Pharmalink

A Publication of Ecumenical Pharmaceutical Network Vol 13 : Issue 1 - October 2013

Implementing Standard
Operating Procedures,
Guidelines and Standards

Strategies for quality services

which may be of interest to organizations accomplish an activity and clearly indicating the In this issue who find themselves at the base of this mountain. requisite resources and references. certification in 2011. Total Quality: processes. SOPs Benefits of SOPs 1. products 8 how the Kabgayi Eye Unit. gramme is daunted with several challenges that 2008. i+solutions. • Facilitating training for learn from is their ISO 9001-2008 certification. These usually effective and efficient pharmaceutical services. is procurement. The examples in this edition of Pharmalink give a statement by which to determine a course of Joint Medical Store (JMS) is a supply chain or- www. when they started developing guidelines and duct. How do we design our processes. people The success of SOPs at JMS health systems provide and promote just and compassionate quality pharmaceutical services for to interact with.org. ble for a large part of the diversity. proto. materials. The article provides insight step by step guide having the force of a direc. About Ecumenical Pharmaceutical Editorial Network (EPN) “I have not failed. in real Inquiries or comments about this edition of Finally. that prescribes or directs an action. a Rwandan manufacturer ence between SOPs and related management son) thus promoting process consistency 4. They emphasise the plementing the quality man- need to not only look at the processes but also achieve uniformity of the quality improvement Editorial Committee the people and products involved. a rule on how an activity should be per. which culminated into acquisition of ISO A Standard Operating Procedure (SOP) is a tion describes step by step what you should do The image was used in the EPN Guidelines for certification in 2011. A rule differs Differences in organizational culture. shares Emmanuel Higenyi About the cover image experiences regarding the implementation of an The image depicts health professionals discussing SOP programme under the quality management a standard operating procedure for procurement. customers. ac. acknowledged and high- Letters to the editor especially in the case of high staff turnover. It will not just happen. References and resources 15 direct effect on patient care. This is closely related to a SOP but does ganization in Uganda whose prime engagement Andreas Wiegand not prescribe steps. how towards services that allow no discrimination and do we organise ourselves? Who is responsible for guarantee equal access to all. They are also very sensitive if we tasks. A rule is dowed in these tools. into the steps taken in the process of developing tive. determine decisions. people. assuring patients of the safety and be defined as a principle set up by an authority riences with development and use of SOPs. The formed (in written or unwritten form). Much SOPs have a number of compelling benefits such Procedures in Kabgayi Eye Unit: local expose them to dust or spills and eyedrops if as this definition appears rather straightforward. Elisabeth Goffin for quality management can be very relevant but tended to influence and Although SOPs are widely staff training and staff involvement are crucial. Read the second article and “see” there is usually confusion regarding the differ. vestment due to reduced Extemporaneous Compounding 13 structured processes and quality policies have a defines SOPs as “detailed. layout and design Uganda pinpoints another important aspect: tools course of action made by Organization for Standardization) cies in results an institution or body. • Minimising process variability (person-to-per- 3. • Minimising result variability thus promoting in Kampala Diocesan Health Units . are those of the authors and do not necessarily The tasks to implement quality management A regulation is a rule or order prescribed by reflect the views of Ecumenical Pharmaceutical systems appear huge and sometimes overwhelming. limit realization of the maximum benefit en- communications@epnetwork. process errors written instructions to Joint Medical Store started im. There is diversity among The editor also welcomes author’s initiatives for quality of extemporaneous preparations has since a prescribed guide for conduct or action. A job aid or work instruc.000 ways that Ecumenical Pharmaceutical Network (EPN) is an won’t work. The result consistency and reproducibility 5. as: manufacturing of eye drops 4 contaminated. Christian organization whose mission is to support churches and church work in a hospital.” Thomas Alva Edison. In addition. Whether you independent. nor prescribes steps for carrying out an action. function”. a drug supply organization or production unit. the implementation of a SOP pro- Pharmalink should be directed to: made by Gertrude’s Children’s Hospital since objectives. tions related issues or a guiding principle or ly regarded as important business tools. It may organizations and institutions regarding expe- future editions.org proof that the efforts are worth to be taken. guidelines. Elisabeth Goffin The article by a Diocesan health coordinator in A policy is a plan or acquisition of ISO (International • Investigating discrepan- Translation. outlining the sequence of steps required to work hand in hand with SOPs. potency of their products. To get things right is always a all. we learn of the leaps and bounds in progress course of action adopted toward an objective or practice. Implementation of Standard Operating surroundings. 2.epnetwork. warehousing and distribution of i Pharmalink Pharmalink 1 . rules. The success of SOPs at JMS 1 Our eyes are very important for recognising our may indicate persons responsible for specific When developed and implemented successfully. start and finish points. • Performing continual 6. the work of EPN is aimed at working challenge. not-for-profit. an authority to regulate conduct. you have tools. Uganda. SOPs. what? Get started! Joint Medical Store.Enhanced Netherlands. action. A protocol is a code of correct con. International Conference • Sustained return on in- Gertrude’s Children’s Hospital . greatly improved. Where necessary. Standards-based Pharmacy Practice at From the other side of the ocean. cols and job aids or written instructions. I’ve just found 10. A guideline is The JMS experience with SOPs Network.Uganda 11 manufactured in its department through SOPs. An example to performance of a specific agement system five years ago. system. type of in- Dislaimer It is up to us to organise ourselves and our from a SOP in that it neither refers to a process dustry and employee mindset may be responsi- Opinions expressed in this edition of Pharmalink processes to improve quality. to perform a procedure or task. and last but not least colleagues. policies for extemporaneous compounding. shares its insight on how well on Harmonisation1 (ICH) To realize business excellence. a process that culminated into new employees Dr Andreas Wiegand. Relevancy of tools for quality management of eye drops has improved the quality of eye drops tools such as policies. in.

assigning them controlled many learning points but each milestone was a status and intensive training on their use to per- major achievement. Without doing this. The second step was to review and validate the The quality management system facilitated har- existing SOPs for specific processes. system. SOPs that cut across departments and functions. Currently. This involved formal in 2011. dures. This core responsibility is blended tions while SOPs were reserved for activities. consignment verification at receipt and dispatch. This step was quite interesting because SOPs in use. physical inventory.co. non value tion. including customers. This is because for tem. monitoring and evalua- business processes. This required careful identification of what quali- care institutions and service providers. a member of EPN. ment system five years ago. gramme was adopted for the entire organization sive business review with a view of mapping the with close supervision. As a result of effective SOP imple- initially the SOPs were developed on a predomi. JMS de- cided that section heads should take the lead in consultation with their juniors and thereafter forward the completed SOP for review by de- partmental heads and office managers. Completed SOPs were then compiled To realize business excellence.jms.ug cific SOPs. The third step was commissioning of the SOPs minated into acquisition of ISO (International and other documents such as the quality man- Organization for Standardization)2 certification ual. ly carry out logistics activities such as inventory The real challenge here was moving beyond control.co. a document management system was where a procedure was noted to be a constraint. it is now possible for JMS to effective- nantly function-based organizational structure. easier to implement SOPs. where the procedures were actively used to This step. was one perform different processes. Joint Medical into procedure manuals based on functional Store started implementing the quality manage. guidelines and policies. This was important to create ownership and increase uptake. established to guide creation. fied to be a task/subtask and what qualified to be an activity. deviation. mentation. with provision of technical assistance to health. adding activities were identified and eliminated The fourth step was the implementation phase while the value adding activities were realigned. ed using the root cause analysis technique and mentation.ug to take the lead in reviewing and validating spe. much as it may appear simple. units. it should be founded nal process audits to check for compliance or on processes that provide value to all stakehold. To surmount this challenge. form different activities. About the Author rate but overlapping procedures giving different Emmanuel Higenyi is Head Capacity Building at steps for shared processes. ating in isolation without regard of what hap. A formal training pro- The first step was to carry out a comprehen. JMS has 94 ess map. Deviations were properly investigat- ers. Website: www. a process that cul. product recall and organization silos (departments or units oper. In this exercise. was to do with what level in the structure was Contact details: emmanuelh@jms. The SOPs monization of business processes thus making it were checked for relevance to the new proc. there might have been sepa. An additional challenge was to decide on which activities required work instructions instead of SOPs. The other challenge Joint Medical Store (JMS). Example of a Standard Operating Procedure at JMS health care. It was resolved that individual 2 Pharmalink Pharmalink 3 . review and filing of it was amended through a change management documents including standard operating proce. medicines and other supplies used in delivery of tasks and subtasks be guided by work instruc. To facilitate QMS imple. The phase was supported by regular inter- the QMS to be successful. The process was very challenging with approval of the SOPs. It is also now easier to conduct internal process pens in other departments or units) to develop audits and plan for quality improvement. This was the con- of the most challenging when initiating a quality solidation phase of the quality management sys- management system (QMS).

2009 8 Operating Procedures detailing the cleaning Operating Procedure with the only reason to Contact details: umjpr@yahoo. personnel now give considerable attention been observed. at 60 km of the capital therefore several strategies have been adopted The Standard Kigali. cleaning occupied the first place. ments of GMP and hopes to produced was consisting in organoleptic analysis. and for all steps of manufacturing eye ess. due). taminated by other phar. in this article. The plausible causes estab. collection of distilled water. ation and reduction of possible causes of the turing process failing batches has been reduced. Some eye drops produced did equipments cleaning. 2005 6 About the Author 2006 4 1. the materials ed and done properly. Main goal of the specialist called for sit. some difficulties have lished were inappropriate level of apparatus and used. ted a positive evolu- The unit utilizes simple and appropriate technol. As shown in the Standard Operating Procedure Pharmacist Jean Paul Umuhire (B. The situation has been a concern of the unit as tion of the situation as ogy in manufacturing the pharmaceutical prod. etc. The evalu. which belongs to the network for the specialist was the writing of Standard have been documented and put into a Standard of Bufmar.Pharm. drops. By implementing the gain more benefits in services Standard Operating physical-chemical analysis for some products and After analyzing the major factors that may ex. The percentage of uct. This unit was started in 2003 with the sole in order to put on the market drugs of good Operating Procedure objective to make locally produced. vation has been that different steps of cleaning In order to comply with the good manufactur.bufmar. the By implementing the Standard the SOPs are taken as quality control laboratory showed that a high eye drops manufacturing process. Cleaning in pharmaceutical manufac. many problems were still occurring. Sterilization after cleaning glassware proposed has permit- eye drops available for the Rwandan population. thinks to meet the require. Operating Procedure. next product can be con. This SOP was put into practice in December 2012. a member of EPN. the absence of for processing different nel have been trained and The analysis of the products by an external written standard operating procedures for the products or the same. through the SOPs put in in international standards. 2007 11 uation analysis on the next page. tamination between products during manufac. The pharmacist are essential. six years. the cross con. the different steps of clean. maceutical products (resi. M. ally come from the environment. 3. and in-process control Jean Paul Umuhire (filtration). quirements of good manufacturing process of 4 Pharmalink Pharmalink 5 . Evolution of the situation after The Kabgayi Eye Unit is a department of oph. contamination and cross-contamination usu. in order to meet the re- 2011 2 in local manufacturing of eye drops. Procedures in Kabgayi Eye Unit: Other SOPs devel- oped in the same pe- riod cover issues such local manufacturing of eye drops as batch documenta- tion and identification. the process and the operators.org process of the filtration unit (see page 6-7) used improve the cleaning. Scientifically. the Unit thinks external laboratory LABOPHAR (Laboratoire improved standard operation procedures of quate cleaning procedures to meet the requirements Pharmaceutique au Rwanda).Pharm QC&QA) is Chief pharmacist at 2008 13 After analyzing the situation. The person- not meet the quality requirements. long as it has been validated.fr 2010 5 Website: www. the lack of validated or avoid this disaster. When the place. good quality quality. previously not well done have been document- ing procedure (GMP) requirements as specified drops in the unit. or by microorganisms. handling of re- turned drug product. 2. The analysis of eye drops turing. personnel not being well same equipment is used to any steps. the Unit tools for the company’s number of batches did not meet the quality re. ade- rendered to the population. Another obser- contamination have been done during the last During the pharmaceutical manufacturing proc. by cleaning agents. Procedure. cleaning of premises. Rwanda. trained and not experienced. To control of microbiologic contamination by the acerbate the problem. 2004 15 Kabgayi Eye Unit. the demand was increasingly noticed and procedure ern province of Rwanda. pharmaceutical pro- Implementation of Standard Operating ducts. of GMP and hopes to gain Year Batches failed (%) in charge has taken up this concern in order to the procedure must be validated using analytical more benefits in services rendered to the popu- improve the service rendered to population by techniques but this option will not be presented lation. As the unit strives for the availability of eye implementing the thalmology of Kabgayi Hospital situated in south. the first work ing the filtration unit used in Kabgayi Eye Unit Kabgayi Hospital. quirements (see table). success.

Example of an SOP: Cleaning of glassware: filtration unit 6 Pharmalink Pharmalink 7 .

etc. handler of complaints). products (medicines. the International Organization processes/activities. appointing process. working with kpi’s (key performance indi. In line with ards and regulations specified by the European principles on which the family of standards is dures. affordable medicines and health products. setting norms/goals. im- needs of customers and other stakeholders while plementation and technical support on project meeting statutory and regulatory requirements An i+solutions training on quality aspects design for low and middle income countries. Not the QA policy has been formulated to articulate voor de Gezondheidszorg. Davey Groothoff In order to realize total quality for your patients. basic. related to the product. training and consul. and available through tences. in school: getting your organization and people management of all pharmaceutical and medi- from grade C to B to A and possibly A+. The key objective is to organize and i+solutions’ vision of universal access to high Union (Guidelines 2013/C 68/01 and 2001/83/ based (Wikipedia): Customer focus. supply chains. tancy services. Quality Assurance (QA) focuses more on the all pharmaceutical and medical products sup- National standards bodies2. we implement the Supply Chain and training programme in Rwanda. down to earth. the commitment of i+solutions for operating a ent country’s National Regulatory Authority and improvement.g. The standards are Important building blocks are: describing all published by ISO. We have to docu. including the eight management (independent) external audits. this is called learning loops. The Netherlands’ Government (Inspectie involvement of people. EC). The implementation of this policy i+solutions Pharmaceutical Quality Assurance 300 million USD of pharmaceuticals. Government/PEPFAR program and the Voluntary Pooled Procurement program (VPP) for the ISO 9001-2008 Global Fund. distribution and social market- agement. formance of each function. ISO 9000 deals cators). contain detailed written instructions on per. Another pro- partner in the Partnership for Supply Chain gramme is a comprehensive health commodity Management. We have made substantial savings for our do- you need to secure the whole supply chain: your nors/recipients.g. IZG) and the recipi- system approach to management. responsibilities and compe. your relations (e. i+solutions The ISO 9000 family of standards is related to is ISO 9001-2008 certified since 2010. WHO. with the fundamentals of quality management owners (e. ing of female condoms in countries like Nigeria. ment and supply management and the develop- ment of projects that address bottlenecks in i+solutions is an international organization spe. Quality Assurance i+solutions considers Quality Assurance of for Standardization 1. products Drs. factural approach to decision keeping it simple and workable. process approach. realize a continuous improvement in the way quality. Total Quality: processes. This cer- quality management systems and designed to tification covers our procurement and supply help organizations ensure that they meet the delivery services as well as capacity building. your training and capacity development in procure- people and your products. Let’s say like quality system for the procurement. internal and the whole supply chain including the necessary i+solutions commits to comply with the stand- systems. We currently have a programme cialized in pharmaceutical supply chain man. contribut. leadership. In ISO cal products. Last year we procured for almost ISO (International Organization for Standardization)1 9001-2008 focuses primarily on processes. of thinking and doing in your organization. Other important activities are processes. making. As pharmaceutical procurement Cameroon and Mozambique. together with Cordaid and Swiss TPH. quality standards and referential norms set by from Malaria. on procurement. reproductive health) in plied to its clients as its primary responsibility. supply chain the Donor’s Quality Assurance Policies. mutually beneficial supplier relationships. continual bureaucratic. vendors). training proce. people. in particular the WHO Model Quality 8 Pharmalink Pharmalink 9 . process controls and competences. but active. relations and people. Burundi and Management System (SCMS) funded by the US DRC. is supported by i+solutions Pharmaceutical QA Standard Operating Procedures (SOPs) are con- ing to the treatment of more than 2 million HIV/ ment lessons learned and convert them in action standard operating procedures (SOPs) which tinuously updated to be aligned with the latest AIDS patients and 15 million patients suffering points to become better all the time. capacity building.

tle. your patients needs to be embedded in a broad. And management in Kampala Diocesan specification. The initiation of this survey came as a result of inte- grated support supervi- sion visits with the district teams.and post-shipment quality control. treatment guidelines is an important factor to realize real Our QA policy covers all activities in the entire quality care for the patient. UCMB in partnership with the MOH plus other (SOPs).org proper service delivery • Human resources: for example. perspective on health to ensure if individuals and commu. recommendations Community members lining up for free HIV counselling and testing on World Health from in charge review Day in April 2013 held at Muzinda Katereke Health Centre 11 in Nabbingo Parish 10 Pharmalink Pharmalink 11 . preventing stock-outs in some remote areas. a member of EPN. developed by JMS. JMS last trained in charges 5 years ago. supply chain to ensure that all commodities pro- cured or supplied by i+solutions meet specified requirements and standards including: product • Health care technology: for example. creased costs. Regina Bakitte N. and in. can quality care reach the Medical Bureau (UCMB). As professionals mitted infections or cultural restraints to use of in the field. For monitoring purposes. compliance with national regula.M products and the supply chain.org and management of health happen that a medical professional describes services at health facilities in Kampala Archdiocese. and inventory manage.Uganda storage and distribution. the approved 2010 Uganda Clinical Guidelines turer for female condoms. or too much or too lit- Relevance of tools for quality (WHO MQAS). Only for Health Centre 111s and enrolled nurses for ing Monitoring & Evaluation tools in April 2012 care result for the patient. there could be all kinds of human barriers Quality policies normally are focused on the for making your quality care for people effective. Diocesan Health Coordinator Regina Bakitte carried out a survey in 15 DHUs. Uganda Clinical guidelines by • Health information: for example clinical. (JMS) and other partners have developed manu. we should be medicine. Uganda Catholic • Health market dynam. it could Website: www. Joint Medical Store Guidelines and SOPs ics: for example. pre. management information plays a major role in health unit management committee tools. • Health financing: for example. with the purpose to look into ordering. This formed a barrier In summary. existing tools to monitor cess to your excellent quality care system. tive in the field. procedures and guidelines used in manage. Let’s think of: total quality of care to the patient. and a patient safety manual developed by With regard to Standard Operating Procedures gistical. Assurance System for Procurement Agencies the wrong medicine. In January 2013. financial information. The survey showed that 90% of the units had cently there was only one prequalified manufac. lo. nities are really convinced. in Nairobi. include a standard operating procedure manual ease. makes your quality care system even more effec- ment. sick patients may not go to the doc. Health Centre 11s. QA. with the help of E-learning. more medical profes- sionals can be reached in the coming years. Adviser at i+solutions.g. other health quality influencers) to ensure total MOH. Davey Groothoff is Business Development designs or uses already tor. • Health individuals/communities: for exam- Total quality in a broader perspective ple. Think of lack of knowledge on sexually trans- ing and delivering of the goods. mobile phones already play an important role in tion. This requires aware there are all kinds promotion and explana- of influencing factors that High quality services delivery for tion in the field of the The diocesan health units (DHU1) in Uganda meetings and experience sharing in meetings at- could be a barrier to re. Operational and quality of care to the patient. The Ministry of Health (MOH). in which case they possibly can not have ac. These and were making use of them in diagnosis of dis- to the possibility to select and choose. It Health Units . till re. Contact details: DGroothoff@iplussolutions. Kenya. your patients needs to be what-why-when-where of are headed by in charges at clinical officer level tended such as the EPN workshop on develop- alize an excellent quality embedded in a broader the use of medicine. als. without health About the Author the health coordinator insurance. only 10% of those effective quality for the patient. Therefore effective training in e.iplussolutions. At the time of the survey. the manufactur. er perspective on health (ISO 9001-2008. patient. procurement and distribution processes. high quality services delivery for ment of health services at facility level.

58% Website: www. was not an exception approximately eight years ment. This tal and all its satellites. 80% of the health units had received IEC3 material from In conclusion. One area in which the enacting of stand- preparing. it is common to prepare oral standard operating procedures (SOPs) that di. designing tools is one aspect but ensuring that staff have the training. it was noted that 80% of the health units had placenta pits. ware known as Q-pulse and addressed to the at an affordable cost.M is the Diocesan Health Coordinator at Kampala Archdiocese. lations intended for adult use into suitable forms for paediatric use1. Due to the absence of ready- The department has policies. The processes. The important for access. HIV/AIDS. capsules or powdered medi- rect the practice of pharmacy at the main hospi. ity of our extemporaneously document is amended. D On quality of services. place and in use.com ing. stock man. HIV counselling and testing (HCT). cine dispersed or dissolved in suitable bases.ug qualified medical staff. with certainty. the pharmacy Chief Pharmacist. distributing. waste management through sort. Quality of services The Kampala Archdiocesan Health department is one of the dioceses under the UCMB network. efficiency and quality of materials covered issues such as integrated man. dispensing. etc.Uganda. establishing improve. Gertrude’s Children’s Hospital - On guidelines for treatment of disease. liquids from tablets. sensus is generated. protocols and Gertrude’s Children’s Hospital pital. About the Author bites. administering and moni. support supervision from the district. Once evidence-based con- best practices. inpatient (IP).co. were in health units to design SOPs on procurement i. storage (FIFO2). the ment priorities and work. systems to ensure continuous improve. the tools are Enhanced Extemporaneous Compounding the Ministry of Health and the district and these understood.ucmb. consumption). Regina Bakitte N. This made it impossible for most of the (OPD). guidelines and made products. version number altered. ing to close the targeted re-uploaded onto Q-pulse gaps. sensitized on their roles. bage disposal. prepared formulations. with the challenge of modifying oral dose formu- portive to this end. but aging equipment and Gertrude’s Children’s Hospital has over the toring of medication therapies. it can either be reviewed practice. the gaps. This has been driven by the need to through the hospital’s quality management soft- consistently offer patients high quality of care. Depending on the scope of the department in the hospital has embraced in its proposed amendment.e. ago. by a team of pharmacy personnel or tabled as ment in the delivery of an agenda for discussion pharmaceutical care by by the Medicines and regularly benchmarking Therapeutics Committee. These guide all the phases in many cases is done without evidence-based of medication management and use in the hos. a Jaguga Pambo C. tures and resources that must be in place for the provision of safe and Extemporaneous compounding high quality care are given utmost priority and Pharmacy practitioners have always been faced the hospital’s management has been very sup. peer-reviewed components cal staff to recommend amendments before the of best practice in the delivery of healthcare to review date. Contact details: nreginaka@gmail. implemented and evaluated is very were found at visible places in the facility. ards has led to consistent quality of pharmaceu- 12 Pharmalink Pharmalink 13 . practice standards with We can now. antenatal care (ANC). procure. identifying assure patients of the qual. Such recommendations are raised patients. Only 1 unit had a medi- cines and therapeutics committee in place. The standards years recognized the need to adopt in its prac. struc. As a result. member of EPN. agement of childhood illnesses (IMCI4). and circulated to staff. the rest tools. The registers for outpatient department Standards-based Pharmacy Practice at had left. ANC. storing. designing dispensing logs. proper gar. among others. are revised once a year with provision for clini- tice evidence-based. These phases include selection. health in charges were still in place. had patient committees but they were still not agement (update of stock cards. Only 10% of the health units minimum and maximum stock levels. ordering/prescribing. services in the network.

http://www. First Out 3.sbgh. http://en. ward some of the formulations we prepare to http://www.this record can be used tical care in the department is with extempora. 2. Compounding ARTICLE: The success of SOPs at JMS (p. with certainty. compounding formulae.pdf gard to their physico-chemical properties. FIFO – First In. a member of The developed guidelines outlined the required EPN.ca/Pharmacy/Compounding-Service/ the national quality control laboratory for analy- The department defined its desired performance sis of quality.Calgary (AHS) published the latest edition of their Pharmacy Compounding Manual to the introduction of guidelines and standard counselling. apron or gloves). shelf life. tions for the appropriate use of the medicine. which is a health-care. capsules opened and contents dissolved in dis. coordinated by the respective diocesan health coordinators. final verification and provision of patient The Alberta Health Services . D. Contact details: cjaguga@gerties. documentation for each preparation made.nz / manual / Formulation sembling of all relevant materials and equipment.iso. 1. with certainty. The alphabetic list allows you to click on a link of a the potency of the compounded preparations. Gertrude’s Children’s Hospital.org beling details and standards.pdf. http://www. instructions to be Website: www.Information. guidelines has led not only to the consistency http://www. appropriate References protective apparel and handling of deviations from the formulae among others. products (p. clarity. but also to better quality no reliable information on stability and storage products with evidence-based medication use Compounding recipes conditions for the preparations made. ARTICLE: Standards-based Pharmacy Practice at Gertrude’s Children’s Hospital - ing of hands. Prior date. colour.ca/dop/files/calgaryCompManual. documentation of A pharmacy staff compounding an extemporaneous preparation the compounding process in the extemporane. Documentation was scanty and medication la. immunization. adding up to over 600 certain medicine in order to access the compounding recipe. in 2008.org/wiki/Standards_organization#National_standards_bodies ingredients and quantities. in the manner in which extemporaneous prep- patibility and bioavailability properties. Uganda (p. 2013. procedure for com- pounding. 1-3) formulae for different formulations were collated 1. September. It was information.co. desirable storage conditions. performance of the necessary calculations to establish the amount of each ingredient needed and independent verification of the same. We can now. IEC . assure The Hospital for Sick Children (SickKids).org 14 Pharmalink Pharmalink 15 . people. Extemporaneous formulations of oral liquids. prepared formulations. 2.iso. is Chief Pharmacist at sensitization sessions for pharmacy staff held. out for each compounded formulation: cleaning of the compounding area and equipment. The development and implementation of these tilled water or multivitamin syrups without re. Plans are underway to for- bels were not of a standard format. prevention of at a minimum the following steps are carried diarrhoea.org/ information. 13-14) coats. nutritional information. guidelines were About the Author developed. ARTICLE: Total Quality: processes. putting on protective apparel (dust Enhanced Extemporaneous Compounding (p. standards in line with best practices and noted the gaps.A guide.mb. identification and as. These are lower level health units in the 19 dioceses. tablets were crushed or It offers a well written introduction with many state of the art aspects to assure the quality of the compounding process and the resulting products. com- pounding according to laid down procedure. given to patients during dispensing. Consequently. teaching and research centre affiliated with the not possible. odour. Accessed: 14th August 2013. There was arations are made. 2. 8-10) Each compounding formula has the following 1. ARTICLE: Relevance of tools for quality management in Kampala Diocesan Health Units - correct packaging and other relevant instruc. Resources on compounding of children’s medicines ous preparation form . to assure patients of patients of the quality of our extemporaneously University of Toronto offers a lot of data on their website. wash.gerties. http://www. assessing patient weight variation. 11-12) 1.sickkids. name of product. formulations per year. adequacy of mixing.wikipedia. formula number. la.ich. http://www.org/ from several peer-reviewed references and com. to address any questions that may arise at a later Pharmacy Compounding Manual neous compounding of such formulations. consistency of prep- aration and pH as appropriate. Education and Communication The standard operating procedure requires that 4.pharminfotech. appropriate resources acquired and Jaguga Pambo C. com. These are services at consultation such as weighing. on the internet: PHARMACY COMPOUNDING MANUAL . / extemprep.org/ piled to form an extemporaneous formulary.

epnetwork.00606 Nairobi.com/EPN.facebook.org Just and compassionate quality pharmaceutical services for all 16 Pharmalink . Ecumenical Pharmaceutical Network P.org http://www. O.epnetwork Visit us: www. Box 749 . Kenya Tel: +254 724 301755 | 572 522702 info@epnetwork.