Minutes of meeting no. 1 of the Network for the Prevention of Medication Errors held on 8 April 2008

19 May 2009

The meeting was held on 8 April 2008 at 13:00-16:00 at the Danish Medicines Agency.

Agenda
Minutes
Participants


Agenda

  1. Welcome
  2. Introduction to the Network for the Prevention of Medication Errors
    1. - by the Danish Medicines Agency
  3. Introduction of participants
  4. Danish Patient Safety Database
    1. - by the National Board of Health
  5. Results of the Danish Medicines Agency’s action plan project ”prevention of medication errors”
    1. - by the Danish Medicines Agency
  6. The Danish Medicines Agency's labelling control of medicinal products
    1. - by the Danish Medicines Agency
  7. Amgros’ development of a new packaging and label design for SAD products
    1. - by Amgros I/S
  8. The tasks of the network - discussion
  9. Next meeting
  10. Any other business

Re item 1 Welcome

Anne-Marie Vangsted welcomed members to the meeting

Re item 2 Introduction to the Network for the Prevention of Medication Errors

Anne-Marie Vangsted informed the members that the aim of the network is to promote dialogue between the pharmaceutical industry, the professional users of medicine as represented by the scientific organisations in the health area and the Danish Medicines Agency. In addition, the network will also work on specific tasks in working groups. The network participants may propose future tasks to the network.

The Danish Medicines Agency will prepare draft terms of references, which will be circulated for commenting by the network.

Re item 3 Introduction of participants

All participants introduced themselves round the table.

Re item 4. Danish Patient Safety Database

Jørgen Hansen from the National Board of Health gave a presentation of the Danish Patient Safety Database and the relevant legal framework.

Jørgen Hansen recommended that the network be joined by the suppliers association responsible behind the EPM/EPJ solutions (IT systems for electronic patient modules and electronic patient records).

Re item 5 Results of the Danish Medicines Agency’s action plan project ”prevention of medication errors”

Presentation by Marie Melskens.

It was noted that instructions for mixing and diluting medicine ought to be integrated into the hospitals' IT systems, i.e. EPM and EPJ.

A question was raised about whether adverse incidents related to dose dispensing had been reported to the Danish Patient Safety Database. The Danish Medicines Agency replied that it had not yet received any reports of adverse incidents related to dose dispensing.

It was added that the Association of Danish Pharmacies has asked pharmacies to report any adverse incidents involving dose dispensing. Hence, it is an area that receives attention.

Re item 6 The Danish Medicines Agency's labelling control of medicinal products

Presentation by Heidi Skjødt Andersen.

Questions were raised in relation to the Danish Medicines Agency's processing of cases on adverse incidents that had been held not constitute violations of the executive order on labelling. The Danish Medicines Agency briefed the members that companies involved in such cases are informed of labelling mix-ups by letter.

The network discussed legislation in the area of barcodes on the inner packaging of medicinal products. Amgros stated that its tendering documentation includes a requirement for medicinal products to carry a barcode.

The Danish Medicines Agency was encouraged to add the assessment of new packaging material to its list of services, as it is done in the USA.

The Danish Medicines Agency received positive feedback about its routine of publishing the names of medicinal products that have undergone label control.

Re item 7 Amgros’ development of a new packaging and label design for SAD products

Presentation by Flemming Sonne, Amgros I/S.

The design agency e-types owns the rights to Amgros' new design and the font Medic. It is possible for companies to buy the rights to use the design. Amgros has the right of use in the Nordic countries.

Amgros has given selected medicinal products a yellow label as a precautionary warning. If the same medicines from other manufacturers are not fitted with a yellow label, there is a risk that these medicines are underestimated.

Amgros replied that only four out of approx. 500 products had been fitted with a yellow label. In addition, only some 20% Amgros' products overlap with the products of the remaining pharmaceutical industry.

Re item 8 The tasks of the network - discussion

The Danish Medicines Agency proposed the following tasks to the network:

  • Labelling and handling of solutions for infusion: Flemming Sonne, Amgros, added that requirements were in the process of being drafted. Thus, the area is not relevant at present.
  • Guidelines on the layout and labelling of packaging material: It was stated that the Danish market is too small to justify the drafting of specific guidelines. Nordic/international guidelines would be relevant and useful. In the long term, the establishment of a working group serving as a preliminary study group for Nordic cooperation could be considered.
  • High-risk medicine: Several initiatives on high-risk medicines have been launched, e.g. the National Board of Health's theme report and Infomatum's work with high-risk medicine. The Danish Medicines Agency proposed that a working group dedicated to this focus be established, the aim being to make a coordinated approach in the area of high-risk medicines. The Danish Medicines Agency will serve as project facilitator and will circulate a draft document to the network before the summer. The working group could also be joined by relevant persons outside the network.
  • Instructions for mixing and diluting: A tangible task that could be addressed at one of the next meetings.
  • Adverse incidents involving medical devices: It was also mentioned that it might be relevant to include participants from the relevant industry organisations for manufacturers of medical devices. The Danish Medicines Agency said that it would send out invitations for the next network meeting.
  • Other proposed themes:
  • The communication in the link between the primary and secondary sectors.

Re item 9 Next meeting

The topics proposed by the Danish Medicines Agency' for presentation at the next meetings were discussed. The participants were encouraged to hold presentations and submit proposals for presentations to be held at future meetings.

Next meeting will be held on 30 October 2008. The Danish Medicines Agency will convene the meeting.

 

Re item 10 Any other business

It was proposed that patient associations be included in the network. At present, the Danish Medicines Agency has chosen to limit the network to the pharmaceutical industry and scientific organisations in the health area to keep the focus on specific themes.

It was also noted that it would be desirable to highlight the work of nurses and risk managers through presentations at the meetings of the network.

Amgros proposed that the Danish Society for Patient Safety participate in the working group on high-risk medicines.


Participants:

  • Amgros I/S: Flemming Sonne, Bente Dam
  • Association of Danish Pharmacies: Lotte Fonnesbæk, Pia Knudsen
  • Danish Society for Patient Safety: Annemarie Hellebek, Marianne Lisby, Majken Nørskov Petersen, Lene Stenbek, Mette Faber
  • Danish Nurses’ Organization: Janne Due Sommerset
  • FOA – Trade and Labour: Ulla Rosenkvist
  • Danish Association of Pharmaconomists: Christina Durinck
  • Danish Poison Control Hotline: Kim Dalhoff
  • Danish Generic Medicines Industry Association: Lea Storm, Anni Søgaard
  • Infomatum A/S: Jørgen Aagren Nielsen, Anette Petersen, Niels Lunding, Christianna Marinakis, Louise Thrane
  • Institute for Rational Pharmacotherapy: Marianne Møller
  • Danish Medical Association: Jens Peter Kampmann
  • Danish Association of the Pharmaceutical Industry: Ulla Høegh, Helen Shennan, Mette Bjersing
  • Danish Medicines Agency: Anne-Marie Vangsted, Heidi Skjødt Andersen, Christina Palvad, Charlotte Mortensen, Jan Harlev, Lisa Larsen, Laila Mulla, Marie Melskens, Mona Laursen, Mette Lykkebo
  • Danish Association of Parallel Importers of Medicine: Heidi Greve Nielsen
  • Pharmadanmark: Helle Byg Armandi, Sonja Paltoft
  • National Board of Health: Jørgen Hansen, Helle Landberger Johansen

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