both as a Word document and a PDF document. Contact: info@pcne. This classification should be referred to as ‘The PCNE Classification V 8.01’.

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PCNE classification 1 15 – 6 – 2017 V8.01 Classification for Drug related problems V 8 .0 1 © 2003 – 20 1 7 Pharmaceutical Care Network Europe Foundation This classification can freely be used in Pharmaceutical Care Research and practice, as long as the PCNE association is informed of its use and results of validations. The classification is available both as a Word document and a PDF document. Contact: info@pcne.org This classification should be referred to a 8 .0 1 This version is not directly backwards compatible with older versions.

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PCNE classification 2 15 – 6 – 2017 V8.01 Introduction During the working conference of the Pharmaceutical Care Network Europe in January 1999, a classification scheme was constructed for drug related problems (DRPs). The classification is part of a total set of instruments . The set consists of the classification scheme, reporting forms and cases for training or validation. The classification system is validated and adapted regularly. The current version is V 8 , which has been developed during an expert workshop in February 2 016 and a subsequent specialist meeting in April 2017 . It is no longer compatible with previous versions because a number of major sections ha ve been revised. In V 8.01, a necessary code C3.5 (which had dropped out) is re – added. The classification is for u se in research into the nature, prevalence, and incidence of DRPs and also as a process indicator in experimental studies of Pharmaceutical Care outcomes. It is also meant to help health care professionals to document DRP – information in the pharmaceutical care process. The hierarchical classification is based upon similar work in the field, but it differs from existing systems because it separates the problems from the causes. Quality experts will recognise that the The following official PCNE – DRP definition is the basis for the classification: A Drug – Related Problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes. The basic classification now has 3 primary domains for problems, 8 primary domains for causes and 5 primary domains for Interventions. In V7 a nce of the Intervention However, on a more detailed level there are 7 grouped sub domains for problems, 3 5 grouped sub domains for causes and 1 6 grouped sub domai ns for interventions , and 10 subdomains for interve ntion acceptance . Those sub – domains can be seen as explanatory for the principal domains. In 2003 a scale has been added to indicate if or to what extend the problem has been solved , containing 4 pr imary domains and 7 sub domains . J.W.Foppe van Mil/ Nejc Horvat / Tommy Westerlund Zuidlaren, Ap ril/May /June 2017

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PCNE classification 3 15 – 6 – 2017 V8.01 PCNE Classification scheme for Drug – Related Problems V8.0 – Page 1 The basic classification Code V 8 .0 1 Primary domains Problems (also potential) P1 Treatment effectiveness There is a (potential) problem with the (lack of) effect of the pharmacotherapy P2 Treatment safety Patient suffers, or could suffer, from an adverse drug event P 3 Others Causes (including possible causes for potential problems) C1 Drug selection The cause of the DRP can be related to the selection of the drug C2 Drug form The cause of the DRP is related to the selection of the drug form C3 Dose selection The cause of the DRP can be related to the selection of the dosage schedule C4 Treatment duration The cause of the DRP is related to the duration of treatment C 5 Dispensing The cause of the DRP can be related to the logistics of the prescribing and dispensing process C 6 Drug use/ process The cause of the DRP is related to the way the patient gets the drug administered by a health professional or carer , in spite of proper instructions (on the label ) C7 Patient related The cause of the DRP can be related to the patient and his behaviour (intentional or non – intentional) C8 Other Planned Interventions I0 No intervention I1 At prescriber level I2 At patient level I3 At drug level I4 Other Intervention Acceptance A1 Intervention accepted A2 Intervention not accepted A3 Other Status of the DRP O0 Problem status unknown O1 Problem solved O2 Problem partially solved O3 Problem not solved

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PCNE classification 4 15 – 6 – 2017 V8.01 PCNE Classification scheme for Drug – Related Problems V 8 .0 – Page 2 The Problems Primary Domain Code V 8 .0 1 Problem 1.Treatment effect iveness There is a (potential) problem with the (lack of) effect of the pharmacotherapy P1.1 No effect of drug treatment/ therapy failure P1.2 E ffect of drug treatment not optimal P1. 3 Untreated symptoms or indication 2. Treatment safety Patient suffers, or could suffer, from an adverse drug event P2.1 Adverse drug event (possibly) occurring 3 . Others P 3 .1 Problem with cost – effectiveness of the treatment P3.2 U nnecessary drug – treatment P 3 . 3 Unclear problem/complaint. Further clarification necessary (please use as escape only) Potential Problem Manifest Problem

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PCNE classification 5 15 – 6 – 2017 V8.01 PCNE Classification scheme for Drug – Related Problems V 8 .0 – Page 3 The Causes (including possible causes for potential problems) N.B. One problem can have more causes Primary Domain Code V 8 .0 1 Cause Prescribing 1. Drug selection The cause of the (potential) DRP is related to the selection of the drug C1.1 Inappropriate drug according to guidelines/formulary C1.2 Inappropriate drug (within guidelines but otherwise contra – indicated) C1. 3 No indication for drug C1. 4 Inap propriate combination of drugs or drugs and herbal medication C1. 5 Inappropriate duplication of therapeutic group or active ingredient C1. 6 No drug treatment in spite of existing indication C1. 7 Too many drugs prescribed for indication 2. Drug form The cause of the DRP is related to the selection of the drug form C2.1 Inappropriate drug form ( for this patient ) 3. Dose selection The cause of the DRP is related to the selection of the dose or dosage C3.1 Drug dose too low C3.2 Drug dose too high C3.3 D osage regimen not frequent enough C3.4 D osage regimen too frequent C3.5 Dose timing instructions wrong, unclear or missing 4 . Treatment duration The cause of the DRP is related to the duration of treatment C 4 .1 Duration of treatment too short C 4 .2 Duration of treatment too long Disp 5 . Dispensing The cause of the DRP is related to the logistics of the prescribing and dispensing process C 5 .1 Prescribed drug not available C 5 .2 Necessary information not provided C5.3 Wrong drug, strength or dosage advised (OTC) C5.4 W rong drug or strength dispensed Use 6 . Drug use process The cause of the DRP is related to the way the patient gets the drug administered by a health professional or carer , despite proper dosage instructions (on the label) C 6 .1 Inappropriate timing of administration and/or dosing intervals C 6 .2 Drug under – administered C 6 .3 Drug over – administered C 6 .4 Drug not administered at all C 6 .5 Wrong drug administered 7 . Patient related The cause of the DRP is related to the patient and his behaviour (intentional or non – intentional) C 7 .1 Patient uses/takes less drug than prescribed or does not take the drug at all C 7 .2 Patient uses/takes more drug than prescribed C 7 .3 Patient abuse s drug (unregulated overuse) C 7 .4 Patient uses unnecessary drug C7.5 Patient takes food that interacts C7.6 Patient stores drug inappropriately C7.7 Inappropriate timing or dosing intervals C7.8 Patient administers/uses the drug in a wrong way C7.9 Patient unable to use drug/ form as directed 8 . Other C8.1 No or inappropriate outcome monitoring (incl. TDM) C 8 . 2 Other cause; specify C 8 . 3 No obvious cause

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PCNE classification 6 15 – 6 – 2017 V8.01 PCNE Classification scheme for Drug – Related Problems V8 – Page 4 The Planned Interventions N.B. One problem can lead to more interventions Primary Domain Code V 8 .0 1 Intervention No intervention I0. 1 No Intervention 1. At prescriber level I1.1 Prescriber informed only I1.2 Prescriber asked for information I1.3 Intervention proposed to prescriber I1.4 Intervention discussed with prescriber 2. At patient level I2.1 Patient ( drug ) counselling I2.2 Written information provided ( only ) I2.3 Patient referred to prescriber I2.4 Spoken to family member/caregiver 3. At drug level I3.1 I3.2 I3.3 I3.4 Instructions for use changed I3.5 Drug stopped I3.6 New drug started 4. Other intervention or activity I4.1 Other intervention (specify) I4.2 Side effect reported to authorities Acceptance of the Intervention proposals N.B. One level of acceptance per intervention proposal Primary domain Code V 8 .0 1 Implementation 1. I ntervention accepted (by prescriber or patient) A 1 .1 Intervention accepted and fully implemented A1.2 Intervention accepted, partially implemented A1.3 Intervention accepted but not implemented A1.4 Intervention accepted, implement ation unknown 2. Intervention not accepted (by prescriber or patient) A2.1 Intervention not accepted: not feasible A2.2 Intervention not accepted: no agreement A2.3 Intervention not accepted: other reason (specify) A2.4 Intervention not accepted: unknown reason 3. Other (no information on acceptance) A3.1 Intervention proposed, acceptance unknown A3.2 Intervention not proposed

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PCNE classification Help 8 15 – 6 – 2017 V8.01 PCNE Classification for Drug related problems Help V 8 .0 1 © 2003 – 20 1 7 Pharmaceutical Care Network Europe Foundation This classification can freely be used in Pharmaceutical Care Research and practice, as long as the Foundation is informed of its use and results of validations. The classification is available both as a Word document and a PDF document. Contact: info@pcne.org This help document is related to as Help to the PCNE Classification V 8 .0 1

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PCNE classification Help 9 15 – 6 – 2017 V8.01 Finding or selec ting codes in the PCNE classification A Drug – Related Problem is an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes. For the use of the PCNE classification it is important to separate the real ( or potential) problem (that affects or is going to affect the outcome) from its cause (s) . Often such problems are caused by a certain type of error e.g. prescribing errors or drug – use or administration errors. But there might be no error at all involved. Also, a medication error does not necessarily have to lead to a drug – related problem , there can be no problem or the problem is potential . The cause is usually the behaviour that h as caused (or will cause) the problem , and most often t hat is a medication error . A cause or a combination of causes and a problem together, will usually lead to one or more interventions. The classification can be used in two ways, depending on the level of information needed. If only the main domains are used, there is in general enough information for research purpose s. If the system is used for documenting pharmaceutical care activities in practice, the sub domains can be useful . Problem section Basica or might be wrong, in therapy with drug – codes) There are 3 major domains in the problem section. The following descriptions could help to find the right pro blem domain: The clinical effect of the treatment is not as expected or there is no treatment See P1 The patient suffers from an AD R at normal dose or from a toxic reaction See P2 Nothing seems wrong in the treatment, but there is another problem . See P 3 Causes section Each (potential) problem has a cause. The cause is the action (or lack of action) that leads up to the occurrence of a potential or real problem. There may be more (potential) causes for a problem. (The C – code) The cause of the DRP is r elated to the selection of the drug See C1 The cause of the DRP is related to the selection of the drug form See C2 The cause of the DRP is related to the selection of a dose or dosage schedule See C3 The cause of the DRP is related to the duration of the therapy See C4 The cause of the DRP is related to the logistics of the prescribing or dispensing process See C 5 The cause of the DRP is related to the way the patient gets the drug administered by a health professional or carer, despite proper dosag e instructions (on the label) . (principally used for hospital or home – care by caregivers) See C 6 The cause of the DRP is related to the personality or the behaviour of the patient See C7 Other See C8

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PCNE classification Help 10 15 – 6 – 2017 V8.01 Planned Intervention section The problem will usually lead to one or more in interventions to correct the cause of the problem. (The I – code) There is or can be no intervention See I0 Intervention through the prescriber See I1 Intervention through the patient, his carers or relatives See I2 Intervention directly by changing drug or indicating change in drug use See I3 Other intervention See I4 Level of acceptance of intervention proposals In this section you can indicate if the suggestion for the intervention to patient or prescriber has been accepted. Intervention accepted (by prescriber or patient) See A 1 Intervention not accepted (by prescriber or patient) See A 2 No intervention proposed or accept ance unknown (no information) See A 3 Status of the DRP For evaluation purposes it is desirable to indicate if the problem has been solved by a specific intervention (the I – code) , that has been not, partially or fully accepted by the prescriber and patient (the A code) . Problem totally solved See O1 Problem partially solved See O2 Problem not solved See O3

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