Tag Archives | Guidelines and SOPs

Standard Operating Procedures for Planning and Implementing a Continuous Results Monitoring and Support System in Sierra Leone at the Primary Health Unit Level

Since May 2016, the Directorate of Drugs and Medical Supplies (DDMS) and SIAPS have supported district health management teams (DHMTs) to implement the continuous results monitoring and support system (CRMS) in their respective health facilities. By the end of 2017, 10 of the 13 districts and more than 1,000 health facilities had conducted three rounds of quarterly CRMS supervisions, reviewed the evidence in stakeholder review workshops, and produced reports. The indicators tracked are generally classified as service indicators (monitoring treatment uptake, consumption, stock status, and rational use) and system indicators (monitoring availability and functioning of information systems and forms, storage and handling, availability of skilled staff, and capacity building). CRMS supervisors use a checklist and various tools and forms to complete their findings and observations; they also provide real-time mentorship and support to address challenges. The findings and observations of CRMS exercises are summarized and presented to key stakeholders and owners of the system in a CRMS review forum where actionable plans are discussed and operationalized by the next quarterly exercise. The purpose of this standard operating procedure (SOP), which was prepared as a job aid, is to provide a frame of reference for implementing a CRMS to conduct comprehensive, participatory, and responsive monitoring using the first exercise as a baseline to track trends in improvement following continuous engagement of target facilities. This approach is in line with supportive supervision and monitoring system but is more proactive and action oriented.

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SOP for the Adverse Drug Reaction Advisory Committee (ADRAC) on Adverse Drug Event Reporting

The purpose of this SOP is to describe the procedures and activities of ADRAC in the review and evaluation of ADE reports received by ADRMC. It is applicable to all ADE reports received for medicinal products, including Unani, Ayurvedic, herbal, homeopathic and biochemical systems of drugs, vaccines, and biological products.

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SOP for the Adverse Drug Reaction Monitoring Cell in DGDA on Adverse Drug Event Reporting

The purpose of this SOP is to outline the management of spontaneous reporting of ADEs by the ADRMC. It is applicable to medicinal products, including Unani, Ayurvedic, herbal, homeopathic, and biochemical systems of drugs, vaccines, and biological products. The SOP has been written to describe the procedures to be used by ADRMC members to collect, record, review, and manage ADE reports received by the PV center.

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Optimizing the Marketing Authorization Process in Benin: Institutionalization and Development of Medicine Registration Standard Operating Procedures

DPMED is responsible for registration of medicines prior to importation by licensed importers and their use by health providers and consumers. However, the department is hindered in execution of its mandate because of several challenges. The extent of illegal and unregistered medicines in circulation is not uncommon. DPMED is constrained by its capacity to effectively regulate the pharmaceutical sector with consequent inefficiencies in key processes, such as medicine registration, leading to delayed access to life-saving medicines. For these reasons, the Benin MOH sought assistance from USAID to help strengthen the medicine registration system for effective performance to hasten access to quality assured medicines. The SIAPS Program conducted a rapid assessment of the medicine registration system in November 2016, and in August 2017, conducted a detailed assessment of the medicine registration system at DPMED. Based on the findings from the two assessments conducted by the SIAPS Program, several recommendations were made. One of the recommendations was to optimize the medicine registration process by establishing a consistent way of handling registration dossiers to promote an efficient process. Standard operating procedures (SOPs) were developed so that the registration department could operate more efficiently. In addition, the SOPs served as a prerequisite for establishing an effective and sustainable electronic medicine registration system.

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Standard Procedure for Inspection of Retail and Wholesale Pharmacy (Post-Marketing Surveillance)

The purpose of this SOP is to provide guidance to DGDA officials on the steps required to conduct PMS of medicinal products available in retail and wholesale pharmacies, drug shops, and outlets. It is applicable to medicinal products, including traditional complementary and alternative medicines (TCAM), vaccines, and biological products.

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Guidelines and Standard Operating Procedures for the Supply Chain Management of Drugs Used in Mass Drug Administration of Neglected Tropical Disease Programs

One of the constraints to effective control of neglected tropical diseases (NTDs) is that the needed medicines are often not available in sufficient quantities at service delivery points at the time of scheduled mass drug administration (MDAs). Supply systems for NTD drugs (NTDDs) differ from those for most other essential medicines in that NTDDs need to be delivered to selected endemic target sites on a defined schedule based on the frequency of the MDA, which could be once or twice a year. Consequently, NTDD supply chain systems need to be well designed and efficiently managed to ensure that health workers and communities have access to NTDDs and supplies, such as registers, medicines for managing adverse drug reactions (ADRs), height measuring poles, etc., at time of MDA. Availability of these items may be influenced by a variety of factors, including availability of the supplies at the central level, poor stock control, provider experience, economic influences, and transport. This guidance and standard operating procedures (SOPs) document will be valuable additional material for anyone who manages NTDDs—from program managers to service providers, community health workers (CHWs), community drug distributors (CDDs), teachers, technical assistance providers, and public- and private-sector partners. This document describes how to properly manage NTDD supplies throughout the supply chain and distribution process. The guidelines and SOPs serve as a reference document that NTD programs can use to review and enhance their own procedures for managing NTDDs and develop or refine their own SOPs to support the proper implementation of the supply chain components of MDA. These guidelines and SOPs are based on the assumption that countries already have the systems, structures, and processes in place to implement MDAs for NTDs.

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Department of Health Training Guide on Warehousing and Distribution of Family Planning, TB, and other Health Commodities in the Philippines

This guide is written for the DOH Philippines’ LMD. It can be used as support material in the training and development of new and existing staff involved in warehouse and distribution operations at all levels, particularly those who are involved in the process of receiving, putaway and storing, picking and packing, and dispatching of FP, TB, and other health commodities in DOH warehouses.

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Development of Standard Operating Procedures to Strengthen Demand and Supply Planning of DOH Philippines

In line with the objective of the Department of Health (DOH) to strengthen supply chain management for pharmaceuticals and health commodities and ensure access for all Filipinos, this technical assistance aimed to support the DOH in strengthening demand and supply planning for pharmaceuticals. The assistance aimed to facilitate consensus building to harmonize demand and supply planning activities of the DOH, initiate the development of selected SOPs on demand and supply planning at the central level, identify data sets and requirements for performing consumption-based quantification for selected commodities.

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Warehousing Operating Procedures Manual

There has been a long‐recognized need of Central Medical Stores Depot (CMSD) staff for a complete collection of documents representing the up‐to‐date warehouse management
standard operating procedures (SOPs) of CMSD: there was no such resource capturing all the
operational procedures, circulars, registers, office orders, and so on used in the different sections
involved in CMSD’s logistical activities. In answer to this need, CMSD management has taken the initiative to develop a single volume containing all the required documents they have been adopted into existing procedures over the years of operation.

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Technical Assistance to Strengthen the Angola Central Medical Warehouse System

The purpose of this activity was to design and implement warehouse operations system improvements for CECOMA, and to design and implement a human resource capability development and performance improvement (HRCD&PI) program based on the identified gaps.  The assignment entailed conducting a rapid analysis of warehouse and distribution system capacity, including staff capacity, to identify gaps and validate previous findings, and then to design and implement customized warehouse system strengthening improvements as well as an appropriate HRCD&PI program. Information was gathered through record reviews and interviewing CECOMA management and key informants in the different operational units of the warehouse. Qualitative data were collected through one-on-one interviews and focus group discussions.

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