Corex cough syrup - no more OTC opioid dependence

Reducing codeine supply forces Corex users to the spiral of change

Corex Cough Syrup opioid dependence

Codeine cough syrup is no longer available over-the-counter (OTC) without a prescription. Record keeping by the dispensing pharmacist is now mandated by a new government notification. This one legislation will aid relapse prevention in abstinent Corex cough syrup addicts. Many former codeine addicts have relapsed after visiting their dispensary for another medication; the pharmacist casually offers opioid containing Corex cough syrup and provides a visual cue to trigger craving and retard their progress through the stages of change.

Codeine cough syrup addiction is fuelled by dispensaries that distribute litres of codeine in the form Corex Cough Syrup and other brands like Mits Linctus. The key ingredient in these ‘cough syrups’, Codeine, is derived from opium and is an addictive substance. Codeine containing cough syrup abuse made its entry to India in the 1990s and since then has contributed to the steadily increasing opioid dependence case-load.The estimated number of opium users in India is well over 5 million with codeine being a major oral source. Opioid dependence in a de-addiction centre increased significantly from 37 to 52% over the last three decades.

Relapse prevention at the pharmacy

Codeine dependent individuals are exposed to visual cues of Corex and other codeine containing cough syrups at every visit to the dispensary. Modification of addictive behaviours involves progression through five stages of change - precontemplation, contemplation, preparation, action, and maintenance. Individuals cycle through these stages many times before termination of the addiction. During relapse individuals regress to an earlier stage of codeine use. Stimulus control - avoiding or countering reminders of codeine use - is a key process for relapse prevention on the spiral of change. Cutting off easy access in the dispensary aids stimulus control and helps prevent relapse to codeine use. The common sight of multiple discarded codeine cough syrup bottle on stairwells would also disappear (see image).

Codeine cough syrup abuse prevention

1. Pharmacy-based approaches help in minimising the harm associated with OTC medicine abuse, and supporting and treating affected individuals.
• Removing products from sight
• Alerting or counselling customers to the abuse potential of products is effective.
• Refusing sales without a prescription
• Suggesting customers contact their doctor
• Supplying only limited amounts.
2. Raising awareness of the addiction potential of codeine cough syrup is necessary for both the public and the prescribers (many doctors are unaware of the ingredients that go into Corex and other cough syrups).
3. Preventing access is the domain of the government.  Regulating and monitoring codeine prescription and dispensing is a welcome step. The finance ministry is now attempting to enable tracing of batches of codeine containing cough syrups  to their suppliers in a bid to control smuggling of Corex and other codeine containing cough syrups.

Nature's vengeance

Unexpected help in relapse prevention by restricting supply has also come in the form of mother nature. Opium growers in Mandsaur, MP are ruing the increasing numbers of nilgai (Boselaphus tragocamelus) that have developed opioid dependence after chance grazing in farms that were once grassland. The nilgai now run amok and destroy swathes of poppy fields in search of their fix.

References

1. Debasish Basu, Munish Aggarwal, Partha Pratim Das, Surendra K. Mattoo, Parmanand Kulhara & Vijoy K. Varma. Changing pattern of substance abuse in patients attending a de-addiction centre in north India (1978-2008). Indian J Med Res 135, June 2012, pp 830-836
2. Richard J. Cooper. J Subst Use. Over-the-counter medicine abuse – a review of the literature. Published online Oct 3, 2011. doi: 10.3109/14659891.2011.615002. Apr 2013; 18(2): 82–107.
3. Gary Reid and Genevieve Costigan. Revisiting ‘The Hidden Epidemic’ A Situation Assessment of Drug Use in Asia in the context of HIV/AIDS. The Centre for Harm Reduction, The Burnet Institute, Australia. 2002. 
4. Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14.

Corex Cough Syrup - Opioid Addiction Over-the-Counter

Codeine is methyl-morphine

Corex Cough Syrup contains codeine – an addiction causing opioid. One 100ml bottle of codeine containing Corex cough syrup has the same effect as a 30mg tablet of morphine. The drug belongs to the same class of substances as heroin. Medicines are routinely purchased over-the-counter at most pharmacies in Pune and cough syrups very frequently so. Always read the fine print.

Codeine suppresses the cough reflex through a direct effect on the cough centre in the brain stem. However, there is little evidence in the medical literature to support its use as a cough suppressant. Several studies show that codeine does not reduce cough frequency, intensity, or duration (Herbert & Brewster, 2000).

Patients who are prescribed Corex cough syrup or those who buy it over-the-counter are not warned of its addiction potential. They subsequently continue using it as they 'feel restless and anxious' without it. These feelings are part of the spectrum of withdrawal symptoms associated with all opioids, and are another sign of addiction. A 36 year old woman who came to me for treatment of lethargy and lack of interest was consuming a bottle of Corex cough syrup every day for more than two years. Patients and parents should be educated about the lack of benefit and the addiction risk of codeine cough syrups (American Academy of Pediatrics, 1997).

Pharmacists dispensing Corex cough syrup know its potential for addiction. They have their 'regulars' who buy litres of Corex cough syrup over the month. The bottles are handed over in a paper bag without the exchange of a word, leave alone a prescription.

Corex is the top selling medication in India earning Pfizer, the drug manufacturer, Rs 1,820,000,000 during the year 2009. U.S.-based Pfizer and Abbott Laboratories are leading players in India's $103-million market for codeine-based cough syrups. The ministry of finance is now pressuring the companies to enable tracking of each batch produced. The sheer malevolence of this entire chain is brought home by the patient who relapses repeatedly during treatment. Every time he tries to fill his prescription for deaddiction the pharmacist takes advantage of his craving cues to resupply him with codeine containing Corex cough syrup.

So it was with a certain joy that I read

Store employee nabbed for selling drugs without prescription

That was the Indian FDA (Food and Drug Administration) in action in Pune. Their sting on a reputed chain of pharmacies gives us new hope for control of over-the-counter codeine opioid addiction. 

Codeine prescription restrictions - Update

Ministry of Health (2016)
Bans codeine containing cough syrups. Ban upheld by Drugs Technical Advisory Board in July 2018

EMA-CMDh (2015)
(European Medicines Agency – Coordination Group for Mutual Recognition and Decentralised Procedures - Human)
Use of codeine for cough and cold

• contraindicated in children below 12 years. This means it must not be used in this patient group.
• not recommended in children and adolescents between 12 and 18 years who have breathing problems

Govt of India Notification 2014

• Codeine cough syrup is not available over-the-counter (OTC) without a prescription
• Record keeping by the dispensing pharmacist is now mandated

References

1. Committee on Drugs, American Academy of Pediatrics. Use of codeine-and dextromethorphan-containing cough remedies in children. Pediatrics 1997;99:918-20
2. EMA-CMDh. Codeine Article-31 referral - Codeine not to be used in children below 12 years for cough and cold. EMA/249413/2015. 24 April 2015
3. Herbert ME, Brewster GS. Myth: codeine is an effective cough suppressant for upper respiratory tract infections. West J Med 2000;173:283.