They are called extemporaneous medicines – preparations that are tailored for patients that cannot be treated with the medicines that are available on the market. The reasons are many: the right substance, strength or preparation format is lacking, or an approved medicine contains a substance or an excipient that the patient reacts against. Individually adapted medicines are a complement to approved medicines, and also fill an important need when medicines become de-registered. All extemporaneous medicines prescribed are covered by the pharmaceuticals benefit.
For individual patients, the chance of getting individually adapted medicines is very valuable. Often their quality of life is significantly enhanced, and sometimes extemporaneous medicines mean the difference between life and death. There are lots of diseases and conditions where extemporaneous medicines may be the solution, and we describe some of them here.
Our societal task is to develop and manufacture individually adapted medicines for patients with special needs.
Ulf Skough, acting CEO and Marketing director APL
Congenital chloride diahorrea
A few children in Sweden suffer from congenital
chloride diahorrea, a condition that is psycho-socially challenging. There is no approved medicine for it, but the raw material sodium butyrate has proved effective. We have investigated the raw material source and produced a suitable composition in close collaboration with healthcare, and now patients can receive sodium butyrate in 250 mg capsules.
Tuberculosis is one of the most prevalent infectious diseases in the world; more than 9 million persons fall ill with it every year, and around 2 million of them die. The disease affects young adults in particular, but also children and older persons. In the last decade, the number of cases in Sweden has increased by as much as 50%, in particular among members of the foreign-born population. APL’s oral solution isoniazide is used together with the antibiotic rifampicin to treat tuberculosis in children.
Many cancer patients at the end of life are cared for in a home environment. As painkilling medicines constitute a significant part of the treatment at this stage, it is important to adapt them according to the needs of each individual. Often, there is a demand for several medicines with varying effects on pain. There are approved medicines, but not always in the combinations, strengths or preparation formats needed by the patients. For this reason, we manufacture preparations with the most suitable substances and strengths. One example is morphine 10 mg/ml infusion solution in a Deltec cassette, which the patient can carry around for continuous pain relief and increased freedom.
Around 5,000 persons in Sweden (2017) have been diagnosed with Osler’s disease. The symptoms are nose bleeds and anaemia, caused by the expansion of small blood vessels that burst. Bevacizumab, a mono-clonal antibody for local treatment in the nose has been requested by healthcare, but currently it only has approval in the form of an infusion liquid used for cancer treatment. Based on existing scientific documentation and our experience, we have re-formulated the approved medicine into a nose spray.
Serious eczema risks becoming infected, usually by Staphylococcus or Streptococcus bacteria. There used to be an approved medicine containing neomycin, but this was de-registered in 2008. As there is still a clinical need, we began manufacturing a cream that includes betametason-neomycin – something that both patients and dermatologists
APL is a key supplier to healthcare, pharmacies and patients with special needs of a stable supply of quality-assured and individually adapted medicines. For healthcare as a whole, APL contributes clearly to continuity, patient safety and cost effectiveness.