1Socio-demographic data of respondents.http://phcfm.org/index.php/phcfm/article/downloadSuppFile/225/623
MethodsMaterials The population of this study comprised all patients attended to during the period of study mentioned earlier. SettingThe study was carried out at two sites in Goma City in the Democratic Republic of the Congo. The CCLK Health Centre, located downtown, is a church-owned health centre mainly used by poor, displaced communities in the south of Goma on the road to South Kivu Province. It is situated approximately 20 km from the city, and inhabited by internally displaced, poor people. It is a theological training site with a health centre used as a centre for training in community-oriented primary care and community health for residents studying for their Master’s Degree in Family Medicine. The second site, the Casop Health Centre, is a state-owned clinic which is located in Goma city-centre and serves mostly urban people in the lowest socio-economic group. It is located in a densely populated part of the city at the border between Congo and the Republic of Rwanda. These two clinics were integrated in the district health system as two of the affiliated health centres around the Goma health district. Both centres meet the requirements for adequate staffing levels and have, apart from the mobile care, waiting rooms as well to observe patients for stabilisation and/or referral to district hospitals. The two centres have the same climatic conditions and socio economic status even though CASOP has lower standards of hygiene. Both centres are located in high endemic zones of malaria. The two centres draw on a user’s fee system for cost recovery but part of the expenses are covered by an Irish NGO (Non-government organisation), Association Régionale d’Approvisionnement en Médicaments Essentiels [Regional Association for the supply of essential drugs], ASTRAMES, for common ailments, including malaria. The management of malaria is in line with the National Malaria Control Program of which the guidelines are reported in Box 1. DesignIt is a descriptive retrospective study. Data collection One thousand two-hundred-and-seventy-two malaria patients were reviewed between January 2004 and April 2005. Data were collected with regard to demographic (age, sex, address and date) information, and clinical (symptoms, treatment given, dosage, administration route, the duration of treatment, the route of administration, the dose recorded and the indication) information, by using the malaria register’s review. DefinitionsFor the purpose of the study: Under dosage (and over dosage) respectively refer to the administration of a single dose of less (or more) than 25 mg base/[kg body weight], (1.25 mg base/[kg body weight]) sulfadoxine-pyrimethamine (SP) in simple cases, or less (or more) than 30 mg/[kg body weight] of quinine in severe cases. For artemisine-based combination therapy in uncomplicated cases, artesunate is administered at a higher dosage than 4 mg/[kg body weight], (and lower than 10 mg/[kg body weight]) of amodiaquine over a period of 3 days. Inappropriate Routes include any administration of medication in a route which is not in line with the severity of the malaria incidence. An example would be the administration of parenteral quinine in an uncomplicated case of malaria and vice versa. Long duration of treatment was any administration of drugs more than once for SP, 7 days for quinine, and 3 days of artemisine combinations therapies or chloroquine for a few patients. Inappropriate intervals were defined as the administration of quinine more or less than three times per day (or every 8 hours), or of ACT less or more than twice per day (the same applied in the case of quinine in infusion), and for chloroquine every 12 hours. No documented data were classified as abnormal during analysis. AnalysingQuality was defined as the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current knowledge19 in terms of dosage given, intervals between administration, route of administration, and duration of treatment. Variables were assessed against the Congolese National Guidelines of Malaria programme; borrowed from WHO’s guidelines (Box 1). The assessment was carried out firstly, comparing the reported medicine with the recommended regimen in the guidelines. Secondly, the appropriateness of the prescribed drugs in terms of dosage, duration, route and the intervals of administration, was assessed. Finally, the two sites were compared to identify possible variations across sites. Data analysis was carried out using SPSS 11.0 for Windows, (SPSS Inc., Chicago, IL) software. Firstly, a descriptive statistical analysis was carried out. Proportions (and their 95% confidence intervals) were computed. Chi-square (with Yates’s correction or Fischer’s exact test when appropriate) was calculated to assess categorical variables. Significant differences were detected when p ≤ 0.05.
2Quality Insurance of malaria case management assessment. http://phcfm.org/index.php/phcfm/article/downloadSuppFile/225/624
ResultsThe majority of the participants, 806 (66.7%), were aged 5 years or older, and 654 (56.5%) participants were from within the same catchment area as the clinics (Table 1). The sex-ratio is almost equal to 1 and the two facilities have approximately the same proportion of participants (Table 1). Under dosage is more prevalent in CCLK with 52 patients (62.5%; 95% CI, 52% – 71.8%), whilst over dosage is more common in CASOP with 64 patients (80%; 95% CI, 69.9% – 87.2%), (Table 2). The shortest duration of treatment is found mainly in CCLK with 15 patients (93.7%; 95% CI, 71.6% – 98.8%). CASOP had a high number of participants with inappropriate intervals between administrations, that is, 14 patients (82.3%, 95% CI 58.9% – 93%). Despite the low standard of the health care system, intravenous drugs were administered to 61 patients (37.4%; 95% CI, 30.3% – 45%) in CCLK against 102 patients (62.5%; 95% CI, 54.9% – 69.6%) in the CASOP health centre. There was a statistically significant difference in the intervals of administration (χ2 = 7.11, p = 0.007), in durations of treatment (χ2 = 8.51, p = 0.003) and in dosages (χ2 = 3.91, p = 0.05) between the two health centres (Table 3). The routes of administration were used in the same manner at the two sites. Sulfadoxine and pyrimethamine were the drugs most used by 919 patients (78.3%; 95% CI, 74.9% – 81.3%) in CCLK, compared to 429 patients (66.7%; 95% CI, 63.0% – 70.3%) in CASOP, followed by quinine in 86 patients (13.7%; 95% CI, 11.3% – 16.7%) in CCLK, compared to 122 patients (16.4%; 95% CI, 16.1% – 22.2%) in CASOP (Table 4).
3Comparison of administrations between the two facilities. http://phcfm.org/index.php/phcfm/article/downloadSuppFile/225/625
DiscussionOutline of the results Irrational prescription practices such as the use of subtherapeutic doses and inappropriate administration frequencies were found in both sites in different proportions, confirming the sub-optimal treatment of malaria. Despite a high percentage of those abiding to guidelines, the frequency of the disease and its life threatening prognosis when mismanaged, cannot be overemphasised. A study carried out some years ago in Congo, for example, showed that the development of resistance to anti-malarial drugs in children lead to a 4.5-fold increase in the number of anaemic patients. We know that anaemia as a complication of malaria is the leading cause of death in paediatric age groups which constituted almost one-third of our participants in this study. Mismanagement of malaria is not specific to our settings. A review carried out by Durrheim et al.20 found a failure in the administration of the correct anti-malarial drug, at the correct dosage and frequency amongst providers. The explanation for this must be seated firstly in the high medicines’ unordered dosage in the register which was considered as an abnormality, nurses with no experience in the health centre’s workload, the lack of in-service training targeting nurses who are in touch directly with patients instead of the staff in charge; and insufficient dissemination sessions of new guidelines due to financial constraints. The same explanation is applicable to the difference of intervals in administrations. However, the pronounced abnormal interval in administration in CASOP could reflect the higher lack of abidance to medical advices found in towns and cities, compared to suburban and rural settings. Furthermore, the busy daily schedule of coping strategies to face the high cost of living in the CASOP catchment area and surroundings can result in forgetfulness with regard to taking medication. The last postulation could explain also the higher use of intravenous quinine at the peripheral level. Seeking a quick relief and a return to normal life, patients prefer perfusion which can provide rapid relief and allow them to return to normal activities. From the perspective of the providers, in a system of self-funding and user-fees for services as mode of payment, intravenous quinine is almost 10 times more expensive than ACT. Some providers face a dilemma between the quality of care they have to preserve, and the resources they have to obtain from patients to sustain the facility on the other hand. Patients with severe malaria in health centres should be provided pre-referral treatment of intramuscular quinine and should be transferred for full parenteral treatment and supportive care.21,22 Paradoxically there was a high number of patients and a delay before referral, in the two facilities in the cases of severe malaria where quinine was administered intramuscularly in emergency situations. This high rate use could be placed in the socio-economical context of Goma in general and CCLK-CASOP catchments areas in particular. The cost of parenteral quinine is several times higher than that of the arthemeter combination or SP and will enable a health centre to earn money quickly. Government-related funds were almost absent during and some years before this study, and consequently the misuse of quinine was aimed probably at the alleviation of the financial constraints that the health centres were experiencing. The facilities could then cope more easily with their monthly expenditure including utilities, salaries and other expenses. Anecdotal reports acknowledge that fast symptom alleviation of parenteral quinine in conjunction with its relatively mild side effects encouraged patients to opt for quinine, even in uncomplicated incidences of malaria. The rapid onset of action of quinine causes patients to assume that they are cured and consequently they do not see any reason for a maintenance dosage, which results in incomplete treatment. In addition, quinine, well known by both patients and providers as an established medicine, manufactured in the country, and more competitive in terms of prices compared to ACT combination, remains the preferred medication. This misuse of quinine in uncomplicated incidences of malaria is very common, irrespective of the level of care in Congo. The misuse is probably related to the national policy in drug management, the continuous use of some old medicines such as chloroquine despite the change to new drugs, and the difficult access to care at policy level. Short course and inappropriate routes of administration are in addition to intervals of treatment, reasons non-specific to this study. These conditions are not found only in those two facilities. It has been found, for example, that up to 84.1% of patients with uncomplicated malaria were prescribed quinine in Kinshasa in the casualty department of a teaching hospital in Kinshasa, Congo.22 Another study24 carried out on the prescription of quinine in several facilities, found under dosage and over dosage in respectively 66.7% and 2.7% of patients. Some prohibited routes of administration of quinine such as intramuscular administration, were used in 13.4% of patients throughout the course of treatment. Those weaknesses in anti-malaria drug use are very dangerous, because medication errors and adverse drug reactions (ADRs) may result in disability and even death.25 Concomitant use of new ACTs combination with chloroquine and sulfadoxine-pyrimethamine is a matter of great concern. Studies26 carried out previously have already demonstrated the emergence of some resistance to the two drugs; mostly in the eastern Congo where our study has been conducted. This will cause numerous preventable deaths, in addition to those due directly or indirectly to war and natural disasters in this fragile part of the country. Limitations Some limitations of this research must be taken into account when interpreting the findings. Providers’ self-report or interviews about their own performance have certain pitfalls which can lead to bias. Most of the time they provide information on what providers know and not necessarily what they routinely do.27 Furthermore, self-reported performance through some interviews is likely to overestimate what providers do, both for tasks they do not perform often, as well as for tasks they perform often. By conducting the register review we reduced the subjectivity of self-reported performance as stated above. Secondly, the two sites have been purposefully selected; hence results of the current research cannot be extrapolated to other facilities within the district or beyond. However, with a detailed description of the study settings and the review of literature supporting our findings, we think that the results can be translated at least to similar settings. Thirdly, by collecting data from registers, there is a risk that some officers can report what is ideal instead of writing up what really happens to minimise criticism from supervisors and employers. In future, this bias will be reduced by carrying out a prospective study and/or study with a triangulation of data using several approaches and data sources of information.
4 Anti-malarial drugs used during the study period.http://phcfm.org/index.php/phcfm/article/downloadSuppFile/225/626
ConclusionThis study highlighted weaknesses in malaria case management in terms of dosage, duration of treatment, intervals between doses and route of administration which present variations across the study’s sites. Use of quinine in non-indicated patients remains also a reason of concern. All of this is taking place in a context of socio-economic constraints despite training in malaria case management. From the current study, we can conclude that use of guidelines in primary health care cannot only be tailored to scientific evidence for its success; in addition it must also consider social and economic contextual factors, as well as cultural and political contextual factors. 1 Adapted Summary of DRC National protocol of malaria treatment at PHC level. http://phcfm.org/index.php/phcfm/article/downloadSuppFile/225/627We are grateful to Professor J.M.F. Hugo for his valuable advice during the earlier stages of this paper. We also want to extend our appreciation to the staff and management of CCLK and CASOP for facilitating the data collection. Competing interests The authors declare that they have no financial or personal relationship(s) which may have influenced them inappropriately in writing this article. Authors’ contributions P.L.M. designed the study, analysed the data and wrote the first draft. C.M.K. collected data, and E.K.K. assisted with the analysis of data and the drafting of the manuscript. J.I. conducted a literature review and contributed in shaping the manuscript. I.S. played a role in data analysis, and in redrafting the final manuscript. 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