Condition category
Not Applicable
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information



Primary contact

Mr Jesus Becerra Camargo


Contact details

Escuela de Farmacia
Facultad de Ciencias
Universidad Nacional de Colombia
Ciudad Universitaria
Edificio 450 Oficina 204
+57 (0)1 3165000

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effectiveness of a Pharmacist-acquired medication History in an Emergency department: a randomized controlled trial



Study hypothesis

The Intervention (a pharmacist-acquired medication history in an emergency department) reduces the number of patients with at least one admission medication discrepancies related to home medications.

Ethics approval

University Hospital of the Samaritan woman (Hospital Universitario de la Samaritana), Bogotá, Ethical approval committee by Act 142, 27/06/2012

Study design

Multicenter randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact to request a patient information sheet


Medication reconciliation


One group of patients will be included in a MedRec programme (intervention group) and the other used for comparison/control. A team made up of pharmacists, blinded to the assignation and intervention, will obtain the clinical history regarding the drugs which a particular patient is currently consuming in his/her home (R1). The participants will then be randomly assigned to the intervention or control group by simple randomisation using a random number table and data stored on an Excel calculation spreadsheet. The assignation will be concealed by using sequentially-numbered, sealed opaque envelopes, in sequentially-numbered, sealed containers; there will be two exactly similar copies which will be guarded under lock and key by the emergency coordinator. Another team of pharmacists blinded to the patients’ assignation and each intervention and control group will prospectively obtain the medication history for each patient being attended by the emergency service (R2).

Another independent team, consisting of a pharmacist and a doctor, will carry out standardized MedRec procedure by comparing R1 to R2. The medication history prepared by the pharmacist in triage and that regarding prescriptions issued by the emergency doctor will also be compared to identify discrepancies which may have arisen during the admission procedure. If there are any differences then these will be clarified and resolved, leading to corrected medical orders and MedRec history (R3) being established for all patients.

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Medication discrepancies associated with the intervention. The following definition of medication discrepancy has been adopted for the present study: “Any patient medication-related statement regarding medication consumed at home, made during admission to the emergency service.” Discrepancies will be prospectively identified. The main result will lie in identifying patients having at least one discrepancy regarding the medication being taken at home, then recording it and communicating it.
Medication discrepancies may be associated with drugs, medication brand-name, dose, duration, frequency, formulation, administration route, resumption of appropriate medication, illegible medical orders/prescriptions.
Identifying the type of discrepancy: Detecting the presence of some of the following events:
1.1. Omission (not ordering medication which a patient has been taking before admission)
1.2. Therapeutic duplicity (receiving more than one similar medication for the same indication)
1.3. Slowness in resuming therapy (selecting one of the following categories: before 6 hours, 6-12 hours, 12-24 hours or more than 24 hours after being admitted)
1.4. Therapy instituted too soon (i.e. treatment being reinitiated without taking frequency of taking a prescribed drug at home into account: before 6 hours, 6-12 hours, 12-24 hours or more than 24 hours)
2. Prescription discrepancies
2.1. Inconsistency or omission of some type of the following information: medication brand-name, dose, frequency, administration route or illegible orders
2.2. Prescription omission (when a patient has been given medication which has not been prescribed)
2.3. Medications lacking indication (medication administered without any indication, not associated with a diagnosis or consuming unneeded medication)
2.4. Allergies and interactions (these should be classified according to the following categories: higher (interaction could affect a patient’s life or cause permanent damage must be suspended immediately), moderate (when this does not put a patient’s life at imminent risk but could complicate his/her general state and lead to reversible damage), lower (not affecting a patient’s clinical condition but could involve adjusting the dose), none (interaction is present but documentation is lacking regarding the clinical effect), others (some of those which are not described in this protocol but which could be of clinical interest).
Number of discrepancies per category. Describing events which could arise: omission, therapeutic duplicity, slowness in resuming therapy, therapy instituted too soon, prescription discrepancies, prescription omission, medication lacking indication, allergies, interactions, other events.

Secondary outcome measures

Classifying and evaluating discrepancy safety: Involuntary medication discrepancies which may cause damage are defined as, “An incident potentially leading to a medication-related lesion.” The potential to cause damage has been used to measure medication safety and its reduction as an action to reduce real medical administration records (RAM). Discrepancy risk has been defined in three classes (according to Cornish et al.,):
1. Class 1 (those probably not causing clinical deterioration or nuisance)
2. Class 2 (those having the potential to cause moderate nuisance or clinical deterioration)
3. Class 3 (those having the potential to cause serious discomfort for a patient or significant clinical deterioration)

Characterising the population seeking help from emergency services will involve recording date regarding chronological age in years, gender, socioeconomic strata, number of prior hospitalisations, number of morbidities, type of co-morbidity, how many medications are being taken, the type of medication and interventions made by the pharmacist.

Characterizing and evaluating reconciliation will involve evaluating the opportunity and suitability of pharmaceutical action. The number of interventions made by a pharmacist will be measured, as will the medication history’s level of acceptance and average time spent on MedRec in hours.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Adults (18 years or older)
2. Patients admitted and assessed as triage I and II
3. Prescribed at least one prescription medication before admission
4. To be hospitalized for at least 24 hours
5. Only patients with a time admission income less than 24 hours and
6. Had signed study participation agreement and completion of informed consent form

Participant type


Age group




Target number of participants

A minimum enrollment of 100 patients in each arm is necessary for the study to have sufficient power.

Participant exclusion criteria

1. They are scheduled for discharge on the same day
2. They are not able to answer the questions needed to complete the study
3. They are unable to communicate due to language difficulties, were under psychiatric care, medical record documentation of dementia or confusion and/or are unable to give consent. If a patient had more than one admission during the study period, only the first admission will be evaluated

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Universidad Nacional de Colombia

Sponsor information


National University of Colombia (Universidad Nacional de Colombia) (Colombia)

Sponsor details

Escuela de Farmacia
Facultad de Ciencias
Ciudad Universitaria
Edificio 450 Oficina 204
+57 1 3165000

Sponsor type




Funder type


Funder name

Research Division Bogota (DIB) - National University of Colombia [División de Investigación Bogotá. (DIB) Universidad Nacional de Colombia, Código QUIPU] (Colombia)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in:
2015 results in:

Publication citations

  1. Results

    Becerra-Camargo J, Martinez-Martinez F, Garcia-Jimenez E, A multicentre, double-blind, randomised, controlled, parallel-group study of the effectiveness of a pharmacist-acquired medication history in an emergency department., BMC Health Serv Res, 2013, 13, 337, doi: 10.1186/1472-6963-13-337.

  2. Results

    Becerra-Camargo J, Martínez-Martínez F, García-Jiménez E, The effect on potential adverse drug events of a pharmacist-acquired medication history in an emergency department: a multicentre, double-blind, randomised, controlled, parallel-group study, BMC Health Serv Res, 2015 , 15, 337, doi: 10.1186/s12913-015-0990-1.

Additional files

Editorial Notes

02/02/2016: Publication reference added.