Ethical dilemma: Side effect liability

Supplying medication on prescrription carries responsibility for pharmacist to provides advises on medication. I would always check with patient about any allergy and look out for allergy symptoms when new medicine prescribed. PIL must be supplied with all the medication dispense as legal obligation of pharmacist.

If the pharmacist fulfilled all the legal and ethical requirments i.e. counselled on dispensing, supplied a PIL , and dispensed a reaonable dose in accordance with the prescription they are not liable. The legal system will view this as 'principle of double effect'. The correct way to respond is empathetic in a non judgemental mannor, asking after the welfare of her son. The insurance company must also be informed.

Michael Winner approach "Calm Down Dear ... " or " Keep your hair on" approach are not reccommended... in this sort of scenario...Presumption... facts are reported accurately...
Best way to deal , as I see it thru Legal eyes, is to ask Is your son Johnny OK and Home?.... Then proceed with There are occasional known allegy to this type of medication.. Was he first time on this? Do you or can you remember " Did the Dr ask any question on allergy before he gave the prescription? Hope she calms down by now... a smile.... and Emphatic " Unfortunately,medication do unpredicted reaction and this is the case with your son, hopefully by now you know his name.... Glad he is better but make sure this allergy is recorded at the surgery but I will put it on my records so it does not happen from this pharmacy.

One should apologise and complete an incident form. This should hopefully satisfy the mother of the patient and hopefully stop her taking the matter any further.
If the mum was determined to pursue the matter in court then a judge would have to consider whether the inclusion of a PIL would have prevented the allergic reaction from occurring and whether the pharmacist, prescriber or mum had any responsibility for preventing this reaction - as it is an allergic reaction never experienced before and totally unpredictable no one is to blame and the allergic reaction could not have been avoided with or without a PIL.

Right, here goes:

1. Who was the RP on duty when this occurred? Was it you or another colleague? Was there a 2nd pharmacist.
2. The label on the box, are the dispensed by / checked by signatures present and can the individuals who dispensed it be identified?
3. Can the person who checked the medication remember there being a PIL in the box?
4. Who collected the medication? Was it the patient?
5. What advice was given to the patient regarding the antibiotic?
6. Amoxicillin tablets? Surely not!
7. Any other medication taken at the same time?
8. The reaction, can it be confirmed that it is a penicillin reaction or could it be something else?

There are many other questions that need to be answered.....

However, if this happened to me:

1. Patient confidentiality to be considered. Is the 15 year old lad Gillick competent? Can you talk to the patient and is the patient happy for you to discuss this with his mum?
2. Take the patients mum to one side and get as much information as you can regarding the circumstances surrounding the incident.
3 Is the GP aware of this happening - inform the mum that you will be discussing the incident with the practice as a critical incident
4. Important to inform you insurance provider

The law governing PIL is derived from the regulations covering labelling and patient information leaflets which are set out in Title V of Council Directive 2001/83/EC and this was amended by Council Directive 2004/27/EC.

However this has led to confusion regarding what information should be supplied.

The GPhC have taken the stance that a PIL should always be supplied and failure to supply a PIL may constitute misconduct which could lead to a referral to the Investigating Committee for consideration.

From a civil law perspective, failure to include a PIL may be negligence (from a civil law point) and therefore you could be liable for any damage that flowed from that negligence, including a nice large amount of cash for Pain Suffering and Loss of Amenity (PSLA).

Providing you have counselled the patient correctly, checked that they are not penicillin allergic (in this case you would not know as it is clearly stated that it is an allergy that is previously unknown) and have ensured that a PIL is present and somebody can back this up, you should be in the clear from a professional and legal position.

You should always check that a patient has had an antibiotic before, especially penicillin and if in doubt, a quick call to the prescriber to discuss the situation is normally the best course of action. Also remember that TRUE penicillin allergy is rare.

PS - Please forgive the spelling!

Sorry, I have my old title on there. I am no longer a Superintendent

Given that the allergy to the amoxycillin was unknown, omission of the " PIl" would not have made any difference in preventing the said reaction, but it may have helped the customer in understanding and coping with the symptoms, if the pil was was included,and if the customer were able to understand the information contained in the leaflet. From the legal stand-point damages arising from the omission of the leaflet, would not follow, as the omission of the "pIl" could not have prevented the allergic reaction.However, given the time frame in which we dispense and hand out prescription, it is best policy to include a "PIL". Post event, one can extend aplogies & sympathy for the incident, and afford re-assurance to the customer, that the allergy whcih has now been established, would be recorded on his "P.M.R." to prevent any future incidents.