According to the Chief Executive Officer of the FDA, Mrs Delese Mimi Darko, her outfit is partnering with the Pharmacy Council to boost their surveillance.

Speaking on the Citi Breakfast Show on Tuesday, Mrs Darko said a joint task force will be formed in coming days to champion that agenda.

[contextly_sidebar id=”PhlAs8qhkqTEVpfzD0gxyGzVrKCQ5vYg”]“We are collaborating with the Pharmacy council because they are responsible for the practice of pharmacy and also with the health facilities regulatory agency which also registers pharmacies and chemicals and licensed medicines sellers. We are forming a task team in the next few days. They are doing what they are doing but we think that we should actually come together and move out wider within the regions.”

The FDA CEO said the task force will, among other things, visit possible places that Tramadol is sold, adding that the team will also “visit chemical shops because they [chemical shops] would be obtaining some [of the product] legally, some as well may be obtained at places that we are not aware of.”

Tramadol is a pain relief drug, which according to medical experts, functions like heroin and can cause psychotic problems as well as damage vital organs in the human body if abused.

Recent surveys have shown that the drug is being abused by some youths as well as some market women, drivers and in some cases students.

The Head of Substance Abuse at FDA, Olivia Boateng said on the Citi Breakfast Show last week that FDA is intensifying its surveillance to curb the smuggling of Tramadol in the country.

According to the FDA, its investigation shows that most of the drug comes into the country through unapproved routes making it difficult for them to track its final destination.

“Our investigations revealed that there are people, who were sourcing it from unapproved routes, not from the pharmacy and hospitals. We have intensified monitoring at the ports of entry, trying to curb it through the unauthorized routes,” Olivia Boateng added.

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By: Godwin Akweiteh Allotey/citifmonline.com/Ghana
Follow @AlloteyGodwin

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They were made up of herbal medicines, alkaline water, and some expired drugs, which were voluntarily brought from pharmacies and hospitals to the FDA in accordance with the Public Health Act.

[contextly_sidebar id=”SArfAJvWDj6Mkf0KcNDtw0hYYP15ibNR”]The products were disposed off and burnt at the Nkanfoa dumping site in the presence of officials from the Environmental Protection Agency (EPA), Public Health Division of Cape Coast Metropolitan Assembly and the security agencies.

Mr John Odai-Tettey, Regional Head of the Authority in an interview with the Ghana News Agency, said the products were seized during its market surveillance, unannounced inspections and investigations into product complaints by people.

He said some of them were unregistered while others had expired.

The FDA, he said, was mandated to monitor the safety quality and efficacy of products on the market to ensure that the products met the requirement and conditions under which they were registered to guarantee consumer safety.

Mr Odai-Tettey said the FDA would not relent on its mandate of ensuring public safety by insisting that products met quality standards.

He advised consumers to critically read the labels on food items, check the expiry date, batch number and legibility of the manufacturers before patronising products.

Again, he reminded consumers to properly examine products to satisfy themselves of the quality and the expiry date before purchasing to avoid consuming expired products ahead of the Easter festivities.

Mr Odai-Tettey encouraged consumers to be bold to expose those dealing in such unwholesome goods by reporting to the FDA for prompt action.

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Source: GNA

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The medication in question, o.9% Normal Saline, is believed to have been contaminated after being used multiple times, according to a statement from the FDA.

[contextly_sidebar id=”HwoIKeXY2LeKr7ke8tlOngIzQ8IFVful”]The deceased include a 31-year-old man, a 42-year-old woman and a 78-year-old man.

The deceased persons suffered “adverse reactions described as injection site abscess, skin necrosis and ulcers leading to the deaths,” the FDA said.

“Preliminary investigations revealed that these reactions may be due to contaminated 0.9% Normal Saline, the solution which was used to reconstitute (mix) the Benzathine Penicillin Powder for Injection. The 0.9% Normal Saline Solution was reported to have been opened and used repeatedly for several days which might have resulted in the contamination,” the statement from the FDA explained.

The FDA has also dispatched a team to Akrade to investigate the issue in collaboration with the Ghana Health Service.

The Director of Public Health at Ghana Health Service, Dr. Badu Sarkodie earlier confirmed the developments to Citi News and said the service was in the process of compiling a situational report.

Find below the full FDA statement

SERIOUS ADVERSE REACTION REPORTS, NEW SENCHI HEALTH CENTRE, AKRADE

The Food and Drugs Authority (FDA) has become aware of serious adverse reactions described as injection site abscess, skin necrosis and ulcers leading to the deaths of three (3) patients who had injections of Benzathine Penicillin from the New Senchi Health Centre at Akrade in the Asuogyaman District in the Eastern region. These serious adverse reactions were reported during the 3rd week of March 2018.

Preliminary investigations revealed that these reactions may be due to contaminated 0.9% Normal Saline, the solution which was used to reconstitute (mix) the Benzathine Penicillin Powder for Injection. The 0.9% Normal Saline Solution was reported to have been opened and used repeatedly for several days which might have resulted in the contamination.

Benzathine Penicillin is presented as powder for Injection and should be reconstituted with STERILE water for injection and also used immediately to avoid contamination.

The FDA has dispatched the Pharmacovigilance team from the Eastern Regional Office to Akradie to investigate the issue in collaboration with the Ghana Health Service and will keep you updated as more information becomes available.

Meanwhile, healthcare professionals and consumers are encouraged to be vigilant and report untoward effects of medicines and health products to the FDA by completing adverse reaction reporting forms provided in hospitals and Community Pharmacies designated as Patient Safety Centres across the country or through the contacts below:

HOTLINES – 0299802932, 0299802933,

TOLL FREE NUMBER – 0800151000 (free only on Airtel and Vodafone)

SMS SHORTCODE – 4015

SIGNED

CHIEF EXECUTIVE OFFICER

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By: Delali Adogla-Bessa/citifmonline.com/Ghana

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“We have a full alert at the port of entry to make sure that those products will not come in. We’ve intensified post-market surveillance throughout the Easter period, we will be going around to check if any has been brought in at all. We will make sure that we collect them all, in what we call a full recall. We will go round all the supermarkets to make sure that there is none,” Chief Executive Officer of the Authority, Delese Mimi Darko, told Citi News.

[contextly_sidebar id=”JpEoUyri5Q0kCPLe5bw774do0mtGLzDf”]In the last few weeks since Rwanda’s caution on food imports from South Africa, the FDA has warned Ghanaians against purchasing possibly listeriosis infected processed meat products by Enterprise Foods.

The Authority also announced that it would destroy the meat products from Enterprise Foods in Polokwane, South Africa.

The outbreak of listeriosis has been going on since the start of 2017. According to the World Health Organisation, 978 laboratory-confirmed listeriosis cases have been reported in South Africa between January 1, 2017, and March 14, 2018. 42% of the cases have been neonates who were infected during pregnancy or delivery.

In January, Rwanda warned Ghana to ban the importation of some food products from South Africa to avert the outbreak of listeriosis. Before the warning, Rwanda had already placed a ban on some food products from South Africa.

After the warning, the Ghana’s Ministry of Health assured Ghanaians that it had beefed up surveillance in the country to forestall the outbreak and spread of the disease.

About Listeriosis

Listeriosis is food poisoning that is caused by eating foods contaminated with the Listeria monocytogenes bacterium. In pregnant women, the infection can result in miscarriage, premature delivery, serious infection of the newborn or even stillbirth.

It mainly affects pregnant women, newborns, the elderly, and adults with impaired immune systems.

According to the WHO, the outbreak in South Africa is the largest that has been detected worldwide. Due to the potentially long incubation period (one to three weeks and up to 70 days), further cases are expected before the impact of the recall of the affected food products is observed.

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By: Jeffrey Owuraku Sarpong/citifmonline.com/Ghana

The post FDA intensifies surveillance to stop sale of Listeriosis meat products appeared first on Citi 97.3 FM - Relevant Radio. Always.

According to the FDA, its investigation shows that most of the drug comes into the country through unapproved routes making it difficult for them to track its final destination.

[contextly_sidebar id=”IdszG1LjwdSXnjkLzypVHbWdIVwLgePI”]”Our investigations revealed that there are people, who were sourcing it from unapproved routes not from the pharmacy and hospitals. We have intensified monitoring at the ports of entry, trying to curb it through the unauthorized routes,” Head of Substance Abuse at FDA, Olivia Boateng said on the Citi Breakfast Show on Tuesday.

Tramadol is a pain relief drug, which according to medical experts, functions like heroin and can cause psychotic problems as well as damage vital organs in the human body if abused.

Recent surveys have shown that the drug is being abused by some youth as well as some market women, drivers and in some cases students.

Olivia complained that although the drug is highly regulated, the country is inundated with influx of the product which she said comes through illegal means.

She said her outfit has collaborated with the various security agencies especially those who operate along the country’s borders to block the smugglers from bringing it into the country.

“Tramadol is a restricted and a controlled drug. It has been registered as a prescription only medicine, so you can only get it at the hospital and pharmacy on a valid prescription. We have registered 50mg and 100mg indicated for managing moderate and severe pain. In our laws now, it is considered a controlled drug. They come in through Kotoka and Tema. We have also put in monitoring mechanism. We even have local manufacturers.”

“What we found when we heard of the isolated cases is that… they are those that come through the unauthorized means, drug peddling mainly. We arrested people between 14 and 16 years who were peddling it in our open market with other aphrodisiacs and other substances including tramadol,” she added.

Olivia Boateng said her outfit has also beefed up public education after reports emerged that the drug is being abused.

“We’ve done a lot of training for our security men who man these ports. We are doing a lot of collaboration with other stakeholders. We are doing collaboration with the IGP and his mean, DVLA among other stakeholders.  So we really have upped our game especially on the education and the swoop to make sure that we curb the supply and the illicit channel,” she added.

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By: Godwin Akweiteh Allotey/citifmonline.com/Ghana
Follow @AlloteyGodwin

The post FDA intensifies surveillance to curb influx, abuse of Tramadol appeared first on Citi 97.3 FM - Relevant Radio. Always.

According to the FDA, the producers are confirmed by South African authorities as the people responsible for the outbreak of Listeriosis, a bacteria causing disease in South Africa.

[contextly_sidebar id=”W9qgaPIcbkrG5RTVwNusolTYyq6k9pC9″]A statement signed by Mrs Delese A. A. Darko, the acting. Chief Executive Officer of the FDA, said it has intensified its post market surveillance activities nationwide and any ready-to- eat (RTE) processed meat products from Enterprise Foods in Polokwane, South Africa found would be detained and destroyed.

It added that “in addition, vigilance at the various ports of entry has also been intensified, as no imports should be made from this company. Any products from Enterprise Foods in Polokwane, South Africa (a subsidiary of the Tiger Brands Company) will be detained and the necessary regulatory actions taken.”

The statement read: “Following news on the outbreak of Listeriosis in South Africa, the Food and Drugs Authority (FDA) has intensified market surveillance and monitoring at the ports of entry for meat products from South Africa. The FDA has been in constant communication with the International Network of Food Safety Authorities (INFOSAN) which shares food safety alerts.”

“Update from INFOSAN indicated that investigations conducted by the South African Authorities on the outbreak revealed that the affected RTE products are now subject to recall.”

The FDA said since Ghana is a known export country for Enterprise Foods, the INFOSAN has warned that there is a possibility of some of the recalled products having been exported to Ghana.

According to the FDA, Listeria monocytogenes is typically a food-borne organism, which causes the illness called listeriosis and can grow and reproduce inside the host cell. Listeria is a bacterium that is naturally found in the environment and is capable of surviving with or without oxygen.

“It therefore has the ability to survive and grow at temperatures as low as 0°C thereby allowing multiplication at refrigeration temperatures.

“It commonly occurs in soil, water, vegetation and in the faeces of some animals. Listeria monocytogenes has been associated with foods such as raw milk, pasteurized fluid milk, cheeses, ice cream, raw vegetables, fermented raw-meat sausages, raw and cooked poultry, raw meats (of all types), and raw and smoked fish. This fact, coupled with variable incubation period can range from 6 hours to 70 days.”

“The prevention of listeriosis is similar to guidance used to help prevent other foodborne illnesses. This includes practicing safe food handling and following the WHO Five Keys to Safer Food (1. Keep clean. 2. Separate raw and cooked Food. 3. Cook and reheat thoroughly. 4. Keep food at safe temperatures. 5. Use safe water and raw materials.)”

The statement said: “Additionally, persons in high risk groups should avoid consuming ready to eat meat products such as sausages, hams, patés and meat spreads.”

The FDA urged the public to read and carefully follow the shelf life period and storage temperatures indicated on the product label to ensure that products are not from Enterprise Foods, Polokwane, South Africa (a subsidiary of the Tiger Brands Company).

It urged the public to give information to the FDA on the following numbers and social media platforms; “0800151000 (Toll free on Vodafone and Airtel only), 0299802932 or 0299802933 (Hotline), 4015 (SMS short code), 0206973065 (Call and WhatsApp), Facebook (Food and Drugs Authority-GH), and Twitter (@ GH_FDA)”

–

Source: GNA

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The deceased persons suffered severe stomach ache after eating the akple and banku, and were admitted at the Hospital, where they later died.

[contextly_sidebar id=”iv2FUT4pFlh0Y4oDNTeMzisa4Vd0HWwM”]The FDA officials, who visited the town picked samples for analysis, and also forwarded them to the Ghana Standard Authority (GSA) for further analysis.

In a statement issued on Wednesday, the FDA stated that “Laboratory results received indicated the presence of Chlorpyrifos, a very toxic substance found in commonly used pesticides which when ingested can cause death.”

In the statement signed by the acting Chief Executive Officer of the FDA, Delese A.A Darko, she said they will forward the findings to the Public Health Directorate of the Ghana Health Service for further action.

Below is the FDA’s full statement 

Following the recent deaths at Akakpokope, a village in the South Tongu District of the Volta Region after the consumption of Banku and Okro soup, the FDA took samples of the food for analysis and forwarded samples to the Ghana Standard Authority (GSA) for further analysis.

It may be recalled that on 4th of March, 2018, the Food and Drugs Authority’s (FDA’s) Volta Regional Office was alerted on a purported food poisoning incident involving two households after consuming a popular delicacy, Banku and Okro soup where the corn dough was made from tailings also known as “Gatemewor” by the locals which was bought from a corn mill owned by one of the affected families.

As indicated in our earlier communication, the FDA alerted the Regional Foodborne Disease Focal Person, other Public Health experts, officials from the Ghana Health Service, Municipal Assembly, the Ghana Police Service and the Municipal Health Directorate went to the scene.

The initial investigations of the team revealed that 8 people had been affected but five had passed on as at the time they arrived at the scene, and the three others were at the hospital. Samples of the corn dough and left over banku were taken and forwarded to the FDA Quality Control Laboratory on Monday 5th March, 2018 for analysis of which part of same samples were sent to the Ghana Standards Authority (GSA) for further analysis.

Laboratory results received from the GSA on the 13th of March, 2018 indicated the presence of Chlorpyrifos, a very toxic substance found in commonly used pesticides which when ingested can cause death. This result confirmed the initial laboratory analysis conducted by the FDA Quality Control Laboratory on 7th March, 2018.

In toxicological analysis, there is normally no fixed turnaround time as being suggested by the Consumer Advocacy Centre in their statement since the analyte is not known from the beginning.

The FDA is forwarding its findings to the Public Health Directorate of the Ghana Health Service for further action.

As earlier communicated when the news broke out, the FDA is not mandated to determine the cause of death. This can only be established after a pathological Investigation.

We wish to state emphatically that as a Regulator, we need to be factual in every information put out to the public in order to avoid creating fear and panic.

The FDA would like to assure the general public that there is no cause for alarm as the corn mill from which the corn dough was sourced remains closed and the situation is under control.

The FDA appreciates the fact that increased consumer awareness of food safety issues has raised concerns regarding the authenticity of some foods on the Ghanaian market and the FDA is committed to addressing these concerns.

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By: Farida Yusif/Citifmonline.com/Ghana

The post Banku deaths: Lab results reveal toxic substance in corn dough appeared first on Citi 97.3 FM - Relevant Radio. Always.

Four other persons who consumed the meal are reported to be in critical condition.

[contextly_sidebar id=”XI9dn4yM5UG5dzxLKktCyYMYe9wNOHjN”]The South Tongu District Chief Executive, Emmanuel Agamah, who has since convened a DISEC meeting on the issue, told Citi News there is growing panic in the village following the deaths.

“After eating Banku, they complained of stomach pains…the father of the children survived and one child, but as to exactly what happened, I’m not in the position to say because the Food and Drugs Authority came for a sample of the food yesterday [Sunday], so we are yet to ascertain whether it is a poison from someone or it was a contaminated food,” he added.

Reports indicate that officials of the FDA spent two hours in the area, and picked samples of the corn dough used in the preparation of the banku to find out what exactly caused the deaths.

The victims were said to be relatives of two separate families.

One dead, 6 others hospitalized after eating poisonous fish

In January 2018, one person died, while six others were hospitalized at Nkonya in the Volta Region  after they reportedly ate meals prepared with puffer fish, which is said to be highly poisonous.

The FDA subsequently urged residents of the area to stop eating such fish to forestall any more deaths.

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By: citifmonline.com/Ghana

The post FDA probes death of 4 persons who died after eating banku appeared first on Citi 97.3 FM - Relevant Radio. Always.

The FDA assured the public that it has put together regulatory measures to ensure the wholesomeness of palm oil sold on the Ghanaian market.

In a statement signed by the acting Chief Executive Officer of the FDA, Mrs. Delese Darko, the Authority said that it’s attention had been drawn to reports on social media about the seizure of two brands of palm oil in Switzerland purported to contain Sudan dyes.

[contextly_sidebar id=”uEHsDzcrofLXcAAkj8ulvcvIW2QFjTtV”]The statement said the publication attributed its source to the Swiss Federal Food Safety and Veterinary Office (FSVO), and warned against the use of the said palm oil brands.

Below is the FDA’s statement

The attention of the Food and Drugs Authority (FDA) has been drawn to news making rounds on social media about a seizure of two brands of palm oil (POLIFUDS and ZOMI) in Switzerland purported to contain Sudan dyes.

The publication attributed its source to the Swiss Federal Food Safety and Veterinary Office (FSVO) and warned against the use of the said palm oil brands.

It may be recalled that the FDA has worked extensively on this subject in the past in collaboration with other agencies including its European partners to ensure the safety of palm oil used in Ghana and for export.

Preliminary investigations conducted so far by the FDA about the publication indicate that the implicated brands are not registered with the FDA and there is no information regarding the country of origin.

Market surveillance carried out so far by the FDA has also not established that the said brands are in circulation on the Ghanaian market.

It must be noted that ZOMI is a generic name for a type of palm oil in many West African countries and its origin should not be necessarily associated with Ghana only.

The FDA wishes to assure the general public that it has put in place regulatory measures to ensure that palm oil on the Ghanaian market, as well as export consignments, are safe for consumption.

The export control measures include the sampling and testing of consignments for Sudan IV dyes among other parameters. Failed consignments are disposed of.

The FDA will continue to monitor the industry and trade practices to promote public health and safety. Meanwhile, the public is encouraged to alert the FDA on any issue regarding its mandate through any of the following contacts

Toll-free: 0800151000(Vodafone and Airtel)

Hotlines: 0299802932, 0299802933

Shortcode: 4015

–

By: citifmonline.com/Ghana

The post Alleged unwholesome palm oil not from Ghana – FDA appeared first on Citi 97.3 FM - Relevant Radio. Always.

[contextly_sidebar id=”YggNTLIlB9o4xECfhiWI7tISUF8NjSAO”]The Authority said it has been compelled to take the decision due to the consistent failure of a number of media houses to heed the ban.

The FDA, in January 2018, said it would strictly enforce the regulations which prevent manufacturers of alcoholic products from advertising their products on radio and television between the hours of 6am and 8pm.

The FDA’s current guidelines for the Advertisements on Foods (Section 3.2.6) and specifically the requirements for advertisements of alcoholic beverages, states that: “Radio and Television advertisements shall not be aired between the hours of 0600 am and 2000.”

However, lax enforcement of this regulation has seen alcoholic beverages advertised at all times of the day.

Following the FDA’s threat, some alcoholic beverage-producing companies have sought to get the ban reviewed.

But the Public Relations Officer of the FDA, James Lartey said the Authority will not compromise on its stance and will ensure that those found culpable are dealt with according to the law.

“Where there is a guideline the FDA has come up with to regulate an industry and one goes against the guideline, a person is supposed to be fined 2,500 penalty units [GH¢30,000]. But we have an LI that was passed for us by Parliament and it allows us to charge a maximum of GH¢25,000.”

“Anyone who refuses to pay the amount will be prosecuted. You will be jailed a period of 5 years in addition to the fine the person refused to pay. We have written to them [erring organizations], we have written to the police. When it comes to the area of prosecution, the police will pick it up, do the investigation and the rest will follow,” he said.

Regulation needed

The FDA earlier stated that the ban had become necessary because of the rise in the number alcohol ads during the day enticing minors to try these beverages, and ultimately affecting their health.

“Currently we have looked at the level of alcohol consumption in the media, it is very bad. And I think the earlier, we bring some stringent measures the better. So we feel that this is an attempt to actually enforce that aspect of the regulation,” he said.

He said, for now, the FDA is targeting the traditional media outlets although they are aware other channels could be used to promote these beverages.

James Lartey, however, suggested that in time the Association will look at enforcing the law on these other channels, including the various social media platforms.

“For now we are looking at TV and radio, that is what our regulations say, TV and radio, but like I mentioned earlier, regulation is dynamic, as we go along if we realized the need to include another medium, why not we will,” he said.

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By: Jonas Nyabor/citifmonline.com/Ghana

The post Alcohol ads ban: Errant media houses to be prosecuted appeared first on Citi 97.3 FM - Relevant Radio. Always.