On the market today there are an abundance of medicinal products. Someone with the common everyday flu can go to the pharmacy and find an array of different drugs to treat their symptoms.
But occasionally an individual can find that the available medication is not suitable for them, or they are suffering from a disease for which there is no licensed treatment available in their home country. In such cases, a patient’s physician can prescribe a pharmaceutical special.
A pharmaceutical special is European term referring to an unlicensed medicinal product that is specially manufactured, imported, or supplied in order to meet an individual patient’s clinical needs. In the US, the same product would be referred to as a compounded drug.
Specials are usually used to treat the most vulnerable groups within society who have no other viable treatment options available to them.
There are a number of reasons why a special can be prescribed for an individual patient;
- A patient cannot take available medication in the form in which it is provided. For example, a young baby, elderly individual, or patient who has lost the swallow reflex might not be able to swallow a tablet and may require medication in a liquid form.
- A patient cannot tolerate the dosage of an available medication. For example, a standard dosage might be too much for a premature baby. Or, a patient might have a rare form of a disease which requires a stronger or weaker dosage of the medication
- A patient is allergic to an ingredient/s in the available medication
- There is no licensed medication available, or a licensed medication has been discontinued and is no longer available on the market
Specials can only be manufactured by company with a Manufacturer (Specials) License. This license ensures that the sourcing of the ingredients, development of the product, manufacturing and supply process, and the packaging and labelling are all completed in line with regulatory standards.
A company that intends to import an unlicensed medication, rather than manufacturer it, is required to have a Wholesale Dealer License which covers importation of unlicensed drugs. A company must always notify the proper regulatory body of its importation intentions before it begins the importation process. Even with the necessary license, however, a company can still have its importation request denied due to any health and safety concerns.