Réada Cronin (Kildare North, Sinn Fein)
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312. To ask the Minister for Health his policy on vitamin D supplementation in the population; his policy on the strategic use of drugs such as HCQ and ivermectin in the treatment of Covid-19; and if he will make a statement on the matter. [10860/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Vitamin D

With regard to Vitamin D supplementation in the population, the Deputy is advised that the existing guidance on vitamin D was updated in November 2020 and advises that adults aged 65 and older to take a 15 microgram (600 IU) daily supplement for bone and muscle health.

An evidence synthesis paper on vitamin D and COVID-19 prepared for the NPHET was discussed at its meeting on 28th January 2021. The NPHET agreed that at present, there is insufficient high-quality evidence with respect to vitamin D in the prevention and treatment of COVID-19, and noted that ongoing developments, particularly Randomised Control Trials, in this area be monitored by the NPHET with guidance reviewed accordingly.

The NPHET agreed that efforts should be made to increase awareness of existing guidance. Adults spending increased time indoors or those who are housebound or in long-term residential care or have dark skin pigmentation are also recommended to take a daily vitamin D supplement.

These recommendations for the use of vitamin D are being incorporated into wider messaging, and additionally are being communicated across the health service, including nursing homes and social care settings, as necessary.

The Department of Health has recently written to the HSE and Nursing Homes Ireland to encourage implementation of guidance on vitamin D in nursing homes.

The Government will continue to look to the NPHET to provide recommendations with regard to Vitamin D and COVID-19.

Hydroxychloroquine and Ivermectin

The Deputy is advised that, at the request of the NPHET, HIQA conducted a rapid evidence review to identify studies on the effectiveness of (i) pharmaceutical and (ii) non-pharmaceutical interventions, in the ambulatory setting, aimed at reducing progression to severe disease in individuals with confirmed or suspected COVID-19. This evidence review included a review of relevant studies in relation to Hydroxychloroquine and Ivermectin.

Low certainty or very low certainty evidence was identified in relation to a small number of interventions. However, HIQA noted the low quality of the evidence available including the high risk of bias, small sample sizes and short durations of follow-up different trials and advised that results from these studies should not be used to inform decision-making with respect to effectiveness. The HIQA’s overall finding was that there is currently insufficient evidence of either effectiveness or safety to support the use of any pharmaceutical intervention in the community setting to reduce the risk of progression to severe disease in patients who have been diagnosed with COVID-19 unless as part of an ongoing monitored clinical trial. Furthermore, no evidence was identified for the effectiveness or safety of any non-pharmaceutical intervention in the community setting.

As confirmed by the HIQA’s COVID-19 Expert Advisory Group (), evidence regarding the effectiveness of pharmaceutical treatments intended for systemic use, must be subject to the highest standards of rigour. Where a pharmaceutical intervention is recommended in the absence of appropriate supportive evidence, there is a significant potential for harm to the patient. Whereas this risk of harm may be justified in certain circumstances (e.g. the intervention poses minimal risk, or the setting involves patients with high potential to gain due to almost certain risk of severe adverse consequences in absence of any intervention) this is less likely to be the case in the setting of mild disease, where a great number of otherwise well patients would potentially receive the intervention.

The HIQA has also advised my Department that several international health technology assessment or guideline development organisations have specifically reviewed the evidence to date on ivermectin in COVID-19 and have cautioned or advised against the use of ivermectin outside the setting of clinical trials on the basis of the current evidence. The HIQA has also advised that the pharmaceutical company MSD (Merck, USA), which holds a license in the USA for the use of ivermectin as an antiparasitic agent, on 4th February 2021 published a statement including the following:

“It is important to note that, to-date, our analysis has identified:

- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;

- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;

- A concerning lack of safety data in the majority of studies.

We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”

I trust that the above information satisfactorily addresses your question.