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Bad medicine - Some local producers flouting the rules in the production of medication

Published:Sunday | May 29, 2016 | 5:00 AMNadine Wilson-Harris
Tufton
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Scores of Jamaicans may not be getting exactly what they pay for when they purchase some of the medication produced locally.

A Sunday Gleaner probe has confirmed that some pharmaceutical companies are engaged in unethical practices such as changing the expiry dates of drugs, reducing the number of active ingredients in their products, and allowing their workers to flout safety standards during production.

In confirming the findings of our news team, the Ministry of Health said it has evidence of local pharmaceutical companies misleading consumers. The health ministry has also received reports of substandard chemicals and pharmaceuticals such as antibiotic skin ointments, cough syrups, and disinfectants being dispensed on the local market.

"In the course of Good Manufacturing Practices audits of 2015, manufacturers were found to be using close-dated and even expired raw material without adjusting the expiration date of the finished product, which often has shelf life of two to five years," the ministry said through its public relations department.

The health ministry is required by law to audit or inspect manufacturing pharmacies annually to ensure compliance with the Food Drug Act and to reissue licences to manufacturers, while the Pharmacy Council has jurisdiction for retail pharmacies.

For health minister Dr Christopher Tufton, while he is not aware of the particular allegations, he is in discussions with the Pharmacy Council to look at how to improve the overall framework for regulating the sector.

According to Tufton, this could result in an increase in the cost for registration of companies that market and manufacture drugs.

"All of this is intended to make the system more efficient and to also improve the monitoring and inspection process so that facilities, whether at the level of manufacturing, or distribution, or retail, are complying with the rules in the interest of public safety," he told The Sunday Gleaner.

The health minister said the monitoring of the local market will take a multi-sectorial approach to ensure that consumers' interests are safeguarded.

"Everything you do has margins of error. What we will have to do is to ensure that we strengthen the monitoring process.

"Beyond the monitoring, clearly, there must be sufficient punitive measures to deal with the deviants within the environment," added Tufton.

The Sunday Gleaner probe was launched after a lab technician told our news team that on several occasions, he witnessed the manager of the pharmaceutical company where he worked sanctioning changes in the expiry dates for products to reduce possible wastage.

"So they might change the batch number to say that it was manufactured at this time so as to extend the shelf life in the view of the public, but it would have been expired," said the technician, who asked not to be named.

"You will have raw material that is expired, but a whole lot remains, and so they would still use it even though it should be retested," he added.

The technician, who said he is a Christian, claimed that he has always felt uncomfortable with these practices and expressed this to his manager on several occasions. He argues that his protests may have resulted in his recent dismissal from the company, where he worked for the past 10 years.

He said he knows of at least one medication being produced by his previous employer where the active ingredient being advertised is not contained in the product. There have also been cases where the quantity of the active ingredient in a product falls below the net weight advertised on the package.

"Up to the time of my departure, that had not been corrected. It is illegal to have ingredients on the label but not actually in the product itself," said the lab technician, who stated that discussions with his colleagues at other pharmaceutical companies had also highlighted other infringements.

The lab technician said he also had serious concerns about the safety practices of the company as workers were often given one hairnet to last 10 days, although the standard practice is for a hairnet to be changed daily.

"You are making some anti-fungal products and then you go into tablets the next day with the same hairnet, and there are things that can fall out of the hairnet. You are making external things today, and then you go on to making internal stuff tomorrow, and it's the same hairnet for 10 working days."

In the meantime, President of the Pharmaceutical Society of Jamaica (PSJ) Dr Lisa Bromfield said the production of counterfeit and substandard medicines is a global phenomenon and has become increasingly sophisticated.

But Bromfield said she believed that Jamaica has one of the highest quality-control standards in the region.

She said that the PSJ had not received any reports of substandard pharmaceuticals being produced by local companies.

"If it was happening, as a Society, we would be concerned," said Bromfield.

nadine.wilson@gleanerjm.com