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Rx: safeguarding medicine that is given to children
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CHINA is still debating gaps and inefficiencies in medicine for children, two years after the death of a 23-month-old baby in a hospital.
Promethazine, marketed under the trade name Phenergan, was blamed for the death. The drug is an antihistamine used most commonly to treat allergy symptoms and nausea associated with surgeries or motion sickness. It is sold over-the-counter in many countries and is sometimes used by parents to sedate young children during long flights.
In 2006, the US Food and Drug Administration required pharmaceutical makers to print label warnings on Phenergan that it should not be used on children under two and should be used with great caution on children over two, after the agency linked the drug to 22 cases of respiratory depression among infants, seven of which proved fatal.
Chinese authorities haven’t been quite that diligent about warnings to doctors and parents about administering drugs to children, nor about recommended dosages on drugs that may be safe.
Children 14 years and younger comprise about 17 percent of this nation’s population and account for about a fifth of those being treated in health facilities.
Yet less than 2 percent of medicine is specifically made for children, according to the Medicine Chamber of Commerce of the National Federation of Industry. Nine in 10 domestic medicines don’t specify dosages for children.
In many cases, doctors simply pare the recommended adult dosage, according to Liu Zhiwei, physician of neonatology at the International Peace Maternity and Child Health Hospital of China.
“Surely it would be better to prescribe particular children’s medicine for children, but we cannot prescribe what isn’t available, can we?” said Liu.
It may be relatively easy to reduce a liquid medicinal dose for children, but dividing a capsule into quarters or even eighths is a bit trickier.
Jess Zhang still remembers the hard job of grinding and dividing pills for her 8-month son. She did it in the dark because light can cause faster oxidation, reducing the effectiveness of medicine. At the same time, losing some of a capsule’s coating may cause unwanted side effects.
A deviation of more than 5 percent can lead to either ineffective treatment or even adverse drug reaction, according to Chen Yunbin, a member of the pediatrics arm of the Guangdong Medical Association.
It is relatively safe to prescribe medicines that have clear advice on recommended dosages for children according to their weight or age, said Liu. But many drug instructions simply contain vague language about a “discretionary reduction for children,” which leaves the prescription largely dependent on the experience of the doctor.
“Many pediatric doctors are nervous when prescribing medicines because they aren’t sure about possible side-effects,” said Chen.
The National Monitoring Report on Adverse Drug Reactions concluded that there were adverse reactions in about 10 percent of cases involving children 14 years and younger in 2013.
That year, a 23-month-old baby suffered respiratory arrest about 20 minutes after ingesting Phenergan and was pronounced death four hours later. A post-mortem blamed an initial inaccurate diagnosis, use of Phenergan and a tardy response when the patient took ill.
Other media reports have sounded similar alarms, like the story of the 3-year-old who suffered an allergic shock after being given cordate houttuynia, a traditional Chinese medicine know as bishop’s weed in English, or the story of a 5-year-old dying after taking the domestic antibiotic drug Lijunsha.
Some children’s hospitals have even tried producing their own medicines to fill the gap in the children’s drug market. Many of these hospital-made medicines are based on existing formulas from traditional Chinese medicines that have proven effective in thousands of years of use, said Liu. But such practices don’t conform to international standards that require extensive clinical trials, which most hospitals cannot afford.
Getting pharmaceutical companies to do the testing is difficult because they are unwilling to invest the long times and considerable costs of drug trials that may lead to no profitable end.
It’s a fact of demographics that the adult population far outnumbers that of children. Most drug-makers prefer to concentrate on the biggest market. Medicine designed for children often requires special methods of administering or special flavoring.
Echo Zhou, who works on the staff of a foreign-invested pharmaceutical company, said she recalls only one instance when her company produced a drug with specific dosages for children.
“Profit is still what drives most companies,” she said. “You cannot expect them to shift to a lesser lucrative business simply because it is needed.”
In mid-2014, six national commissions and administrations in China issued a joint notice on children’s medication. It said a channel for clinical trials on children’s medicine needs to be established and pricing support given.
Several provinces, including Henan, Hubei and Jiangxi, have issued formal responses to the national call. There’s been no response from Shanghai yet.
Jiangxi said it plans to establish a pediatrics medicine center at the Jiangxi Children’s Hospital.
“Encouragement from the government is surely good news for us and for young patients,” said Liu. “But it is still too early to estimate just how much pharmaceutical companies can be motivated to participate.”
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