KNH knocked syrups off its drug list 12 years ago

Health bosses secretly withdrew popular cough syrups as treatment for children aged two years, and Kenyatta National Hospital stopped prescribing them 12 years ago, the Nation has learnt.

The Ministry of Health, through the Acute Respiratory Infection Programme, in 1992 adopted a policy not to use any cough syrup in the treatment of children. As a result, KNH stopped prescribing them for children under 12.

Medical Services Permanent Secretary Kiyiapi said cough syrups were removed from the Kenya Medical Supplies Agency supplies chain two years ago. But it was not clear why this was not communicated to the public or new regulations for their use announced.

On Thursday, Dr Kiyiapi accused the Pharmacy and Poisons Board, charged with drug safety, of “sleeping on the job” and directed it to immediately order the withdrawal of the medicines. The United Kingdom banned the medicines on March 1.

In the meantime, the Government asked parents not to panic and that cough medicines are not poisonous but recommended that they are not to be used for children under the age of six. The pharmaceautical industry defended their products as safe and legal, but said they should be used after consulting a doctor.

And the Nairobi Hospital on Thursday joined the list of top hospitals in removing cough mixtures from their prescriptions for children.

Poisons board

Director of Medical Services Francis Kimani, reassuring the public, said the Poisons board was reviewing data on the medicines and would take “appropriate regulatory action” once this was done.

“I’m therefore directing the newly inaugurated board members to immediately act on this issue with,” Prof Kiyiapi told journalists at the Kenyatta International Conference Centre in Nairobi.

The withdrawal of the syrups, reported in the Nation on Thursday, drew sharp reactions from a cross-section of pharmacists who defended them and said they would continue selling them until they got formal notice from the regulator.

The pharmacists said there is no concrete evidence that the syrups are ineffective and could be harmful, as alleged by earlier research findings.

A visit to four dispensing chemists in Nairobi showed they have not withdrawn the cough syrups in question. Some of those brands include paediatric dosages of Actifed, Benilyn, Linctifed and Ascoril. Pentapharm and Thorn Tree however said they had not filled any prescriptions on the cough syrups.

Thorn Tree’s pharmacist, Mr James Kinyanjui, said that when the medicine is correctly prescribed, it benefits ailing children. “These syrups have always been used by patients and so long as the medicine is used as prescribed by the doctor, there are no side effects,” he said.

However, he cautioned that people should only use over the counter medicines with young children after consulting with a doctor who has examined the sick child. Therein lies the source of the debate here in Kenya: Most of the people who rely on these relatively affordable, easy to use medicines do so because they cannot afford medical advice.

Still, pharmacists are insisting on official clarification over which medicines were perceived ineffective or harmful since they have dispensed them for many years without any complaints of side effects.

Dr M. Shah, who owns Jacaranda Chemists, argued that the studies done in the US do not adequately represent Kenya. He questioned the reason for the research.

Dr Shah said side effects are often inevitable, and that is why dosages are always given. “Sometimes it is the customer who does not listen when we are giving instructions,” he said.

However, the doctor added that if the Pharmacy and Poisons Board made a formal request, he would withdraw the medicines. Many parents were confused by the news on the popular medicine.

Ms Martha Muchiri, who was waiting for her niece to be admitted at the paediatric ward of Kenyatta Hospital, said had always been cautious when buying drugs for her children. She said she always took her children to hospital and only bought what the doctor had prescribed.

“I never go to the chemists and buys cough syrup without a prescriptions, only pain killers,” said the mother of five.

On Thursday, Dr Kimani, in a statement, urged parents and caregivers to ensure they consulted their doctors on the use of all cough and cold products in children. “Whereas hospitals are free to amend their stock of drugs, any removal of any medicine from their lists is an individual institutional decision,” the DMS said.

Dr Kimani said the syrups will be available for 6 to 12 year-olds but will only be sold in pharmacies with clear advice given. His Permanent Secretary, Prof Kiyiapi, had a different view, saying: “A majority of the cough syrups lack active compounds to heal coughs and only end up in suppressing the condition.

“At the same time, we are concerned that like other popular medicines, some might be counterfeits which could be harmful to those taking them,” he added. Dr Kimani explained that cough syrups do not cure or treat coughs, they only relieve symptoms.

Scientists in the United States of America have for the past two years questioned the effectiveness of the syrup and even suggested that it may have been responsible for some deaths among children.

In 2007, several drug makers, including Johnson and Johnson, Wyeth and Novartis, voluntarily withdrew cough and cold products labelled for infants over what they said were fears the medicines could be misadministered.

Two of Kenya’s top paediatrics hospital--Gertrude’s Children’s Hospital and the Aga Khan University Hospital--on Wednesday announced that they were withdrawing all cough syrups from their pharmacies for children aged 12 years.

On Thursday, the medical director of GlaxoSmithKline, Dr Willium Mwatu, said they did not sell cough and cold medicines for children less than two years old.

Dr Mwatu advised parents to buy cold and cough products after getting advise from qualified medical personnel and avoid overdosing. He said the drugs are safe to use.

On Thursday, the Pharmaceutical Society of Kenya and other medical professionals are planning to meet to deliberate on what advice to give to the government, according to its chairman Dr Dominic Karanja.

He however asked the public not to panic because the drugs in the market are safe. “Parents should not panic because the drugs in our market are safe, however we shall be meeting with other medical professional bodies to discuss the merits of the studies and come up with a common position,” he said.

Reacting to the news that two leading hospitals in Nairobi Agah Khan and Getrude’s had withdrawn cold and cough medicines for use in children under 12, the chairman of the Kenya Pharmaceutical Distributors Association Dr Kamamia wa Murichu said the issue should be handled with care because it could have devastating effects on the sector.

“If for some reason this ban becomes an official policy then it could cripple the Sh14 billion pharmaceutical industry and wipe out many retail pharmacists from business because the drugs in question represent almost 20 per cent of the market,” he told the Nation.

Most affected, he explained would be local manufacturers, almost all of whom have a cold or cough product in the market. “The liquid line is the cheapest to establish in a pharmaceutical establishment and the products are fast movers, hence a general withdrawal would not be advisable,” he said.

However, a member of the Kenya Pharmaceutical Distributors Association, who did not wish to be named, broke ranks with colleagues and said the hospitals withdrawing the medicines had a strong case because in most cases the cold or cough will clear on their own.

“Unless there is an underlying infection, the child should shrug off the cold after a few days. But to make it comfortable the infant needs to be kept on a lot of fluids. In case of an infection the child may require a paediatrician to prescribe a suitable antibiotic,” he told the Nation on Thursday.

The problem with most of these drugs, he explained, is that they are designed to use the shogun effect — hit the problem with many compounds hoping one of them will achieve the desired effect.

One product could contain a suppressant, which suppresses the urge to cough and an expectorant that thins the mucus. These and other products may send the baby to sleep which could inhibit the clearance of mucus.

A senior marketing official with the Swiss giant Roche Pharmaceuticals, Dr Paul Njoroge, said a blanket withdrawal of these would be ill advised in the absence of comprehensive studies.