By Rocío Bao
Estela Izquierdo is the head and technical director of the Pharmacy Service at the Sanatorio Güemes in Buenos Aires. She is also the vice-president of the Argentine Health Auditing and Management Association (SADAM). She recently presided over the Conference: “Advances and Technical Solutions in the Implementation of the National Medication Traceability System”.
In an exclusive interview for E-Health Reporter Latin America, she talks about patient safety, the advances in the implementation of the NTS and the current proposals for optimizing the system.
At the event “Medications: Traceability and Patient Safety,” you said that Law of Traceability of Medications is an opportunity to improve patient safety. Do you think that the current regulations are insufficient in this area?
Patient safety isn’t just related to issues linked to traceability of medications. What the implementation of the National Traceability System (NTS) allows us to do is ensure the provenance of each medication throughout the sales chain and to implement the means necessary – within the schedule of each hospital center – to reach the bedside and verify the 5 correct steps once there: correct patient, correct time, correct medication, correct dosage and correct form of application.
You also mentioned that for the traceability processes to be implemented in the institutions it is necessary to review the culture of each place. What aspects do you believe need to be reviewed?
The implementation of the traceability system in an institution is a project that involves everyone: from management to the different sectors involved in the different stages in the supply chain. From its purchase to its administration to patients. To carry out the changes necessary for implementation of traceability, reviews must be carried out of all the different sectors which must be agreed upon (this is where the culture of each place comes in) and the staff must be trained so that they are implemented successfully.
Given how fast ANMAT is growing, what improvements do you believe will be implemented in the coming years?
I think that the NTS is a model that’s here to stay. It arrived in our country amid a backdrop of falsification scandals, irregularities and thefts but as it has advanced it has overcome and adapted to many processes in the sales chain that weren’t being run properly. To be able to trace products on a mass scale will need a general adaptation of the entire sales chain given the huge quantity of units in question, and it will also be necessary for blisters and packages in treatment areas to be identified with their laboratory of origin. Otherwise, each care center will have to become a repackaging and labeling center.
According to ANMAT, the system will only allow returns within a two hour period. How are these cases managed at the Sanatorio Güemes?
At the Sanatorio Güemes we inform ANMAT of their receipt and are starting to report that they have reached the patient only when they assure us that they themselves have received it in that period and this has been confirmed. At most care centers currently operating the traceability system, they do so upon receipt and a few do so at the patient level for high-cost and less used medications. Each institution will have to assess when to inform ANMAT that the medication was consumed by each patient, bearing in mind that if the data is not reliable and then there’s a return, there is a risk that the medication will be discarded.
Are you considering extending the traceability system, i.e: so that it actually reaches the patient’s bedside?
Yes, at the Sanatorio we are holding our first bedside test in the Oncology Outpatient Department: when the patient is admitted they are given an identification bracelet with their data (including the type of program they will undergo). Furthermore, we have internal traceability for all our oncology medication and high-cost medication sent by third parties and acquired by the Sanatorio. Then we will prepare the mixtures in our own cytostatic fractioning department, assigning each mixture a Data Matrix code and that code will be sent to the outpatient’s electronic health record. In this way, when the patient sits on the HDP chair, the correlation between the medication program, the patient and the nurse to administer it will be checked. Once everything is confirmed, the infusion begins and ANMAT is informed that the medications were administered.
