Patient information leaflets (PILs)

[helvella]

We continue to see people getting medicines dispensed in various anonymous pots and bottles, without essential information. This is unacceptable. People shouldn't have to use a magnifying glass and an online forum to find out what they have been given.

If you are in the position of getting given anything not in its full, original, unbroken packaging, please ask for, if necessary DEMAND (politely but firmly), the Patient Information Leaflet, the product code, the serial number which is a numeric or alphanumeric sequence, the batch number and the expiry date.

EVERY item dispensed should have:

Patient information leaflets (PILs)

Unless all the information is on the pack, all medicines must include a PIL, regardless of how patients get them. PILs must:

be easy to understand

not contain personal information that can identify an individual, including names of staff members or digital signatures

Each product authorised under a marketing authorisation must have its own leaflet as explained in our best practice guidance on patient information leaflets.

gov.uk/guidance/medicines-p...

Further, the official packaging must have the information below. In my view, the fact that the pharmacy has decanted product into another container does not remove this requirement.

Safety features legislation

The European Parliament and Council has approved and published a Delegated Regulation (EU2016/161) in the Official Journal of the European Union. This supplements the Falsified Medicines Directive (FMD) and introduces two mandatory safety features that will allow medicines to be verified and authenticated.

These safety features are:

a unique identifier (a 2D data matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain

tamper evident features on the pack

The unique identifier comprises:

a product code which allows the identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type

a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated

a batch number

an expiry date

gov.uk/guidance/medicines-p...

[shaws Administrator]

Thanks Helvella for a timely reminder. We are entitled to have written information along with the medication.

[Valarian]

Considering the older we get, the more medicines we are likely to need, the size of print used for patient information leaflets is ridiculous. Older people are less likely to look the information up on the internet

[helvella Administrator in reply to Valarian]

Valarian,

I agree. Just looked at one which was produced in a condensed font. Even I found it difficult to read - and I rarely have a problem on a screen.

The former XPIL site, which tried to produce easy-to-read versions of Patient Information Leaflets (PIL) is gone. The standard EMC site doesn't have all PILs. Where they do exist, the standard zooming and assistive technologies available on many computers are likely to help. Does rely on the patient, or friend, having access and someone thinking of doing so.

medicines.org.uk/emc/

[Valarian in reply to helvella]

Do pharmacies offer ‘large print’ versions of PILs, on request or where they think they might be needed ? This would be a reasonably cheap and easy way of helping those without internet access, or with less confidence.

[helvella Administrator in reply to Valarian]

Found this document - didn't see a requirement in it - but I'd consider it part of the job to print as required.

How to support patients with sight loss in pharmacy

The Pharmaceutical Journal

15 AUG 2017

By Nina Barnett, Amani El Bushra, Hugh Huddy, Funmi Majekodumni, Sarah Thomas, Fiona Chiu

More than two million people are affected by sight loss across the UK, which may impact on their ability to use and take their medicines correctly and safely. Here, the Royal National Institute of Blind People, Medicines Use and Safety team and Moorfields Eye Hospital provide advice and recommendations for pharmacy to provide appropriate support for people with sight loss.

pharmaceutical-journal.com/...

[SilverAvocado]

Completely off topic, but I recent bought a magnifying glass to help me with an electronics project. My eyes are pretty good as far as I know, but it's been very useful for all kinds of things. I'd never realised I needed one, and I keep it close at hand in the kitchen now.

[lady_eve]

This is really interesting. My latest Levo prescription of 100mcg, 50mcg and 25mcg has just arrived - two in boxes with PILs and one in a brown bottle with an expiry date scribbled on the label. Do you think by issuing some of the medication with PILs the pharmacy have discharged their duty, or am I entitled to a PIL for every item, regardless of crossover in information? I'd be interested to know your opinion on this, please.

[helvella Administrator in reply to lady_eve]

I believe they have not fulfilled their obligation. We’re you told the make in the bottle?

[lady_eve]

The label just says "Levothyroxine 100 mcg". The dispensary know that I will only take Eltroxin - it's the brand that suits me best - and I must admit I've not checked the tablets to make sure that's what they are. It's such a pain having to remember what the tablet markings are, especially as they changed a little while ago. I hate the childproof caps, too, as my hands are often not great, but that's by-the-by.

I'm really interested to hear you confirm my suspicion on this. Thank you.

[helvella Administrator in reply to lady_eve]

100 microgram Mercury Pharma (Eltroxin or Levothyroxine) have LT 100 on them

[lady_eve in reply to helvella]

Thank you.