Dr KK Aggarwal
Padma Shri Awardee
Off-label use of drugs is a common practice all over the world. Off label use means that the particular drug is used for an indication that is not otherwise approved by the regulatory authority, the Drug Controller General of India (DCGI) in our country, and is not included in the package insert. The package insert or label carries instructions about indications, contraindications and dosing and other instructions. This information is approved by the DCGI for every drug sold in India.
In the Anuradha Saha case of medical negligence, the dose of the injection depomedrol prescribed (80 mg twice daily) was much higher than the maximum recommended dose as recommended by the manufacturer. Anything, which is not as recommended by the manufacturers or is outside DCGI’s recommendations is off-label use and can be called a trial.
Informed and documented consent must be taken from the patient and/or relatives before any off-label use of a drug. And, this ‘documented’ consent must be preserved.
The NICE guidelines on the diagnosis and management of constipation in children and young people also emphasize that PEG is not approved for use to treat chronic constipation in children younger than two years. And, before using it in this age group, informed consent should be taken, which must be documented.
It is time that we begin to read about the DCGI drug approval procedure in the country. Because if we do not, then patients might start challenging us.
Padma Shri Awardee
Off-label use of drugs is a common practice all over the world. Off label use means that the particular drug is used for an indication that is not otherwise approved by the regulatory authority, the Drug Controller General of India (DCGI) in our country, and is not included in the package insert. The package insert or label carries instructions about indications, contraindications and dosing and other instructions. This information is approved by the DCGI for every drug sold in India.
In the Anuradha Saha case of medical negligence, the dose of the injection depomedrol prescribed (80 mg twice daily) was much higher than the maximum recommended dose as recommended by the manufacturer. Anything, which is not as recommended by the manufacturers or is outside DCGI’s recommendations is off-label use and can be called a trial.
Informed and documented consent must be taken from the patient and/or relatives before any off-label use of a drug. And, this ‘documented’ consent must be preserved.
The NICE guidelines on the diagnosis and management of constipation in children and young people also emphasize that PEG is not approved for use to treat chronic constipation in children younger than two years. And, before using it in this age group, informed consent should be taken, which must be documented.
Table 4 Laxatives: recommended doses
Knowledge is our best defense. Forearmed
is better prepared…Unfortunately, these important subjects of CDSCO and
DCGI are not taught in Pharmacology.| Laxatives | Recommended doses |
| Macrogols | |
Polyethylene glycol 3350 + electrolytes
|
Paediatric
formula: oral powder: macrogol 3350 (polyethylene glycol 3350)a 6.563
g; sodium bicarbonate 89.3 mg; sodium chloride 175.4 mg; potassium
chloride 25.1 mg/sachet.
Disimpaction
Ongoing maintenance (chronic constipation, prevention of faecal impaction)
|
- Unless stated otherwise, doses are those recommended by the British National Formulary for Children (BNFC) 2009. Informed consent should be obtained and documented whenever medications/doses are prescribed that are different from those recommended by the BNFC.At the time of publication (May 2010) Movicol Paediatric Plain is the only macrogol licensed for children under 12 years that includes electrolytes. It does not have UK marketing authorisation for use in faecal impaction in children under 5 years, or for chronic constipation in children under 2 years. Informed consent should be obtained and documented. Movicol Paediatric Plain is the only macrogol licensed for children under 12 years that is also unflavoured.
It is time that we begin to read about the DCGI drug approval procedure in the country. Because if we do not, then patients might start challenging us.
Diacetone Alcohol price climbed up during the first half of the quarter in USA, due to steep rise in feedstock Acetone prices in the region. Prolonged plant turnarounds in the previous quarter due to freezing storm in the Gulf of USA, created extreme shortage of feedstock Acetone, which raised the prices of derivatives. Meanwhile, the demand for Diacetone Alcohol from its downstream solvent sector improved effectively till the end of May due to active pickup in market activities. However, in the month of June, prices started declining with increase in production activities in USA.
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Polyethylene Glycol price (PEG) fluctuated in a narrow range throughout the quarter across North America region. The demand from the downstream ethoxylates derivatives and pharmaceuticals remained firm, while the overall supply activity was tight. The price of feedstock Ethylene Oxide also fluctuated in USA due to frequent change in availability within the country. However, the demand from the global market was also responsible for the overall buoyancy in the PEG prices. Improved production activities across the gulf of USA, increased the availability of upstream Ethylene in the country
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