Promoting Quality and Temperature Controlled Distribution in South Africa



Cold Chain IQ
11/17/2010

Cold chains are becoming increasingly important within the pharmaceutical industry as the number of products requiring temperature control increases.

By the year 2014, seven of the top ten pharmaceutical products are expected to require cold chain handling, according to the Biopharma Cold Chain Sourcebook 2010.

Growth within the vaccine manufacturing industry, which is not necessarily related to new influenza strains, has also increased the need for cold chain distribution.

In 2009 the worldwide market for preventative vaccines was worth $22.1 billion (£13.7 billion), research by Kalorama Information suggests.

Yet is often the countries which have the most urgent need for these vaccines which have the most underdeveloped infrastructure and there are those predicting that the lack of cold chain facilities could hinder the use of these products.

Malaria vaccine

South Africa is among the countries on the African continent where Malaria is a risk, although the risk is generally much lower than a number of other African nations. Those living near the borders of Mozambique and Zimbabwe are deemed to inhabit a high-risk area.

Vaccines for the treatment for Malaria are advancing rapidly. Phase III clinical trials are currently underway on thousands of infants in several African countries and it is believed that a vaccine could be on the market as early as 2013.

However, even once the vaccine has been approved for use, challenges still remain in how the product will be distributed.

IPS reported that regions which are introducing a new vaccine must consider the cold chain facilities it requires.

The large numbers of Malaria vaccines which would need to be delivered could also represent capacity issues for existing cold chain facilities, although efforts have been made to address this issue.

Dr. Ahmadu Yakubu, regional immunisation adviser for Unicef in East and Southern Africa, highlighted that such problems were presented with the introduction of the pneumococcal vaccine in Rwanda in 2009.

Yakuba explained that the vaccine was first delivered in 58 cc glass syringes, meaning children would require three doses, which is far higher than the 48cc dose needed for most immunisations.

This was said to place increased strain on both regional and district level storage centres.

"Changes like these are made over time by vaccine manufacturers even after introduction, otherwise it puts stress on countries that are already financially constrained," Yakuba explained.

"They are trying to use the little money they have to expand on their basic capacity"

Consumer protection regulations

The introduction of the Consumer Protection Act in South Africa may also have an effect on pharmaceutical companies and those operating cold chains in the country, some have suggested.

Ian Lester, chief executive officer of Beyond Wireless, a wireless communications firm, highlighted that the opportunity for redress that the act offers consumers could lead to serious consequences for both the food distribution and pharmaceutical industry.

The act only applies to transactions involving a supplier and consumer, not those involving the state or companies within the supply chain.

Drugs which are exposed to temperatures beyond the range they are intended to be subjected to can potentially have decreased efficacy or not work at all. Such changes can occur even if the cold chain is broken for a short period, and is a particular danger when dealing with vaccines.

"The ethical considerations around temperature-sensitive drugs are enormous. In the past, consumers have suffered because of the lack of cold chain regulation of healthcare products, but the Consumer Protection Act promises them recourse," Lester said.

He added that innovations such as software-as-a-service allow for greater monitoring throughout the cold chain, and predicted that such methods will become more popular in light of the new consumer protection regulations.

Lester said: "With the Consumer Protection Act coming into effect, the proverbial buck stops with the retailer. It is therefore in the retailer's best interest to ensure that the entire cold chain remains unbroken and that when problems occur, the cause can be quickly identified and the issue resolved as rapidly as possible."
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