Patient-specific drug blistering
With patient-specific drug blistering , drugs from a patient are put together and packaged in individual portions according to the dosage prescribed by a doctor, for administration at specified times. This concept, also known as unit dose supply, is a pharmaceutical manufacturing process in Germany and is subject to the Medicines Act. This means that only pharmacies , drug manufacturers or blister centers with permission in accordance with §13 AMG can produce patient-specific drug blisters. With the blistered drugs, the therapy safety is to be increased, especially for patients in hospitals and residents of nursing homes.
Suitable drugs
Solid oral dosage forms such as dragees, tablets and capsules are mainly packaged in blisters; for the hospital sector also other dosage forms such as short infusion and injection solutions, suppositories and pre-filled syringes. Medicines that are particularly sensitive to breakage, moisture or oxidation or which contain CMR substances must not be packaged in this way. In addition, the possibly different requirements that affect the shelf life after the initial blistering must be taken into account.
Forms of blistering
The drugs are removed from their original packaging (blistered out) and placed in
- Cup blisters (manual and machine) or
- Blister cards (manual, possibly IT-supported) or
- Tubular blisters (automated, with manual work)
repackaged.
The blisters are labeled with the name of the patient , the time (s) of taking, the medicinal products they contain and their dose, as well as expiry dates and batch numbers.
Cup blisters and blister cards are the clearest and usually contain the medication for seven days. The blister cups are as hygienic as possible: after removing the foil, the medication can be taken directly from the individual cup . Tubular bag blister packs are more flexible: one sachet is provided for each time of intake, and each sachet contains the medication arranged and packaged for this appointment. In this way, the drugs can be packaged according to pharmaceutical criteria and the times of intake can be adjusted to ensure that the effect is optimal .
These blisters mostly consist of plastic and aluminum foil, which (empty) can be disposed of in the recycling bin. For data protection reasons , the stickers with the patient data must be removed beforehand. The stickers or foils with the corresponding imprint must be destroyed in accordance with the applicable data protection regulations.
Advantages and disadvantages of blistering
costs
In terms of process costs , especially in nursing care, the blister is well below the costs for a corresponding deployment of personnel in the manufacture of drugs. The prerequisites for patient adherence to therapy are improved, while at the same time savings can be made in the costs of illness that arise due to incorrect medication or a lack of compliance. In addition, the risk of errors when placing the pharmaceuticals is reduced to almost zero thanks to mandatory quality assurance processes.
However, since older patients in particular have difficulties removing the medication from the blister pack, nursing staff must take over the removal in this case. In addition, only solid drugs can be blistered for oral administration; other forms of administration (such as drops, syrup, injection solutions, suppositories) will continue to be provided by nurses. Since the legal situation of liability in the event of patient harm due to incorrect drug administration has not yet been clearly clarified, the responsibility for implementation still rests with the nurse. If she complies with this obligation in full, there is hardly any time and thus cost savings: Every single drug must be checked using the 5-R rule and with the help of stored samples (since there are no original packaging).
Improving drug safety
The drug safety is significantly improved if drugs are not portioned manually, but the medication is provided in drug blisters in a validated and qualified process under clean room conditions according to European standards ( Good Manufacturing Practice , GMP). This is the case with blister centers that can present a permit according to Section 13 of the Medicines Act (manufacturing permit).
Patient safety and information
The blistering allows extensive manufacturer batch documentation for the first time to the patient. So far, this batch documentation was ended at the wholesale or pharmacy level . This means an improvement in terms of drug safety for patients; z. B. in a recall.
Drug delivery process
The pharmaceutically most important effect of the drug delivery with the help of blisters lies in the arbitrary number of possible intake times, which can be reproduced exactly as the patient and the drug need and the doctor prescribes. In this way, even complicated intake schemes can be presented individually (for each patient). In addition, particularly sensitive drugs can be packaged separately. Blisters thus form the secure basis for the dispensing of drugs in the context of pharmaceutical care ( “pharmaceutical care” ).
However, short-term changes to the medication (dose increase, change to another preparation) can only be implemented quickly in the case of industrially manufactured tubular blisters if the care facility has a supply of medication from which it can supplement or replace. In practice, however, it is not possible to change the preparation, but only to increase or reduce the dose, because medicines in the home may only be stored in a personal manner. In the case of blister pharmacies, which usually blister themselves in the immediate vicinity of the care facility, quick changes are possible. A drug can only be discontinued immediately if it is clearly identifiable and can thus be distinguished from others in the blister pack.
literature
- Swantje Eisend (for the AKDA Unit-Dose Committee): Requirements for a unit-dose supply in the hospital pharmacy. Guideline of the Unit-Dose Committee of the Federal Association of German Hospital Pharmacists (AKDA) e. V. In: Krankenhauspharmazie 32, 2011; Pp. 407-412
Web links
Individual evidence
- ^ Stefan Schlosser: Unit dose supply in German hospitals - 2013. In: Krankenhauspharmazie Nr. 35, 2014; P. 38
- ↑ Swantje Eisend (for the AKDA Unit-Dose Committee): Requirements for a unit-dose supply in the hospital pharmacy. Guideline of the Unit-Dose Committee of the Federal Association of German Hospital Pharmacists (AKDA) e. V. In: Krankenhauspharmazie 32, 2011; P. 409
- ↑ Eisend, p. 410
- ↑ a b Kuratorium Deutsche Altershilfe (Ed.): H. Kieschnik: Blistering of medicines through pharmacies - an alternative for geriatric care institutions? In: ProAlter 2005 2; Pp. 51-56
- ↑ B. Schmid, F. Hesse Optimization of the drug management ( Memento of the original from October 24, 2014 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. In: pharmaJournal 17, 8th 2011, pages 13–15
