Are unit-dose dispensed medicines dangerous?

At 1.5kg/per person/per year, the levels of wasted medicine in France are worrying. Every year, almost 50 per cent of medicines are unused and left on medicine cabinet shelves. So why are patients still being sold a packet of 10 tablets when doctors only prescribe eight? Why not sell unit-dose medicines like other countries?

To each country its own method
Medicine supply procedures differ from one European country to another: some dispense medicines in packets (Belgium, Austria, Sweden, Italy and France), others dispense the exact number of tablets required to patients (the Netherlands, UK and the Czech Republic).
In the US, for example, unit-dose medicine dispensing has been in force for many years and the system works well: laboratories send loose tablets to pharmacists, who in turn give patients the correct number of prescribed tablets in plastic bottles. A label bearing the patient’s and doctor’s name, and the prescription details, is stuck on each bottle to avoid mistakes. Each bottle is also stamped with a batch number to guarantee traceability. This system means that there is less waste in a country where medicine is rather expensive and inadequately reimbursed. The same system is applied in the UK where unit-dose dispensing was introduced in 1948. If a UK doctor prescribes a five-day course of antibiotics (one tablet per day) the pharmacist will prepare the prescription in a white bottle, stick a detailed label on it and put only five tablets in the bottle. In Canada, if necessary, a second colored label is added with instructions such as: “Take with food or “Do not take with alcohol”, etc. The package leaflet is printed out when the first prescription is dispensed and is given to patients.

What are the risks?
A recent INSERM study which was carried out on approximately one hundred French pharmacies and on unit-dose dispensed antibiotics showed that this system would both encourage patients to take their medication and reduce self-medication. As medicine industry leaders have pointed out, there is, however, a downside to this satisfying result, and that is the safety issue.

Current packaging processes are not adapted to this method: for safety procedures to be fully respected, the packets would have to be opened, then the right number of tablets counted out, the batch number checked – this is vital for traceability – the packet leaflet printed out again if necessary, and the product placed in a bag for the patient. All this would mean extra, and potentially risky handling in terms of safety and traceability. At a time when numerous anti-medicine falsification efforts are currently in place, especially on a European level, repackaging could create new problems:
o Medicine traceability ruptures;
o Mistakes in sorting medicines by hand (product type, dose and expiry date, etc.);
o Hygiene problem (external contamination and from combining medicines).
Some professionals say that traditional packets of medicine are a guarantee that the products have not been tampered with and that, together with the packet leaflet, provide full patient safety. They also feel that dispensing bulk-bought medicines would call this into question.

Is the supply chain the weakest link?
In some countries, complex health product supply chains provide many opportunities for traffickers: lengthy logistics and numerous intermediaries for imported products, parallel imports and repackaging create gaps which make stealing medicines and concealing falsified medicines possible.
The truth of the matter, so frequently highlighted in the media this year, is that potential flaws in the medicine supply chain encourage the introduction of falsified medicines to domestic markets even more so than unit-dose dispensing in pharmacies.

– In January, the Japanese health minister announced that bottles of falsified hepatitis C medicines had been uncovered in a registered pharmacy chain. The products did not contain an active ingredient. The batch numbers on the falsified medicines were the same as the numbers used by the genuine manufacturer, suggesting that the falsified medicines were inserted into the genuine bottles. The Japanese health minister alleged that wholesalers were distributing the falsified treatments via unregistered networks.
– This year, parallel import companies discovered four falsified batches of cancer medication, Velcade, in the Dutch and Danish supply chain. The batches mimicked the genuine product distributed in Bulgaria and Romania, but the folding carton, vial labels and package inserts were all forged. Laboratory testing indicated, however, that the vials contained an active ingredient at the levels and specifications indicated on the label. This would suggest that the culprits were repackaging expired products or sourcing cheaper generic versions of the medication.
– In September, a falsified copy of Valcyte®, an antiviral medication, was found in German pharmacies. The national health agency stated that the only indication that the product was falsified was the lack of a number on the back of the package leaflet. This is the third case of this type in recent months. Falsified copies of Harvoni® and Xeplion® were also found in the legal German medicine supply chain.

How does European legislation provide for supply chain safety?
In June 2011, the EU adopted Directive 2011/62/EU for the prevention of the entry into the legal supply chain of falsified medicinal products. This important legislation introduces safety measures for dispensing medicines on a European level. Firstly, online medicine sales are subject to minimum supervision and secondly a tracking system for medicines in packets is planned, to detect falsified medicines. Furthermore, on 09 February 2016, a delegated European regulation outlining tracking system methods for medicines in packets was introduced and will be implemented in France in February 2019. Laboratories will therefore have to incorporate labeling systems and Datamatrix code scanners to packaging lines. The barcode will include a single product code, batch number, expiry date and series number (completed, when necessary, by a national refund number).

Each presentation of a pharmaceutical product is identified by a CIP code (presentation identification code)
Each presentation is defined by the following:
– its name
– its pharmaceutical format
– its dosage
– its packaging and packaging contents
The 13-digit code is referred to in the Marketing Authorization decision (decision and annexes) for all pharmaceutical products.

The Directive also provides that safety and tamper-evident devices are used to check that a product is genuine, to identify individual packets of medicines and to check that outer packaging has not been tampered with. Safety devices must be attached to all prescription medicine packaging, except when an assessment could prove that the concerned product is dangerous. This will not apply to over-the-counter medicines given their minimal risk of falsification.

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Comment

Name *

Email *

Website