How many regulators does it take to change a lightbulb in a pharmacy? Whatever the maximum number of regulators is, pharmacy doesn’t seem to have reached it yet.
In England alone, depending on what a pharmacy does, the regulators include the General Pharmaceutical Council, the Medicines and Healthcare products Regulatory Agency, NHS England, Integrated Care Boards and the Care Quality Commission.
One of the regulators who is often overlooked is the Health Service Commissioner – usually known as the Health Service Ombudsman - established in England by the Health Service Commissioners Act 1993.
A recent report in C+D about the case of a five-year-old girl who in 2023 was inappropriately prescribed a pessary that was dispensed by a local pharmacy prompted me to take a closer look at the Health Service Ombudsman.
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The Ombudsman’s role includes investigating complaints about providers of NHS primary care services, including pharmacies. Complaints may be made by someone who claims to have sustained injustice or hardship as a result of action taken by the provider of the service. The Ombudsman has no power to order the payment of compensation but can recommend it. Recommendations are usually complied with.
Risk
Section 4 of the Health Service Commissioners Act says that the Ombudsman may not conduct an investigation if the aggrieved person has a remedy by way of proceedings in any court of law, unless the Ombudsman is satisfied that in the particular circumstances it is not reasonable to expect that person to use that remedy.
Perhaps it is because of section 4 that the Ombudsman has dealt with relatively few cases involving pharmacies. After all, a patient who has been injured as the result of a pharmacist’s error or failure to provide a service will usually make a claim for compensation direct to the pharmacy and the claim will usually be settled by the pharmacy’s professional indemnity insurer.
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In fact, one has to dig quite deep to find pharmacy cases that the Ombudsman has investigated. In Spring 2013, a GP practice prescribed too high a dose of clopidogrel for a patient. The pharmacy dispensed the dose on three separate occasions, when it should have done more to check it was correct.
This put the patient’s health at risk for three months. The GP practice paid compensation of £250. The pharmacy apologised to the patient. It also discussed the incident with its staff, and amended its standard operating procedure. The Ombudsman considered this to be an appropriate and proportionate remedy.
In January 2015, the Ombudsman reported that during a visit to hospital, a complainant’s son was prescribed medication for constipation. The hospital pharmacy gave her the wrong medication. The complainant did not realise the error until she got home and read the accompanying leaflet.
She consulted her local pharmacist, who told her that the medication the pharmacy had given her was not suitable for children and could have had serious consequences for her son. The pharmacy had acknowledged the error but did not apologise until the Ombudsman investigated. It then paid her £100 in recognition of the distress caused.
Damages
In February 2015, a patient complained that when she was prescribed medication for a sore leg, she was given another patient’s antidepressant medication which caused dizzy spells for two weeks until the error was discovered. The pharmacy had already apologised and made service improvements. The Ombudsman recommended a compensation payment of £250.
In the case of the five-year-old girl for whom a pessary was prescribed, the Ombudsman particularly focused on communication failures. The Ombudsman recommended both the GP and pharmacy make changes to their respective practices, that the girl’s GP pay her £1000 and that the pharmacy owner pay her £500.
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I was particularly interested to know why, when the unfortunate girl had a clear entitlement to damages that she could claim in a court of law (although any claim would almost certainly be promptly settled by insurers), the Ombudsman took up the case despite section 4 of the Act.
I made a Freedom of Information Act request, asking why the Ombudsman decided it was not reasonable to expect the girl (through her mother) to use that remedy. The Ombudsman refused to provide information about a specific case.
Shrouded in mystery
The Ombudsman did, however, disclose guidance that is used in deciding whether it is reasonable to expect the complainant to pursue an alternative legal remedy. Some of the factors in the guidance involve consideration of whether pursuing a legal claim would be complex or would take a long time. Neither factor seems applicable in this case.
The only factor that might be relevant is that legal action would not achieve all of the outcomes the aggrieved person is looking for. I can see that some complainants want an apology as much as they want compensation, or they may want to know that practices have been changed to avoid a repetition of what occurred. A court of law cannot produce such results – although I can’t help wondering if the unfortunate girl would have been awarded more than £1500 by a court.
The fact that the Ombudsman investigates so few complaints against pharmacies seems positive, but some of the decision-making remains shrouded in mystery.
David Reissner is chair of the Pharmacy Law & Ethics Association