The itinerant behaviour of people inhabiting the hinterland regions (indigenous peoples, miners, and loggers) and the great distances between camps and officially sanctioned public health care facilities are conducive to self-medication and purchase from alternative sources. In these malaria endemic areas, there is a lack of health care professionals correctly dispensing medicines, even in private pharmacies. Anti-malarials are often dispensed by a non-pharmacist in the pharmacies, without requiring a prescription. As for informal sector vendors, the incentive to sell anti-malarials from under the counter is high. The commercial value of the current combination medicines containing artemisinin derivatives is significant and the demand is there.
Many of the anti-malarial medicines sampled from the private and informal sectors were not registered nor were they part of the national standard treatment guidelines. Medicines from both sectors, and across the varied regions, were of poor quality and several were found to be expired. Artemisinin monotherapy were also available, yet WHO guidelines do not recommend their use as treatment for uncomplicated P. falciparum malaria.
In the context of quality problems, of particular note is the case of the ACT, Artecom, which was not registered in either Guyana or Suriname. Based on vendors’ accounts and sampling results, it was the most popular anti-malarial in the informal sector in both countries. Interestingly, the same lot number was found for samples collected in both Guyana and Suriname, suggesting the possibility of a common supply source and/or illegal cross-border commerce of malaria medicines. Also, the packaging did not include dosage strength information for the content of primaquine, making it impossible to assess content and violates labeling requirements established in pharmacopeias and by most MRAs. In addition, the lack of primaquine content poses a safety concern to glucose-6-phosphate dehydrogenase (G6PD) deficient individuals receiving malaria treatment .
Samples of quinine and mefloquine tablets collected were found to not contain API, which may raise the issue of counterfeit medicines. However, according to legislation in Guyana, when a medicine contains no active ingredient it is considered as substandard unless there is other incriminating evidence that proves the drug is counterfeit. Additional incriminating evidence (i.e., suspicious packaging) was not found to make such a claim. In addition, the medicines were both sampled from bulk containers, which brought into play the potential for human error.
Non-compliance to GMP in the production of malaria medicines has been shown to be a problem among domestic and international manufacturers . These results indicate quality problems were observed among locally manufactured and foreign products. Both artesunate (foreign product) and chloroquine (domestic product) failed tests for content, dissolution and uniformity of dosage units, quality attributes that are sensitive to variations in manufacturing. Although regulatory authorities are more capable of addressing problems with local manufactures, most malaria medicines are procured from abroad. Limited human and financial resources hinder their abilities to conduct inspections of international manufacturers.
The test results obtained were shared with regulatory authorities in both countries. It is hoped that the findings from this and other published studies will help provide a basis for targeted interventions. If it is not feasible for the public sector to expand services, it is recommended that health authorities increase inspections, training and monitoring of staff in private sector pharmacies to improve dispensing practices. Furthermore, if it would prove unfeasible to promptly eliminate sales of anti-malarials in the informal sector, the following approaches could be considered: 1) expand programmes, such as the active-case detection component of the “Looking for Gold Finding Malaria” programme in Suriname sponsored by the Global Fund to Fight Aids, Tuberculosis and Malaria; 2) include selected vending sites or stores in a parallel training, monitoring and inspection programme in order to improve knowledge and dispensing of anti-malarials (cf. the model successfully introduced in Tanzania) . Public awareness campaigns about the importance of good quality medicines and the risk of purchasing from the informal sector can also have an impact [27, 28]. The aim is not only to protect patients from harm, but also to protect currently effective treatments and prevent the development of drug resistance.