EAHP EU Monitor 24 June 2013
The EAHP EU Monitor is a weekly round up of news relevant to hospital pharmacy in Europe.
You can subscribe to the EAHP EU Monitor here.
EAHP delighted to welcome Malta and Romania as its newest members
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International Pharmaceutical Federation (FIP) develop 6 recommendations on medices shortages
At the first-ever “International Summit on Medicine Shortages” hosted by the International Pharmaceutical Federation, and co-hosted by the Canadian Pharmacists Association 6 primary recommendations were agreed to help alleviate problems being caused by the common global phenomena of medicines shortages.
The agreed recommendations were:
1. Each country should establish a publicly accessible means of providing information on shortages;
2. A global process to determine the list of critical/vulnerable products should be developed;
3. All procurers of medicines are urged to move towards active procurement processes that assure the continuity of supply of quality medicines;
4. All countries are encouraged to remove unnecessary variability of regulatory practices within and between countries;
5. All countries should investigate the potential to establish a national body charged with gathering and sharing information about demand for, and supply of, medicines within their jurisdiction; and,
6. All countries are encouraged to develop evidence-based risk mitigation strategies which might include strategic buffer stockpiles, contingency plans, pandemic planning and capacity redundancy appropriate to their national needs.
More information here.
European Commission grants export waiver to USA pharmaceutical companies
In advance of a 1 July 2013 Falsified Medicines Directive implementation deadline, the European Commission has granted an exemption from some regulatory requirements to pharmaceutical companies based in the USA who wish to export products to Europe.
Amongst the many requirements of the 2011 Directive on Falsified Medicines, is a “listing” system of countries from outside the EU wishing to export pharmaceutical products into Europe. The listing system is designed to give assurance that products from outside the EU have adhered to the same principles of good manufacturing as would have been the case were they manufactured within the EU.
The USA’s Food and Drug Administration (FDA) had requested that the European Commission consider its own manufacturing requirements and regulatory regime to be at least equivalent to that prevailing in Europe – a request which the Commission has now granted.
The ‘listing” of the USA has helped to alleviate some of the concerns that the new system could unintentionally add to medicines shortage problems by preventing EU countries from importing medicines from outside the European area.
The USA now joins Japan, Switzerland and Australia in benefitting from this special listing category.
More information here.
More information about the Falsified Medicines Directive here.
EJHP: Multisite analysis of missed doses in antibiotics
The online first edition of the EJHP has published an original research article on missed doses of antibiotics administered in hospital care.
Aiming to quantify the incidence of missed antibiotic doses in acute hospitals and identify the underlying reasons, the study made use of data from electronic prescribing and medicines administration systems (EPMAS), and had as an objective, to establish the feasibility of determining a minimal acceptable range for missed antibiotic doses.
More information here.