3Individual risk assessments
Guidelines and policy
30.In the previous section we set out Roche’s clear statement that an individual risk assessment was required before Lariam is prescribed. During the course of this inquiry, we explored the extent to which the Ministry of Defence (MoD) has followed this guidance. In its written evidence, the MoD set out its prescribing policy for Lariam and how those guidelines have been implemented:
Since 2004–05 Defence policy has endorsed [Lariam] to prescribed, with an implied accompanying risk assessment. In 2013, with the formation of the Defence Primary Healthcare (DPHC) organisation, HQ DPHC has been responsible for ensuring that this policy has been followed. Prior to April 2013 the single Services were responsible for the provision of primary care and the procedures for prescribing [Lariam].45
31.Brigadier Timothy Hodgetts CBE, Medical Director, Defence Medical Services explained to us that there were two methods of prescribing Lariam. The first was to conduct an “individual face-to-face consultation” which was what the MoD deemed to be a prescription. The second was an “authorised” patient-specific directive, whereby the individual clinician would “conduct a risk assessment from the patient’s notes” which recognised “other safeguards such as the medical employment standards and the fact that we know our people within our individual units”.46 In oral evidence the Minister sought to clarify that statement saying that “by following the policy, the implication is that a risk assessment will have been carried out”.47 However, Dr Nevin was of the view that an individual risk assessment clearly implied “a lengthy, face-to-face consultation between a patient, and the patient’s prescribing physician”.48 He went on to argue that “simply checking the patient’s notes does not constitute an individual risk assessment”.49
32.A number of our witnesses painted an altogether different picture of MoD practice. Lt. Col. (Retd) Marriott, a campaigner against Lariam, argued that for many years, the MoD’s policy on Lariam was one of “dispensing a stock drug rather than one of prescription”.50 In his written evidence, he argued that, until at least 2012:
Anti-malarials have been administered for deployments to Sub-Saharan Africa, Belize and Afghanistan by medically unqualified personnel such as senior and junior NCOs, and without appropriate reference to individual medical records.51
He also suggested that anecdotal evidence he had received indicated that “at least until two years ago, the drug was routinely handed out by people such as Company Sergeant Majors who would not be medically qualified at all”.52
33.Dr Croft, writing in the Pharmaceutical Journal, a Royal Pharmaceutical Society publication, argued that rather than being prescribed after an individual risk assessment, Lariam had been “handed out on the parade ground by the medical sergeant, along with other tropical kit”.53 Dr Croft also provided us with the following anecdotal evidence:
We keep hearing from soldiers—there have been some written submissions to this effect—who say, “I turned up for my pre-deployment equipment, which would include the tropical uniform, the mosquito net, the sunscreen and the packet of malaria tablets,” and that was it.54
In his opinion, this approach was “pretty much standard, even now”.55
34.During our inquiry, we received written evidence from a number of individuals which appears to support this view. Paul Shephard MBE told us that he had been given Lariam on numerous occasions on deployment between May 1996 and Summer 2002. He stated that he “wasn’t provided with any warning on side-effects other than being told to read the instructions enclosed in the tablet box” and that beyond advice on the appropriate length of time to take Lariam he was given “no other information and no risk assessment was undertaken”.56
35.In oral evidence, the Surgeon General told us that while he was convinced that the policy of individual risk assessments was being adhered to, he could not give a “100% guarantee” that it had happened in every case.57 The reason given was that reviewing every case would require “a disproportionate undertaking, requiring significant diversion of Defence medical resources from existing priorities, and without a clear health benefit outcome”.58
36.Of more concern was the fact that the Surgeon General was unable to confirm that individual risk assessments had taken place since he took over responsibility from the single services. While he said that the procedures put in place since 2013 should prevent prescription without an individual risk assessment, he was unable to give “a 100% guarantee about every single person”.59
37.When we asked the Minister if one-to-one interviews would be conducted in the future, he gave an equivocal response:
Hopefully, as has been demonstrated, this is always an evolving process, but I am confident, as the Surgeon General has stated, that since 2013 when the Defence Primary Health Care organisation was formed, we have had much stricter guidelines and the electronic system automatically flags up the process. So I am confident that we are in a much better place post-2013 than perhaps we were under the single service regimes. Certainly I am determined to continue to make sure that this process evolves and improves—this is an ongoing process.60
38.The clear guidance from Roche is for individual risk assessments to be conducted before Lariam is prescribed. It is the MoD’s policy to adhere to that guidance, but the MoD appears to have interpreted the guidance to include the option of ‘desk-based’ risk assessments using patients’ medical records. We do not believe that to be an adequate alternative to face-to-face interviews. We therefore recommend that the MoD cease conducting risk assessments based solely on patients’ records and prescribe Lariam, if at all, only after detailed face-to-face individual risk assessments. Records of face-to-face assessments should be recorded in individual’s medical notes and a signature obtained confirming that risks have been explained and advice notes provided.
39.We are concerned that the records held by the MoD are insufficient to give certainty that the policy of conducting individual risk assessments has been fully adhered to. While we understand that it would be more difficult to produce records before 2013, it should be a straightforward exercise to provide that detail for the past three years. We recommend that the Ministry of Defence conduct an audit of all prescriptions of Lariam since responsibility was moved to the Surgeon General. As part of that audit, we will expect the MoD to provide figures on the number of face-to-face assessments alongside the number of prescriptions based solely on patients’ records.
Obstacles to individual risk assessments
40.During the course of our inquiry, we questioned our MoD witnesses on the practicality of prescribing Lariam—with the required face-to-face interviews—to a large number of troops. Brigadier Hodgetts acknowledged that the preferred way of prescribing anti-malarials was to have such a consultation, but that there remained the opportunity to conduct “a patient-specific directive if at very short notice a large number of people needed to be deployed”.61
41.A number of our witnesses questioned the practicality of conducting individual risk assessments prior to deployment. Dr Nevin highlighted “numerous challenges” which were encountered by military physicians in prescribing Lariam in a manner that was “fully compliant with the product documentation warnings and precautions”.62 Trixie Foster believed that any policy of individual risk assessments for a taskforce of troops was “unrealistic due to the time it would take for a Battalion (approximately 700 personnel) to be assessed individually”.63 This was also the view of Dr Croft, who argued that it was:
wholly implausible that such individual risk assessments could be carried out, because the scale of the operation would be enormous. It would take at least half an hour to conduct a detailed risk assessment, and we are talking about hundreds of troops deploying at short notice. There just would not be the time before a major deployment for such an exercise to occur.64
42.Dr Quinn also questioned the practicality of prescribing the drug to a large number of military personnel:
The likelihood of such stringent prescribing practices being adhered to where the workplace requires large numbers of personnel to be administered a drug in a short period of time prior to deployment, and the difficulty of carrying out appropriate health monitoring during deployment and after deployment, make the use of Lariam for military personnel at best highly problematic or worst, simply impossible.65
43.It is not clear how the MoD would provide individual risk assessments prior to the prescription of Lariam in the event of a significant deployment. In its response to our Report, the MoD should set out how this would be done and an estimation of the time it would take to conduct face-to-face individual risk assessments at both company and battalion level.
44.We further recommend that the MoD sets out a comparative assessment of the practicalities of prescribing Lariam with face-to-face interviews and prescribing other anti-malarial protections in the event of a large deployment at short notice.
Concealing contra-indications
45.Earlier in this Report, we highlighted Roche guidance which included the clear warning that Lariam must not be prescribed to individuals with an “active or a history of psychiatric disturbances such as depression, anxiety disorders, schizophrenia or other psychiatric disorders”.66 Face-to-face interviews play a vital part in identifying these contra-indications, but there remains the risk that patients may try to hide aspects of their medical history which would disqualify them from receiving medicine.
46.Dr Nevin told us that this was a clear risk in the military and that, unfortunately, not even the “fairly stringent process” of individual risk assessments had prevented the inappropriate prescribing of Lariam to service members with contra-indicating medical conditions.67 Research that he had conducted with the US Army in 2007 had shown that one in seven US Service personnel with contra-indications had still been prescribed Lariam. More disturbingly, Dr Nevin said that the rate of inappropriate prescribing of Lariam had increased “threefold” in subsequent years since restrictions were placed on its use.68 Dr Nevin concluded that “service members simply do not want to report or admit that they may have one of the conditions listed in the product insert that is a contra-indication to the use of the drug”.69
47.When he gave evidence, Surgeon Captain Sharpley, Defence Consultant in Psychiatry, agreed that non-reporting of contra-indications was a “completely appropriate concern” because individuals reacted to psychiatric side-effects in a different way from physical side-effects. He was also clear that it was not always possible to “stop someone from hiding something if they feel that the risk of revealing this outweighs the risk of hiding it”.70 However, he believed that this risk was mitigated by the high level of trust in which doctors—and military doctors in particular—were held. Capptain Sharpley concluded that:
As long as the GPs who are doing the risk assessment ask in an appropriate way for the history—of course they will be looking at the record as well, if the history exists there—we will have done the best we can to make sure that that prescription is safe.71
48.However, in supplementary evidence, Dr Nevin restated the fact that, in his experience, “service members remain strongly motivated to under-report potentially disqualifying mental health conditions, including those that may be formally undiagnosed or undocumented”.72
49.Dr Quinn, in written evidence, also highlighted a number of studies which, she argued, demonstrated the problems with reliable self-reporting. Dr Quinn argued that non-reporting or under-reporting of mental health issues was “a significant confounding factor in the use of [Lariam] in the military because of “institutional stigma, and/or perceptions of workplace disadvantage” which included not being deployed and possible barriers to promotion. Dr Quinn believed that the available evidence pointed to a higher incidence of under-reporting:
Together this evidence suggests that the incidence of pre-existing conditions which would be clear contra-indications for prescription of [Lariam] are significantly higher in the military than has been previously suggested, with significant implications for the health and wellbeing of those involved.73
50.Whilst the extent of non-reporting of contra-indications is not clear, all of our witnesses acknowledged that there was a risk that some military personnel may hide symptoms in the belief that to do otherwise could jeopardise their careers. Doctors are well placed to spot this, but they cannot be guaranteed to do so in every case. This reinforces the need for detailed face-to-face individual risk assessments rather than implied risk assessments based on patients’ records.
Non-use of prescribed Lariam
51.A number of our witnesses reported that some military personnel prescribed Lariam took the decision not to use it. Lt. Col. (Retd) Marriott told us that in his experience, the fear of the side-effects of Lariam was causing personnel to discard their medication with “significant numbers [preferring] the risk of contracting malaria to the risk of Lariam toxicity”.74 Mrs Duncan, whose husband Major General A D A Duncan CBE DSO, suffered severely from the side-effects of Lariam, also wrote that she had heard reports of personnel “throwing the tablets away”.75
52.John Paul Aisbitt, who was deployed to Sierra Leone, asserted that members of his team had “simply stopped taking [Lariam] during their tour, preferring the risk of malaria to the effects and associated risk of continuing with its use”.76 That experience was repeated by Mark Iles during his deployment to Sierra Leone:
I was given Lariam at the RTMC (Chilwell) upon my call-out but like some other Reservists with experience of working overseas I did not take it and used tablets purchased locally in Freetown. I recall that a number of our loan service IMATT personnel in Sierra Leone did similar.77
53.The Minister told us that he was aware of such reports and that it was “probably the case that historically, some people may well have thrown away their drugs and not taken them”.78 He acknowledged that it is “nigh on impossible” to force military personnel to take the tables and argued that educating them on the risks of not taking medication was the solution.79 Surgeon Vice Admiral Walker explained that this education and information included “posters and signs” on the dangers of malaria and that, once deployed, medical staff would remind personnel of the importance of taking the drugs prescribed to them.80
54.The anecdotal evidence we received suggesting that some military personnel preferred to throw away their Lariam rather than use it is deeply disturbing. If true, it is an indication that some in the Armed Forces have completely lost confidence in Lariam. In its response, we shall expect the Ministry of Defence to set out how it monitors compliance rates among military personnel who have been prescribed Lariam.
Choice and an opt-out
55.During the evidence session with the Minister, it was suggested that, alongside clearer labelling of the risks associated with Lariam, military personnel should be offered the option of requesting an alternative anti-malarial drug. In response, Surgeon Vice Admiral Walker declared that he was “happy to use that as part of the risk assessment with the patients”.81 This suggestion also found favour with Dr Nevin who described it as “a low-cost, sensible suggestion” which if implemented would “enhance patient choice, and patient safety”.82
56.In addition to the need for a face-to-face interview, we recommend that the MoD ensures that each individual, when made aware of the risks of Lariam, must be offered the option of receiving an alternative anti-malarial drug.
53 Dr Croft, ‘Mefloquine, madness and the Ministry of Defence’, The Pharmaceutical Journal, 12 November 2015
73 Dr Jane Quinn (LAR0010)
© Parliamentary copyright 2015
19 May 2016