Consultation outcome

Consultation response on proposal to make codeine linctus and codeine oral solutions available by prescription only

Updated 20 February 2024

1. Scope of the report and Background to public consultation

The scope and purpose of this report is to detail the outcome of the public consultation and subsequent decision of the procedure for reclassification of codeine linctus and codeine oral solutions (referred to as codeine linctus throughout). This report confirms the medicine is safe for patients under appropriate medical supervision; it is not intended to be an assessment report.

Consultation documents for Application to Reclassify a Medicine (ARM) 103 which summarise the proposed reclassification from a pharmacy (P) medicine to a prescription only medicine (POM) of codeine linctus for treatment of dry unproductive cough in adults and children aged over 12 years of age without difficulties in breathing, were posted on the GOV.UK website on 18 July 2023.

The deadline for comments was 15 August 2023. ARM 103 documents can be accessed from MHRA Public consultation on the proposal to make Codeine Linctus available as a prescription-only medicine (POM) - GOV.UK (www.gov.uk)

 A medicine will be non-prescription unless it fulfils the criteria for prescription control (POM criteria) as set out below. POM status is required if any of the following criterion apply:

1. A direct or indirect danger exists to human health, even when used correctly, if used without medical supervision.

2. There is frequently incorrect use which could lead to direct or indirect danger to human health.

3. Further investigation of activity and/or side-effects is required.

4. The product is normally prescribed for parenteral administration (by injection).

In the UK, these criteria are laid down in the Human Medicines Regulations 2012, regulation 62(3)^{[footnote 1]}.

Also in determining whether criterion 2 applies, the licencing authority must take into consideration if the medicine;

(c) is likely, if incorrectly used—

(i) to present a substantial risk of medicinal abuse,

(ii) to lead to addiction, or

(iii) to be used for illegal purposes;

The public consultation (ARM 103) was conducted to seek wider views on the reclassification proposal for codeine linctus from pharmacy availability to POM status.

2. Background on codeine linctus

Codeine belongs to a group of medicines known as opioids. Codeine is used to reduce coughing, however opioids are primarily used in the treatment of pain, although may also be used in the treatment of restless legs syndrome and diarrhoea.

Opioids bind to nerves throughout the body and will have a direct effect on the brain.

Codeine is broken down in the body (metabolised) by an enzyme in the liver known as CYP 2D6 into morphine, which is considered to provide the beneficial effects of the medicine. Some medicines will interact with this enzyme to either enhance its activity or inhibit its activity. Some people are also known to be able to metabolise codeine much better than others and will therefore be more susceptible to its effects.

The MHRA has recently conducted a review of safety information from the National Poison Information Service, the Office of National Statistics, Yellow Card reports and literature-based sources. This revealed that codeine linctus is being used recreationally for its opioid effects, rather than for its intended use as a cough suppressant. This carries a serious risk of addiction and overdose which can be fatal.

Codeine linctus is used recreationally to make a drink known as ‘Purple Drank’, ‘Lean’, ‘Dirty Sprite’ or ‘Sizzurp’ (herein collectively referred to as Purple Drank). Purple Drank is a mix of codeine linctus, promethazine (an antihistamine) and fizzy drinks, sometimes with boiled sweets to take away the bitterness of the linctus. Codeine provides the euphoria sought by users and the antihistamine is added to counteract any sensitivity reactions to codeine, however promethazine is also a sedative which can make users sleepy and lose track of how much codeine they have consumed. Recreational use of codeine carries serious risks and could result in loss of consciousness, respiratory suppression and death. Concomitant use with a central nervous system (CNS) depressant, such as alcohol, sedatives or other medicines, will further increase these risks.

The MHRA has found evidence of Purple Drank being popularised through social media targeting young adults and has received an increased number of reports of the sale of codeine linctus through non-regulated and potentially illicit websites. Healthcare professionals (HCP) have also identified individuals repeatedly requesting codeine linctus who are potentially addicted.

3. Summary of Responses to Public Consultation

This is a summary of the responses to the public consultation on the MHRA proposal to reclassify codeine linctus from P to POM.

All responses have been fully considered, however owing to the large number of responses, individual responses will not be published. Some example comments are provided, while maintaining confidentiality.

A total of 992 responses were received, of which 868 completed all questions in the consultation.

A total of 587 (59%) of the 992 responses agreed that codeine linctus should be reclassified to POM. Of those who completed the whole survey, 522 (60%) of the total 868 were in favour of reclassification.

A total of 358 (36%) of the 992 responses were against reclassification. Of those who completed the whole survey, 322 (37%) of the total 868 were against reclassification.

A total of 47 (5%) of the 992 responses were unsure. Of those who completed the survey, 24 (3%) were not sure.

An overall summary of the responses to each question is presented in Annex I.

The majority of responses were received from persons aged between 31 to 45 years of age.

Of all 992 responses, most (573 responses, 65%) came from HCPs and 220 (25%) came from members of the public. Six (1%) responses came from a patient representative organisation, 31 (4%) came from trade or professional associations or organisations and 39 (4%) had personal experience of the effects of codeine linctus. Ten (1%) responses came from other sources.

Of those 587 respondents that agreed with the proposal to reclassify to POM, 419 (78%) were current and retired HCPs, 64 (12%) came from a member of the public, 27 (5%) were representatives of trade or professional association or an organisation, 4 (1%) were representatives of patients, and 18 (3%) had personal experience, either as an individual or from family connections. Other responses came from police drug liaison officers and a safer community network (with members from the emergency services and local authorities). Fifty-Four (9%) did not say who they were.

Of those that disagreed, 140 (43%) were current or retired HCPs, 151 (47%) were members of the public, 4 (1%) were representatives of patients, 4 (1%) were representatives of trade or professional association or organisation and 25 (8%) had personal experience either as an individual or from family connections. Of the total who disagreed with the proposal, 32 (9%) did not say whether they were a HCP, representative of any sort or have personal experience.

Of those that were unsure, a total of 47 responses were received and the majority did not complete all parts of the consultation. Twenty-nine respondents revealed their affiliation, which included: 5 (21%) members of the public, 2 (8%) patient representatives including a social worker in third sector support services, 18 (75%) HCPs including a member of the public with personal and healthcare experience, 3 (13%) representatives of trade or professional associations or an organisation and one (4%) with personal and healthcare experience.

4. Responses in Favour of the Proposal to Reclassify Codeine Linctus as a Prescription Only Medicine

Responses were received from HCPs, patients and those personally associated with patients, or individuals dependent or addicted to codeine, and professional organisations.

Professional organisations in support of reclassification included,

• The Royal Pharmaceutical Society
• The Company Chemists Association
• Pharmacy Forum NI
• The Pharmacists’ Defence Association
• National Pharmacy Association
• Dispensing Doctors Association
• The Proprietary Association for Great Britain (PAGB),
• AAH Pharmaceuticals as a representative of pharmaceuticals wholesalers.
• Via (patient representative organisation),
• Derby & Derbyshire Integrated Care Board,
• Healthcare Improvement Scotland,
• Scottish Pain Pharmacy Network,
• Barnabas Patient Voices,
• Wales Safer Communities Network
• Healthwatch Milton Keynes,
• Police services

Other respondents who identified themselves as members of professional organisations did not reveal their affiliation or wished to remain confidential. Therefore all comments are summarised.

Key concerns

Addiction to codeine was considered to be common and frequently unreported. Pharmacists reported of the pressure put on them to sell the product and their opinion that there were few genuine patients. Therefore many prefer not to stock codeine linctus or treat it as a prescription medicine, to order only when a genuine patient is identified. The increasing use of codeine linctus was observed across the social demographic, although ages of concern were young people and the elderly.

Considerations were provided in terms of licensed bottle sizes and strength of codeine linctus available OTC (15mg/5ml), with the example that codeine combination medicines (containing codeine and paracetamol or codeine and ibuprofen) have a maximum strength of 12.8mg per tablet or capsule OTC with higher strengths only available as POM.

Other concerns:

• the potential for use off-label in children as it may be misinterpreted as a harmless cough linctus
• patients may not understand the risks to their health, especially if codeine linctus is taken in excess of the maximum recommended dose
• distance sales or online sales and lack of sufficient oversight, with an example that some pharmacies may be selling multipacks
• the potential for individuals to unknowingly consume codeine through recreational drinks
• potential contribution to further opioid abuse
• current availability OTC enables the rehabilitated opioid addict to relapse
• environmental issue linked with littering of empty and broken bottles
• recent increases in gang-related crime

Example responses from respondents personally experienced:

“From personal experience, it was an easily attainable drug to fuel dependence. Removing all options to rely on this drug will hopefully encourage people to use local drug support services.”

“My brother, 43, is currently addicted to codeine. He lives on benefits and this gives him a cheap way of getting high.”

“Quite scary the effect that codeine had had on members of my family.  Disorientated and felt terrible.  Few people, including us, had an idea that codeine in linctus was so addictive.”

Physicians commented on their observations of misuse of codeine linctus, including overdose, tolerance and lack of pain control post-operatively in those with habitual use, withdrawal, use in the elderly and risk of falls. Concerns were also raised in relation to the metabolism of codeine, with toxicity in terms of genetic disposition, and potential for drug interactions, or genetic disposition for developing dependency. Concerns were also raised by HCPs and patient representatives in terms of side effects other than abuse and addiction, including constipation, impaired consciousness, opioid-induced headache, mental health and effects on ability to drive safely.

A parent of a person experienced in the use of codeine linctus commented:

“My 22 year old Son has formed an addiction after mixing and drinking Codeine linctus with soft drinks and hard candy. This is a street drug know as Lean, Purple Drank, Dirty sprite. This has affected his mental health and physical health in a very drastic and devastating way. We are currently working with health professionals and charities to help him with devastating withdrawal symptoms such as psychosis.”

Descriptions of behaviours experienced by pharmacists from those seeking to buy it were provided, including:

• shopping between and visiting multiple pharmacies
• phoning ahead
• asking others to buy it for them

Lack of efficacy as a treatment for acute cough is also considered a valid reason for reclassification, as patients whose cough does not resolve between 4 to 8 weeks becoming a persistent cough, would need to have their symptoms investigated more thoroughly. HCPs, members of the public and professional organisations recognised that there are readily available alternatives which are not addictive. Off-label use as an analgesic was observed to be a major use by genuine patients, however the need for assessment by a HCP was considered important to exclude underlying medical disorders.

Barrier to Recreational use

In general it was agreed that reclassification would provide a further barrier to those seeking the linctus for recreational use, although would allow it to be continued to be used when needed by genuine patients. In addition it would reduce the potential for multi-pharmacy shopping.

It was agreed that reclassification would take pressure off pharmacists and counter assistants when approached by persistent buyers and would help to prevent people getting addicted when using for genuine reasons. Patients with persistent cough could be directed to their GP in order obtain a further investigation into their symptoms.

It was also pointed out that recreational users are not addicts, therefore reclassification to POM would limit this potential use. Similarly, that it would not remove the risk altogether, but would make it harder to be misused. However, the potential risk of unintentional development of dependence to codeine was highlighted as an issue which could affect both patients and recreational users.

HCPs commented that there is likely to be an underestimation of availability online and regard that a reclassification to POM would enable better healthcare oversight of the supply chain, with provision of the correct supply to patients and audit trails from wholesalers to pharmacies. The prescriber would also be able to have a clear oversight of the use of codeine linctus and be able to determine its appropriateness.

Other concerns:

• fraudulent prescriptions were raised as an issue, but mainly associated with hand-written ones
• online supplies from multiple pharmacies, and online prescribing is an issue

Example response from a HCP:

“What does worry me, is the proliferation of online doctors who are prescribing with, as far as I’m aware, no access to their patients’ records and relying entirely on what might be falsely presented symptoms for the purpose of obtaining drugs for misuse.”

Example response from a person connected to a family member addicted to codeine:

“My late mother in law was addicted to codeine and would buy several bottles of Codeine linctus each week. She used a range of pharmacies until they stopped selling to her due to her frequent purchases. She would then ask other people to buy it for her.

When she ran out of options to purchase it in person, she then used several online pharmacies and was able to purchase it this way.”

5. Responses Against the Proposal to Reclassify Codeine Linctus as a Prescription Only Medicine

Comments were received from the following professional organisations and patient representatives:

• Drug and Therapeutics Bulletin
• Healthwatch Birmingham
• Scottish Drugs Forum
• Advisor for van dwellers and others

Other representatives preferred to remain anonymous.

Key concerns

In those responses obtained from pharmacists who disagreed, many considered that the current system was sufficient as pharmacies already keep codeine linctus out of sight and will not supply large amounts. Several pharmacies do not stock it although will order it for a genuine patient.

A recovering addict also highlighted that it was very difficult to get from a pharmacist as it is rarely available although supported its continued OTC availability for genuine patients.  However, respondents observed that it is available to buy online and there was concern that the reclassification may increase the number of people buying codeine products from unregulated sites.

The Scottish Drugs Forum responded that this would only increase the number of people buying codeine-based products, quoting:

“….People replacing Codeine linctus with dissolving soluble tablet compound preparations of codeine would increase health risks as large quantities of paracetamol or ibuprofen would be consumed at the same time.”

The main concerns voiced by HCPs and members of the public were in terms of current difficulties to get an appointment to see the GP or the reluctance of a patient to see a doctor about a cough. Drugs and Therapeutics Bulletin acknowledged the dangers of all codeine products, and considered that codeine linctus was not efficacious, therefore by making it a POM would imply that it is an effective medicine.

Conversely, personal experience was provided by patients and a few healthcare providers who considered it to be an effective cough suppressant when alternatives are considered less effective. Specific references were made towards the effectiveness for treating nocturnal cough which can be debilitating for the patient and family alike during the night, especially during the winter months or time of high pollen count. Although GPs were reluctant to prescribe it owing to the lack of evidence of efficacy. However, two responders noted that untreated and excessive coughing can cause complications which can be serious. One HCP commented that it was effective for off-label use in the treatment of diarrhoea.

Comments highlighted that:

• addicts will always find a way to obtain codeine, either by using alternative codeine combination medicines, by extraction of the codeine component from codeine combination medicines and the potential risk that addicts would source stronger opioids from an illicit supply
• reclassification would affect patients economically as the cost of a prescription is higher than the current cost of a single bottle of codeine linctus OTC (for those who are not exempt)
• there is a potential risk that reclassification would increase prescriptions of antibiotics leading to antimicrobial resistance
• a few comments consider that codeine linctus should not be available POM or P owing to the lack of quality evidence to support its use for chronic or acute cough
• the risks associated with codeine and paracetamol combination medicines or codeine and ibuprofen combination medicine are of greater concern

Barrier to Recreational use

Of those that disagreed with the proposal, 47 (13%) agreed that it would limit the potential for recreational use or illegal use, whilst 234 (65%) disagreed and 70 (20%) were unsure.

Many of the responses were similar with concerns that it would increase prescribing, or there would be the potential risk that individuals would source codeine linctus elsewhere, including illegal supply, with the observation that it would be very difficult to monitor codeine usage sourced from illegal sales.

6. Responders who are Unsure on the Proposal to Reclassify Codeine Linctus as a Prescription Only Medicine

Comments were received the following professional organisations and patient representatives:

• Scottish Specialist Pharmacists in Substance Use Management (SPiSMs)
• Change Grow Live (CGL)

Key concerns

In those that were unsure, there were concerns about a potential difficulty to obtain a prescription. Some pharmacies were observed only to provide codeine linctus with a prescription, although doctors were seen either as not being able to or will not prescribe it.

It was not considered to be a product of choice and the majority of pharmacies do not have it on display. While the potential impact of the reclassification on primary care was acknowledged, there was concern that if it remains a P medicine, some serious disorders (such as lung disorders) may be missed as the linctus would only mask the underlying condition. Observations were made that a lot of lives are ruined by addiction and therefore action to prevent this is supported. However, people with personal experience by connection with family members who are addicted, are concerned that addicted individuals would then seek out more harmful alternatives.

The lack of evidence of efficacy was again acknowledged although the anecdotal evidence reports of some benefit was also highlighted, especially with nocturnal coughs.

There was a general concern that if linctus goes POM then so will co-codamol, however another view given was that all codeine medicines should be POM.

Alternative risk minimisation actions proposed include:

• governance through a patient group direction
• screening Qs from pharmacists
• lower strength, or
• smaller bottles

Barrier to Recreational use

For those who were unsure, 17 (36%) agreed that the reclassification would limit the potential for recreational use or use for illegal purposes, 5 (11%) disagreed and 17 (36%) were not sure.

Measures considered needed to ensure that reclassification would have an effect:

• Adequate policing
• Restrictions on internet sales
• Extra funding for opioid dependence clinics

7. Summary Care Records (SCR)

A total of 939 responses were received concerning pharmacy records. Of these 510 (54%) agreed that the proposal to reclassify to POM would help the pharmacist to monitor use in a patient who would benefit from a prescription, 286 (30%) disagreed and 143 (15%) were unsure.

Benefits

The patient record of codeine linctus prescriptions and use would be reviewed at the GP surgery to enable supportive engagement including discussions on patient expectations and experiences. The ability of a pharmacist to access a patient record can assist both pharmacists and GPs as it may be shared between pharmacies and mitigate multiple pharmacy shopping. It also allows the pharmacist to see if there are underlying health conditions that are important to understand and provide better advice to the patient. This enables the pharmacist to concentrate on patients who will benefit from use and direct them to the GP for further investigation into underlying symptoms. It may also mitigate stock shortages for patients who need the linctus and cannot swallow a tablet as supply would be adequately monitored.

Current pitfalls

The patient medical record (PMR) only lists dispensing from specific pharmacies, however access to the Summary Care Record (SCR, England), Emergency Care Record (ECS, Scotland), Individual Health Record (IHR, Wales), or Northern Ireland Electronic Care Record (NIECR) would help all pharmacies within the relevant community to monitor how much is prescribed to a specific patient.

Risks

Patients may choose to ‘opt-out’ of record sharing. In addition, private online prescribing may not pass the information onto the patients GP, consequentially patient records may not be fully complete. A respondent raised an issue that community pharmacists might not consistently possess information regarding patients acquiring medications from other sources (both POM and OTC), therefore called for access to comprehensive patient health records, contingent on patient approval to ensure high-quality patient care.

8. Educational Materials

Generally, pharmacists endorsed the need for educational materials to support HCPs, frontline staff and patients. It was highlighted that educational material would provide useful refresher material for established HCPs.

Responders noted that public educational materials would empower patients and family or carers to make the best decisions for their healthcare and be aware of the signs of misuse, especially if the medicine had been bought by a friend or carer for the patient.

The patient support group ‘Via’ and the College of Mental Health Pharmacy (CMHP) agreed that training was needed which could also address issues around difficult conversations, interventions and harm reduction.

Calls were made for a public awareness campaign. Many respondents called for the inclusion of signposting to support or self-help resources for addicted patients, although added that it is important that the material does not stigmatise the patient and careful phrasing is paramount.

An example booklet was provided by the British Pain Society concerning the use of opioids following surgery

A concern was raised by a pharmacist about the lack of facilities to display literature, with the consideration that it should be discrete, whereas other comments suggested that there should be posters and could involve shock tactics.

Overall, further education for the public, patients and HCPs was supported.

9. Equality

There were 914 responses overall, of which 222 (24%) agreed that the proposal risked impacting people differently, 474 (52%) disagreed and 218 (24%) were unsure.

Figure 1. Agreement or disagreement that alteration in codeine linctus classification would have an effect on people with any of the protected characteristics under the Equality act 2010.

It was considered that all patients with protected characteristics of the Equality Act 2010 should have equal access to GPs as addiction affects all groups. Therefore, the reclassification should have an impact on those intent on abuse, but not the patient as codeine linctus would need to be prescribed and would instigate discussions on the correct use of the medicine. This was considered a positive impact as it would safeguard the health and welfare of the public. For those who are using codeine linctus as a cough suppressant, this would not prevent access although would restrict it to those who would benefit and enable the patient to have discussions with their GP over their symptoms. For those who are using it off-label in the treatment of pain, a GP would be able to monitor their use, and manage the patient’s symptoms appropriately. Those who are addicted could also be directed to seek help.

As efficacy is limited, reclassification was not considered to have an impact on the prescribing of codeine linctus as there are alternatives available for short-term dry cough without prescription which are not addictive.

Patients who were highlighted as more likely to be affected were the elderly, those with chronic pain, disabled and those who live in rural areas. The elderly were thought to be using codeine linctus as their ‘favourite’ medicine. Physical access to GPs was seen as a barrier, although it was noted that prescriptions could be delivered to their home. Telephone consultations with GPs were also considered a barrier to those who are deaf or hard of hearing and there was a concern for people who experience anxiety at GP appointments. One comment noted that areas of social deprivation may have greater access to pharmacies than GPs, similarly that some people may not be registered with a GP. The cost of a prescription was also highlighted as greater than the price OTC, although this would only impact those who are not exempt (those who are exempt include patients over the age of 60 years, under 16 years, aged 16 to 18 years in full time education and a number of other social demographic specifications, disabilities and medical conditions).

10. Impact on Primary Care

A total of 909 responses were received concerning the potential impact on primary care services and was the most closely contested. Of these 366 (40%) agreed that the proposal to reclassify to POM would have little impact on primary care, 396 (44%) disagreed and 147 (16%) were unsure.

Respondents who agreed that the proposal would have little impact on primary care

In those that agreed that it would have little impact, patient health benefit was considered most important. Similarly that it would not change healthcare practice as the GP would be able to diagnose any underlying problems and advise on appropriate treatment.

Example comments from HCPs:

“It may be a small inconvenience for some patients, but it may encourage some patients to get their lung health checked.”

Example comment from a HCP on behalf of The College of Mental Health Pharmacy (CMHP):

“All agreed likely to have minimal impact because misuse identified should be signposted to specialist drug treatment services and those with genuine physical health needs, prescription of such would be appropriate on prescription for Review by general practice – pharmacist or GP or other appropriate person.”

Comment from the Chair of the Scottish Specialist Pharmacy in Substance Use Management:

“Patients wishing to access Codeine linctus as a cough suppressant may request GP appointment for a minor, self limiting ailment. This could have a negative impact on primary care given the limitations of currently available alternatives. However, the need for Codeine linctus prescribing will be minimal in terms of GP as there are alternative available cough suppressants OTC. In terms of pharmacies they will still only be dealing with one enquiry or sale. Appropriate gate keeping at GP level would minimise this.

Codeine linctus is non formulary in a lot of areas and rarely prescribed and by reclassifying a POM medicine there would be little impact on prescribing for cough. By utilising a Pharmacy First approach and educating and advising patients appropriately on alternative self care and treatment options this impact would be minimised.

Reclassification would restrict sale and availability. The impact on those people who are continuing to use alternative sources of codeine, such as those who have problematic substance use may seek more review appointments in attempt to increase dose or supplied quantities, or indeed may require input from specialist services to help deal with their substance use”

Example comment from a member of the public:

“If a person feels they are in need of Codeine linctus they may have underlying symptoms that need attention.  Primary care is the best route for them”

Community pharmacists highlighted in responses to multiple questions that they were also able to recommend alternative products for short term cough and refer the patient to the doctor for a diagnosis of symptoms underlying chronic cough. HCPs with prescribing rights other than GPs, would also be able to reduce the impact on GP practices, although pharmacists rarely stock codeine linctus owing to its abuse potential. Education would also support guidance on treatment with an alternative non-prescription product.

Example responses from HCPs:

“It is not a commonly recommended product by pharmacist and GPs are not going to start prescribing it for dry coughs when there are other OTC products available”

“Might initially [have an impact] but then would settle down. Would need good communication with Pharmacist and as many are prescribers as well hopefully would be beneficial.”

“I anticipate usage would decrease overall and not shift to prescribers especially if supported with education about alternative treatments including non-pharmacological.”

Comments from the Pharmaceutical council:

“We do not anticipate that this change will have a significant impact on primary care. Many pharmacies have already ceased to stock Codeine linctus.”

The overall increase in presentation to drug services was considered to be small, and increased consultations a positive thing as underlying symptoms may be investigated, therefore any increased requests for prescriptions are likely to be short-lived. It would also support pharmacists to prevent inappropriate sales. The potential of an impact to primary care was considered to be small in comparison to the potential for addiction which prompted the following example comment:

“After the initial fuss the long-term impact on primary care would be negligible. OTC CODEINE is a non-essential item. Addictions need treatment, can’t measure the problem properly in the current circumstances. It’s a long term harm reduction measure.”

From a healthcare organisation:

“It will likely have an impact though minimal because if misuse is identified individuals should have care provided by specialist drug treatment services and for genuine physical health needs it would usually be more appropriate to have on prescription.”

From a police officer:

“it would only generate more genuine requests with patients contacting the GP or IP [independent prescriber]”

Respondents who disagreed that the proposal would have little impact on primary care

In those that disagreed, quoting a higher impact on GP services, it was also highlighted that GPs would be able to monitor potential addiction, provide support and be able to manage those patients who are using codeine linctus off-label for pain control. Therefore, it was again considered a positive impact, although the current strain on GP services was not unnoticed by HCPs, patients and members of the public, especially in the winter months (for example see Healthwatch Birmingham). A concern was raised that patients may then go to secondary care to get a prescription. GPs highlighted the ongoing battle to prevent patients from requesting antibiotics for cough and the current attempts to get patients to self-medicate minor illnesses.

Example responses from HCPs:

“No this would have an impact as it will create work for the practice, but I still support this for patient safety”

“It would have a significant impact on primary care, prescribing costs AND antimicrobial resistance due to more acute coughs/URTI [upper respiratory tract infections] presenting in primary care and urgent treatment centres.”

“It would increase demand at the busiest times of the year. In practice meaning longer waiting times for people to get a GP appointment.”

From a participant of a patient representative organisation:

“GPs will be met with prescription needs. And will need training as they have no idea of the number of scripts people will seek. There is a GP crisis already on NHS - why add pressure”

Example comments from members of the public:

“I think that there is not enough known about the overuse of Codeine linctus for recreational or addiction purposes.

I believe that it is likely that people may need support in overcoming their addictions safely and will need additional pain management guidance or support.”

“Given that people can’t see their GP at the best of times and surgeries are only able to offer 28-day prescriptions it would impact primary care as more people would have to have more contact with the surgery”

Respondents who were not sure if the proposal would have little impact on primary care

In those responders who were unsure, similar issues, both negative and positive, were raised in terms of the current pressures on GP services, the potential support that can be provided by independent prescribers and overall benefit over the long-term in reducing potential for addiction and associated risks and enabling routes of support. The need for further education was again highlighted in terms of impact, as a way to explain the risks and availability of alternatives.

Example responses from HCPs:

“Management of dry cough was predominately done via Community Pharmacy, the loss of both Codeine and Pholcodine linctus may lead to more presentation to independent prescribers for Codeine Linctus (which could be GPs, ANPs [Advanced Nurse Practitioner] and Pharmacists)”

“Could go either way, people who normally get their supplies from pharmacy would now need to get them from their GP; but as said, the clinical evidence relating to the use of Codeine linctus is fairly weak and there are many other cough preparations available as a P- the impact to people who genuinely need this medicine should be minimal.”

Example comments from members of the public:

“Primary care cannot cope with numerous inquiries and informed self-care should be further considered. Pharmacists should play a bigger part.”

Comments from patient representative organisation:

“If people attempting to buy Codeine Linctus are given the correct information and advice by their pharmacist - about how long their ailment may last before they should seek a GP appointment - and people are given confidence in the skill and knowledge of their community pharmacist to give this advice, the period where people try to make an unnecessary appointment with their Dr should be shorter than if there is no education alongside the changes.”

Response from the Pharmacists Defence Association:

“Patient and user behaviours are difficult to predict. In general, pharmacists are well versed in suggesting suitable alternative or similar products for many clinical conditions so there may not be a significant impact on primary care (which we presume in this context means GP practices). We would expect that all prescribers in primary care settings would be part of the awareness raising campaign alert that we suggest.”

Response from the Wales Safer Communities Network:

“Primary Care is already under pressure with capacity with one in five GP surgeries closing between 2012 and 2022 in Wales. It is also reported publicly that there are a number of GP surgeries with only one GP partner with ageing GPs who are retiring at a higher rate than new doctors are entering into Primary Care.

The impact on primary care will depend on how much the common ailment scheme running in Wales pharmacists is able to prescribe Codeine Linctus products, with appropriate permission and training. It could also be impacted if there is a need for more appointments linked to potential substance misuse and the need for referral where there appears to be prolonged use where a consultancy with a doctor is appropriate to identify any underlying health issues”

A patient safety commissioner responded:

“It is not known how many patients will seek additional help from primary care. It is however, important that primary care teams are fully informed about the decision and the reasons for the public consultation so that patients can be given the right information to make the right decisions about their care.”

11. Conclusion

Careful assessment of the significant number of responses to the consultation on the reclassification of codeine linctus for the treatment of dry unproductive cough in adults and children aged over 12 of age without difficulties in breathing, has identified some safety concerns associated with the supply of such a product in the pharmacy setting.

Following a review of all available evidence, including the responses to the public consultation the CHM advised that codeine linctus is likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction, or to be used for illegal purposes.  The POM criteria, in particular criterion 2 (there is frequently incorrect use which could lead to direct or indirect danger to human health) applies to codeine linctus.

The CHM also noted the lack of effectiveness for short-term cough and advised that the product information should include information on addiction, similar to POM opioid medicines.

Patients will still be able to access codeine linctus with a prescription from a qualified healthcare professional. This will ensure that the medicine is used safely and appropriately under medical supervision.

Alternative non-prescription cough medicines are available. Patients are advised to speak to their pharmacist for advice.

Annex 1

Codeine Linctus Consultation - Summary of responses

Figure 2. Summary of responses to questions posed during the public consultation (percentage total responses for each individual question)

Table 1. Numbers of responses to questions during consultation

Questions	Agree n (%)	Disagree n (%)	Not sure n (%)	Total responses n (%)
1. Do you agree that Codeine Linctus should only be available as a prescription Only (POM) medicine?	587 (59.17)	358 (36.09)	47 (4.74)	992 (100)
2. Do you agree that the proposal to reclassify to POM would limit the potential for recreational use or use for illegal purposes?	595 (61.79)	250 (25.96)	118 (12.125)	963 (97.08)
3. Do you agree that the proposal to reclassify to POM would help the pharmacist to monitor use in patients who would benefit from the prescription of Codeine linctus?	510 (54.31)	286 (30.46)	143 (15.23)	939 (94.66)
4. Do you agree that pharmacist training materials would help to educate pharmacists and patients?	590 (63.51)	137 (14.75)	202 (21.74)	929 (93.65)
5. Do you agree that the proposal to reclassify would have little impact on primary care?	366 (40.26)	396 (43.56)	147 (16.17)	909 (91.63)

Example responses to Question 5:

“There will not be any impact on primary care. There has been a shortage of Codeine linctus for the last few years and the primary care have not seen an increase in demand for codeine prescriptions. So it will not impact at all.”

“There should be very little use of Codeine linctus over the counter as it would be hope that most pharmacies would not sell it anyway”

“Very few patients try to buy Codeine linctus over the counter anyway - it is a red flag as soon as someone asks for it. There are plenty other cough suppressants available”

“It will likely have an impact though minimal because if misuse is identified individuals should have care provided by specialist drug treatment services and for genuine physical health needs it would usually be more appropriate to have on prescription.”

“GPs would be able to monitor potential addiction more easily.”

“May have more addicted to codeine coming forward which would impact primary care but in a positive manner”

“I suspect this will adversely affect primary care as it will generate, in the short term, a large volume of patient contacts to discuss the need for a Codeine linctus that were previously able to buy OTC. This may also bring up discussion about dependence and other underlying social needs not otherwise engaged with.”

“Initially I think this would increase demand. However, if prescribing is managed well and this is only used when absolutely necessary, patients would soon realise they are unlikely to be successful in asking for it so demand should hopefully drop again. I think this risk is outweighed by the benefits.”

“Depends on utilisation of pharmacist prescribers”

“As stated demand will rise and we Will be even more overwhelmed. The population over years have finally learnt we don’t issue cough linctus just as there is no longer such a thing as a tonic! We are not in the 1950’s”.

“save lines [lives?] and addiction long term”

“Requires people to book an appointment to acquire a prescription to address a severe cough, so burden on primary care increases.”

“I would have to seek additional GP appointment when I don’t yet necessarily need one. I acknowledge that I may have already or may need to eventually see the GP but not necessarily at the point I need to use the medication.”

“It will add to number of people wanting to visit already hard pressed GP’s to obtain a winter cough remedy - just bureaucracy to further inflate the already overloaded NHS”

“I do not think the impact will be unreasonable, it may result in higher volumes of requests at surgeries for the medication, though that may end up helping in the long run”

“To prevent an impact on primary care processes need to be put in place to ensure availability through other health professionals.”

“May result in more patients seeking a GP appointment but if advised appropriately by the pharmacist this should be minimal”

“I have never recommended codeine in a Pharmacy for a cough and have never prescribed it in practice or in 111 for this either. Any impact would vary with locality as it always does. The difference is we would find the patients already at risk of harm or suffering harm.”

Annex 2

Demographics

Figure 3. Distribution of respondents age (years)

-	Number of respondents
0-17 years	0
18-30 years	148
31-45 years	325
46-60 years	261
61 years and over	128

Figure 4. Distribution of respondent profession / familiarity with codeine linctus

-	Number of respondents
Member of the public/patient	220
Patient representative organisation	6
Healthcare professional	573
Trade/professional association/organisation	31
Personally experienced in the effects of codeine linctus	39

Figure 5. Distribution of respondents by geographical area

-	Number of respondents
United Kingdom	201
England	544
Northern Ireland	25
Scotland	64
Wales	38

Table 2. Declared ethnicity of respondents

a.     Any other Asian background	0
b.     Any other Black/African/Caribbean background	3
c.      Any other ethnic group	3
d.     Any other mixed ethnic background	3
e.     Asian/Asian British – Bangladeshi	10
f.       Asian/Asian British – Chinese	9
g.     Asian/Asian British – Indian	51
h.     Asian/Asian British – Pakistani	23
i.       Black/African/Caribbean/Black British – African	11
j.       Black/African/Caribbean/Black British – Caribbean	2
k.      Mixed ethnic group – White and Asian	1
l.       Mixed ethnic group – White and Black African	0
m.    Mixed ethnic group – White and Black Caribbean	4
n.     Not Known	10
o.     Other ethnic group – Arab	11
p.     Prefer not to say	92
q.     White – Any other White background	76
r.       White – English/Welsh/Scottish/Northern Irish/British	529
s.      White – Travellers	2
t.       White – Irish	20

1. The Human Medicines Regulations 2012 ↩