Lo scorso ottobre la Food and Drug Administration (FDA) ha annunciato il ritiro dal mercato statunitense di diversi farmaci oftalmici. Una decisione significativa, che ha sollevato interrogativi e preoccupazioni in tutta la filiera farmaceutica, oltre che destare sconcerto nei clienti finali. Come produttori europei di packaging farmaceutico oftalmico, la notizia ha destato subito il nostro interesse e abbiamo deciso di capire meglio cos’è accaduto: i dettagli di questo ritiro, le sue implicazioni e soprattutto le ragioni che hanno portato la FDA a compiere un passo così drastico. Perché qui si parla di marchi molto noti al grande pubblico, con una forte storicità non solo sugli scaffali delle farmacie, ma anche su quelli dei negozi di largo consumo. E questa è la terza volta che accade in un anno: tra gennaio e febbraio 2023 erano già stati ritirati dal mercato due brand di prodotti oftalmici, in quanto correlati a una possibile contaminazione batterica. Poche settimane dopo, la stessa sorte è toccata ad altri due prodotti oftalmici, per rischi di diversa natura. La domanda non può che nascere spontanea: cosa sta succedendo?
Specifichiamo subito che il mercato europeo, a quanto ne sappiamo oggi, non sembra coinvolto da questi specifici accadimenti. Ma da circostanze simili, c’è sempre molto da imparare, specie se accadono in un Paese come gli USA, che costituisce un importante mercato per molte aziende europee che operano nel Pharma.
Farmaci oftalmici ritirati negli USA: i fatti
Secondo quanto riportato dal New York Times, la decisione dell’FDA dello scorso ottobre, che coinvolge prodotti di diversi brand, è dovuta alla prudenza: sebbene non siano state riportate infezioni oculari associabili ai prodotti, l’agenzia ha riscontrato condizioni igieniche non adeguate e risultati positivi ai test batteriologici in aree-chiave degli impianti produttivi in India (lo riporta anche la CNN in questo articolo che include anche un link diretto al report della FDA). Una prudenza per nulla eccessiva, se si considera che, invece, i prodotti contaminati ritirati a gennaio 2023 sono stati associati ad infezioni gravi, perdita della vista, rimozione chirurgica dell’occhio e persino 4 casi di decesso. L’azienda farmaceutica ha poi richiamato anche un unguento oftalmico, sempre per rischio di contaminazione microbica.
A marzo 2023 un’altro noto brand ha richiamato i suoi prodotti oftalmici, questa volta per un problema di packaging farmaceutico: alcune capsule di chiusura avevano sviluppato delle crepe, compro
Last October, the Food and Drug Administration (FDA) announced the withdrawal of several ophthalmic drugs from the US market. This was a significant decision, which raised questions and concerns throughout the pharmaceutical supply chain, as well as causing dismay among end customers. As European manufacturers of ophthalmic pharmaceutical packaging, the news immediately aroused our interest and we decided to better understand what happened: the details of this recall, its implications and above all the reasons that led the FDA to take such a drastic step. Because we are talking here about brands that are well known to the general public, with a strong history not only on pharmacy shelves, but also on the shelves of consumer shops. And this is the third time this has happened in one year: between January and February 2023, two brands of ophthalmic products had already been withdrawn from the market because they were linked to possible bacterial contamination. A few weeks later, the same happened with two other ophthalmic products, due to risks of a different nature. The question can only arise: what is going on?
Let us specify at the outset that the European market, as far as we know today, does not seem to be affected by these specific events. But there is always much to learn from such circumstances, especially if they happen in a country like the USA, which represents an important market for many European Pharma companies.
Ophthalmic drugs withdrawn in the USA: the facts
According to a report in the New York Times, the FDA’s decision last October, involving products from several brands, is due to caution: although no eye infections have been reported to be associated with the products, the agency found inadequate hygiene conditions and positive bacteriological test results in key areas of the production facilities in India (this is also reported by CNN in this article, which also includes a direct link to the FDA report). A caution not at all excessive, considering that the contaminated products recalled in January 2023 were associated with serious infections, loss of vision, surgical removal of the eye, and even four cases of death. The pharmaceutical company also recalled an ophthalmic ointment, again due to risk of microbial contamination.
In March 2023, another well-known brand recalled its ophthalmic products, this time for a pharmaceutical packaging problem: some of the capsules had developed cracks, compromising the sterility of the product. A few days later, it was the turn of a third pharmaceutical company, for a different reason: its eye drops were not sterile.
The ophthalmic pharmaceutical sector: significant growth
This news resonated strongly with the American public. First and foremost, among ophthalmic patients: whether they were suffering from serious illnesses (such as glaucoma) or simple conjunctivitis, they suddenly lost their reference product and had to rush to the ophthalmologist to find a viable alternative quickly. But the repercussion was felt throughout the market, as there is a large use of over-the-counter ophthalmic products in the US, particularly eye drops with moisturizing and anti-inflammatory properties. As Statista.com reports, as many as 117 million people in USA made regular use of these products in 2020. But the Old Continent is not to be outdone, if we consider that in Great Britain alone, in 2022, more than 6,8100,000 people said they used them regularly (and of these, more than 4 million confirmed a frequent use). This success can partly be explained by changes in our lifestyles: we spend many hours in front of electronic screens, whether PCs or mobile phones, we are exposed to cooling or heating systems that can dry out the air. Moreover, as we age, the natural lacrimation that hydrates and protects the eye tends to diminish; the progressive aging of the population in Western countries is therefore another reason behind the market consolidation of eye health and wellbeing products. The global ophthalmic drug market has been valued at $39.28 billion in 2022, and recent research predicts a compound annual growth rate (CAGR) of 5.3% from 2023 to 2032 (source: Precedence Research, 16 August 2023).
Packaging for ophthalmic drugs: much more than a commodity
What happened in the United States reminds us of two things:
- the importance of choosing reliable and safe packaging for ophthalmic medicines. Packaging that protects the product inside, providing an effective barrier to air and light. But that is also easy to handle and carry around. All these characteristics are well embodied by Perfektüp’s aluminium tube for ophthalmic ointments, gels and creams, available in two versions: with a standard ophthalmic gland, made entirely of Pharmalene®, or with a soft gland, an innovation designed to combine comfort and precision dispensing. Safe for both self-medication and application to third parties, especially if they tend to become agitated and uncooperative (such as very young children or pets).
- attention to production processes: in Pharma, one small detail out of place is enough to trigger a domino effect that affects the entire production chain, with results that in the worst cases can be dramatic. As specialists in pharmaceutical packaging for over 90 years, our entire production is oriented towards the high standards required by Pharma. A mentality shared by the entire Perfektüp team, from the aluminium extrusion department to the warehouse, via production, offset printing and packaging. We follow the entire production process, including the sterilisation of the tubes by irradiation: thanks to our partnership with a leading Italian irradiation plant, we can supply our customers with tubes already irradiated at the standard dose of 25 kGray. We also take care of all documentation directly: our customers can rely on the long experience and regulatory knowledge of our Quality Department. All documents and certificates are made available in the Perfektüp Online reserved area, as is information on the progress of orders.
Packaging for ophthalmic drugs is the spearhead of our production: several international companies have already chosen us as their partner for the production of pharmaceutical packaging.
Please contact us with your requirements: we will be happy to find the most suitable solution together and send you a product sample.
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