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Pharmaceutical Technology in Hospital Pharmacy

Editor-in-Chief: Lagarce, Frédéric

Ed. by Crauste-Manciet, Sylvie

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Risks for Workers Handling Solid Oral Doses: Development of a Tool to Improve Personal Protection

Amandine Sgarioto / Olivier Aupee / Laurent Simon / Hélène Ginestet / Sophie Armand-Branger
Published Online: 2016-08-06 | DOI: https://doi.org/10.1515/pthp-2016-0007

Abstract

Handling of pharmaceutical specialities is required before its distribution or administration. Unpackaging and repackaging solid oral doses (SOD) in pharmacy settings; crushing, pills fragmenting or capsules opening inside care units may expose nurses and pharmacy dispensers to chemical contamination according to three recent North American studies. In the absence of a regulatory framework the application of the “principle of precaution” implies at first an analysis of the medication circuit and then the implementation of protective measures to prevent healthcare workers from contamination. Comparison of professional recommendations published in other countries allowed us to select a group of protective methods. We gathered these technical and organisational methods to compose a matrix of recommendations intended to hospital staff involved in SOD handling. This tool aims to improve the development of good manufacturing practices (GMP). It combines the issue of personal protection with other criteria such as quality, efficiency and safety of a medication.

Keywords: crushing; hazardous drugs; occupational exposure; recommendations; repackaging; solid oral doses

Introduction

Handling solid oral doses removed from its immediate packaging occurs just before drug administration, or when repackaging or modification is needed. Repackaging enables optimal identification of medications [1] while the modification makes the administration easier or possible in compliance with a medical prescription [2]. These are consistent practices carried out by healthcare professionals, caregivers or even family aids, out hospital. In hospitals, handling solid oral doses (SOD) increases with automation of drug patterns aiming at the securing of drug safety management [3]. Nowadays, SOD manipulations are increased by three major factors: first, a preferential use of oral route over intravenous administration; second, the medical condition of patients (swallowing disorders, feeding tubes) and finally various drug formulations.

In France, lack of legal requirements regarding the process of SOD has led to a wide disparity in practices such as blister processing (removal, cutting), automation and early cutting of scored tablets.

Three recent North American studies have emphasized the risk of contamination by active pharmaceutical ingredients (API) in community pharmacies or mail order pharmacies [46]. To do so, they identified the airborne dust generated by pharmaceutical processes such as automation by automatic dispensing machine (ADM) or classical activities as the use of tablet counter trays in community pharmacies. Among dust, they found many APIs including lactose, lisinopril and methotrexate. They finally analysed the pharmaceutical forms and practices mostly involved in aerosolization of APIs. It reveals, first that bulked uncoated tablets have the greatest potential of aerosolization. In a second hand, practices as manual counting, loading of canisters, cleaning with compressed air systems or spilling of tablets aggravate this potential.

Moreover, some case-reports highlight consequences of occupational exposure during solid oral doses handling: clozapine and pneumonitis [7], tetrazepam and dermatitis [8].

In the light of these observations, we initiated a reflexion on professional risks referring to these practices and the protective measures that could be applied for the safety of medical staff.

Material and Methods

The aim of this work is to identify and characterize protective measures for staff handling SOD in order to provide a tool for workers protection.

State of current practices

We first reviewed the existing international publications dealing with the manipulation of SOD. The following key-words were used for a search in PubMed and Google: “repackaging”, “hazardous drugs”, “oral”, “occupational exposure”, “safe handling”, “tablet”, “capsule”, “crush”, “pharmaceutical dust”, “guideline”.

Older and/or redundant publications were removed and we only selected the most relevant professional documents. We then identified and indexed the various recommendations focused on protecting staff from contamination due to handling of SOD. We made a comparative table for each document and each category. Categories are divided into items for better readability.

Implementing a tool: matrix of recommendations

In order to establish a tool to improve protection of staff handling SOD, we decided to use data from international documents and to present them in a concise manner so as to meet the needs of as many users and practices as possible. We identified consensus-based recommendations and isolated measures respecting original and documented principles.

The ranking of these measures, taking into account the constraints on their implementation enabled the development of a protection-helping tool for workers handling SOD. At last, we wrote an instruction manual for this tool aimed at pharmacy hospital staff.

Results

Typology of analysed documents

We initially listed 17 documents and retained 10 of them for complete analysis

Among these 10 documents, three deal with hazardous drugs in general [911] and seven deal with cytotoxics only [1218]. One is written in French, the remaining nine are written in English. Five were published by national health agencies while learned societies or expert panel published the other five. At last, most of these documents were written by north Americans (USA: 2); Canada: 3), Australians (2) and British (1) teams while two were published by international teams. They can either refer to hospital (5/10) ambulatory practice (2/10) or both (3/10) (Figure 1).

Typology of analysed documents.
Figure 1:

Typology of analysed documents.

State of current practices

We exhaustively listed the protective measures to handle SOD proposed in these 10 documents (Table 1). After analysis, we sorted them out in two categories: technical measures (related to specific installations or devices) and the so-called “political measures” related to process organizations.

Technical measures can be divided in 4 categories containing 11 items. 1) Supply (vendor, transport). 2) Stock (labeling, storage). 3) Preparation, dispensation, managing (premises, stock, ADM, working outfits). 4) Follow-up and good practices (patient advising, spill, waste management).

Policy measures may also take 4 different dimensions: 1) Responsibilities. 2) Risk evaluation. 3) Training. 4) Monitoring.

Table 1:

State of current practices.

Creation of a tool: matrix of recommendations

Choice of measures to implement the matrix

Comparison between the 10 pre-selected documents enables to identify recurrent protective measures, i. e. measures describing several declinaisons of a single pattern. For example, most guidelines deal with the release of a document gathering hazardous drugs and recommend either to elaborate a local one or to use an existing one. In the same way, we qualified some measures as “original” because as they seem very relevant regarding the diversity of potential users, they were quoted in only one document. As a total, we extracted 60 measures from the comparative table; among them, seven were considered as original and 53 as recurrent.

Presentation of the matrix

This matrix is a double-entry table where measures are stratified into items and levels of constraints (Table 2). Items have been extracted from the comparative table as mentioned above. We kept four levels of scoring because it was the maximal number of measures found by item in our comparative table. Several axes have only two or three levels; in this case, the highest quotation is given for the measure, which, was prescribed at the inferior level. The measures are scaled from 0 to 3 in accordance with the following:

  • A recommendation of level 0 means there is no specification to set-up;

  • A recommendation of level 1 will be less costly (in time or needed resources) than a recommendation of level 2. In the same way, a recommendation of level 2 will be less costly than a recommendation of level 3.

Table 2:

Matrix of recommendations.

As an example, concerning protective gloves, the level 0-recommendation means that there is no requirement about wearing protective gloves, the level 1 consist in wearing one pair of gloves while level 2 and 3 consist in wearing two pairs of gloves.

Medical follow-up is not part of the matrix as an item because it is ruled by labor code regulation and completed by application of collective agreements. Occupational exposure to pharmaceutical dust is considered as a chemical risk. The medical follow-up is adapted to the exposure level and specific medical documents are annually updates. We have therefore decided not to make a specific recommendation for this item in our matrix.

How-to-use the matrix

The matrix can be used in a two-step approach.

First, it can be seen as a grid of internal audit applying to the protection of staff handling SOD. Each level of quotation should be assessed for each item in order to check if every item is taken into account and if the available measures of protection are appropriately implemented.

Secondly the deviation of a level or the omission of an item can initiate a change in practices or help reconsider it. This matrix should be used by multidisciplinary groups such as the health and safety committees and not be reserved for the exclusive used of pharmacists.

Discussion

Comparison of international recommendations

Analysis of international recommendations shows that there are many protective measures that can be set up in hospitals or in health care settings. The identified measures are based on organizational, political and technical means and a broad spectrum of practices range from simple hygiene precautions to binding measures as chemical containment isolator. Most protective measures were common in all documents even if we found diverging ones that were in relation with a specific context or regional/national habits..

Among international guidelines, common threads are highlighted. For example, the necessity to circulate a list of hazardous drugs in the healthcare setting or to establish policies, procedures and training for clinical staff. Some technical measures are universally approved as the need to use dedicated equipment (counting trays, spatulas) for hazardous drugs.

On the contrary, some measures are totally opposite from one text to another. For example, the use of a drug safety cabinet for a mixed activity of sterile and non sterile preparation is well tolerated for the British Columbia Cancer Agency (BCCA) and for the American Society of Hospital Pharmacists (ASHP). But according to International Society of Oncology Pharmacy Practitioners (ISOPP) or Society of Hospital Pharmacists of Australia (SHPA), this type of sharing must not take place in a pharmacy. Other differencies can be identified between these guidelines, as such as the type of personnal protective equipment per activity. Some ask double gloving in every routine handling of non injectable HD [12], some other recommend to use disposable gloves without more details [15, 17]. Concerning respiratory protection, most of the documents precise that surgical masks do not provide adequate protection, but only three of them detail the type of operation that need to wear a mask [9, 11, 12].

The availability of this comparative table is of interest because there is no framework of this kind although the manipulation of solid oral doses is spreading.

Matrix of recommendations

This matrix is adapted to many workers’ profiles and to various technical aspects. This tool is as little constraining as possible and enables an easy census and the graduation of protective measures.

It can be used to evaluate practices in a hospital setting or be integrated in a quality policy. The matrix can be used as a proposition force: it gathers organizational methods including the appointment of an advisor for hazardous drugs, the identification of involved drugs or the positioning of automation, and technical measures such as medication withdrawal, high-risk procedures and use of protection equipment.

The only required measure is the prescription of cleaning with compressed air systems in accordance with international guidelines’ recommendations. Vacuum aspiration remains possible provided that a closed chamber is used for collected dust and that dust is safely eliminated.

Limitations

First, as the international documentation basis is currently being overhauled (USP 800, ASSTSAS guidelines) it could bring changes in key aspects of our recapitulative table. Modifications will be addressed and our document constantly updated following the evolution of international guidelines.

Second, occupational risk when handling hazardous drugs remain poorly studied which is why consequences are so widely under-considered. Moreover such consequences are difficult to evaluate and so to prevent. When analyzing the risk of handling hazardous drugs, it should be appreciated depending on the drug formulation, the type and frequency of handling and the workers’ profile [19].

The relevancy of protective measures proposed in the matrix is a difficult point to tackle. The aim of this work was to identify existing measures and to compile them in a table. It is possible to justify some of the measures with scientific literature (e. g. use of PPE, as gloving [20]) but some other are quite single and can not be include in this type of analysis (e. g.: impact of an HD advisor or HD comitee to improve safety of HD in a health care setting).

Finally, the matrix of recommendations is actually in the process of validation by a committee of users through a consultative methodology using a Regnier abacus and the Delphi method of investigation. To our knowledge, there is no regulatory framework for handling solid oral doses. Moreover, drug compounding can also be carried out outside hospital settings and the implementation of constraining measures might compromise the development of this activity.

Conclusion

Appropriate protective measures should be implemented to protect healthcare workers from occupational exposure to hazardous drugs presented as solid oral doses. In France, the risk of contamination is underestimated because of the absence of any regulatory framework and the variety of handling practices.

The matrix, drawn up in French, is adapted to many workers profiles. It should be considered as a tool of awareness and discussion for all healthcare workers.

In the long term, the matrix can be used to foster the development of GMP for compounding and administration of medications. Although there is no regulatory framework, it is ethical to implement efficient protective measures for pharmaceutical staff, nurses, and caregivers.

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About the article

Amandine Sgarioto

Amandine Sgarioto is a military pharmacist, graduated in 2007. After three years of pharmaceutical tasks in Val-de-Grâce hospital, she studied at Paris V Descartes faculty of pharmacy to complete a superior diploma.Since 2016, she deals with hospital functions as pharmacist in charge of chemotherapy preparation at Bégin military hospital. Her point of interest consists in every way to prevent healthcare personnel from occupational exposure.

Olivier Aupee

Dr Olivier Aupee has practiced as pharmacist in the Pharmacy Department of Val-de-Grâce Military Hospital during 10 years, where he devoted his time to clinical pharmacy and radiopharmacy. He is now Head of the Pharmacy Department of Percy Military Hospital.

Hélène Ginestet

Hélène Ginestet practiced during three years as deputy to the production supervisor in the Central Armed Forces pharmacy. Then she studied hospital pharmacy and built up a multi-skilled course. Her thesis’s topic was concerning the pharmacy technician’s training to the chemotherapy compounding. She graduated in 2013. Then she supervised the medical device’s circuit at the Hôpital d’Instruction des Armées Bégin pharmacy. She cares about safety process, personnel training and looks into the optimisation of existing tool.

Sophie Armand-Branger

Sophie Armand-Branger is a pharmacist, former resident in Assistance Publique-Hôpitaux de Paris.Since 2014, she deals with hospital functions as pharmacist in chief at CESAME Angers and as CUAP coordinator (Club des Utilisateurs d’Automates de Pharmacie), which regroup a hundred members interested in pharmacy automates.


Received: 2016-03-30

Revised: 2016-06-27

Accepted: 2016-06-27

Published Online: 2016-08-06

Published in Print: 2016-09-01


Conflict of interest statement: Authors state no conflict of interest. All authors have read the journal’s Publication ethics and publication malpractice statement available at the journal’s website and hereby confirm that they comply with all its parts applicable to the present scientific work.


Citation Information: Pharmaceutical Technology in Hospital Pharmacy, Volume 1, Issue 3, Pages 123–137, ISSN (Online) 2365-242X, ISSN (Print) 2365-2411, DOI: https://doi.org/10.1515/pthp-2016-0007.

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