Seid, Sofia (2017) Assessment of Non-Sterile Pharmaceutical Compounding Practices among Selected Community and Hospital Pharmacies in Addis Ababa, Ethiopia. Masters thesis, Addis Ababa University.
![[img]](http://thesisbank.jhia.ac.ke/style/images/fileicons/application_pdf.png) |
PDF (Assessment of Non-Sterile Pharmaceutical Compounding Practices among Selected Community and Hospital Pharmacies in Addis Ababa, Ethiopia)
Sofia Seid.pdf - Accepted Version Restricted to Repository staff only Download (1MB) | Request a copy |
Abstract
Background: The drug products available in the market are mostly ready-made finished drug products. These drugs should be manufactured in pharmaceutical industries using the standard on Good Manufacturing Practice (GMP). But, it is a common practice to prepare topical preparations in compounding laboratories in premises like hospital pharmacies and community pharmacies in order to fulfill the special needs of individual patients. These preparations, like other finished drug products, should fulfill efficacy, safety, and quality parameters. This is achieved by adherence to the established standards that guide the preparation of compounded pharmaceutical preparations. Objective: To assess the practices of non-sterile pharmaceutical compounding in selected community and hospital pharmacies in Addis Ababa. Methods: A descriptive cross-sectional study supported by qualitative study was conducted to assess the practices of non-sterile pharmaceutical compounding in community and hospital pharmacies in Addis Ababa from April 1, 2016 to May 15, 2016. The study was done in 42 community pharmacies and 3 hospital pharmacies. Results: The study revealed that the most commonly prescribed and compounded non-sterile pharmaceutical formulations in the community and hospital pharmacies in Addis Ababa were dermatological creams and ointments. Except for one community pharmacy, no community and hospital pharmacy provided on-the-job training to the pharmacy personnel involved in compounding. The compounding personnel in 41(97.6%) of the community and 2 of the hospital pharmacies were not familiar with the non-sterile pharmaceutical compounding laboratory standards developed by DACA in 2002.Twenty (47.6%) of the community pharmacies and 1 of the hospital pharmacies had no suitable place for compounding. All of the assessed hospital pharmacies had dedicated place for compounding and only authorized personnel is allowed in the specified room but 20 (47.6 %) of the community pharmacies had a compounding area with other works performed in that area. All of the hospital pharmacies and 39 (92.9%) of the community pharmacies had adequate potable water. The compounding area was maintained in a clean and sanitary condition in 25 (59.5 %) of the community pharmacies and all of the hospital pharmacies.Standard operating procedures were not maintained in 41 (97.6%) of the community pharmacies and 1 of the hospital pharmacies. No community and hospital pharmacy created a master formulation record the first time before compounding new preparation. The equipment and materials required by the national regulatory authority for the extemporaneous preparation were not fulfilled in 18 (42.2%) of the community pharmacies and in 1 of the hospital pharmacies. Sixteen (38%) of the community pharmacies had no compounding record at all and 26 (62%) of the community pharmacies had compounding records which only contained the name and the strength of the compounded preparations. There were containers and closures that were not suitable for the preparation compounded in 18 (42.9%) of the community pharmacies and 1 of the hospital pharmacies. Conclusions: The study revealed that, both the community and the hospital pharmacies did not fulfill most of the requirements set by the regulatory authority. However, the hospital pharmacies were found to be better than the community pharmacies in some of the requirements such as labeling of finished preparations, documentation, availability of equipments and compounding room dedication. As per the findings of this study, only one community pharmacy is practicing most of the standard requirements set for non-sterile pharmaceutical compounding. The major limiting factors for the implementation of the standard requirements set was identified to be lack of awareness on the standard set for non-sterile pharmaceutical compounding laboratories; the limited number of demands for the service; lack of on-the-job training and follow up from regulatory body and other stakeholders. Recommendations: The non-sterile pharmaceutical compounding service has to be regulated and inspected strictly. The standards of good compounding laboratories developed by the regulatory authority should be cascaded and popularized to the professionals working in the community and hospital pharmacies. On-the-job training has to be given for the personnel involved in non-sterile pharmaceutical compounding. Further research should be done on the quality of non-sterile pharmaceutical compounding practices in other parts of the country.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Community pharmacy, hospital pharmacy, non-sterile pharmaceutical compounding Personnel qualification, compounding facility, equipment, documentation, quality control, Addis Ababa |
| Subjects: | R Medicine > RM Therapeutics. Pharmacology R Medicine > RS Pharmacy and materia medica |
| Divisions: | Africana |
| Depositing User: | Emmanuel Ndorimana |
| Date Deposited: | 09 Aug 2018 13:05 |
| Last Modified: | 09 Aug 2018 13:05 |
| URI: | http://thesisbank.jhia.ac.ke/id/eprint/8046 |
Actions (login required)
 |
View Item |