Look-alike, sound-alike medicine in Indian market can cause significant health threat: Lancet

His parents rushed him to Thrissur Medical College Hospital, where he received treatment for three days.

Doctors at the medical college hospital revealed that the boy had been given blood-pressure medication instead of the prescribed painkiller.

The family alleged that the pharmacist had dispensed the wrong medication.

In response to the family’s complaint to the superintendent of the Family Health Centre and the deputy district medical officer (deputy DMO) of Thrissur, the DMO initiated an inquiry into the incident.

It shed light on a peculiar situation in the country, where many of the drugs look alike and sounds alike (LASA), but are meant for different purposes.

A recent article published in Lancet, titled Look-alike, sound-alike (LASA) drugs in India, has highlighted the issues such medicine bring to the fore.

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LASA drugs

LASA drugs refer to medications with similar names or packaging, which pose a significant risk of confusion.

This confusion can lead to medication errors with potentially dangerous consequences for patients.

The researcher looked at the issues related to similar brand names for (i) the same drug and (ii) different drugs, which can cause confusion among doctors, pharmacists, and patients.

For instance, several brands of Molnupiravir (which prevents the growth of the virus that causes COVID-19) — such as Cipmolnu, Molnunat, Molflu, Molxvir, Molulife, Molnumize, and Molnutor — exist in the market.

The last two are manufactured by the same company — Hetero Labs — and both marketed by Torrent Pharma.

“There is perhaps not much of a risk to patients if similar brand names exist for the same drug manufactured and marketed by different entities. One could argue that incorporating International Nonproprietary Names (INN) would help doctors and pharmacists (despite being prohibited by Section 13 of The Trade Marks Act),” said the researchers.

“However, as per WHO’s expert opinion, incorporating INNs endangers the principle that INNs are public property and should not be appropriated by pharma companies by incorporating them into brand names,” they noted.

A more pressing issue is the use of the same or deceptively similar brand names for entirely different drugs.

For example:

• The brand name ‘Olvance’ is used for the antihypertensive drug Olmesartan, while ‘Oleanz’ is used for the antipsychotic drug Olanzapine.
• The brand name ‘IMOX’ is used for amoxicillin tablets for humans, whereas ‘INIMOX’ is used for a combination of amoxicillin and cloxacillin as an injection for veterinary use.

“Since there are many brands of amoxicillin + cloxacillin combination in tablet form and for human use, it is possible that a pharmacist will not just dispense but also administer this injection when a doctor prescribes either amoxicillin or the amoxicillin + cloxacillin combination tablets,” said the researchers.

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Sounds like

For instance, Lenalidomide, a drug used to treat multiple myeloma, and Linagliptin, a drug used to treat diabetes, are both sold under the brand name “Linamac” by two different companies.

The Lancet article also mentioned instances where different drugs shared the same brand name but were manufactured and marketed by different entities.

Examples:

1. The brand name Medzol is used for both Midazolam (a sedative) and Pantoprazole (used for GERD).
2. The brand name ‘Medzole’ is used for Metronidazole oral suspension (treats infections caused by bacteria or parasites), Itraconazole capsules (treat fungal infections), and Albendazole tablets (treat infections caused by worms).
3. The brand name ‘Flucor’ is used for both Fluconazole (treats serious fungal or yeast infections) and a combination of Flupentixol and Melitracen (treats mild to moderate mental disorders).
4. The brand name ‘Linamac’ is used for both Lenalidomide (treats anaemia) and Linagliptin (treats high blood sugar levels caused by type 2 diabetes mellitus).

“In the case of drugs with identical or similar brand names, there is no way a pharmacist could tell which drug the doctor had prescribed (in general, prescriptions in major parts of India only mention brand names with no mention of diagnosis or treatment protocol),” said the Lancet article.

“Worse, there is no practical way of working out these ‘duplicates’ for any researcher, doctor, or pharmacist since there is no publicly accessible database that has all the drugs and the associated brands,” it added.

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Looks alike

The researchers points out that poor regulatory control had led to not only similar-sounding brands of drugs but also similar-looking drugs.

For example, GNAP-10 (an anti-hypertensive medication), generic Telmisartan (an anti-hypertensive medication), Glimeimore (an oral hypoglycemic agent), and generic Metoprolol tartrate (a beta-blocker) are all manufactured as round white tablets of nearly the same size.

“For a patient who cannot read, the shape and colour of the drug and its distinctive packaging are the only clues to identify the drug,” said the authors of the Lancet study.

“Thus, similar-looking drugs in similar packaging make it nearly impossible for patients, especially those who do not have an elementary school education, to take their drugs in the prescribed manner,” they explained.

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The impact

The authors said LASA drugs could lead to significant medication errors, potentially causing harm to patients.

Identical brand names were the primary contributors to these errors, which could result in unnecessary drug effects, side effects, and the progression of untreated diseases.

“In low-income and middle-income countries (LMIC) like India, prevalence of untrained pharmacists also makes LASA drugs a significant public health threat,” said the authors.

Following judicial directives, Indian law now mandates the drug regulatory body to review trademark search reports to prevent misleading brand names before granting marketing authorization.

“The very existence of countless misleading brand names shows that India’s drug regulator, Central Drugs Standard Control Organisation (CDSCO), is not doing what it is tasked to do,” said the authors.

The CDSCO appears to rely on pharmaceutical companies to resolve these issues through trademark disputes.

Compounding the problem, court rulings have been inconsistent and often conflict with fundamental trademark principles.

For instance, variations of the brand Viagra, such as Penagra and Kamagra, have been permitted as long as the pills differ in shape and color from Viagra’s distinctive blue rhomboid pill, despite packaging that conceals these differences.

Earlier, a study had pointed out that LASA drug incidents accounted for around 2.67 percent of total medication errors reported in Indian hospitals.

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Solutions and interventions

The authors of the study suggested that addressing prescription and dispensing errors required a multi-faceted approach.

Immediate steps include ensuring doctors write drug names legibly and in capital letters, and ideally using INNs to reduce confusion.

Drug policy level interventions

Key interventions at the drug policy level include:

• Permitting unique brand names for innovator drugs to avoid confusion.
• Mandating the use of INNs prominently in prescriptions.
• Withdrawing misleadingly named drugs from the market.
• Ensuring uniformity in drug shapes, colors, and designs where misuse could cause serious harm.
• Enforcing pharmacovigilance obligations and tracking prescription and dispensing errors.
• Issuing regular updates and advisories on prescription practices and misleading names.

Manufacturing level interventions

At the manufacturing level:

• Emphasise the quality of drugs and packaging.
• Use tools like the phonetic and orthographic computer analysis (POCA) for deciding brand names.
• Implement tall man lettering on drug labels to distinguish similar names.

Healthcare provider level interventions

For healthcare providers:

• Include diagnosis and indications in prescriptions.
• Promote generic prescriptions and enforce guidelines.
• Avoid distractions during prescription writing.
• Use barcodes and computerised prescription systems with alerts.
• Regularly train providers on prescription writing and update them on LASA drugs.

Drug dispensing level interventions

In drug dispensing:

• Implement double-check systems for matching prescribed and dispensed drugs.
• Avoid distractions during dispensing.
• Require trained pharmacists to dispense drugs.
• Confirm that dispensed drugs are appropriate for the indication.
• Enforce rules against selling drugs without valid prescriptions.
• Store LASA drugs separately to avoid mix-ups.