Antibiotic prescription needs both moderation and informed counseling

Health Care, Heart Care Foundation of India, Medicine Comments Off

Wrong antibiotics can stimulate bacteria instead of killing them

New Delhi, 8th April 2019: More than 150 combination drugs have been found to lack therapeutic justification and have been recommended to be banned by an expert panel, as per sources. A panel led by Chandrakant Kokate was probing the efficacy of about 500 fixed dose combinations (FDCs) drugs and submitted its report to the Drug Technical Advisory Board (DTAB) on 2 April 2019. It has suggested that many fixed-dose combinations (FDCs) are irrational and hence recommended them to be banned.

Therapeutic benefits of many combination medicines sold in India are suspected to be doubtful and some may even pose health risks, prompting the government to launch a crackdown on such “irrational” drugs. The government banned 344 such combination drugs in 2016.

Speaking about this, Padma Shri Awardee, Dr KK Aggarwal, President, HCFI, said, “In recent years, drug makers have increasingly been blending fixed doses of this medicine with fixed doses of other diabetes drugs that attack the disease differently. A study has also noted that the five top-selling fixed dose combination pills in India account for 500 different brands. Clinical trials demonstrating safety and efficacy of these FDCs are not publicly available. Indian patients taking these combinations should discuss with their clinicians before making a switching to a different agent. Bioequivalence studies are conducted to establish that two medicines, normally the original patented drug and a generic version, have the same biological equivalence – that is, that they work the same way, to the same extent and for the same purpose. Bioequivalence to the innovator product helps prove a drug’s safety, clinical efficacy equivalence and cGMP compliance on continuous basis for sustainable supply.”

Drugs banned in 2017 include: FDCs of nimesulide + levocetirizine; fixed dose combinations of ofloxacin + ornidazole injection; FDCs of gemifloxacin + ambroxol; FDCs of glucosamine + ibuprofen; and FDCs of etodolac + paracetamol.

Adding further, Dr Aggarwal, who is also the Group Editor-in-Chief of IJCP, said, “The wrong antibiotics can stimulate the bacteria or other microorganisms to fight back instead of killing the germs. This is possible due to either spontaneous DNA mutations or transfer of resistant genes between them. We are on the verge of a post-antibiotic era where many of the antibiotics to which bacteria have developed resistance may become obsolete and there may no longer be any cure for many common infections which once again may take their toll on human life like in the pre-penicillin era.”

Some tips from HCFI

When prescribing antibiotics, clear instructions should be given to the patient about no refill of antibiotic prescription without the signature of the doctor. The role of antibiotics should be discussed in an informed counseling. Apart from this, doctors should not prescribe antibiotic cover or prophylactic antibiotic without a high degree of clinical suspicion. No antibiotics should be prescribed for small bowel diarrhea, fever with cough and cold, dengue, chikungunya, malaria and fever with rashes. However, early initiation of antibiotics is the rule in suspected sepsis bacterial pneumonia meningitis and confirmed tuberculosis cases.