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Administering vaccines without authorization
Sunday, February 20, 2011
The doses of the vaccine were applied to the population without first ensure longer effective. PHOTO: AGENCIES
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22/02/2011
They were not guaranteed to be safe and effective against H1N1 influenza: ASF
MEXICO CITY .- The Ministry of Health implemented millions of vaccines against influenza A H1N1 opinion without the authorization by the Federal Commission for Protection Against Health Risks (Cofepris).
For the first 8.2 million doses used in Mexico as part of the epidemic that occurred in 2009, the opinion was released five months after the start of immunization.
"The doses of the vaccine were applied to the target without first ensure that they are within specifications issued by the health regulatory body authorized by the federal government without ensuring they are safe and effective to bring the consumer a vaccine safe, potent and effective in every batch of production, "concluded the Superior Audit of the Federation (ASF).
In its report the results of the Audit Institutions of the Public Accounts 2009, states that the Ministry of Health (SSA), IMSS, ISSSTE and the secretaries of Defense and the Navy acquired the pandemic vaccine against H1N1 influenza A Birmex parastatal instead of buying directly from drug companies, Sanofi Pasteur and Glaxo, which resulted in an overrun of 117.9 million pesos.
The FSA described as unacceptable the fact that the sales contracts concluded between Birmex vaccine and the SSA did not include the obligation to deliver the parastatal trade biological release by the health authority, which it did in the For the other units.
In total, the SSA acquired the 13 million doses for distribution to government health services. The National Center of Epidemiological Surveillance and Disease Control (Cenavece) did not monitor the vaccines will have the opinion of authorization by the Cofepris before Birmex distribute them in the states.
Asked about the issue, said Cofepris presidential decree in April 2009 authorized the SSA to take emergency measures against the epidemic.
Waste
According to the report of the Supreme Audit during the first period of immunization against influenza A H1N1 were wasted 82,813 doses of pandemic vaccine, which accounted for losses of about 6 million pesos.
The results report found that the most frequent causes were accidents in the cold chain to preserve the vaccines, electrical power failures, contamination of the bottles and biological expiration to maintain the open bottle.
According to the internal control questionnaire applied in the state health services, 14 states had waste, being Tamaulipas, Sinaloa, Oaxaca and Quer?taro states with higher losses.
"As a result of the review, the National Center for Health for Children and Young asked the state health services supporting documentation showing that the waste of the vaccine doses were not attributable to the civil servants responsible for receipt and application, "said the FSA.
(Margarita Vega / Agency Reform)