected from various departments.
Main Outcome Measures: Number of health workers reporting adverse drug reactions; awareness of the adverse drug reaction reporting scheme

Chikuni, O.

Khoza, S.

Madungwe, I.

Mthethwa, J.

Nyambayo, P.

Central African Journal of Medicine

English

IDS OpenDocs

Vol. 50, Nos. 11/12 CONTENTS November-December 2004
ORIGINAL ARTICLE
Adverse drug reactions reporting at a referral 
hospital in Zimbabwe........................................
An experience with surgical admissions to a 
paediatric ICU (PICU) in Harare, Zimbabwe....
Chronic lymphocytic leukaemia (CLL) in 
Central Africans................................................
REVIEW ARTICLE
Making research ethics review work in 
Zimbabwe — the case for investment in 
local capacity.....................................................
NOTES AND VIEWS
Reviewer’s List For 2004..................................
Instructions to Authors......................................
S Khoza, I Madungwe, P Nyambayo,
J Mthethwa O Chikuni ....................................104
I-E Pazvakavambwa........................................107
J M Mukiibi, B Paul, C M Nyirenda,
J O Adewuyi, C Gwanzura, ELB Mzulu,
E M Mbvundula, E D Magombo,
H N M alata..................................................... I l l
J Mielke, P Ndebele.........................................115
Central African Journal of Medicine.............  119
Central African Journal of Medicine............. 120
THE CENTRAL AFRICAN 
JOURNAL OF MEDICINE
ORIGINAL ARTICLES
Adverse drug reactions reporting at a referral hospital in
Zimbabwe
*S KHOZA, *1 MADUNGWE, **P NYAMBAYO, *J MTHETHWA * 0  CHIKUNI
Abstract
Objectives: To establish factors influencing voluntary reporting of adverse drug reactions among health 
workers. A  second objective was to establish the level of awareness on adverse drug reaction reporting and 
attitudes towards the voluntary adverse drug reaction reporting scheme.
Design: Cross sectional descriptive study, t „
Setting: Parirenyatwa Hospital, a major referral and teaching hospital in Harare, Zimbabwe.
Subjects: 200 health professionals randomly selected from various departments.
Main Outcome Measures: Number of health workers reporting adverse drug reactions; awareness of the 
adverse drug reaction reporting scheme.
Results: 144 (72%) questionnaires were completed. About half (47.2%) of the respondents did not know how 
to report an adverse drug reaction and 47.1% were unaware of the existence of a formal adverse drug reaction 
reporting scheme in Zimbabwe. One fifth (20.1%) of the respondents had reported an adverse drug reaction 
at some point. Two main factors contributing to under-reporting cited by respondents were the poor feedback 
from the national reporting centre (59%) and inaccessibility of reporting facilities (45.8%). Beliefs that one 
should only report an adverse drug reaction if certain of causality (46.5%) and that really serious adverse drug 
reactions are well documented before a drug is marketed (35.4%) could also account for under reporting. 
However, 75.7%, viewed adverse drug reaction reporting as a professional obligation.
Conclusion: Lack o f awareness of healthcare professionals to the national (Medicines Control Authority of 
Zimbabwe) adverse drug reaction voluntary reporting scheme, poor feedback and inaccessibility of reporting 
facilities are the main factors contributing towards underreporting.
\\ / . Cent Afr J  Med 2004;50(ll/12):104-7
Introduction \ /serious and result in illness, injury or even death. Early
\ / recognition of a drug’s potential adverse reaction profile
Adverse drug reactions (ADRs) are fairly common and are \ is, therefore, critical in ensuring safety for the user of 
responsible for a significant number of hospital admissions \ , drugs, as well as reducing costs attributable to ADRs. An 
with reported ranges o f 0.3-7%.1 Studies have also shown '\ j attempt is made during pre-marketing trials to identify the 
that ADRs are very costly.2The outcome of an ADR can be adverse reaction profile of the drug, but these trials do not
^Departm ent o f  C linical Pharmacology Correspondence and reprint requests to:
' ' A  
A • \
University o f  Zimbabwe S  Khozd
M edical School *Department o f  Clinical Pharmacology
P  O B o x A I7 8 , Avondale University o f  Zimbabwe
Harare, Zim babwe M edical School
**Medicines Control Authority o f  Zimbabwe P  O Box A.178
109 Baines A venue  
Harare, Zimbabwe
Avondale, Harare
Cent Afr J Med 2004;50(11/12) Ar-CA 104
quite effectively identify all ADRs mainly due to the 
relatively small number of patients evaluated. Clinical 
trials, are usually of short duration and hence are not 
"■adequate to detect delayed consequences associated with 
long term drug administration. These trials also exclude 
special groups such, as pregnant women, children, the very 
old and patients with multiple disease states or any other 
complicating factors, who may be at higher risk for unique 
ADRs compared to the general population.3 ADRs due to 
drug interactions are difficult to detect in pre-marketing 
studies.4
The limitation of pre-marketing trials means that approval 
of a new drug does not exclude the possibility of rare but 
serious ADRs or common delayed ADRs. Continuous 
post-marketing monitoring and reporting of ADRs is, 
therefore, necessary. Voluntary reporting of ADRs is almost 
certainly the most cost effective and practical way of 
gathering post-marketing drug safety information 
continuouslyrSome studies have suggested the voluntary 
reporting system may. be the only affordable mechanism 
available for early detection of serious clinical events that 
occur less frequently than once per 10 000 drug exposures.5
Accumulating evidence suggests that healthcare workers ’ 
attitudes towards their national ADR reporting schemes 
are significant determinants of reporting rates. Therefore 
insights into the reasons for under reporting might enable 
the national reporting centre, Medicines Control Authority 
of Zimbabwe (MCAZ) to take appropriate measures to 
increase reporting rates, hence the need to investigate 
factors influencing ADR reporting.
Voluntary ADR reporting schemes have operated since 
the 1960s in many western countries. These surveillance 
systems enable healthcare workers to report suspected 
ADRs and thus act as a tool to identify new ADRs and risk 
factors predisposing to recognised ADRs. However, under 
reporting has been shown to be the major weakness of the 
system and a small proportion of ADRs are actually 
reported to national reporting centres. Professionals in the 
field of pharmacovigilance agree that international ADR 
reporting rates, even of serious reactions are very low.6
In Zimbabwe there has been a very slow response from 
health workers in reporting ADRjs.. Improvement of 
reporting rates is thus a major priority of the national 
reporting centre. __
M aterials and Methods
 ^ The study was carried out at Parirenyatwa Hospital, a 
teaching hospital in Harare during the period February to 
March 2004. Healthcare professionals from internal 
medicine, paediatrics, the interiSve care unit, outpatients, 
casualty, obstetrics, ophthalmology, dentistry, pharmacy 
and rehabilitation departments were interviewed and these 
included: nurses, doctors, dentistsypharm acists, 
physiotherapists and pharmacy technicians.
Participating doctors and nurses were systematically 
selected from the lists obtained from the staffing department
(every third nurse and every second doctor on the respective 
lists). However, beqause of the small number of staff in the 
other professions in the hospital, all were targeted.
Aself-administered questionnaire was distributed to 200 
targeted participants: 100 nurses, 50 doctors, 18 dentists, 
15 physiotherapists, 14 pharmacists and three pharmacy 
technicians. The questionnaire was distributed to the 
participants in their respective departments and collected 
within a period of two weeks, after which the participants 
were considered as non-responders. The questionnaire 
was adapted from that used in other studies6 and modified 
after a pilot study. Demographic data, awareness of the 
MCAZ’s voluntary reporting scheme, knowledge about 
the operation and purpose of the reporting scheme as well ' 
as attitudes towards ADR reporting was collected. 
Knowledge and attitudes were measured using a series of 
statements, to which the respondent was to indicate if he/ 
she agreed, did not agree or was not sure.
Results
One hundred and forty four (72%) participants completed 
and returned the questionnaire, of which 57.6% (83) were 
females, and 51.4% (74) were nurses, 24.3% (35) 
doctors, 6.9% (10) dentists, 6.3% (nine) physiotherapists,. 
9% (13) pharmacists and 2.1% (three) pharmacy 
technicians. The sample consisted of participants mainly 
below the age of 30 years (71%) and those between 30 to 
40 years (26%). Those above 40 years constituted 3% of 
the respondents. Of the respondents 75% had less than five 
years of post-training working experience, 19.4% had 
between five to 10 years whilst 5.6%.had over 15 years of 
service. \
Figure I: Awareness of Medicines Control Authority of 
Zimbabwe Adverse drug reaction reporting scheme.
* Awareness ol MCAZ MIR reporting scheme 
70
reporting torms
Figure I above shows that 58.3% of the respondents 
knew that a formal ADR reporting scheme exists while 
52.8% knew how to report an ADR and 66% knew about 
ADR forms in the Essential Drugs List of. Zimbabwe 
(EDLIZ). Out of all the respondents only 20.1% had
C e n t A f r J  Med 2004;50(11/12) 105
Discussionreported an ADR to the MCAZ even though all indicated 
that it was important to do so. Of those who had reported 
an ADR, 69% were females and 65.5% were nurses, while 
21% were doctors. However, there was no significant 
difference in the reporting fates between nurses and other 
j professionals (p = 0.0883). • . ,
Table I: Knowledge on purpose of, ADR reporting.
Response (%)
Question , Agree Not Sure Disagree
/
P u r p o s d  o f  A D R  re p o r t in g  s c h e m e  
. E n a b le  s a fe  d ru g s  to  b e  u s e d . 82.6 16 1.4 :
M e a s u r e  in c id e n c e  o f  a ll A D R s 77,1 ' 16. . 6.9 .
Id e n t ify  fa c to rs  p re d is p o s in g  to  A D R s .• 72.9 22.9 4.2 ’
(d e n t i fy p r e v io u s ly  u n r e g o n is e d  A D R s 84 13.9 2.1
C o m p a r e  b ra n d  a n d  g e n e r ic  p ro d u c ts 38.9 48.6 12.5
T o  b b ta in in fo r m a t io n  a b o u t  c h a ra c te r is t ic s  
' o f  c e r ta in  A D R s  . , ' 83.3 14.6 2.1
T o  c o m p a re  A D R s  in. Z im b a b w e  to  th o s e  
e x p e r ie n c e d  e ls e w h e r e . 50.7 38.2 11.1
P o te n t ia l fo r  im p ro v in g  q u a li ty  o f  c a r e 97.9 1.4 0.7 '
Most of the respondents were able to correctly identify 
the purposes of having a reporting scheme as shown in 
Table I; However, only 38.9% knew that such a system 
could be used to compare brand and generic products and: 
some did not realise it could be used to compare ADRs in 
Zimbabwe to those experienced elsewhere.
Table [I; Attitudes towards ADR reporting.
Response (%)
Attitude or opinion Agree Neutral Disagree
R e a l ly  s e r io u s  A D R s  a r e  w e ll d o c u m e n te d  
b e fo re  a  d ru g  is  m a rk e te d 35.4 31.9 32.6 '
It is  re a lly  im p o s s ib le  to  d e te r m in e  if a  d ru g  is 
re s p o n s ib le  fo r  a  p a r t ic u la r  A D R . .18.1 ' 36.8 45.1
I w o u ld  o n ly  re p o rt  a n  A D R  if I a m  s u re  th a t  
it is  re la te d  to  th e  u s e  o f a  p a r t ic u la r  d ru g 46.5 9.7 - 43.8 . ’
T h e  o n e  c a s e  a  p h y s ic ia n  m ig h t  s e e  c a n n o t  
c o n tr ib u te  to  m e d ic a l k n o w le d g e  c a n n o t 10.4 29.2 60.4, ■ -
I s h o u ld  b e  f in a n c ia lly  re im b u rs e d  o r p ro v id in g  
s e r v ic e  o f  A D R  re p o rtin g 9 9 81.9
I h a v e  a  p ro fe s s io n a l o b lig a t io n  to  
re p o rt in g  A D R s 75.5 14.6 9.7 .
R e p o r t in g  A D R s  r is k s  m y  c a r e e r 5.6 11.1 83.3
It is  o n ly  n e c e s s a r y  to  re p o rt  s e r io u s  A D R s 17.4 13.9 68.8,
It t a k e s  to o  m u c h  t im e  to  re p o r t  A D R s 16 43.8 40.3 .
M a y  lo o k  fo o lis h  in  re p o rtin g  s u s p e c te d  A D R s 9.7 11.1 79.2
L a c k  o f , o r  s lo w  fe e d b a c k  f ro m  n a t io n a l  
re p o rt in g  c e n tr e  d is c o u ra g e s  re p o rt in g . .' 59 31.9' 9
S o m e  A D R s  a r e  to o  tr iv ia l to  b e  re p o rte d  ' 30.6 29.9 39.6
S o m e  A D R s  a r e  to o  w e ll k n o w n  to  b e  re p o rte d 16.7 14.6 68.8
R e p o r t in g  fa c ilit ie s  n o t r e a d ily  a c c e s s ib le 45.8 39.6 14.6
It appears the slow feedback from the national reporting, 
centre and unavailability of reporting facilities are two of 
the major factors that could be contributing to the low 
reporting rate.
j
The lack of awareness (41.7%) on MCAZ’s voluntary 
reporting and the fact that about half (47.2%) of the 
respondents did not know how to report an ADR may 
mean that quite a significant number of ADRs worth 
reporting go unreported. This low level of awareness- 
could mean that the MCAZ ADR reporting scheme is not
■ well,published. Several studies have reported improved 
reporting of ADRs following awareness campaigns and 
education on the'importance of reporting.7’8 Therefore 
continuous education, explaining reporting procedures to 
new members of staff and emphasising the importance of 
reporting may improve the reporting of ADRs.
; The quality, of the relationship between the individual 
. arid the national reporting centre is a strong motivating 
factor. In 6ne study, those who were given feedback or 
, whose efforts were positively appreciated and who were 
helped to understand the part their contribution played in 
. the national drug safety programme, expressed a 
commitment to ADR reporting, while those that felt 
distanced from the national programme and had no evidence 
- of-positive tiseipf their reports, showed less commitment in 
. ’future.9
• Other studies have also reported similar results to those 
presented in this study, for example, the lack of, or slow 
feedback from the national reporting centre has been 
found to discourage reporting.
Inaccessibility, of reporting facilities and lack of means 
of reporting also hamper the process of ADR monitoring. 
Reporting forriis should always be accessible in all 
•, departments: in a health institution and must be postage
■ , paid to facilitate reporting. Increased accessibility of these 
,. reporting facilities resulted in an increase in ADR reporting
1 in the Rhode Island ADRs Reporting Project.7 
.0 When reporting an ADR, a health worker is not required
■ to be certain of causality. Suspecting a drug in an observed 
ADR is sufficient to make a report to the national reporting 
centre. One of the reasons for not reporting an adverse
; event is when it is:too trivial. This is a valid reason as it 
spares the voluntary reporting system, because reporting 
all side effects, and nuisance symptoms will overburden
■ the system and hamper it in efficiently responding to 
signals of serious risk.
The belief among some respondents that some ADRs are 
too well known to be reported may result in underestimating - 
the prevalence of some adverse events in the population. 
If an intolerable adverse event occurs in more than 20% of 
patients and there are other safer drugs, it may be worth 
.considering alternatives in place of the drug in question. 
However, this decision to protect,the patients from such an 
adverse event can only be made if the monitoring centre 
has sufficient data. As such, reporting of even common 
ADRs is very important for the quality care of patients.
The good attitude among respondents that it is their 
professional responsibility (75%) to report ADRs will go 
a long way in protecting patients from serious adverse 
. events if the reporting scheme is publicised well.
C en t  A f r J  M e d  2004;50(11/12) i 106
The. sample consisted of more females of which most 
were nurses. Nurses are in continuous contact, with 
hospitalised patients and hertce have more chances of 
detecting adverse events and making a report. This study 
observed that nurses w6re more likely to make an ADR 
report than other health care workers.
The study underscores the need to raise the profile of 
pharmacovigilance and create a reporting culture in health 
workers in Zimbabwe. The reporting system should be 
widely publicised and if possible have an ADR bulletin 
that will be circulated to all health institutions. The national 
reporting centre should positively encourage and appreciate 
voluntary reporting and provide feedback through the 
ADR bulletin or newsletter.
Conclusion
Lack of awareness and knowledge on the operation of the 
MCAZ's voluntary reporting system is a major contributing 
factor in under-reporting of ADRs. This is further 
compounded by the poor feedback from the reporting 
centre and the unavailability of readily accessible reporting 
facilities.-Publicising the reporting scheme is likely to 
improve ADR reporting in Zimbabwe.
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Island ADRs Reporting- Project. JAMA 1990; 
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6.
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Adverse drug reactions reporting at a referral hospital in Zimbabwe

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Adverse drug reactions reporting at a referral hospital in Zimbabwe

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