mweaverling Much progress made by the GAP-f working group in recent months

The Global Accelerator for Paediatric Formulations (GAP-f) — an evolving collaboration among a number of partner organizations — has continued to develop in 2018 and has announced some recent key accomplishments:

New website

The GAP-f website has been launched, which brings together key information on paediatric drug optimization and aims to be the place to go for updates in this broad area of work. The website includes links to guidance (such as the PADO list of priority paediatric ARVs and the IATT paediatric ARV formulary), important peer-reviewed publications, and past and upcoming events.

 

 

Papers published in JIAS and the Lancet

Two peer-reviewed commentaries recently published by the GAP-f outline pre- and post-approval activities coordinated by the GAP-f, key features of the GAP-f and its phased implementation, and future opportunities for change that will contribute to ensuring rapid development and uptake of key paediatric drugs in age-appropriate formulations:

  • “Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries,” published in JIAS in February. This paper is part of a supplement on “Paediatric and Adolescent HIV and the Sustainable Development Goals: the road ahead to 2030,” convened by CIPHER and guest-edited by Douglas Webb, Chewe Luo, and Lucie Cluver. It is available here.
  • “Catalysing the development and introduction of paediatric drug formulations for children living with HIV: a new global collaborative framework for action,” published in The Lancet HIV in early May. It is available here.

Webinar hosted

On April 24, the AIDS Free Working Group co-chairs hosted a webinar among Vatican meeting participants and other key stakeholders to provide an update on their efforts to monitor implementation of the Rome Action Plan and to allow those who made commitments to provide updates. The webinar showed that activities are ongoing on the majority of action points. An overall assessment of implementation status across the Action Plan will be performed to identify any significant gaps.

A recording of the webinar is available upon request to Tamar Gabelnick (tgabelnick@pedaids.org).

 

 

Satellite session to be held at AIDS 2018

At the upcoming 22nd International AIDS Conference (AIDS 2018), GAP-f partners will be hosting a satellite session to present GAP-f concepts and work outcomes so far. The session – to be held Monday, July 23, 10:15-12:15, in Hall 11B of the RAI Convention Center – will include perspectives from different disease angles and stakeholders. More information will be circulated closer to the conference.

PFSCM’s role in GAP-f

In 2017, PFSCM joined this newly formed working group that builds on global efforts to promote a faster, more efficient, more focused approach to paediatric formulation development. Wesley Kreft, PFSCM’s Director of Global Supply Chain, serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.

Read more about the GAP-f in a post from January on this blog.


Sinette Goosen World Malaria Day 2018: Reflecting on the public health supply chain with a focus on IRS

Globally, the efforts to end malaria in endemic, high-burden countries are vast and ongoing.

The fight against malaria brings together thousands of entities, from researchers, manufacturers, governments, and funders, to humanitarian groups and non-government organizations (NGOs). Supporting these institutions in their work is a myriad of interwoven service providers (SPs), executing many unseen tasks.

Among these SPs is the public health supply chain, working diligently to ensure:

    • Best value and quality products are procured to make available funds go further.
    • Commodities reach the point of care, on time and in full.
    • Infrastructure, such as storage facilities, are developed along the supply chain to ensure compliant pharma-grade storage of products.
    • Chain of custody is enforced through technology that captures information about shipment location, product integrity, and patient consumption.

On World Malaria Day 2018, the Partnership for Supply Chain Management (PFSCM) reflects on some of its most recent successes achieved in sourcing and moving complex and sensitive malaria commodities to some of the hardest-to-reach places on earth.



Sourcing and moving malaria commodities: IRS focus

PFSCM has been procuring and delivering malaria commodities for the Global Fund to Fight AIDS, Malaria and Tuberculosis since 2009.

Since then, more than 1,600 shipments of malaria commodities, worth more than $527 million, have been delivered to more than 45 countries for the Global Fund.

Commodities include artemisinin-based combination therapy (ACT), malaria rapid diagnostic tests (MRDTs), insecticide-treated bed nets and indoor residual spraying (IRS) products.

In recent years, PFSCM has refined and streamlined processes for the procurement and delivery of IRS products specifically.

IRS in a nutshell
Indoor Residual Spraying (IRS) is the application of long-acting chemical insecticides on the walls and roofs of all houses and domestic animal shelters in a given area, in order to kill the adult vector mosquitoes that land and rest on these surfaces.

The primary effects of IRS toward curtailing malaria transmission are:

  • To reduce the life span of vector mosquitoes so that they can no longer transmit malaria parasites from one person to another;
  • and to reduce the density of the vector mosquitoes.

In some situations, IRS can lead to the elimination of locally important malaria vectors. Some insecticides also repel mosquitoes and, by so doing, reduce the number of mosquitoes entering the sprayed room, and thus human-vector contact.

In terms of IRS, PFSCM mostly procures and ships a World Health Organization Pesticide Evaluation Scheme (WHOPES)-approved long-lasting microencapsulated formulation of the organophosphate insecticide, pirimiphosmethyl. The product is specifically designed for use in IRS programs to provide up to one year’s residual control of mosquitoes and other public health pests. It is effective against pyrethroid resistant Anopheles, Aedes, and Culex species.

PFSCM Senior Procurement Specialist Martin Mugisha says the procurement and shipping of IRS products comes with unique challenges, especially for public health supply chains.

“The sensitivities relating to IRS products are intertwined. These include complex sampling; pre-shipment inspection and quality control testing processes; relabeling; multiple shipments owing to the hazardous classification of products; limited delivery periods to various developing countries; constraints in order placement; and a lack of awareness and education about the role supply chains play in supporting IRS programs.”

Quality control testing, sampling, and pre-shipment inspection: Product quality is of utmost importance to PFSCM, and quality control batch testing is continuously undertaken.

PFSCM works with a WHO-prequalified laboratory in Belgium to execute the critical batch testing, which is especially important for pirimiphosmethyl — although pirimiphosmethyl is a trusted product, quality testing is done on each batch, owing to the hazardous classification of the product.

Further, quality assurance measures include sampling and pre-shipment inspections often undertaken by renowned inspection, verification, testing, and certification company Standard Global Services (SGS).

Sampling and/or pre-shipment inspections may be pursued at SGS’s own discretion, or as a result of a client request or a specific country requirement.

These safety measures are essential in safeguarding humans and the environment. By managing the quality testing process firmly and partnering with world-class laboratories, PFSCM reduces the cost and lead time of quality testing.

Relabeling for country-specific languages: Another important IRS supply chain activity is the translation of user directions and relabeling of the products. This ensures that country-specific language pairs — such and English and French, and English and Portuguese — are clear and accurate for safe and easy use by spray operators and others involved.

This process requires specialized outsourced services, which are undertaken at the manufacturing facility and coordinated by the procurement agent.

Moving hazardous products: The WHO has classified pirimiphosmethyl as a Class U product, meaning it is unlikely to present acute hazard to humans and the environment. Pirimiphosmethyl presents no significant risk to spray operators or householders when used as directed.

However, for the shipment of large quantities of the product, regulations pertaining to the shipment of hazardous cargo need to be followed. These requirements increase the complexity of the shipping procedure and may result in several vessels being used per order to comply with the allowable amount of dangerous goods per ship.

PFSCM has longstanding agreements with reputable freight forwarders who have extensive experience in managing hazardous cargo in a safe and cost-effective manner.

Time-sensitive products: IRS products need to be delivered before the spraying seasons start. Spraying usually occurs before the rainy seasons, and provisions for the in-country distribution and spray operator training need to be made.

PFSCM actively engages with stakeholders to align processes for smooth delivery of goods.

Constraints in order placement: Forecasting and order placement at the in-country level can be challenging, especially when data is in short supply and resources limited. Accurate forecast data plays a crucial role in manufacturer production scheduling and stockholing.

Improved forecasting data generates market confidence and encourages vendors to enter into long-term agreements with SPs, thereby also ensuring that recipients can enjoy better product pricing and stable supply.

The procurement agent and supply chain SPs need to be flexible and agile in responding to the consumption patterns of public health supply chains in developing countries, and need to drive advancements in this area for optimized spend.

Lack of awareness about the role of supply chains: Stakeholders need to be educated on the importance of collaboration, especially where roles start overlapping. Quick execution of waiver applications, accurate monitoring of warehouse capacity, and attention to details such as the availability of staff for unloading cargo can make a significant impact on a project.

In the public supply chain space, PFSCM often acts as advisor and educator, traveling to engage with stakeholders in person, to ensure all parties understand their roles and are equipped to fulfil their responsibilities.

“Having navigated these challenges and barriers for some years, PFSCM has become an expert in the field of IRS procurement logistics,” notes Mugisha.

Adapting to an ever-changing malaria environment
The malaria landscape is evolving, with drug and pesticide resistance, diminishing funding, environmental concerns, counterfeit and stolen goods, and a need for increased supply chain efficiencies driving new treatment innovations.

With new innovations, the supply chain will need to adapt and gear up for temperature-controlled conditions for new vaccines, while contemplating how new biomedical nanotechnology drug delivery systems will impact on the future of public health supply chains and patient care.

Working with SGS

PFSCM and SGS have a well-established business relationship, with SGS playing a key role in PFSCM’s operations for over a decade now.

SGS facilitates the pre-shipment inspections and sampling of IRS products as per client or country requirements.

In 2018, PFSCM and SGS again had the opportunity to share knowledge and engage about ways of streamlining quality assurance systems in the unique IRS environment.

The collaboration has proven exceptionally fruitful ahead of a major consignment of IRS products due for delivery to Mozambique by mid-2018.

Mugisha explains that stakeholder engagement such as this has been essential in orchestrating complex IRS deliveries.

“IRS shipments comprise many individual processes and products, and therefore the harmonious alignment of QC testing and pre-shipment inspection is critical to ensure the order not only arrives on time, but also in its entirety,” stresses Mugisha.

He adds that direct insight into the specialized tasks managed by SGS, as well as continuous interaction, has helped PFSCM simplify quality assurance procedures to reduce lead time, proactively manage risks, and, ultimately, ensure that the most critical logistics step is well executed.

Further, the efficiency of the quality assurance process is also accelerated by reputable vendors offering excellent quality products.

“The outstanding track record of the pirimiphosmethyl we procure is a contributing factor to the success we have had in reducing quality assurance lead time,” notes Mugisha.

Proactive approach in harmonizing major 2017 IRS deliveries to Mozambique

In 2017, PFSCM made inroads in engaging with IRS program stakeholders and aligning various parallel processes for the shipment of IRS products to Mozambique.

In August 2017, PFSCM orchestrated the delivery of a large consignment of IRS commodities to be used in the Mozambique Ministry of Health’s IRS campaign, which took place around October 2017.

The milestone consignment of 33 containers was shipped via 3 ports of entry, across more than 2,000 km, to 7 regional warehouses in Mozambique.

PFSCM Senior Logistics Services Specialist Jerome Sabatier says it was critical that the shipments were delivered on time, that sufficient compliant storage was available in all seven regions, and that the quality sampling and logistics was done in a cost-effective manner.

“This shipment entailed many complex facets. To save time and money, we conducted the product quality testing early in the preparation phase and tendered part of the shipment to save about $50,000. Apart from this, we anticipated that poor infrastructure, language barriers, and bureaucracy would likely attribute to the complexity of distribution.”

Sabatier explains that PFSCM took a proactive approach to solving the logistics challenges and visited several of the designated warehouses, ports, and in-county stakeholders to ensure all requirements were met before the 33 containers of IRS were delivered.

Further, PFSCM also greatly improved supply chain communication channels by building rapport with in-country stakeholders, such as the logistics SPs, agents, warehouse managers, and other institutions.

“Through the in-country groundwork, we avoided many pitfalls, such as incorrect delivery addresses, availability of labor for offloading at warehouses, and import waiver delays.”

The team not only succeeded in ensuring successful deliveries, but also managed to create awareness about the importance of this malaria prevention project and the shipment of commodities that make it possible.

By sharing their expertise and conveying a genuine sense of responsibility, the PFSCM team motivated the various stakeholders to uphold the same level of ownership.

Price reduction to yield future savings

Meanwhile, earlier in 2017, PFSCM negotiated a 17% price reduction on pirimiphosmethyl. Prior to these negotiations, the pricing for this IRS commodity had remained the same since 2014.

The price reduction is expected to yield significant savings on future procurements and will contribute to saving more lives.

Applying refined strategies for IRS to Mozambique in 2018 and expanding into Zimbabwe

In 2018, PFSCM will again deliver a large consignment of IRS products to Mozambique.

In total, 27 containers will be delivered to 3 provinces in preparation for the spraying season, which is again due to start in October.

In addition, an order of 10 containers will also be delivered to Zimbabwe.

For these shipments, PFSCM will leverage the groundwork done and relationships built in 2017 and will again:

  • Actively engage with stakeholders; and
  • Reassess warehouses inspected in 2017.

This year, PFSCM has already achieved major successes by saving $133,000 on ocean freight cost through spot-bidding and strategizing with SGS.

Navigating the Sahel region with SMC products
At the start of 2018, PFSCM received a large order for seasonal malaria chemoprevention (SMC) commodities to be delivered to Africa’s Sahel region between July and September 2018. SMC is a relatively new, highly effective intervention to prevent malaria in children under five years of age, those most vulnerable to the disease’s effects.

SMC is a complete treatment course of amodiaquine plus sulfadoxine-pyrimethamine (AQ+SP), which is administered in up to four monthly doses to children aged 3 to 59 months during the peak malaria transmission season (July to December) in the Sahel region.

The $5 million project will see 15 million co-blisters of AQ+SP procured and distributed to three African countries: Burkina Faso, Chad, and Nigeria. More than 3 million infants and children will likely benefit from this preventive treatment in these regions in 2018.

PFSCM Senior Client Account Manager Eva van Tol says this is an exciting and challenging project for PFSCM. In Burkina Faso and Chad, products will be delivered to a central location, from which further distribution will be undertaken by PFSCM partners, such as CAMEG. In Nigeria, PFSCM will leverage its in-country expertise to assist the Malaria Consortium with in-country distribution. The products are procured as part of the ongoing ACCESS-SMC prevention program, which is a UNITAID-funded project led by the Malaria Consortium in partnership with Catholic Relief Services.

 


Sinette Goosen A look at the supply chain implications of TB regimen changes

Even though tuberculosis (TB) is a curable disease, it is still, according to the World Health Organization (WHO), responsible for 4,500 deaths a day.

The reasons behind this are complex and interwoven, ranging from educational and social issues, to a lack of early detection and missed detection opportunities, combined with long diagnostic processes and increasing drug resistance, among others.

Massive global endeavors to address the ever-evolving challenges through research, development, and investment are ongoing. One area of focus for the WHO and global stakeholders is the development of simpler-to-use drugs and treatment regimens that will encourage higher treatment adherence and simplify logistics, while reducing drug resistance.

In 2018, the WHO has already released some new recommendations and treatment guidelines for drug-resistant tuberculosis. These will be incorporated into the Consolidated Guidelines for Treatment and Care of Drug-resistant TB later this year.

Commitment and accountability to manage transition of the TB supply chain

The Partnership for Supply Chain Management (PFSCM)’s Global Supply Chain Director Wesley Kreft says public health supply chains can lead in the fight to end TB through commitment to — and accountability for — effective regimen transitions.

“It is normal for health programs to change — in fact, it is essential to ensuring successful outcomes in changing global markets and environments. The problem is that public health supply chains face unique challenges that often make quick implementation of changes difficult.”

Two such challenges are:

  • The time it takes to make and implement decisions in the public health supply chain; and
  • The operational and logistical weaknesses that hamper flexibility.

According to a report co-authored by PFSCM partner organization Management Sciences for Health (MSH) and entitled Tuberculosis regimen change in high-burden countries, countries committed to considering a change spend about one year on decision making and about two years to roll out or implement changes.

The report — which was compiled after conducting 166 interviews with country stakeholders in 21 of the 22 TB high-burden countries — also found that stakeholders are more often concerned with the program-based implications (logistics and cost) of the change than they are with the patient-focused implications (side effects).

Kreft explains that several logistics and cost factors — such as accurate forecasting, proper phasing out of old and excess products, availability of quality local sources, and uncertainties about future product pricing — need to be addressed during a transition.

He adds that these factors can be difficult for public health supply chains to manage when working with limited resources.

However, Kreft stresses that there are key principles that can be followed to aid in efficient transitions.

1. Preparing and closely monitoring the supply chain

To successfully implement new regimens, the supply chain must align with program changes to ensure proper budgeting, demand forecasting, supply planning, and procurement.

“Regular small orders need to be placed in the introduction phase, and stock and consumption need to be closely monitored to ensure all patients on old regimens can complete their treatment, while enough stock is already available for those newly diagnosed patients. The overlap of these activities should also be finely tuned to ensure as little stock destruction as possible. It is a sensitive process that has both advantages and disadvantages tied to the nature of the TB regimen.”

2. Minimizing risks through vendor pre-qualification and engagement, accurate forecasting, demand planning

Further, Kreft adds that there is also a risk that countries may return to old regimens if new products cannot be produced locally at reasonable prices, local product quality does not meet international standards, or global supply cannot meet demand.

To minimize these complications, it is important for countries to assess the suitability of local sources early in the transition and to determine how national and international guidelines can be harmonized to ensure local economic growth and regulatory compliance.

The challenge is balancing the need for “buying local” with the obligation toward international quality standards.

Countries are always battling the cost-quality dilemma, but pre-qualification groundwork can help governments to bridge the gap between in-country and international regulatory commitments, notes Kreft.

Further, accurate forecasting, demand planning, and vendor engagement is essential to ensure suppliers keep up with demand.

3. Supporting countries that will transition from donor support

In addition, in cases where countries are receiving highly subsidized or free products, there is a risk that the products may become too expensive when countries graduate from donor-funded programs.

“It is important that clear stakeholder engagement is maintained and that agreements or contingency plans are in place for countries with limited budgets or expected future financial constraints.”

Kreft concludes that bringing together multi-sectoral expertise may help countries respond faster to treatment guideline and regimen changes, thereby increasing commitment and accountability in the fight to end TB.


djamieson Major donors and health agencies developing Global Accelerator for Paediatric Formulations (GAP-f)

By David Jamieson

As we have discussed in news blogs last year, limited treatment options and sub-optimal formulations have contributed to poor adherence and outcomes for children living with HIV. To improve coordination in tackling the barriers to research and development that remain, major global players are developing an initiative called the Global Accelerator for Paediatric Formulations (to be known as GAP-f), working to build consensus and define the working group’s structure. Formal launch is planned for later this year.

Figure 1 below shows how the GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most-needed drugs and formulations for children.

Figure 1. The GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children. SRAs: stringent regulatory authorities. NRAs: national regulatory authorities (in high-burden countries). Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.

In November 2017, at a meeting convened by His Eminence Peter Kodwo Appiah Cardinal Turkson, Prefect of the Dicastery for the Promotion of Integral Human Development, key principles of the GAP-f set the basis for commitments to be known as the Rome Action Plan, which promote three key principles:

  • Focusing on priority paediatric drugs and formulations;
  • Accelerating development, review, and introduction of paediatric formulations; and
  • Collaborating to expedite the development and introduction of paediatric products.

Figure 2 below shows how these principles align with the foundations of GAP-f to address challenges in paediatric drug formulation development.

Figure 2. The GAP-f represents an opportunity to address challenges in paediatric drug formulation development. Challenges are grouped around three areas: dependence on adult drug development, paediatric formulation requirements, and paediatric ARV market. Progress to date in addressing these challenges is depicted along a funnel originating from precursor mechanisms (the existing initiatives that are unified under the GAP-f) and leading up to the GAP-f collaborative model. Legal framework challenges are placed outside of the funnel because of the limited influence of the GAP-f to directly address these. Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.

The team behind the GAP-f is an evolving collaboration between a number of partner organizations, including:

PFSCM is committed to supporting initiatives that will improve the position of children living with HIV, and has supplied paediatric ARVs to many countries. Wesley Kreft, PFSCM’s Director of Global Supply Chain, currently serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.


djamieson Big gains in treatment of children living with HIV

Treatment rates for pediatric patients have always lagged behind adults, but now programs like PEPFAR’S ACT Initiative show this doesn’t have to be the case

 

by David Jamieson, PFSCM Senior Supply Chain Advisor

 

In May, we reported on new opportunities for viral load testing of babies and young children at, or close to, the clinic where they see their doctor. In this blog post, we look at how results from PEPFAR’s Accelerating Children’s Treatment (ACT) program show that, with the right policies and a focused approach, rates of treatment of children living with HIV (CLWH) could be as good as those for adults.

When Ambassador Deborah Birx of PEPFAR launched the $200 million ACT initiative in August 2014, the aim was to double pediatric treatment rates in nine African countries in just two years, which would bring 300,000 new patients on antiretroviral (ARV) treatment.

By September 2016, the number of children on treatment worldwide had grown to an estimated 900,0001 with 561,000 patients on treatment in the ACT countries. Even more importantly, the number of children on treatment continues to grow, proving that the ACT program and other initiatives are creating sustained change.

Across the nine ACT countries, the number of children on antiretroviral treatment (ART) increased by 44%. In Kenya, an estimated 73% of CLWH are on treatment; in Zimbabwe, the figure is even higher at 80%, showing that the goal of 90% of known CLWH being on treatment is achievable.

Globally, PEPFAR supports nearly 1.1 million children (0-19 years old) on ART — a 97% increase since 2014.

Though ACT, PEPFAR and the Children’s Investment Fund Foundation focused efforts in high-risk areas, working with local implementers to identify babies, children, and adolescents with HIV and to get them onto treatment without delay, often within a day.

Other barriers tackled included:

  • Training and job aids to overcome health care providers’ lack of confidence in treating pediatric patients.
  • Advocating to change restrictive treatment access policies.
  • Improving the child-friendliness of the medicines — some pediatric solutions tasted bad, making it difficult to get very young children, who could not swallow pills, to take the medicines.

 

The supply chain for ARVs: A critical component

PEPFAR tasked PFSCM, through the Supply Chain Management System project, with ensuring that the drugs would be available at the health facilities when needed. Identifying CLWH and encouraging parents and caretakers to start children on treatment is an enormous effort. If stock levels were not properly maintained at clinics, all the effort would be in vain.

Managing the supply chain for CLWH is challenging because it involves more drugs than for adults, the formulations change as children grow, and, in many countries, the total requirements are small. It is also necessary to strike a balance between preventing stockouts and not overstocking, which could result in products expiring before being used.

Globally, PFSCM engaged in two important supply chain initiatives. We became founding members of the Pediatric ARV Procurement Working Group (PAPWG), an effort to pool the requirements for pediatric ARVs to create and manage sufficient demand to keep the market attractive to suppliers. By coordinating the demand of major purchasers — such as PFSCM and the Global Fund to Fight AIDS, Tuberculosis and Malaria — with demand from smaller countries, supply became more consistent and flexible.

PAPWG results are described on PFSCM’s website and in a paper published on the Global Fund’s website. The PAPWG — now known as the ARV Procurement Working Group (APWG) and chaired by PFSCM’s Director of Global Supply Chain Wesley Kreft — has expanded to include adult formulations in low demand.

To address the challenge of multiple pediatric ARV formulations, PFSCM also joined a team from the UNICEF Inter-Agency Task Team (IATT) for the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children to draw up an optimal formulary of pediatric ARVs. From more than 65 approved pediatric ARVs, the team created a formulary of 10 optimal formulations, as well as a list of a further 10 limited-use products.

The IATT team has also advocated for and supported the development and introduction of small pellets that young children can take in soft food to replace the bad-tasting liquid for Lopinavir/Ritonavir, an ARV essential in treating very young children.

 

What’s next

To build on the achievements of PEPFAR’S ACT program and the other recent progress, the global community is continuing to innovate. Current initiatives include:

  • Start Free, Stay Free, AIDS Free: The ACT Initiative’s lessons are key to UNAIDS’ Start Free, Stay Free, AIDS Free framework — a super-fast-track approach to ending AIDS among children, adolescents, and young women by 2020. The framework is based on the fundamental principle that everyone living with HIV should have access to ART.
  • DREAMS: To address the high risk of contracting HIV for girls and young women, PEPFAR — in collaboration with private sector partners the Gates Foundation, Girl Effect, Johnson & Johnson, Gilead Sciences, and ViiV Healthcare — is driving the ambitious Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) Partnership.

The global community is also continuing to:

  • Update and promote the use of the pediatric ARV optimal formulary.
  • Develop child-friendly effective medicines.
  • Support introduction of new products.

PEPFAR’s 2017 report states: “Saving the lives of children with HIV is not only the right thing to do; it is the smart thing. By treating children early in their HIV infection, they can stay healthy and thrive. Healthy children who can pursue their dreams will grow economies, create jobs and strengthen their communities for decades to come.”

We can’t say it any better, and will continue to do all we can to ensure supply chains support increased treatment for children.


Based on UNAIDS 2017 report of 2.1 million children living with HIV, of whom 43% are on treatment


djamieson Now is the time to take testing of newborns closer to their mother

Pilots have shown that early infant diagnosis can be moved closer to the point of care

by David Jamieson, PFSCM Senior Supply Chain Advisor

We have known for years that if babies born with HIV do not receive treatment, more than 50 percent will die before their second birthday, but we also know that when treated, they can grow into healthy adults. Until very recently, a big challenge has been reaching mothers and their new babies soon enough, testing baby, and getting the results back to mom. Reliable diagnosis could only be completed in larger laboratories, meaning blood samples had to be transported to the lab, kept fresh for testing, and then the results returned — by which time, mother and baby were probably back in their village and might never get the result.

Photo credit: Fabrice Duhal

Recent work by WHO, CDC, and UNITAID means that this is all about to change. WHO and CDC have pre-qualified two point-of-care (POC) instruments: the Alere™q and the Cepheid GeneXpert® (both are and WHO Prequalified). And UNITAID is funding an Early Infant Diagnosis (EID) Consortium, initially to pilot test POC EID in Kenya, Malawi, Mozambique, Tanzania, South Africa, and Zimbabwe, and then to scale up the model if the pilot proved the concept.

The great news is that, yes, the pilot was successful, and as the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) reports, now is the time to accelerate scale-up and usage. UNITAID’s EID Consortium, EGPAF, Clinton Health Access Initiative (CHAI), UNICEF, and Médecins Sans Frontières (MSF) are now working with local governments and stakeholders to get the rollout moving, but we can all be involved.

Although these new instruments get a lot closer to mother and baby, it is not practical to put a machine in every location. The experience of the rollout of CD4 POC instruments is that many lay idle for long periods because of low demand. With EID, it will be important to learn the lessons from CD4. One thing that is clear is that to accelerate EID, we will need multiple inputs from many stakeholders.

How PFSCM can contribute to scaling up POC EID

PFSCM has always been firmly committed to improving the care, detection, and treatment of the youngest patients. Drawing on our expertise in managing global supply chains and optimizing laboratory networks, our contribution will be to ensure that the supply chain doesn’t let these patients down; that smart network design places these new instruments where they will make the most difference; and that results get back to mom and her health caregivers at the earliest opportunity. Specifically, we can:

  • Use software and GIS technology to design smart networks of laboratory-based instruments and POC diagnostics to reach as many mothers and babies as possible;
  • Consolidate supply chains to deliver complete packages of commodities needed for each and every test; and
  • Apply our expertise in data management and mobile technology to get the results back to mother and baby quickly.

The growing success of PMTCT (prevention of mother-to-child transmission) means that fewer babies are being born with HIV, but for those who are, EID is essential. And PFSCM can help ensure that pediatric antiretrovirals (ARVs) are available to treat babies born with HIV. (We will cover pediatric treatment in subsequent blog posts.)

PFSCM strongly supports the goal of an AIDS-free generation, and the three “frees” — start free, stay free, AIDS free.

 

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Noor Al-Gallas Antimicrobial resistance and supply chain: A neglected relationship

Delegates at the 68th World Health Assembly in May 2015 endorsed a global action plan to tackle antimicrobial resistance (AMR), directing the world’s attention toward AMR as an acknowledged serious threat to global health. The recent World Antibiotic Awareness Week campaign further raised AMR awareness, aiming to encourage best practices among the public, health professionals, and policy makers. WHO’s overarching message for the campaign was that “antibiotics are a precious resource and should be preserved. They should be used to treat bacterial infections, only when prescribed by a certified human or animal health professional. Antibiotics should never be shared or saved for the future.”

This threat of AMR has not developed overnight. WHO attributes it to the overuse and misuse of antimicrobial drugs everywhere in the world, which causes infectious organisms to adapt and become resistant to the antimicrobial drugs that were designed to kill them. The Center for Disease Dynamics, Economics & Policy’s report, “The State of the World’s Antibiotics, 2015,” suggests that 20 percent to 50 percent of global antibiotic use can be classified as inappropriate. “Inappropriate” is largely defined as prescribing and usage when no health benefit is possible, prescribing the wrong antibiotic, prescribing the wrong dosage, or patients’ poor adherence to a prescription.

The supply chain component. In the African region, there are two significant AMR-related supply chain challenges, according to WHO. Stockouts of essential medicines and antibiotics can lead to increased circulation of counterfeit or substandard antibiotics. While overall supply is a challenge, it is clear that increased appropriate prescribing and usage would decrease the burden of stockout.

The second and more urgent challenge is a lack of laboratory reagents and consumables, which makes proper testing, diagnosis, and treatment difficult or impossible, even when appropriate laboratory equipment is available. Physicians then face the hard decision of treating patients using antimicrobial agents to the best of their knowledge rather than based on an accurate diagnosis from test results. Addressing this gap in the supply chain of diagnostic tests can make the difference between appropriate use of antibiotics and overuse or inappropriate use.

The availability of diagnostic tests is only one part of the equation. WHO has also asserted that AMR is not monitored in low-resourced countries because they often lack a surveillance network or data system to collect and analyze the results of diagnostic tests, making it harder to identify the profile of infectious agents and their distribution in certain regions. Without data collection and analysis, properly monitoring prevailing infectious profiles and identifying new emerging ones is ever more challenging.

A starter package to address AMR. Diagnostic tests and a data collection system are a potential “starter package” for developing countries to jump-start the efforts to tackle AMR. Such an approach would encourage public health policy makers to enforce AMR surveillance, and would enable physicians to access diagnostic tests before prescribing antimicrobial agents.

WHO also calls for strengthening health systems, including diagnostic laboratories. Ensuring a strong supply chain of reliable diagnostic tests, reagents, and consumables is one of the key factors for creating a sustainable, strong diagnostic laboratory system.

During the last decade, we have observed the role of strong supply chains in addressing and managing the availability of diagnosis and treatment of HIV/AIDS, malaria, and TB; ensuring the availability of reproductive health commodities; and responding to other health challenges in the developing world. Making diagnostic tests and treatment available for these health burdens has helped to save millions of lives in the developing world.

The same consideration for the necessity of a strong supply chain is now urgently needed in addressing the significant risk of AMR.

Amna-Noor Al-Gallas, MD, MA
Global Health Expert
Market Dynamic Committee Strategic Advisor
Procurement Operations Manager—NPU


Rich Owens World AIDS Day — December 1, 2016

 

heroeslogoADear friends,

This is PFSCM’s 11th year commemorating World AIDS Day. We have come a long way since 2005 in helping to ensure essential commodities are affordable and readily accessible to those who need them.

In 2005, an HIV diagnosis was still a death sentence for many people in developing countries. Now, around 55% of adults living with HIV have gained access to antiretroviral (ARV) medication. To reach the UNAIDS “90-90-90” targets by 2020 and reduce the HIV epidemic to a low-level endemic disease by 2030, the number of people living with HIV and on ARV treatment must rise from the current level to close to 30 million by 2020. Those who start treatment early are expected to live a normal lifespan.

2016 marked many accomplishments of the people, organizations, and countries engaged in the fight against AIDS. Consider these notable highlights:

  • AIDS-related deaths have fallen 45% since the peak in 2005.
  • New HIV infections among children have declined by 50% since 2010.
  • More than 18.2 million people are accessing ARV therapy. 9.2 million of them are receiving ARV treatment through Global Fund-supported programs, with steady increases each year.
  • PEPFAR is supporting lifesaving ARV treatment for more than 9.5 million men, women, and children worldwide. In 2015, SCMS procured 80 percent of all ARVs directly funded by PEPFAR.
  • PEPFAR has directly supported 8.9 million voluntary medical male circumcision procedures (VMMC) for HIV prevention, assisted in large part by SCMS deliveries of VMMC kits. By pooling procurement across many countries and buying in large volumes, SCMS negotiated a 30% reduction in VMMC kit prices since they were first procured.

We are tremendously proud of the work PFSCM has done to assist in the fight against AIDS — on behalf of the US Government through the Supply Chain Management System (SCMS); on behalf of the Global Fund to Fight AIDS, Tuberculosis, and Malaria thr0ugh its Pooled Procurement Mechanism (PPM); and on behalf of all our other clients and collaborators.

  • Through SCMS and PPM, PFSCM has procured $4.78 billion of lifesaving commodities — ARVs, essential medicines, laboratory commodities, and more.
  • PFSCM delivered these commodities to 91 countries, including some of the hardest-to-reach places in the world.
  • PFSCM has contributed to driving down ARV costs per patient from $1,500 in 2005 to as low as $80-$90 today.
  • We have also helped 41 countries build the capacity of their supply chains, working to make them sustainable and to increase local ownership.
  • Looking forward, today PFSCM launches a new web site focused on how we contribute to the ambitious targets for tackling HIV and AIDS and support other health supply chains through innovation and high-quality performance. You can see the new site here: www.pfscm.org

Today, on World AIDS Day, we celebrate the achievements of PFSCM’s supply chain heroes and the many, many individuals dedicated to the fight against AIDS. Tomorrow, we get back to work. There is no time to lose and much left to do if we are to meet the ambitious goals of the global community to turn the tide and defeat AIDS by 2030. Achieving an AIDS-free generation requires dedication, planning, daring, and innovation, continuing onward from today.

With our best wishes,

rich-signature                         gordon-signature

Richard C. Owens, Jr.                     Gordon Comstock
Director                                              Director, Global Supply Chain

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President of MSH reflects on 10 years of progress

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Jono Quick, President of Management Sciences for Health, one of the key partners, along with JSI, on the SCMS project, looks back on 10 years of work strengthening global health supply chains for people living with HIV/AIDS.  This video is part of a collection of reflections we are highlighting as we look back on the legacy of SCMS and what it has meant to its many stakeholders and beneficiaries.



djamieson Dare to Innovate – Meeting the Supply Chain Challenge of 90-90-90

PFSCM IAS luncheon flyer FINAL 2UNAIDS’ ‘‘90-90-90’’ strategy calls for 90% of people with HIV to be diagnosed, 90% of those diagnosed to be on anti-retroviral therapy (ART) and 90% of those on ART to achieve sustained virologic suppression. Additionally, growing numbers of countries are adopting the universal test and treat model, in which all people diagnosed with HIV receive ART regardless of CD4 level.  It is widely recognized that these strategies will challenge public health systems in resource-limited settings, including global and local supply chain systems.

For supply chains, each of the ‘‘90s’’ presents complications and challenges in getting to 90-90-90 by the 2020 target date. Ensuring that 90% of people with HIV know their status will require a large increase in access to HIV tests, often in unconventional settings. The number of people living with HIV and on treatment must rise from the current level of around 17 million to close to 30 million by 2020, a near doubling of the demand for anti-retroviral (ARV) drugs.  Similarly, monitoring those on treatment means an unprecedented scale-up of viral load testing.

The Partnership for Supply Chain Management (PFSCM) will host a luncheon and panel discussion at the International AIDS Conference in Durban, South Africa to discuss the procurement, supply chain and logistics challenges in reaching each of the 90-90-90 targets (see below for event details).  Funding will obviously be key, and innovative solutions and reforms to the supply chain in developing countries will be essential, but we believe it can be done.

It is important that the fight against HIV continues to be led by governments, primarily through the Ministry of Health, but also include Ministries of Finance and Trade or similar institutions, to set policy and goals, although it is not necessary for the response to be solely from the public sector.  The private sector and voluntary and community groups also have much to offer.  This is especially true for supply chains.

The commercial private sector is already essential to combating HIV, whether by producing drugs, diagnostics and other health commodities or by transporting those products from the manufacturer to the countries heavily affected by the pandemic.  But there is much more that the private sector, for-profit, and not-for-profit organizations can do, especially in supporting and extending in-country supply chains to the so called “last mile,” before the drugs get to patients.  There are also many lessons we can learn from the commercial sector in creating and sustaining flexible, responsive supply chains that keep essential goods in constant supply.  We are confident that the supply chain can respond as needed, but it won’t be easy and will need dedication, planning, daring, and innovation.

The supply chain challenges and opportunities in treating all those living with HIV and reaching the 90-90-90 targets are further discussed in a new paper from PFSCM published in the Journal of the International AIDS Society entitled “The 90 90 90 strategy to end the HIV Pandemic by 2030: Can the supply chain handle it?”

If you are at the International AIDS Conference in Durban, please join us for lunch and the panel discussion on Wednesday, July 20, 12:45-14:00 at the Rainbow Terrace Restaurant of the Hilton Hotel.  We look forward to seeing you there!