The Sins of the Pharmaceutical Industry and BPOM against Doctors
Doctors know that when a drug is available, it is worthy of prescription, with it having obtained a license and passed BPOM supervision. The pharmaceutical industry and BPOM have clearly committed sins against doctors.
As a doctor, it grieves me to see that so many children have become victims of acute kidney injury, while the government seems lukewarm in its cautionary measures.
The government has yet to take concrete steps to solve the problem thoroughly. Look at the Kanjuruhan Stadium tragedy. The government immediately responded by forming a fact-finding team.
The Health Ministry, through its spokesman Dr. Mohammad Syahril, reported that cases of acute kidney failure in children began to increase in August. He said the number of cases of atypical progressive acute kidney injury (GGAPA) in Indonesia had reached 269 people as of 26 Oct.
Hundreds of cases were spread across 27 provinces. A total of 157 patients, or about 58 percent, died, and 39 patients have recovered.
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Cases of acute kidney injury, or acute renal failure, in children are thought to be related to ethylene glycol, which has now been identified in certain drugs. Ethylene glycol is a member of the glycol (alcohol) family of chemical compounds derived from ethylene. This chemical substance with the formula C2H6O2 is a clear, sweet, viscous liquid when boiled at 198 degrees Celsius.
It is odorless, soluble in water and commonly used in commercial and industrial products. Ethylene glycol can be dangerous when used disproportionally. In some countries, this substance appears to have caused a poisoning that has led to acute kidney failure in children.
Government responses
Mohammad Syahril said the cases should be taken as an call to educate the public. Those who have toddlers – children under 5 years old, locally known as balita – are warned against giving drugs without prescriptions or a doctor’s consultation.
He said the ministry had taken a conservative step by issuing a circular telling pharmacies to suspend selling liquid medicines to the public freely. Medical workers at healthcare facilities have been asked to temporarily hold back from prescribing drugs in the form of liquids until the results of the investigation and examination are confirmed.
Syrup drugs that are used to treat critical illnesses are still allowed, but they must be prescribed by a doctor.
The Health Ministry has promised to immediately issue a list of medicines in the form of liquids that do not contain hazardous chemicals based on laboratory testing by the Food and Drug Monitoring Agency (BPOM). The ministry still allows the use of drugs in the form of syrup for some critical illnesses on a doctor's prescription.
The ministry has communicated with the Indonesian Pediatrician Association and the Indonesian Pharmacists Association about some syrup medicines that are really needed to cure critical illnesses. Syrup drugs that are used to treat critical illnesses are still allowed, but they must be prescribed by a doctor.
Regarding medical treatment, the ministry is still looking to procure fomepizole for patients with acute kidney injuries. Fomepizole is said to have brought a positive impact on the patients. The ministry has received 20 vials of the drugs from Singapore and is awaiting another 16 vials from Australia. The ministry is also trying to bring in those medicines from the United States and Japan.
Meanwhile, BPOM head Penny Lukito, in a release, said the agency had conducted an investigation into kidney injury-causing drug manufacturers. The investigation found that manufacturers had made changes to the composition of drugs without permission, with them switching suppliers of raw materials for their medicinal products without the knowledge of BPOM.
Since the Covid-19 pandemic, manufacturers have been switching their chemical substance suppliers. Many of the raw materials for products deviate from pharmaceutical certification standards. As a result, the medicines are found to exceed safety levels of ethylene glycol (EG), diethylene glycol (DEG) and ethylene glycol butyl ether (EGBE). In this case, the BPOM seems to be blaming only manufacturers.
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> Fast Referral Process for Patients with Acute Kidney Disorders
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Going forward, the BPOM says it will improve and strengthen both the pre-market and post-market supervision. The agency has promised to adopt heightened precautionary measures over solvent-containing drug sampling and testing. It says it will not simply accept the report but verify the documents submitted by the company and check the company's track record of compliance.
The BPOM has issued a list of liquid drugs that contain or do not contain EG, DEG and EGBE. A cooperative effort with the National Police has been in place to follow up on two pharmaceutical companies suspected of producing drugs that contain extreme levels of EG and DEG.
In response to the deaths and the BPOM's follow-up move, Coordinating Human Development and Culture Minister Muhadjir Effendy has appealed to National Police chief Gen. Listyo Sigit Prabowo to investigate. His appeal was extended following a virtual coordination meeting among relevant ministries and government institutions, which included the Health Ministry, Trade Ministry, Industry Ministry and BPOM.
Minister Muhadjir sees the investigation as being crucial to determine whether there was a criminal act behind the widespread incidence of acute kidney injury, which is threatening human resource development efforts, especially the protection of children.
His statement has prompted panic among pharmacists and medical practitioners. They feel they often find themselves being implicated in drug-related toughening up measures, despite the fact they are not drug manufacturers nor are they authorized to issue distribution and monitoring permits. The statement, which reflects the responses from the three government institutions above, has yet to show government’s seriousness in the efforts to reveal the exact cause of the disastrous acute kidney injuries among Indonesian children.
The government's responses have come up in stark contrast to its approach to the Kanjuruhan Stadium tragedy in Malang. In the acute kidney injury cases, the government has not seemed to bother forming a fact-finding team. The government appears in a negligent mood over the deaths of hundreds of children.
Pharmaceutical firms’ responses
Likewise, pharmaceutical industry circles have opted to stay silent amid what has become a traditional tantrum that when there are cases of drug issues, the public's target of accusations will always be pointed at medical practitioners and pharmacists.
The accusations are either that doctors prescribed the wrong medicines or pharmacists handed over the wrong medicines, and other speculations. Very rarely do the accusations reach the pharmaceutical industry itself. In fact, doctors and pharmacists are not part of upstream industry in creating medicines for the public. The upstream is the pharmaceutical industry. Doctors are downstream, with pharmacists in between. The medicine’s safety, efficacy and quality are the responsibility of the pharmaceutical industry, while drug use monitoring is the responsibility of the BPOM.
A crucial question that needs to be answered in the case of syrups containing EG is whether the BPOM truly does its supervisory job over the pharmaceutical industry, pharmaceutical wholesalers, pharmacies and drugstores. Does the BPOM make cross checks and verify every incoming report?
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If all these are not done adequately, then the BPOM's move to scrutinize the pharmaceutical industry and manufacturers of syrups containing EG is just a maneuver to find a scapegoat.
Doctors take it for granted that the drugs they prescribe are safe. Unless being cautioned, doctors do not necessarily bother with matters of safety, efficacy and quality of drugs, because doctors do not have the tools to examine them.
Doctors know that when a drug is available, it is worthy of prescription, with it having obtained a license and passed BPOM supervision. In this EG-related disaster, the pharmaceutical industry and BPOM have clearly committed sins against doctors. Wallahu a’lam bishawab.
Zaenal Abidin
Zaenal Abidin, Former chairman of the Indonesian Doctors Association (IDI), 2012-2015This article was translated by Musthofid.
