Ministry of Health open to revision of the pharmacopoeia
The ministry is open and supportive if it is considered absolutely important.
Jakarta (ANTARA) – The Ministry of Health has said it is open to a revision of the national pharmacy or pharmacopoeia management guidelines based on the assessment of cases of acute kidney failure.
“Because this pharmacopoeia is a collectively developed regulation, based on the current development, the ministry is open to reforming and revising it,” ministry spokesman Mohammad Syahril told a press conference on Wednesday. on line.
Pharmacopoeia is a book of medical standards published by government agencies that describes pharmaceutical materials, chemical materials in medicines and what they are, as well as their usual dosage, he said.
It was formulated by involving the Minister of Health as well as relevant officials, the Food and Drugs Oversight Agency (BPOM) and experts from various public and private pharmaceutical universities.
“This pharmacopoeia is like a pharmaceutical holy bible in Indonesia, which serves as a guideline for pharmacy management in Indonesia,” he explained.
The suggestion to revise the pharmacopoeia came from BPOM based on its assessment of acute kidney injury cases, he said.
“The ministry is open and supportive if it is considered absolutely important,” Syahril added.
Meanwhile, Penny K. Lukito, head of BPOM, said ethylene glycol (EG) and diethylene glycol (DEG) contamination standards linked to cases of acute renal failure are not addressed by the pharmacopoeia. Indonesian. for finished products, in particular syrups.
“We cannot control the finished product of drugs that contain propylene glycol (PG) and polyethylene glycol (PEG) solvents suspected of also having EG and DEG contamination,” she informed.
So far, BPOM has identified six gaps in the drug safety and quality assurance system, from upstream to downstream, based on cases of acute kidney injury in children.
The first is the lack of stocks of pharmaceutical raw materials and the price differences of pharmaceutical grade solvents containing chemicals.
The second is the entry of syrup drug solvent materials through limited non-restriction instead of BPOM import license.
The third is the absence of provisions on the contamination limits of finished products in the Indonesian pharmacopoeia.
Fourth, there is no deterrent to prosecution for drug and food related crimes due to lack of evidence on the cause of death.
Fifth, the diverse maturity of the Indonesian pharmaceutical industry, and sixth, the non-use of the Medication Side Effect Reporting System or MESO by health workers.
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