Guidelines On Management of HPTs in Kenya
Guidelines On Management of HPTs in Kenya
Guidelines On Management of HPTs in Kenya
MINISTRY OF HEALTH
GUIDELINES ON MANAGEMENT OF
HEALTH PRODUCTS AND TECHNOLOGIES IN KENYA
OCTOBER 2020
REPUBLIC OF KENYA
MINISTRY OF HEALTH
Recommended Citation
Ministry of Health. Guidelines on the Management of Health Products and Technologies in Kenya. 2020. Nairobi, Kenya.
ACKNOWLEDGEMENT
The Ministry of Health and in particular the Division of Health Products and Technologies
(DHPT) wishes to acknowledge the support and contribution made by various partners and
stakeholders towards the development of these guidelines. We greatly appreciate USAID,
through Afya Ugavi, for their funding and technical support in the development process of
this guideline.
Finally, we acknowledge the invaluable inputs of all experts drawn from the Government
and other stakeholders. We also recognize the contribution of the reviewers who took
their valuable time to review and edit the content of these guidelines to ensure they are
comprehensive and meet the desired standards.
The policy direction envisages that investments in health systems will be scaled up
for improved health outcomes. Amongst its objectives are improved service quality,
responsiveness, efficiency and effectiveness in the delivery of the Kenya Essential Package
for Health (KEPH).
These guidelines have been prepared in line with the Health Products and Technologies
Supply Chain Strategy 2020-2025 as a sound response to key challenges in the sector
regarding HPT supply chain. They have been prepared in response to the need to harmonize
the procedures for essential health products and technologies management throughout
the various levels of service delivery under the KEPH. They are targeted at health facility
staff handling HPTs in various ways, including those working under the health programs.
The guidelines aim to provide them with information, procedures and tools required to
ensure regular and reliable supply of HPTs, their appropriate storage, control and issuing.
ANNEXES ........................................................................................................................ 44
Annex 1 – Data Collected at Various levels .................................................................. 45
Annex 2 – Types of logistics records ............................................................................. 46
Annex 3 - Global harmonized system of classification and labelling of chemicals
(Symbols from the United Nations Economic Commission for Europe, UNECE) ......... 47
Good management of Health Products and Technologies (HPT) is important to ensure that
the quality of these valuable commodities is maintained up to the point of use and that
items required for delivery of quality health care are continuously available.
HPT management in Kenya is faced with a large number of challenges similar to those
found in many other developing countries. Many of these challenges have been
documented in various pharmaceutical sector surveys and reports in Kenya.
1. Shortage or absence of trained staff (not necessarily pharmaceutical staff but staff trained
in provision of basic commodity management of HPTs)
2. Poor or inadequate infrastructure, facilities and equipment
3. Lack of policies, guidelines and Standard Operating Procedures (SOPs) for HPTs
logistics management
4. Ineffective or absent supportive supervision and mentorship
5. Poor logistics information management
6. Weak regulations, laws and poor enforcement of the same
7. Inadequate quality assurance practices
The key to improved HPT management is therefore an integrated approach with targeted
interventions addressing each of the challenges listed above.
These guidelines are intended to provide clear practical guidance on the main procedures
involved in HPT management. This will in turn result in improved availability of required
items and contribute towards efforts to provide better quality of health services for clients.
The Constitution of Kenya (2010) Article 43 (1) (a) provides that ‘every person has the right
to the highest attainable standard of health, which includes the right to health care services,
including reproductive health care’.
The Health Act (2017) aims to establish a unified health system, to coordinate the inter-
relationship between the national government and county government health systems,
to provide for regulation of health care service and health care service providers, health
products and technologies and for connected purposes.
The Kenya Health Policy (2014-2030) underscores the importance or need to improve
procurement processes to ensure availability of HPTs, according to essential HPT lists. The
public procurement process in Kenya is generally guided by the Public Procurement and
Disposal Act (2015).
Universal Health Coverage (UHC) - The objective of Universal Health Coverage is to ensure
that all Kenyans have access to preventive, promotive, curative, rehabilitative and palliative
health services at minimum financial burden. In the three drivers for UHC, under access to
health services, HPTs are recognized as a critical component.
The objectives of these guidelines are to describe and document the processes listed below
for HPTs:
The Ministry of Health has the mandate to develop policy and guidelines that will guide
management of HPTs in the Country.
These guidelines will be applicable at National and County levels, and health facilities in
line with their respective operational needs.
The guidelines will be used by National, County and health facility teams involved in
management of HPTs.
DEVELOPMENT PROCESS
• Align to;
- Universal Health Coverage (UHC) in attainment of the Big Four Agenda
- The Health Act (No. 21 of 2017)
- The Health Products and Technologies Supply Chain Strategy 2020-2025
• Widen the scope of application of The Guidelines on Management of Medicines and
Medical Supplies for Health Facilities in Kenya (2015)
The initial meetings to define the scope and content of the guidelines were held in September
2019 and were followed by detailed background work. A workshop was convened in
December 2019 to review and harmonize the process maps and develop the guidelines
content. The output from the workshop provided the basis for drafting of the guidelines,
which was presented to various stakeholders for technical review and input in May 2020
and September 2020. The final document was thereafter approved for dissemination and
use.
INTRODUCTION
The purpose of this chapter is to provide the necessary background information and key
issues regarding HPTs
The Health Act (2017) defines health products and health technologies.
Health products includes human and veterinary medicines, medical products, medicinal
substances, vaccines, diagnostics, medical devices, blood products, traditional and
alternative medicine, therapeutic feeds and nutritional formulations, cosmetics and related
products
Health technologies means the application of organized knowledge and skills in the form
of devices, medicines, vaccines, procedures and systems developed to solve a health
problem and improve the quality of life
Health products and technologies are recognized by WHO as one of the key building
blocks of a health system. The Kenya Health Policy (2014-2030) outlines HPTs as one of the
eight policy orientations. Investments under this policy orientation will be aimed towards
ensuring that effective, safe and affordable HPTs are available and rationally used at all
times, while moving towards a strategic National HPTs reserve.
Improvement of procurement and availability of essential HPT is one of the priority reform
areas for the health sector in Kenya Vision 2030. Scaling up of investment in HPT is one of
the anchors for the achievement of the six health objectives/outcomes of the Kenya Health
Policy 2014-2030 (Sessional Paper 7 of 2012), the overarching framework guiding the nation
towards attainment of the highest standard in a manner that is responsive to the need of
the population. The Kenya National Pharmaceutical Policy (Sessional paper 4 of 2012) is the
overall guiding policy on HPT with the goal of achieving universal access to quality essential
medicines, essential health technologies, and pharmaceutical services in Kenya.
Governance
The Ministry of Health continues to provide stewardship over the HPT supply chain in line
with the Kenya Health Policy and Health Act, 2017. At the apex level, HPT Inter-Agency
Coordination Committee (ICC) has been set up as part of the coordination structures
encapsulated in the Health Sector Partnership Framework. The Framework outlines how
the Ministry of Health, county governments, external and non-state partners should interact
with each other. The ICC is meant to provide oversight on matters HPT and should meet
on a quarterly basis.
In 2019, the MOH elevated the HPT coordination function from a unit to a division under
the department of health systems strengthening in the directorate of healthcare services
with a ten-items mandate cutting across policy, standards, regulation, coordination and
capacity building.
Under the devolved governance, the overall governance structures for health service delivery
for county governments have been established and rationalized. At county level, the health
sector is headed by a County Executive Committee Member for Health, who is supported
by a Chief Officer for Health who is the accounting officer. The County Director for Health
oversees the technical aspects of the health sector and heads the county health management
team. Most counties have designated members of CHMT, domiciled in the departments of
health, to coordinate health products and technologies (HPT) functions in collaboration with
the county supply chain units that are mostly centralized. In line with the Public Financial
Management Act, 2012, the supply chain directorates for county governments, through
the County Treasuries are responsible for development of consolidated county government
procurement plans and quarterly reporting on implementation.
County governments have commodity security working groups designed alongside the
parallel priority programs for HIV/AIDS, Malaria, TB, and Immunization. Counties and
hospitals are expected to have active Medicines and Therapeutics Committees so that there
is harmony in handling of HPT supply chain functions such as quantification, procurement,
warehousing, and distribution. Focus on HPT at intergovernmental relations level should be
strengthened through the HPT ICCs.
Regulation
The Health Act, 2017 provides for the establishment of a regulatory body to regulate
the licensing, manufacturing, laboratory testing and inspection, storage and distribution
facilities, clinical trials, advertising and promotion, and post marketing surveillance for quality
safety and disposal of health products and technologies through an Act of Parliament. This
expanded the classes of products covered to include therapeutic feeds and nutritional
formulations. Additionally, the Act also requires that the procurement of HPT for public
health services be undertaken in line with the Public Procurement and Asset Disposal
(PPADA) Act No. 33 of 2015 and agreed intergovernmental arrangements; KEMSA has
the mandate for procuring, warehousing, and distributing essential medicines and medical
supplies in Kenya under the KEMSA Act 2013. The KEMSA Act also provides guidance for
procurement of health products for the public sector both at the National and county levels.
The Health Act also makes a provision for the establishment of a regulatory body on the
practice of traditional and alternative health practices, that shall set the minimum standards
of practice and licensing for traditional medicine and alternative medicine in Kenya.
Nationally, the Public Procurement and Asset Disposal (PPADA) Act No. 33 of 2015 guides
procurement of HPT.
Other legislation applied in management of HPT supply chain include the Public Financial
Management Act, 2012 and County Government Act, 2012. State agencies such as KEMSA,
PPB, NQCL and Academic Institutions are also governed under the State Corporations Act,
Cap 446.
A better understanding of the HPT regulations has also been outlined within the Health
Products and Technologies Supply Chain Strategy 2020-2025.
The Kenyan health system has evolved to incorporate the role of county governments and
new national initiatives removing user fees, with both benefits and challenges for health
service delivery. At the same time, the GOK is strengthening the institutions that can deliver
UHC, and these goals are articulated in the KHFS (MOH). The proposed reforms to health
financing arrangements, as stated in the KHFS, are intended to better mobilize and pool
funds for healthcare, as a part of this process, to raise insurance coverage with the result
that better access to health services will be achieved. Utilization of health services will rise,
and financial protection from the costs of ill health for vulnerable families will be provided.
There are 4 major sources of funding for HPTs in Kenya these include the following,
• Government - national government through MOH, County governments, parastatals,
other government agencies (33%).
• Development partners - mainly in the following programs TB, Malaria, HIV, EPI vaccines,
Family Planning and Nutritional supplements (22%).
• National Hospital Insurance Fund (NHIF), Private employers, private insurers and Non-
profit institutions serving households (12%)
• Households thru out of pocket expenditure (OOS at 33%)
According to the 2015/2016 National Health Accounts, the Total Health Expenditure was
estimated at KES 346 Billion and accounting for 5.2% of the nominal GDP while per capita
health expenditure was KES 6,602. This is considered below the desired target investment
of about KES 23,407 per capita for coverage of Essential Health Benefits. In terms of sources
of financing, the government remains the biggest healthcare financier accounting for 33%,
followed by households, donors, and corporations at 33%, 22% and 12% respectively.
Donor investments are mainly concentrated on the priority public health programs. The
government allocation to health has been increasing stabilizing at 7.5% of the national
budget. Allocation to HPTs account for 13% of the health budget. Under the affordable
health for all initiative, there are deliberate attempts to improve health financing through
pooling mechanisms and strategic purchasing. Health insurance coverage is still low at
19%, an estimated 4.9% of Kenyans incur catastrophic expenditure from out of pocket
healthcare payments while many others (28%) fail to seek treatment owing to affordability
barriers. The proportion of Public Health Expenditures (Government and donor) spent on
Health Products has stagnated at 15%. Strategic HPTs (HIV, TB, malaria, Family Planning, EPI
vaccines and Nutrition commodities), except for family planning commodities, are mainly
funded by Development partners. Donors invest about KES 77 billion per year in the 3
major communicable diseases meeting 92% of those HPT need, with government meeting
the less than 10% difference in program HPTs needs.
Kenya Medical Supplies Authority (KEMSA) operates a revolving fund business model
for the supply of Essential HPTs, having been initially capitalized in 2013, to the tune of
KES 8 billion though it has not received additional seed capital for to support HPT PSM
functions. KEMSA re-configured its business model to align itself with the devolved system
of government to ensure that public health facilities access medical commodities. Under
the new not-for-profit self-sustaining commercial business model, the county health facilities
order and pay for their medical commodities on a demand driven supply system. The funds
acquired from these sales goes towards replenishing stock. Sustainability of this model is
hampered by delays in payments by counties and other facilities such as national referral
facilities.
Prices of HPT in Kenya are unregulated and generally higher than those in other EAC
countries. Recent reviews, such as HAI Pricing study and KEMSA Assessments, indicate
that KEMSA and MEDS have been able to negotiate for competitive prices compared
to international reference prices, leveraging economies of scale. Similarly, market price
surveys undertaken have also aided in negotiations of prices during tendering. Sourcing
from local producers has increased. However, the prices for HPT charged to patients at the
public health facilities and faith-based facilities have not always reflected these gains owing
to add on charges.
In the private for-profit sector, the variations in pricing of HPTs are high. Retail prices in the
low-income settlements have been noted to be higher than corresponding international
reference prices, and vary across regions despite similarity in socio–economic status. Prices
in the private sector have been noted to be higher than the international reference prices,
and for some products more than 30 times. Various assessments and studies in the health
sector have attributed the unaffordable prices for HPT to the following factors including but
not limited to;
• High cost of local production
• Lack of appropriate consumer information
• Fragmentation of sources, which leads to inconsistent supply
• Lack of agreed framework of operation between private and public health facilities
• Lack of data on HPT price trends in the market
• Unjustifiable mark-ups along the distribution chain
• Lack of coherent policy guidance on pricing of HPT
• Gaps in regulation with regards to registration of products
• Lack of transparency in the whole supply chain, which encourages corruption
The following were identified as the priority gaps in HPT financing and pricing in Kenya,
• Over-reliance on external/donor resources for strategic HPTs
• Inadequate budgetary allocation for supply chain management costs
• High outstanding debt and pending bills by both MOH and Counties to suppliers
including KEMSA
• KEMSA does not have sufficient resources to ensure commodity availability for all
essential health commodities, due in part to funds flow delays and outstanding debts
• Lack of aggregated pricing data and inadequate sharing of pricing information and
other commodity information among key stakeholders
• Lack of a pricing structure for HPTs dispensed to clients in levels 4-6 hospitals
• Delays in disbursement of funds for HPTs
• Lack of clear Resource Allocation Criteria (RAC) for HPT at the Counties
• Program Based budgeting has not yet been implemented in a way that sufficiently
monitors actual spending against programmatic objectives including for HPTs
• High price disparities within and across the dealers’ public including hospitals even for
similar brands
• Lack of transparency and accountability
This can be attained through the development and implementation of a national HPT policy
and relevant regulatory frameworks that will further elaborate the following strategies:
II. Establishing a national appraisal mechanism for health products and technologies.
This will provide guidance on the clinical and cost-effectiveness of new health products,
technologies, clinical practices, and interventional procedures.
III. Putting in place a harmonized national regulatory framework for health products and
technologies. This shall advance quality, safety, and efficacy/effectiveness based on sound
science and evidence. The regulatory framework shall be autonomous in its operations
and shall encompass human drugs; vaccines, blood and its products; diagnostics, medical
devices, and technologies; animal and veterinary drugs; food products, tobacco products,
and cosmetics; and emerging health technologies.
IV. Rational investment in and efficient management of health products and technologies.
This aims to ensure the most effective management of patients in line with established
standards. This will incorporate cost-effective prescribing and other interventions to improve
the rational use of drugs and other health products.
V. Have in place effective and reliable procurement and supply systems. These shall
leverage public and private investments to advance patient access to essential health
products and technologies and deliver value for money across the system.
VI. Promoting local production, research, and innovations of essential health products
and technologies. This shall be done in a manner that advances universal access and
promotes national competitiveness.
VII. Ensuring availability of affordable, good quality health products and technologies.
This shall be done through full application of all options (e.g., promoting use of generics
and exploiting all provisions in the trade-related aspects of intellectual property rights)
and public health safeguards relating to health products and technologies, through multi
sectoral interventions on trade, agriculture, food, and related sectors.
VIII. The national government to ensure strategic reserves for public health commodities
(Tuberculosis, Vaccines, Antiretrovirals, Family Planning) and any other commodities for
emerging global conditions of public health concerns.
Health Products management has five fundamental elements that underpin supply chain
activities; product selection, procurement, distribution, use and management support.
These elements are outlined in the cycle below (Figure 1), and described in details in the
Ministry of Health. Quantification Handbook for Health Products and Technologies. 2020.
Nairobi, Kenya.
SELECTION
PROCUREMENT
MANAGEMENT
SUPPORT
USE
ON
DISTRIBUTION
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The National Government will acquire and maintain adequate stocks of the Strategic
and Special/Expensive categories of products whereas county governments will focus on
ensuring the availability of Essential/Basic products at county health facilities and in line
with Kenya Essential Medicines List (KEML), Kenya Essential Medical Supplies List (KEMSL)
and Kenya Essential Diagnostics List (KEDL).
INTRODUCTION
The purpose of this chapter is to provide the necessary background information and context
to assist policy and decision makers, managers and health workers to understand why good
management of HPTs is important in the provision of health services at all levels.
The following key aspects of health products and technologies management are explained
in this chapter:
• Product selection and quantification
• Procurement
• Warehousing and distribution
• Quality management and rational use of HPTs
• Health products and technologies waste management
• Supply chain information management system
• Monitoring, evaluation and research for HPTs
Purpose of Selection
• To prioritize the various HPTs, in order to maximize therapeutic benefits and optimize
patient outcomes, as well as leading to better supply, more rational use and lower costs
• It is a prerequisite to quantification as it identifies the products to be procured.
Public Sector
• In the public sector, the selection process is conducted at National and County level to
determine which items should be available at each level of care
• Based on essential national HPT lists
• At facility level, the facility chooses it’s required HPT from a predetermined list based on
level of care.
Private Sector
Quantification
Quantification is the process of estimating quantities and costs of products required for a
specific health program or service, and determining when the products should be delivered
to ensure uninterrupted supply of HPT.
Quantification Methodologies
a) Using consumption data (this is the preferred method when consumption data is available)
Use of historical consumption data to estimate future needs.
NB: For detailed information about quantification, refer to the Ministry of Health.
Quantification Handbook for Health Products and Technologies. 2020. Nairobi, Kenya.
PROCUREMENT
Procurement is the process of acquiring by purchase, rental, lease, hire purchase, license,
tenancy, franchise or by any other contractual means of any type of HPTs or services in the
supply chain system. In Kenya, HPTs can also be acquired through donations. Value for
money is the core principle underpinning public procurement.
Procurement should be carried out within the confines of applicable laws, policies,
regulations and good procurement practices as provided for in the Public Procurement
and Disposal (PPAD) Act 2015 and PPAD Regulations 2020 to ensure transparency,
accountability and efficiency of its processes.
• National level
• County level
• Facility/organization level
KEMSA is the national procuring entity for HPTs in the public sector as provided for in the
KEMSA Act 2013 and in the Health Acts amendments for May 2019.
The procuring entities should adapt the processes as outline in figure 2 below
start
Review Determine Reconcile Choose Locate and Specify
HPTs quantities needs and procurement select contract
selection needed funds method suppliers terms
Collect Monitor
consumption Distribute Make Receive and order
information HPTs payment check HPTs status
The procurement cycle describes most of the decisions and actions that guide the specific
HPTs quantities, prices paid and quality of products procured. The steps in the procurement
cycle can be summarized as follows:
1. Select HPTs: This is based on the essential HPT lists (KEML, KEMSL and KEDL and
any other official list). Develop and document specifications for the products prior to the
procurement
3. Reconcile needs and funds: Reconciliation of needs to the available funds culminates
into development of a procurement plan. One of the recommended methodologies for
reconciliation is the ABC/VEN analysis, as discussed below. Procurement plans are subject
to periodic review
4. Choose procurement method: in the public sector several procurement methods are
applicable as outlined in the Public Procurement and Disposal Act 2015 i.e. Open Tender
(OT), Direct Procurement, Framework Agreements, Request for Quotations, Restricted
Tender, Request for Proposals, etc. In the private sector various internal mechanisms may
be applied
5. Locate and select suppliers: Select suppliers based on value for money, quality, reliability
and service. Selection of suppliers for the public sector should follow a competitive process
as outlined in the Public Procurement and Disposal Act 2015 and other applicable laws.
8. Receive and Check HPT: When HPTs are delivered to the warehouse, a visual inspection,
verification of quantities and documentation for the consignment is conducted.
9. Make payment: Once the delivered consignment is checked and it is ascertained that
the HPTs meet specifications, they are received into the warehouse and payment made to
the suppliers
10. Distribute medicines: for further details refer to the section on distribution
11. Collect consumption information: Having a reliable mechanism to collect, collate and
report consumption information is critical in ensuring more accurate matching of demand
and supply. Accurate, complete and timely consumption information will enable the
Government to avoid wasting resources in procuring either excess or obsolete commodities.
It also avoids extra spending on emergency orders and redistribution of commodities from
one facility to another.
VEN classification
This is the grouping of items into Vital, Essential and Non-essential in order to guide the
allocation of resources. The vital and essential classification of items is usually by consensus
of the Medicines and Therapeutics Committees (MTC)
• Vital HPTs (V): potentially life-saving or crucial to providing basic health services
• Essential HPTs (E): effective against less severe but significant forms of disease, but not
absolutely vital to providing basic health care
• Non-essential HPTs (N): used for minor or self-limiting illnesses; these may or may not
be formulary items and efficacious and they are the least important items stocked.
When procuring public sector HPTs, no resources should be allocated for non-essential
HPTs.
ABC classification
VEN/ABC analysis
Inventory management is the process of ordering, receiving, storing and issuing of health
products and technologies. It entails keeping of accurate and up to date records of receipts
and issues which are critical for accountability and reliable quantification.
The basic inventory management tools are bin cards/stock control cards. It is desirable to
have the same records in an electronic version with effective backup. However, an electronic
system is not a substitute for the manual system. Audit systems will always make reference
to hard copies of documentation tools.
2. Storage - This is the keeping of the products in the designated locations in the store/
warehouse
• Update the manual and where applicable electronic stock control cards
3. Issuing - This is the release of the products from the store to various points of use which
can be to internal departments or external facilities. It involves:
• Receipts of orders from departments or facilities
• Processing of the orders
• Issuing of orders through First Expiry First Out (FEFO) or First In First Out (FIFO)
• Picking, Packing and labelling
• Documentation
• Dispatch
4. Delivery - This is the movement of the products from the point of issue to various users
• The delivery method will depend on the nature, quantity and the point of use.
• Available options include collection by the user, delivery by courier services, vans
• Signing and return of proof of delivery
5. Disposal of expired, obsolete or damaged products - This is the process of getting rid of
products that can no longer be used. This should comply with various statutory regulations
such as the Public Procurement and Disposal Act (2015) and the Environmental Management
and Coordination Act (1999)
6. Reverse logistics
• This involves the return of products to the original source.
• The process of issuing and documentation should be followed at the source
• The receiving store should follow the receipt and storage procedures as described
above
These processes can include repair, warranty recovery, redistribution, value recovery, end-
of-life recycling or any combination of these activities. Depending on the volume, a separate
reverse supply chain may be established.
There are series of activities required to retrieve HPT including the five R’S
• Returns - it involves receiving, sorting, inspecting and testing of the product through
verification and trucking system
• Recall - the product is transported for replacing, reclaiming, resells and or disposition.
For pharmaceuticals however, the products recalled in specific batches due to quality
and safety issues are destroyed
• Repair - the products are refurbished, remanufactured like new, then returned to stock
to be reused
• Repacking - in case of minor flaws found, the products are reconditioned and repacked
for distribution
• Recycling - the products are either recycled or disposed
HPTs can also be withdrawn from the market completely when they do not meet the required
standards of quality, safety and efficacy.
v. Have an efficient and rapid real time communication system to help in facilitating disposal
or reused
vi. Have a packing list to assist in tracking and retrieval
vii. Have maintained current lists of HPT stocks in each area
Each item should be tracked with the same level of visibility and transparency.
Rational use of HPTs means patients receive HPTs appropriate to their clinical needs, in
doses that meet their individual requirements, for an adequate period of time and at the
lowest cost to them and their community. Rational use criteria include:
• Appropriate indication
• Appropriate HPT considering efficacy, safety, suitability and cost
• Appropriate utilization (dosage, duration, administration)
• Appropriate patient (assess contraindications or likely adverse reactions)
Quality control refers to the sum of all procedures undertaken to ensure the identity and
purity of a particular pharmaceutical or other HPT.
Post Marketing Surveillance is the continuous process of monitoring the quality, safety
and efficacy of all medical products and health technologies on the market.
Rational Use
For rational use to be achieved, HPTs are required to be available in the facility and at the
service delivery point for appropriate use by the patient.
ISSUING
HPTs need to be moved from the facility store to the places where they are used, such as
treatment areas, wards, or outpatient facilities. The procedures are similar, whatever the
size of the facility.
• Ensure that the sites you are issuing to are authorized by the program and/or your SOPs
• Ensure proper records are used and maintained, e.g. S11 or other facility-based order/
issue form
• Develop SOPs for issuing commodities
These guidelines have used the approach of appropriate use as opposed to rational use
because there are many rational uses which are not appropriate e.g. use of antibiotics in
acute upper respiratory infections may be rational but not appropriate.
Appropriate use of HPTs constitutes; the right item, in the right dosage, right strength and
right duration.
DIAGNOSIS
PRESCRIBING
MANAGEMENT
SUPPORT
ADHERENCE BY
ON
PATIENT /
DISPENSING
CONSUMER
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Elements of GDP:
• Based on a complete prescription/requisition
• Use of generic names/INN for medicines
• Use of effective SOPs
• Qualified staff
• Clear labelling
• Use of clean and suitable equipment
• Use of appropriate packaging material
• Clear instructions
• Good record keeping
MANAGEMENT SUPPORT
The support is best provided through Medicines and Therapeutics Committees (MTC) at
the various levels i.e. National, County and the health facilities (Refer to the Guidelines for
Medicines and Therapeutics Committees, Ministry of Health Kenya, 2020).
Quality Management
This entails the procedures to address aspects of quality control, pharmacovigilance and
post marketing surveillance of HPTs
Key guidance
• Reporting of ADRs
• Analysis of ADR reports for decision making at policy, regulatory, and facility level
• Regulatory function as regards poor quality HPTs e.g. quarantine, future procurement
sources etc.
• Perform physical quality control checks for HPTs
Safe management of HPT waste requires taking all practical steps to ensure that the waste is
managed in a manner that protects human health and the environment against the adverse
effects which may result from the waste.
Health products waste includes expired, unused, spilt and contaminated HPTs e.g.
prescribed and proprietary drugs, vaccines and sera that are no longer required, and, due
to their chemical or biological nature, need to be disposed of carefully. The category also
includes discarded items heavily contaminated during the handling of HPTs, such as bottles,
vials and boxes containing pharmaceutical residues, gloves, masks and connecting tubing.
HPTs are considered hazardous if they demonstrate one or more of the following six criteria:
• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses in humans or animals
• Genotoxicity
• New drugs that are similar to existing HDs in structure or toxicity
Genotoxic waste is highly hazardous and may have mutagenic (capable of inducing a genetic
mutation), teratogenic (capable of causing defects in an embryo or fetus) or carcinogenic
(cancer-causing) properties. The disposal of genotoxic waste raises serious safety problems,
both inside hospitals and after disposal, and should be given special attention. Genotoxic
waste may include certain cytotoxic drugs, vomit, urine or faeces from patients treated with
cytotoxic drugs, chemicals and radioactive material.
Any person whose activities generate pharmaceutical waste has an obligation to ensure
that such pharmaceutical waste is transferred to a person who is licensed to dispose of such
pharmaceutical waste in an approved pharmaceutical waste disposal facility. Therefore,
health-care facility managers and their supervisors have a responsibility to ensure that health
products waste is always kept under control within a health-care facility and disposed of
safely either onsite or offsite. Proper segregation, onsite storage and transportation systems
provide a continuous sequence of safe keeping at each step in the process, from the point
of generation of waste to its final treatment or disposal.
The following general principles of waste segregation, storage and transportation relate to
the control of waste flow from generation to disposal:
• HPT waste generated in a medical area should be segregated into different fractions,
based on their potential hazard and disposal route, by the person who produces each
waste item;
• Closed local storage inside or near to a medical area may be needed if wastes are not
collected frequently;
• Hazardous and non-hazardous wastes should not be mixed during collection, transport
or storage;
• Staff should understand the risks and safety procedures for the wastes they are handling.
Conduct regular capacity building on waste disposal for all healthcare providers
including support staff.
• Minimize the risk of contaminating the local water supply and/or soil with hazardous
drugs (HDs). Hazardous drug waste should never be discarded into waste water (sink or
toilet) or into a landfill
• Specific disposal systems should be mandatory for radioactive effluents. This system
should be effectively and carefully maintained to prevent contamination and exposure
of personnel to the radioactive waste both within and outside the facility
The correct segregation of health-care waste is the responsibility of the person who
produces each waste item, whatever their position in the organization. The health-care
facility management is responsible for making sure there is a suitable segregation, transport
and storage system, and that all staff adhere to the correct procedures.
Based on the WHO recommended color schemes, chemical and pharmaceutical waste
should be segregated in brown plastic bags or rigid containers and labelled with appropriate
hazard symbols using the globally harmonized system of classification and labelling of
chemicals. (see annex)
Various chemical and pharmaceutical wastes should be segregated and collected separately:
subcategories include mercury, batteries, cadmium-containing wastes, photo chemicals,
stains and laboratory reagents, cytotoxic drugs and other pharmaceuticals. All should be
clearly labelled with the type of waste and the name of the major chemicals, with any
necessary hazard labels attached to corrosive, flammable, explosive or toxic chemicals.
Note that
• Liquid chemical wastes should never be mixed or disposed of down the drain but should
be stored in strong leak-proof containers.
• Unused pharmaceuticals should be taken back to the pharmacy for return to the
manufacturers or dispatched to specialist waste-treatment contractors
• Spilt and contaminated chemicals and pharmaceuticals should not be returned to the
pharmacy but should go directly from the point of production to a waste store
STORAGE
HPT waste should be stored in a suitable location or facility where isolation, environmental
and health protection and human control are provided in order to ensure that the waste is
subsequently retrieved for disposal. All storage locations for health products waste should
be clearly marked HPT WASTE STORE and be away from usable products. These storage
areas should be cleaned regularly.
Storage facilities for pharmaceutical waste should be labeled on the outside with the hazard
sign of a skull and 2 crossbones and with the ‘No Entry for Unauthorized Persons’ signage.
TRANSPORT
• Transporter must have access to a spill kit and be trained on how to use it
• Task of receiving and unpacking of hazardous waste delivery should be responsibility of
specific individuals who are trained on safe handling of the same
• There should be an auditable trail on HPT waste detailing the products, source,
transporter and recipient. The generator of the waste should receive an official
confirmation that the waste was received at the expected destination.
DISPOSAL METHODS
The following are the options for disposal of small quantities of health products waste
• Return of expired pharmaceuticals to the donor or manufacturer where possible
• Discharge into a sewer with or without dilution for intravenous electrolyte solutions and
water for injection
• Dilution in large amounts of water and discharge into a sewer for solutions containing
vitamins and amino acids
• The storage room should be secure and access limited to authorized staffs
• All the staff who are involved in receiving hazardous drugs packages must be trained on
safe handling
• Damaged or package with visual sign of damage should be opened in an isolated area
by workers wearing full PPE including double gloves, gown, eye protection, and
respirator. Potentially contaminated items such as PPE’s and damaged vials should be
disposed as hazardous waste. Damaged items should immediately be quarantined and
suppliers contacted
• Hazardous spill kit must be readily available, and personnel handling HDs must be
trained to perform spill cleanup
• There should be work policies, SOPs, job aids etc. to ensure unintentional occupation
exposure is avoided
• Staff should wash their hands with soap and running before and after handling cytotoxic
medicines
• Clear visual symbols should be put on the products as well as storage area to prevent
risk of error in picking
The following are the recommended disposal methods for pharmaceutical waste comprised
of cytotoxic drugs such as antineoplastic agents:
• Return to original supplier
• Chemical degradation in accordance with manufacturers’ instructions
• Incineration at high temperatures. Full destruction of cytotoxic drugs may require
incineration temperatures up to 1200°C and a minimum gas residence time of two
seconds in the second chamber.
MIS is the use of information technology, people, and business processes to record, store
and process data to produce information that decision makers can use to make day to day
decisions. Through use of MIS, data is extracted from varied sources and used to derive
insights for decision making.
Of importance within a health supply chain system, is the Logistics Management Information
System (LMIS). An LMIS is a system of records and reports – whether paper-based or
electronic – used to aggregate, analyze, validate and display HPT data (from all levels of
the logistics system) that can be used to make logistics decisions and manage the supply
chain. LMIS data elements include stock on hand, losses and adjustments, consumption,
demand, issues, shipment status, and information about the cost of commodities managed
in the system.
Data collection
All staff responsible for maintaining logistics records—whether stock keeping, transaction
or consumption—should be appropriately trained and have adequate time to carry out this
responsibility. The forms should be clear and simple, with enough writing space. On-the-
job training (OJT) and supportive supervision should be undertaken to ensure the forms are
being completed correctly.
Data for decision making needs to be categorized, defined and frequently collected. Data
need to be collected and recorded daily at all levels of the supply chain, compiled and
reported within defined periodic intervals (monthly or quarterly). The data collected may be
analyzed daily to assess stock status, monthly or quarterly to determine resupply or order,
and track quantities. On annual basis, the data may be used for purposes of quantification of
HPTs. From a logistics point of view, supplies in a pipeline can be stored, moved (in transit),
or consumed (used). Three types of logistics records are needed to monitor products in the
pipeline and track their movement. Each record type has a distinct form and use.
1. Stock keeping records. Holds information about products in storage.
2. Transaction records. Holds information about products being moved.
3. Consumption records. Holds information about products being consumed or used.
NOTE: Refer to Appendix 1 for description and examples of the above records
To make logistics decisions, a logistics manager needs three essential data items that are
necessary to manage a logistics system. To ensure efficiency, the staff must use an LMIS to
record and report them:
1. stock on hand,
2. consumption,
3. losses and adjustments.
NOTE: Refer to Appendix 2 for description and examples of the above records
Data should be reported regularly, and logistics managers should review the reports to
verify the quality of the data. Feedback reports and incentives can be used to motivate
lower levels to turn in complete, error-free reports. Linking reporting with ordering also
encourages timely reporting.
To make the collected data useful, the records must be available to HPT staff in a form
useful for decision making. Data must be of the right quality (i.e. complete and accurate)
and at the right cost (not spend more to collect information than spend on supplies). For
informed decision-making, summary reports are prepared and relayed to the relevant HPT
staff at various levels for their action (budgeting and supportive supervision)
Reporting systems
• Reports provide decision makers at various levels with the right information, at the right
time, in the right place, in the right quantity, of the right quality, and the right cost
• A reporting system must be in place to ensure that this information flows correctly and
consistently
• A reporting system in a supply chain may include levels outside storage and distribution
points. For example, a County Health Office might not hold stock or be involved in the
distribution of products, but that office still needs to receive LMIS reports to ensure that
facilities are stocked appropriately to determine if additional funding and/ or resources
are required.
Type of Reports
The purpose of a primary summary report is to avail all essential logistics data items
for products, for a specific facility, and for a specific time (such as monthly, bimonthly,
or quarterly) to decision makers. One of the most important decisions HPT staff face in
collecting data on any report is determining when and at what level data is required.
Important points include:
• How visible does the facility-level data need to be higher up in the system (i.e., does the
central level need to know exactly what each health facility distributed and has
on hand?)
• What are the current tasks and work responsibilities of staff that will be required to
compile the aggregated data? Will aggregating data be too much of a burden? Which
levels have tools (computers) and staff that can more easily aggregate data?
The table below summarizes the various types of reports, their description and inputs/
contents
Once data is reported, it paves way for monitoring, aggregation and analysis. The data
should be validated by comparing different indicators to ensure that data are accurately and
consistently entered, aggregated, and reported. It is important to ensure optimal quality of
the raw data that is subsequently analyzed, so that reports are reliable for decision making.
This data ought to be;
• Correct: within normal ranges
• Timely: Available when needed.
Wrong information can easily be reported when aggregating data, unless the procedures
for aggregation are clear. It is important that staff at all levels correctly understand the data
that is to be reported and how the aggregation is done – for example aggregation from
source documents at the facility to summary forms (DAR, Bin Card to summary forms).
For analysis purposes, below are possible indicators to review:
Monitoring refers to reviewing, on a continuous basis, the extent to which HPT activities
are implemented consistently. It aims to know if we are undertaking interventions in the
right way. Evaluation on the other hand refers to the periodic assessment of the progress
towards meeting expected outcomes. Monitoring and Evaluation (M&E) relies on indicators,
which are variables that measure change. They may be numerical and expressed in terms
of numbers, percentages, or averages. They may also be expressed as binomials such as
“yes” and “no.”
Using indicators, monitoring tracks outputs such as availability of medicines and supplies,
number or percentage of trained staff and quality of services. Comprehensive list of HPT
indicators can be referenced from the M & E matrix of the Health Products and Technologies
Supply Chain Strategy 2020-2025.
Evaluation on the other hand provides feedback on the overall performance and makes
it possible to gauge how much has changed and provides direction for future planning in
line with set objectives. Evaluation can be conducted biannually, annually or at a stipulated
time in the life of a strategy. Continuous evaluation provides enough data and information
to inform research on topical areas of HPT management and provide solutions to long
standing issues e.g. Adverse Drug Reactions, Rational use of medicines, prescribing habits,
supply chain optimization etc.
For M&E to be effective, we require predetermined tools to assess progress against the
identified indicators. Examples of these tools include the following;
Information and data use will be enhanced using research and evaluation. Operation
research studies can be carried out from time to time to determine the extent to which the
objectives are met.
The Health Products and Technologies Supply Chain Strategy 2020-2025 has an embedded
M&E framework for HPTs, and is also aligned to the larger Ministry of Health’s M&E
framework.
Indicators are useful tools or directional signals used by managers to track the performance
of particular aspects or activities of the HPT supply system as well as the performance of the
Indicators can be used to monitor the performance of the following aspects, among others:
• Selection
• Procurement
• Distribution performance
• Financial performance
• Patient/client/user behavior/quality of care
• LMIS reporting
• Storage conditions
• Supply chain client satisfaction
• % Forecast accuracy
• % of facilities that reported on stock status (reporting rate)
• % of facilities/SDPs that reported on time (on time reporting)
• % of facilities that had their requested orders supplied in full (order fill rate)
• # of emergency orders
• Proportion of health supply chain budget by admin unit
• Supply chain loss ratio
The table below outlines the different types of data collected at various levels.
National Level
Data Category Data Elements Required Source
Receipts Data Date of Receipt, Source of Funds, KEMSA
Product Category, Product Code,
Product Name, Batch No, Source of
Funds, Expiry Date, UOM, Qty Re-
ceived, Unit Value, Cost Value
Issues data Issue Date, Delivery Note No, Facility KEMSA
Code/MFL No, Facility Name, Facility
Level, Facility Type, Facility Category,
County, Product Category, Item
Code, Product Name, Batch No,
Source of Funds, Expiry Date, UOM,
Qty Issued, Unit Value, Cost Value
Pipeline data Product Name, Supporting Agency, KEMSA
Quantity, Estimated Time of Arrival
• They are organized by date and transaction reference (the unique number
of the corresponding transaction record for a receipt or issue, and/or the
name of the facility from which products are received and issued). They
record receipts, issues, losses and adjustments, and the balance on hand.
They also record the results of physical inventories (when items are counted
to verify the quantity in storage)
• Types of stock keeping records include stock cards (an individual stock
keeping record that holds information about a single product by lot number
or batch number), inventory control cards (an individual stock keeping
record that holds information about all the lots of a single product), and bin
cards
Transaction • Transaction records are used to record information about the movement of The most common
records stock from one storage facility to another. In addition, transaction records formats are Bills of
are proof of requisition, issue, and/or delivery Landing; receiving
records; issue
• Although transaction records are essential in recording the movement of vouchers; receipt
stock, they do not need to include any of the essential data items vouchers; and
mentioned earlier. Sometimes, a transaction record will be combined combined requisition,
with a type of report and will include data like current stock on hand and, issue, and receipt
depending on the system design, losses and consumption data. vouchers. The
content of the
• Completed by stores/warehouse personnel at both issuing and receiving transaction record
facilities. In pharmacies or SDPs, e.g. storekeepers, nurses etc. may will depend on how
complete the transaction records. many transactions
and which parts
• They are started any time a facility requests or issues supplies. They are of the transaction
filled in at any point in the order, issue, and receipt process when custody are tracked on the
of the product being moved changes. They are completed when the record. In all cases, a
receiving facility confirms receipt of the items shipped. pre-printed voucher
number on each
• Data in a transaction record - usually organized by date and by transaction transaction record
number, which helps identify the transaction. Extra copies of transaction helps track individual
records can be a reminder that a request was made and not yet received, shipments.
or that an item was issued, but confirmation of receipt is still pending.
Ideally, transaction records should include a reference number that
identifies each transaction. Data on the transaction record are organized by
the product requested or issued. One transaction record is usually used to
request or issue any number of products. On paper transaction records, the
product names may be pre-printed or written by hand.
Corrosive (C)
These substances attack and destroy living tissues, including the eyes and skin
Toxic (T)
These substances can cause death. They may have their effects when swallowed or breathed
in, or when absorbed through the skin.
Harmful (Xn)
These substances are similar to toxic substances but are less dangerous.
Explosive (E)
An explosive is a compound or mixture susceptible to a rapid chemical reaction,
decomposition or combustion, with the rapid generation of heat and gases with a combined
volume much larger than the original substance
Irritant (I)
These substances can cause reddening or blistering of skin.
Oxidizing (O)
These substances provide oxygen, which allows other materials to burn more fiercely.
Inventory Management
Systematic recording of all stock movements using Stock Control Cards (Bin Cards) in order
to provide a basis for quantification, ordering and receipt, and monitoring of use.
Law
Written, detailed agreed upon rule that defines appropriate behavior and consequences of
illegal behavior.
Policy
Written or unwritten general framework that guides use of resources to achieve national
goals.
Procurement / Ordering
Facilities order from KEMSA on a pre-determined schedule, currently every 3 months for
levels 2 and 3 and every 2 months for the higher levels. Orders from the parallel programs
are based on the same schedules
Quantification
Estimation of the amounts of each item required in order to cover expected consumption
over the supply period plus some safety stock, and avoid overstocks/expiries and stock-
outs
Regulation
Written specific statement based on existing laws to be modified/adapted to the changing
needs of society.
Selection
The choice of required HPT from preprinted lists (i.e. standard order form, hospital order
forms and order forms provided under the various parallel programs) in order to enable
management of common conditions.
Storage
Proper storage of items in order to maintain quality and facilitate access
Note: Use, which involves appropriate prescribing and dispensing of HPT and effective patient
counseling in order to obtain maximum therapeutic benefit for the patient, is only briefly covered
in these guidelines. This area will be the subject of a whole series of activities and interventions,
including the preparation of guidelines, SOPs and implementation of (re)training programs.
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Telephone: +254-20-2717077
Email: dms@insightkenya.com
dms@health.go.ke