Search

Africa represents a challenge to the provision of plasma-derived medicinal products (PDMPs) as there are many competing health priorities on a continent with limited investment and resources to support some of the poorest nations. To compound this, the availability of suitable plasma, although improving, severely limits better access to PDMP for patients in the region. The National Bioproducts Institute NPC (NBI), as a fractionator in South Africa, illustrates a model of local fractionation which successfully addresses some of the dilemmas faced by lower resourced countries in the broader African context. NBI is a relatively small fractionator in the South African pharmaceutical manufacturing landscape, which is characterised by rigorous local and international regulatory requirements, a volatile currency and restrictive pharmaceutical pricing practices. Further, NBI is confronted by a constantly evolving regulatory and operating environment, a paucity of active raw materials, dynamic market trends and variable patient demand for plasma derivatives, as diagnosis of many of the clinical conditions for which plasma derivatives are indicated, improves. Despite these challenges, NBI remains a sustainable and viable local fractionator, positioned to realise its strategic intent of providing accessible, affordable and a comprehensive range of essential PDMPs to patients in South Africa and the Southern African Development Community region. A key to NBI’s success is the strategic partnerships with the South African Blood Transfusion Services (BTS) and other industry associations, as well as a good working relationship with the local regulatory authority, the South African Health Products Regulatory Authority (SAHPRA).

Objective To quantify the extent of potentially inappropriate prescribing among elderly patients seen at public sector primary health care facilities and old age homes in a South African urban setting. Method Cross-sectional survey of the prescription charts of patients aged 65 years or older, using a list of potentially inappropriate medicines in elderly patients, modified from that established by Beers and further developed by consensus. Setting A provincial government chronic prescription pharmacy servicing public sector primary health care clinics and old age homes in the Durban metropole. Key findings Of the 6,410 prescriptions that were reviewed, 1,926 (30.0%) included at least one medication listed as potentially inappropriate in the elderly. The median number of chronic medications prescribed per patient was 4 (range 1 to 11). Although the prevalence of potentially inappropriate prescribing in patients receiving medication at primary health care clinics (29.7%) was similar to the prevalence in those resident in old age homes (31.8%), this difference was shown to be significant upon multivariate analysis. Age was not found to be a predictor of inappropriate prescribing. An association was found between sex and inappropriate prescribing, with female sex being associated with a greater degree of potentially inappropriate prescribing. Conclusion This study has shown that 30% of elderly patients were prescribed at least one potentially inappropriate medicine. Women were more likely than men to be prescribed potentially inappropriate medicines.

Purpose of review Donor selection and viral screening methods combined with pathogen reduction have increased the safety of pooled plasma to a level which makes reintroduction of ABO-universal plasma an important option. Recent findings Solvent detergent-treated pooled plasma has proved to be well suited for the production of pathogen-reduced ABO-universal plasma. One such product, Bioplasma FDP, was licensed in South Africa in 1994 and has since 1996 been in successful clinical use. A clinical study with this product and two studies with the European product, Uniplas, have confirmed the efficacy and safety of pathogen-reduced ABO-universal plasma. Summary Pooling of plasma enables the production of ABO-universal plasma. Pathogen reduction with solvent detergent eliminates lipid-enveloped viruses, whereas neutralizing antibodies in the plasma pool and nucleic acid amplification testing ensures the safety for recognized nonlipid-enveloped viruses. Pooling also eliminates transfusion-associated acute lung injury (the leading cause of plasma transfusion-related death), reduces immunologic/allergic adverse events by 60-80% and standardizes plasma protein content. Thus, in addition to ABO compatibility, pathogen-reduced ABO-universal plasma has important supplementary benefits that improve the product's cost-effectiveness.