Criminalising pain? Scheduling tramadol would hurt those most in need

This blog post is published ahead of the 41st World Health Organisation's Expert Committee on Drug Dependence (ECDD) meeting, which will critically review tramadol and issue a recommendation on its scheduling for the consideration of the 62nd Session of the Commission on Narcotic Drugs. IDPC has submitted contribution to the ECDD's meeting on the matter. IDPC is of the view that scheduling tramadol is presently unnecessary and would be counter-productive in its effects on public health.

Tramadol in Africa is presented as a ‘drug issue’ that can be corrected with drug control measures: repression, arrests, seizures and bureaucratic controls. After all, there is a logical appeal to responding in a way that is familiar and for which a process is already in place: All we have to do is the same as we have done for hundreds of other products in the past…

Letting administrative convenience determine the direction of policy-making, however, will simply maintain and exacerbate the harms being caused by our current drug policies – arriving at a cure before having the diagnosis, and using the criminal justice system to address a public health problem.

When researching into tramadol use in West Africa, we found two key factors that are as essential as they are often overlooked:

1. The structure of medical care provision across the region

West African health care systems are still struggling from decades of neglect and sharp spending cuts. Existing services focus on preventing infectious diseases and improving the life expectancy of children and mothers, and are struggling to meet the growing burden of non-communicable diseases. Sharp increases in the case load of cancer and HIV are leaving large numbers of people in need of regular medical attention. Growing social inequality means that large sections of rural but also of the urban poor are sorely neglected.

These populations rely on the informal sector. Most West Africans obtain their medications from markets, chemist shops and itinerant traders. These medicine vendors are often not able to ascertain the quality of the medications they source from distributors and wholesalers. They are more likely to sell substandard and falsified medicines and less likely to ensure that medicines are sold for the right purpose. Yet these informal channels continue to play a critical role in providing medical services to hard-to-reach communities.

In Ghana, the Pharmacist Council and the Pharmacy Association are working closely with the Foods and Drugs Authority in the regulation of pharmacies. They ensure that all registered pharmacists abide by regulations – and these include selling controlled medicines only in exchange for a verified prescription.

City centres such as Accra are well supplied with pharmacies that are as professional as any in Europe. But these pharmacies cater for a small part of the market, and the rural areas are not well serviced. Recognising this, the authorities relax their standards for informal service providers and chemist shops in rural areas.

In the village of Sor, for instance, in the north of Ghana, we interviewed Naabil1, a farmer who had been stung by a scorpion days before we met. Formal channels to obtain pain relief are inaccessible, or inexistent, to the rural poor. So, Naabil procured tramadol from a local chemist shop that does not require a doctor’s prescription. Were tramadol to be treated as an illicit narcotic drug, thousands like Naabil would be unable to satisfy their legitimate medical need or, worse, face criminal sanctions for doing so.

Were tramadol to be treated as an illicit narcotic drug, thousands, particularly the rural poor, will be unable to satisfy their legitimate medical need or, worse, face criminal sanctions for doing so.

The tramadol (and other medications) that is available to farmers, fishermen and other workers is mainly from generic pharmaceutical producers. Some are genuine, but in recent years there has been a sharp increase in illicitly-produced products that are adulterated with other substances. Some of these are clearly not intended for medical use because they are of a potency far in excess of the usual medical practice.

The tramadol that doctors prescribe in Accra for treating post-operative pain, neuropathic pain or lower back pain, or for people in late stages of cancer, is of a strength of 50 to 100 mg, or 150 mg with slow release formulations. The tablets on the informal market, however, can be 225 mg, 400 mg or even more.

These high-potency formulations guarantee a faster onset, which gives a sensation that some people seek. Yet these products are not imported by the established medical wholesalers, but rather trafficked across porous borders or through the large container ports, just like the falsified antibiotics and antimalarials that are responsible for thousands of fatalities, according to the World Health Organisation.

Ensuring that medicines are of a high standard is the role of regulatory agencies. But, across West Africa, pharmaco-vigilance is poorly resourced, with far less international support than the fight against ‘illicit drugs’.

2. Motivations and entry routes for consumers

For many people, tramadol provides legitimate and essential pain relief – especially in the absence of other pain relief options. Tramadol is the only stage two medication with a good safety profile that is available for pain management in the region. Adding it to the list of prohibited medicines will deprive patients of the last opioid available – it will become as hard to obtain as, for example, morphine.

There is a ready supply of tramadol in the private hospitals catering for the elite, but State hospitals are often short of stock. Without this medicine, patients would have to resort to far less potent options such as paracetamol or non-steroidal anti-inflammatory drugs which can have severe side effects.

We already know that many health care professionals avoid internationally-controlled substances because of (or through fears and misconceptions of) the heavy regulations involved. Experience shows that medicines simply become unavailable once they become under the gaze of drug law enforcement. Getting prescriptions for a strong, effective medication takes longer, and finding a pharmacy that stocks it becomes harder. Patients are then more likely to buy these from informal providers and markets where medications may be falsified and adulterated.

In Niamey, for instance, the pharmacy of the national hospital is usually out of morphine, and patients go into surgery bringing their own medications – obtained from the informal market. Adding tramadol to the list of controlled substances will penalise the poor, and push people who are in pain onto the criminal market – it will effectively criminalise being in pain.

Moreover, many people who are using tramadol in the markets, on the fields, or when driving long distances do so at least initially because they are performing very demanding, physically strenuous jobs for very poor pay. They are the working poor, living in extremely difficult conditions with few exit options. Including tramadol in the international drug control schedules will also criminalise these people, with dire consequences.

In Nigeria, tramadol's national scheduling has fueled arrests and enabled corruption by law enforcement officers.

In Lagos, where tramadol is under national control, two labourers speak of police raids where people were arrested for standing near a tramadol wrapper, held at police stations until their family brought “bail money” (a euphemism for the undocumented bribes collected by the police).

Conclusion

The tramadol flowing from unauthorised routes in West Africa requires a more balanced way forward. In Ghana, for instance, there was a joint effort by the Food and Drugs Authority, Pharmacy Council, Pharmaceutical Association and civil society organisations to sensitise the populace on the dangers of unprescribed tramadol use among the youth. Pharmaco-surveillance was increased by the regulatory bodies in the country and that successfully brought down consumption among recreational users. By mobilising multi-agency teams to enforce existing national laws and working with civil society groups and the media, Ghana has shown that there is an alternative way forward.

Ghana’s approach is a clear example of how African countries can address non-medical use without increasing harms to patients – using quotas for local manufacturers and importers, designating one single point of entry for importation of tramadol, and increasing funding for demand reduction strategies such as education and sensitisation.

As Dr Amaning Danquah, Registrar of the Ghana Pharmacy Council, asked rhetorically during the research: “How long can countries keep scheduling substances that become problematic?”

[1] Names have been changed to protect privacy.