E-DRUG: The need for interdisciplinary collaboration to reduce poor-quality
medical products in the supply chain (2)
----------------------------------------------------------------------
Dear e-druggers,
In their paper (The abstract and the ink of this paper posted by Raffaella Ravinetto <http://lists.healthnet.org/archive/html/e-drug/2022-03/msg00016.html>, Masini and colleagues (2022) argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. The authors also argue that by triangulating of different datasets, researchers could untangle the link between quality and price, given the unproven, but common assumption, that quality-assured medicines are always more expensive (Masini et al 2022). Oppositely, other researchers (see for example, Aivalli et al 2018 and Patel et al 2010) reported negative perceptions about the quality of low-cost generic medicines that affect utilization and raise issues of confidence and trust in medicines.
These scientifically unproven perceptions could negatively impact the efforts to improve access to medicines. We would like to emphasize the importance of untangle the link between quality and price of medicines, by presenting empirical experience of the National Medical Supplies Fund (NMSF), the procurement and distribution agency in Sudan.
The success of Universal health Coverage depends on access to low-cost, high quality medicines. As part of its reform that started in 2011 to contribute to this goal, the NMSF has shifted from a policy that emphasizes cost as the primary consideration when choosing between competing producers, to a policy of quality-assured medicines as the primary deciding factor, thereby protecting public health and welfare through the procurement of quality-assured, safe and effective medicine at affordable prices. Before the reform, staff at NMSF generally believed the unlawful practice of purchasing non-registered medicine using an international open tender improved affordability by obtaining the cheapest medicines from the global market.
At that time, the NMSF decision-makers thought quality testing of non-registered medicines would assure their safety, efficacy and quality. According to the World Health Organization (WHO) this was not true because quality testing will not guarantee the safety, efficacy and quality of medicines regarding stability and bioavailability since pharmacopeial specifications do not necessarily address these issues (WHO 1997).
Figure 1: Product Management Cycle
One of the reform targets is to stop this extraordinary situation. To do so, the NMSF decided to restrict purchases to registered medicines. The level of procurement of non-registered medicines had reduced from more than 95% in 2008 to 4% in 2018, demonstrating the increasing effectiveness of the NMSF¡¯s understanding the importance of using, and therefore procuring, registered medicines. Does purchasing of quality medicines increase its acquisition cost? The answer is no in light of the following analysis of the NMSF tenders.
According to WHO (2007), prices of publicly procured medicines are considered 'acceptable' if they have a median price ratio of 1 or less than 1, which means that the price of the awarded medicine is the same or less than the IRP[1] of the same medicine. The analysis of the NMSF tender of 2015 revealed that the prices of 68% (64% in 2011) of the awarded medicines were ¡Ü 1. It is important to notice that 82% (85% in 2011) of these medicines have marketing authorization in Sudan.
Despite 96% of awarded medicines in 2008 had no marketing authorization, only 9% of the prices of non-registered medicines were ¡Ü 1. The NMSF experience proves that shifting to purchasing of quality-assured medicines is more cost-effective to achieve the goal of the medicines procurement by reducing the overall costs of pharmaceuticals.
Table 1: Comparison of the prices of the awarded products with IRP (i.e. awarded price/IRP)
In conclusion, to succeed in enhancing access to quality-assured, low-cost medicines, stakeholders (such as regulators, policy-makers, public medical supplies agencies, donors, patients associations, consumers¡¯ protection societies, media) at all levels need to regularly disseminate in information that untangle the link between quality of medicines and their cost. They also need to develop strategies and organize campaigns to build trust in low-cost medicines dispensed in both public and private pharmacies.
References
Aivalli PK, et al 2018. Perceptions of the quality of generic medicines: implications for trust in public services within the local health system in Tumkur, India. BMJ Glob Health; 2:e000644. doi:10.1136/ bmjgh-2017-000644
Masini, T, et al 2022. Out of the boxes, out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain. Research in Social and Administrative Pharmacy; in press. Available online 17 March 2022
Patel A., et al 2010. This body does not want free medicines! South African consumer perceptions of drug quality. Health Policy and Planning; 25: 61¨C69 doi:10.1093/heapol/czp039
WHO 1997. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. Vol 1, World Health Organization, Geneva.
WHO 2007. Technical Discussion on Medicine Prices and Access to Medicines in the Eastern Mediterranean Region. World Health Organization, Regional Office for the East Mediterranean, Cairo [online], available at: www.scribd.com/doc/78173351/WHO-2007<http://www.scribd.com/doc/78173351/WHO-2007> [accessed June 2012].