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Can my medicine be returned to the refrigerator? Minimisation of wastage in case of storage incidents of cold-chain homecare medications

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European Statement

Clinical Pharmacy Services

Author(s)

Hilde Omestad, Maria Grønkjær Abrahamsen, Fatima Afif Mouaanaki, Charlotte Mosbæk Dybdahl, Anne Wulff Petersen, Emil Dalsgaard Züricho, Philip Hojrizi, Charlotte Arp Sørensen

Why was it done?

The sustainability strategy of the Central Denmark Region include less consumption and less waste. Our Pharmacy delivers an increasing amount of high-cost homecare medications, requiring refrigerator storage. In case of an accidental temperature exposure, patients may ask whether their medicine can be used or not. There may be a delay during transport or a breakdown of their refrigerator at home. During these medicines’ shelf-lives, most products can be kept at room temperature for days, weeks or months. When SmPC and the insert package leaflet says that the product should not be returned to the refrigerator, high-cost medicines sometimes are wasted, only because of this warning, instead of giving them a shorter shelf-life. When we hesitate to return packages to the refrigerator, time can elapse while waiting for the manufacturer’s or pharmacist’s answers to the patient’s questions after storage incidents.

What was done?

The Hospital Pharmacy categorized 47 Blood Coagulation Factors and Monoclonal Antibody Products requiring storage at 2-8 °C if Summary of Product Characteristics (SmPC) had any warning of returning a product to the refrigerator or not, after an unwanted time at room temperature

How was it done?

We asked manufacturers if a return of their product to the refrigerator would cause any harm. Should their product be disposed of because it has been put back into a refrigerator after being left out? Our findings were documented in a local guideline and in the Danish national information database (SAID).
Drug Information Pharmacists discussed several cases of real-world handling situations to be more confident to reduce medicine wastage.

What has been achieved?

Being aware of the reasons for these warnings, reduced medicine wastage in certain cases of incidental storage. The pharmacists have been given tools for pharmaceutical professional assessments in cases of temperature challenges.

What next?

Spread the good news. Improve communication between manufacturer and pharmacy, because manufacturer can’t be responsible for storage different from their SmPC. Inspire manufacturers to improve their storage warnings in SmPC

OPTIMIZATION OF RISK MANAGEMENT OF DRUGS COLD CHAIN IN HOSPITAL BY FAILURE MODES, EFFECTS AND CRITICALITY ANALYSIS “FMECA” METHOD

European Statement

Selection, Procurement and Distribution

Author(s)

Ismail Bennani, Amine Cheikh, Hafid Mefetah, Mustapha Bouatia

Why was it done?

The strict control of medicines cold chain is linked to a triple risk for a hospital: a risk for the patient through the efficiency and safety of the drug, a financial risk, and a regulatory risk.

What was done?

Our study aimed to map the process of management of medicines requiring a strict cold chain control at a referral pediatric hospital and to identify the critical points associated to this process in order to realize a risk analysis using the FMEA method

How was it done?

The method used is FMEA for a priori inductive risk analysis which aims to identify potential system failures. These failures are analyzed to determine their criticality by establishing an index for each failure that will be scored and calculated using the formula: Criticality index = frequency × severity × detectability.
The rating of each criterion is based on predetermined rating tables.

What has been achieved?

Process Mapping: The mapping of the process allowed identify 7 major actors: the supplier, the general store, the logistics platform for product reception, the transportation, the logistics department of hospital, the pharmacy and the patient.
Identification of the critical points: All failures modes that were ranked between 201 and 504 on criticality index are considered as main critical points:

Problem of breakdown of electricity and its management: 504
Respect of the cold chain at the level of the care services until administration: 448
Temperature indicators at the level of care services: 384
Conditions of transportation: 315
Temperature monitoring at pharmacy level: means and management: 245
Logistics agents transport time management: 210

Implementation of improvement actions: Corrective and preventive improvement measures have been defined and implemented, such as: setting up alternatives to power outages, periodic temperature assessments at all critical levels, and integration of remote control and monitoring computer devices.

What next?

The continuous improvement of the medicines’ cold chain remains an important topic for the institutions in view of the overall risks associated with the quality of these medicines, therefore to the medical treatment of the patient.

LEARNING FROM RETURN: HOW RETURNS CAN HELP TO IMPROVE THE PROCESS OF DISTRIBUTION

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European Statement

Selection, Procurement and Distribution

Author(s)

Claudia Wunder, Szabolcs Tobi

Why was it done?

To introduce returns to supply chain is a critical process in distribution of medicinal products, as non-compliance with storage conditions or inappropriate handling can impair the quality and hence endangers patient safety. In terms of a continous improvement process we considered a standardization and a supervision of this field as mandatory.

What was done?

A standard form for handling of returns was developed. It was designed to ensure that important process steps are done and documented. Furthermore it should offer the opportunity to learn about the reasons why users return medicinal goods to the pharmacy. After one year of usage (2015) the forms were evaluated with the objective of validation and improving the process. According to PDCA-cycle measures were deduced based on the results.

How was it done?

The standard form guides the process and assures
– that medicinal products are stored under quarantine until approval by pharmacist,
– that storage conditions are proved for the time the goods were out of pharmacy,
– that the quality of each returned medicinal product is checked carefully and
– that the reason for return is documented.
The standard forms were collected and evaluated concerning
– number of returns,
– reasons for returns,
– value of returns.

What has been achieved?

The standard form proved to be a useful tool to gain information about gaps in the process of distribution. The evaluation demonstrated that users had problems with ordering due to article changes and unclear names in the warehouse management system. It showed the need for education of trainees and pointed out lacks of communication between pharmacy and wards. The analysis also presented the money-saving potential of re-utilization of returns. What was achieved is an improvement of distribution process by
– implementing an intensive and standardized education for trainees,
– optimizing main data in warehouse management system,
– sensitizing the responsible persons and
– getting in closer communication with nurses on wards.
Besides that the economic benefit of the process could be proved.

What next?

At the end of 2016 the impact of the measures shall be reviewed. Benchmarks shall be deduced to audit the functionality of the process in future.

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