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ETMM > Pharmacy in the developing world (excluding neglected disease overlap) > Flashcards

Pharmacy in the developing world (excluding neglected disease overlap) Flashcards

1
Q

What is bioterrorism?

A

The use of infectious agents or other harmful biological/biochemical substances as weapons of terrorism e.g. anthrax

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2
Q

What are the 5 main causes of mortality in the developing world?

A
  • Lower respiratory tract infections
  • HIV/AIDs
  • Diarrhoea
  • Malaria
  • Tuberculosis
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3
Q

The average age expectancy in developing countries was on the increase until the 1990s. It then dramatically decreased- why?

A

HIV

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4
Q

What are the 4 economically developing countries?

A

BRIC

Brazil
Russia
India
China

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5
Q

What country has the largest number of neonatal deaths a year?

A

India

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6
Q

Name 4 pandemics that have spread worldwide

A

HIV/AIDs
Ebola
Zika
Spanish flu

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7
Q

What are Zoonoses?

A

Infections derived from animals

These are currently the most emerging infections

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8
Q

What are re-emerging diseases and give two examples?

A

Once major health problems but then declined

However, now becoming health issues again

Malaria and TB

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9
Q

What is the most common viral cause of lower respiratory tract infections?

A

Respiratory syncytial virus

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10
Q

What is the prophylaxis of upper respiratory tract infections?

A
  • Vaccines (even unrelated ones e.g. measles will help to boost immune system)
  • Adequate nutrition
  • Environmental factors
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11
Q

What are the two HIV variants?

A
  • HIV-1 is the worldwide one

* HIV-2 is concentrated in West Africa mainly, and is less infectious and progresses slower than HIV-1

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12
Q

What are some approaches to HIV vaccine development?

A
  • Whole inactivated
  • Live attenuated
  • Recombinant viral vectors
  • Recombinant bacterial vectors
  • DNA - non-replicating plasmid DNA that encodes HIV proteins
  • Synthetic peptides - recombinant HIV proteins e.g. gp120
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13
Q

How is diarrhoea transmitted?

A

Contamination via drinking water, person-to-person, poor hygiene

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14
Q

What are the causes of diarrhoea?

A

Salmonella

E.Coli

Rotavirus in children

Norovirus in adults

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15
Q

What are the symptoms of diarrhoea?

A

Leading cause of malnutrition in children

Early dehydration- no symptoms

Moderate dehydration

  • Thirst
  • Restless behaviour
  • Decreased skin elasticity
  • Sunken eyes

Severe dehydration

  • More severe
  • Shock, lack of urine output
  • Rapid pulse
  • Low BP
  • Pale skin
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16
Q

How do you prevent diarrhoea?

A
  • Access to safe drinking water
  • Good hygiene
  • Exclusively breast feeding for first 6 months of life
  • Education
  • Rotavirus vaccine- Gavi (Vaccine alliance) offers co-financing for rotavirus vaccine introductions to low income countries
  • Stop diarrhoea initiative by Reckitt Benckiser, WHO, save the children
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17
Q

What are the treatment options in diarrhoea?

A
  • Antibiotics may increase the risk of haemolytic uremic syndrome in people with E.Coli, as well as the problem with antibiotic resistance
  • Some antibiotics can cause diarrhoea
  • Bismuth compounds (pepto bismol) decreases number of bowel movements but do not decrease length of illness
  • Loperamide – does not decrease length of illness
  • Cholestyramine bile acid sequestrants if bile acid malabsorption
  • Zinc in infants >6 months

Oral rehydration therapy: sodium chloride, potassium chloride, anhydrous glucose and trisodium citrate dihydrate. Vomiting can occur if the child drinks it too quickly.

Optimal fluid is clean plain water/ juice etc when it is not available. However, drinks in high sugars may increase dehydration in children <5 years

ORT is not withheld on the basis of potentially unsafe water, as rehydration takes precedence. Water can be boiled or treated with chlorine

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18
Q

What is the ideal habitat for a mosquito?

A

Rainfall, warm temperatures and stagnant water

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19
Q

What is uncomplicated malaria?

A
  • Most common and widespread

* Not immediately life threatening, but if P.falciparum is present, it can develop into severe malaria

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20
Q

What is severe malaria and who are at risk?

A
  • Infection complicated by organ failure/abnormalities in patient’s blood or metabolism
  • Pregnant women and children at risk
  • Often fever and septic shock are misdiagnosed as severe malaria
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21
Q

What are the 4 diagnostic test options for malaria?

A
  1. Blood films:
    - Thin films allow species identification
    - Thick films allow large volumes of blood (can be more difficult to identify species)

Antigen dipsticks:

  • Finger print
  • Don’t need a lab

Molecular methods:
- PCR- accurate however need a lab and is expensive

Subjective diagnosis

  • Areas that cannot afford lab diagnostic tests use symptoms to diagnose
  • E.g. history of subjective fever
  • However, correct diagnosis was low so look at other symptoms such as rectal temperature which increased correct diagnosis %
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22
Q

What are the 7 reasons why drugs are becoming resistant to malaria?

A
  1. Selection pressure through genetic mutations of wild-type genes
  2. Monotherapies e.g. in Cambodia with artemisinin as it is cheaper and has fewer side effects
  3. Lack of compliance and adherence- Current treatment regimens make it difficult for patients to finish their full course of treatment leading to inadequate drug dosing
  4. Counterfeit and substandard drugs - poor quality medicines leading to prolonged infections
  5. Self-treatment in the private sector e.g. Cambodia and artemisinin (there has been a ban but need to ensure people stick to this policy)
  6. Mobile and migrant populations, as well as those living in rural areas (difficult to locate for education and treatment)
  7. Incorrect diagnosis and incorrect dosing via self-medication. e.g. Pakistan pharmacies and medicine sellers (African village stalls). These need to be replaced by government medical centres with trained specialist volunteers
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23
Q

Why is there no malaria vaccine?

A
  • Inadequate understanding of mechanisms of disease and immunity
  • Multi-antigen vaccines may be effective but are costly to manufacture and cannot be evaluated quickly enough in the clinic
  • Lack of funding and capacity
  • Mosquirix has been found to be partially effective in trials and needs a 4 dose schedule. This will be trialled in children in several African countries in 2018
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24
Q

What are the 4 priorities of malaria vaccine research?

A
  1. Developing a standard set of immunological assays
  2. Standardise clinical trial design and assessment
  3. State of the art approaches- functional genomics- what are the functions of the proteins?
  4. Develop web-based information sharing tools
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25
Q

How do you prevent malaria from spreading?

A
  • e.g. indoor spraying with insecticide, bed nets
  • Insecticides- carbamates
  • To reduce resistance, rotate and use combinations of insecticides
  • Access and delivery of healthcare
  • Vector control
  • Partnership with research and development- universities e.g. Liverpool school of tropical medicine
26
Q

What condition are TB patients often co-infected with and what is the problem with this?

A

HIV

HIV - TB drug interactions make therapy difficult

27
Q

What is the TB vaccine called?

A

BCG

28
Q

What is the WHO control strategy treatment called for TB?

A

DOTS

Directly observed therapy short course

29
Q

What is DOTS?

A
  • Short course chemotherapy regimens with first line drugs under observation
  • RIPE (Rifampicin, Isoniazid, Pyrazinamide, and ethambutol) for 2 months followed by rifampicin and isoniazid for 4 months (total 6 months)
30
Q

What is the treatment for extreme drug resistant TB?

A

There is none

31
Q

How do you treat latent TB?

A

9 months isoniazid

32
Q

What are the 3 aims for future TB treatment?

A
  • Shorten treatment for all types
  • Effective against the MDR and XDR-TB
  • Can be co-administered with HIV medicines
33
Q

What pharmaceutical company has the largest global vaccine base and highest access to medicines index?

A

GSK

34
Q

What are the roles of industry in improving delivery of healthcare?

A
  • R&D
  • Clinical trials
  • Regulatory and manufacturing skills
  • Supply, medical training and distribution
  • Capacity building:

Actions that improve non-profit effectiveness e.g. breast cancer programme in Ethiopia ran by AZ and the Pfizer malaria partnership in Ghana

  • Product donations:
  • GSK have agreed to donate Albendazole free of charge for Elephantiasis
  • Merck have agreed to donate ivermectin for river blindness
35
Q

What is a product development partnership?

A

Non profit organisational structure that enables the public, private and academic sectors to aggregate funding for development of drugs and vaccines

They target neglected diseases (particularly in developing countries)

36
Q

What is a public private partnership?

A

Public-private partnerships between a government agency and private-sector company can be used to finance, build and operate projects for drug development

37
Q

What does the access to medicines foundation do?

A

Takes an inclusive and collective approach to the defining role of the pharmaceutical industry via consultation with all the major stakeholders including industry itself (multi-stakeholder approach)

38
Q

What can be done to improve access to healthcare in developing countries?

A
  • WHO- example of HIV AIDs global leadership
  • Industry help- accelerating access initiative
  • Providing medicines at affordable prices, and no profits for poorest countries
  • Donates to prevent mother-child transmission
39
Q

What are the 7 things the research pharmaceutical industries are focused on doing?

A
  1. Complying with health and safety and economic regulations
  2. Performing ethical clinical trials
  3. Promoting medicines
  4. Fighting against counterfeit medicines
  5. Fighting corruption in the healthcare system
  6. Preparing for pandemics e.g. flu
  7. GMP
40
Q

What is the WHO R&D blueprint priority diseases and give examples?

A

Attempts to identify those diseases that pose a public health risk due to epidemic potential and there are no or insufficient countermeasures

Ebola and Zika

41
Q

What is the coalition for epidemic preparedness innovations?

A
  • Want to speed up development of vaccines
  • Alliance to finance to coordinate these new vaccines
  • 3 groups in order of funding available
  • e.g. Group 1 has West Nile virus with immediate funding
42
Q

In 2016, WHO and UNICEF found that what proportion of infants worldwide did not receive any vaccines?

A

1 in 10

43
Q

What is poverty caused by?

A
  • AIDs
  • Drought
  • Isolation
  • Civil war
  • Corruption
44
Q

What does poverty result in?

A
  • Chronic hunger
  • No healthcare
  • Lack of safe drinking water and sanitation
  • Lack of basic shelter

Lack of treatment causes a vicious cycle of poverty (inequality) and disease (deprivation)

45
Q

What is the WHO essential medicines list

A

Core list of medicines needed for a basic healthcare system

Lists the most efficacious, safe and cost-effective medicines for priority conditions

Selected on the basis of current and estimated public health relevance

Virtually all are out of patent and available as cheap generic products

However, access to these essential drugs still remains a problem with 1/3 world’s population continuing to lack these drugs

46
Q

What are the 11 principal factors affecting access to medicines in the developing world?

A
  1. Prices
  2. Tariffs
  3. Quality (counterfeits , falsified, substandard, degraded)
  4. Corruption
  5. Healthcare and medicines financing
  6. Incompetent demand forecasting/supply decisions
  7. Bureaucracy
  8. Lack of healthcare infrastructure (staff, facilities
  9. Logistics (transport, storage)
  10. Political issues
  11. Donor support/fatigue
47
Q

How does price affect access to medicines in the developing world?

A
  • Factory cost
  • Cost of delivering the medicine
  • Wholesale/further distributor/Pharmacy margin
  • Taxes
  • Tariffs
  • Corruption
48
Q

How does taxes and tarriff affect access to medicines in the developing world?

A
  • Duties (tax from a certain country to protect their economy and controlling the flow of goods)
  • Reduction/elimination of duties, taxes and tariffs for both generic and patented essential medicines.
  • Developing countries- the final price of a medicine may be 2-5 times the producer/importer price.
  • This reflects the effects of multiple middlemen e.g. distributor, pharmacy seller costs, import.
  • Taxes are over 20% in some countries.
  • Patents are not blocking access to essential medicines as patent-holders are offering these medicines to poor countries at face value or even for free.
49
Q

How does quality affect access to medicines in the developing world?

A

i) Counterfeits/falsified:
- Deliberately/fraudulently mislabelled with respect to identity or source
- Can apply to generic and branded products
- May include incorrect ingredients
- May not contain active ingredient/ it may be insufficient
- Fake packaging

ii) Substandard drugs:
- Genuine drug products which do not meet the quality specifications set for them
- Bioavailability could be compromised
- ? Potency

iii) Degraded:
- Poor transport
- Poor storage

iv) Unregistered/unlicensed:
- Have not gone through evaluation and/or approval by the NRRA
- May not have obtained the relevant authorisation from the regulatory authority of its geographical origin

50
Q

What was operation ACIMin 2016 and what did they find?

A

Operation ACIMin 2016- more than 113 illicit and dangerous pharmaceutical products were intercepted during inspects at 16 African seaports, the biggest being Nigera. The drugs seized were supposedly to treat:

  • Malaria
  • Infections (ABX)
  • Pain and inflammation
  • GI medicines

Main countries of origin were from China and India

51
Q

What did the international children’s heart foundation find when they visited a teaching hospital in Nigeria?

A
  • They found that prognosis of operations in children were good, however things kept going wrong during operations
  • They found that adrenaline vials, used to restart hearts, just contained water and 4 children died
  • People had taken empty vials out of hospital bins and filled them up with water to resell
52
Q

Who was Dr Dora Akunyili?

A
  • Her sister had died due to a fake insulin injection administered on her
  • Pharmacist with a PHD working in Nigeria to combat fake drugs and deal with producers of such drugs
  • Levels of fake drugs fell from 70% to 35% within 3 years of her being director general of NAFDAC (Nigeria’s national agency for food and drug administration)
  • Attempted assassination on her
53
Q

How does corruption affect access to medicines in the developing world?

A
  • Unethical practices
  • Dishonest conduct by those in power
  • Bribery
  • Leaders deciding not to get help from developed world as these diseases are “sorting out their population problem”
  • Creating a barrier for access to medicines
  • Negative impact on quality of health services
  • Need to raise awareness of the problem and increase transparency in regulations and supply systems – GGM (good governance for medicines) programme
54
Q

How does healthcare funding and medicine financing affect access to medicines in the developing world?

A
  • High income countries- over 70% of pharmaceuticals are publicly funded
  • Low and middle-income countries- public medicine expenditure does not cover the basic medicine needs of the majority of the population
  • In these countries, 50-90% of medicines are paid by patients themselves
55
Q

How does bureaucracy affect access to medicines in the developing world?

A
  • Most important decisions are taken by state officials rather than elected representatives
  • Low salaries
  • Inadequate lab equipment
56
Q

How does a lack of healthcare infrastructure affect access to medicines in the developing world?

A
  • Lack of HCPs – a lot of qualified staff move to the developed world due to better healthcare system and QOL (also spreads disease)
  • Correct diagnosis, treatment, dispensing and follow up care is missing
  • Where is the monitoring of outcomes?
  • Pathology labs to diagnose etc.
  • Lack of patient education
57
Q

How does logistics affect access to medicines in the developing world?

A
  • The need for heat stable injectables including vaccines

* Formulations suitable for use in remote areas e.g. without refrigerators

58
Q

How do political issues affect medicines in the developing world?

A
  • Denial that there is a problem
  • Corruption
  • Mis-information
  • Changing priorities- making the rich richer, oil and diamond trade. Healthcare won’t make them money. What illnesses are a priority?

Ebola denial:

  • Sierre Leone- not believing it exists as no family members have been affected by it. It could be other diseases- people are quick to assume it is Ebola
  • Guinea- Ebola is not true- It is Westerners trying to increase their sales of medicines

AIDs in South Africa denial:

  • President does not know anyone who has died of AIDS so he does not understand why continues to dominate
  • Refusal to accept medical evidence was a major obstacle to provide medicines
59
Q

How does sustainability and donor fatigue affect access to medicines in the developing world?

Give an example

A
  • Non-traditional donors to the Global Fund to fight AIDs, TB and malaria e.g. Bill and Melinda Gates foundation
  • Public donors to the Global fund à US in the largest
  • Donor fatigue- where people no longer donate to charities although they have done in the past. On a larger scale à slowness to act in response to a humanitarian crisis
  • Where should we invest when funds are limited or in decline?

Stalling of malaria:

  • Progress has stalled and reversed in some countries
  • Chances of it being eliminated has decreased because funding has decreased
  • Investments have decreased in high-burden countries
60
Q

We need a holistic solution to the problem of lack of medicines in developing world. Who do we need commitment from?

A

Governments of the developed world to provide funds and resources

Governments from developing world to make healthcare a priority

University and academia to research into neglected diseases

Industry for the supply of medicines

Local governments to provide infrastructure

ETMM (5 decks)

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