Diversion of pharmaceutical opioids for extra-medical consumption: the role of patent and proprietary medicine vendors in Nigeria  

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Yet, the role of informal medicine vendors remains relatively unknown. In Africa, there is a dearth of research on the supply of pharmaceutical opioids for extra-medical consumption, which could help to highlight the role of informal medicine vendors. Nevertheless, research has implicated these vendors in other public health problems such as distribution of falsified and substandard drugs. Methods: We conducted in-depth interviews with young Nigerian men (aged 15–35 years) who consume pharmaceutical opioids extra-medically (n = 39) to explore the sources from which they obtain pharmaceutical opioids for this consumption and the factors that inform their choice for these sources. We used ‘liminal legality’ as a conceptual tool to understand the role of Patent and Proprietary Medicine Vendors (PPMVs) in this supply process. Results Accounts revealed that participants obtained pharmaceutical opioids for extra-medical consumption from Patent and Proprietary Medicine Vendors (PPMVs), street drug dealers and friends/relatives. PPMVs were identified as an important source of these drugs due to their liminal legality, which is a state of quasi-authorization by the Nigerian state. The position of PPMVs betwixt the formal and informal drug markets create unique opportunities for obtaining prescribed drugs (such as pharmaceutical opioids), which PPMVs are not authorized to sell, in the guise of selling/buying over-the-counter drugs. This affordance in turn made buying pharmaceutical opioids from PPMVs easier compared to street dealers and provided a measure of protection from law enforcement, which is unavailable in street drug markets. The dependence of most street drug dealers and other consumers (i.e. those who supply friends and relations) on PPMVs for primary supply further establishes these vendors as a primary source of pharmaceutical opioids for extra-medical consumption. Conclusion The study shows how the absence of effective policy framework to regulate the operations of PPMVs creates opportunities for accessing pharmaceutical opioids for extra-medical consumption. It calls for government regulation of these vendors through licensing, training and routine monitoring. Africa diversion health system liminal legality pharmaceutical opioids health policy Introduction The consumption of pharmaceutical drugs, especially opioid analgesics, for purposes other than directed by a healthcare professional (i.e., ‘extra-medical consumption’ [ 1 ]) has increased globally [ 2 ] and is now considered a serious public health issue in many parts of the world. In many developed (western) countries, the prevalence of extra-medical consumption of pharmaceutical opioids now rivals the use of illegal drugs (e.g., cannabis). For example, in the United States, Canada and Australia, general population surveys have shown that prescription drugs (especially opioids) are among the top three most consumed drugs [ 3 , 4 , 5 ]. In many African and Middle Eastern countries, extra-medical consumption of tramadol, a synthetic opioid used to manage mild to severe pain in both acute and chronic cases, is now seen as a public health crisis [ 6 ]. Consequently, tramadol has been placed under control at national levels and is now classified as a prescribed drug in many countries [ 6 ]. Extra-medical pharmaceutical opioids consumption has been linked to diversion, defined as the redirection of drugs from legitimate to non-legitimate channels of supply and consumption [ 7 ]. Although an extensive research literature exists on pharmaceutical opioids diversion in the developed world (e.g., North America, Australia) [ 8 , 9 , 10 , 11 ], less is known about this problem in Africa. As a result, questions about the factors driving extra-medical consumption of pharmaceutical opioids on the continent remain unanswered. This study explores diversion of pharmaceutical opioids for extra-medical consumption in Nigeria. The international literature on diversion has shown that pharmaceutical opioids consumed extra-medically may be obtained directly from medical sources (i.e., from a pharmacy with a prescription) or from non-medical sources such as friends and relatives, street dealers and online markets [ 12 , 13 ]. Obtaining pharmaceutical opioids for extra-medical consumption usually involves diversion from legitimate channels through mechanisms such as doctor or pharmacy shopping, prescription forgery, over-prescribing by healthcare professionals, illegal sales, theft, online sales as well as sharing by friends and relatives [ 10 , 11 , 14 , 15 , 16 , 17 , 18 , 19 ]. The bulk of existing research on this topic comes from North America and Australia. There is a dearth of research on this subject from Africa, even in the context of rising levels of extra-medical pharmaceutical opioids consumption on the continent [ 6 ]. Consequently, the role of informal medicine vendors, who are major sources of medicines in many African countries, have not been captured in the current literature. In Africa, much of what is currently known about diversion of pharmaceutical opioids comes from reports produced by international organizations such as United Nations Office on Drugs and Crime (UNODC). These reports usually focus on pharmaceuticals trafficking and related organized crime [ 6 ], and not on retail-level supply to consumers. There is an emerging body of academic research on extra-medical pharmaceutical opioids consumption in Africa that explores the perspectives of consumers [ 20 , 21 , 22 , 23 , 24 , 25 ]. Nevertheless, most of these studies investigate motivations and other proximate factors influencing this consumption. Diversion of opioid analgesics for extra-medical use, and the role of informal medicine vendors, remain under-explored, even though research has implicated these vendors in other public health problem such as distribution of falsified and substandard drugs [ 26 ]. This paucity of research on the role of informal medicine vendors in the supply of pharmaceutical opioids for extra-medical consumption in Africa is also significant from the standpoint of health policy, especially because lack of policy framework to regulate informal medicine vendors has been identified as a key contributor to the distribution of substandard and falsified medications [ 27 ], and research has indicated that these actors are also involved in the supply of prescribed drugs (including opioid analgesics) for extra-medical use [ 28 ]. Therefore, exploring the role of informal medicine suppliers in the supply of pharmaceutical opioids for extra-medical consumption could provide evidence and rationale for developing policies to regulate these providers and the medical products the supply. As a way of providing this evidence and rationale, this study explores diversion of pharmaceutical opioids for extra-medical consumers in Nigeria, especially the critical role of Patent and Proprietary Medicine Vendors (PPMVs). Our exploration of the role of PPMVs is informed by the concept of ‘liminal legality’, which helps to highlight how the position of these vendors between the formal and informal markets (due to the lack of regulatory policy) makes them a primary source of pharmaceutical opioids for extra-medical consumption. Liminal legality, developed from socio-legal studies, describes the interstice or space between legality and illegality. It has been used to explore legal ambiguities and related negative consequences. For example, it has been used to explain how migrant populations are simultaneously positioned both inside and outside of the law due to their subjection to dual criminal and immigration systems [ 29 ]. In this context, liminal legality ‘creates and recreates an excluded population and ensures its vulnerability and precariousness by blurring the boundaries of legality and illegality to create grey areas of incertitude’ [ 30 ]. In this study, we use liminal legality as a conceptual tool to explore how the failure to effectively regulate PPMVs, which makes it possible for them to participate in both legal and illegal markets, creates unique opportunities for individuals to access pharmaceutical opioids for extra-medical consumption while also providing a measure of protection from law enforcement. PPMVs occupy a position of liminality because while they are authorized by the state to sell over-the-counter drugs, are large part of this sector remains unregulated. This situation is crucial for understanding the importance of PPMVs in pharmaceutical opioids diversion to extra-medical consumption. This study thus develops a nuanced understanding of ‘diversion’ of pharmaceutical opioids consumption for extra-medical consumption through showing how health policy failures create opportunities for consumers to access these drugs. Pharmaceuticals opioids and Patent and Proprietary Medicine Vendors in Nigeria Pharmaceutical opioids such as tramadol and codeine are on Nigeria’s essential medicines list [ 31 ]. They are used in the healthcare system to treat moderate to severe pain in both acute and chronic cases [ 32 ]. The non-prescribed and non-regulated consumption of these drugs outside the healthcare system has generated significantly negative public reactions due to concerns about potential adverse effects. Public concern reached a crescendo in 2018, when the Nigerian government, in response to a documentary by the British Broadcasting Corporation (BBC), imposed a ban on the sale of Codeine and made access to higher dosages of Tramadol (i.e., above 100mg) illegal [ 33 ]. Nigeria has one of the highest prevalence of extra-medical pharmaceutical opioids consumption in Africa. Past-year use of pharmaceutical opioids (mainly tramadol, and to a lesser extent, codeine and morphine) was estimated at 4.7% (about 4.6 million people) in 2017, and pharmaceutical opioids was the second most used category of psychoactive drugs after cannabis [ 34 ]. Studies have reported diverse reasons for extra-medical pharmaceutical opioids consumption in Nigeria, including to self-medicate pain and depressive symptoms, improve mood, and increase energy levels for work or sexual performance [ 35 , 36 ]. Research has also identified some channels for the supply of pharmaceutical opioids for extra-medical consumption, including PPMVs [ 28 ], although the processes of drugs diversion remain unknown. PPMVs, i.e., ‘persons without formal pharmacy training selling orthodox pharmaceutical products on a retail basis for profit’ [ 37 ], are a major informal healthcare provider in Nigeria and other countries in Africa [ 38 , 39 ]. According to the Pharmaceutical Society of Nigeria (PCN), there are close to 2 million unlicensed patent medicine vendors operating in Nigeria, compared to only 25,000 registered medicine vendors, which includes community and hospital pharmacies [ 40 ]. PPMVs serve as the first point of care for the majority of Nigerians, especially in local communities [ 41 , 42 ]. They are authorized to sell a limited range of pre-packaged, over-the-counter drugs and medical products, but not to sell prescribed medications such as opioid analgesics and antibiotics [ 31 ]. Although PPMVs are supposedly under the supervision of PCN, most operate without a license and routine monitoring [ 43 ]. PPMVs are often seen as a temporary measure to ensure better coverage of healthcare services and pending the expansion of the formal healthcare sector. Poor systems of registration, training and accreditation as well as weak monitoring of PPMVs has created an enabling environment for provision of substandard care and unlawful practices such as sales of prescribed drugs and of falsified and sub-standard medical products [ 27 ]. These practices have made PPMVs a key target of campaigns aiming to stem the distribution of substandard and falsified drugs, often involving crackdowns on vendors by law enforcement agents. Methods and materials This study is based on primary (qualitative) research on the supply and consumption of pharmaceutical opioids in Akwa Ibom state in Nigeria, which lasted between February and June 2019. Data gathering took place in two (2) cities in the state – Uyo, a large urban centre with an estimated population of 1,294,276 people [ 44 ], and Ikot Ekpene, a relatively smaller city with a population estimated at 400,320 people [ 45 ]. Informed by findings from a national survey of drug use, which showed an increase in drug consumption (annual prevalence estimated at 12.5% of the population aged 15 to 64) in the state, particularly pharmaceutical opioids [ 34 ], the study aimed to explore the supply and consumption of pharmaceutical opioids among youths (15–35 years according to the African Youth Charter of 2016). Study participants were regular high-risk consumers, defined as using high doses of opioids (250 to 500 milligrams) at least once in a week. We aimed to include female consumers in the sample through allocation of 30% quota. However, difficulties in recruiting female consumers due to stigmatization of women’s drug use [ 46 ], resulted in participants being all male. In Uyo, participants (n = 23) were recruited purposefully through a drop-in centre (DIC) for people who use drugs (PWUD) operated by a local Non-Governmental Organization to which one of the authors is affiliated. Attendees of the DIC were informed about the research by the social workers and those who indicated interest were referred for screening to determine eligibility. Recruitment in Ikot Ekpene was through snowball sampling based on contacts developed in previous research (n = 16). This brought the total number of participants to thirty-nine (n = 39). Eligible participants were aged 23–35 years (mean age of 29). Although none was married, the majority had regular heterosexual partners (Uyo – 17, Ikot Ekpene – 11). The sample from Uyo had diverse occupations, including artisans, unskilled public and private sector employees, small-scale business owners and students. The majority of participants from Ikot Ekpene were students, with a few artisans and unemployed persons. All participants were of low socioeconomic status and represented high-risk consumers based on their drug use patterns (polysubstance use, heavy and regular use). Semi-structured interviews lasting 45 to 60 minutes were conducted in both locations, addressing different topics. The ‘unit of analysis’ for the present study was sources of pharmaceutical opioids for extra-medical use. Interviews took place at a convenient time and location for participants (e.g., the DIC, canteen, community meeting hall), to make them feel safe. Participants were given adequate information about the research, and they gave verbal consent to participate in interviews. Recruitment and data collection continued until data saturation was reached (i.e., further interviews did not produce new insights relevant to the research questions). Each participant received a five hundred-naira (US $ 0.31 at the time of writing) recharge voucher appreciation gift. Interviews were recorded digitally with participants’ consent, transcribed professionally, and checked to ensure accuracy. Analysis of the data was informed by the thematic approach developed by Graneheim and Lundman [ 47 ], which involves the development of themes and categories through the identification, condensation and abstraction of ‘meaning unit’. Transcripts were read repeatedly to gain an understanding of the content area (i.e., sources of pharmaceutical opioids supply for extra-medical use). Thereafter, meaning units (i.e., words, sentences, and paragraphs with common meanings or shared content and context) were identified. Further, these units were condensed, grouped and assigned codes (e.g., ‘purchase from vendors’). Codes were then sorted into categories (e.g., ‘primary source’) based on manifest content. Finally, themes (e.g., ‘patent medicine vendors’) and sub-themes (e.g., ‘relative legitimacy’, ‘covert supply’) were developed to capture the underlying meanings. Liminal legality was used as a conceptual tool to interpret findings on the role of PPMVs in pharmaceutical opioids supply for extra-medical consumption. Verbatim quotations are used for illustration Identifying information are excluded on ethical grounds. The study was approved by health research ethics committee of the University of Uyo Teaching Hospital, Uyo, Akwa Ibom state, Nigeria. Findings Sources of supply Accounts revealed three sources of pharmaceutical opioids for extra-medical consumption, namely PPMVs, street drug dealers and social supply through friends and family members. Participants highlighted interconnections between these sources, where street drug dealers and social suppliers obtain primary supply of the drugs from PPMVs, thus making the latter the significant source of supply. Patent and proprietary medicine vendors As explained earlier, although PPMVs are recognized as medicine suppliers by the Nigerian government, they are not effectively regulated. This leaves them in a regulatory limbo that creates room for illegal practices. Accounts showed that this situation places them in a unique position as a source of pharmaceutical opioids for extra-medical consumers. For example, accounts highlighted that in addition to selling over-the-counter medications (which they are authorized to sell), most PPMVs also sell prescribed drugs, including and especially to extra-medical consumers (which they are not authorized to sell), thus engaging in illegal practices alongside legal ones. A participant stated: The truth is that most of these chemist stores (i.e., PPMVs), they sell drugs that people can take for sickness and also sell the ones that people take to get high. They are not allowed to sell those ones (i.e., psychoactive prescription drugs), but they hide and sell it. So, they also do illegal stuff even though they are like legit business. It is like a very common thing. The sentence ‘they also do illegal stuff even though they are like legit business’ shows the illegal practices that arises from the liminal legality or regulatory limbo in which PPMVs exist. Participants described PPMVs as the most important source of pharmaceutical opioids for extra-medical consumption, with some claiming that most extra-medical consumers of these drugs obtain them from PPMVs. Even the participants themselves reported obtaining the drugs from these vendors. For example, a participant reported that he buys tramadol without prescription from the PPMV store in his neighbourhood (‘…I buy it at the chemist close to my place’). Another participant noted: My own I buy it (tramadol) from the chemist store that is close to where I live. I don’t go far away to look for it because the chemist there sells it. Like I know he sells it because I am a customer (i.e., regular client). Whenever I want to take it, I just go there and buy as much as I need. The phrase ‘as much as I need’ indicates that this is an unapproved, non-prescribed supply. A major reason given by participants for buying their pharmaceutical opioids from PPMVs was the relative ease of purchasing these drugs from these vendors when compared to other sources of supply (e.g. street drug dealers). Ease in purchasing pharmaceutical opioids from PPMVs was linked to their liminal legality. For example, participants explained that buying pharmaceutical opioids from PPMVs was easier because one could pretend to be purchasing over-the-counter drugs. The authorization to sell over-the-counter drugs serves as a pretext for covert sales of pharmaceutical opioids. On the other hand, buying from a street dealer is riskier due to the absence of such a pretext (‘With the chemist you can say I wanted to buy Aspirin [over-the-counter medication], but on the streets it is very difficult’). Further to this, purchasing pharmaceutical opioids from PPMVs was said to be easier to explain as being meant for medical purposes (e.g., pain treatment) compared to purchasing on the streets (‘It is easy to say that you want to take it for sickness, if you bought from chemist, though they are not allowed to sell it’). In this context, authorization to sell some types of drugs offers a leeway for negotiating law enforcement and evading potentially negative outcomes. Additionally, the liminal legality of PPMVs provided a measure of protection from law enforcement, although participants acknowledged that safety was never fully guaranteed. Speaking from the standpoint of personal experience, participants described how they used over-the-counter drugs as a pretext to covertly buy pharmaceutical opioids from PPMVs (‘I will pretend that I want to buy like other drugs, but when I am alone with the person selling, I will then buy what I wanted’). This strategy reduced the risk of being identified as an extra-medical consumer. A participant stated: The only place you will be able to buy it confidentially (secretly) is at the chemist store. Because at the chemist people will think you are buying normal paracetamol. They will not know that you are looking for like illegal stuff. Even the chemist seller will tell you no problem. He will give it to you when the other people have all gone, and you will go your way. In addition to the relative protection linked to the pretext of buying over-the-counter drugs, being able to buy pharmaceutical opioids for this consumption without the demand to present a prescription note was also identified as an additional advantage that further made PPMVs a preferred source of pharmaceutical opioids for extra-medical consumers. A participant noted: Most chemists will not ask for a paper from the doctor (i.e. prescription note) before they sale like tramadol to you. They are really into the business, you get it. They sell to those who want it; whoever wants it, even if they are taking it to get high. That is why most people who use tramadol to get high go there. Nevertheless, the liminal legality that create opportunities for easier and relatively safer purchase of pharmaceutical opioids also mediates unique risks for law enforcement interdiction. This risk exists because of the targeting of PPMVs by law enforcement as part of a campaign against falsified and sub-standard drugs (‘The chemist stores [i.e., PPMVs] are being hunted by police for selling fake drugs’). In attempt to mitigate this risk, most PPMVs sell prescribed drugs (such as tramadol) covertly to extra-medical consumers. A participant stated: Tramadol is being sold in the chemists. But when you want to go and buy, you won’t just bash in like there are many people there trying to buy drugs and you now open up and say I want to buy tramadol. No, the pharmacists or the chemists will not sell for you because he knows he is not allowed to sell it. So, you will observe the environment well; If the chemist person (i.e., PPMV) is alone you will ask if he has tramadol. The chemist will look at who is asking for this drug again, and before you know, he will now sell it to him. As seen in the above quote, unauthorized distribution of pharmaceutical opioids (such as selling without medical prescription) establishes a context of risk for interdiction by law enforcement agents. Both sellers and consumers were concerned about the risk of being detected by law enforcement officials. To conceal such transactions, PPMVs were said to adopt different strategies, including carefully monitoring the surroundings for signs of police presence (as indicated in the above quote). Interviews also revealed that PPMVs only sell pharmaceutical opioids to regular buyers, another risk navigation strategy that provides a further layer of protection against law enforcement interdiction. A participant commented based on his experience purchasing tramadol from PPMVs: … I tell them that I want to use it for groove (i.e. for fun). When I tell them like that, they will sell it for me. Because it is a place that I know. Several chemist shops that I know. They don’t put it on the shelf; they hide it inside. If you want it, they will look at you. If you are their core customer (i.e. regular buyer), they will sell it for you. But if it is your first time of coming to buy, they will never sell it for you. Overall, the accounts presented in this section shows that the liminal legality of PPMVs enables extra-medical consumers to purchase pharmaceutical opioids in the pretext of buying over-the-counter drugs as well as navigate the risk of law enforcement interdiction. These advantages make PPMVs the preferred source of these drugs for consumers. Street drug dealers Apart from PPMVs, pharmaceutical opioids consumed extra-medically could also be purchased from street drug dealers. Although these dealers usually sell illegal drugs (such as cannabis and heroin), research has shown that some also sell pharmaceutical drugs, including opioids analgesics, either solely or alongside illegal drugs [ 28 , 48 ]. A participant stated: I have bought it (tramadol) from the drug dealers on the streets before. In fact, I have bought many times from the street dealers. That is, the street dealers are all these boys who sell hard drugs on the streets to make money. They sell like weed (i.e., cannabis) and Thai (i.e., street heroin). They also sell Tram (i.e., tramadol) and Penta (i.e., Pentazocine). Yet, the involvement of street drug dealers in illegal supply of pharmaceutical opioids to extra-medical consumers was said to be limited because only a few dealers sell these drugs (‘They [street dealers] do sell [pharmaceutical opioids], but only one or two here and there’; ‘Only like few street barons will sell tramadol and stuff like that…’). The reason many street drug dealers do not sell pharmaceutical opioids was the bulkiness of these drugs, compared to illegal drugs, which makes concealment difficult (‘They [i.e. street drug dealers] cannot hide it like weed, that is why [they don’t sell it often]’). It was also observed that most consumers prefer to purchase from PPMVs, which made selling pharmaceutical opioids less rewarding for street drug dealers (‘The chemists are the real place for getting those ones’; ‘Most people who take it will always go to the chemist’). Furthermore, most street drug dealers who sell prescription drugs did so irregularly due to difficulty obtaining bulk supply (‘They always have like the hard [illegal] drugs, but the tramadol they don’t have all the time…’). Those who regularly sell pharmaceutical drugs on the streets were said to be intermediaries for PPMVs (‘Some of them are working for the chemists’). Accounts emphasized linkages between street dealers who sell pharmaceutical opioids and PPMVs, where the former depends on the latter for supply. This linkage demonstrates the primacy of PPMVs in illegal supply of pharmaceutical opioids to extra-medical consumers. A participant noted: … the area boys at the park buy [tramadol] from the chemists to sell and make some money for themselves. They buy from the chemists to sell and make pocket money. Sometimes these street boys also they used to take it around and sell the same way people sell marijuana. They buy it from chemist and take it around to sell to their own customers [i.e. those who regularly buy illegal drugs from them]. This, and similar accounts, demonstrate that PPMVs occupy an important position in the illegal retail market for pharmaceutical drugs such as opioids, with street drug dealers sometimes serving as their intermediaries. Social supply Accounts revealed that consumers also accessed pharmaceutical opioids for extra-medical consumption through friends and relations, a distribution process known in the literature on illegal drugs as ‘social supply’ [ 49 ]. Most participants considered this an unreliable source since friends and relations do not always have the drugs. Similar to street drug market, social supply was linked to PPMVs because those who supplied the drugs to others usually purchase them from PPMVs. According to a participant: …it was my friend that gave it to me. Like he used to take it when he wants to work. He used to share it with me, like give me some tablets. So, after the whole thing I now asked him what he gave to me and he said it was tramadol. I went on to ask him where he got it and he said he bought it at the chemist. He used to buy much, and he will give me some to also take. Relative risk of law enforcement interdiction Interviews also explored the risk of law enforcement interdiction associated with obtaining pharmaceutical opioids from these different sources. Obtaining the drugs from street dealers was seen as being associated with a greater risk of interdiction by law enforcement agents. Going to buy stuff from the dealer on the streets is always going to be more dangerous because police is always patrolling… You already know it is like fifty-fifty (i.e., there is a fair chance that the individual could be arrested). Those who take Tram know that buying on the streets is not safe. They are worried about meeting police. On the other hand, and as previously explained, PPMVs were considered a relatively safer source of supply mainly because consumers could purchase pharmaceutical opioids in the pretext of purchasing over-the-counter drugs. A participant opined: The chemist is better (than street drug dealers) because you will be like a regular customer who wants to buy medicines. Other people who see you will think that you want to buy the regular drugs. It is not like on the streets that everyone who sees you giving money to a dealer at the corner somewhere will know what you are doing. Furthermore, PPMVs were said to be highly discrete when selling prescribed drugs such as pharmaceutical opioids (‘They are very smart; they will sell in a coded way, you understand’). Additionally, some consumers were said to carry falsified prescription notes, which they present to law enforcement officers in the event of encountering the later. A participant recounted a friend’s experience: One of my friends was involved when he bought (Tramadol) at night... So, as he was leaving the chemist, police arrested him and when they searched him, they collected the drugs. He now talked to them and used a fake prescription to convince them … He told them that the drugs were prescribed by the doctor. So, when the police saw the doctor’s report (prescription note) they couldn’t detain him. In this case, the consumer was let go because he presented a (falsified) prescription note. It is most unlikely that this note would have been honoured if he purchased the drug from a street dealer (in the words of the participant, ‘they [police]would not have listened to him if they caught him buying from the baron’). This example illustrates how liminal legality creates ‘grey areas of incertitude’ for law enforcement in relation to sells of prescribed drugs. Discussion The findings presented have shown that pharmaceutical opioids consumed extra-medically in the study setting are obtained from different sources - PPMVs, street drug dealers and social supply through friends and colleagues. Past research has reported on the roles of street drug dealers as well as friends and relations in illegal supply of pharmaceutical opioids for extra-medical consumption [ 11 , 13 , 17 ]. The present study corroborates these past works through identifying street drug dealers and social supply as sources of pharmaceutical opioids for extra-medical consumers. Yet, as the accounts presented reveal, these sources are secondary to PPMVs. PPMVs feature as the primary source of pharmaceutical opioids because they offer an opportunity for accessing these drugs with relative ease through allowing consumers to pretend to be purchasing over-the-counter drugs, a dynamic that also provides a measure of protection from law enforcement. The role of PPMVs in the supply of prescribed drugs for extra-medical consumption highlights a deeper problem of ineffective regulatory policy and its contribution to this growing public health problem in Nigeria. Past works have implicated health policy issues such as over-prescription and inadequate access restrictions (e.g. absence of prescription monitoring systems) in the diversion of pharmaceutical opioids to extra-medical consumption [ 11 , 13 , 17 , 19 ]. The present study adds further insight to this discussion based on research in Africa. The study shows how the lack of effective regulation of informal medicine vendors enables the supply of prescribed drugs for non-prescribed consumption since consumers can access these drugs from PPMVs with relative ease and safety. The findings help to develop a nuanced understanding of the concept of ‘diversion’ as an explanation for the supply of pharmaceutical opioids for extra-medical consumption in the Nigerian context. This is achieved through the concept of ‘liminal legality’ [ 30 ], which helps to further foreground the role of health policy failures in this growing problem. Liminal legality enables a nuanced understanding of the role of health policy issues (i.e. ineffective regulation of informal medicine suppliers) in illegal supply of pharmaceutical opioids for extra-medical consumption. As demonstrated by the accounts canvassed, PPMVs constitute a category of providers with ‘liminal legality’ in that while they are recognized by the Nigerian state as medicine suppliers (and thus part of the health workforce), they are not effectively regulated in terms of accreditation, licensing, training and monitoring. They are authorized to sell over-the-counter drugs [ 31 ], which makes them a part of the system of medicines supply. Yet, lack of effective regulation of their activities creates opportunities for a parallel supply of prescribed drugs (such as pharmaceutical opioids), which they are not authorized to sell. Thus, PPMVs operate within a regulatory limbo that blurs the line between legal and illegal supply and creates ‘grey areas of incertitude’ [ 30 ] in law enforcement responses. These ‘grey areas’ may be seen in a participant’s account of how law enforcement officials honoured a falsified prescription note he used to purchase tramadol from a PPMV. Most importantly, the ability to purchase pharmaceutical opioids from PPMVs in the pretext of buying over-the-counter drugs shows how regulatory failure creates uncertainty for law enforcement agents. As a conceptual tool, liminal legality also helps to understand how both PPMVs and consumers navigate the risk of drug enforcement. Study participants highlighted the risk of interdiction by enforcement officers associated with purchasing pharmaceutical opioids from PPMVs. This risk arises from potential crackdown on PPMVs aimed at checking sales of falsified and sub-standard medical products as well as unauthorized sales of prescribed drugs [ 48 ]. This means that while PPMVs may not face the same level of risk of interdiction as street drug dealers, since they are authorized to sale over-the-counter drugs, their violation of regulations on prescribed drugs and sales of falsified and substandard medical products establishes a context of risk for interdiction by enforcement officers. In this respect, and as the participants’ accounts has shown, the liminal legality of PPMVs provide opportunities for navigating this risk of interdiction, which are not available to those who purchase these drugs from street drug dealers. For example, the fact that, compared to street drug dealers, PPMVs are authorized to sale some drugs potentially lessen the intensity of enforcement and, as the accounts have shown, made enforcement officers begrudgingly honor falsified prescription notes, in contrast to the kind of violent crackdowns documented in relation to street market enforcement [ 50 ]. The relatively low level of risk associated with purchasing pharmaceutical opioids from PPMVs, along with the opportunities it offers for navigating law enforcement, further elevates the appeal of these vendors to extra-medical consumers. Currently, state response to extra-medical consumption of pharmaceutical opioids in Nigeria reflects a long-standing emphasis on enforcement-based approaches in drug policy. This includes stricter control on availability and dispensing of these drugs and intensive policing of sellers (especially street drug dealers) and consumers [ 48 , 51 ]. This approach has had significant unintended consequences, including further limiting access to pharmaceutical opioids for healthcare purposes such as pain management [ 48 ], without effectively preventing or reducing extra-medical consumption. This study highlights the importance of addressing the systemic drivers of this problem, including through developing a policy framework for the regulation of PPMVs. Effective regulation is important because PPMVs occupy the second tier in the medicine distribution system in Nigeria (after hospitals and pharmacies). They play an important role in ensuring access to medicines in Nigeria, serving as the first point of care for most people especially in local communities [ 41 ]. Nevertheless, the lack of effective governance of these providers (and the informal healthcare sector more broadly) has created conducive (maybe even enabling) environment for the participation of some PPMVs in illegal activities such as selling prescribed drugs, which is outside their remit. Developing a policy framework to effectively regulate PPMVs could, therefore, help to mitigate illegal market activities without undermining their role in ensuring access to drugs for the Nigerian populace. Effective regulation of PPMVs involves developing and implementing efficient and adaptable systems for training and accreditation along with establishing viable mechanisms for monitoring and enforcement to ensure compliance with existing regulations. Monitoring and enforcement should be based on a collaborative approach involving partnerships between relevant government agencies (e.g. National Food and Drug Administration and Control [NAFDAC], Pharmacists Council of Nigeria [PCN], law enforcement agencies) and trade associations (such as PPMVs associations at the national, state and local government levels) to ensure effectiveness. On the other hand, the regulation of medical products should involve enforcing regulations on sales of prescribed drugs by PPMVs as well as adoption of effective measures (such as health insurance, subsidy programmes) to improve the accessibility and affordability of prescribed drugs (such as pharmaceutical opioids) for medical purposes through approved channels (e.g. pharmacies). Measures to prevent supply through secondary sources (street drug dealers, social supply), including various supply and demand reduction measures (e.g. targeting of largescale trafficking and improving access to treatment for opioid use disorder), should be implemented complementarily to interventions focusing on the core systemic (policy-related) factors fueling the diversion of pharmaceutical opioids for extra-medical consumption. Limitations and suggestions for further research The study has some limitations, which should be considered when interpreting the findings. First, the study is based on qualitative interviews conducted in two communities, which means that the findings are not generalizable to other locations. Nevertheless, past research has highlighted the role of informal medicine vendors, including PPMVs, in the diversion of prescription drugs for extra-medical consumption [ 28 , 48 ], which means that the findings have a measure of confirmability. Secondly, it is based on the views of consumers alone. While this does not undermine the credibility of the findings, it does imply that further research should include the views of other actors (such as PPMVs, policy makers/regulatory agents and law enforcement officers) to develop a better understanding of these diversion processes. Conclusion This study has demonstrated that the diversion of pharmaceutical opioids for extra-medical consumption, though involving different sources, revolves around the unique opportunities and protection arising from the liminal legality of PPMVs within Nigeria’s health system. It also highlights the limitations of current government responses as well as the importance of a policy-focused approach to addressing this problem. Summarily, the study offers preliminary findings that implicates the lack of effective regulatory policy in the rising problem of extra-medical consumption of pharmaceutical opioids in Nigeria, thus laying the groundwork for further research. Specifically, it makes two important contributions that would be relevant for research and action on diversion of pharmaceutical opioids for extra-medical consumption. First, it demonstrates the utility of liminal legality as a conceptual tool for understanding the role of policy-related factors in the supply of pharmaceutical opioids for such consumption. This concept has helped to highlight how inadequate policy framework for regulating the informal medicine vendors and related medical products fuels the supply of pharmaceutical opioids for extra-medical consumption parallel to supply for medical purposes. Secondly, and based on the above, the study points to the need to develop a policy framework to effectively regulate these vendors. Declarations Author Contribution Ediomo-Ubong Nelson - conceptualization, research design, data collection, data analysis, writing, revisionUchenna Nnam Macpherson - data analysis, writing, revision Data Availability The data used is not publicly due to ethical considerations. References Larance B, Degenhardt L, Lintzeris N, Winstock A, Mattick R. Definitions related to the use of pharmaceutical opioids: Extramedical use, diversion, non-adherence and aberrant medication‐related behaviours. Drug Alcohol Rev. 2011;30(3):236–45. United Nations Office on Drugs and Crime. World Drug Report. Vienna: WHO; 2024. Australian Institute of Health and Welfare. National drug strategy household survey 2016: detailed findings. Canberra: AIHW; 2017. Health Canada. 2012. 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Milani SA, Lloyd SL, Serdarevic M, Cottler LB, Striley CW. Gender differences in diversion among non-medical users of prescription opioids and sedatives. Am J Drug Alcohol Abus. 2020;46(3):340–7. Merlo LJ, Cummings SM, Cottler LB. Prescription drug diversion among substance-impaired pharmacists. Am J addictions. 2014;23(2):123–8. Fuseini AG, Afizu A, Yakubu YH, Nachinab G. Facilitators to the continuous abuse of tramadol among the youth: A qualitative study in Northern Ghana. Nurs open. 2019;6(4):1388–98. Dumbili EW, Gardner J, Degge HM, Hanewinkel R. Enhancement motivations for using prescription drugs among young adults in Nigeria. Int J Drug Policy. 2021;95:102995. Madukwe AU, Klein A. Tramadol as a pain relieving and physical work performance enhancement medication. Drugs Alcohol Today. 2020;20(1):27–35. Peprah P, Agyemang-Duah W, Appiah-Brempong E, Akwasi AG, Morgan AK. With tramadol, I ride like a Jaguar: a qualitative study of motivations for non-medical purpose tramadol use among commercial vehicle operators in Kumasi, Ghana. Subst Abuse Treat Prev Policy. 2020;15(1):49. Nelson EU. Addiction stigma and opioid use in chronic non-cancer pain management in Nigeria. Sociol Health Illn. 2024;46(3):457–72. Osei-Tutu S, Asante F, Agyemang-Duah W, Owusu-Sarpong OJ, Siaw LP, Gyasi RM. Patterns and social factors associated with non-prescription use of Tramadol: a cross-sectional study among youth in urban informal settlements in Ghana. J Health Popul Nutr. 2024;43(1):191. Mekonnen AB, Yizengaw G, M., Chanie Worku M. Prevalence of substandard, falsified, unlicensed and unregistered medicine and its associated factors in Africa: a systematic review. J Pharm Policy Pract. 2024;17(1):2375267. Amadi C, Tsui EK. How the quality of essential medicines is perceived and maintained through the pharmaceutical supply chain: A perspective from stakeholders in Nigeria. Res Social Administrative Pharm. 2019;15(11):1344–57. Ezenwa MO, Orjiakor TC, Ukwuma MC, Oraetue HI, Ude EN, Nweze T. Tracking opiate routes in Nigeria: identifying trafficking routes through dealers and users of tramadol and codeine. Bull Narc. 2019;62:27. Chacón JM. Producing liminal legality. Denver Univ Law Rev. 2014;92:709. Menjívar C. Liminal legality: Salvadoran and Guatemalan immigrants' lives in the United States. Am J Sociol. 2006;111(4):999–1037. Federal Ministry of Health. (2020). Essential medicine list, 7th Edition. https://cdn.who.int/media/docs/default-source/essential-medicines/national-essential-medicines-lists-(neml)/afro_neml/nigeria-2020.pdf?s World Health Organization. WHO Expert Committee on Drug Dependence: forty-first report. World Health Organization; 2019. BBC News Africa Eyes. (2019). Sweet sweet codeine. What happened next? https://www.bbc.co.uk/programmes/p07gbs1x United Nations Office on Drugs and Crime. Drug use in Nigeria, 2018. Vienna: UNODC; 2019. Nwafor CE, Okoye CFA, Nwankwo NI, Ugwu PC. It worked for my friend: non-medical use of tramadol among manual labourers in Anambra state, Nigeria. Drugs Habits Social Policy. 2023;24(4):285–95. Nelson EU, Alichie BO. Chronic pain and prescription opioid use among socially marginalized Nigerian women: Exploring supply channels and pathways to misuse. J Drug Issues. 2022;52(4):473–87. Brieger WR, Osamor PE, Salami KK, Oladepo O, Otusanya SA. Interactions between patent medicine vendors and customers in urban and rural Nigeria. Health Policy Plann. 2004;19(3):177–82. Baxerres C, Le Hesran JY. Where do pharmaceuticals on the market originate? An analysis of the informal drug supply in Cotonou, Benin. Soc Sci Med. 2011;73(8):1249–56. Hampshire K, Hamill H, Mariwah S, Owusu SA, Amoako-Sakyi D, Mshana G. (2025). Medicines in motion: An ethnographic exploration of the informal cross-border pharmaceutical trade in Africa. Soc Sci Med, 118327. Ojuroungbe S. (2023). Nigeria has over two million unregistered pharmaceutical outlets, says PSN. Punch Healthwise . 24 October 2023. https://healthwise.punchng.com/nigeria-has-over-two-million-unregistered-pharmaceutical-outlets-says-psn/ Beyeler N, Liu J, Sieverding M. (2015). A systematic review of the role of proprietary and patent medicine vendors in healthcare provision in Nigeria. PLoS ONE, 10(1), e0117165. Prach LM, Treleaven E, Isiguzo C, Liu J. Care-seeking at patent and proprietary medicine vendors in Nigeria. BMC Health Serv Res. 2015;15(1):231. Liu, J., Prach, L. M., Treleaven, E., Hansen, M., Anyanti, J., Jagha, T., … Isiguzo,C. (2016). The role of drug vendors in improving basic health-care services in Nigeria.Bulletin of the World Health Organization, 94(4), 267.. World Bank. (2020). World Population Stat 2017–2020. Geneva. https://populationstat.com/nigeria/uyo National Population Commission. National census report. Abuja: NPC; 2023. Nelson EU. Intersectional analysis of cannabis use, stigma and health among marginalized Nigerian women. Sociol Health Illn. 2021;43(3):660–77. Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004;24(2):105–12. Nelson EU, Odeigah OW, Dumbili EW. Tramadol regulation, illegal markets and consumption practices: Exploring frictions of drug control in Nigeria. Drugs Habits Social Policy. 2023;24(4):296–309. Coomber R, Moyle L. Beyond drug dealing: Developing and extending the concept of ‘social supply’of illicit drugs to ‘minimally commercial supply’. Drugs: Educ Prev policy. 2014;21(2):157–64. Nelson EU. Police crackdowns, structural violence and impact on the well-being of street cannabis users in a Nigerian city. Int J Drug Policy. 2018;54:114–22. Klantschnig G, Dele-Adedeji I. Opioid of the people: the moral economy of tramadol in Lagos. Politique africaine. 2021;163(3):85–105. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 22 Jan, 2026 Editor assigned by journal 21 Jan, 2026 Submission checks completed at journal 21 Jan, 2026 First submitted to journal 13 Jan, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8594332","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":574063710,"identity":"d932b06b-9ea8-42d9-9099-94d79822f7b4","order_by":0,"name":"Ediomo-Ubong 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consumption of pharmaceutical drugs, especially opioid analgesics, for purposes other than directed by a healthcare professional (i.e., ‘extra-medical consumption’ [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]) has increased globally [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] and is now considered a serious public health issue in many parts of the world. In many developed (western) countries, the prevalence of extra-medical consumption of pharmaceutical opioids now rivals the use of illegal drugs (e.g., cannabis). For example, in the United States, Canada and Australia, general population surveys have shown that prescription drugs (especially opioids) are among the top three most consumed drugs [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn many African and Middle Eastern countries, extra-medical consumption of tramadol, a synthetic opioid used to manage mild to severe pain in both acute and chronic cases, is now seen as a public health crisis [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Consequently, tramadol has been placed under control at national levels and is now classified as a prescribed drug in many countries [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Extra-medical pharmaceutical opioids consumption has been linked to diversion, defined as the redirection of drugs from legitimate to non-legitimate channels of supply and consumption [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Although an extensive research literature exists on pharmaceutical opioids diversion in the developed world (e.g., North America, Australia) [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], less is known about this problem in Africa. As a result, questions about the factors driving extra-medical consumption of pharmaceutical opioids on the continent remain unanswered. This study explores diversion of pharmaceutical opioids for extra-medical consumption in Nigeria.\u003c/p\u003e \u003cp\u003eThe international literature on diversion has shown that pharmaceutical opioids consumed extra-medically may be obtained directly from medical sources (i.e., from a pharmacy with a prescription) or from non-medical sources such as friends and relatives, street dealers and online markets [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Obtaining pharmaceutical opioids for extra-medical consumption usually involves diversion from legitimate channels through mechanisms such as doctor or pharmacy shopping, prescription forgery, over-prescribing by healthcare professionals, illegal sales, theft, online sales as well as sharing by friends and relatives [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The bulk of existing research on this topic comes from North America and Australia. There is a dearth of research on this subject from Africa, even in the context of rising levels of extra-medical pharmaceutical opioids consumption on the continent [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Consequently, the role of informal medicine vendors, who are major sources of medicines in many African countries, have not been captured in the current literature.\u003c/p\u003e \u003cp\u003eIn Africa, much of what is currently known about diversion of pharmaceutical opioids comes from reports produced by international organizations such as United Nations Office on Drugs and Crime (UNODC). These reports usually focus on pharmaceuticals trafficking and related organized crime [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], and not on retail-level supply to consumers. There is an emerging body of academic research on extra-medical pharmaceutical opioids consumption in Africa that explores the perspectives of consumers [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Nevertheless, most of these studies investigate motivations and other proximate factors influencing this consumption. Diversion of opioid analgesics for extra-medical use, and the role of informal medicine vendors, remain under-explored, even though research has implicated these vendors in other public health problem such as distribution of falsified and substandard drugs [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis paucity of research on the role of informal medicine vendors in the supply of pharmaceutical opioids for extra-medical consumption in Africa is also significant from the standpoint of health policy, especially because lack of policy framework to regulate informal medicine vendors has been identified as a key contributor to the distribution of substandard and falsified medications [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e], and research has indicated that these actors are also involved in the supply of prescribed drugs (including opioid analgesics) for extra-medical use [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Therefore, exploring the role of informal medicine suppliers in the supply of pharmaceutical opioids for extra-medical consumption could provide evidence and rationale for developing policies to regulate these providers and the medical products the supply. As a way of providing this evidence and rationale, this study explores diversion of pharmaceutical opioids for extra-medical consumers in Nigeria, especially the critical role of Patent and Proprietary Medicine Vendors (PPMVs).\u003c/p\u003e \u003cp\u003eOur exploration of the role of PPMVs is informed by the concept of ‘liminal legality’, which helps to highlight how the position of these vendors between the formal and informal markets (due to the lack of regulatory policy) makes them a primary source of pharmaceutical opioids for extra-medical consumption. Liminal legality, developed from socio-legal studies, describes the interstice or space between legality and illegality. It has been used to explore legal ambiguities and related negative consequences. For example, it has been used to explain how migrant populations are simultaneously positioned both inside and outside of the law due to their subjection to dual criminal and immigration systems [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. In this context, liminal legality ‘creates and recreates an excluded population and ensures its vulnerability and precariousness by blurring the boundaries of legality and illegality to create grey areas of incertitude’ [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn this study, we use liminal legality as a conceptual tool to explore how the failure to effectively regulate PPMVs, which makes it possible for them to participate in both legal and illegal markets, creates unique opportunities for individuals to access pharmaceutical opioids for extra-medical consumption while also providing a measure of protection from law enforcement. PPMVs occupy a position of liminality because while they are authorized by the state to sell over-the-counter drugs, are large part of this sector remains unregulated. This situation is crucial for understanding the importance of PPMVs in pharmaceutical opioids diversion to extra-medical consumption. This study thus develops a nuanced understanding of ‘diversion’ of pharmaceutical opioids consumption for extra-medical consumption through showing how health policy failures create opportunities for consumers to access these drugs.\u003c/p\u003e\n\u003ch3\u003ePharmaceuticals opioids and Patent and Proprietary Medicine Vendors in Nigeria\u003c/h3\u003e\n\u003cp\u003ePharmaceutical opioids such as tramadol and codeine are on Nigeria’s essential medicines list [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. They are used in the healthcare system to treat moderate to severe pain in both acute and chronic cases [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. The non-prescribed and non-regulated consumption of these drugs outside the healthcare system has generated significantly negative public reactions due to concerns about potential adverse effects. Public concern reached a crescendo in 2018, when the Nigerian government, in response to a documentary by the British Broadcasting Corporation (BBC), imposed a ban on the sale of Codeine and made access to higher dosages of Tramadol (i.e., above 100mg) illegal [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Nigeria has one of the highest prevalence of extra-medical pharmaceutical opioids consumption in Africa. Past-year use of pharmaceutical opioids (mainly tramadol, and to a lesser extent, codeine and morphine) was estimated at 4.7% (about 4.6\u0026nbsp;million people) in 2017, and pharmaceutical opioids was the second most used category of psychoactive drugs after cannabis [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. Studies have reported diverse reasons for extra-medical pharmaceutical opioids consumption in Nigeria, including to self-medicate pain and depressive symptoms, improve mood, and increase energy levels for work or sexual performance [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. Research has also identified some channels for the supply of pharmaceutical opioids for extra-medical consumption, including PPMVs [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e], although the processes of drugs diversion remain unknown.\u003c/p\u003e \u003cp\u003ePPMVs, i.e., ‘persons without formal pharmacy training selling orthodox pharmaceutical products on a retail basis for profit’ [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e], are a major informal healthcare provider in Nigeria and other countries in Africa [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e]. According to the Pharmaceutical Society of Nigeria (PCN), there are close to 2\u0026nbsp;million unlicensed patent medicine vendors operating in Nigeria, compared to only 25,000 registered medicine vendors, which includes community and hospital pharmacies [\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e]. PPMVs serve as the first point of care for the majority of Nigerians, especially in local communities [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e, \u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. They are authorized to sell a limited range of pre-packaged, over-the-counter drugs and medical products, but not to sell prescribed medications such as opioid analgesics and antibiotics [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. Although PPMVs are supposedly under the supervision of PCN, most operate without a license and routine monitoring [\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e]. PPMVs are often seen as a temporary measure to ensure better coverage of healthcare services and pending the expansion of the formal healthcare sector. Poor systems of registration, training and accreditation as well as weak monitoring of PPMVs has created an enabling environment for provision of substandard care and unlawful practices such as sales of prescribed drugs and of falsified and sub-standard medical products [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. These practices have made PPMVs a key target of campaigns aiming to stem the distribution of substandard and falsified drugs, often involving crackdowns on vendors by law enforcement agents.\u003c/p\u003e "},{"header":"Methods and materials","content":"\u003cp\u003eThis study is based on primary (qualitative) research on the supply and consumption of pharmaceutical opioids in Akwa Ibom state in Nigeria, which lasted between February and June 2019. Data gathering took place in two (2) cities in the state – Uyo, a large urban centre with an estimated population of 1,294,276 people [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e], and Ikot Ekpene, a relatively smaller city with a population estimated at 400,320 people [\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. Informed by findings from a national survey of drug use, which showed an increase in drug consumption (annual prevalence estimated at 12.5% of the population aged 15 to 64) in the state, particularly pharmaceutical opioids [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e], the study aimed to explore the supply and consumption of pharmaceutical opioids among youths (15–35 years according to the African Youth Charter of 2016).\u003c/p\u003e\u003cp\u003eStudy participants were regular high-risk consumers, defined as using high doses of opioids (250 to 500 milligrams) at least once in a week. We aimed to include female consumers in the sample through allocation of 30% quota. However, difficulties in recruiting female consumers due to stigmatization of women’s drug use [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e], resulted in participants being all male. In Uyo, participants (n = 23) were recruited purposefully through a drop-in centre (DIC) for people who use drugs (PWUD) operated by a local Non-Governmental Organization to which one of the authors is affiliated. Attendees of the DIC were informed about the research by the social workers and those who indicated interest were referred for screening to determine eligibility. Recruitment in Ikot Ekpene was through snowball sampling based on contacts developed in previous research (n = 16). This brought the total number of participants to thirty-nine (n = 39).\u003c/p\u003e\u003cp\u003eEligible participants were aged 23–35 years (mean age of 29). Although none was married, the majority had regular heterosexual partners (Uyo – 17, Ikot Ekpene – 11). The sample from Uyo had diverse occupations, including artisans, unskilled public and private sector employees, small-scale business owners and students. The majority of participants from Ikot Ekpene were students, with a few artisans and unemployed persons. All participants were of low socioeconomic status and represented high-risk consumers based on their drug use patterns (polysubstance use, heavy and regular use). Semi-structured interviews lasting 45 to 60 minutes were conducted in both locations, addressing different topics. The ‘unit of analysis’ for the present study was sources of pharmaceutical opioids for extra-medical use. Interviews took place at a convenient time and location for participants (e.g., the DIC, canteen, community meeting hall), to make them feel safe. Participants were given adequate information about the research, and they gave verbal consent to participate in interviews. Recruitment and data collection continued until data saturation was reached (i.e., further interviews did not produce new insights relevant to the research questions). Each participant received a five hundred-naira (US\u003cspan\u003e$\u003c/span\u003e 0.31 at the time of writing) recharge voucher appreciation gift. Interviews were recorded digitally with participants’ consent, transcribed professionally, and checked to ensure accuracy.\u003c/p\u003e\u003cp\u003eAnalysis of the data was informed by the thematic approach developed by Graneheim and Lundman [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e], which involves the development of themes and categories through the identification, condensation and abstraction of ‘meaning unit’. Transcripts were read repeatedly to gain an understanding of the content area (i.e., sources of pharmaceutical opioids supply for extra-medical use). Thereafter, meaning units (i.e., words, sentences, and paragraphs with common meanings or shared content and context) were identified. Further, these units were condensed, grouped and assigned codes (e.g., ‘purchase from vendors’). Codes were then sorted into categories (e.g., ‘primary source’) based on manifest content. Finally, themes (e.g., ‘patent medicine vendors’) and sub-themes (e.g., ‘relative legitimacy’, ‘covert supply’) were developed to capture the underlying meanings. Liminal legality was used as a conceptual tool to interpret findings on the role of PPMVs in pharmaceutical opioids supply for extra-medical consumption. Verbatim quotations are used for illustration Identifying information are excluded on ethical grounds. The study was approved by health research ethics committee of the University of Uyo Teaching Hospital, Uyo, Akwa Ibom state, Nigeria.\u003c/p\u003e"},{"header":"Findings","content":"\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSources of supply\u003c/h2\u003e \u003cp\u003eAccounts revealed three sources of pharmaceutical opioids for extra-medical consumption, namely PPMVs, street drug dealers and social supply through friends and family members. Participants highlighted interconnections between these sources, where street drug dealers and social suppliers obtain primary supply of the drugs from PPMVs, thus making the latter the significant source of supply.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePatent and proprietary medicine vendors\u003c/h3\u003e\n\u003cp\u003eAs explained earlier, although PPMVs are recognized as medicine suppliers by the Nigerian government, they are not effectively regulated. This leaves them in a regulatory limbo that creates room for illegal practices. Accounts showed that this situation places them in a unique position as a source of pharmaceutical opioids for extra-medical consumers. For example, accounts highlighted that in addition to selling over-the-counter medications (which they are authorized to sell), most PPMVs also sell prescribed drugs, including and especially to extra-medical consumers (which they are not authorized to sell), thus engaging in illegal practices alongside legal ones. A participant stated:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe truth is that most of these chemist stores (i.e., PPMVs), they sell drugs that people can take for sickness and also sell the ones that people take to get high. They are not allowed to sell those ones (i.e., psychoactive prescription drugs), but they hide and sell it. So, they also do illegal stuff even though they are like legit business. It is like a very common thing.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThe sentence \u0026lsquo;they also do illegal stuff even though they are like legit business\u0026rsquo; shows the illegal practices that arises from the liminal legality or regulatory limbo in which PPMVs exist. Participants described PPMVs as the most important source of pharmaceutical opioids for extra-medical consumption, with some claiming that most extra-medical consumers of these drugs obtain them from PPMVs. Even the participants themselves reported obtaining the drugs from these vendors. For example, a participant reported that he buys tramadol without prescription from the PPMV store in his neighbourhood (\u0026lsquo;\u0026hellip;I buy it at the chemist close to my place\u0026rsquo;). Another participant noted:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eMy own I buy it (tramadol) from the chemist store that is close to where I live. I don\u0026rsquo;t go far away to look for it because the chemist there sells it. Like I know he sells it because I am a customer (i.e., regular client). Whenever I want to take it, I just go there and buy as much as I need.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThe phrase \u0026lsquo;as much as I need\u0026rsquo; indicates that this is an unapproved, non-prescribed supply. A major reason given by participants for buying their pharmaceutical opioids from PPMVs was the relative ease of purchasing these drugs from these vendors when compared to other sources of supply (e.g. street drug dealers). Ease in purchasing pharmaceutical opioids from PPMVs was linked to their liminal legality. For example, participants explained that buying pharmaceutical opioids from PPMVs was easier because one could pretend to be purchasing over-the-counter drugs. The authorization to sell over-the-counter drugs serves as a pretext for covert sales of pharmaceutical opioids. On the other hand, buying from a street dealer is riskier due to the absence of such a pretext (\u0026lsquo;With the chemist you can say I wanted to buy Aspirin [over-the-counter medication], but on the streets it is very difficult\u0026rsquo;). Further to this, purchasing pharmaceutical opioids from PPMVs was said to be easier to explain as being meant for medical purposes (e.g., pain treatment) compared to purchasing on the streets (\u0026lsquo;It is easy to say that you want to take it for sickness, if you bought from chemist, though they are not allowed to sell it\u0026rsquo;). In this context, authorization to sell some types of drugs offers a leeway for negotiating law enforcement and evading potentially negative outcomes.\u003c/p\u003e \u003cp\u003eAdditionally, the liminal legality of PPMVs provided a measure of protection from law enforcement, although participants acknowledged that safety was never fully guaranteed. Speaking from the standpoint of personal experience, participants described how they used over-the-counter drugs as a pretext to covertly buy pharmaceutical opioids from PPMVs (\u0026lsquo;I will pretend that I want to buy like other drugs, but when I am alone with the person selling, I will then buy what I wanted\u0026rsquo;). This strategy reduced the risk of being identified as an extra-medical consumer. A participant stated:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe only place you will be able to buy it confidentially (secretly) is at the chemist store. Because at the chemist people will think you are buying normal paracetamol. They will not know that you are looking for like illegal stuff. Even the chemist seller will tell you no problem. He will give it to you when the other people have all gone, and you will go your way.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eIn addition to the relative protection linked to the pretext of buying over-the-counter drugs, being able to buy pharmaceutical opioids for this consumption without the demand to present a prescription note was also identified as an additional advantage that further made PPMVs a preferred source of pharmaceutical opioids for extra-medical consumers. A participant noted:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eMost chemists will not ask for a paper from the doctor (i.e. prescription note) before they sale like tramadol to you. They are really into the business, you get it. They sell to those who want it; whoever wants it, even if they are taking it to get high. That is why most people who use tramadol to get high go there.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eNevertheless, the liminal legality that create opportunities for easier and relatively safer purchase of pharmaceutical opioids also mediates unique risks for law enforcement interdiction. This risk exists because of the targeting of PPMVs by law enforcement as part of a campaign against falsified and sub-standard drugs (\u0026lsquo;The chemist stores [i.e., PPMVs] are being hunted by police for selling fake drugs\u0026rsquo;). In attempt to mitigate this risk, most PPMVs sell prescribed drugs (such as tramadol) covertly to extra-medical consumers. A participant stated:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eTramadol is being sold in the chemists. But when you want to go and buy, you won\u0026rsquo;t just bash in like there are many people there trying to buy drugs and you now open up and say I want to buy tramadol. No, the pharmacists or the chemists will not sell for you because he knows he is not allowed to sell it. So, you will observe the environment well; If the chemist person (i.e., PPMV) is alone you will ask if he has tramadol. The chemist will look at who is asking for this drug again, and before you know, he will now sell it to him.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eAs seen in the above quote, unauthorized distribution of pharmaceutical opioids (such as selling without medical prescription) establishes a context of risk for interdiction by law enforcement agents. Both sellers and consumers were concerned about the risk of being detected by law enforcement officials. To conceal such transactions, PPMVs were said to adopt different strategies, including carefully monitoring the surroundings for signs of police presence (as indicated in the above quote). Interviews also revealed that PPMVs only sell pharmaceutical opioids to regular buyers, another risk navigation strategy that provides a further layer of protection against law enforcement interdiction. A participant commented based on his experience purchasing tramadol from PPMVs:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026hellip; I tell them that I want to use it for groove (i.e. for fun). When I tell them like that, they will sell it for me. Because it is a place that I know. Several chemist shops that I know. They don\u0026rsquo;t put it on the shelf; they hide it inside. If you want it, they will look at you. If you are their core customer (i.e. regular buyer), they will sell it for you. But if it is your first time of coming to buy, they will never sell it for you.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eOverall, the accounts presented in this section shows that the liminal legality of PPMVs enables extra-medical consumers to purchase pharmaceutical opioids in the pretext of buying over-the-counter drugs as well as navigate the risk of law enforcement interdiction. These advantages make PPMVs the preferred source of these drugs for consumers.\u003c/p\u003e\n\u003ch3\u003eStreet drug dealers\u003c/h3\u003e\n\u003cp\u003eApart from PPMVs, pharmaceutical opioids consumed extra-medically could also be purchased from street drug dealers. Although these dealers usually sell illegal drugs (such as cannabis and heroin), research has shown that some also sell pharmaceutical drugs, including opioids analgesics, either solely or alongside illegal drugs [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. A participant stated:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eI have bought it (tramadol) from the drug dealers on the streets before. In fact, I have bought many times from the street dealers. That is, the street dealers are all these boys who sell hard drugs on the streets to make money. They sell like weed (i.e., cannabis) and Thai (i.e., street heroin). They also sell Tram (i.e., tramadol) and Penta (i.e., Pentazocine).\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eYet, the involvement of street drug dealers in illegal supply of pharmaceutical opioids to extra-medical consumers was said to be limited because only a few dealers sell these drugs (\u0026lsquo;They [street dealers] do sell [pharmaceutical opioids], but only one or two here and there\u0026rsquo;; \u0026lsquo;Only like few street barons will sell tramadol and stuff like that\u0026hellip;\u0026rsquo;). The reason many street drug dealers do not sell pharmaceutical opioids was the bulkiness of these drugs, compared to illegal drugs, which makes concealment difficult (\u0026lsquo;They [i.e. street drug dealers] cannot hide it like weed, that is why [they don\u0026rsquo;t sell it often]\u0026rsquo;). It was also observed that most consumers prefer to purchase from PPMVs, which made selling pharmaceutical opioids less rewarding for street drug dealers (\u0026lsquo;The chemists are the real place for getting those ones\u0026rsquo;; \u0026lsquo;Most people who take it will always go to the chemist\u0026rsquo;).\u003c/p\u003e \u003cp\u003eFurthermore, most street drug dealers who sell prescription drugs did so irregularly due to difficulty obtaining bulk supply (\u0026lsquo;They always have like the hard [illegal] drugs, but the tramadol they don\u0026rsquo;t have all the time\u0026hellip;\u0026rsquo;). Those who regularly sell pharmaceutical drugs on the streets were said to be intermediaries for PPMVs (\u0026lsquo;Some of them are working for the chemists\u0026rsquo;).\u003c/p\u003e \u003cp\u003eAccounts emphasized linkages between street dealers who sell pharmaceutical opioids and PPMVs, where the former depends on the latter for supply. This linkage demonstrates the primacy of PPMVs in illegal supply of pharmaceutical opioids to extra-medical consumers. A participant noted:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026hellip; the area boys at the park buy [tramadol] from the chemists to sell and make some money for themselves. They buy from the chemists to sell and make pocket money. Sometimes these street boys also they used to take it around and sell the same way people sell marijuana. They buy it from chemist and take it around to sell to their own customers [i.e. those who regularly buy illegal drugs from them].\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThis, and similar accounts, demonstrate that PPMVs occupy an important position in the illegal retail market for pharmaceutical drugs such as opioids, with street drug dealers sometimes serving as their intermediaries.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eSocial supply\u003c/h2\u003e \u003cp\u003eAccounts revealed that consumers also accessed pharmaceutical opioids for extra-medical consumption through friends and relations, a distribution process known in the literature on illegal drugs as \u0026lsquo;social supply\u0026rsquo; [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e]. Most participants considered this an unreliable source since friends and relations do not always have the drugs. Similar to street drug market, social supply was linked to PPMVs because those who supplied the drugs to others usually purchase them from PPMVs. According to a participant:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u0026hellip;it was my friend that gave it to me. Like he used to take it when he wants to work. He used to share it with me, like give me some tablets. So, after the whole thing I now asked him what he gave to me and he said it was tramadol. I went on to ask him where he got it and he said he bought it at the chemist. He used to buy much, and he will give me some to also take.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eRelative risk of law enforcement interdiction\u003c/h3\u003e\n\u003cp\u003e Interviews also explored the risk of law enforcement interdiction associated with obtaining pharmaceutical opioids from these different sources. Obtaining the drugs from street dealers was seen as being associated with a greater risk of interdiction by law enforcement agents.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eGoing to buy stuff from the dealer on the streets is always going to be more dangerous because police is always patrolling\u0026hellip; You already know it is like fifty-fifty (i.e., there is a fair chance that the individual could be arrested). Those who take Tram know that buying on the streets is not safe. They are worried about meeting police.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eOn the other hand, and as previously explained, PPMVs were considered a relatively safer source of supply mainly because consumers could purchase pharmaceutical opioids in the pretext of purchasing over-the-counter drugs. A participant opined:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThe chemist is better (than street drug dealers) because you will be like a regular customer who wants to buy medicines. Other people who see you will think that you want to buy the regular drugs. It is not like on the streets that everyone who sees you giving money to a dealer at the corner somewhere will know what you are doing.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eFurthermore, PPMVs were said to be highly discrete when selling prescribed drugs such as pharmaceutical opioids (\u0026lsquo;They are very smart; they will sell in a coded way, you understand\u0026rsquo;). Additionally, some consumers were said to carry falsified prescription notes, which they present to law enforcement officers in the event of encountering the later. A participant recounted a friend\u0026rsquo;s experience:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eOne of my friends was involved when he bought (Tramadol) at night... So, as he was leaving the chemist, police arrested him and when they searched him, they collected the drugs. He now talked to them and used a fake prescription to convince them \u0026hellip; He told them that the drugs were prescribed by the doctor. So, when the police saw the doctor\u0026rsquo;s report (prescription note) they couldn\u0026rsquo;t detain him.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eIn this case, the consumer was let go because he presented a (falsified) prescription note. It is most unlikely that this note would have been honoured if he purchased the drug from a street dealer (in the words of the participant, \u0026lsquo;they [police]would not have listened to him if they caught him buying from the baron\u0026rsquo;). This example illustrates how liminal legality creates \u0026lsquo;grey areas of incertitude\u0026rsquo; for law enforcement in relation to sells of prescribed drugs.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe findings presented have shown that pharmaceutical opioids consumed extra-medically in the study setting are obtained from different sources - PPMVs, street drug dealers and social supply through friends and colleagues. Past research has reported on the roles of street drug dealers as well as friends and relations in illegal supply of pharmaceutical opioids for extra-medical consumption [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The present study corroborates these past works through identifying street drug dealers and social supply as sources of pharmaceutical opioids for extra-medical consumers. Yet, as the accounts presented reveal, these sources are secondary to PPMVs. PPMVs feature as the primary source of pharmaceutical opioids because they offer an opportunity for accessing these drugs with relative ease through allowing consumers to pretend to be purchasing over-the-counter drugs, a dynamic that also provides a measure of protection from law enforcement. The role of PPMVs in the supply of prescribed drugs for extra-medical consumption highlights a deeper problem of ineffective regulatory policy and its contribution to this growing public health problem in Nigeria. Past works have implicated health policy issues such as over-prescription and inadequate access restrictions (e.g. absence of prescription monitoring systems) in the diversion of pharmaceutical opioids to extra-medical consumption [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The present study adds further insight to this discussion based on research in Africa. The study shows how the lack of effective regulation of informal medicine vendors enables the supply of prescribed drugs for non-prescribed consumption since consumers can access these drugs from PPMVs with relative ease and safety.\u003c/p\u003e \u003cp\u003eThe findings help to develop a nuanced understanding of the concept of \u0026lsquo;diversion\u0026rsquo; as an explanation for the supply of pharmaceutical opioids for extra-medical consumption in the Nigerian context. This is achieved through the concept of \u0026lsquo;liminal legality\u0026rsquo; [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e], which helps to further foreground the role of health policy failures in this growing problem. Liminal legality enables a nuanced understanding of the role of health policy issues (i.e. ineffective regulation of informal medicine suppliers) in illegal supply of pharmaceutical opioids for extra-medical consumption. As demonstrated by the accounts canvassed, PPMVs constitute a category of providers with \u0026lsquo;liminal legality\u0026rsquo; in that while they are recognized by the Nigerian state as medicine suppliers (and thus part of the health workforce), they are not effectively regulated in terms of accreditation, licensing, training and monitoring. They are authorized to sell over-the-counter drugs [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e], which makes them a part of the system of medicines supply. Yet, lack of effective regulation of their activities creates opportunities for a parallel supply of prescribed drugs (such as pharmaceutical opioids), which they are not authorized to sell. Thus, PPMVs operate within a regulatory limbo that blurs the line between legal and illegal supply and creates \u0026lsquo;grey areas of incertitude\u0026rsquo; [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e] in law enforcement responses. These \u0026lsquo;grey areas\u0026rsquo; may be seen in a participant\u0026rsquo;s account of how law enforcement officials honoured a falsified prescription note he used to purchase tramadol from a PPMV. Most importantly, the ability to purchase pharmaceutical opioids from PPMVs in the pretext of buying over-the-counter drugs shows how regulatory failure creates uncertainty for law enforcement agents.\u003c/p\u003e \u003cp\u003eAs a conceptual tool, liminal legality also helps to understand how both PPMVs and consumers navigate the risk of drug enforcement. Study participants highlighted the risk of interdiction by enforcement officers associated with purchasing pharmaceutical opioids from PPMVs. This risk arises from potential crackdown on PPMVs aimed at checking sales of falsified and sub-standard medical products as well as unauthorized sales of prescribed drugs [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. This means that while PPMVs may not face the same level of risk of interdiction as street drug dealers, since they are authorized to sale over-the-counter drugs, their violation of regulations on prescribed drugs and sales of falsified and substandard medical products establishes a context of risk for interdiction by enforcement officers. In this respect, and as the participants\u0026rsquo; accounts has shown, the liminal legality of PPMVs provide opportunities for navigating this risk of interdiction, which are not available to those who purchase these drugs from street drug dealers. For example, the fact that, compared to street drug dealers, PPMVs are authorized to sale some drugs potentially lessen the intensity of enforcement and, as the accounts have shown, made enforcement officers begrudgingly honor falsified prescription notes, in contrast to the kind of violent crackdowns documented in relation to street market enforcement [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]. The relatively low level of risk associated with purchasing pharmaceutical opioids from PPMVs, along with the opportunities it offers for navigating law enforcement, further elevates the appeal of these vendors to extra-medical consumers.\u003c/p\u003e \u003cp\u003eCurrently, state response to extra-medical consumption of pharmaceutical opioids in Nigeria reflects a long-standing emphasis on enforcement-based approaches in drug policy. This includes stricter control on availability and dispensing of these drugs and intensive policing of sellers (especially street drug dealers) and consumers [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e]. This approach has had significant unintended consequences, including further limiting access to pharmaceutical opioids for healthcare purposes such as pain management [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e], without effectively preventing or reducing extra-medical consumption. This study highlights the importance of addressing the systemic drivers of this problem, including through developing a policy framework for the regulation of PPMVs. Effective regulation is important because PPMVs occupy the second tier in the medicine distribution system in Nigeria (after hospitals and pharmacies). They play an important role in ensuring access to medicines in Nigeria, serving as the first point of care for most people especially in local communities [\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]. Nevertheless, the lack of effective governance of these providers (and the informal healthcare sector more broadly) has created conducive (maybe even enabling) environment for the participation of some PPMVs in illegal activities such as selling prescribed drugs, which is outside their remit. Developing a policy framework to effectively regulate PPMVs could, therefore, help to mitigate illegal market activities without undermining their role in ensuring access to drugs for the Nigerian populace.\u003c/p\u003e \u003cp\u003eEffective regulation of PPMVs involves developing and implementing efficient and adaptable systems for training and accreditation along with establishing viable mechanisms for monitoring and enforcement to ensure compliance with existing regulations. Monitoring and enforcement should be based on a collaborative approach involving partnerships between relevant government agencies (e.g. National Food and Drug Administration and Control [NAFDAC], Pharmacists Council of Nigeria [PCN], law enforcement agencies) and trade associations (such as PPMVs associations at the national, state and local government levels) to ensure effectiveness. On the other hand, the regulation of medical products should involve enforcing regulations on sales of prescribed drugs by PPMVs as well as adoption of effective measures (such as health insurance, subsidy programmes) to improve the accessibility and affordability of prescribed drugs (such as pharmaceutical opioids) for medical purposes through approved channels (e.g. pharmacies). Measures to prevent supply through secondary sources (street drug dealers, social supply), including various supply and demand reduction measures (e.g. targeting of largescale trafficking and improving access to treatment for opioid use disorder), should be implemented complementarily to interventions focusing on the core systemic (policy-related) factors fueling the diversion of pharmaceutical opioids for extra-medical consumption.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eLimitations and suggestions for further research\u003c/h2\u003e \u003cp\u003eThe study has some limitations, which should be considered when interpreting the findings. First, the study is based on qualitative interviews conducted in two communities, which means that the findings are not generalizable to other locations. Nevertheless, past research has highlighted the role of informal medicine vendors, including PPMVs, in the diversion of prescription drugs for extra-medical consumption [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e], which means that the findings have a measure of confirmability. Secondly, it is based on the views of consumers alone. While this does not undermine the credibility of the findings, it does imply that further research should include the views of other actors (such as PPMVs, policy makers/regulatory agents and law enforcement officers) to develop a better understanding of these diversion processes.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study has demonstrated that the diversion of pharmaceutical opioids for extra-medical consumption, though involving different sources, revolves around the unique opportunities and protection arising from the liminal legality of PPMVs within Nigeria\u0026rsquo;s health system. It also highlights the limitations of current government responses as well as the importance of a policy-focused approach to addressing this problem. Summarily, the study offers preliminary findings that implicates the lack of effective regulatory policy in the rising problem of extra-medical consumption of pharmaceutical opioids in Nigeria, thus laying the groundwork for further research. Specifically, it makes two important contributions that would be relevant for research and action on diversion of pharmaceutical opioids for extra-medical consumption. First, it demonstrates the utility of liminal legality as a conceptual tool for understanding the role of policy-related factors in the supply of pharmaceutical opioids for such consumption. This concept has helped to highlight how inadequate policy framework for regulating the informal medicine vendors and related medical products fuels the supply of pharmaceutical opioids for extra-medical consumption parallel to supply for medical purposes. Secondly, and based on the above, the study points to the need to develop a policy framework to effectively regulate these vendors.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eEdiomo-Ubong Nelson - conceptualization, research design, data collection, data analysis, writing, revisionUchenna Nnam Macpherson - data analysis, writing, revision\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data used is not publicly due to ethical considerations.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLarance B, Degenhardt L, Lintzeris N, Winstock A, Mattick R. Definitions related to the use of pharmaceutical opioids: Extramedical use, diversion, non-adherence and aberrant medication‐related behaviours. Drug Alcohol Rev. 2011;30(3):236\u0026ndash;45.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eUnited Nations Office on Drugs and Crime. 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Politique africaine. 2021;163(3):85\u0026ndash;105.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pubh","sideBox":"Learn more about [BMC Public Health](http://bmcpublichealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pubh/default.aspx","title":"BMC Public Health","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Africa, diversion, health system, liminal legality, pharmaceutical opioids, health policy","lastPublishedDoi":"10.21203/rs.3.rs-8594332/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8594332/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground:\u003c/h2\u003e \u003cp\u003estudies have identified various sources from which pharmaceutical opioids are obtained for extra-medical consumption. Yet, the role of informal medicine vendors remains relatively unknown. In Africa, there is a dearth of research on the supply of pharmaceutical opioids for extra-medical consumption, which could help to highlight the role of informal medicine vendors. Nevertheless, research has implicated these vendors in other public health problems such as distribution of falsified and substandard drugs.\u003c/p\u003e\u003ch2\u003eMethods:\u003c/h2\u003e \u003cp\u003eWe conducted in-depth interviews with young Nigerian men (aged 15\u0026ndash;35 years) who consume pharmaceutical opioids extra-medically (n\u0026thinsp;=\u0026thinsp;39) to explore the sources from which they obtain pharmaceutical opioids for this consumption and the factors that inform their choice for these sources. We used \u0026lsquo;liminal legality\u0026rsquo; as a conceptual tool to understand the role of Patent and Proprietary Medicine Vendors (PPMVs) in this supply process.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAccounts revealed that participants obtained pharmaceutical opioids for extra-medical consumption from Patent and Proprietary Medicine Vendors (PPMVs), street drug dealers and friends/relatives. PPMVs were identified as an important source of these drugs due to their liminal legality, which is a state of quasi-authorization by the Nigerian state. The position of PPMVs betwixt the formal and informal drug markets create unique opportunities for obtaining prescribed drugs (such as pharmaceutical opioids), which PPMVs are not authorized to sell, in the guise of selling/buying over-the-counter drugs. This affordance in turn made buying pharmaceutical opioids from PPMVs easier compared to street dealers and provided a measure of protection from law enforcement, which is unavailable in street drug markets. The dependence of most street drug dealers and other consumers (i.e. those who supply friends and relations) on PPMVs for primary supply further establishes these vendors as a primary source of pharmaceutical opioids for extra-medical consumption.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe study shows how the absence of effective policy framework to regulate the operations of PPMVs creates opportunities for accessing pharmaceutical opioids for extra-medical consumption. It calls for government regulation of these vendors through licensing, training and routine monitoring.\u003c/p\u003e","manuscriptTitle":"Diversion of pharmaceutical opioids for extra-medical consumption: the role of patent and proprietary medicine vendors in Nigeria ","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-14 07:12:24","doi":"10.21203/rs.3.rs-8594332/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-01-22T05:23:55+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-21T08:41:55+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-21T08:39:17+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Public Health","date":"2026-01-13T16:24:12+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pubh","sideBox":"Learn more about [BMC Public Health](http://bmcpublichealth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/pubh/default.aspx","title":"BMC Public Health","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a6dac31c-09b8-446e-a72a-397863dccfb3","owner":[],"postedDate":"January 14th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-02-09T15:25:07+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-14 07:12:24","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8594332","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8594332","identity":"rs-8594332","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}