Labelling and packaging of medicines: Complaints

Directions for the patient and other appropriate safety information is presented on the carton, label and with the patient information leaflet (PIL) accompanying medicines that are bought or prescribed.

Regulations lay down detailed controls on the content and layout of information;  in particular that all information must be legible, comprehensible, compatible with the Summary of Product Characteristics (SPC) and to the exclusion of any elements of a promotional nature.

The MHRA investigates complaints about the labelling and packaging of medicines made by patients, healthcare professionals or pharmaceutical companies.  A complaint may arise about a particular product, a particular pack size or an entire product range.  The MHRA Patient Information Quality unit (PIQ) will consider all complaints received on behalf of the Health Ministers.

Handling of complaints
The process the MHRA follows in handling complaints is explained below.

All complaints are acknowledged on receipt and a fact-sheet detailing the procedure for handling complaints is enclosed. An anonymised copy of the complaint is sent to the marketing authorisation holder (MAH) (or the UK representative), with a request for a response to the issues raised.  If necessary the Agency will, at the same time, request an empty sample of the marketed product.

Accelerated action is taken on any case that is judged to pose a serious risk to public health.  In these cases assessment is “fast-tracked” to allow the Agency to provide, as soon as possible, a provisional view of any compliance issues and any action the MAH must take to address the concerns raised.

All complaints are considered by the Product Information Quality assessors at their regular fortnightly meetings. Only those issues which are the subject of the complaint are considered and acted upon, if other issues of regulatory compliance are identified during the review of a complaint case they are notified to the marketing authorisation holder who is expected to address these points at the earliest opportunity.

Timelines
The Agency aims to turn complaints around quickly and expects companies to do so as well.  Short deadlines, usually seven calendar days, are set to ensure that any action is timely.  Once the company’s response is received, a thorough review of the complainant’s concerns is undertaken, aligning these with current statutory requirements, the needs of patients, healthcare professionals and carers.  The case may be referred to a medical or other specialist assessor within the Agency for advice.  An assessment of the remainder of the labelling and packaging is then carried out to identify any other issues that should be alerted to the marketing authorisation holder.

Many cases are resolved at an early stage either because the Agency decides that there is no case to answer or the company recognised the concerns of the complainant and takes appropriate action.   If action is not agreed, the Agency will review the case again and then consider what further steps are appropriate.

The Agency endeavours to complete investigations of complaints which pose a serious risk to public health within 30 days.  This time may however, be extended where there is detailed discussion between the Agency and the company, or when statutory action is taken.
 
Publication of outcomes
Once the Agency has reached a decision on a complaint, both the complainant and the marketing authorisation holder are advised of the outcome of the investigation and receive a copy of the draft outcome report.  This details the origin of the complaint – an anonymised source, unless it is a competitor company, substance of the complaint, the MHRA conclusion and any agreed action.  If the complainant is not happy with the decision they may ask for the case to be re-investigated. The outcome report is then published on the Agency’s website.  Occasionally, the MHRA may also issue a statement about a particular case in order to highlight concerns and provide guidance on good practice.

Outcome of investigations
Clarityn Allergy Tablets (Loratadine) 10mg (Schering Plough) – PL 00201/0175
This provides important updated information concerning changed details to the packaging of Clarityn Allergy Tablets 10mg, and information on the availability of stock.

Healthcare professionals and members of the public have complained to the MHRA about the carton for Clarityn Allergy Tablets 10mg produced by Schering-Plough. The complainants were concerned that the prominent roundel stating “2 years+” on the front of the carton could result in the product being given inappropriately to young children. The product is licensed for use in children aged 2-12 years who weigh more than 30kg.

Schering-Plough have agreed to remove the roundel from the front face of the carton and embolden the weight guidance for children between 2-12 years on the rear face of the carton. New packaging will start to be received mid-July and all packs will be in new packaging by 15 August 2006.

Schering-Plough have been requested to cease supply of the 7 tablet pack and have agreed to this request. Stock is delivered on a weekly basis and that currently in transit will continue to be delivered. Pharmacists have been notified by the company of the possible problems with the packs and will advise patients and carers appropriately until the new packaging is received.

A syrup formulation of Clarityn is available, which has a dosage for children under 30kg and may be more suitable for younger children.
Date of publication: 23 June 2006

Contact for further information
The Unit responds to and investigates enquiries and complaints regarding patient information reported by members of the public and the pharmaceutical industry. Enquiries and complaints should be made in writing and sent to: The Patient Information Quality Unit, MHRA, 14-1, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ or e-mail patient.information@mhra.gsi.gov.uk.