CHAPTER 5 CHALLENGES IN PDW

Question 1

Give 3 examples of public-private partnership

Answer 1

Medicine for Malaria venture (MMV)
Global alliance for TB drug development.
Gavi

Question 2

Briefly the explain the mission of Medicine for Malaria Venture.

Answer 2

MMV is a not-for-profit product development partnership devoted to developing and facilitating access to lifesaving antimalarials.

Question 3

Which Pharma companies are collaborating with Medicine for Malaria Venture.

Answer 3

GSK
Takeda
Novartis

Question 4

How much did Bill and Melinda Gates fund Medicine for Malaria Venture.

Answer 4

To find new antimalarial drugs: 168 million
Continue research for newly found agents: 208 million

Question 5

What are the screening the strategies are done in Medicine for Malaria Venture.

Answer 5

HTS: One mechanism for developing antimalarial target through understanding the drug target. Global phenotype screening.

Question 6

What drug properties does MMV want for new antimalarial drug.

Answer 6

Must be cheap to produce $1, and short course (<3 days) to be accessible to low-income countries that are targeted.

Question 7

What new target has been identified by MMV

Answer 7

In cytosol: glycolysis pathway (e.g. lactate dehydrogenase) has been targeted.

Question 8

How many compounds are in the open source for MMV

Answer 8

5,000,000 compounds are in the MMV medicine box.

Question 9

Name a recent success by MMV

Answer 9

450 million Coartem Dispersible (artemethur-lumefantrine) paediatric treatment has been distributed to over 50 countries since 2009, saving more than 960,000 children’s lives.

Question 10

How many countries received Coartem Dispersible paediatric treatment.
(a) 50 countries
(b) 60 countries
(c) 28 countries
(d) 40 countries

Answer 10

(a) 50 countries. [ since 2009]

Question 11

How many children lives have been saved by Coartem dispersible paediatric.
(a) 400,000
(b) 500,000
(c) 525,000
(d) 960,000

Answer 11

(d) 960,000

Question 12

Give example of new target found by Global alliance for TB development.

Answer 12

Novel InhA inhibitor which can deal with resistance mycobacterium tuberculosis by targeting inna gene.

Question 13

How has pharmaceutical companies contributed to developing words.

Answer 13

Question 14

What was GSK access to medicine index value. How many of their projects incorporated an access place.

Answer 14

GSK was ranked 1 in 2021 Access to medicine index with 80% of their relevant projects having an access plan.

Question 15

Why did Novartis beat GSK in the product delivery.

Answer 15

Novartis is the only company to apply equitable pricing strategies in at least one low income country for all products assessed. They consider they patient population across the income pyramid.

Question 16

Give example of product HIV medicine granted voluntary licensing.

Answer 16

GSK access plans for dolutegravir paediatric project by Viiv healthcare includes registration commitments and 15 non-exclusive royalty-free voluntary licensing.

Question 17

What does the Live Well initiative combat.

Answer 17

It address supply chain constraints in Zambia (social enterprise).

Question 18

How many Gavi- eligible countries has Rotarix vaccine reached.
(a) 34
(b) 23
(c) 32
(d)36

Answer 18

(C)

Question 19

What is a key target held by Reckitt when delivering ORT. ( think Sara)

Answer 19

To reduce 50% in diarrhoea incidences.

Question 20

What is the % of infants (under age of X) who did not receive any vaccines in (X) year.
(a) 19% under one years
(b) 20% under one years
(c) 17% under two years
(d) 17% under one years

Answer 20

(d) 17% of infants under age of one did not receive any vaccine in 2019.

Question 21

One of the main reasons why there is a lack of access to treatment is due to the viscous cycle between (a) and (b). (b) leads to deprivation, (c) living conditions, lack of basic (d) medicines that predisposes a population to (a).

Answer 21

(a) Disease
(b) Poverty.
(b) Poverty
(c) poor
(d) essential
(a) disease.

Question 22

What are the challenges faced when getting medicines to the developing world.
Describe each factor (1,2,3: 3 As).

Answer 22

Availability:
Is the treatment available? Is it available in formulation that can withstand high temperatures (without refrigerator)/appropriate for patient group (e.g. paediatric population). Heat stable injectables?

Accessibility:WHO model list of essential medicine off patent are not reached in almost 1/3rd of the world’s population in low and middle income countries. Rural areas?

Affordability: Who will pay for the treatment? 50%-90% medicines in low- and middle-income countries are paid by the patients themselves.

Question 23

Vaccine produced by start up company requires to be kept in temperatures between -2-+2°C. What factor is affecting this vaccines reach to the developing world (give brief reason why).

(a) Availability
(b) Accessibility
(c) Affordability

Answer 23

(a) Availability. If there is no available vaccine formulation that is heat stable injectable not requiring refrigeration then the formulation is not stable to be distributed to Africa.

Question 24

Patent drugs are affecting the accessibility of medicines to the low-and middle income countries.
(A) True
(B) False

Answer 24

False patents are not blocking the access to essential medicines in poor countries.

Question 25

What is the % of drugs on WHO essential medicine list that are off-patent.

Answer 25

95%.

Question 26

F.O.B stands for.

Answer 26

Free on board which are international shipping agreement fees used in transportations of good between buyer and sellers.

Question 27

What are the principle factors affecting Access to medicines in the Developing World. For each point explain briefly (look at empty mind map).

Answer 27

Question 28

For both generic and patented essential medicines in developing countries what is the final price compared to the producer or importer. What does this final price reflect.

Answer 28

Question 29

What is the % taxation in some of the developing worlds.

Answer 29

Over 20% in some countries.

Question 30

How would you overcome the issue of price, taxes and tariffs. (+bonus: why would you do that intervention).

Answer 30

Reduction or elimination of duties, taxes and tariffs for generic and patented drugs on WHO essential list because taxes and tariffs on medicine are a form of regressive taxation since targets the poor and sick who cannot afford it. Awareness and cultural perception change on medicines: Developing world Governments need to be aware of their own corruption and choose healthcare as one of their priorities for their country.

Question 31

Define counterfeit medicine

Answer 31

Deliberately and fraudulently mislabeled with respect to identity and/or source.

Question 32

Define substandard medicine.

Answer 32

Genuine drug products which don’t meet the quality specifications set for them.

Question 33

What is the proportion of antimalarial drugs that are counterfeit in X region.

Answer 33

1/3rd antimalarial drugs are counterfeit in Sub-Saharan Africa.

Question 34

How would you overcome the issue of counterfeit/substandard medicines.

Answer 34

In Europe to counteract falsified medicine, unique identifier must be carried in a 2D data matrix code. Government should actively intervene to close down manufacturing sites that are non-GMP and individuals caught should be convicted of their crimes. Having activist such as Dora Akunyili fighting the good fight. Having collaborative efforts: King’s college London is involved in the fight the fakes.

Question 35

What is the name of the Nigerian pharmacist who fought against counterfeit medicine.

Answer 35

Dora Akunyili.

Question 36

What are the clinical consequences of substandard medicines being distributed in Developing World.

Answer 36

Clinical consequences: resistance (already seen with artemesinin monotherapy), poor prognosis, prolonged duration of ailment and poor bioavailability.

Question 37

What are formulation consequences associated with substandard medicines.

Answer 37

Formulation consequences: Variable bioavailability, stability issues, degradants may be in the formulation affecting the potency, incorrect drug may be given due to API not be known.

Question 38

Give an example of where counterfeit medicine had deleterious effect in the developing world.

Answer 38

In teaching hospital, located in Enugu, four children died due to counterfeit adrenaline which was actually filled with water.

Question 39

In the medicine chain where can corruption take place.

Answer 39

At procurement import and distribution step: corruption in the form of counterfeit/substandard medicine, tax evasion, collusion, falsification safety/efficacy data. At prescription level: Theft, bribery, over-invoicing can take place.

Question 40

What have bed nets in Africa been used for (think children in the pool).

Answer 40

Fishing/Wedding dress.

Question 41

How can in proper dispensing and in proper selection of treatment be overcome in the developing world.

Answer 41

Having specialised medical centers like India dealing with certain diseases plagued by the community e.g. malarial centres with trained specialist. DDQC: Correct diagnosis, Correct dosing , Quality drugs, appropriate monitoring on Compliance.

Question 42

How is accessibility in the Zambia overcome.

Answer 42

Zambikes which are bikes with stretchers attached that transport patients to local clinical if they were malaria symptomatic.

Question 43

What was the name of the president that denied the presence of AIDs in SA.

Answer 43

Thabo Mbeki.

Question 44

What are the five solutions that can combat the problems affecting the accessibility to medicine.

Answer 44

Question 45

Answer 45

Question 46

How many deaths did Thabo Mbeki denial cause

Answer 46

300,000

Question 47

Describe the graph and how it links to political issues affecting access to medicines.

Answer 47

Sleeping sickness cases were high when political priorities changed for example when Congo was in crisis and the Belgium withdrew themselves and there was withdrawal in AID international sanctions there was increase in sleeping sickness cases. Then when WHO introduced Next there was decrease in sleeping sickness cases and it has been sustained low number of cases since.