Evidence review: Patient information and support

National Guideline Centre (UK)

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Evidence review: Patient information and support

Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults

Evidence review A

NICE Guideline, No. 215

National Guideline Centre (UK).

London: National Institute for Health and Care Excellence (NICE); 2022 Apr.

ISBN-13: 978-1-4731-4508-5

1. Information and support for people who are being offered, taking or stopping prescribed medicines associated with dependence or withdrawal symptoms

1.1. Review question: What information and support is needed by people who may develop dependence, or who have developed dependence or withdrawal symptoms and their families and carers

1.1.1. Introduction

Perceptions about starting, switching, and stopping medicines that cause dependence or withdrawal have many influences including the views of the person with pain, those around them and the prescriber about medicines and their choice of treatment, . Additionally, previous experiences, confidence in making changes, representation of the roles of and harms of medicines in the media and current personal circumstances will nuance the person’s decision about what is best for them. This means it is particularly important for the prescriber to listen to the patient’s story and consider his or her context before initiating a conversation about starting, switching, or stopping these medicines.

People who are prescribed medicines associated with dependence or withdrawal require up-to-date information about their treatment options including information on effectiveness, benefits, harms, and reasonable alternatives for their treatment, including the option to take no action. While these medicines can be of benefit, they can also cause serious harm, especially when taken long term. Shared decision-making and consent are fundamental to good medical practice and are particularly important for medicines associated with dependence or withdrawal. This review intends to explore what elements patients, their families and carers feel are important, as well as what’s lacking in conversations with healthcare professionals about medicines associated with dependence and withdrawal and what information and support, they would like to receive.

People require information before the start of their treatment, so that they can provide properly informed consent. They also require up-to-date information and support during their treatment and when considering withdrawal from one of these medicines, as well as during the withdrawal process itself.

1.1.2. Summary of the protocol

For full details see the review protocol in Appendix A.

Table 1

PICO characteristics of review question.

1.1.3. Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and the methods document.

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

1.1.4. Qualitative evidence

1.1.4.1. Included studies

Twenty-eight qualitative studies were included in the review;²¹^, ²²^, ⁸⁴^, ⁹⁴^, ¹⁰⁶^, ¹²⁰^, ¹³⁴^, ¹⁴²^, ¹⁵¹^, ¹⁵²^, ¹⁶³^, ²⁰⁶^, ²²⁹^, ²⁴⁴^, ²⁷⁸^, ²⁸⁷^, ³¹⁶^, ³¹⁹^, ³²⁵^, ³²⁸^, ³⁹⁸^, ⁴⁵²^, ⁴⁵⁶^, ⁴⁶¹^, ⁴⁶⁸^, ⁴⁸⁷^, ⁴⁹²^, ⁵⁰⁷ these are summarised in Table 2 below. Key findings from these studies are summarised in the clinical evidence summaries below (Table 3 to Table 5). See also Table 7 to Table 53 for full qualitative evidence tables. See also the study selection flow chart in Appendix C, study evidence tables in Appendix D, and excluded studies lists in Appendix F.

Evidence on different drug classes was stratified and summarised separately as prespecified in the review protocol. Ten studies were relevant to antidepressants, 14 for opioids and 4 for benzodiazepines.

Studies relevant to medicines that can be bought over the counter (OTC) such as codeine or co-codamol were also included for this question as the committee agreed information and support needs of people taking prescribed and OTC medicine will be similar and the evidence emerging from people taking OTC medicine will be applicable to people taking prescribed medicine and vice versa. One study was included reporting views of people taking codeine-containing medicines that they obtained OTC.

Both the views of people being prescribed medicine associated with dependence or withdrawal symptoms and health professionals working with them, including GPs and pharmacists, were included in the evidence. The majority of studies used semi-structured interviews and thematic analysis.

No evidence relevant to Z-drugs or gabapentinoids meeting the protocol criteria was identified.

As a large number of papers were identified for this review, inclusion of papers was halted once saturation was reached. Saturation is the point at which no new information emerged from studies that were found to match the review protocol. These studies are listed in Appendix E Table 55.

In this review the term ‘addiction’ is used where it was reported verbatim from the papers; instead, the term ‘dependence’ is used throughout the guideline.

1.1.5. Summary of studies included in the qualitative evidence

Table 2

Summary of studies included in the evidence review.

See Appendix D for full evidence tables.

1.1.6. Summary of the qualitative evidence

Table 3

Review findings (Opioids).

Table 4

Review findings (Benzodiazepines).

Table 5

Review findings (Antidepressants).

See Appendix E for full qualitative evidence tables.

1.1.6.1. Narrative summary of review findings for opioids

Review finding 1: Information on safety and risks, including addiction, dependence, tolerance and withdrawal

Many people expressed worries about addiction, tolerance, dependency, withdrawal, and problems with the regulation and supply of opioids. However, often, people did not fully understand the potential risks when first starting to take opioids. Many expressed frustrations with their GPs and wished more information had been provided. Often, people taking opioids found information on the above issues through browsing the internet and via other media sources. For example, several people said they learned of potential dependence and addiction to opioids through watching television programmes about celebrities addicted to them. This reliance on poor information sources could in some cases be caused by negative experiences and consequent feelings of disengagement from their GP and the health care system.

Commonly, patients did not know that there was a difference between physical dependence (leading to withdrawal) and addiction in terms of compulsive use. In absence of information, some people taking opioids only learned about withdrawal from the experience of stopping their own strong opioids suddenly and suffering a severe reaction. Patients were usually aware that there was a risk of opioid overdose, however, they did not perceive themselves to be at risk, with some attributing overdoses to intention rather than accidental misuse. When talking about over-the-counter opioids, people identified issues in terms of availability of these medicines and thought that addiction could be prevented through the use of information and in particular addiction warnings.

Explanation of quality assessment: very minor concerns about methodological limitations due to the majority of supporting studies having very minor or minor limitations due to recruitment methods introducing potential bias (including highly selective sampling, small sample size and participants responding to an advertisement) and only one study having moderate limitations (due to abovementioned concerns over recruitment and the potential influence of the researcher on the findings not being discussed); no concerns about coherence; minor concerns about relevance with moderate limitations in one study due to the sample population being made up of people with addiction to over-the-counter opioids rather than NHS prescribed opioid medications (people only on prescription opioids were excluded), minor limitations in one study due to participants being taken solely from an RCT with a different aim/design, and very minor or no concerns in the other three supporting studies; and no concerns about adequacy; no concerns about adequacy. Overall assessment of confidence was high as concerns over methodological limitations and relevance were minor, and the wealth of information supporting the theme strengthened our confidence.

Review finding 2: Information on appropriateness of medication & lack of alternatives

Accepting that there were no better or alternative explanations, interventions, or cures available, was found to influence people’s attitudes towards starting or continuing opioid medication. People found that information and reassurance about the appropriateness of opioid treatment were useful, particularly when having doubts about whether to start taking them. These doubts were usually due to a patient’s fear of addiction. These fears were often countered with education about appropriate use of the medications, including the risks of escalating doses, uncontrolled use, and opioid-related euphoria (‘highs’).

Explanation of quality assessment: minor concerns about methodological limitations due to the three supporting studies having very minor or minor limitations due to recruitment (in one study the majority of the sample consisted of people recruited in a clinical trial and as the paper reported being biased towards people interested in nonmedication pain management options) or inadequacy or lack of detail about data analysis; no concerns about coherence; very minor concerns about relevance with very minor concerns in two studies due to participants being taken from a different trial, one of which was more focussed on non-medical pain management; very minor concerns about adequacy due to this research finding being supported by three studies. Overall assessment of confidence was high.

Review finding 3: Pain management education

Pain management education is an important part of a patient’s pain management and if done well and in a timely way can help prevent opioid misuse. Persistent pain, made worse by poor pain management, was seen as an important influence of participants’ experience of misusing opioids; it was not only physical pain that influenced opioid dependence but also the psychological and emotional impact of balancing pain and life responsibilities, where pain management strategies might provide help. Pain management education was particularly identified as an important part of the opioid tapering process. Many patients reported that they received little or no advice from health care professionals about how to manage pain and withdrawal in the context of opioid tapering. When discussions with clinicians were had, often as required for prescription or referral, it was reported that generally only a small fraction of pain management strategies were discussed. Decreased opioid supply and withdrawal led some patients to pursue their own pain management strategies, with some seeking alternative opioid sources and consequent negative outcomes including overdose on counterfeit pills.

Explanation of quality assessment: minor concerns about methodological limitations with minor concerns in two studies due to unclear or inadequate data analysis (in one study some data was discarded due to lack of commonality among transcripts) and minor possibility of selection bias; no concerns about coherence; very minor concerns about relevance with minor concerns in one study due to participants being taken from an RCT and whom all had eventually developed opioid use disorder; and minor concerns about adequacy due to this research finding being supported by only two studies. Overall assessment of confidence was high.

Review finding 4: Realistic expectations of what health care professionals can provide

Clinicians described that there was often a difference between a patient’s expectations of what treatments their GP could provide and the reality of pain management. It was reported that clinicians could not always meet the patient’s expectations due to pressures to restrict opioid prescriptions, and that this was at odds with their consideration of opioids as the historical mainstay of treatment for patients with chronic pain.

Explanation of quality assessment: minor concerns about methodological limitations with minor concerns in one study due to an unclear statement of findings; no concerns about coherence; minor concerns about relevance with minor concerns in one study due to the study sample being limited to clinicians caring for people of lower socioeconomic status; serious concerns about adequacy due to research finding being based on one study in which the statement of findings was unclear. Overall assessment of confidence in this finding was low.

Review finding 5: Communicating the rationale for dose changes

The communication of the rationale for dose changes was something health care professionals found difficult. Some clinicians described experiences in which patients had angry, aggressive and sometimes violent responses, when clinicians altered their opioid prescriptions. Changes could also lead to complaints to patient advocates or hospital administrations. Clinicians found it difficult to receive complaints about perceived lack of concern for patients’ pain when they were trying to act in the person’s best interest and some described resistance to prescription changes as emotionally taxing and time intensive.

Explanation of quality assessment: minor concerns about methodological limitations with minor concerns in one study due to the unclear role of the researcher; no concerns about coherence; no concerns about relevance; moderate concerns about adequacy due to this research finding being based on only one study. Overall assessment of confidence in this finding was moderate.

Review finding 6: Importance of adherence

Health care professionals highlighted the importance of setting expectations for patients about adherence to their opioid treatment plan. This includes setting ground rules such as early refills and ensuring that the patient knows that prescribing practices would not be flexible.

Review finding 7: Information on impact on mood after cessation

Some participants reported that opioids had improved their mood and worried about depression and worsening mood after cessation. Participants described the opioids as immediate ‘relief from depression’ and sometimes had taken more medication to experience relief from depression.

Explanation of quality assessment: very minor concerns about methodological limitations with very minor concerns in one study due to unclear role of the researcher; no concerns about coherence; no concerns about relevance; moderate concerns about adequacy due to this research finding being based on only one study. Overall assessment of confidence in this finding was moderate.

Review finding 8: Sources of support

Several sources and forms of support for people taking opioids were identified. Peer support, including attending a pain management clinic where people could meet others with similar problems, helped people and their families process and overcome negative feelings around taking opioids, particularly around stigma. Online social support was seen as an important part of this. People valued the chance to speak to others online about their pain and opioid therapy; as part of this, sharing stories, support and tips for pain management were particularly valued. The non-judgemental aspect of peer support was identified as key for maintaining recovery and re-abuse prevention in those stopping opioid treatment. Health care professionals supported the use of online communities and thought they were of benefit to their patients. People often favoured online support groups rather than offline groups, such as alcoholics or narcotics anonymous, because of the time commitment involved and because it was easier to find support more tailored to their patient demographic online. In regard to Alcoholics Anonymous and Narcotics Anonymous specifically, some patients found the completely drug-free philosophy of these groups judgemental and unwelcoming when admitting the need for pharmaceuticals in their life. Social support, from family, partners and friends, was seen as key for supporting people through tapering of opioid medications, while most people going through opioid tapering identified the benefits of support from other patients who were doing the same and could share their experiences.

Internet support groups were also identified as helpful by those taking OTC opioids, as well as specialist NHS drug and alcohol treatment services and narcotics anonymous. Two online support groups that were identified by OTC users were Overcount and Codeinefree; these were the most positively viewed source of support by those who identified them, with their positive confirmatory function valued most highly.

Explanation of quality assessment: very minor concerns about methodological limitations due to all supporting studies having very minor or minor limitations due to recruitment methods introducing potential bias (including highly selective sampling, small sample size, and participants responding to an advertisement); no concerns about coherence; minor concerns about relevance with moderate concerns in one study due to minor concerns about relevance with moderate limitations in one study due to the sample population being made up of people with addiction to over-the-counter opioids rather than NHS prescribed opioid medications (people only on prescription opioids were excluded) and very minor or no concerns in the other three supporting studies; and no concerns about adequacy. Overall assessment of confidence was high.

Review finding 9: Relationship with health care professionals

People who had gone through opioid tapering explained that a positive relationship with a health care provider was key in their willingness to initiate and sustain dose reductions. Attributes that were identified as positive were: being supportive, non-judgemental, flexible and accessible. Patients who had positive experiences talked about effective patient-clinician communication, and included the importance of mutual honesty as a prerequisite for successful opioid tapering. Confirming this, patients who had negative interactions with clinicians thought that their clinicians had not been honest about reasons for tapering, for example suspecting institutional anti-opioid pressures. Conversely, some patients described the negative impact of a poor relationship with their health care professional as sometimes enabling their addiction. Feeling judged and not being believed were commonly reported negative experiences in interactions with health care professionals.

People addicted to OTC opioids explained that they often did not seek GP advice due to either poor existing relationships, the hidden nature of the issue, or concerns about a record being made of their addiction. People in this group felt that health care professionals thought of OTC medicine addiction as less serious than other addictions.

Explanation of quality assessment: very minor concerns about methodological limitations due to all supporting studies having very minor or minor limitations due to recruitment methods introducing potential bias and unclear or inadequate data analysis (in one study some data was discarded due to lack of commonality among transcripts); no concerns about coherence; minor concerns about relevance with moderate concerns in one study due to minor concerns about relevance with moderate limitations in one study due to the sample population being made up of people with addiction to over-the-counter opioids rather than NHS prescribed opioid medications (people only on prescription opioids were excluded) and very minor or no concerns in the other three supporting studies; and no concerns about adequacy. Overall assessment of confidence was high.

Review finding 10: Support in decision making

Participants described being given little or no information about their new medications and often couldn’t distinguish between opioids and other drugs. Some participants described adverse effects that reflected a lack of understanding that could be associated with a lack of information from health care professionals. Over time, they developed a more active role in developing coping strategies and making decisions related to pain management that was less reliant on opioids alone. Medication-related decisions were frequently made without consulting the health care professionals.

Explanation of quality assessment: very minor concerns about methodological limitations with very minor concerns in one study due to the role of the researcher not being discussed; no concerns about coherence; no concerns about relevance; and moderate concerns about adequacy due to the research finding being based on only one study. Overall assessment of confidence was moderate.

Review finding 11: Need for empathy/acknowledgement of pain

Participants believed that the extended time taken for diagnosis and treatment was a consequence of the pain being invisible. This was discussed on an individual level where patients minimised, or ignored their own pain or on a social level where their families became used to seeing them in pain and became indifferent to it. Participants described the challenges to get healthcare professionals to believe and take their pain seriously. They explained that they had to attend several times or wait until their pain led to physical symptoms such as mobility issues before they were believed. This led to long waiting times and delays before receiving appropriate care.

Review finding 12: Support in cessation/tapering

Most patients stopped taking opioids without the recommendation or guidance of a physician. Some stated that their physician had discouraged them from quitting or even wanted to increase their dosage. For those that had been advised to stop, several had quit in preparation for surgery or due to another medical condition or because they were ineffective. Several participants described being coached or supported through quitting. “Well, he told me to contact him on email if I had any problems so he could slow down the taper or if I was fine maybe he could get me off it quicker, but I was always in contract with him”.

Review finding 13: Need for tailored support

Patients identified a need for more tailored support which more specifically addressed the person’s needs. Patients who described positive experiences with health care professionals explained that their clinicians took the time to learn about their needs, build mutual trust and devise individualised plans, particularly for opioid tapering. Open-ended discussions and exchanges of information initiated by questions such as ‘how are the pain medicine working for you?’ and ‘what problems are you having?’ were seen as particularly useful for establishing a supportive relationship. Patients preferred it when they did not receive a ‘one-size-fits-all’ approach. Positive experiences were reported when health care professionals were willing to adjust tapering plans based on a patient’s experience or in response to a patient’s emotional state and health status. Conversely, people who had negative experiences felt that their clinicians did not listen to them or individualise tapering plans, and instead, stuck to an inflexible plan once started.

Some people felt that tailored support should be separate from the community support for those people addicted to non-prescription drugs. People who had tried both online and offline community support expressed a need for a tailored support environment which included people with a shared demographic, socioeconomic, environmental and medication histories. Some people felt that there was not currently a specific support group that focused on the needs of non-cancer chronic opioid therapy patients.

Explanation of quality assessment: minor concerns about methodological limitations with minor concerns in two studies due to unclear or inadequate data analysis (in one study some data was discarded due to lack of commonality among transcripts); no concerns about coherence; no concerns about relevance; and minor concerns about adequacy due to the research finding being supported by only two studies. Overall assessment of confidence was high.

Review finding 14: Multimodal care and coordination between providers

Clinicians and patients acknowledged the complexity of chronic pain and long-term opioid treatment, issues with personalised pain care delivery and the need for better multimodal care in chronic pain. Patients identified a need for better coordination between their primary care clinician and other specialists involved in their care as this could lead to separate and even conflicting care plans. Some patients felt responsible for their own care coordination and making sense of plans that lacked coordination.

Explanation of quality assessment: very minor concerns about methodological limitations with very minor limitations in one study due to most themes not relevant to review, no concerns about coherence; no concerns about relevance; and minor concerns about adequacy due to the research finding being supported by only one study. Overall assessment of confidence was moderate.

Review finding 15: Emotional support

Emotional support was an important factor for people taking opioids. Patients described significant emotional distress as a result of their opioid use, and in some cases, this was severe enough to seek mental health counselling. Sources of this emotional distress identified included the stigma associated with opioid use, the fear that stricter prescription regulations might limit their access to opioids and distress associated with reliance on medication for their well-being. The tapering process, and the changes and life adjustments it requires, was in particular identified as an experience that needed emotional support. People going through the tapering process explained that discussions with health care professionals tended to focus on opioid dosing and medically prescribed pain treatments, while discussions about day-to-day experiences, social relationships, and their emotional state were rare.

Explanation of quality assessment: minor concerns about methodological limitations with very minor or minor limitations in two studies due to unclear role of the researcher and lack of detail or inadequate data analysis (in one study some data was discarded due to lack of commonality among transcripts); no concerns about coherence; moderate concerns about relevance due to serious concerns in one study which was conducted in the USA, reportedly at a time of increasing pressures on providers to reduce opioid doses and on patients who were receiving care from an integrated delivery system as Kaiser Permanente Northwest location health plan members, who may not share the same views to people in primary care in the UK, and due to recruitment of participants whose pain interference score suggested that opioid treatment was not fully successful in managing their pain who may hence hold different views to patients whose opioid treatment has been successful; and minor concerns about adequacy due to the research finding being supported by only 2 studies. Overall assessment of confidence in this finding was low.

Review finding 16: Family support

Family support was considered essential when dealing with chronic pain and its emotional burden. That dependence on their help also raised perceptions of being a burden to their family. Sometimes participants felt neglected when their family got used to seeing them in pain.

Review finding 17: GP supervision

Another form of support identified was GP supervision of prescriptions and codeine intake. People who received prescription opioids through repeat prescription reported few restrictions on amounts and frequency, which could for some, result in increased intake. Minimal supervision from a health care professional was seen as a facilitator for increasing doses of opioids over their initial consultation, increasing the chance of dependence. Some people felt that they had been prescribed opioids as a first-line response to pain, even when they were motivated to try other pain treatments, and that they were sometimes prescribed opioids to ‘get rid of them’ rather than a GP taking the time to deal with underlying problems or referring to specialist services. Where people engaged with their GP regarding their codeine use, either due to GP instigated follow-up consultations concerning their use of codeine or to the participant asking for an appointment, their GP was able to help via effective interventions such as tapering codeine and replacing compound products with pure codeine formulations. This suggests that in an environment where GPs have resources to support the patient, they reduce the likelihood of harm occurring.

Explanation of quality assessment: moderate concerns about methodological limitations with moderate concerns in one study due to recruitment (majority of participants contacted the researchers if they wanted to take part, possibly making them more motivated to give stronger or more negative views) and the potential influence of the researcher on the findings not being discussed; no concerns about coherence; no concerns about relevance; moderate concerns about adequacy due to research finding being based on only one study. Overall assessment of confidence in this finding was moderate.

Review finding 18: Role of pharmacists

For people taking opioids, their relationship with their pharmacist was often seen as less important to them than their relationship with their GP. People did not establish a strong relationship with a single pharmacist due to accessing multiple pharmacies and the short amount of time spent interacting with them when buying codeine. This meant that a patient’s relationship with their pharmacist provided less support, risk education, opioid use regulation or interventions than their GP. However, people explained that they were more likely to go to their pharmacist due to easier and quicker access than a GP appointment.

Review finding 19: Referral to specialists

People taking opioids who were referred by the GP to specialist drug and alcohol services described this as a positive experience. However, there were views that such services were not set up to accommodate people with OTC opioid addiction. Issues with these settings included the mixing of clients with different addictions and the perception that staff viewed OTC addition as a less problem and did not have the experience to deal with OTC addiction.

Explanation of quality assessment: minor concerns about methodological limitations with minor concerns in one study due to unclear role of the researcher and lack of details about data analysis; no concerns about coherence; moderate concerns about relevance with moderate concerns in one study due to a focus on addiction to over-the-counter medications and exclusion of people addicted to only NHS prescribed opioids; moderate concerns about adequacy due to research findings being based on only one study. Overall assessment of confidence in this finding was low.

Review finding 20: Help accessing benefits

Clinicians were aware of the limitations that poverty posed in terms of the care that patients could access and raised how their work involved obtaining health benefits and other financial benefits for patients.

Explanation of quality assessment: minor concerns about methodological limitations with minor concerns in one study due to the unclear statement of findings; no concerns about coherence; minor concerns about relevance with minor concerns in one study due to the study sample being limited to clinicians caring for people of lower socioeconomic status; serious concerns about adequacy due to this research finding being based on very limited information from one study. Overall assessment of confidence in this finding was low.

1.1.6.2. Narrative summary of review findings from benzodiazepines

Review finding 1: Short-term length of prescription

GPs considered benzodiazepines to be useful in assisting with acute stressful situations as long as patients were informed that they would only be prescribed on a short-term basis. Health professionals reported that they set a clear time limit within a relatively short time frame, especially for new prescriptions of benzodiazepine, emphasising that ‘when you start it, you must have a plan to stop it’. Most practitioners believed that it was extremely difficult to break the habit of benzodiazepine use once it had become a lifestyle and blamed their predecessors who prescribed the medication without setting a time limit for its use. These views were shared by their fellow pharmacists, who also tend to believe that prescriptions are renewed too readily. One experienced pharmacist in particular condemned prescribing the medication on long-term basis saying benzodiazepines should be used wisely on a short-term basis. Many health professionals believed that their use is appropriate in a short-term basis and in specific circumstances such as life crisis or following a psychiatric diagnosis, but most appeared to concur that chronic use is a life habit, devoid of intrinsic medical goals other than a quick solution and deplore the ensuing dependency on and increased tolerance for the drug, which results in higher dosage to obtain the same effect.

Explanation of quality assessment: minor methodological limitations with minor concerns in one study (due to the potential influence of the researcher not being discussed and themes occasionally illustrated by single quotes) and very minor concerns in the other contributing study (due to the potential influence of the researcher on the findings not being discussed); no concerns about coherence; minor concerns about relevance due to the information only emerging from health professionals and not people taking benzodiazepines; no concerns over adequacy with sufficient information from two studies to support the theme. Overall assessment of confidence was moderate due to minor concerns over methodological limitations and relevance.

Review finding 2: Addiction potential, safety and withdrawal symptoms

GPs typically reported providing patient education when they prescribed benzodiazepines, including advice that they were addictive, were only to be used short term and withdrawal symptoms may occur when the drug was stopped. Users who had positive interactions with health professionals while using benzodiazepines, reported their GP was advising them that the medicine could be addictive.

In the eyes of benzodiazepine users, the message conveyed by the media about their prescribed medicine was confusing, with users hearing that the use is too widespread and on the other hand that the drug is not overly dangerous. People appear to selectively retain information that confirms their way of thinking about the issue. Some enquire about a seemingly miracle drug while others seek further information about various side effects. To justify their habit, users appeared to downplay the potential side effects, for example reporting the drugs are not that powerful and comparing them to narcotics. People taking benzodiazepines felt immune from side effects and attributed memory loss to normal aging rather than the medication. Some, although aware of the inherent potency of benzodiazepines, had a false sense of control related to the fact that it could be taken in limited quantities.

Some older adults reported concerns about withdrawal symptoms or relapse in their health condition if they stopped taking benzodiazepines, including worsening of original symptoms. Most participants when asked in a hypothetical scenario about lowering the dose or frequency of their medication, were accepting of this idea or despite having some concerns were willing to try this approach.

Explanation of quality assessment: minor methodological limitations with minor concerns in one study (due to the potential influence of the researcher not being discussed and themes occasionally illustrated by single quotes), very minor concerns in one study (due to the recruitment strategy) and very minor concerns in the other contributing study (due to the potential influence of the researcher on the findings not being discussed); no concerns about coherence; minor concerns over relevance due to the patient sample contributing to the theme being limited to older adults whose concerns and information and support needs may slightly differ from those of younger populations taking benzodiazepines; no concerns over adequacy with sufficient information from two studies to support the theme. Overall assessment of confidence was moderate due to minor concerns over methodological limitations and relevance.

Review finding 3: Consequences of long-term use and benefits of stopping

A small number of GPs mentioned reinforcing the benefits of ceasing benzodiazepines, describing problems that could arise from ongoing use, associating the person’s current ill health with use or raising the possibility that some people may already be addicted. They reported conducting a thorough assessment of benzodiazepine use and health, explaining the benefits of stopping use. The typical reasons identified by GPs for patients successfully completing a dose reduction regime included perceived benefits in ceasing. Long-term elderly users of benzodiazepines expressed concerns about the impact of drug use on their health citing memory problems and the absence of benefits associated with their benzodiazepine use for example noting that they have not been useful in helping them sleep; leading patients to question their usefulness. Many reported that they had previously tried stopping benzodiazepines unsuccessfully. Those who viewed stopping as desirable expressed concerns with the impact of drug use on their health and the absence of benefits. Several older adults reported concerns about long-term use, with one acknowledging “I don’t think I’m immune to dependency problems”. However, many explained how stopping was not desirable with some expressing fear that symptoms of anxiety would return if the drug was stopped or argued that because of age, the benefits of stopping would not outweigh the disadvantages. Some reported that stopping would not be desirable precisely because they were dependent, with some evoking withdrawal symptoms or questioning ‘what good would it do to stop’ at their age. Another reason given for the undesirability of stopping was that participants did not want to physically distance themselves completely from benzodiazepines, wishing to keep a supply ‘in reserve’ in case they experience a problem or a crisis.

Explanation of quality assessment: moderate methodological limitations with minor concerns over one study (due to the potential influence of the researcher on the findings not being discussed and themes occasionally illustrated by single quotes), very minor concerns over another study (due to the recruitment strategy and serious concerns in the other contributing study (due to the role of the researcher not being explored, the recruitment strategy with participants selected for a different project, the data analysis being unclear); no concerns about coherence; minor concerns over relevance due to the patient sample contributing to the theme being limited to elderly long-term users whose concerns and information and support needs may slightly differ from those of younger populations taking benzodiazepines; no concerns about adequacy, this finding was supported by sufficient information from two studies. Overall assessment of confidence was low due to concerns over methodological limitations and relevance.

Review finding 4: Rationale for medication and benefits

People who had positive interactions with health professionals while using benzodiazepines also reported their GP was providing them with a rationale for the treatment while many perceived that medication was too easily prescribed. Long-term elderly users of benzodiazepines, expressed concerns about the impact of drug use on their health, citing memory problems and the absence of benefits associated with their benzodiazepine use, for example citing that they have not been useful in helping them sleep, leading patients to question their usefulness.

Explanation of quality assessment: moderate methodological limitations with minor concerns over one study (due to the potential influence of the researcher on the findings not being discussed and themes occasionally illustrated by single quotes) and serious concerns in the other contributing study (due to the role of the researcher not being explored, the recruitment strategy with participants selected for a different project, the data analysis being unclear); no concerns about coherence; minor concerns over relevance due to the patient sample of one study contributing to the theme being limited to elderly long-term users whose concerns and information and support needs may slightly differ from those of younger populations taking benzodiazepines or those who have not been using benzodiazepines longer; moderate concerns over adequacy with relatively limited information from two studies supporting the theme. Overall assessment of confidence was very low due to concerns over methodological limitations, relevance, and adequacy.

Review finding 5: Alternative treatment approaches

GPs working with people taking benzodiazepines appeared to prescribe alternate medication if appropriate (particularly antidepressants) or encouraged patients to use non-drug therapies such as coping strategies, relaxation, and counselling. Contrarily, when working with more mature adults, health professionals appeared to be influenced by the prevailing perceptions of aging and sometimes made remarks with strong ageist undertones, especially in relation to possible alternatives to prescribing psychotropic medications for older patients. For example, appearing reluctant to send elderly patients to psychological therapy.

Explanation of quality assessment: minor methodological limitations with minor concerns in one study (due to the potential influence of the researcher not being discussed and themes occasionally illustrated by single quotes) and very minor concerns in the other contributing study (due to the potential influence of the researcher on the findings not being discussed); no concerns about coherence; moderate concerns over relevance due to the information supporting theme emerging from the practice of health professionals rather than the thoughts of patients themselves and the theme being of potentially limited applicability to long-term benzodiazepine users of more mature age whose health professionals may be reluctant to provide alternative approaches; moderate concerns over adequacy with relatively limited information from two studies to support the theme. Overall assessment of confidence was very low due to concerns over methodological limitations, relevance, and adequacy.

Review finding 6: Administration of benzodiazepines

People who had positive interactions with health professionals while using benzodiazepines also reported their GP was providing them with information on when to take the tablets. Although they acknowledged that GPs provided some information on the use of benzodiazepines, they typically perceived the information as inadequate or limited. There was also a perception that the medications were too easily prescribed, that scripts were often written without seeing the GP and that cessation of use was never discussed.

Review finding 7: Information from pharmacists

People on benzodiazepines commented on their interactions with pharmacists which appeared to be variant, with pharmacists more likely to advise not to drink alcohol while using medication or not to use certain medications while on benzodiazepines due to drug interaction. Some pharmacists provided information leaflets on benzodiazepines while others questioned why the participant was taking it. Pharmacists were often seen as either not providing any information on the medications or providing inadequate information.

Explanation of quality assessment: minor methodological limitations (due to the potential influence of the researcher on the findings not being discussed and some findings supported by single quotes); no concerns about coherence; moderate concerns about relevance with the need for more information from pharmacists emerging from peoples’ dissatisfaction with the information they are given by pharmacists probably reflected as a result to a prompted question rather than directly emerging as a source of information people wish to have; serious concerns about adequacy with limited information from one study supporting the theme. Overall assessment of confidence was very low due to concerns over methodological limitations, relevance, and adequacy.

Review finding 8: Tailored information for older adults

Doctors and pharmacists reported that the transmission of information is not always adapted to the older patient’s special needs and is done too quickly to permit sound management of the medication. Some admit their lack of knowledge and expertise in working with older people and fear that this information gap may be detrimental to the quality of their discussions with older patients.

Explanation of quality assessment: very minor methodological limitations (due to the potential influence of the researcher on the findings not being explored) that were too minor to lower our confidence; no concerns about coherence; minor concerns over relevance with information supporting the theme only emerging from health professionals rather than people taking benzodiazepines; serious concerns about adequacy with limited information from one study supporting the theme. Overall assessment of quality was low due to concerns about relevance, and adequacy.

Review finding 9: Support with cessation

People taking benzodiazepines often reported they had previously tried stopping but were all current users. Weaning off medication appeared troublesome, often giving rise to feelings of discouragement, especially if undertaken under medical supervision or advice. Ideas of future attempts were sometimes discarded, which contributed to long-term use. Many explained how stopping was not desirable with some expressing fear that symptoms of anxiety would return if the drug were stopped or argued that because of age, the benefits of stopping would not outweigh the disadvantages. Some reported that stopping would not be desirable precisely because they were dependent, with some evoking withdrawal symptoms or questioning ‘what good would it do to stop’ at their age. Another reason given for the undesirability of stopping was that participants did not want to physically distance themselves completely from benzodiazepines, wishing to keep a supply ‘in reserve’ in case they experience a problem or a crisis.

Older adults reported their experiences of attempting to stop had included relapse symptoms and withdrawal symptoms. Others without personal experiences had concerns relating to experiences of friends or family or from reading about cessation. When asked if they would consider discontinuing benzodiazepine in a hypothetical scenario the most common response was resistance.

GPs acknowledged that cessation of benzodiazepine use was a long-term process and that tailoring reduction regimes to a person’s coping ability was important. Individually tailored dose reduction schedules were also reported as a useful strategy for cessation by patients. However, some professionals seemed to have given up trying to wean long-term users off benzodiazepines because of the perceived difficulty in educating these particular patients about the benefits of a drug-free lifestyle. The same was true for some pharmacists who were not proactive.

Explanation of quality assessment: moderate methodological limitations with serious concerns over one study (due to the influence of the researcher on the findings not being discussed, concerns over the recruitment strategy with participants selected for a different project, and the data analysis being unclear in one study), minor concerns in one study (due to the potential influence of the researcher on the findings not being discussed and some findings supported by single quotes), very minor concerns in one study (due to the recruitment strategy) and very minor concerns in one study (due to the potential influence of the researcher on the findings not being discussed); no concerns about coherence; no concerns about relevance; no concerns about adequacy. Overall assessment of confidence was moderate due to the concern over methodological limitations identified.

Review finding 10: Sources of support during cessation

Obtaining additional support from health professionals other than their GP (such as pharmacists, local mental health services, community pharmacists, community counselling services) was a factor identified by some GPs for patients successfully completing a benzodiazepine dose reduction regime. People taking benzodiazepines also reported seeking assistance from other health professionals apart from GPs for cessation. A perception that their doctor was unsupportive (e.g., had not given them sufficient assistance, continued to write prescriptions, never questioned whether they were still needed) was identified by benzodiazepine users as a reason contributing to an inability to cease use.

One of the less frequently identified factors highlighted by people on benzodiazepines as contributing to an inability to cease use was the absence of an appropriate support network (feelings of isolation and being on one’s own, the cost of long-distance telephone calls to a specialist tranquiliser recovery service, lack of contact with individuals who had ceased use). Social factors such as family support or pressure, a partner, control of medication and a stable home or social environment were among the typical reasons identified by GPs for patients successfully completing a dose reduction regime. Family and friends were also regarded as a significant source of support with ceasing benzodiazepines.

Explanation of quality assessment: very minor methodological limitations (due to the potential influence of the researcher on the findings not being explored and findings occasionally supported by single quotes); no concerns about coherence; no concerns about relevance; minor concerns about adequacy with relatively sufficient information from one study supporting the theme. Overall assessment of confidence was moderate due to methodological limitations and concerns about adequacy.

1.1.6.3. Narrative summary of review findings for antidepressants

Review finding 1: Information on the need for medication

Some patients think that being prescribed antidepressants is vital for them and gladly accept the treatment option, with the medicines being viewed as important to maintaining a normal life, as supplying an otherwise deficient substance ‘needed’ to function normally. The belief that suffering from a chronic condition, and thus needing lifelong medication also emerged as a factor influencing discontinuation for some. Many people, however, appear to have concerns about whether or not they actually need their medicines before treatment initiation. Some people resisted the suggestion of taking antidepressants and experienced dilemmas and uncertainty about: the use of medicines continued as treatment progressed, whether it was essential to take the antidepressant, and whether it was actually needed. Some reported feeling reluctant and apprehensive about taking their prescribed antidepressants, thinking that: their effects are likely to be short term, they are not going to help resolve the depression, or because of concerns over their side-effects or long-term adverse effects. Many expressed concerns at the speed with which GPs offered medication, usually as the sole treatment approach.

Explanation of quality assessment: moderate methodological limitations with moderate concerns in two studies (due to the potential impact of the researcher on the findings not being explored and issues with data richness with themes mostly supported by limited information and single quotes in one study and due to the lack of sufficient detail on the data collection method and analysis in the other study) and very minor concerns in one study (due to the potential influence of the researchers on the findings not being discussed and very minor concerns over potential bias in recruitment with participants having already been selected for a different project); very minor concerns about coherence with not all participants across contributing studies experiencing uncertainty towards their need for medication; no concerns over relevance; no concerns over the adequacy of information supporting theme. Overall assessment of confidence was moderate due to moderate methodological limitations and concerns about coherence being very minor.

Review finding 2: Information about what to expect from the medicine

People expressed strong views about wishing to be informed about their actual health conditions and medicines before treatment initiation. They appeared to feel unsure about what to expect once they started taking the antidepressant, how long it would take for the antidepressant to take effect, the extent to which it might help, and about what to expect in the first few weeks. In the absence of information from their doctors, before taking their first antidepressant tablet, some were reluctant to start their prescriptions. Some feared it could make them feel worse rather than better, that they could become addicted to medication or that it would seriously reduce their alertness, make them lose control over their life or even affect their personality. The need for information particularly occurred when participants started or changed an antidepressant with some reporting that they were unable to absorb or did not receive all the information they required during their initial consultation with their physician. To deal with peoples’ reluctance towards antidepressants, pharmacists appeared to demystify the use of antidepressants by describing in general terms how the medication works while stressing the psychological causes of depression.

Disconnected relationships with doctors were precipitated if patients were less informed about their health conditions and their prescribed medicines. A persistent tension was observed between ‘what was promised’ and ‘what was actually delivered’ in practice. Lack of information on their antidepressants appeared to be a key issue of dissatisfaction for many respondents’ expectations of them. People often sought information from the health care system or public sources and often felt the information they received from doctors was inadequate. Very few reported receiving helpful verbal information from their doctors; most reported receiving little or no information about depression and their antidepressants (e.g., side effects, length of treatment, expected treatment outcomes and benefits) and seeking out information from other sources, such as books, the media, friends and the internet.

Explanation of quality assessment: Minor methodological limitations with moderate concerns in two studies (due to concerns over recruitment in one study where participants contacted the researchers if they wanted to take part, hence being potentially more motivated to give stronger or more negative views and lack of detail or rigour of analysis and due to the lack of sufficient detail on the data collection method and analysis of the other study) but very minor concerns in two studies (due to the potential influence of the researchers on the findings not being discussed in both studies and very minor concerns over potential bias in recruitment in one study with participants having already been selected for a different project) and no concerns in one study; no concerns about coherence; no concerns about relevance; no concern about adequacy. Overall assessment of confidence was high as methodological limitations were minor and there were no further concerns to lower our confidence.

Review finding 3: Side-effects & long-term adverse effects

Although some described antidepressants as being a natural and bodily substance that could do no harm, the vast majority of people appeared worried about the dangers of being on antidepressants long-term and questioned why they had not been told. Several reflected on how they had not been warned about side-effects, how GPs had neglected to inform them when the medication was prescribed and how this lack of communication was a source of worry. Others who were informed often appeared worried or confused by lists of potential adverse drug reactions which led them to not take antidepressants as prescribed. The availability of information prompted some to request additional information about risks and benefits of specific antidepressants from their physician. Some had fears of becoming addicted to medication or that it would seriously reduce their alertness or change their personality. Many reported various side effects which they considered most troubling to them such as dizziness and sleep disruption, others highlighted they had lost their thinking capability, and/or memory as a result of long-term antidepressant medicines or experienced unexpected difficulties in performing their routine work while they were taking medicines. Adverse effects often appeared to amplify the degree of dissatisfaction with doctors or the health care system or altered their medicine behaviour (e.g., leading to discontinuation or withdrawal). Women struggling with sexual difficulties at an early stage of medication in particular, who had not been informed about them by their GPs, questioned whether their experiences were normal and felt that having more information at an early stage would have assisted them in coping.

Pharmacists reported that they prepared patients to deal with side-effects during the first meetings, describing the planned steps for the first weeks, and mainly focussed on the gradual increase in dosage and the possible occurrence of side-effects. They appeared to be aware that patients find it difficult to cope with side-effects and then persevere with antidepressant treatment without having experienced some degree of benefit. From the start, pharmacists invited patients to pay attention to side-effects, not to worry if they occur, not to stop the treatment but to contact their pharmacist or their doctor. Pharmacists reported they told patients that ‘side effects will often occur before the therapeutic effects and that they have to persevere. To help patients overcome hesitation towards antidepressant treatment, some pharmacists emphasised the benefits and the fact that potential side effects are quickly overcome.

Explanation of quality assessment: moderate limitations with serious concerns in one study (due to concerns over the design and data collection (retrospective analysis of independently submitted free text feedback from consumers) where the design was dictated by the data/consumer feedback process, results were reported interspersed with references and insights from other studies, making it unclear what conclusions were based on this study alone), moderate concerns in three studies (due to various methodological details being unclear in one study, the lack of sufficient detail on the data collection method and analysis in the other study, due to the potential impact of the researcher on the findings not being explored and issues with data richness with themes mostly supported by limited information and single quotes in one study), very minor concerns in two studies (due to the potential influence of the researchers on the findings not being discussed in both studies and very minor concerns over potential bias in recruitment in one study with participants having already been selected for a different project), no concerns over one study; very minor concerns about coherence with some contradictory information about the extent to which side-effects should be emphasised from the start between pharmacists and people taking antidepressants but the vast majority of information clearly indicating its importance; no concerns over relevance as concerns over applicability of the population (due to the study population (n=10) being very narrow and homogenous and hence of possibly limited relevance to the overall review population) were only associated with one contributing study and hence did not lower our overall confidence; no concerns about adequacy. Overall assessment of confidence was high due to the wealth of information supporting the finding strengthening our confidence despite the methodological limitations of the individual studies.

Review finding 4: Expected length of treatment at the start

People beginning antidepressants fretted over how long they would need to take the medicine for, while some reported they had not been given any verbal information at all, such as: not to stop taking their medication or whether they needed to continue after remission of depressive symptoms. Mentioning the limited duration of antidepressant usage at first prescription was found to facilitate the tapering process, with some patients accepting discontinuation advice reporting they knew from the start that they would stop as soon as possible and that their GP made it clear that the antidepressant treatment was only a temporary solution that would help but that the problem lies elsewhere.

Explanation of quality assessment: Moderate methodological limitations with moderate concerns over two studies (due to the role of the researcher on the findings not being discussed and due to issues with data richness with themes mostly supported by limited information and single quotes in one study, due to lack of sufficient detail on the data collection method and analysis) and no concerns over one study; no concerns about coherence; no concerns over relevance; minor concerns over adequacy, the finding emerging from three studies, one of which contributed particularly limited information, and due to concerns over data richness in one contributing study. Overall assessment of confidence was low due to moderate methodological limitations and concerns about adequacy.

Review finding 5: The time lag between treatment initiation and benefits

People appeared unsure about how long it would take for the antidepressant to take effect. Many described a period of uncertainty about the effects of antidepressants at the start of taking their medication. For some, when improvement was taking a long time, they started considering other solutions, such as raising the dosage, as they were disappointed in the effects of the prescribed medicine or experimenting with adding benzodiazepines when they were in stressful situations or when they could not sleep. Besides self-experimenting with benzodiazepines, some looked to improve their condition by adding, when necessary, their own alternatives, such as homeopathic medicines, psychological therapies.

Pharmacists describing the steps of the first weeks of treatment, referred to the time lag before experiencing beneficial aspects and were aware that patients found it difficult to cope with side-effects and then persevere with antidepressants without having experienced some degree of benefit. Pharmacists reported they told patients that ‘side effects would often occur before the therapeutic effects and that they have to persevere because unfortunately they start with the inconveniences’; they reported that ‘support in the first few weeks is important because the person is expecting a positive outcome and sometimes there are possible side effects that will occur at the start.

Explanation of quality assessment: Minor methodological limitations with moderate concerns in one study (due to concerns over participant recruitment as participants contacted the researchers if they wanted to take part, hence being potentially more motivated to give stronger or more negative views and lack of detail or rigour of analysis) and no concerns in the other two contributing studies; no concerns about coherence; no concerns about relevance; no concerns over adequacy, the theme emerging from three studies, one of which contributed very limited information but with sufficient information to support the theme overall. Overall assessment of quality was high as concerns over methodological limitations were minor and there were no further concerns to lower our confidence

Review finding 6: The benefits and positive aspects of medication

Pharmacists reported that many patients hesitate about taking antidepressants as they often fear; becoming dependent, having to take them for their entire life, or gaining weight. They also reported that patients are often embarrassed to come to the pharmacist with a prescription for antidepressants. In this situation, most pharmacists report they try at the first meeting to persuade patients to take or at least try the medication. To facilitate this, they give information about the treatment, emphasising the benefits and the fact that potential side effects are quickly overcome, making an effort to reassure patients and assuage their guilty feelings. Some pharmacists demystify the use of antidepressants by describing in general terms how the medication works while stressing the psychological causes of depression. Pharmacists also said they try to inspire hope by focusing on the positive aspects of treatment (e.g., the first benefits in four weeks) and being somewhat reticent about mentioning right from the beginning the long-term negative aspects patients may experience with medication (e.g., long duration, weight gain, decrease of libido).

Patients also reported being worried or confused by lists of potential adverse drug reactions, but most agreed that this information should be disclosed to patients. Some described the likelihood of experiencing an adverse drug reaction as the reason for not taking an antidepressant as prescribed. Online information prompted some participants to request additional information about the risks and benefits of specific antidepressants from their physician.

Explanation of quality assessment: very minor methodological limitations due to very minor concerns over one study (due to the potential influence of the researcher on the findings not being discussed) no concerns in the other contributing study; moderate concerns about coherence with pharmacists reflecting on the importance of focusing on the benefits rather than the potential risks of medication at the start of treatment while patients wishing to be informed about both; no concerns over relevance; no concerns about adequacy with two studies contributing to the theme but with rich information to support it. Overall assessment of quality was moderate due to concerns about coherence as methodological limitations were too minor to further lower our confidence.

Review finding 7: The consequences of stopping the medicine

People taking antidepressants wanted to know what could happen to them when they stopped taking medications. They appeared to experience uncertainty and fear about what would happen when medication use stopped (once they had become used to it and were feeling better), the potential for bad consequences when stopping antidepressants, the process of stopping itself, as well as the continuation of medication. In addition to anticipated problems, actual problems encountered during past attempts to stop instilled trepidation about future attempts to stop. Fear of recurrence or relapse appeared to be a great barrier to attempts to discontinue with people being afraid of reliving the negative feelings they had in the past and anticipated this recurrence, if they were to discontinue. Others described the fear of disturbing the balance or equilibrium they had achieved.

Explanation of quality assessment: Moderate methodological limitations with minor concerns over one study (due to concerns over recruitment with participants only recruited from one group practice within one primary care trust) but moderate concerns in two contributing studies (due to concerns over participant recruitment as participants contacted the researchers if they wanted to take part, hence being potentially more motivated to give stronger or more negative views and lack of detail or rigour of analysis in one study and due to issues with data richness with themes mostly supported by limited information and single quotes and the influence of the researcher on the findings not being discussed in one study); no concerns about coherence; no concerns over relevance; no concerns about adequacy with sufficient information from three studies supporting the theme. Overall assessment of confidence was moderate due to the methodological concerns identified.

Review finding 8: Internet resources

People prescribed antidepressants had used the internet to find information about different types of antidepressants and side effects, as well as to find out about others’ experiences with them. They reported using the internet to complement rather than replace information received from health professionals. The internet was often described as the first source of additional information when specific or unexpected information needs arose, especially among students and younger participants. It was perceived as valuable when fear of stigmatization and embarrassment limited communication in community pharmacies and, as a key component in the shift towards greater patient access to drug information, which was described as empowering. Most felt confident, relieved, and reassured after reading online antidepressant information. However, many were concerned about information quality and reliability, with some people doubting their ability to discriminate trustworthy information, and some being frightened by the information they retrieved. Two people, in particular, indicated that they would rather communicate face-to-face with a person and older people commonly preferred books, physicians, pharmacists and telephone services over the internet, particularly when an immediate answer was required.

Explanation of quality assessment: very minor concerns over methodological limitations due to very minor concern in one contributing study (due to the potential influence of the researcher on the findings not being explored) and no concerns in the other contributing study; moderate concerns about coherence with some people questioning the reliability of the information found online or preferring face-to-face contact and different sources of information over the internet; no concerns about relevance; no concerns about adequacy with sufficient information to support the theme emerging from two studies.

Review finding 9: Patient accounts and peer support

The use of the internet was also related to the need to maintain contact with the outside world and share experiences with peers. Discussion forums and electronic support groups were often used to read about other peoples' experiences taking antidepressants. People on antidepressants talked about how finding information about others’ experiences with drugs via internet forums helped them understand their own experience better. Those faced with uncertainty about stopping and addiction, said they tried as much as possible to collect information about the experiences of other users who had stopped using medications. However, some recognized that discussion forums could contain inaccurate or non-evidence-based information that could lead others to misuse antidepressants. Explanation of quality assessment: minor methodological limitations with moderate concerns over one study (due to concerns over participant recruitment with participants having contacted the researchers if they wanted to take part, hence being potentially more motivated to give stronger or more negative views and lack of detail or rigour of analysis), but very minor concerns over one study (due to the potential influence of the researcher on the findings not being discussed in one study) and no concerns in the third contributing study; minor concerns about coherence with some recognising that online forums through which patient accounts were accessed could contain inaccurate and potentially misleading information; no concerns about relevance; no concerns about adequacy. Overall assessment of confidence was moderate due to minor concerns over methodological limitations and coherence.

Review finding 10: Information and support through medical consultations

Physicians were generally considered the primary source of antidepressant information, and support from their doctor was seen as a key factor for coping with uncertainty about stopping or modifying their treatment. Yet some people reported having received no, little or conflicting information and advice from health professionals about issues such as the acceptable length of treatment, addiction and stopping. Being given sufficient information during consultations was recognised as positive and valuable, and key to the trust and rapport established between them and their health practitioner. These initial dialogues appear to be key to people developing a sense of agency with respect to their decision-making about taking antidepressants.

Explanation of quality assessment: minor methodological limitations with moderate concerns over one study (due to concerns over participant recruitment with participants having contacted the researchers if they wanted to take part, hence being potentially more motivated to give stronger or more negative views and lack of detail or rigour of analysis), but very minor concerns over one study (due to the potential influence of the researcher on the findings not being discussed in one study) and no concerns in the third contributing study; no concerns about coherence; no concerns about relevance; minor concerns about adequacy the theme emerging from three studies with relatively limited information. Overall assessment of confidence was moderate due to minor concerns over methodological limitations and adequacy.

Review finding 11: Patient leaflets

Some people taking antidepressants stated that they found patient information leaflets enclosed with their medication useful and that it was much less stressful reading quietly at home than trying to absorb what was being said to them in a surgery. However, a small number of people admitted that the patient information leaflet caused anxiety about side effects of medication and felt that the content could be more encouraging or reported using the internet to check the meaning of a medical term or to have additional information. Pharmacists also indicated that patient education tools, such as information leaflets could be useful in their efforts to support patients at the various stages of their treatment. A lot of information needs to be provided to patients, yet a consultation is usually only a few minutes long. Important information concerning the treatment is often not communicated to patients or often not remembered by them and the pharmacists often judged the information leaflets available in addition to the drug information sheet to be incomplete.

Explanation of quality assessment: minor methodological limitations with moderate concerns in one study (due to lack of detail on the method of data collection and analysis), but very minor concerns in one study (due to the potential influence of the researcher on the findings not being discussed) and no concerns in one study; minor concerns about coherence with a small number of people taking antidepressants and pharmacists not always finding patient leaflets that helpful, although this appears to be related to content of the leaflets they had encountered rather than patient leaflets as an information tool in general; no concerns about relevance; no concerns about adequacy. Overall assessment of confidence was moderate due to minor concerns over methodological limitations and coherence.

Review finding 12: Different means of communication

Telephone services such as drug information call centres were preferred over the internet if an immediate answer was required by people taking antidepressants. Many indicated they would communicate with their health professionals by email, although some perceived that their health professionals would be poorly equipped to respond to their questions in this manner.

Explanation of quality assessment: very minor concerns over methodological limitations in the contributing study (due to the potential influence of the researcher on the findings not being discussed) that were too minor to lower our confidence; no concerns about coherence; minor concerns about relevance with the information emerging from a study conducted in 2009, ever since health professionals might have become better equipped to respond to patients via email; serious concerns about adequacy with very limited information in one study supporting the theme. Overall assessment of confidence was very low due to the serious concerns over the adequacy of information supporting the theme and concerns over relevance.

Review finding 13: Type of information

People who had been taking antidepressants recognized that discussion forums could contain inaccurate or non-evidence-based information. Some people were concerned that discussion forums could lead other people to misuse antidepressants, although all reported being cautious themselves. Some people appeared to read online information targeted to health professionals, the main reason being to access the most up-to-date and comprehensive sources of information.

Explanation of quality assessment: very minor concerns over methodological limitations in the contributing study (due to the potential influence of the researcher on the findings not being discussed); no concerns about coherence; moderate concerns over relevance with the theme emerging from a study examining the views of people who had access to the internet, whose perceptions may differ from people who do not have internet access or due to the focus of the study (to assess how and why people use the internet to access antidepressant information and the self-reported impact of information obtained online) that may overestimate a person’s need for information via the internet, not providing any evidence about the type of information people may value via other sources; moderate concerns over adequacy with evidence on the type of information people taking antidepressants prefer only emerging from one study. Overall assessment of confidence was low due to moderate concerns over relevance and adequacy.

Review finding 14: Health professional support with adherence & self-monitoring

Pharmacists stated that non-adherence, especially non-persistence was a frequent problem among their clientele with antidepressant treatments and that one of their important goals was to have people stick to their medication. As one pharmacist particularly reported, they ‘have a very important support role at the start of therapy’ and that they ‘have to keep encouraging the client’. Actions taken by pharmacists following the identification of an adherence problem were usually in the form of a brief consultation at the counter and by the provision of advice and strategies to improve medication-taking behaviour.

Some people taking antidepressants had been told that they themselves were the best people to observe the effects of medication and were encouraged to keep themselves under review. Respondents found being invited to monitor their own progress and difficulties very helpful in building their self-esteem and putting them in control of their own recovery. Specific questions by GPs such as whether the person had noticed any changes, whether they had lost any weight, experienced panic attacks, or had problems with early morning waking or getting off to sleep at night, helped respondents understand their illness better and monitor for themselves their response to medication and their progress towards recovery.

Explanation of quality assessment: Minor methodological limitations with moderate concerns in one contributing study (due to concerns over the lack of sufficient detail on the data collection method and the data analysis) but no concerns over the other contributing study; no concerns about coherence; very minor concerns over relevance with information in one study emerging from pharmacists rather than people prescribed antidepressants; moderate concerns over adequacy with information on the need for professional support with adherence and self-monitoring, each emerging from one study. Overall assessment of confidence was low due to concerns over methodological limitations, relevance and adequacy.

Review finding 15: Support with tapering and discontinuation

Some people talked about not wishing to be on antidepressants for life but not yet being able to come off them. There also appeared to be great uncertainty and fear surrounding continuing, or what would happen when medication use stopped as people had become used to their medication and were feeling better. When given, antidepressant discontinuation advice was often seen as the nudge needed to start tapering. It was reported that without the advice some would have kept taking the medication and that advice prompted them to think that it should be possible to stop and thus maybe they should try. Advice on tapering can provide the validation needed for people to think they can do without medication, for patients already questioning their use and the sense of security people need to try tapering. It also emerged that attempts to discontinue were frequently made without informing or receiving guidance from GPs.

Explanation of quality assessment: Moderate methodological limitations with minor concerns over one study (due to concerns over the recruitment strategy with participants being recruited from one group practice from one primary care trust) and very minor concerns over one study (due to the potential influence of the researchers on the findings not being discussed and very minor concerns over potential bias in recruitment with participants having already been selected for a different project) but moderate concerns in two studies (due to concerns over participant recruitment as participants contacted the researchers if they wanted to take part, hence being potentially more motivated to give stronger or more negative views and lack of detail or rigour of analysis in one study, due to the potential impact of the researcher on the findings not being explored and issues with data richness with themes mostly supported by limited information and single quotes in the other study) ; no concerns about coherence; no concerns over relevance; no concerns about adequacy. Overall assessment of confidence was moderate due to the methodological limitations identified in the contributing studies.

Review finding 16: Advocacy from health care professionals and mutual decision-making

People on antidepressants referred to dissatisfaction with the doctor-patient interaction in terms of lack of attention or acknowledgment on the part of the doctor and superficial responses. Examples included thinking that the physician did not spend enough time with them, did not communicate with them, did not listen well to them, and did not behave as if the relationship were a partnership. Respondents described how some doctors decided too quickly to prescribe antidepressants, and so had curtailed discussions. Many were dissatisfied with the working style of their doctors, and had experienced dismissive attitudes, they reported that the extent to which their condition was real was challenged by their psychiatrist.

People describing positive experiences of consultations reported on a good discussion of their views, fears and apprehensions and previous experiences of taking antidepressants. Being listened to and given sufficient time and information was universally recognised as positive and valuable, and key to the trust and rapport established between them and their health practitioner. These initial dialogues appear to be key to people developing a sense of agency with respect to their decision-making about taking antidepressants. Having a good relationship with a doctor was an important indicator of whether people would discuss their need for information about adverse events. People valued their GP’s interest in how they were progressing. They appreciated being asked how they were doing, and it made them think about their life in general and to what extent they were improving. For women experiencing sexual difficulties as a result of taking antidepressants in particular, having their sexual concerns validated, played an important part in helping them to cope. They felt the difficulties were serious enough to consider seeking professional help but their experiences of not having concerns validated by GPs, had an impact on how they understood and hence coped with difficulties initially. Furthermore, women reported that GPs appeared unwilling to accept their sexual side effects as a legitimate problem. This led them to seek validation and support through online discussions forums.

Explanation of quality assessment: minor methodological limitations due to moderate concerns over two contributing studies (due to lack of sufficient detail over data collection and analysis) but very minor concerns in one contributing study (due to the potential influence of the researcher on the findings not being discussed and concerns of participant recruitment with the sample having been previously recruited in a different project) and no concerns in one contributing study; no concerns about coherence; very minor concerns over relevance due to the population of one contributing study being very narrow (n=10) and homogenous and hence of possibly limited relevance to the overall review population, but no similar concerns for any other contributing study; no concerns over adequacy. Overall assessment of confidence was moderate due to minor concerns over methodological limitations as concerns over relevance were too minor to further lower our confidence.

Review finding 17: Relationship with clinicians and continuity of care

Developing a relationship with their doctor during the initial consultation was very important for people taking antidepressants and seeing the same GP on subsequent visits became a critical part of their ongoing treatment. Continuity of care meant not having to repeat the same details over and over again, feeling that one was not a nuisance, and being treated as a ‘friend’. Many were fearful that having developed a special relationship with the GP they would have to see different doctors on follow-up visits. As one said, ‘You cannot be reassured by someone you don’t know’. It was considered by many to be especially helpful when members of the team were aware that they were being seen by another member of the team. Nevertheless, some people described a lack of communication between doctor and patient, but also that there were no follow-ups of the treatment, and that prescriptions were renewed without a personal contact, for instance, by telephone.

Explanation of quality assessment: moderate methodological limitations with moderate concerns in one study (due to concerns over the lack of sufficient detail on the data collection method and data analysis) and serious concerns in the other contributing study due to concerns over the design and data collection (retrospective analysis of independently submitted free text feedback from consumers) where the design was dictated by the data/consumer feedback process, results were reported interspersed with references and insights from other studies, making it unclear what conclusions were based on this study alone); no concerns about coherence; no concerns about relevance; moderate concerns over adequacy with the theme emerging from one study. Overall assessment of confidence was low due to moderate concerns over methodological limitations and adequacy.

1.1.7. Economic evidence

The committee agreed that health economic studies would not be relevant to this review question, and so were not sought.

1.1.8. The committee’s discussion and interpretation of the evidence

1.1.8.1. The quality of the evidence

Evidence was found for 3 drug classes: antidepressants (10 studies), opioids (14 studies), and benzodiazepines (4 studies). No evidence was found for Z-drugs or gabapentinoids. The majority of the evidence was taken from qualitative studies in people being prescribed the above medicines, but also included some evidence on views from prescribers (GPs, nurses, pharmacists). In studies relevant to opioids, views from both populations were often combined within studies, and themes were generated from interviews across these subgroups. Studies frequently discussed the information needed across multiple parts of the treatment pathway, from when people are offered one of the relevant prescribed medicines to when they are altering the dosage or stopping. Accordingly, evidence was presented and discussed as a whole by the guideline committee with subdivision by drug class where appropriate.

The level of confidence in the majority of the themes identified for antidepressants was moderate (for 10 out of 17 themes), with confidence in 3 themes being high and confidence level of 4 themes being low or very low. The level of confidence in evidence for opioids was overall higher, with confidence in 6 out of 20 themes deemed high, confidence in 10 themes deemed moderate and in 4 themes deemed low. The majority of evidence for benzodiazepines was of low or very low confidence level (for 6 out of 10 themes), with confidence in the evidence for the other 4 themes being moderate.

The primary reason for downgrading the level of confidence in the evidence was potential recruitment and selection bias in the contributing studies. This included for example recruitment processes in which people interested in participating would contact the researcher to take part, possibly leading to a sample of people with stronger opinions more motivated to get their views across or sampling of participants from a previously conducted trial in which the aims and therefore recruitment strategy differed to the aims of the qualitative study. A common but minor methodological limitation that led to an overall lower confidence rating in much of the evidence was an unclear role or influence of the researcher in conducting or interpretation of the research findings. Lack of data richness or unclear statements of findings were also limitations in several contributing studies, with themes supported by only single quotes and limited explanation, no clear statement of findings, or combining the study’s findings with the findings of cited work from other sources. Similarly, several studies lacked detail about their methods (data collection, interview process, thematic analysis) which also led to a lower overall assessment of confidence in the evidence. In many places, the evidence confidence level was also downgraded due to lack of relevance or applicability to this review’s population. The primary reason for this was when studies were conducted in a healthcare service different to the NHS, such as in the USA healthcare system. Some study populations were also small, narrow, and homogenous, for example with recruitment skewed towards an older or lower socio-economic population, and therefore may not be generalisable to a wider population.

1.1.8.2. The committee’s discussion and interpretation of the evidence

Overall, the committee agreed that the review identified important themes which should be reflected in the recommendations, including where the confidence in the findings was low. Predominant themes around information included: the need for information about safety and long-term effects prior to initiation of treatment; lack of information around a person’s condition and what to expect from a prescription leading to reluctance to initiate or alter medication, dissatisfaction with treatment and poor relationship with healthcare professionals; the benefit of receiving information on the need and appropriateness of a prescribed medication. In terms of support, a number of themes particularly resonated with the committee’s experience, these were: the need for support during tapering or cessation of medication; the importance of peer support (e.g., online forums); GP supervision as an effective method of support for improving treatment adherence or successful tapering/cessation.

The committee noted that some of the review findings are already covered by recommendations in NICE Guideline CG138 patient experience in adult NHS services. These included:

Enabling people to actively participate in their care and make informed decisions, by ensuring verbal and written information is presented to facilitate shared decision making.
Considering the individual’s need for continuity and consistency of care, in order to establish a relationship between the person and the healthcare professional, which is trusting, empathetic and reliable.
Tailoring healthcare services to each person, especially with regard to the involvement of family members and carers.

The committee agreed that although these didn’t need to be included in full in this guideline, the evidence demonstrated these were of particular importance in this context, and evidence may suggest that these recommendations are not always being implemented. They, therefore, agreed to include a recommendation highlighting that recommendations in CG138 should be followed, drawing particular attention to the relevant sections.

The committee agreed all of the evidence pointed towards the importance of achieving a shared agreement with the person and the prescriber when making decisions about prescribing medicines. Thus, they agreed it was important to use the NICE guideline on shared decision making NG197 to support people when making decisions.

Evidence, including review themes relating to opioids and antidepressants rated at a high confidence level, highlighted that people need support in decision-making and that they often perceive that there is a lack of information from healthcare professionals about the medicine being prescribed and the associated potential risks. The committee, including the lay members, was also aware from experience that people say they would have liked to have had more conversations around the harms before starting the medicine to enable them to make a shared decision with the prescriber. Therefore, although the principles in NG197 are always important, the committee agreed they are of even more relevance to this guideline, with evidence to suggest a discussion and shared agreement is not always happening in current practice.

It was discussed that people often have fears of stopping medicines due to adverse withdrawal symptoms or re-emergence of their condition and that people don’t often see the benefits until they stop. The committee agreed this should be carefully considered and talked through as part of shared decision-making. The committee also noted that decisions about medicines can be difficult for a person who is in distress and that this should be recognised and acknowledged. They emphasised that in some cases it may be appropriate to delay prescribing until after the first appointment if people are in distress. The committee added from their experience that these conversations can also be difficult for healthcare professionals. It was important that this was acknowledged and to ensure healthcare professionals had support, and were reminded that additional time could be taken to consult with colleagues where required. The committee were mindful of ensuring this should not unduly delay prescribing and it was important to note that a follow-up appointment was arranged if there were to be any delay.

The committee noted that shared decision making can be particularly difficult for people with communication difficulties, for example those with learning disabilities or people with dementia. The committee agreed by consensus that it was important to recommend that additional considerations will be required in these situations, to ensure prescribing decisions are made in the persons best interest, and that the person is able to participate in those decisions as fully as possible. It may be particularly important to involve family members, carers or others close to the person, with the persons consent where appropriate. The committee noted adjustments could include longer, more frequent appointments, using short clear sentences and visual aids, or adapting the format of information provided. They agreed this is covered within NICE guidelines on shared decision making, care and support of people growing older with learning disabilities, and dementia, however it was an important point to re-state in this guideline as well as cross-referring to the more condition specific guideline.

The committee noted that there are circumstances where a shared decision on tapering is not possible which can be difficult if there is a need to taper for safety reasons, but the person taking the medicine doesn’t agree. The committee commented that in their experience this can be more problematic when taking over care of patients from another prescriber who started taking the medicines some time ago. The committee discussed the importance of still aiming to achieve a shared decision and not enforcing a unilateral tapering decision unless in exceptional circumstances where there were significant safety concerns. The committee discussed situations that arise where patients insist on re-prescribing of high or unsafe doses believing they are benefitting them, and there may be situations where the healthcare professional is duty bound to reduce medication where the risks and harms are too great. This was reflected in recommendations discussed in the prescribing strategies and withdrawal interventions reviews within this guideline, cross-referring to General Medical Council guidance.

The committee discussed the high confidence evidence emerging from opioids, highlighting the importance of forming a good relationship with the patient, and what would enable this, including continuity of care. The committee also discussed the time pressures within a GP consultation and that this can be at odds with the time needed to form this relationship.

The committee recognised that informed consent and shared decision making for tapering off psychotropic medication may be initially difficult for people who have complex issues including those that have led to addiction or circumstances that have resulted in persisting distress. However, they agreed that additional recommendations weren’t necessary, as it is equally important to ensure relational continuity and to adhere to the principles of the shared decision-making guideline in these situations.

The committee discussed the importance of being honest with the person, and that clear and evidence-based information should be provided in the persons’ preferred format before the initiation of treatment so that the person can make an informed decision about whether to start treatment. Findings from the review indicate that people feel they are given insufficient information on their condition and the medication prior to treatment initiation. This can result in discrepancies between their expectations of treatment and reality.

The review identified a discrepancy between what the healthcare professional thought they had told people, and what people thought they were told. The committee suggested this could be addressed by ensuring information is provided in both verbal and written formats (as appropriate to the person’s needs) that they can take away. The committee discussed the evidence that healthcare professionals may sometimes de-emphasise the risks, whereas the patient would prefer to be better informed of the risks beforehand. This was highlighted by evidence from opioids and antidepressants that was rated of high confidence. The importance of a tailored approach was also highlighted by evidence of high confidence from studies relevant to opioids, and that different people would be able to take in different levels of information. For this reason, some people can find it helpful to have a family member, carer, advocate or other person present at appointments, especially if the person is distressed or unable to remember or understand information for any reason.

The review findings indicated that people valued information from a variety of healthcare professionals involved in their care, including GPs and pharmacists. The committee agreed that the term ‘prescriber’ should be used in the recommendations to be inclusive of all roles with prescribing responsibilities.

The committee discussed the evidence for what information should be provided prior to prescribing a medicine associated with dependence or withdrawal symptoms. It was agreed that the word ‘prescribing’ would be used in the recommendation wording, in order to encompass both the initiation of treatment and re-prescribing. This included information on the underlying condition and the role of the medicine as highlighted by evidence from antidepressants rated as high confidence. In line with the evidence and the committee’s experience, information should highlight if the medicine is to treat symptoms and is not a cure, as most of the medicines considered here are not a cure. It was also discussed that it is important to highlight what aspects of the person’s condition the medicine is being prescribed for, and what it is not being prescribed for, as people may not be fully informed about what to expect from their medicine, in terms of what benefits to expect. The committee’s view was that this can contribute to people continuing on medicines for reasons unrelated to the original purpose of treatment. It is also important to highlight the signs and symptoms of dependence to be aware of, and the benefits and consequences of stopping the medicine.

There was some evidence of high confidence identified in the review findings, suggesting that people would be more inclined to stay on opioids if they thought there were no alternative treatment options. Although the committee discussed that long term use of opioids is generally not recommended, even if there are no alternative treatment options suitable for the person, the committee did agree that it was important, that information was provided on all relevant treatment options before prescribing, so that an informed decision could be made about treatment choices, based on the risks and benefits of all of the available options, including non-pharmacological treatment and watchful waiting. It was agreed that this should apply to all medicines. It was further supported by evidence of high confidence from studies relevant to opioids, demonstrating that people value information on how to manage their pain, and this can help avoid misuse of medicines.

Evidence from studies relevant to opioids rated at high confidence, indicated that people are not adequately informed about the risks of dependence, addiction, or withdrawal symptoms before initiating these medicines. The committee agreed this was an important finding that needed to be highlighted in the recommendations. There was consensus that information about the risk of developing dependence should be provided to people before starting treatment with an opioid, gabapentinoids, benzodiazepine or Z-drug and that the signs and symptoms of dependence and the risk of developing tolerance should also be highlighted. It was noted it is important to highlight both the risks and benefits of treatment with these medicines. The committee’s experience was that people may be focused on their acute symptoms at the time of considering whether to start taking a medicine. Therefore, it was agreed that in addition to the risks and benefits, it was important to include in the recommendation that people should be provided with information to support them to balance the potential benefit of the medicine in treating their current symptoms with the risk of long-term consequences.

Lay members within the committee expressed that people are not explicitly told that they might find it very difficult to come of medicines such as opioids if they are taken for long periods. The committee agreed that information should be given prior to initiation of treatment on the expected time until the medicine is reviewed, and to make clear from the outset that if the medicine is not working then stopping is an option. Within this framework, the committee agreed it was important to provide information about potential options if the medicine does not work. Evidence from the review indicated that, for people starting antidepressants, the duration of treatment often remains unaddressed. The review findings also show that health care professionals emphasised the importance of setting short-term timeframes for the prescription of benzodiazepines. The committee agreed that it is important to provide information on the expected duration of treatment before starting and that this applies to all drug classes, especially when a medicine should only be prescribed short-term such as benzodiazepines and opioids.

Evidence rated as high confidence, showed that people were unsure about the time taken for antidepressants to start having a therapeutic effect, and people are not aware that side effects can occur before the therapeutic effects. The review findings indicated that if people are aware of this early on, this could facilitate coping with side effects. They also noted that in their experience people being prescribed gabapentinoids can experience a time lag between the initiation of treatment and any benefits. The committee agreed it is important to emphasise the time lag between the initiation of treatment and any anticipated benefits, and that side effects may occur before the benefits. It is important not to disregard the side effects and to emphasise that these side effects are likely to settle over time. It was agreed that the time lag can vary depending on the indication for which the medicine is prescribed. Based on their clinical experience the committee agreed these points are also applicable to gabapentinoids but emphasised that the time lag for gabapentinoids, may only be around a week when gabapentinoids are prescribed for pain. The committee agreed that information on potential side effects, whether they are likely to be temporary or permanent, whether they might improve or worsen over time should be provided to people considering any of the drug classes.

The committee also noted from their clinical experience, some of these medicines had particular storage requirements and that it was important to ensure people were aware of how to safely store their medicines. They also noted that this is covered in the NICE guideline for controlled drugs and so agreed to include a statement in the recommendation highlighting the importance of this and cross-referring to the existing guidance.

The importance of providing information on adherence for people being prescribed medicines was discussed by the committee. However, they agreed that this is adequately covered by NICE guideline CG76 (Medicines adherence).

The review identified that people need support when stopping the prescribed medicine and evidence, including a review finding of high confidence from studies relevant to opioids, showed that people value alternative sources of information and support (such as peer support networks, or online forums) when deciding whether to start taking medicines associated with dependence or withdrawal symptoms or for concerns around stopping medicines and the occurrence withdrawal symptoms. The committee discussed that these resources are seen as essential for some people, but the quality of the information found online is often unknown. They highlighted the importance of providing information in the persons preferred format and agreed to include within the recommendation that healthcare professionals should consider supplementing verbal and written information they provide with sources of support such as peer support networks or suitable online forums. Although not identified in the review findings, the committee also agreed that in their experience social prescribing can be a useful alternative source of support. It was agreed that this could not be recommended within the guideline as there was no evidence for its use in this context.

The committee agreed based on their clinical experience that much of the information that people require would be best recorded in a management plan that is formed as a result of the discussions and shared decisions made in the consultation. They agreed this would include information about the medicine, what it is prescribed for and how to take it safely, as well as detailing the plans for review.

No evidence was identified on the information needed by the families and carers of people who are being offered, taking, or stopping prescribed medicines associated with dependence or withdrawal symptoms. However, limited evidence highlighted the value people placed on receiving support from their family particularly when dealing with chronic pain. The committee discussed that families and carers can be an important source of support for many people being offered, taking or stopping prescribed medicines associated with dependence or withdrawal symptoms, particularly as it may be difficult for people to take in information or make decisions when in distress. Therefore, the committee made a recommendation for healthcare professionals to ask people whether they would like to have support during appointments from a family member, carer, advocate or another person close to them. The committee also agreed that in order to ascertain what information families and carers need, a research recommendation should be included.

No evidence was identified for Z-drugs or gabapentinoids. The committee agreed that there was no reason that the themes that arose from the evidence review, and recommendations made should not be generalised across the 5 medicine classes considered in the review protocol. The committee also agreed that similarly to antidepressants, people being prescribed gabapentinoids can experience a time lag between the initiation of treatment and any benefits.

1.1.8.3. Cost effectiveness and resource use

Cost-effectiveness evidence was not sought as this was a qualitative review. The recommendations provide guidance regarding the information that should be provided when prescribing medicines associated with dependence or withdrawal symptoms to allow patients

to actively participate in their care consistent with NICE guideline CG138 on Patient Experience and NG197 on Shared decision making. The additional information should enhance the efficiency of prescribing but not lead to an increased consultation time. Therefore, the recommendations are unlikely to have a substantial resource impact on the NHS.

1.1.8.4. Other factors the committee took into account

The committee discussed that for opioids, this guideline is only concerned with opioids prescribed for chronic pain, and opioids when prescribed for acute pain are outside the scope of the guideline. This was agreed as important to be aware of when implementing recommendations, as some of the recommendations would not be applicable for people being treated for acute pain. However, the committee acknowledged that some people who initially start taking opioids for acute pain remain taking them for longer than necessary, and in these cases, some of the recommendations within this guideline may be useful. It was also discussed that the context may be important in other situations. For example, if someone was being prescribed a dose of diazepam prior to air travel, then a detailed management plan may not be necessary.

The committee discussed some more specific points around efficacy and side effects of certain drug classes, however, these points are beyond the remit of the guideline, as efficacy and side effects are covered by the relevant condition-specific guidelines.

1.2. Recommendations supported by this evidence review

This evidence review supports recommendations 1.1.1, 1.1.2, 1.2.1, 1.2.4, 1.2.5, 1.2.8, 1.2.9, 1.2.10, 1.3.1, 1.3.2, 1.3.3, 1.5.2, 1.5.8, and the research recommendation on information for family members or carers. Other evidence supporting these recommendations can be found in the evidence review C on Safe Withdrawal.

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Appendices

Appendix A. Review protocols

Appendix E. Qualitative evidence summary

1.1.8.5. Opioids

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1.1.8.6. Benzodiazepines

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1.1.8.7. Antidepressants

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Appendix F. Excluded studies

F.1. Clinical studies

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Appendix G. Research recommendations

G.1. What information and support is needed by family members and/or carers of people being prescribed an opioid, benzodiazepine, z-drug, antidepressant or gabapentinoid?

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Appendix H. List of medicines to be included

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Final

Evidence reviews underpinning recommendations 1.1.1, 1.1.2, 1.2.1, 1.2.4, 1.2.5, 1.2.8, 1.2.9, 1.2.10, 1.3.1, 1.3.2, 1.3.3, 1.5.2, 1.5.8 and the recommendation for research in the NICE guideline

These evidence reviews were developed by the National Guideline Centre

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.

Bookshelf ID: NBK580674PMID: 35609129

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National Guideline Centre (UK). Evidence review: Patient information and support: Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults: Evidence review A. London: National Institute for Health and Care Excellence (NICE); 2022 Apr. (NICE Guideline, No. 215.)
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Information and support for people who are being offered, taking or stopping prescribed medicines associated with dependence or withdrawal symptoms
Appendices

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NICE Guideline 215: Medicines associated with dependence or withdrawal symptoms: safe prescribing and withdrawal management for adults

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Evidence review: Patient information and support
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Evidence review: Patient information and support

1. Information and support for people who are being offered, taking or stopping prescribed medicines associated with dependence or withdrawal symptoms

1.1. Review question: What information and support is needed by people who may develop dependence, or who have developed dependence or withdrawal symptoms and their families and carers

1.1.1. Introduction

1.1.2. Summary of the protocol

Table 1

1.1.3. Methods and process

1.1.4. Qualitative evidence

1.1.4.1. Included studies

1.1.5. Summary of studies included in the qualitative evidence

Table 2

1.1.6. Summary of the qualitative evidence

Table 3

Table 4

Table 5

1.1.6.1. Narrative summary of review findings for opioids

Review finding 1: Information on safety and risks, including addiction, dependence, tolerance and withdrawal

Review finding 2: Information on appropriateness of medication & lack of alternatives

Review finding 3: Pain management education

Review finding 4: Realistic expectations of what health care professionals can provide

Review finding 5: Communicating the rationale for dose changes

Review finding 6: Importance of adherence

Review finding 7: Information on impact on mood after cessation

Review finding 8: Sources of support

Review finding 9: Relationship with health care professionals

Review finding 10: Support in decision making

Review finding 11: Need for empathy/acknowledgement of pain

Review finding 12: Support in cessation/tapering

Review finding 13: Need for tailored support

Review finding 14: Multimodal care and coordination between providers

Review finding 15: Emotional support

Review finding 16: Family support

Review finding 17: GP supervision

Review finding 18: Role of pharmacists

Review finding 19: Referral to specialists

Review finding 20: Help accessing benefits

1.1.6.2. Narrative summary of review findings from benzodiazepines

Review finding 1: Short-term length of prescription

Review finding 2: Addiction potential, safety and withdrawal symptoms

Review finding 3: Consequences of long-term use and benefits of stopping

Review finding 4: Rationale for medication and benefits

Review finding 5: Alternative treatment approaches

Review finding 6: Administration of benzodiazepines

Review finding 7: Information from pharmacists

Review finding 8: Tailored information for older adults

Review finding 9: Support with cessation

Review finding 10: Sources of support during cessation

1.1.6.3. Narrative summary of review findings for antidepressants

Review finding 1: Information on the need for medication

Review finding 2: Information about what to expect from the medicine

Review finding 3: Side-effects & long-term adverse effects

Review finding 4: Expected length of treatment at the start

Review finding 5: The time lag between treatment initiation and benefits

Review finding 6: The benefits and positive aspects of medication

Review finding 7: The consequences of stopping the medicine

Review finding 8: Internet resources

Review finding 9: Patient accounts and peer support

Review finding 10: Information and support through medical consultations

Review finding 11: Patient leaflets

Review finding 12: Different means of communication

Review finding 13: Type of information

Review finding 14: Health professional support with adherence & self-monitoring

Review finding 15: Support with tapering and discontinuation

Review finding 16: Advocacy from health care professionals and mutual decision-making

Review finding 17: Relationship with clinicians and continuity of care

1.1.7. Economic evidence

1.1.8. The committee’s discussion and interpretation of the evidence

1.1.8.1. The quality of the evidence

1.1.8.2. The committee’s discussion and interpretation of the evidence

1.1.8.3. Cost effectiveness and resource use

1.1.8.4. Other factors the committee took into account

1.2. Recommendations supported by this evidence review

References

Appendices

Appendix A. Review protocols

A.1. Review protocol for Patient information and support

Appendix B. Literature search strategies

Appendix C. Qualitative evidence study selection

Appendix D. Qualitative evidence