Side event: On the access to Tramadol and preventing its diversification to illicit markets in the Africa Region

Organized by the Tanzania Green Crescent Community with the support of the African Union Commission, Green Crescent Health Development Initiative, the Institute of Leadership and Development and the Rwanda Youth Impact

Prof. Johan Strijdom, African Union:  Thank you, moderator, for this opportunity to shed some light and to focus attention on the AU Plan of Action on Drug Control and Crime Prevention and how it relates to our discussion this afternoon on this important topic of tramadol now my name is John Strijdom I used to work at African Union for many years on the issue of (…) and for traffickers of illicit drugs. The two last pillars basically deal with international and regional cooperation based on the principle of common and shared responsibility that we all know. And lastly the one dealing with implementation of the regional strategies contains clear implementation plan with the objectives, activities, timetables and introduces forms of responsibility, including a results-based management approach. Coming back to the important feature of the second filler which deals with availability of medicines, at least barriers to suppress their availability and accessibility to controlled substances for medical purposes including for the relief of pain and suffering. Here we look at barriers, in some cases we have experienced challenges with reporting to the INCB through the online system etc. and then broadly also to reduce the non-medical use of medicines to include assessment of the supply chain for diversion including counterfeit products or open markets outside the regulated system for control and activities of promoting electronic systems for the prescriptions of pharmaceuticals. Also contained in the outcome documents, regulation of the trade in the aquatic and tropic substances including licensing let’s say, and then exchanging best practices among member states. Now I’m going to share a little bit more specifically about Tramadol. This is about the challenges of tramadol it is used and abused in much more strengths than used in medical settings between 225 and 250 milligrams in tablets and that is these strengths that are mostly sold in the informal market, and I’m not thumb sucking when I’m saying this it’s based on solid stand by Dr Axel Klein, I was also part of it in Southern Africa. We visited Botswana and Namibia and looked at their control systems indicating that Tramadol sold in unregulated settings has been produced illegally and enters African countries illegally. What is sold in pharmacies are the 50 and 100 milligram strength Tramadol and it’s very important to have access with Tramadol and higher scheduling of the drug will not provide protection against abuse. As we say abuse happens because of these imported substances so I’m concluding with this broad brush saying we should make a case for community epidemiological networks like neighborhood watch which is used in the case of safety and security and have people especially parents and mothers be on the lookout for the use of these substances also including Tramadol. And then again as I said barking up the tree of supply reduction to assess the supply chain for diversion including counterfeit products for open markets outside the regulated system for controlled substances. We know in West Africa we find youngsters walking around with little rucksacks and with all the tablets in there and selling it on the streets and in their informal markets and that is the real challenge for us to follow the chain from where it comes from, and to see who is involved in the supply when it comes, also corruption and other means than trying to regulate this stuff. Thank you

Dr Bakari Ali Mohammed (Tanzania Green Crescent Community): Tramadol is a medication used to relieve pain. You can buy this from the pharmacy but people do not know that it is an opioid. Tramadol is a synthetic opioid that is used for relieving pain. Many people use is to relieve pain and yet they do know that this is an opioid. This drug has many effects including seizures. If someone takes high doses of Tramadol this can lead to addiction and most people do not know that. In the case of Tanzania, Zanzibar, we have rehabilitation centers called sober houses. We use these to rehabilitate people who use drugs, including cocaine and heroin. When they go to the sober house, they have one week to get a drug that helps to relieve their pain and they use Tramadol and yet they do not know that this drug can cause addiction like normal drugs. Other side effects include dizziness, stomach ulcers and more. Some people also get liver diseases. Studies in Egypt found that 3% of users were using tramadol yet they did not know that it is an addictive drug. Tramadol can cause addiction, overdose including death, like other drugs such as cocaine and heroin Tramadol in Africa is increasingly used in hospitals and accessible in pharmacies, in Tanzania it can be found in all pharmacies. Even though they provide precautions, people still do not understand that it is fatal, and overuse of this drug can lead to drug dependence. In Zanzibar, Tramadol is used as a remedy for people who struggle with substance abuse in sober houses to help relieve their pain as a normal drug but actually it is not. The UNODC’s World Drug Report shows that there is an increase in non-medical use of tramadol in Ghana and Nigeria. As I said earlier, Tramadol also helps people sleep *showed a map of the illegal use of Tramadol* So now we can go to the prevention. The drug market should be safe. Actually, the drug market for Tramadol should be controlled, and no one should use Tramadol unless there is a special body to deal with this kind of drug. Tramadol should be under the following internal control. For example, an international organisation like the UNODC should come up with a policy to control Tramadol that will assist countries to control this drug. Like other drugs, for example, cocaine and heroin. Prevention should be increased and people should be made aware of the harms of Tramadol. Sensitisation should be provided in order for people to understand, because people think this drug has no effects this it is like a normal pain reliever like paracetamol. However, people should be taught that this drug is very harmful, especially if they take it regularly Treatment services should be increased and tailor-made. In Tanzania we have different stakeholders who can provide this drug but instead it should only be provide by health professionals. It should not be easily accessible. Thank you.

Luqman Usman (Institute of Leadership and Development (INSLA), Ghana: Tramadol is man-made and is an analgesic right that means that it is a pain reliever that is the medical report for which this drug was being made. Also, the medicinal benefits of Tramadol can quickly become harmful when not taken as prescribed. Scientifically it is proven that excess amounts of regular usage of this drug can cause side effects which are dangerous and can also affect the brain in the same ways as illegal drugs. Unfortunately, the abuse and use of pharmaceutical opioids in Africa is on the rise. In line of our law enforcement with regards to participants what we see rising or being abused in addition to Tramadol is Morphine, Codeine and so on. However, today we are focusing on Tramadol, and it is being abused by the youth in Africa. In Ghana especially most of my presentation would rely solely within the Ghanaian context because that is where I find myself. In Ghana, even though there are regular inceptions and seizures illegally trafficked Tramadol across the country’s borders. Law enforcement conduct raids and arrests of people who are illegally trading in these things. It’s what we know. However, a comprehensive scientific baseline study is yet to be conducted for us to extent of this situation. There hasn’t been any baseline study. What has happened so far is observations of what we see in the reports that we have and from some of these observations, it indicates that there are abuses of Tramadol.  In Ghana, what they normally do is that for them to have such a high they mix it with alcohol or other beverages, drinks and so on and then we have different types of energy drinks in the market. According to them when they mix these drinks, they  get very high. They use the prescribed dosage within the medical context of 100 milligram within one drink. Scientifically mixing Tramadol with alcohol acts as an anti-depressant so they begin to slow down the bodily function which can lead to loss of consciousness, brain damage respiratory functions and increased depression. So these are some of the notable negative effects of the use of Tramadol, especially with the mix which of something like alcohol. Now we talking about access within the African market. And for this region, I did my categorisation within two main areas where Tramadol finds itself within the African market industries and in the second is importation from other continents. as it stands, Ghana doesn’t rely on its production capacity, they also import from other countries to complement what it has. Now let us quickly look at the local manufacturing, generally, most African countries have local manufacturers that produce Tramadol from imported ingredients that complements their national demands through importation from other countries. Equally in Ghana for instance, most of the drug importation comes from India which is from the Asian continent and from Europe, the UK and so on. When some pharmacies or dispensing technicians who supply Tramadol for authorized uses realized the high demand for Tramadol by abusers, they find a way of sneaking to sell it to them. Let’s say for instance if a box of tramadol costs 50 Ghana cedes, they can sell it to them up to they can double it or triple 100 Ghana cedes and 150 Ghana cedes. And just to mention briefly, what you need to understand  in Ghana, from our study we realize that some of these young guys that have used the tramadol are guys that find themselves in this fraud activities and through the fraud activities there this is where they get entertainment and so on. So they have money to buy the drugs, that is what is currently happening. Now the second aspect is importation of Tramadol. The importation of Tramadol is clearly regulated by state authorities across Africa. In Ghana for instance, we import Tramadol from abroad. The importing company must be registered with the Registrar General’s department, that is the importing organization. The company must be an appropriate body which is duly registered license to commence business under the laws of the country. Also, the importer must obtain an Import Permit for that specific consignment from the Food and Drug Authority in the Narcotics Control Commission. So, for instance, if there is a company that wants to import Tramadol into the country, they ought to go to the Narcotics Control Commission and indicate that they are having the intention to import one container or a particular container of Tramadol into the country and this is how they are expected to dispense it. It is like an Expression of Intention to the Food and Drugs Authority and the Narcotics Control Commission, so that when the consignment eventually lands in the country the company would be known and the document would be verified before it would be allowed into the market. However, registered wholesale pharmaceutical companies licensed by the Pharmacy Council allowed to import reasonable quantities for their shops. Pharmacies have that power because they are with the Pharmacy Council. Now, the smuggling of Tramadol which appears to be the catch of the discussion. So aside this license to import drugs, their drugs can be easily checked and tracked. There are Tramadol smugglers who smuggle tramadol in and out of the country to supply unauthorized traders. The smuggling of Tramadol across Africa is not a one way traffic thing, we need to understand this, In Ghana for instance, we cannot say that we only smuggle Tramadol in. There are instances whereby we smuggle it in excess to other neighboring countries, Togo, Benin, Nigeria. in Ghana for instance law enforcement admit to intercepting and making seizures of Tramadol pills smuggled in and out of the country across the country’s land borders. And also, because regulatory authorities have intensified checks from pharmacies and medical facilities, it is now making it difficult to obtain tramadol without prescription, so this is a headway or some achievement. Now the way forward quickly, we need to conduct a baseline study to understand the actual level of Tramadol abuse in Africa because when you say you actually want data as to the extent of this, it was surprising not to get something concrete that’s why I’m stating this important point. Secondly relevant stakeholders must join hands to regulate the quantities of tramadol for each, locally, as well as those imported in order to match admitted Tramadol legally for medical attention. We also need to strengthen monitoring exercises by ensuring that locally produced and imported Tramadol are dispensed for the rightful purposes. Thank you very much

Memory Usaman (Rwanda Youth Impact): Greetings to you all from Rwanda Youth Impact Memory Usaman is my name I’m going to give you this presentation which we have done jointly with RBC which is the Rwanda Biomedical Center implementation wing for Minister of Health of Rwanda. As we are a side event together with Tanzania on the topic on the access of tramadol and preventing and preventing its diversification through illicit markets in the African region. Allow me to share a bit about Rwanda Youth Impact, Rwanda Youth Impact was formed in 2020. As Rwanda Youth Impact we believe that change is possible to anyone we engage in awareness campaigns against addictions like tobacco addiction, alcohol addiction, drug addiction technology and gambling addiction here in Rwanda. In doing so we raise awareness campaigns, advocacy activities and preventative and rehabilitation nature working together with RBC. These are the activities that we’ve done from the signing ceremony, which we had during our initiation stage and then the signing ceremony which we had with RBC. Leveraging on RBC allowing us to do activities in an easier way than before where we get to reach out to the target audience like children, youth with the various things or sharing information on how they can actually shun addiction. Back to the topic which we are going to be discussing on Tramadol, allow me to give you the introduction on Tramadol. Tramadol is used worldwide and is listed in many medical guidelines for pain treatment, and it is mentioned in WHO guidelines as one of the pain relief medicines. I think this has been highlighted by the previous speakers regarding the Tramadol as well. As we speak there is a growing evidence of abuse of tramadol in some African countries in tramadol is also listed is listed on several national essential medicines list in terms of pain relief it is generally considered as the medicinal drug with a low potential for dependency but compared to morphine but you see that with the statistics that we are having now it shows that Tramadol is also one of the painkiller which is so addictive and people are resorting to it. Tramadol abuse is at the center of a debate that weighs up those concerns globally. Practitioners are at a dilemma to see how best they can also restrict it and for it to be given under normal legal medicine to care. The abuse is jeopardizing access to this pain treatment for legitimate patients. In Rwanda, tramadol is generally used under regulation of FDA and can only be accessed through a prescription without a prescription one cannot get tramadol from pharmacies so it’s not an OTC drug, but you need to have a prescription when it is being used, it is normally generally being used under the management of health professionals. Misuse is managed at other cases because at times even if pharmacies are not selling it, you can find it being sold on the black market. So, we manage many cases where it is being misused, being managed and they are treated as drug abuse and awareness on prevention and management of intoxicated cases if any, are actually being done. Tramadol is used to treat both acute and chronic pain of moderate and moderately severe intensity. Symptoms of tramadol intoxication are similar to those of actual analgesics. The symptoms may include serotonergic and also noradrenergic components, depression, cardiovascular collapse, seizures, respiratory depression up to respiratory breaks are some of the symptoms that we have actually found under the use of Tramadol. Illicit manufacture and trafficking related information, there is evidence of increase in the trafficking in Tramadol preparations to North and West Africa. Egyptian authorities seized about 120 million tablets containing Tramadol in 2011 and about 320 million tablets in the first quarter of 2012. According to information available to the INCB, the preperations were smuggled into Egypt mainly from China and India. Saudi Arabia also reported increasing amount of seizures of preparation containing Tramadol. In Benin, Ghana, Togo and Senegal under West Africa, large amounts of tramadol preparations totaling more than 130 tons of were seized in 2012. The preparations had been concealed in sea containers sent from India and were intercepted by the local law enforcement authorities. According to UNODC, in 2017 a steady rise in three years between 2007 when we had  0.00545kg seized and in 2015  we had more than 111,000kg were also seized. So virtually all these seizures in 2015 were associated with dealing with more than 111,000 kgs. But the pattern in seizures by each country varied one year by year. For example in 2014 total of seizure were more than 25,000kgs which were predominantly from Jordan with more than 14,000kgs, in 2013 total seizure were 1271kgs which are predominantly from Saudi Arabia with more than 700kgs. The way forward in our conclusion we realise that nations need to adopt a holistic approach that includes cooperation international bodies such as UNODC and Interpol while engaging health professionals, educators and families to address the demand-side of the trafficking.  This would be in line with the UNODC position, which since 2016 has been stressing the importance of demand in reduction efforts as part of the balanced approach to reduce the use of tramadol as a painkiller and also being abused to the extent that people become addicted to it and getting end results which are negative to their health. With that I conclude my presentation and thank you for your time bye for now.


QUESTIONS

For Prof Johan Strijdom

Is a single study enough to validate this kind of findings?

It’s a really good question but I think there has been quite broad discussions in West Africa on this matter, we know about folder we are so much aware of the devastation caused by tramadol also in North Africa we are very fortunate in Southern Africa that it’s very well controlled nationally I’m talking about South Africa Botswana where I live and I’m a Namibian and also in my country so we are very lucky there and we are very concerned. However, we cannot see that Tramadol is more higher scheduled than is the case at the moment especially, in our context we really need this drug and I think generally from our perspective and in line with the with the  2012 Common African position I think that the African Union look at it you know also in terms of its therapeutic uses in the first place and as I said it seems to be a very big challenge when it comes to the supply reduction component and that is a challenge to us all i mean that is also a straight responsibility among communities among community members and between member states in that regard.

 

For Dr Bakari

Is Tramadol under national control in Tanzania?

Actually, it is not because now the people who actually access it in whatever ways they want. For example, I told you in sober houses, they are rehabilitation centers where those people who are using substance get Tramadol as an anti-pain. There is no guideline specifically as a policy that tries to control this drug but when you go to pharmacy, they can say that okay these drugs can be offered can it be given to those people who go to a pharmacy that is under control. People still have access to using Tramadol without a proper precaution and without a proper policy to control that drug.  That is why I said, I need this now in Africa to have policies that control Tramadol among the drugs that can be used illegally and can cause addiction.

 

Final question

Can each speaker state whether they support international control?

Dr Bakari Ali Mohammed: Yes, because Tramadol is a drug that if use illegally, can lead to abuse. We see the effect; we see the consequence of this drug and the main the consequence included death. So, I think should be under control should be under control according to me.

Memory Usaman : I want to believe it is important to accept the international controls because it will actually mitigate some of the challenges that we face in Africa when we work as one body because information can actually be transferred easily so we support that engagement.

Luqman Usman: I fully support the fact that there must be an international control for the menace of this tramadol because from the presentation I gave earlier or understand that it is transnational in nature plus we have international movement of some of these. And as mentioned, we would need intelligence sharing which would help to get the smuggling or trafficking. If there is this international collaboration will be able to I mean ensure that the movement is purely for legitimate purposes. Johan indicated, for the tramadol we need it for medical we can’t see that we need to strip it off but once we all agreed that we need it how can we ensure that the rightfully produced are meant for the legitimate purpose.

Johan Strijdom: thank you very much I can just say well my brother Usman has said it all I don’t need to repeat what he said in terms of the need for control yes but also the need that it’s being that is available for use by people who need it in pain relief we don’t want our people to die in pain we see it too much on our continent but really we must make sure that it’s properly controlled. thank you very much.

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