Healthcare has never had so many medicines to choose from and medication is often crucial for most healthcare interventions. However, inefficient use and production of medicines is a recognized problem. To address this, international authorities are now focusing on introducing stricter regulations to streamline and quality assure the management of medicines.
Quality control in the pharmaceutical industry
Quality control in the pharmaceutical industry includes all work to produce safe medicines using reproducible processes, good controls, and regular follow-up. National regulations, European directives and WHO emphasize that pharmaceutical compounding in healthcare should be conducted according to Good Manufacturing Practice (GMP) and have therefore developed several regulations that must be applied in the production and compounding of medicines. The regulations apply to all pharmaceutical manufacturing processes and cover hospitals and hospital pharmacies that prepare narcotics and cytostatics.
Stricter international regulatory requirements
Quality control of pharmaceutical products is receiving increasing attention. In Europe, there are currently three directives from the European Commission with mandatory regulations governing the production and control of medicinal products for human use by GMP. In the UK, National Health Service (NHS), responsible for the public healthcare, has recently developed guidelines for analysis of aseptically prepared products. The US is also working on developing updated regulations for quality control in the pharmaceutical sector and during the autumn several new and revised standards for the compounding of injectable drugs will be issued.
Ensures safe drug management
The Uppsala-based medical technology company Pharmacolog develops the products DrugLog and PrepLog with great potential to offer solutions that contribute to compliance with the international regulations in quality control. DrugLog enables control of injectable drugs prior to patient administration and PrepLog are integrated with the hospital’s electronic prescription system, which allows users to receive preparation requests and track pharmaceutical use. Both solutions are quick and easy to use and thus help hospitals to effectively comply with GMP requirements.
Comments from Marketing Director Åsa Stroofe
BioStock contacted Pharmacolog’s newly recruited Marketing Director Åsa Stroofe about the recent international attention regarding quality control of pharmaceuticals and how the company’s products can contribute to the quality assurance work.
New medicines are being developed at a rapid pace and internationally the focus is now on quality control of pharmaceuticals. What does this development mean for Pharmacolog?
“Since the same requirements are imposed on quality control according to Good Manufacturing Practice (GMP), whether it is the manufacture of medicines in high-tech factories with access to advanced equipment, or whether it is the compounding of medicines in hospitals and hospital pharmacies, our existing products meet an accelerating customer need for the latter group.”
“In drug development, there is a great focus on precision medicine and personalized treatment. To achieve optimal treatment effect, the right dose for an individual patient may be as important as the right drug. One example is antibiotic treatment in case of sepsis or septic shock. The infection must be treated with the right antibiotics, but an excessive dose can be toxic, and an excessively low dose can lead to long-term treatment which in turn can lead to resistant bacteria. Our products DrugLog and PrepLog enable easy verification of both the identity and concentration of an antibiotic preparation before it is administered to the patient.”
How have your healthcare customers reacted to the technology and new routines that your products bring?
“Healthcare is strained and customers welcome our quick and easy solutions that make it possible to confirm the quality of their drug preparations without significantly affecting their workflow. In chemotherapy, for example, the consequences can be devastating if the preparation were to be administered at the wrong dose.”
“It doesn’t matter if the compounding is done manually of performed by a compounding robot. Our systems can verify both the identity and concentration of the preparations before they are administered to the patient, and it gives users peace of mind.”
What does the competitive landscape look like and how do your products differ there?
“A lot of people have said “Isn’t this available already?” when they first encountered Pharmacolog, but DrugLog and PrepLog are unique. There are no other convenient systems, specifically designed for quality control of injectable drugs that can be used by both hospital pharmacies and wards.”
Pharmacolog now has two major international partners B. Braun in Spain and Codonics in the US. Can you describe how your products fit into their range and what your collaboration looks like in practice?
“Both B. Braun and Codonics have solid knowledge and experience of sales to our target groups. The synergies are very clear and our products, which complement theirs, have been seamlessly integrated for a more complete customer offering. In the US, Codonics started out by selling WasteLog, our product that prevents discarded or returned narcotics from ending up in the wrong hands after, for example, a surgical procedure, so-called Drug Diverson Prevention. Now they have also started offering quality control with DrugLog and both products have been integrated into their Codonics Safe Label System for safe drug management.”
“In Spain, B. Braun has realized an impressive investment in chemotherapy and expanded its already extensive product range by adding quality control with DrugLog and PrepLog to their OncoSafety Remote Control system.”
