Sunday, April 1, 2018

Informed and documented consent is a must before any off-label use of a drug

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.
Table 4 Laxatives: recommended doses
LaxativesRecommended 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
  1.  Child under 1 year: ½ to 1 sachet daily (non-BNFC recommended dose)
  2. Child 1–5 years: 2 sachets on 1st day, then 4 sachets daily for 2 days, then 6 sachets daily for 2 days, then 8 sachets daily (non-BNFC recommended dose)
  3. Child 5–12 years: 4 sachets on 1st day, then increased in steps of 2 sachets daily to maximum of 12 sachets daily (Non-BNFC recommended schedule)
Ongoing maintenance (chronic constipation, prevention of faecal impaction)
  1.  Child under 1 year: ½ to 1 sachet daily (non-BNFC recommended dose)
  2. Child 1–6 years: 1 sachet daily; adjust dose to produce regular soft stools (maximum 4 sachets daily) (for children under 2, non-BNFC dose)
  3. Child 6–12 years: 2 sachets daily; adjust dose to produce regular soft stools (maximum 4 sachets daily)
  1. 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.
Knowledge is our best defense. Forearmed is better prepared…Unfortunately, these important subjects of CDSCO and DCGI are not taught in Pharmacology.
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.

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