URBAR INGENIEROS, S.A

In the medication process, other actors than pharmacists, notably physicians and nurses, are also involved and it is illogical not to disseminate to all those who are directly concerned. We believe that for better implementation of the recommendations, the CMR needs to disseminate its output (e.g., the alerts and newsletters) to the most appropriate healthcare providers. For the CMR the most efficient way to disseminate output to healthcare providers is to collaborate with their professional organisations. The current dissemination to hospital pharmacists and community pharmacists is already through the collaboration between the CMR and the two professional national organisations of hospital pharmacists and pharmacists. These professional organisations can send a direct email to their members. Collaboration with these organisations will also increase professional support for the CMR recommendations.

Beside healthcare providers the CMR should send specific warnings and/or recommendations to the most appropriate parties such as software vendors, health authorities (healthcare inspectorate, medicine regulatory agency), university educators, and national guideline developers. This is especially relevant for recommendations which are not directly aimed at daily clinical practice, such as recommendations about changing the naming of a medicine, IT problems

(e.g. computer screen lay out), or the content of guidelines.

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ISMP in the United States has a special edition of a newsletter for patients. It is a health education newsletter and it teaches patients to become active partners with their healthcare providers. If feasible, the CMR should develop a newsletter which is especially targeted to patients and to society at large. The patient newsletter should focus on issues about the use of medicines and especially the use of medicine at home.

Uptake and impact of the recommendations

The degree of uptake of the CMR recommendations in three alerts varied (chapter 9). The CMR should consider ways to increase awareness and uptake of recommendations. For instance, the CMR could follow the example of the ISMP in the United States to present its recommendations in the form of a checklist for implementation in which healthcare providers can tick off each recommendation after they have implemented it into daily practice. If this tool would be offered through a website, it would not only show healthcare providers which recommendations still need attention but it would also provide the CMR with direct feedback on the degree of implementation of its recommendations. In the same checklist, healthcare providers should also be allowed to explain why they did not implement certain recommendations. Research will be necessary to explore the usefulness of such a feedback system and its impact on the uptake of recommendations. Secondly more and larger studies are necessary to investigate the association between the degree of uptake and potential determinants. In this thesis we only investigated a few potential determinants.

The degree of uptake is an indication for the implementation of the recommendations, but the actual effects on practice and patient safety are still unknown. Currently formal evidence what effects scientific case reports, alerts and newsletters actually have on patient safety, is lacking. It also needs to be explored and evaluated what is the effectiveness and efficiency of different methods of output.

CONCLUSION

This thesis presents a series of studies of the Dutch nationwide reporting programme (CMR).

Healthcare providers use the CMR reporting programme to report medication errors and to share their experiences with other professionals. The CMR organisation collects medication errors, selects and analyses them, provides feedback, and disseminates recommendations. The objective of the CMR is to support risk management in the medication process by informing healthcare providers and other actors about the risks in the medication process and by sending out alerts, newsletters and other signals to prevent or reduce reoccurrence of specific high-risk medication errors.

This thesis shows that the current main input comes from individual healthcare providers in hospitals and community pharmacies. Input from individual healthcare providers needs to be broadened. In coming years patients and other healthcare providers such as general

involved in the reporting to the CMR. Beside reports from individual healthcare providers the CMR can benefit from newsletters and alerts of other national reporting programmes. The input itself can improve by raising the reporting rate and especially the reporting of relevant medication errors that meet the three basic selection criteria of the CMR for analysis. The quality of the reports can be enhanced by introducing the combination of a dedicated person and a web based response system.

In order to respond to this growing input the CMR also needs to incorporate new selection and supplementary screening methods. Selection methods using a list of search terms or marking reports during the screening are especially useful to reselect reports that already have been screened in the past.

On the output side, the CMR should disseminate its alerts and newsletters not only to pharmacists, but also to other healthcare providers involved in the medication process, such as physicians and nurses. These professionals need to be informed about high risk medication errors. The output of the CMR is not only relevant for healthcare providers but also for healthcare agencies and third parties, such as the Ministry of Health, pharmacovigilance centres, regulatory authorities, pharmaceutical industries, software vendors, guideline developers, and international reporting programmes. Additionally the CMR needs to improve the degree of uptake of the recommendations.

Ultimately the CMR is dependent on healthcare providers for sufficient and informative input, but the same healthcare providers are also involved in the reception and uptake of the recommendations. An interdependence exists between the healthcare providers and the CMR.

Together they can reach the goal of providing and guarantying a safe environment for patients.

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Summary

Patient safety has become an important issue in healthcare and actions are needed to increase  patient safety. One of the strategies to enhance safety is the professional reporting and analysing  of medication errors in order to explore the actual nature of the errors, the consequences for the  patients  and  the  underlying  causes  of  the  errors.  The  aim  is  that  sharing  this  information  with  other healthcare providers will help to prevent the reoccurrence of similar medication errors. 

Medication errors and adverse drug reactions are both belonging to the domain of adverse drug  events.  Despite  the  overlap  between  adverse  drug  reactions  and  medication  errors,  also  differences  exist.  An  adverse  drug  reaction  is  always  directly  related  to  the  pharmacological  characteristics of the medicine. In an adverse drug reaction a medicine is always involved and in a  medication  error  the  medicine  and/or  the  device  to  administer  the  medicine  are  involved.  An  adverse  drug  reaction  always  has  some  harm  to  the  patient  and  a  medication  error  can  have  some harmful outcome or potential harm (near misses) to the patient. The root cause analysis of  a  medication  error  is  related  to  underlying  human  and  organisational  causes,  while  an  adverse  drug  reaction  focuses  on  the  pharmacology  of  the  drug.  Furthermore,  the  recommendations  related to adverse drug reactions and medication errors are different. For adverse drug reactions  the most common recommendations are to withdraw the medicine or to adapt the Summary of  Product  Characteristics  (SPC).  In  contrast,  recommendations  concerning  medication  errors  are  more  extensive  and  related  to  the  medication  process,  work  process  and/or  handling  by  healthcare providers. The definition of an adverse drug event is a harmful outcome that occurs  while  a  patient  is  taking  a  drug  or  at  some  time  afterwards,  but  that  may  or  may  not  be  attributable  to  it.  A  medication  error  can  occur  at  any  stage  of  the  treatment  process:  from  prescribing to dispensing and compounding and eventually to the administration of a medicine  and monitoring of its effect. 

In  the  Netherlands  medication  errors  can  be  reported  to  a  nationwide  reporting  programme  named  Central  Medication  incidents  Registration  (CMR).  The  research  in  this  thesis  focuses  on  the  usefulness  of  the  CMR  as  a  patient  safety  enhancing  tool  for  healthcare  providers  in  the  context  of  clinical  practice.  Three  aspects  of  the  nationwide  reporting  programme  are  highlighted: (1) input of data to the CMR; (2) basic methods of working of the CMR programme  providers  via  a  web  based  reporting  form  and  the  redirection  of  reports  collected  from  local  reporting  programmes  in  hospitals  or  community  pharmacies.  Another  possible  route  for  the  CMR  to  receive  input  is  consulting  scientific  literature.  Chapter  2  reviewed  studies  about  dispensing  errors  in  Pubmed®  online  that  were  published  from  2003  to  2008  inclusive.  The  objective  was  to  explore  dispensing  errors  in  scientific  literature  to  get  insight  into  the  nature,