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VENOUS THROMBOEMBOLISM PREVENTION MEASURES FOR WOMEN IN PREGNANCY AND THE PUERPERIUM (submitted in 2019)

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European Statement

Patient Safety and Quality Assurance

Author(s)

Sheena Patel, Sima Purohit, Jennifer Hanna

Why was it done?

• VTE remains the leading cause of direct maternal death, with no evidence of a consistent decrease in mortality over the past 20 years.
• Alongside changes in national guidelines, the maternity population and interventions are changing e.g. women giving birth are now older with more risk factors for thrombosis e.g. obesity. More interventions e.g. caesarean section are undertaken placing women at higher risk of VTE.
• VTE prevention measures were introduced in 2010, and nearly 10 years on further changes were implemented to reduce mortality and morbidity.

What was done?

Venous thromboembolism (VTE) prevention measures introduced and embedded for women in pregnancy and the puerperium, with an aim to reduce potentially preventable hospital-associated events

How was it done?

• Electronic VTE risk assessment introduced with mandatory alerts at relevant time-points e.g. at booking, on admission, post-delivery • Simplification of the national VTE risk scoring system to ensure accurate completion of assessment and user-ability • Clear hospital guidance on VTE prevention for pregnant women, including a pocket guide covering risk assessment and thromboprophylaxis • Staff education on mechanical thromboprophylaxis for correct use and monitoring to avoid adverse effects • VTE patient information leaflet covering signs and symptoms of VTE and when to seek urgent medical attention • Introduction of a ‘mum and baby’ app with information during pregnancy and postpartum • Root cause analysis performed on hospital associated VTE events, with shared learning of root causes and actions to prevent recurrence to multidisciplinary teams • VTE education introduced in medical, midwifery and pharmacy staff training programmes, with regular updates in the maternity risk newsletter

What has been achieved?

• Over 95% of women with VTE risk assessments on admission, with weekly and monthly performance reports for local monitoring • Pharmacy staff perform quarterly audits on appropriate thromboprophylaxis. 97% inpatients received pharmacological thromboprophylaxis, and 88% inpatients were wearing anti-embolism stockings • Pre-printed VTE management plan in maternity documentation to assist with transfer of care • Development of an ‘app’ to provide patient information • Patients counselled on anticoagulant therapy to support medication compliance • VTE education embedded in training programmes • VTE ward rounds for ongoing stewardship

What next?

• Staff engagement to embed VTE prevention measures in practice
• Increasing patient education on VTE prevention
• Robust and sustainable interventions improving patient outcomes

THE IMPACT OF AN ELECTRONIC ALERT IN PREVENTING DUPLICATE ANTICOAGULANT PRESCRIBING (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

Alison Brown, Gillian Cavell, Nikita Dogra, Cate Whittlesea

Why was it done?

Anticoagulants are high-risk drugs. An NHS England Patient Safety Alert was published in 2015 highlighting harm from inappropriate co-prescription of anticoagulants1.

What was done?

A ‘duplicate anticoagulant alert’ (Anticoagulant MLM) was implemented within our electronic prescribing system (EPMA) to alert prescribers if co-prescription of two or more anticoagulants was attempted, with the intention of preventing the completion of a potentially harmful prescription. We conducted a retrospective review of the impact of the Anticoagulant MLM on preventing co-prescription of low-molecular weight heparin (LMWH) and direct oral anticoagulants (DOACS)

How was it done?

The study took place in a 950 bed UK acute teaching hospital. A report of all Anticoagulant MLM alerts generated for adult inpatients between 26th June 2017 and 8th October 2018 was extracted from EPMA. Data on drugs prescribed, alert acceptance or override and duplicate anticoagulant administration were collected. Where alerts were overridden, appropriateness of the override was assessed by an anticoagulation specialist pharmacist. Ethics approval was not needed.

What has been achieved?

The Anticoagulant MLM triggered on 894 occasions; 113 in response to attempted prescription of a LMWH for a patient already prescribed a DOAC. 65 of 113 alerts were overridden (duplicate prescription completed). 48 alerts were accepted (duplicate prescription avoided). Of the 65 overridden alerts, consecutive doses of both anticoagulants were scheduled appropriately. No duplicate doses were administered in 44 cases (44/65, 67.7%). 15 duplicate prescriptions were either cancelled before administration or not administered concurrently (15/65, 23.1%). Duplicate doses were administered against 6 prescriptions (6/65, 9.2%), on 3 occasions. No patient harm was identified. The alert prevented inappropriate co-prescription of anticoagulants to 48 patients. Overrides were justified in 44 cases. Anticoagulants were correctly prescribed for 92/113 (81.4%) patients. It was outside the scope of this project to investigate why alerts were overridden. ‘Alert fatigue’2 and alert frequency3 are recognised factors limiting the effectiveness of electronic alerts in changing a planned course of action.

What next?

The alert remains in place as a barrier to error. Further work is needed to identify reasons for anticoagulant alert overrides.

PARENTERAL NUTRITION: HOW TO PREVENT THE NEXT MISTAKE? (submitted in 2019)

European Statement

Patient Safety and Quality Assurance

Author(s)

saif salah

Why was it done?

In Carmel Medical Center, the infusion pack is delivered by a pharmacist according to the prescription given from PN staff, and afterwards the infusion instructions are recorded by one of the department physicians in the patient EHR. Recently there have been several mistakes that have been reported, which made it urgent to check matching between PN staff decision and the record of instructions in the EHR.

What was done?

Recognise the mismatch between the electronic health record (EHR) instructions for delivery of parenteral nutrition (PN), against the actual delivery by the pharmacy according to prescription from PN staff and characterisation of these cases in terms of mismatching.

How was it done?

Issuing a report of the PN doses delivered by the electronic system called “UNIT-DOSE” in the pharmacy according to the name of patient and days of treatment of 2018 vs. electronic instructions that have been recorded by one of the department physicians in the “Kamelyon” system or “Meta Vision ” The parameters examined were: type of solution, composition, volume, supplements-additives (electrolytes, vitamins, trace elements), infusion rate and method of infusion (central / peripheral). Infusion rate was examined separately as a follow-up by a nutritionist.

What has been achieved?

From our research, we found a significant difference between computerised recording of PN instructions and what the patient actually received. This is due to the separation between the hand-written prescription by the PN staff and the computerised instruction recording by the treatment team. This may constitute a danger to patients.

What next?

Examination and follow-up by the pharmacist is important for identifying and treating errors of this nature appropriately. Guidance sessions for the treating staff should be conducted in the different departments. The prescription must be matched by the PN staff to the computerised instruction by placing a prescription pattern. Set up protocols in the computerised system that guide the treatment staff in the department to record the correct instructions.

PROMOTING THE USE OF SAFER INJECTABLE MEDICINES USING A NOVEL METRIC

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European Statement

Patient Safety and Quality Assurance

Author(s)

Gillian Cavell

Why was it done?

Despite the availability of RTU and RTA formulations of high-risk injectable medicines they were not always used. We developed the metric, to compare the use of RTU and RTA injectable medicines with the use of concentrates requiring further dilution or manipulation prior to administration e.g. dilution of morphine 10 mg/ml to 10 mg/10 ml prior to intravenous administration, e.g. withdrawal of 5 x 10 ml fentanyl 500 mcg/10 ml into a 50 ml syringe for continuous infusion, and identify areas for improvement.

What was done?

We have developed a series of metrics to measure compliance with national guidance for the safe use of injectable medicines. The guidance recommends use of ready-to-use (RTU) or ready-to-administer (RTA) injectable products, where these are available, to reduce the risk of patient harm from errors in the preparation of injections and infusions on hospital wards.

How was it done?

The metric utilises pharmacy-issue data to compare the number of units of RTU or RTA formulations issued to wards and clinical areas with the numbers of units of alternative products of the same drug entity. Expressed as a percentage the metric informs the organisation of the extent to which safer injectable medicines are being used, providing a baseline against which to review practice and reinforce the need to use alternative, safer formulations. A high percentage indicates good compliance.

What has been achieved?

The metrics have been used to successfully maximise the use of a range of safer formulations including RTA potassium chloride, RTU fentanyl 2500 mcg/50 ml vials for critical care infusion, 100 mg/10 ml paracetamol in neonatal units and RTU magnesium sulphate 20% (50 ml vials) for obstetric emergencies. Since the introduction of the metrics in 2016 a monthly scorecard of performance is reviewed by the Hospital Medication Safety Committee to identify and account for deviations.

What next?

The metrics are being shared with other organisations to benchmark performance. Ideas to promote implementation and business cases can be shared between organisations who may find implementing RTA and RTU injectable medicines challenging, especially where these are more expensive than formulations in established use.

IMPLEMENTING THE PRODUCTION OF STERILISED SYRINGES IN THE HOSPITAL: IMPROVING MEDICATION SAFETY AND SAVING HEALTHCARE COSTS

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European Statement

Patient Safety and Quality Assurance

Author(s)

Karin Larmene-Beld, Rommert Wijnsma, Gerrit de Weerd, Maarten Postma, Erik Frijlink, Katja Taxis

Why was it done?

Medication administration errors are common in hospital practice. Meta-analyses suggest that about 10% of administrations are erroneous, with much higher error rates occurring during intravenous drug administrations. It has been demonstrated that 21% of the errors can be eliminated when prepared syringes are used. Many countries struggle with the problem of optimising the process of safe parenteral medication in hospitals. Different guidelines across countries outline how preparation of parenteral medication in the clinical environment should be done. Recently the Council of Europe published a resolution about preparation of medication which encourage the supply of ready-to-administer products by the pharmacy. Moving the activities of preparation of medication from the clinical environment to the pharmacy requires investments in pharmacy equipment but will result in efficacy, better quality and reduction in preparation medication errors in the hospital.

What was done?

Development and implementation of sterilisable plastic syringes produced in the hospital pharmacy for large-scale production of ready-to-administer products.

How was it done?

A new development in this area are ready-to-administer pre-filled sterilised syringes (PFSS) produced by the pharmacy. PFSS are produced on stock under GMP conditions by the hospital pharmacy using (semi) automatic filling and closing machines whereby quality and safety are embedded in the whole process of manufacturing. A total cost of ownership analysis is performed showing PFSS prepared in the hospital pharmacy yielded cost savings compared to conventional preparation on the ward. The process of production, filling, closing and sterilisation has been validated using newly acquired equipment. With the introduction of the cyclic olefin polymer (COP) syringes a new type of primary container is implemented in the pharmacy. To ensure patient safety and product quality a science- and risk-based strategy has been developed for testing extractables and leachables to qualify the new container as primary packaging material.

What has been achieved?

Introducing PFSS is cost saving for the healthcare system:– COP syringes are suitable as primary packaging material; –enhancement styles for better readability of labels are established; and – already, 15 products are validated and available for use in the hospital.

1. KHM Larmené-Beld KHM, Touwen-Spronk J, Luttjeboer J, et al. A cost minimization analysis of ready-to-administer pre-filled sterilized syringes in a Dutch hospital.. Submitted for publication in Clinical Therapeutics.
2. Larmené-Beld K, Kuiper A, van Berkel S, et al. A science- and risk-based strategy to qualify sterilized prefilled syringes as primary packaging material in a hospital pharmacy. Abstract submitted for 24th EAHP Congress.
3. Larmené-Beld KHM, Kim Alting E, Taxis K. A systematic literature review on strategies to avoid look-alike errors of labels. Eur J Clin Pharmacol 2018 74:985–93.

What next?

Introducing more drugs as ready-to-administer products. Optimising the label of ready-to-administer syringes to avoid look-alike errors based on the results of the review.

PROTOCOL IMPLEMENTATION FOR PRESCRIBING AND DISPENSING POSTEXPOSURE PROPHYLAXIS KITS FOR HUMAN IMMUNODEFICIENCY VIRUS IN A THIRD-LEVEL HOSPITAL

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European Statement

Patient Safety and Quality Assurance

Author(s)

Clara Estaún-Martínez, Isabel Moya-Carmona, Laila Dani-Ben Abdel-lah, Jose Manuel Fernández-Ovies

Why was it done?

This initiative was taken in order to improve uptake and completion rates of PEP, and to homogenise the healthcare circuit for these patients and the prescribed drugs.

What was done?

A protocol was implemented in order to standardise the prescription and dispensation of postexposure prophylaxis (PEP) after occupational or nonoccupational exposure to human immunodeficiency virus (HIV).

How was it done?

A multidisciplinary team including Infectious Diseases and Preventive Medicine (PM) doctors, pharmacists and Emergency Room (ER) staff developed the following protocol for PEP according to World Health Organisation and national guidelines: – standard three-drug regimen for PEP: Tenofovir disoproxil fumarate/Emtricitabine + Raltegravir for 28 days. The pharmacy service (PS) repackages kits for five, 23 or 28 days that include antiretroviral drugs (AD) and written information about the treatment (use, length of the treatment, main interactions and side effects, contact number). Only 5-day PEP kits will be located in the ER. – Twenty-four-hour access granted to PEP kits as it is strongly recommended to initiate PEP as early as possible (ideally within 72h). –
Established healthcare circuit for patients in the ER:
• Monday–Fridays (8h00–15h00): patients will be immediately referred to PM, then they will go the PS in order to receive a 28-day PEP kit and pharmaceutical care.
• Out of this schedule and bank holidays: ER doctors will give patients a 5-day PEP kit and they will be referred to PM the next working day. After visiting PM, the patient will go to the PS in order to receive the rest of PEP (23-day kit) and pharmaceutical care. –
Several meetings took place in order to explain this new circuit to the health professionals involved and written copies were available on the ER as well as on the intranet.

What has been achieved?

The implementation of this protocol was well embraced by all the staff involved, since it allowed a more efficient healthcare circuit for the patients. It also optimises the evaluation and monitoring of these patients by PM and the pharmacist, and grants prompt PEP initiation and 24h access to the AD. The 28 days (or 5+23 days) kits help to accomplish the proper length of treatment, without using the regular packages which include 30 days of treatment (saving €43.17 per treatment).

What next?

We will monitor the compliance with this protocol and the drugs prescribed for PEP.

HOSPITAL PHARMACY UNIFIES ELECTRONIC STANDARD PRESCRIPTION THROUGHOUT THE REGION

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European Statement

Patient Safety and Quality Assurance

Author(s)

Linda Jeffery

Why was it done?

The primary aim was to increase patient safety by quality-assuring ESPs and guiding clinicians to rational and safe prescribing. The Central Denmark Region (1.3 million citizens) has five hospitals, each with their own hospital and ward management. ESPs were previously set up and maintained locally, often by clinicians at ward level, resulting in several thousand, and a huge variety of ESPs for the same indication/treatment. Often only small differences separated these, but larger differences were also observed. Both patients and clinicians move around hospitals within the region. Varying ESPs from hospital to hospital confused clinicians and compromised patient safety.

What was done?

The regional Drug and Therapeutics Committee (DTC) commissioned the Hospital Pharmacy, Central Denmark Region to take over management of electronic standard prescriptions (ESP) in the shared Electronic Prescribing System (EPS). The pharmacy was also commissioned to lead the unification of local to regional ESPs, in collaboration with clinical specialists. ESPs are electronic ‘packages’ of one or more prescriptions, set up for treatment of defined conditions/procedures e.g. knee-replacement. When the clinician prescribes an ESP, the predefined prescriptions appear automatically in the patient’s medicines list.

How was it done?

The Hospital Pharmacy highlighted clinical areas/treatments with several variations of the same ESP. The DTC appointed relevant clinicians to work with a pharmacist on unifying these, to one (or more) standardised ESPs, to be used in the whole region. The pharmacist was coordinator for the ad-hoc working groups. After approval by the DTC, these ESPs replaced the existing. If a department wanted an ESP that differed from the regional ESP, this had to be approved by the DTC.

What has been achieved?

Regional ESPs have been approved for:
• Abortion (reduced from 17 to six).
• Helicobacter pylori eradication (reduced from 28 to two).
• Treatment of paracetamol-overdosage.
Many new ESPs have been approved, promoting:
• Safe prescribing of complicated regimes e.g. fosphenytoin loading/maintenance.
• Use of regional formulary drugs e.g. antibiotics for pneumonia/urosepsis.

What next?

We continue to work on other regimes that can be unified e.g. treatment of Wernickes prophylaxis/syndrome and parenteral nutrition. We recently met with pharmacists from two other regions that use the same EPS as us – maybe we can share ESPs nationwide in future.

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.

A SET OF QUALITY IMPROVEMENT INTERVENTIONS TO INCREASE THE PERCENTAGE OF STAT IV MEDICINES, MEETING THE GOAL OF BEING READY WITHIN 30 MINUTES

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European Statement

Patient Safety and Quality Assurance

Author(s)

MELINDA LITAO, HANY ELATROUSH , KHATHLEEN ESER, ARWA AFANA, AHMED BAIBRAHIM, JAYSON DE JUZMAN, BAYAN RAMBO, DERI PASCUAL, MA ENCARNACION DELOS ANGELES, MANAL SALLAM, MALIK KHUWAJA

Why was it done?

STAT orders have always been a priority, however there are some areas which require some modification in the workflow to attain higher efficiency and to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

What was done?

A set of quality improvement interventions to increase the percentage of STAT IV medicines, meeting the goal of being ready within 30 minutes.

How was it done?

This was a pre-post study in a government hospital between January and September 2018. LEAN and FOCUS-PDCA models were implemented to design the process of improvement. A medication-tracking system (MedBoard) was used to collect the data to measure the number of STAT IV medicines ready within 30 minutes. Data was also collected from the number of phone calls and faxes received from the day procedure unit (DPU) and home health care unit (HHC).

What has been achieved?

The cumulative data showed an increase in the percentage of STAT IV medicines being ready by 7%, equivalent to 707 orders per month (90% vs 97%), a reduction in the number of phone calls by 87.5% (48 vs six calls per day) and fax by 100% from the DPU and HHC units, which means that implementing the set of interventions were associated with an increase in percentage of STAT IV medicines being ready within 30 minutes. Additionally, there was a significant decrease in the number of phone calls and faxes, which allowed pharmacists to focus more on STAT IV orders.

What next?

Since the hospital pharmacy receives numerous orders on a day-to-day basis, this will facilitate prioritisation during the entire process. This aligns with the hospital goal of attaining ‘zero harm’, and is therefore a good example of good practice in a hospital setting. The use of Medboard in tracking medications and monitoring performance can be applied to allow any healthcare setting to ensure that goals are reached, and performance is maintained at the highest level. Designing a list of eligible medications that can be ordered as STAT can be used as a guide to avoid the abuse of STAT orders and can help in prioritising order preparation in the STAT IV room.