Consumer advocates say the present system allows potentially harmful medications to stay on the shelves indefinitely, with no restrictions on their sale
When her young daughter had a fever, Suda (not her real name) would buy cheap medicine in a small shop in her village. With a picture of a child on its packaging, she assumed that the medicine was safe for children. One day she looked at the small print on the label, however, and saw a warning not to give the medicine to children under 18 years of age. Unfortunately there are a number of medicines registered as safe and effective on the shelves of local Thai pharmacies when in fact they may not be safe for children, and in many cases for adults either. Consumer advocates argue that warning labels are often ineffective because people don't bother to read them.
Part of the difficulty in choosing the right medicine lies in the sheer number of products on the market. As of April last year, a total of 25,026 drugs were registered with the Food and Drug Administration (FDA). Of the total, 19,462 are locally made and 5,544 are imported.
Under the Drug Law (1967), the FDA withdraws a drug formula registration only when the drug is proved to adversely affect health, or after a manufacturer stops producing a product for two years.
According to Dr Niyada Kiatying-Angsulee, director of the Social Research Institute and manager of the Drug System Monitoring and Development Programme under the Faculty of Pharmacology at Chulalongkorn University, the drug formula registration system is flawed because the registration never needs to be renewed.
''It can stay forever. Many drugs have been registered since 1983 and they remain on the market,'' she said. Prior to 1983 the law required that a drug's registration had to be renewed every five years. In 1979 there was a change in the 1967 Drug Act to abolish the drug renewal system, which went into effect in 1983.
According to FDA reports, a total of 230 drug formulas still on the market were registered in 1983. Dr Niyada said that those ''old medicines'' might not be suitable today, in part because since then there have been advancements in treating many illnesses.
Dr Niyada proposed that drug registrations should be renewed every five years as before.
''Most countries renew drug registrations every three to five years so as to pull out the unsuitable drug formulas before they cause irreversible damage,'' she said.
She added, however, that this move alone wouldn't solve the problem of dangerous or inappropriate medicines on the shelves, and urged the FDA to establish an efficient post-approval safety evaluation system to thoroughly review a product's safety and efficacy records.
''The FDA needs sufficient information to support decisions on whether to renew or not to renew medicines,'' she said.
While the authorities are not shy about approving drug formulas _ 1,241 remedies were approved in 2000 _ they are slow or reluctant to seek withdrawals of registration, even after receiving complaints or reports of significant harm to consumers. Dr Yaowaluk Amsiriampai, of the Faculty of Pharmacology of Silpakorn University, wrote in a report on drug evaluation that just 17 registered drug formulas had been withdrawn from 2002 to 2008.
Dr Niyada cited the example of one locally produced drug, Anapromine syrup, which is used as an appetite stimulant for children (see sidebar). The product was linked to abnormal sexual organ development in two patients, a four-year-old boy and a two-year-old girl. A doctor at Ramathibodi Hospital exposed the problem to warn the public.
However, rather than withdraw the syrup, the FDA required that the manufacturer list its ingredients and dispense it by prescription only.
Consumer advocate groups disagreed with this solution and strongly demanded that the FDA withdraw the formula. In June 2009 the FDA ordered a withdrawal of the registration.
This case points to another major and very real problem with the Thai system. Despite the fact that the registration has been withdrawn, the drug has remained on the market because of a lack of monitoring and enforcement by authorities. The FDA warns that 13 other withdrawn drugs _ including diet pills, pain killers and antibiotics _ probably remain on the market as long as there are supplies available.
Dr Niyada, a member of the National Drug Committee, said: ''We can work more aggressively to protect the public.'' She praised FDA officials for working more systematically to serve the public's interests in recent years. Last year a number of drug registrations were withdrawn for safety reason, and during the past two years the FDA has ordered drug companies to pull lots, or batches, of some 30 drugs from the market because of substandard ingredients.
DANGEROUS DRUGS
Following a survey in communities in ten provinces _ Samut Prakan, Chiang Mai, Chiang Rai, Uttaradit, Khon Kaen, Yasothon, Chaiyaphum, Surat Thani, Tak and Chachoengsao _ the Rural Pharmacist Society (RPS) said it had found a large number of medicines in shops and even in hospitals that were unsafe or ineffective. The society and its network took four months to do the survey last year.
''In rural communities we can find drugs which people in big cities like Bangkok have never heard of,'' said Darin Jeungpattavadee, a pharmacist in Loei province who chairs the society. ''Actually, a large number of drugs found during the survey raise our concerns. Different areas have different problems, with varying levels of severity. Therefore, we need new approaches.'' She added that a number of registered medicines contain mixtures of ingredients that should not be taken together.
''For instance, an anti-tussive [cough suppressant] drug is mixed with a medicine for head cold symptoms. Each of them has a different therapeutic quality. The anti-tussive will ease coughs and act as an expectorant. The anti-cold medicine makes sputum condense, leading to acute coughing symptoms,'' Ms Darin said.
The group identified four medicines which it says should be pulled from the shelves immediately. ''We have a list of unsuitable drugs or medications that includes some banned from the market in at least five countries and others which are not approved for registration in some countries,'' said Ms Darin.
''There is enough medical and scientific information to support our assertion that their potential risks outweigh their claimed potential benefits.''
The four medications are an antidiarrhoeal combination, an antibiotic powder, a widely used tablet for kidney problems and common aspirin _ which the RPS says should never be given to children.
ANTIDIARRHOEAL COMBINATION: The World Health Organisation suggests using oral rehydration salts to treat diarrhoea. Antibiotics are not recommended since they have no proven efficacy for the treatment of diarrhoea. Besides, they may cause side effects and result in antibiotic resistance, which is at present an important public health problem in Thailand and around the world. However, antidiarrhoeal combinations, in both tablet and syrup forms, are easily found on pharmacy shelves and even in small community markets. The RPS says these medicines normally are comprised of four or five chemical compounds and each of them may cause side effects such as fever, rash and nausea, as well as hinder the absorption of important nutrients. One of the chemical compounds commonly found in these medications is furazolidone, which has been shown to cause cancer and induce abortion in mice.
AMOXYCILLIN POWDER: The antibiotic powder is promoted for the treatment of infections of the respiratory tract, stomach, bladder, intestine and kidney. The RPS objects to placing the antibiotic in the bag, as it says this makes it difficult to manage. For example, the label states that a child up to two years old should be given only half of the amount in the bag. But in practice few people weigh or meter out the exact amount of powder as recommended. Consequently, there is a possibility that the patients do not receive a proper dose of medicine, leading to overdose or treatment failure.
Another problem, said Ms Darin, is that the powder in the paper bag will not stay stable and will probably decompose before its expiration date. What's more, a number of registered amoxycillin powders also contain ''inappropriate ingredients''.
A small bag containing amoxycillin in pow der form with the trade name ''Ka Ou Lin'' and two parrots on a cup as its trademark is a very old and recognisable medication in Thailand. In fact the manufacturer has discontinued the product, but according to the RPS surplus stocks of the product can still be found in many shops in rural Thailand.
As noted above, according to regulations, if the manufacturer stops producing a medication its registration will automatically expire. Ms Darin said this is an ineffective procedure as it allows for abuse of the system.
''It would be better if the authorities withdrew the formula to make sure that it will not resurface under a different brand name,'' she said.
KIDNEY TABLETS: The RPS says that because of unclear efficacy and a high risk of overdose, these tablets should be withdrawn from the market. The drug is claimed to improve kidney function, reduce backaches and improve urination. The best selling brands in Thailand are Cystosin, Marwitt and Zoro.
The survey team talked to 43 persons who regularly take the pills and 29 shop owners who sell them. Most of the users were working people who said they took the medication once a day for back pain and trouble urinating. Many reported side effects including nausea, vomiting and blue urine.
ASPIRIN FOR CHILDREN: The RPS says children should never take aspirin. Studies have linked the use of aspirin or aspirin-containing medications to development of Reye's syndrome _ a disease which most often strikes children or teenagers, and sometimes adults as well, during or soon after a viral disease. It affects all body organs, the liver and brain most seriously. The main symptoms include persistent vomiting, lethargy or sleepiness. In the later stages those stricken may exhibit irrational behaviour, confusion, severe weakness and loss of consciousness.
In 2007, the FDA issued a regulation for aspirin-containing medications to print warnings or recommendations on package labels. The warnings prohibit the use of the medication for children under 18 unless it is prescribed by a doctor. They also prohibit use by any persons who are suffering or recently recovered from a viral disease such as influenza, dengue fever or chicken pox. Treatment for body pains and aches is prohibited, as is use by pregnant and breast-feeding women. Moreover, the FDA warns against long-term use because of the risk of bleeding in the stomach, asthma and liver and kidney damage.
The RPS and its network are upset with the authorities' solutions, as they feel safety information and recommendations on the label won't solve the problem.
''The authorities cannot rely on labelling precautions to resolve the safety concerns. People who use aspirin are often simple workers or farmers and their children. They do not read the recommendations. They understand that the drug can be used to treat children with fever because pictures of children are displayed on the packaging,'' said Ms Darin.
''Besides, it is difficult to read the companies' tiny printed warnings and recommendations.''
In 2008, the Ministry of Public Health issued another regulation saying that aspirin can be used for juvenile rheumatoid arthritis and for Kawasaki disease. Ms Darin said that those who have these illnesses need to be treated by doctors who will prescribe the appropriate medicines.
The RPS submitted its proposal to withdraw the four medications to the Ministry of Public Health last November. ''We asked the authorities to take three months to review the proposal and then to withdraw the four drugs to protect the people,'' said Ms Darin.
A PROLONGED WITHDRAWAL
In 1989, the Ministry of Public Health ordered the withdrawal of two medicine formulas for safety reason. One was a combination of the anabolic steroid methandienone, vitamins and/or cyproheptadine, an antihistamine which is sometimes used to promote weight gains. The other formula contained the anabolic steroid as a significant ingredient and was used as an appetite stimulant for children.
In 1990, the ministry revised its earlier order, saying that it only applied to formulas used for children. A formula administered for adult sufferers of diabetes or bone disease was exempted.
In 1993, a medicine formula combining methandienone and cyproheptadine in syrup form under the brand name Anapromine was registered with the FDA. However, it was classified as a prescription drug.
In 1999, a doctor at Ramathibodi Hospital and faculty member of the hospital's medical school, Assistant Professor Patt Mahachoklertwattana, gave a report to the FDA of a two-year-old girl suffering from abnormal sexual organ development after she had taken Anapromine syrup. He suggested the formula's registration should be withdrawn. However, the FDA insisted that since it was sold only by prescription it was already adequately controlled.
In December, 2007, Prof Patt reported another case, this time of a four-year-old boy suffering the same symptoms after he had taken Anapromine syrup.
To warn the public he decided to call a press conference in which the child's mother said that the syrup had been a popular appetite stimulant for children for a long time.
Again, the FDA insisted that the syrup was regulated as a prescription drug and therefore would not be approved for children.
In January, 2008, consumer advocate groups submitted a letter demanding the withdrawal of the formula after it was discovered that despite the FDA prohibition it was being sold over-the-counter and children were continuing to use it.
In May, 2008, the National Drug Committee agreed that the FDA should withdraw the medicine formula. However, it took a year, until June, 2009, for the FDA to issue an announcement to withdraw the drug formula. Besides Anapromine, two other medicines use the formula _ Cetabon tablets and Azolol plus.
After the announcement was issued it took another two months to publish the order in the Royal Gazette.
Posts
No comments:
Post a Comment