Pharmacy Practice in Developing Countries: Gaps and Challenges Mohamed Izham M.I., PhD Professor of...

Pharmacy Practice in Developing Countries: Gaps and Challenges

Mohamed Izham M.I., PhDProfessor of Social & Administrative PharmacyCollege of Pharmacy, Qatar UniversityDoha, Qatar

Congress of Scientific Association of the Pharmacy Colleges in the Arab World

Acknowledgement

1. Omdurman Islamic University, Faculty of Pharmacy

2. Academic Press, Elsevier Inc. (Book: Pharmacy Practice in Developing Countries, 2016)

3. Co-editors: Dr. Ahmed Fathelrahman & Professor Albert I. Wertheimer

4. All contributors from 19 LMICs

Presentation OutlinesBackgroundHow was the analysis done?FindingsGaps and challengesRecommendationsConclusions

IntroductionPeople across the globe are living

longerPositive development of the

health care system◦technology advancement◦new cost-effective medicines◦better lifestyles◦better understanding of diseases◦various research discoveries◦better trained health care personnel

At the same time, we could also observe:◦growth in population◦increase in life expectancy◦more people experiencing chronic

diseases◦people consume more medicines

The improvement in the quality and responsible use of medicines in society is very much dependent on the overall quality of the health care and pharmaceutical system

There is a great need for an effective pharmacy practice to ensure responsible and quality use of medicines from all perspectives

ARE WE/PHARMACISTS READY WITH THESE DEMANDS AND CHALLENGES?

The question is:

Good pharmacy practice (GPP)◦FIP first adopted the guidelines in

1993◦WHO then endorsed a revised

version in 1997◦In 2011, both the FIP and the WHO

adopted an updated version of GPP◦WHO in addition produced guidelines

in relation to community and hospital practice

HOW FAR SINCE 1993 (AFTER

MORE THAN 2 DECADES) HAS

PHARMACY PRACTICE

IN THE DEVELOPING

COUNTRIES IMPROVED AND

RESPONDED TO THE

PROPOSAL AND GUIDELINES?

Study on 19 LMI countriesCritically analyze the status of

the 19 countries in terms of the practice of pharmacy in each country and to compare between them

Objectives:◦to find, via comparisons, which

countries are practicing well based on satisfying community needs and making use of resources;

◦to identify the gaps (present

situations vs recommended conditions); and

◦to recommend the way forward

How was the analysis done?We divided countries into

categories based on the World Bank list of countries by income classifications

A list of variables was used to compare the pharmacy practice, policy and regulation, and education and training aspects

Performance was then compared to see how well a country was doing generally and compared to other countries of similar wealth

Scores were assigned to positive practices in countries (maximum of 14)

Data were analyzed descriptively (i.e., frequency (%), mean (SD), and median (IQR)) using IBM SPSS Statistics® version 22

Findings

UN category based on income

Income bracket Country

Low income $1,035 or less Burkina Faso, Nepal

Lower middle income

$1,036 to $4,085 Egypt, India, Indonesia, Nigeria, Pakistan, Palestine, Sri Lanka, Sudan, Yemen

Upper middle income

$4,086 to $12,615 China, Iraq, Jordan, Malaysian, Thailand

High income $12,616 or more Chile, Qatar, Saudi Arabia Source: World Bank. World development indicators: size of the economy. 2014

Table 1: Country – Economies by per capita GNI in 2012

Criteria for comparison Country  Burkina Faso NepalCountry background    Population (million)** 18,365,123 (2014) 30,986,975

(2014)GDP per capita ($, ppp)** 1,700 (2014 est) 2,400 (2014 est)

Life expectancy (years)** 54.78 67.19Number of licensed pharmacist (per 10,000 of population) 409 (0.2) 1200* (0.387)

     Practice criteria    Is selling medicines outside of pharmacies allowed? No No

What is the popular areas of practice? Community pharmacy

Pharmaceutical industry

Any unique services? None NoneHow controlled substances are handled? Only with

prescriptionOnly with prescription

Is continuing education for pharmacist required? Yes No

Is there enough pharmacists to cover the community needs? No No

Does practice matching available resources? No No

Using e-health technologies in pharmacy practice No No

     Policy and regulation    Is state licensure is required to practice? Yes YesIs a non-pharmacy degree holder allowed to operate a retail pharmacy without a pharmacist?

Yes (but under the license of a pharmacist)

Yes

Must a pharmacy shop have a registered/licensed pharmacist present to operate?

Yes Yes (due to the lack of pharmacists license is

given to pharmacy assistant)

Are there location requirements for opening a community pharmacy?

Yes No

Is there regulation to handle controlled substances? Yes Yes

Does NDP exist? Yes YesScore 9/14 7/14

Table 2: Criteria in low income country

Criteria for comparison

Country

  Egypt India

Indonesia

Nigeria

Pakistan

Sri Lank

a

Sudan

Yemen

Palestine

Score 9/14 8/14 12/14

11/14

6/14 7/14 10/14

9/14 12/14

Table 3: Criteria in lower middle income country

Criteria for comparison

Country

  China Iraq Jordan Malaysia ThailandScore 9/14 10/14 12/14 10/14 8/14

Table 4: Criteria in upper middle income country

Criteria for comparison

Country

  Chile Saudi Arabia Qatar

Score 7/14 13/14 10/14

Table 5: Criteria in high income country

Number of Arab countries above average = 6/8

More critical analysis…..Population: India – QatarLE: Chile & Qatar – NigeriaGDP per capita: Qatar – Burkina

fasoNumber of pharmacists per

10,000 population ratio: Jordan – Burkina Faso

Five (26%) countries do not allow selling of medicines outside of pharmacies

Most popular area of practice is community pharmacy (n = 10; 53%)

Majority of the countries do not have any unique service in the pharmacy practice (n = 12; 63%)

All countries have laws that regulate controlled substances

Pharmacists in 13 (68%) countries are not required to do their CE; only one country require pharmacists to attend CE for their renewal of registration

17 (90%) countries do not have enough pharmacists

14 (74%) countries are not matching available resources

6 (32%) countries use e-health technologies to a certain extent

Only four (21%) countries allow a non-pharmacy degree holder to operate a retail pharmacy

Only three (16%) countries do not require a pharmacy shop to have a registered/licensed pharmacist present to operate

42% (n = 8) of the countries put a requirement on the location for opening a community pharmacy

All countries have regulations on handling controlled substances

Only four (21%) countries are without a national medicines (drug) policy

Scores ranged from 6.0 to 14.0 (mean score (SD) = 9.4 (2.0))◦low income countries = 8.0 (1.4)◦lower middle income countries = 9.3

(2.0)◦upper middle income countries = 9.8

(1.5)◦high income countries = 10.0 (3.0)

a clear upward trend; the higher the income category, the higher the mean score, which indicates more positive practices

Many countries have a national medicines policy and pharmaceutical acts and regulations, but◦ ineffective policies◦weaknesses in enforcement◦ lack of punitive action◦ lack of motivated and dedicated

authoritiesLow salaries of employees

◦vulnerable to corruption◦ lack of motivation & commitment

Lack of human resources

All these will contribute to poor pharmaceutical sector

In addition, the market possibly be exposed to◦substandard and counterfeit drugs◦illegal distribution of Western

medicines

There are countries with few (earlier was none) colleges of pharmacy◦allowing non-pharmacy graduates

with few or no qualifications to operate a retail pharmacy or drugstore

◦controlled medicines that can be bought easily without prescription

Plus countries with lack of enforcement, matters get worse

Lack of ethical practices and professionalism plus the conditions explained above:◦makes the pharmaceutical sector

weak, and◦places the society at risk

In many of the developing countries, prices of medicines are not effectively controlled◦medicine availability and

affordability are a major concern◦unhealthy business – “price wars”

In many of the developing countries, issues of medicine production, procurement, and consumption are critical◦domestic medicines production is not

sufficient for the country◦medicines have to be imported◦none or ineffective generic

medicines policy◦high public out-of-pocket

expenditures◦inefficient of procurement process

Ill health and poverty are closely associated

Ineffective financing systems have placed a high burden on the poor people

What else are we suffering from?◦Quality of the pharmacy colleges

Lack of faculty members Lack of qualified and quality faculty and staff Lack of quality infrastructure Lack of quality graduates Lack of quality curriculum Mismatch between curriculum content &

knowledge and skills needed in practice

◦Quality of the government Weak, incompetent, inexperienced

◦Continuous crisis…..

Gaps and ChallengesHow far is the gap?Gap analysis: a technique for

identifying needed improvements by comparing the current environment and current processes against an envisioned future state◦the gap between current practice

and the desired practice

Benchmark countries with a high score◦better practice standards, within the

same category of economy, environment, or geographical type

◦look for best practices learn, adopt, and adapt a set of best

practices

Few considerations:1. Professionalism—How far is the professionalism factor built in the pharmacy practice?

2. Decision-making—Are pharmacists the main players and key decision-makers in matters related to medicine use?

3. Health care team—Are pharmacists key players on the health care team? And how is the pharmacist’s relationship with other members of the health care team?

4. Patient information—Do pharmacists have access to patient information, e.g., medication profile, in order to perform effective pharmaceutical care?

5. Academic programs—Does the country have adequate pharmacy colleges? And what is the quality of the pharmacy program and the credentials of the faculty members in the pharmacy colleges?

6. CE—Do pharmacists have the opportunity to upgrade or improve their knowledge, skill, and competency throughout their career?

7. Standard of practice—Does the country has a minimum standard of practice in all pharmacy settings?

8. Scholarly activity—How far is the pharmacy practice research? How many publications in quality journals? And what is the impact on pharmacy practice and pharmaceutical policy?

What is next? A way forwardBrodie (1981): pharmacists must

identify the boundaries of duty and responsibilities and he encouraged the practice of pharmacy to move toward the patient and fulfill the needs of the society

In 1980, the American Public Health Association recognized pharmacy as a profession with major responsibilities for public health

FIP and the WHO (2011) reemphasized the importance of the role of pharmacists through their GPP guidelines

Albanese and Rouse (2009) in their article “Scope of contemporary pharmacy practice: roles, responsibilities, and functions of pharmacists and pharmacy technicians” concluded that◦the evolution of health care and

pharmacy practice has created excellence opportunities for pharmacists to serve the society beyond the traditional roles

Conduct quality studies to evaluate the status of pharmacy practice and the overall pharmaceutical sector in the country

Build more evidence-based information and research

Effort is critically needed to narrow the gap of practice within a country, and between countries

Pharmacy education in each developing country should be directed toward addressing local needs and making use of the available opportunities◦Hospital pharmacy◦Community pharmacy◦Public health pharmacy◦Industrial pharmacy

Examine guidelines and best practices from most advanced countries

Develop and strengthen the national medicines policy

Ensure an essential medicines list exists and benefits the society

Ensure an effective drug regulatory system exists

Review the quality of pharmacy education and build a competence-based education

Build a quality CE program and progressively implement compulsory CE points for registration renewal of pharmacists

Strengthen the research capacity in the area of pharmacy practice

Conclusions…take home message !It is clearly indicate that for many

countries, gaps, barriers, and challenges to effective pharmacy practice still exist

The role of pharmacists still has a long way to go

The pressure on the whole health care system worldwide will continue; there is no escape for the pharmaceutical sector

The pain of the pressure is felt more by the low- and middle-income countries

Further work and effort in the developing countries is warranted to bring the pharmacy practice and profession to another level and standard

ReferencesWorld Bank (2014)Brodie (1981)American Public Health

Association (1980)FIP-WHO (2011)Albanese and Rouse (2009)