Lack of robust research jabs holes in policy

MEDICAL MATTERS: THE MINISTER for Health announced last week that pharmacists will administer the annual influenza vaccine starting this autumn. It's a significant move in broadening the delivery of health services in the community. But have the powers that be thought the issue through from the perspective of patient safety?

Until now, vaccination has taken place either in GP surgeries or in HSE-run clinics. Often administered by trained nurses as well as by doctors, one of the basic safety rules is that vaccination does not occur unless there is a doctor physically present in the building. The reason? So that in the event of an adverse reaction to the injection, full resuscitation is immediately available for the patient.

Pharmacists must now take responsibility for properly injecting the patient, but crucially must be competent to carry out cardiopulmonary resuscitation (CPR) and to administer life-saving drugs should a person suffer anaphylactic shock on their premises.

The Minister has acknowledged there will be a need for legislative change to facilitate his plan. For example, flu vaccination is legally a prescription-only medicine, so it will have to have its status changed if pharmacists are to prescribe it.

Pharmacies offer a convenient location, often with extended opening hours. The initiative will almost certainly increase vaccination uptake among at-risk groups, so from a public health perspective, the move makes sense. And although no specific fees have been negotiated as yet, given the tight budgetary situation, the Minister’s agenda must include a cost-savings target.

But when searching for an evidence-base for community pharmacy vaccination, all I can find are some observational studies. There is a distinct absence of the kind of rigorous research normally associated with significant public health policy change.

A 2000 report from the Centre for Disease Control warned of the following specific challenges to pharmacy-provided vaccination: adverse reactions to vaccines; record keeping; liability of pharmacists; legislative change; and the safe integration of all immunisation services. Patient safety also demands timely communication between pharmacists and other health professionals.

The major safety concern must be dealing with an allergic reaction. Anaphylaxis is a clinical syndrome characterised by its sudden onset, rapid progression and the involvement of multiple organs. At its most severe, the cardiovascular and respiratory systems are involved with low blood pressure, narrowing of the airways and swelling of the voice-box. Subcutaneous tissues may swell and the person can quite rapidly become unconscious.

Full-blown anaphylaxis following vaccination is a rare event. According to the Journal of Clinical Pathology, for all vaccines the estimated rate is one case per million vaccines given. But there is a paucity of research on the risk of allergic reaction to influenza vaccine. "Research in this area to date has shown that reliable and well-defined incidence rates cannot be derived from passive reporting systems used in post-marketing surveillance," the journal editorial notes. "Only by providing robust data can we expect to reliably assess vaccine safety and maintain public confidence in our immunisation programmes."

Both the Pharmaceutical Society of Ireland (PSI) – the profession’s regulator – and the Irish Pharmacy Union (IPU) will no doubt ensure that all of these concerns are dealt with before entering into a formal agreement with the HSE.

The PSI must ensure the necessary legal changes are in place to allow pharmacists to administer adrenaline and other essential resuscitation drugs by injection. And the IPU must set up a credible training programme for qualified pharmacists, one that is independently validated and includes a formal assessment of the vaccine-giver’s competency.

Patient safety cannot be compromised just because the EU/IMF are breathing down our neck.