child-friendly medicine – still a dream
Medicine goofed up has resulted in the death of two infants recently. It was also reported that another twenty-five children have fallen sick. The children were brought to an urban primary health canter for vaccination and were given the pentavalent vaccine, the immunization agent against diphtheria, whooping cough, tetanus, hepatitis B and Haemophilus influenza type B. The caregiver was advised to give a quarter of tablet for fever that usually occurs after immunization. But due to negligence tramadol tablets were given to children. The similar packaging for Paracetamol and Tramadol was the main reason for the error. Tramadol, an opioid analgesic, was the killer. The incident raises several concerns, important issues relating to the safety of medicines is of prime importance: why were children a friendly liquid form of paracetamol not given? why was Tramadol available at the vaccination site?
This incident was a human error and preventable too. Paracetamol is available in different forms like tablet, drop and liquid both in syrup and suspension. Splitting of the tablet is neither scientific nor convenient to give medicine to children. This shows the insensitivity of our health system towards children. The second issue was the availability of tramadol at the vaccination site. It is a drug used for combating drug abuse and it is a Scheduled H drug and has been brought under Narcotic Drugs and Psychotropic Substances Act in 2018. There is regulatory control of its procurement, sale, and prescription. It is a big lapse on the part of government which failed to keep limited access to this medicine.
The medication error is reported to cause 7000 deaths (adults and children) per year in the US. According to WHO documents “The medication error is common in pediatrics and harmful medication errors are three times more common in pediatrics than in adults.” The children are at a unique risk of medication error mainly due to the need for dose calculation. Manipulation of the adult drug to a child’s dose through cutting and grinding up tablets or dispersing and mixing with food or drinks are associated with a high risk of errors. Dispensing errors in hospitals are reported to be ranging from 4% to 30%. We still do not have any system to report medication errors. Some researchers engaged only in drug-related issues including medication errors as a part of acquiring the research degree.
The safety issue with medication for children is not new. In 1938, an American company prepared sulphanilamide elixir using diethylene glycol and marketed. Over 100 children were dead due to solvent toxicity before medicine could be removed from the market. The company could not be prosecuted as there was no need for the safety requirements of additives. The company was prosecuted for misbranding as it did not have the alcohol component in the product. US government enacted law ensuring the safety of medicines in its whole form rather than just active components of the drug. Diethylene glycol is a highly toxic organic solvent that can cause acute renal failures and death. Even after this tragic episode of diethylene glycol was used in cough and paracetamol syrups which resulted in deaths in different parts of the world including India.
Children are different from adults and adult medicine cannot be extrapolated to satisfy the needs of children. The children’s medicine must suite age, physiological condition and body size of the child. The development of pediatric formulation requires careful consideration of benefit-risk and specific needs for this group of population.
It’s not only important to develop children friendly medicine but there is a need to protect them from accidental and incidental poisoning. The medicine packaging must have inbuilt for this. Many countries like the USA, European countries, Australia have standards and norms for child-resistant medicine packaging. ISO has also developed standard test procedures for checking re-closable child-resistant packaging.
Child-resistant packaging is difficult to be opened by young children but easily opened by adults. There are three common types of child-resistant closure practiced in medicine: press-turn, squeeze-turn, and combination lock. It is an effective measure in reducing child mortality from intoxication by prescribed drugs. It is the responsibility of regulatory bodies to ensure that the child-resistant packaging system is followed in the interest and welfare of children both for prescribed and non-prescribed.
In India, we need to be proactive rather than reactive. Bihar and Chhattisgarh have developed essential medicine lists for children under the WHO project but were not used for improving the healthcare system. National List of Essential Medicine is not revised periodically, it is done only for regulating the prices of medicines. The NLEM 2015 has no liquid paracetamol product while the WHO model Formulary has oral liquid and suppositories besides tablets. India has 20% of children’s population of 0 to 9 years of age and yet children do not have a fair deal in medicine.