dear all...

maaf kalau sudah pernah baca. these articles highly recommended to read.

begitu byk obat generik dikemas ulang dan diberi merk. Harganya jadi
mahal spt obat paten,tapi isinya generik.
di sisi lain begitu banyak obat dihambur2 untuk pengobatan yang mungkin
hanya membutuhkan home treatment..

*"That's why children in Jakarta go to the same doctor every two
weeks, with the same disease, to receive the same, wrong medication
which reduces their immunity," he said (Prof Iwan Darmansjah)*

regards,

reyna


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http://www.thejakartapost.com/detailheadlines.asp?
fileid=20060214.B01&irec=1

Pill-popping public 'victims of unregulated market'


Hera Diani, The Jakarta Post, Jakarta

If you are a health consumer in Indonesia some of these situations
may be familiar to you.

-- You go to a doctor instead of self-medicating for your cold and
fever and end up with three different types of medicines, plus
vitamins, which cost you a cool Rp 400,000 (US$43.50).

-- You are stuck in an emergency room of a hospital with a bad case
of food poisoning, when you get another reason to vomit -- the price
of your bill for the medicines is Rp 700,000. Then the doctor gives
you a shot and you feel fine, but annoyed.

-- *You take your toddlers to the pediatrician almost every month,
forking out good money for many packets of medicines to treat the
same reoccurring cold and flu symptoms. Your pocket hurts and you
worry about the effect the many pills are having on your children's
development. *

-- Unable to afford your medical bills, you pay half -- and get only
half -- of the prescribed drugs. Or you risk all and go to the
Pramuka black market in East Jakarta for cheaper medicine.

Health is wealth, as the saying goes, which in this country could
translate to mean "getting sick can rob you blind".

Experts say doctors here often overprescribe drugs to unwary
patients, who are also paying too much for medicines -- a situation
they say is caused by a lack of regulations and monitoring.

University of Indonesia medical school professor and pharmacologist
Dr. Iwan Darmansjah said an absence of regulations governing the
retail prices of prescription drugs here had caused some doctors and
companies to inflate prices to ridiculous, rip-off levels.

"The amoxycillin antibiotic, which in other countries only costs
between Rp 400 and Rp 500 (about 4 U.S. cents) a tablet, is being
sold here by several companies for as much as Rp 2,800 a pill.
That's deceiving, unfair business," Iwan said.

Health Ministry rational drug use department director Husniah
Rubiana Th-Akib said manufacturers were also taking advantage of the
erroneous public perception that generic drugs were less effective
than their patented counterparts.

Husniah said all drugs were categorized as either generic or
patented. Patented drugs were generally the latest generation of a
drug, and were usually more expensive. But generic drugs -- often
made specifically for low-income consumers -- should be no less
effective and prices should be considerably cheaper in most cases,
she said.

Patented drugs have only a 2 to 3 percent market share but make up
15 percent of national drug revenue.

"What manufacturers do, however, is take a generic drug, make it
more appealing with packaging and everything, and then slap
a 'brand' and a high price on it. We can call this type of drug
a 'branded' generic drug," Husniah said.

*"For amoxycillin, for example, there are over 100 brands on the
market, with (wildly) fluctuating prices, while the content (in the
tablets) is the same."
*
Often cheaper generic drugs are sold at the same price as patented
drugs -- or worse, were packaged as such, she said.

Marius Widjajarta of the Indonesian Health Consumer Empowerment
Foundation said drug prices should not fluctuate much.

"(Prices) tend to decline because newer, more sophisticated drugs
enter the market."

However, international Pharmaceutical Manufacturers Group director
Parulian Simanjuntak said drug prices here were based on the simple
market mechanisms of supply and demand.

Because health insurance is not common in Indonesia, about 80
percent of drugs are being bought by individuals or companies,
Parulian said.

Large insurers, as big buyers of drugs, could help set market limits
on prices, he said.

With a total market value of about $2 billion a year, many companies
here are involved in drug manufacturing -- 34 multinational
companies and another 170 local ones, according to data from the
group.

In such a competitive market, companies often pay doctors
commissions to prescribe drugs, meaning patients often get medicines
they do not need.

Indonesian Doctors Association chairman Farid Anfasa Moeloek said
the government should subsidize drugs for low-income groups, who
were supposed to get free medical treatment.

Farid said the unregulated system, not doctors, was to blame for the
high prices.

Husniah, meanwhile, said the Health Ministry planned to regulate the
packaging of drugs to ensure consumers could easily tell the
difference between generic and patented medicines.

Branding on generic packaging would be 20 percent smaller and retail
prices and ingredients would also be listed, she said.

"It's important for consumers to know what is in the tablets they
buy," she said. If they had a choice between three chemically
identical drugs, they could then choose the cheapest one, she said.

Manufacturers are opposed to the new labeling rules, which they say
are against trade laws and will only increase their costs.

Parulian said international manufacturers already labeled their
drugs clearly and included tablet ingredients.

"The plan would change the layout of the whole packaging. Besides,
(the idea) goes against the regulation for Trade-Related
Intellectual Property Rights on brands."

"We need brands, we invest in them. By including a drug's generic
name, it will weaken our brands. We are going to protest this plan,"
Parulian said.

The industry has yet to make up its mind on price labeling, but
Parulian believes it would be difficult to impose.

"Price labeling already exists on the primary packaging that
(doctors' buy and) consumers do not see. If there was a change in
prices, it would be impossible for manufacturers to relabel the old
stock."




=========
http://www.thejakartapost.com/detailheadlines.asp?
fileid=20060214.B02&irec=4

Embattled BPOM chief says agency doing its job to monitor drugs


Although known for his Javanese politeness and fine manners, Food
and Drug Monitoring Agency (BPOM) chief Sampurno was clearly
irritated when asked about criticism his organization has failed to
properly monitor and regulate the pharmaceutical industry.

"It's all talk with no proof," he said.

After the flak BPOM received last month, when carcinogenic
formaldehyde was found being used to preserve tofu and other food,
his sensitivity is understandable.

Many also fault the agency for the haphazard drug situation in the
country, which is not limited to high pricing and overdosage.

Prof. Iwan Darmansjah of the University of Indonesia's medical
school said the local market was awash with useless drugs which
drained the funds of unwitting consumers.

"False drug claims and wrong doses are blatantly condoned and fill
the pages of the formal drug information (guide) called MIMS
Indonesia," said the pharmacologist and doctor.

For those who like to self medicate, cheap drugs are readily
available on the black market, such as Pasar Pramuka in East Jakarta
and Pasar Senen in Central Jakarta. There are dozens of drug stores,
selling products of questionable quality, safety and efficacy over
the counter.

Cases of fake drugs are rampant, as well as substandard drugs, which
contain less active compounds than defined on their labeling.

"In Indonesia, governance of drugs has never been well organized.
The BPOM never had the manpower and the organization to protect the
public from the presence of bad drugs on the market. The BPOM has
been closer to and more protective of the industry than the public,"
Iwan said.

Marius Widjajarta of the Indonesian Health Consumer Empowerment
Foundation said the situation worsened after the BPOM was removed
from the auspices of the Health Ministry in 2001.

The agency was separated to become a stronger, independent body (the
only other country to do this is China) after butting heads with the
ministry on authority.

"The agency liked to usurp the ministry's authority, from drug
registration to issuing permits to build pharmaceutical factories.
>From 2002 through 2004, the agency approved 240 import licenses,
which they had no right to do. Monitoring drugs is already a
gargantuan task, so why trespass on other's authority?" he said,
adding the agency should be moved back to the health ministry.

Sampurno defended his ministry against all the allegations, saying
the BPOM did its job. He noted it was selected the fourth best
agency in the world according to the 2005 audit of WHO.

He denied drugs were too pricey here, saying there was a wide
selection of products available with a varied price range but of
similar quality.

"When it comes to generic drugs, it's very competitive. The key is
to exercise patients' rights, so they don't just bow to doctors'
prescription prices," Sampurno said.

Effectiveness of drugs, he added, was a subjective matter.

He also termed "an emotional recommendation" the calls to return the
BPOM to the Health Ministry.

"Come on, compare the performance of the agency (now) to when it was
still part of the ministry. You can see that we perform better as an
independent body."


http://www.thejakartapost.com/detailheadlines.asp?
fileid=20060214.B03&irec=6

Overmedication of children does more harm than good


Whether it's a simple case of the sniffles or the worrying onset of
diarrhea, parents here are likely to trust a doctor and his
prescription pad to put their children right.

Yet it's children who stand to suffer the most as victims of the
chaotic drug situation in the country.

With doctors prescribing them medicines they do not need, and the
danger of significant side effects, the country's kids are
considered overmedicated.

In a society with a tradition of self-medication, a recent study
showed about 70 percent of parents gave their toddlers more than
four kinds of drugs at one time to treat their illnesses.

More than 35 percent of toddlers were taking from five to seven
different kinds of medicine, according to Foundation of Concerned
Parents' spokeswoman Purnamawati S. Pujiarto.

Moreover, 85 children in the study had taken antibiotics, on the
advice of doctors, for every malady they suffered.

*"This phenomenon is dangerous. First, not all diseases can be
treated with medicines -- like influenza, for example. Second, such
an amount of consumed drugs could harm our children's health,
especially their livers," said the pulmonary specialist. *

Pharmacologist and physician Iwan Darmansjah said there were few
clinical trials -- tests done on humans to determine the efficacy of
a new drug -- specifically for children.

Tests showing the different reactions of the drugs in adults and
children, whose smaller body mass would affect how they were
absorbed, are also extremely rare.

"It was only in 1998 and 1999 that the FDA required pharmaceutical
companies to do the study on all medicines for children," the
professor emeritus at the University of Indonesia said, referring to
the U.S. food and drug regulating body.

"Before then, the data was always based on adults. It's not like a
child is a small adult that you can just halve the adult dosage the
dosage."

There have been a few studies since, he said, but none conducted in
developing countries.

*"That's why children in Jakarta go to the same doctor every two
weeks, with the same disease, to receive the same, wrong medication
which reduces their immunity," he said. *

"Ninety-five percent of the children are suffering from cough, fever
and cold, which should've been treated with a symptomatic drug
instead of stuffing them with antibiotics."

Executive director of the International Pharmaceutical Manufacturers
Group Parulian Simanjuntak said that clinical trials of children
were difficult to conduct due to ethical concerns.

"A trial must be carried out voluntarily, where a person knows what
s/he is doing, the risks and so on. It is still being debated
whether children can give informed consent, as an adult could, or
whether parents can decide for the children. That's why studies on
children are not as wide as adults," Parulian said.

"And it's why pharmaceutical industries estimate the dosage for
children based on the dosage for adults."

Parulian said developed countries have discussed "assent consent",
where children can say yes or no about participating in trials.

"But so far, it's still only under discussion."

-- JP/Hera Diani


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