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DRUG-FOOD INTERACTION GUIDE PREPARATION FOR OUTPATIENT CONSULTATION

European Statement

Patient Safety and Quality Assurance

Author(s)

Gregorio Romero Candel, Paula Ruiz Belda, Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio, Juilan Castillo Sanchez, Luna Carratala Herrera

Why was it done?

Some drugs dispensed in the outpatient office present interactions with food, leading to changes in their bioavailability. These changes which can result in a decrease in therapeutic activity or an increase in adverse effects, when dealing with narrow therapeutic margin drugs, may lead to alterations in their efficacy and/or toxicity. Developing the quick and accessible consultation table, we improved the quality and effectiveness of the treatment.

What was done?

Preparation of the drug and food interaction guide for outpatient consultations.

How was it done?

The technical specifications of all drugs that are dispensed in the hospital outpatient office were consulted, and the possible interactions with food of every one of them were analysed by consulting the following electronic databases: Technical sheet, Bot Plus, Micromedex, Pubmed, UpToDate and Online Medicine Information Centre of the AEMPS. A database was developed with drugs that presented some type of restriction with meals, designing a quick reference table for outpatient consultation.

What has been achieved?

One-hundred specialities were reviewed, of which 22 were to be taken without food, 43 with food and 35 could be taken with or without food. The information given to the patient was quick and efficient, improving the effectiveness and safety of the treatment.

What next?

Our goal is to continue developing tools that allow us to provide quality information to the patient, improving the effectiveness and safety of treatments.

PREPARATION OF A CYTOSTATIC STABILITY GUIDE AFTER RECONSTITUTION AND DILUTION

European Statement

Patient Safety and Quality Assurance

Author(s)

Gregorio Romero Candel, Paula Ruiz Belda, Maria del Carmen Caballero Requejo, Maria Jesus Sanchez Cuenca, Jose Marco del Rio , Julian Castillo Sanchez, Luna Carratala Herrera

Why was it done?

In common clinical practice, the stability of medications is an area of interest to obtain maximum security and efficiency. After reconstitution and dilution, knowing the validity period is very important for the effectiveness and safety of the treatment, since it must be administered to the patient under the appropriate conditions. In recent years, a large number of high-impact cytostatic medicines with limited stability data have been registered and incorporated into clinical practice. Frequently, the stability data results are contradictory or insufficient. The main goal is to make a reliable quick guide of reference with the validity periods of the reconstituted and diluted active principles according to physicochemical stability, therefore increasing safety, reducing queries for these doubts and improving the management of unused remains that have high economic impact.

What was done?

A cytostatic stability guide after reconstitution and dilution has been made. The active principles and commercial presentations that are used in the intravenous mixtures area were reviewed.

How was it done?

The obtaining of the physical-chemical stability data has been done by reviewing the information available in Stabilis, Pubmed, Lexicomp and technical data sheets.

What has been achieved?

Fifty-four pharmaceutical specialities from 44 active principles, all in the cytostatic group, were checked. Tables of reference for the elaboration sites were made for consultation. It has reduced the number of consultations conducted and improved the time of preparation of these products. The rest of the elaborations for other administrations have been taken advantage of, making a better use of the pharmacotherapeutic resources.

What next?

The next step is to keep developing consultation tools that improve the safety and management of hospital drugs.

PHARMACISTS IMPROVE DOCUMENTATION OF DRUG ALLERGIES

European Statement

Patient Safety and Quality Assurance

Author(s)

Mohammed Almeziny, Fahad Alkharji , Ali Alkhudair , Jameel Al Mutairi

Why was it done?

Poor allergies’ documentation may cause harm to the patients, if the concerned medication reaches them. The hospital is planning to implement a new Health Information System, which includes a Computerised Provider Order Entry. However, this is a long-term project, so in order to minimise that risk, the hospital administration gave the pharmacists the privilege to do so. The percentage of documented drug allergies was 14%. The issue of compliance from the medical, nursing and pharmacy staff was a major obstacle in allergies’ documentation. For that reason, the pharmaceutical services initiated an improvement project to enhance allergies’ documentation. it is the responsibility of the physician to document any allergy on the inpatient prescription form (IPPF). On the other hand, it is the responsibility of the nurse to ensure that all information is completed on the IPPF before it is sent to the pharmacy. The role of the pharmacist is to document the patient’s allergy in the pharmacy system.

What was done?

Increase the allergy documentation from 14% to 96%.

How was it done?

The FOCUS PDCA was adopted. Find: It was found that the compliance rate was not satisfactory. Patients might receive a medication that is known to cause an allergic reaction, because the allergy was not documented and communicated with other healthcare providers. Organise: The team consisted of all involved departments. Clarify: Some IPPF may not contain allergies and some pharmacy staff do not document the allergy in the pharmacy system. Understand: The factors that may influence the process were identified, although some healthcare professionals consider the documentation as a time-consuming process. The pharmacy system is an old system which does not support enforcing function. Select: The targeted outcome was 90% within 1 year of its inception, July 2017 to July 2018. Plan: All allergies MUST be assisted, and the pharmacy will act as the enforcing body. Do the plan: All pharmacists were reminded to enforce hospital policies by not accepting any incomplete prescription and document all drug allergies in the pharmacy system. Check: Statistics regarding compliance were presented in monthly meetings to highlight the challenges, difficulty or any serious issue. It is a proactive meeting and members can freely suggest any tools required to improve the situation.

What has been achieved?

There was a significant improvement from 14% to 96%.

What next?

Start e-prescription to enforce the documentation of allergies.

SAFER DRUGS WITH AWARD-WINNING DATABASE

European Statement

Patient Safety and Quality Assurance

Author(s)

Teimori Kaveh

Why was it done?

Hospitalised patients often need multiple IV drugs simultaneously which are commonly mixed in-line before entering the bloodstream. Physicochemically incompatible drugs cause reduced efficacy, clogged catheters and drug precipitation, which can be harmful or even fatal. The risks add uncertainty to the stressful working environment for clinical practitioners. According to a local 2012 survey 68% (n=44) of Sahlgrenska University Hospital (SUH) intensive care unit (ICU) nurses had co-administered drugs uncertain of their compatibility. Hospital pharmacists were hence asked for guidance to optimise compatibility and patient safety.

What was done?

Nurses, doctors and pharmacists were provided with accessible and evidence-based information on IV drug compatibility in order to improve drug therapy, working environment and patient safety.

How was it done?

Drug compatibility data was collected by hospital pharmacists who assessed its applicability to Swedish conditions. The results were documented in charts and procedure documents. A project for creating a database was initiated in collaboration with the IT organisation in Västra Götaland Region (VGR). A survey was designed to evaluate how the SUH’s ICU nurses experienced the database. Collaboration with nurses, doctors and clinical pharmacists helped to improve the quality of the database.

What has been achieved?

Drug compatibility lectures were given to nurses, doctors and pharmacists on a continuous basis. Procedure documents were implemented in eight clinics. A peer-reviewed workflow was established. The database contains over 2,500 assessed drug combinations. Over 700 nurses, doctors and pharmacists from 11 counties plus Norway and Denmark have requested access to the database. Clinics avoid drug mixing by choosing multi-lumen catheters with greater capacity. The 2016 survey showed that 88% (n=86) of SUH’s ICU nurses had co-administered drugs uncertain of their compatibility. The database affected their decisions in 93% (n=45) of the cases, 85% (n=34) found information easier and 88% (n=34) felt more certain when making decisions. A new pharmacist role – IV Compatibility Manager – was introduced and implemented in VGR. In 2016, this work received the national annual award Guldpillret (‘The Golden Pill’).

What next?

In the next years, the database will become nationally available and integrated into electronic journal systems. Compatibility issues may then be identified when prescribing, further improving patient safety.

ELIMINATION OF THE RULE-OF-SIX IN A TERTIARY HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

Mohammed Almeziny, Ali Alkhudair , Fahad Alkharji

Why was it done?

The Rule-of-Six has been used in hospitals for many years. in the last years it has been under investigations due to the variable concentrations that result when making the calculation to mix critical medication drips. The rule, or formula, multiplies a patient’s weight (Kg) by 6 to determine the dose of a medication (mg) to be added to an appropriate diluents for a total volume of 100 mL. The rate in mL/hr is equivalent to the dose in mcg/kg/min. Therefore, for each patient, there would be a different concentration infused, although the rate/dose would be the same. In addition, the drastic changes in a patient’s weight would require compounding a new drip.

What was done?

developed and implemented a standardised list of IV medication concentrations across a tertiary hospital to enhance medication safety.

How was it done?

A task group was formulated from all involved parties to standardise I.V. infusion concentrations. The task group adopted the following strategies: first strategy is enhancing safety through standardised and limited concentrations available, simplifies calculations and minimise its effect on fluid restriction patients. Second strategy the concentration should be broadly applicable through meets needs of 80-90% patients, frequently used in current practice and appropriate for peripheral as well as central lines and the third strategy is developing comprehensive IV references using guideline validated by expert review and stakeholder consensus, education and training of stakeholders, comprehensive drug information, appendices for specialty settings and populations (ICU, NICU etc) and index of commercially available ready to administer finally these strategies are subjected to periodic revision and update. Infusion charts were developed to facilitate use of standardised concentration

What has been achieved?

Within 9 months the task group were able to eliminate the rule of six and created a list of standardised IV concentration. The hospital has successfully implemented a standardised IV infusion concentrations. The multidisciplinary consensus was achieved. The list of standardised IV concentration meets patient safety goals and provides numerous safety features. In addition system is highly efficient on a day to day practice as well as it is highly adaptable to most patient groups.

What next?

The health information system will be used to calculate the infusion rate

SAFER DRUGS WITH AWARD WINNING DATABASE

European Statement

Patient Safety and Quality Assurance

Author(s)

Kaveh Teimori, Hannah Colldén, Reza Asasdian

Why was it done?

Hospitalized patients often need multiple intravenous drugs simultaneously which are commonly mixed in-line before entering the blood stream. Physicochemically incompatible drugs cause reduced efficacy, clogged catheters and drug precipitation, which can be harmful or even fatal. The risks add uncertainty to the stressful working environment for clinical practitioners. According to a local 2012 survey 68% (n=44) of Sahlgrenska University Hospital (SUH) intensive care unit (ICU) nurses had co-administered drugs uncertain of their compatibility. Hospital pharmacists are hence asked for guidance to optimize compatibility and patient safety.

What was done?

Nurses, doctors and pharmacists were provided with accessible and evidence based information on IV drug compatibility in order to improve drug therapy, working environment and patient safety.

How was it done?

Drug compatibility data was collected by hospital pharmacists who assessed its applicability to Swedish conditions. The results were documented in charts and procedure documents. A project for creating a database was initiated in collaboration with the IT organization in Västra Götaland Region (VGR). A survey was designed to evaluate how the SUH’s ICU nurses experienced the database. Collaboration with nurses, doctors and clinical pharmacists helped improving the quality of the database.

What has been achieved?

Drug compatibility lectures given to nurses, doctors, pharmacists on a continuous basis. Procedure documents implemented in eight clinics. A peer-reviewed work flow is established. The database contains over 2500 assessed drug combinations. Over 700 nurses, doctors and pharmacists from 11 counties plus Norway and Denmark have requested access to the database. Clinics avoid drug mixing by choosing multi-lumen catheters with greater capacity. The 2016 survey showed that 88% (n=86) of SUH’s ICU nurses had co-administered drugs uncertain of their compatibility. The database affected their decisions in 93% (n=45) of the cases, 85% (n=34) found information easier and 88% (n=34) felt more certain when making decisions. A new pharmacist role – IV Compatibility Manager – was introduced and implemented in VGR. In 2016, this work received the national annual award Guldpillret (“The Golden Pill”).

What next?

In the next years, the database will become nationally available and integrated into electronic journal systems. Compatibility issues may then be identified already when prescribing, further improving patient safety.

PREPARATION OF A COMPATIBILITY CHART IN “Y” FOR AREAS OF CRITICALLY ILL PATIENTS

European Statement

Clinical Pharmacy Services

Author(s)

Gregorio Romero Candel, Esther Domingo Chiva, Laura Rodenas Herraez, Cristina Urbano, Jose Marco del Rio, Nieves Cuenca Cano, Maria Jesus Sanchez Cuenca, Antonio Sanz Arrufat, Ana Valladolid Wals, Angel Escudero Jimenez

Why was it done?

In the areas of critically ill patients such as emergency, intensive care and resuscitation, the use of intravenous drugs (IV) in “Y” are common in clinical practice. Stability and physical-chemical compatibility of IV drugs admistered in “Y” are important, affecting directly the safety of patients and the therapeutic efficacy of medicines, which can lead to medication errors (ME). A quick reference chart was developed in order to facilitate the administration of these drugs and reduce errors in these areas.

What was done?

A chart for quick reference of compatibility of drugs in “Y” for the most commonly used drugs in the areas of critically ill patients of our hospital.

How was it done?

It was a team composed of a doctor specializing in emergency medicine, a nurse and two hospital pharmacists. Economic management of pharmacy program Farmatools® was used to obtain the list of drugs most consumed and those most relevant and specific of these areas were selected.
A chart was made where the header of the rows and the columns was the list of drugs in the study. Finally, we conducted a systematic research on Micromedex® “Y” compatibility with each drug with the remaining, completed the chart with a visual color code: green (compatible), red (incompatible), white (not tested) and orange (precaution, existence of various stability dilutions and consult your pharmacist).

What has been achieved?

The elaboration and implementation of this table will provide a fast and visual consultation instrument to nurses before the administration of drugs in “Y”. This tool intended to facilitate decision-making, contributing to increase the effectiveness of the drugs and avoid possible adverse reactions in patients, increasing the quality of care and lowering the ME.

What next?

We are still working on the same areas to increase safety in drug therapy in critical care. Currently, that improvement measures that are being developed are: new pharmacotherapeutic protocols specifically for those units: high risk medications perfusion protocols and new safety guidelines.

IMPLEMENTATION OF A SAFETY ALERT SYSTEM IN A HOSPITAL

European Statement

Patient Safety and Quality Assurance

Author(s)

MERCEDES GIMENO-GRACIA, TRANSITO SALVADOR-GOMEZ, ROSA MARECA, JOSE IGNACIO GARCIA-MONTERO, MIGUEL ANGEL SALVO, PILAR ABAD, BEATRIZ ABAD, CESAR VELASCO

Why was it done?

The Spanish Agency of Medicines and Health Products (AEMPS) issues drug and health product-related alerts to the health centres through each region’s Department of Health. The means through which said alerts reach the health professional is not always adequate. The procedures for alert dissemination in our hospital hadn’t been standardized yet: some professionals were alerted more tan once while others weren’t alerted at all. Furthermore, there was no record of these alerts

What was done?

We developed a safety alert management and dissemination system implementation in a hospital setting.

How was it done?

In April 2014, a multidisciplinary workgroup was established (3 members of the Preventive Medicine Service, 2 pharmacists, 2 members of the Supplies Service, 2 computer technicians and 2 members of the hospital’s Management) to analyse management and dissemination of alerts within the hospital at that time. Safety alerts can attain to different elements: drugs, medical devices and public health. Throughout 2015 new circuits and actions were established and in 2016 their implementation was initiated.

What has been achieved?

The workgroup held 7 meetings from April 2014 to June 2016. The project started focusing on drug-related alerts. An algorithm was designed to handle them, in which a pharmacist filtered the alerts (via e-mail) and assessed which had to be spread, and among which professionals. Additionally, the pharmacist managed the alert. The dissemination worked as follows: from the Pharmacy Service to Medical or Nursing Directors, who spread the message to the different units recommended by pharmacist, specifically to their respective Manager, Tutor of Residents and Quality Manager. All alerts were recorded in a database, along with how they were handled.
From January to June of 2016, a total of 235 drug-related alerts were sent from AEMPS. The dissemination was as follows: 44.3% (104) were spread among pharmacists, 36.6% among doctors, 5.5% among nurses and 9.4% to other professionals. The types of drug-alert received were classified as: supply problems (84.7%), use recommendations (7.2%), quality alerts (7.7%) and others (0.5%).

What next?

Next step is implantation of this alert management system with medical devices alerts and public health alerts.

TRAINING NURSING STAFF ON SAFE DRUG ADMINISTRATION IN THE EMERGENCY DEPARTMENT

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European Statement

Patient Safety and Quality Assurance

Author(s)

Gregorio Romero Candel, Esther Domingo Chiva, Nuria Martinez Monteagudo, Jose Marco del Rio, Marca Diaz Rangel, Francisca Sanchez Rubio, Ismael Perez Alpuente, Eva Garcia Martinez, Ana Valladolid Wals

Why was it done?

The ED is an area where medication errors are common given it´s complexity, the large number of patients with different pathologies, having to make quick decisions with little clinical information and the coexistence of professionals with different training.
The use of intravenous (IV) and high risk drugs, as well as the mixture of two or more intravenous drugs in the same diluent are usual and can lead to medication errors.
We designed an educational program based on a session for nurses of the ED to standardize the use of the most commonly administered drugs and improve patient safety

What was done?

A training session for nursing staff on safe drug administration in the emergency department (ED) was performed

How was it done?

A training session was conducted by the fourth year resident during a two month rotation period in this area. The most common mistakes were presented to nurses based on national studies, as well as techniques for safe administration of drugs. Guides on parenteral administration of the hospital were reviewed with special emphasis on high risk drugs and how to manage them according to the Institute for Safe Medication Practices. We also developed a guide including the most frequent drug incompatibilities and direct intravenous administration of drugs for the ED.

What has been achieved?

The aim of the session was to train personnel at the ED in order to reduce medication errors and promote a safety culture. In turn, the development of guidelines to standardize clinical practice are useful, making information accessible and easy to use. Clinical sessions between departments allow the integration of the pharmacist in other areas.

What next?

We are still working with the ED to increase safety in drug therapy by developing new pharmacotherapeutic protocols (high risk medications protocols, perfusion protocols and new safety guidelines and training sessions). We are also working with more departments at our hospital with the experienced gained

Medical treatment of high blood pressure in patients with ileostomy

European Statement

Clinical Pharmacy Services

Author(s)

Guillaume Wabont, Jean-Philippe Hammelin, Guénaëlle Faure, Cathy Debruille, Kévin Raynaud, Pascale Guillain

Why was it done?

Clinical pharmacists and nephrologists noticed a recurrence of rehospitalization of patients who recently underwent ileostomy because of prerenal acute kidney injury. Ileostomy tends to enhance dehydration, but in each case there was a drug that was exacerbating the phenomenon by inhibiting the RAAS. The digestive and urologic surgeons had no knowledge of such pathophysiology and iatrogenia, explaining why they continued to prescribe such drugs.

What was done?

We elaborated an internal guideline for the treatment of high blood pressure (HBP) in patients with ileostomy. We decided to contraindicate to those patients the inhibitors of renin-angiotensin-aldosterone system (RAAS) such as angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARBs) or direct renin inhibitors (DRI); as well as the diuretics – even-though none of the summaries of the product characteristics (SmPC) of those drugs in question require such prohibition.
From now on, the drug(s) of the first line of treatment must be a beta-blocker and/or a calcic inhibitor. The drug(s) of the second line of treatment must be an alpha-blocker and/or an imidazoline-receptor agonist.

How was it done?

Therefore, we decided to set up a collective analysis of the situation with pharmacists, nephrologists and surgeons in digestive and urologic surgery, to understand the pathophysiology and to elaborate an internal guideline for HBP in patients with ileostomy.

The pharmacists first wrote a working paper retailing:
– the pathophysiology (water–electrolyte imbalance with ileostomy and deterioration under RAAS inhibitors or diuretic)
– the lack of information in the SmPC of the drugs in question
– an argued suggestion to contraindicate those drugs
– the therapeutic alternatives

Then we all met and exchanged views on the subject.

What has been achieved?

The guideline has been written in a collaborative and multi-disciplinary work. It applies to all the physicians and pharmacists of the hospital who have been informed of our approach and they have received a copy of it.

What next?

We will evaluate the respect of the guideline in our hospital as well as its impact in the lowering of the rehospitalization rate of patients who recently underwent ileostomy.
We will notify our national agency for medicines of our procedure because we think it should be a national standard.

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Problems caused by shortages are serious, threaten patient care and require urgent action.

Help us provide an overview of the scale of the problem, as well as insights into the impact on overall patient care.

Our aim is to investigate the causes of medicine and medical device shortages in the hospital setting,  while also gathering effective solutions and best practices implemented at local, regional, and national levels.

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Join us in Prague for the 2nd edition of BOOST!

Secure your spot in the Movement for Shortage-Free World

BOOST is where visionaries, innovators, and healthcare leaders come together to tackle one of the biggest challenges in hospital pharmacy—medicine shortages.