Codeine-containing Medicines Research Articles

The misuse of codeine containing medicines: Perceptions and behaviours of qualified pharmacy professionals.

Pharmacy professionals working in community pharmacies frequently provide pharmacist-initiated therapy, including codeine-containing medicines. Codeine is an opioid with great potential for misuse, adding to the global opioid epidemic burden. Professional pharmacy personnel are the first intervention point in relation to management of codeine use. This study highlights the importance of pharmacy professionals' perceptions and behaviours in combatting the opioid epidemic. A descriptive cross-sectional study was conducted. Simple random sampling included pharmacy professionals in the metropolitan city of Johannesburg. An electronic questionnaire was distributed via e-mail and data analysed descriptively. Findings indicate that pharmacy personnel routinely ask patients about codeine use (n= 48; 53.9%), avoid dispensing over-the-counter (OTC) codeine as an initial treatment (n= 61; 69%) and express confidence to identify and manage codeine misuse (n= 69; 77.5%). Despite this, increased patient demands for OTC codeine (n= 69; 77.5%) were concerning, highlighting the ease of availability from internet sources (n= 76; 85.4%) and multiple pharmacies (n= 84; 94.4%). Apprehension about the lack of patient awareness on adverse health consequences (n= 66; 74.2%) and the risk of codeine dependence (n= 79; 88.8%) was expressed. Growing concern regarding availability and accessibility of codeine-containing medicines within the community pharmacy sector is highlighted. Adverse health consequences of codeine misuse and dependence are not understood by customers and the ineffective information provided by pharmacy personnel was highlighted as a concern.Contribution:The results of this study give insight to the influence of dispensing personnel's attitude towards the growing challenges with respect to codeine containing medication abuse.

Substance misuse: raising awareness, new referral pathway and developing a new flowchart for sale of codeine-containing medicines in the community pharmacy

Substance misuse: raising awareness, new referral pathway and developing a new flowchart for sale of codeine-containing medicines in the community pharmacy

Medications Containing Low-Dose Codeine for the Treatment of Pain and Coughs


 Codeine and codeine-containing medicines are used to treat people experiencing pain or cough symptoms. Whereas most products containing codeine require a prescription in Canada, some jurisdictions permit over-the-counter sales of products containing low doses of codeine mixed with other non-narcotic medicinal ingredients.
 Three overviews of reviews and 13 systematic reviews of variable methodological quality failed to identify studies on the effectiveness of low-dose codeine (i.e., 8 mg of codeine per tablet or 20 mg of codeine per 30 mL in liquid products) for the treatment of pain or coughs.
 There is a lack of evidence on the clinical effectiveness of oral analgesics and oral antitussives containing low doses of codeine.

The impact of codeine upscheduling on overdoses, Emergency Department presentations and mortality in Victoria, Australia

Background and aimsPrior to February 2018, codeine was available over-the-counter (OTC) in Australia as a pharmacist-only medicine (Schedule 3) in low-strength formulations when in combination with simple analgesics. In February 2018, The Advisory Committee on Medicines Scheduling (ACMS) upscheduled codeine-containing medicines (CCM) to Schedule 4 (prescription-only medicine). This study aimed to determine the impact of upscheduling on prescriptions, overdoses and deaths. MethodsThis study used interrupted time series analysis, a quasi-experimental design, to retrospectively evaluate the impact of upscheduling on overdose poisoning calls to the Victorian Poisons Information Centre (VPIC), Emergency Department (ED) presentations to Austin Health, and deaths reported to the Victorian Coroner from 1 January 2013–31 December 2019. ResultsThere was a significant reduction in the trend of high-strength codeine poisoning calls by 0.36 (P = 0.03, 95 % CI = [−0.69, −0.04]). Low-strength codeine poisoning calls to the VPIC reduced by 13.31 (P <0.001, 95 % CI = [−16.80, 9.82]]) calls in February 2018, followed by continued reduction of 0.12 calls per month. High-strength codeine overdose ED presentations reduced in the first quarter of 2018 by 3.72 presentations (P = 0.004, 95 % CI = [−6.13, −1.31]). Low-strength codeine overdose ED presentations after the first quarter of 2018 by 0.33 (P = 0.03, 95 % CI = [−0.63, −0.03]) presentations per month. Codeine-related deaths reduced by 7.19 (P < 0.001, 95 % CI = [−9.44, −4.94]) deaths in February 2018. ConclusionsCodeine upscheduling to prescription-only medicine has reduced codeine-related poisoning calls, overdoses and unnatural death in Victoria.

Codeine-containing medicines to be reclassified in NZ

Codeine-containing medicines to be reclassified in NZ

‘It’s like making your own alcohol at home’: Factors influencing adolescent use of over-thecounter cough syrup

Background. Adolescents are increasingly experimenting with new ‘craze drugs’, including over-the-counter cough medicine (OTCCM). However, there is limited empirical evidence regarding South African (SA) adolescents’ use of codeine-containing medicines, especially OTCCMs. Objective. To describe SA adolescents’ views of OTCCM misuse, and the factors that may promote its use. Methods. The research adopted an exploratory qualitative design. Focus group discussions ( N =24) were conducted with 144 learners between 14 and 17 years old in two township communities in SA. Data were analysed thematically supported by Atlas.ti. Results. Three core themes emerged from the analysis, namely knowledge of OTCCM use; factors that influence OTCCM use; and effects of OTCCM use. Participants reported that young people use OTCCM recreationally. Four main factors were noted to influence OTCCM misuse in their communities, namely accessibility, affordability, social influences and the clandestine appeal of cough medicine. Adolescents also said that OTCCM had similar euphoric effects to alcohol or marijuana, but could not readily describe any negative impact. Conclusion. This exploratory study with adolescent participants provides contextualised empirical evidence about OTCCM. The findings call for the South African Health Products Regulatory Authority (SAHPRA) to promptly consider pending regulations on OTC codeinecontaining medication and demands increased awareness of codeine misuse in communities.

Identification of factors influencing tampering of codeine-containing medicines in England: a qualitative study

BackgroundTampering of psychoactive medicines presents challenges to regulation and public health. However, little is currently known about what influences the decisions to treat codeine-containing medicines (CCM) with cold water extraction (CWE) from the perspective of individuals employing these techniques. The article identifies factors influencing utilisation of CWE to separate codeine from compounded analgesics, such as paracetamol and ibuprofen, found in CCM.MethodsPurposive sampling of 27 participants residing in England who took part in a qualitative interview. Of these, 14 individuals (11 males and 3 females) reported tampering of psychoactive medicines, and the relevant transcripts were included in the analyses for the study. Participants were recruited from one addiction treatment service and from an online survey. The mean age of the participants was 31.5 years (range = 18–42 years). Qualitative data analysis followed the processes of iterative categorization (IC). The codes ‘harm reduction’, ‘information sources’ and ‘changes on the drug markets’ were grouped and summarised. The coding of the data was done in a Microsoft® Word document.ResultsTwo groups of participants were identified in the data analysis: (i) individuals who used CCM (n = 5), and (ii) individuals who used CCM and heroin (n = 9). Participants in both groups used CWE due to concerns of paracetamol overdose from the use of excessive dosages of CCM. For both of them, information obtained from the internet encouraged the use of CWE. Participants using CCM described how the many steps involved in conducting CWE, including sourcing codeine boxes from pharmacies (over the counter), presented a barrier against using CWE. Participants using CCM and heroin explained how reduced availability in the local heroin supply influenced utilisation of CWE techniques to maintain their use of opioids and avoid withdrawal. Withdrawal symptoms and cravings outweighed the concerns about the quality of the extracted codeine mixtures in this participant group, especially the ability of CWE to remove paracetamol and tablet fillers.ConclusionsUtilisation of CWE of codeine was influenced by several factors including drug market supply, the availability of detailed information on the internet about CWE and restrictions on codeine sourcing in pharmacies. Risks identified with CWE include consumption of unknown doses of paracetamol if the CWE techniques are not used correctly. Attempts at extracting codeine from CCM should be considered in risk assessments of opioid medicines.

Designing Effective Warnings about Addiction on the Patient Information Leaflet of Over-the-Counter Codeine Sold in England to University Students.

(1) Background: The harm of misusing over-the-counter (OTC) codeine-containing medicines among university students in England is being increasingly recognized. Based on English university students, this paper aims to study the importance of information design on information communication, explore methods for effective warning design, and investigate university students’ perception of OTC codeine. (2) Methods: The effective warning design is addressed through case studies, answering correctness by the heat map generated from the eye-tracking experiment (ETE), and the total time spent on the tasks. User perceptions are made though online surveys. (3) Results: Information design significantly affects the way user processes information. Therefore, two emphasized warnings displayed in the headline, and the “possible side effect (PSE)” sections and warning signs of addiction presented under the PSE are suggested as effective ways to display warnings. For students’ perception of OTC codeine, 80% of university students are unfamiliar with the substance. After reading the patient information leaflets (PILs), 47% recommended tight regulation on codeine. (4) Conclusions: The misuse of OTC codeine could be a potential problem among English university students. The design of the PIL significantly influences the chance of unintentional medicine misuse. The display of warnings on the PILs of OTC codeine should be redesigned for better understanding.

Use of analgesics following rescheduling of codeine in Australia: An interrupted time series analysis in the veteran population

BackgroundThe Australian medicines regulator, the Therapeutic Goods Administration (TGA), rescheduled all codeine-containing medicines to be available only on prescription on 1 February 2018. This study was conducted to determine whether use of analgesics changed following codeine re-scheduling to prescription only status, and whether there was a change in the use of codeine preparations and a therapeutic shift to stronger opioids or other analgesics in the Australian veteran population following the change. MethodsInterrupted time series analysis using Repatriation Pharmaceutical Benefits Scheme (RPBS) claims data from the Australian Government Department of Veterans’ Affairs (DVA) for clients with dispensing of opioid and non-opioid analgesics between January 2015 and April 2019. Trends in the monthly rate of analgesic dispensings (opioid and non-opioid) were compared for the period between January 2015 and January 2018 with the period February 2018 to April 2019. ResultsParacetamol with codeine 8mg was the only analgesic with an increased rate of dispensing following the February 2018 codeine scheduling changes. Prior to codeine re-scheduling, the rate of dispensing of paracetamol with codeine 8mg was decreasing by 0.9% each month. Immediately after the scheduling changes, dispensing of paracetamol with codeine 8mg increased by 45% (95%CI=1.282-1.676, p<0.001) and in the fifteen month period thereafter (February 2018 to April 2019), the rate of dispensing increased by 4% each month (95%CI=1.027-1.054, p<0.001). Therapeutic shift from over-the-counter codeine products to other opioids was not observed, with no increase in the rate of dispensing of any of the other opioid (or non-opioid) analgesics following the codeine scheduling changes. ConclusionA significant increase in prescription use of paracetamol with codeine 8mg was observed after the February 2018 codeine re-scheduling. Therapeutic shift to stronger opioid analgesics was not observed in the study population.

Advertising of Over-the-Counter Codeine-Containing Medicines in the EU: Differences in the Regulation of Advertising Between Member States

The availability of over-the-counter (OTC) medicines containing codeine has generated worldwide debate with increased focus on its safe use. Medicine agencies across the European Union (EU) have responded to the public health concern by placing restrictions and warnings on codeine medicines sold OTC in High Street and internet pharmacies. These restrictions include direct-to-consumer advertising; however, there are few published studies examining conditions of advertising across member states. A review of the conditions of advertising was conducted by accessing information pertaining to each medicine’s regulatory agency allowing the sale of codeine in the EU. Each agency was asked to respond to three topics: (1) level and type of restrictions placed on all forms of direct-to-consumer advertising of OTC medicines containing codeine; (2) labelling criteria on packaging including indication related to the risk of addiction and any other patient information specific to codeine; and (3) complaints received by the medicines agency related to direct consumer advertising of OTC medicines containing codeine. Data were collated and tabulated in Excel to demonstrate its position on OTC codeine advertising. In the EU, 12 countries allow the sale of OTC codeine, while 16 do not. Of the 12 countries permitting its sale OTC, 4 countries prohibited direct-to-consumer advertising of codeine. The majority of the countries permitting advertisements did not have any additional or special restrictions or warnings for codeine-containing products with the exception of the UK where advertising codeine was only permitted under certain restrictions including product endorsement and special warnings including its indication of use for a maximum of 3 days. There is wide disparity in advertising of OTC codeine in the EU. Safeguards for OTC codeine use are likely to continue to remain a priority in the interest of public safety.

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

The challenge of complex drug use: Associated use of codeine-containing medicines and new psychoactive substances in a European cross-sectional online population.

Misuse of codeine-containing medicines in combination with new psychoactive substances (NPS) is inadequately described. This study characterises codeine consumption amongst NPS users and non-NPS users to provide warning of health issues. Online survey conducted between July 2015 and March 2016. Out of 340 respondents, residing in a country in Europe and using codeine recently, 63.8% were female. Mean age: 34.9years (SD=12.4). Substance use included NPS (18.5%) and illicit controlled drugs (55.9%). Factors relating to codeine use found to significantly predict NPS use were consuming codeine extracted from combination tablets (OR=16.79, 95% CI [8.67, 32.51]), obtaining codeine from friends, family, and acquaintances (OR=3.98, 95% CI [1.82, 8.7]), use of illicit controlled drugs (OR=34.99, 95% CI [8.39, 145.94]) and use of codeine to experience euphoria (OR=6.41, 95% CI [3.42, 12.04]). Amongst NPS users, codeine is less likely to be used daily but more likely to be used for recreational purposes. Smaller populations engaging in high-risk use exist who take multiple drugs in high doses. Combinations of misused codeine and NPS highlight the need for policy to respond to a more complex drug situation.

Experiences of Codeine Use, Misuse and Dependence: Application of Liese and Franz's Cognitive Developmental Model of Substance Abuse.

Misuse of codeine-containing medicines is an emerging public health issue. We present the application of Liese and Franz's (1996) cognitive developmental model of substance abuse to the trajectory from legitimate codeine use for pain, towards that of therapeutic and other forms of misuse, and physical and psychological dependence. It illustrates a cognitive behavioural analysis of the experiences of codeine misusers - which 'surfaces' the specific beliefs, thoughts, emotions and behaviours of this group of hidden codeine dependent individuals, who are distinct and unique from other opioid-dependent cohorts. In-depth one-to-one interviews with codeine misusers and dependent individuals in Ireland (n = 21) and South Africa (n = 25) are analysed and applied to Liese and Franz's (1996) cognitive developmental model of substance abuse. Misuse and dependence pathways are maintained by the interplay between physiological determinants relating to pain, withdrawal and tolerance, and psychological influences such as therapeutic need, pre-empting of anticipated physical pain, pleasure from the dreamy sedative opiate effect of codeine and relief of emotional distress. Progression towards habitual use and misuse for therapeutic and intoxication purposes appears to be mediated by external environmental triggers pertaining to availability, internal meta-cognitions around physical pain and emotional distress, and increasing importance of codeine in the life of the user. The concept mapping of codeine misuse and dependence presented here could provide psychological therapists working with individuals experiencing problems with codeine, misusing codeine and those with iatrogenic dependence, with an enhanced understanding of the key concepts involved in misuse and recovery pathways.

"Codeine Is My Helper": Misuse of and Dependence on Codeine-Containing Medicines in South Africa.

Misuse of codeine-containing medicines is an emerging global public health concern. The majority of research has been conducted in developed countries (European Members States, Australia, the United States). This study aimed to gain an understanding of unique individual and collective experiences of trajectories of codeine misuse and dependence in South Africa. In-depth interviews were conducted with a purposive sample of adult codeine misusers and dependents ( n = 25). Narratives were analyzed using the empirical phenomenological psychological five-step method. Nine themes with 63 categories emerged, with two additional high levels of abstraction. Findings are illustrated: participant profile and product preferences, motives for use, transitioning to misuse and dependence, pharmacy purchasing and alternative sourcing routes, effects and withdrawal experiences, help-seeking and treatment experiences, and strategies for prevention. The study underscores the need for continued support for enhanced patient awareness of risk of habit forming use and related health consequences and professional pharmacovigilance.

Australia tightens restrictions over codeine-containing medicines

Australia tightens restrictions over codeine-containing medicines

Codeine--Restrictions on use for children and teenagers

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has issued European-wide restrictions on the use of codeine-containing medicines for cough and cold in children at the age of 0-12 because of the risk of serious side effects, including the risk of breathing problems. The PRAC further recommended that "codeine must not be used in people of any age who are known to convert codeine into morphine at a faster rate than normal ('ultra-rapid metabolisers')". The reasons for this variability in codeine biotransformation lay in a genetic polymorphism in the liver enzyme CYP2D6 leading to 3% of the northern European population being ultrarapid metabolisers due to a gene duplication of the enzyme.This is the first restriction of a common drug in CYP2D6 ultrarapid metabolizers, and more use of pharmacogenetic biomarkers for stratified benefit-risk assessment in drug regulation can be expected and will be a first step to Individualized Medicine Regulation.

Use of codeine-containing medicines by Irish psychiatric inpatients before and after regulatory limitations on their supply.

In recent years, concerns have been highlighted in several jurisdictions, including Ireland, regarding abuse of over-the-counter codeine-containing medicines. On the 1st of August 2010, national regulatory guidelines aimed at limiting the supply of these medicines in Ireland came into force. Aims To study the effects of the new regulations on the use of non-prescribed codeine-containing medicines by psychiatric patients admitted to an Irish university teaching hospital before (n = 117) the regulations came into effect and 6 months afterwards (n = 126). Participants completed a brief self-administered survey questionnaire about their use of over-the-counter codeine-containing medicines in the preceding 3 months. Compared with before the introduction of the new regulations, there was a large decline in the reported 'often' or 'regular' use of codeine-containing medicines in the 3 months before admission (33.3% v. 17.4%, χ 2 = 6.354, p = 0.01) and there was a reduction in the proportion of patients for whom others had expressed concerns about their frequency of use of such medications (15.5% v. 4.8%, χ 2 = 7.29, p = 0.03). There was also a decline in the proportion of patients who stated that they would use codeine-containing medicines for either a 'feel-good' effect or to curb cravings (15.9% v. 1.9%, p < 0.01, two-tailed Fisher's exact test). We conclude that tight regulations on the supply of non-prescription codeine-containing medicines have the potential to reduce the use and abuse of such medicines in patient populations availing of admission to psychiatry hospitals.

P01-01 - Use of codeine-containing medicines by patients admitted to an acute psychiatric hospital

BackgroundAnecdotal evidence suggests that the general public including patients with mental health problems are largely unaware of the potential risks of codeine abuse and dependence. Despite this, little research has been done in establishing the public’s level of awareness on this issue.ObjectiveTo assess the extent of use of codeine-containing preparations, as well as the level of knowledge regarding the dependency potential of codeine, in patients admitted to an acute psychiatric hospital.Method150 patients admitted consecutively to an acute psychiatric hospital over a 2 month period were asked to fill out an anonymous 18-item semi-structured questionnaire. The results were compiled and analysed using descriptive statistics with SPSS version 17.Results116 questionnaires were returned giving a response rate of 77% (54% female, mean age 46.7 years, SD = 15 years). 90% of respondents reported that they had ever used codeine-containing medications, 80% have bought them over the counter, 65% always used them without prescription, and 7% reported daily use of such medicines. 14% reported using them for the euphoriant effect, 5% to curb cravings, and the remaining mainly for migraines or aches and pains. 11% of all patients had used a codeine-containing medication as recently as 24 hours prior to their admission and 66% of patients indicated that they were aware of the dependence potential of codeine.ConclusionAwareness among psychiatric patients regarding the dependence potential of codeine is high. Additionally, a considerable proportion of patients indicated use of codeine for euphoriant effects or to curb cravings

Follow-up control after long-term withdrawal therapy in heroin and multiple drug addicts

A follow-up study was done in 31 rehabilitation probands who were discharged consecutively from a long term drug withdrawal centre for heroin and multiple drug addiction. Referral had been on the basis of section 64 of the penal code and a motivation for treatment had to be established first. After discharge the majority of probands could be reassessed repeatedly. A total of 180 follow-up investigations included also urinanalysis and in 170 of these cannabinoids were looked for. Cannabis was detected in only two cases. When other addictives were demonstrated in a few cases they could be attributed to codeine-containing medicines beyond doubt. Regular follow-up assessments of past drug addicts including urinanalyses serve for further stabilisation of the patients and at the same time indicate long-term success of treatment.

Over-the-counter and prescription medicine misuse in Cape Town--findings from specialist treatment centres.

To provide community-level public health surveillance information on over-the-counter (OTC) and prescription medicine misuse. A retrospective study of OTC and prescription medicine misuse among 9,063 patients from 23 specialist substance abuse treatment centres in Cape Town, South Africa, between 1998 and 2000. OTC and prescription medicine misuse places a burden on health and social services in South Africa. This is evidenced through the constant demand for treatment for OTC/prescription medicine misuse. Benzodiazepines are the class of medicines for which users most often receive treatment, followed by analgesics. Analgesic misuse is most often accounted for by the use of codeine-containing medicines, many of which are available over the counter. Patients using OTC/prescription medicines as their primary drug of abuse are significantly more likely to be female, and aged over 40 years. In contrast, patients using OTC/prescription medicine as an additional drug of abuse tend to be male and over 40 years of age. This study points to the need to develop primary health care protocols for detection, management and referral of patients misusing OTC/prescription drugs and the need to debate the re-scheduling of codeine as a prescription-only substance. The study also points to the need for further community-based research on the nature and extent of OTC/prescription drug misuse among the general population.