By Celina Schocken and Courtney Chang, Jhpiego
Issues with inconsistent oxytocin quality
In 2012, a study by US Pharmacopeia and the Ghanaian Food and Drug Authority found that only 8% of oxytocin samples in Ghana had market authorization. The majority (97.5%) of samples failed either assay or sterility testing and over 55% of samples failed their physio-chemical assay. Even when a product is properly manufactured, storage and labeling of the drug along the supply chain and in facilities varies: in fact, only 8% of oxytocin samples were stored in the proper temperature (2°-8° C). The study ultimately concluded that 65.5% of oxytocin sampled in country did not meet quality standards, severely impairing the ability to prevent and treat PPH.
In most countries, we lack clear information about the quality of oxytocin administered to postpartum women. More studies are underway, as it is critically important to ensure that quality oxytocin is administered.
Limited product choices for quality oxytocin
In order to regulate quality, the WHO prequalification process helps identify quality drugs for countries. Currently, there are no WHO-prequalified oxytocin products; the only regulated products currently in the market are approved by Stringent Regulatory Authorities (SRAs), which are national bodies like the US Food and Drug Administration. This less stringent regulation is present despite a high volume market for oxytocin; globally, 100 million doses per year are used for prevention and treatment of PPH. There are at least 300 different oxytocin products manufactured by at least 100 manufacturers, creating a market that is difficult to regulate.
Most oxytocin in developing countries is procured by national procurement agencies, and most do not require WHO prequalification of oxytocin. These agencies are very resource-constrained and tend to focus on procuring high volume for low cost.
Current market structure threatens quality
For manufacturers, the low price of oxytocin—ranging from about $0.15 to $0.20 per 10 international unit (IU) dose—paired with a large number of competitors, creates a highly price-sensitive market. Achieving prequalification requires a manufacturer to upgrade its factory or improve manufacturing processes, likely adding 5-12% to the cost of products: a cost that makes thriving in the current market too difficult.
In a market where procurers do not require regulatory approval, prequalified or SRA-approved drugs simply will not be competitive against non-quality assured drugs and manufacturers will have no incentive to go through WHO prequalification. Instead, in order to stay competitive in the market, manufacturers will compromise the quality of their products order to keep prices low, boost sales and sustain profits.
Promoting a market shaping strategy for improved oxytocin
As the market for oxytocin grows, national governments and international partners must work together to ensure that manufacturers are incentivized to produce quality oxytocin. National governments and international partners should rally around a market shaping strategy that involves the following components:
- International partners working with national procurement agencies to improve procurement guidelines and procedures to ensure that only quality drugs are accepted into countries
- International partners working with National Drug Regulatory Agencies and others to increase awareness about quality issues with oxytocin
- Stricter enforcement of national guidelines and routine quality audits of drugs
For more information on quality oxytocin, please read the Business Case: Investing in Production of High Quality Oxytocin for Low-Resource Settings
Photo: “DSC_0096″ © 2009 Colin, used under a Creative Commons Attribution license: http://creativecommons.org/licenses/by/2.0/