Safety Leaflets with Prescription Medicine.

seannyhk

Are manufacturing companies required by laws to include product safety information leaflets with their products which explain side effects to patients ?

Does a Pharmacist have any similiar responsibility to a customer ?

General Toilet

I can't answer your first question but I imagine all medicines need a leaflet.

I once asked a pharmacist about my medicine and I was referred back to the doctor prescribing.

Peregrinus

seannyhk wrote: »

Are manufacturing companies required by laws to include product safety information leaflets with their products which explain side effects to patients ?

I think so, yes, but I'm not sure of the exact scope and terms of the obligation.

seannyhk wrote: »

Does a Pharmacist have any similiar responsibility to a customer ?

Not an exactly similar responsiblity, no. What would be the point of a regulation requiring the pharmacist to tell the customer what the leaflet says? The whole point of the leaflet is so that the customer is not dependent on the pharmacist doing that, and the customer remembering what the pharmacist said.

But pharmacists do have a duty of care to customers, which is why you will often be asked "is this the first time you have taken this drug?" and "are you on any other drugs?" and similar questions. If this is a prescribed medicine then obviously the doctor will have diagnosed the patient and determined appropriate therapy and the pharmacist won't second-guess that, but will query anything that looks like an obvious error. But the pharmacist will check that you understand the dosing instructions, check whether you are taking an non-medical preparations (e.g. compelementary medicine) that might be inconsistent, make sure that any required cautionary label are affixed to the package (e.g. "don't drive or operate machinery for 6 hours"), etc.

Victor

seannyhk wrote: »

Are manufacturing companies required by laws to include product safety information leaflets with their products which explain side effects to patients ?

I understand there is an obligation, yes. Importantly, drug formulations change from manufacturer to manufacturer and from time to time.

Does a Pharmacist have any similiar responsibility to a customer ?

Probably. However, it wouldn't be as strict, as the pharmacist will normally have face-to-face contact with the patient and/or the patient is on a repeat prescription. When dispensing small number of doses from larger containers, enough leaflets might not be available. However, the pharmacist shouldn't refuse someone a leaflet.

If you have concerns, talk to the HPRA. https://www.hpra.ie/ or info@hpra.ie

The Patient Information Leaflets are accessible online if you ever need one, just search the drug name and PIL afterwards (ie: Drugname PIL) and the HPRA website will often pop up first giving you all the information you should need. Ensure that the leaflet you are reading is a recent / current one.

The Hound Gone Wild

The manufacturer has a legal obligation to provide a package leaflet with every original pack as outlined in their marketing authorisation with the EMA or HPRA.

There's no legal requirement for a pharmacist to supply a leaflet but it's poor practice not to, especially for a new medication.

For antibiotics like Amoxicillin, Flucloxacillin or Flagyl they can come in pack sizes as large as 500 units so can be impractical to print a leaflet for each dispensing of 21 units unless the pharmacist feels it's needed. If requested they should print you one but again they're not obligated to. Alternatively you have access to the leaflet through the HPRA website.

seannyhk

The Hound Gone Wild wrote: »

For antibiotics like Amoxicillin, Flucloxacillin or Flagyl they can come in pack sizes as large as 500 units so can be impractical to print a leaflet for each dispensing of 21 units unless the pharmacist feels it's needed.

Surely, if correct and I assume you are, it would then be at the discretion of a Pharmacist as to whether a Patient receives a product safety leaflet with their medication.

This could have serious consequences for a Patient who could be prevented applying knowledge gained in reading the leaflet to his/her ailment, whilst presuming that the lack of an information leaflet implies a safe product.

GM228

Package leaflets are legally required to be included in the with the packaging of all medicines under Article 58 of the EUs Medicinal Products Common Code Directive, and transposed into Irish law via Regulation 16 of the Medicinal Products (Control of Placing on the Market) Regulations 2007, they must by law be included for the users benefit, however the law is a little less clear when it comes to larger medical products being dispensed in smaller portions, but:-

The inclusion in the packaging of all medicinal products of a package leaflet shall be obligatory unless all the information required by Articles 59 and 62 is directly conveyed on the outer packaging or on the immediate packaging

I would be of the opinion that outer packaging includes whatever it is dispensed in.

General Toilet

About pharmacists refusing to supply info on medications referring back to the doctor?

GM228

General Toilet wrote: »

About pharmacists refusing to supply info on medications referring back to the doctor?

The law says:-

A person, other than the person responsible for placing a medicinal product on the market, shall not, in the course of a business conducted by him, sell, supply, offer or keep for sale or supply or procure the sale or supply of such product unless the product meets the requirements of this Regulation

It's open to interpretation based on my previous post.

seannyhk

Further, when a patient is dispensed a part supply of a medication from a larger batch of product and takes this assuming no side effects, does the patient have a valid complaint to the HPRA of lack of side effect information, assuming none given, when the patient experiences consequences that his/her untrained knowledge does not recognise ?

Victor

GM228 wrote: »

I would be of the opinion that outer packaging includes whatever it is dispensed in.

Outer packaging would be the manufacturer's outer packaging, not a see-through plastic bag.

GM228

Victor wrote: »

Outer packaging would be the manufacturer's outer packaging, not a see-through plastic bag.

On further thought I actually agree as I just noticed the Directive is specifically not applicable to prescriptions dispensed at a pharmacy, so to answer the OPs query, there isn't any requirement for the leaflet to be given by the pharmacist.

seannyhk

This then seems to me like the Manufacturer doesn't have to worry about patients who don't receive proper information and neither does the Pharmacist.

Victor

No. The manufacturer has a defined role and they take that role seriously.

seannyhk

Victor wrote: »

No. The manufacturer has a defined role an they take that role seriously.

Well, the Manufacturer's product is in at least one type of circumstance dispensed without a product safety leaflet, ( millions of times of the same circumstance ) and the Pharmacist seems to have discretion as to whether to supply small amounts with the product safety leaflet, so, I can only disagree with you.

I wonder if patient safety is compromised for the purpose of saving the cost of leaflet paper and packaging.