Implementation of guidelines on hospital radiopharmacy in low-income settings

Ekoume, Fany Pricile (2020-12)

Thesis (PhD)--Stellenbosch University, 2020.

Thesis

ENGLISH SUMMARY : Although radiopharmacy is more than 50 years old, it is still in a stage of rapid development. This dissertation focuses on quality issues in radiopharmacies in developing countries. Guidelines for radiopharmacy practice in many countries prescribe complex facilities, especially air handling units, and extensive quality assurance and documentation requirements. In developing countries, these guidelines are currently not always met. In numerous countries in Africa, enforcement of the international guidelines would lead to closure of radiopharmacies, and consequently, loss of Nuclear Medicine services. The question arises what the consequences of not meeting the requirements of the guidelines are, and if practice can be improved without major expenditure. This study considered certain aspects of Good Radiopharmacy Practice (GRP) recommendations and collected information from both a relatively well-equipped facility at Tygerberg Hospital (TBH) in South Africa, and a more basic radiopharmacy facility at Yaoundé General Hospital in Cameroon (YGH) to investigate the conditions that will ensure safe and effective products. Factors assessed include efficacy and microbial safety of the radiopharmaceuticals, with some comparison to a state-of-the-art Good Manufacturing Practice (GMP) compliant radiopharmacy at the University Medical Centre Groningen (UMCG) in the Netherlands. An adapted version of the Quality Management Audits in Nuclear Medicine (QUANUM) tool, tailored for the radiopharmacy context, was used to determine the status of practice in the two African radiopharmacies. Once the current situation and product quality in these radiopharmacies was determined, basic, low-cost interventions to minimise deficiencies were implemented at YGH and the effects of the interventions were assessed. Where the necessary level of safety and efficacy could not be met with currently available systems despite interventions, this was reported. The efficacy of radiopharmaceuticals depends on their radiochemical purity. As lack of validation of analytical methods was one of the shortcomings noted in the YGH audit, experimentally validating a cost-effective radiochromatography method to be used at YGH was the first step of corrective actions implemented. As the provision of clean air and maintenance of air handling systems and equipment require a large budget, special emphasis was placed in three further chapters of the dissertation on assessment of microbial contamination of products, and measures to ensure sterility of products. At YGH, we reached better control of microbiological air quality. This was achieved by the implementation of simple microbiological air sampling methods, and subsequent introduction of hygienic and procedural improvements. Sterility testing of SPECT radiopharmaceuticals showed a low contamination rate at both TBH and YGH. Nevertheless, preparing radiopharmaceuticals in a well-maintained laminar air flow cabinet is recommended in order to reduce the risk of contamination of products by airborne microorganisms. The serious consequences that could arise from not meeting GRP requirements, include transmission of microbial infection to patients or administering radiochemically impure products. This dissertation presents the first work evaluating an affordable approach of the implementation of GRP in sub-Saharan Africa. It is highly recommended to all radiopharmacies in the developing world to adapt GRP in their context and to implement an optimised quality assurance programme, striving for continuous improvement.

AFRIKAANSE OPSOMMING : Alhoewel radiofarmasie al meer as 50 jaar bestaan is daar steeds vinnige ontwikkeling op dié gebied. Hierdie verhandeling fokus op vraagstukke ten opsigte van gehaltebeheer in radiofarmasie in ontwikkelende lande. In baie lande vereis riglyne vir radiofarmasiepraktyk komplekse fasiliteite, veral lugversorgingseenhede, en uitgebreide gehaltebeheer en dokumentasie. Hierdie riglyne word tans in ontwikkelende lande nie altyd nagekom nie. In talle lande in Afrika sou afdwing van internasionale riglyne tot sluiting van radiofarmasiefasiliteite lei, en as gevolg daarvan tot verlies van Kerngeneeskunde dienste. Die vraag ontstaan tot watter gevolge dit lei as riglyne se vereistes nie nagekom word nie, en of praktyk sonder groot onkostes verbeter kan word. Hierdie werk bestudeer ‘n aantal aspekte van aanbevelings t.o.v. Goeie Radiofarmasiepraktyk (Engels: Good Radiopharmacy Practice (GRP)) en versamel inligting van beide ‘n relatief goed toegeruste fasiliteit by Tygerberg Hospitaal (TBH) in Suid-Afrika, en ‘n meer basiese fasiliteit by Yaoundé General Hospital (YGH) in Kameroen, om ondersoek in te stel na die omstandighede wat nodig is om veilige en effektiewe produkte te verseker. Faktore wat beoordeel word sluit effektiwiteit en mikrobiologiese veiligheid van radiofarmaseutika in. Vergelyking word ook getref met ‘n moderne radiofarmasie eenheid by die Universiteits Mediese Sentrum Groningen (UMCG), Nederland, wat aan vereistes vir Goeie Vervaardigingspraktyk (Engels: Good Manufacturing Practice (GMP)) voldoen. Die “Quality Management Audits in Nuclear Medicine” (QUANUM) hulpmiddel is aangepas om spesifiek radiofarmasie omstandighede te oudit en vervolgens gebruik om die stand van praktyk in twee radiofarmasie eenhede in Afrika te beoordeel. Nadat vasgestel is wat die huidge omstandighede en produkgehalte in die eenhede is, is basiese, lae-koste veranderinge by YGH toegepas om tekortkominge te verminder. Die effek van die veranderinge is vervolgens beoordeel. Waar die nodige vlak van veiligheid en effektiwiteit na veranderinge steeds nie bereik kon word nie, is dit aan hospitaalbestuur gerapporteer. Die effektiwiteit van radiofarmaseutika hang van hul radiochemiese suiwerheid af. Aangesien ‘n gebrek aan validasie van analitiese metodes een van die tekortkominge in die YGH oudit was, is ‘n koste-effektiewe radiochromatografie metode vir gebruik by YGH eksperimenteel gevalideer as eerste stap van regstellende aksies. Die vereistes om skoon lug te voorsien en die onderhoud van lugvoorsieningsisteme kan baie duur wees. Om hierdie rede is daar in drie verdere hoofstukke van die verhandeling baie klem gelê op beoordeling van mikrobiologiese kontaminasie van radiofarmaseutika en maatreëls om steriliteit van produkte te verseker. By YGH kon die mikrobiologiese gehalte van die lug aansienlik verbeter word deur toepassing van eenvoudige mikrobiologiese lugtoetsing, gevolg deur inwerkingstelling van verbeterings t.o.v. higiëne en prosedures. Steriliteitstoetsing van radiofarmaseutika vir enkelfotonemissietomografie (SPECT) het lae vlakke van mikrobiologiese kontaminasie van radiofarmaseutika by YGH en TBH getoon. Ten spyte van dié bevinding word aanbeveel dat radiofarmaseutika in ‘n laminêre vloeikabinet wat korrek in stand gehou word, voorberei word om die risiko van mikrobiologiese kontaminasie van produkte te vermider. Die ernstige gevolge wat uit nie-nakoming van GRP vereistes kan spruit, sluit oordrag van infeksies aan pasiënte of toediening van radiochemies onsuiwer produkte in. Hierdie verhandeling is die eerste beoordeling van ‘n bekostigbare benadering tot toepassing van GRP in Afrika suid van die Sahara. Dit word sterk aanbeveel dat alle radiofarmasie eenhede in die ontwikkelende wêreld GRP in hulle konteks aanpas en toepas en om ‘n optimale gehaltebeheerprogram in te stel, met ‘n gedurige strewe na verbetering.

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