SUBSTANDARD AND

FALSIFIED MEDICAL
PRODUCTS:
Pharmacists’ Role in Tackling Global Health

Christopher Raymond
Chief of Party USAID TBPS (Tuberculosis Private
Sector)

03/08/2024 1
 USAID TBPS

Tuberculosis
Private Sector
(TBPS)
is a five-year
Activity
(Jan 2019 to Jan 2024)
Funded by USAID,
led by FHI 360
Implementing Partners

R4D Meridian mClinica

Health Financing Strategic Communication, Pharmacies engagement and referral
Advocacy, and Engagement networking
03/08/2024 2
 Programmatic Background: Why Private Sector?

03/08/2024 3
 TBPS STRATEGIC IMPLEMENTATION

STRENGTHE
DESIGN and PRIVATE OPTIMIZED DESIGN AND
N
PILOT TB INVESTMEN PHARMACIE PILOT PRIVATE
DISTRICT
STRATEGIC T ON S ROLES SECTOR
PUBLIC
PURCSHASING GENEXPERT ENGAGMENT
PRIVATE MIX
MODEL
NETWORK
03/08/2024 4
How would TBPS success look like by the end of the project?

Contribute to reduction of 50% of TB incidences and 70% of TB

related mortality in TBPS districts (compare to 2014)

Improved patient Optimized PHC Improved treatment Increased case Well-functioned National
pathway for TB care outcome detection DPPM Scaling up

>50% reduction >50% of TB patients >85% of TB Private sector >50% of all types of Proven models of private
time from first care are treated in private patients are contributed >30% of health facilities in sector engagement are rolled
seeking to TB or public primary successfully treated total notified cases in TBPS districts are out in >30% of districts in
treatment initiation health care in TBPS districts TBPS districts DPPM networked TBPS provinces
SF MEDICINE/MEDICAL PRODUCTS

6
 WHO Definitions of Substandard and Falsified:
Substandard medical products:
Also called “out of specification”, these are authorized medical
products that fail to meet either their quality standards or their
specifications, or both.

Unregistered/unlicensed medical products:

Medical products that have not undergone evaluation and/or
approval by the NMRA for the market in which they are
marketed/distributed or used, subject to permitted conditions
under national or regional regulation and legislation.

Falsified medical products:

Medical products that deliberately/fraudulently misrepresent
their identity, composition or source.
Source: Appendix 3 to Annex, World Health Assembly document A70/23, 2017. 7
 Substandard and Falsified Medical Products

• SF medical products may cause harm to patients and fail

to treat the diseases for which they were intended
• They lead to loss of confidence in medicines, healthcare
providers and health systems
• They affect every region of the world
• SF medical products from all main therapeutic categories
have been reported to WHO including medicines, vaccines
and in vitro diagnostics
• Both Generic and Innovator medicines are falsified

http://www.who.int/medicines/regulation/ssffc/definitions/
03/08/2024 8
en/
 Substandard and Falsified Medicines - Indonesia

“…obat yang diproduksi oleh yang tidak berhak berdasarkan peraturan

perundang-undangan yang berlaku atau produksi obat dengan
penandaan yang meniru identitas obat lain yang telah memiliki izin
edar”
(PMK 1010/2008 tentang Registrasi)

03/08/2024 9
 Consequences of SF medicines

Substandard and falsified drugs may contain adulterated, dangerous

ingredients and cause mass poisoning

Poor-quality medicines compromise treatment of chronic and infectious

diseases, causing disease progression, drug resistance, and death.

As chronic diseases increase in low- and middle-income countries, so will

the need for reliable, quality-assured medicines

Substandard and falsified medicines cause public loss of trust in the health
care system and health care providers (pharmacists, doctors)

Can contribute to Antimicrobial Resistance (AMR)

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 Isu Global Pemalsuan Obat

Prevalence of SF:
between 20% and 30%
between 10% and 20%
between 1% and 10%
less than 1%

Many developing countries of Africa, parts of Asia, and parts of Latin America
have areas where more than 30% of the medicines on sale can be counterfeit*.

*International Medical Products Anti-Counterfeiting Taskforce (IMPACT), 2006, “Counterfeit medicines: an update on estimates”
03/08/2024 11
 Factors facilitating the manufacture and trade in poor quality
medicines
• Access-related: shortages of • Suggested mitigation:
affordable, accessible, acceptable, 1. Prevent, Detect, Respond model
quality-assured medicine;
2. Strengthen Regulatory Authorities
• Governance-related: weak
legislation and sanctions, corruption;
• Limited technical capacity: Pisani, et al have proposed additional
limitations among regulators, political & economic policies and
investigators, prosecutors, practices that drive SCM products in
laboratories etc., as well as among the era of Universal Health Coverage
producers and throughout the supply
chain.
Pisani E, Nistor AL, Hasnida A et al. Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative
research in China, Indonesia, Turkey and Romania [version 1]. Wellcome Open Res 2019, 4:70 (doi: 10.12688/wellcomeopenres.15236.1)
03/08/2024 12
 Demand side
Political ‘promises’ of the Sustainable Development Goals:
SDG 3 “Ensure healthy lives and promote wellbeing for all at all ages”
3.8 Achieve universal health coverage, including financial risk protection, access
to quality essential health-care services and access to safe, effective, quality and
affordable essential medicines and vaccines for all.
Implications:
• Interagency pressure to meet political promises of UHC
• Public budgets stretched
• Allocation of resources to meet targets may not be sufficient, etc.
• Establishing policies on: national formulary, pricing, procurement mechanisms,
03/08/2024
etc. 13
 Supply side
Political promises: delivery of medicines to all, economic growth/jobs  domestic
production and increasing pharmaceutical industry presence, etc.
Implications:
• Required public and private investment in medicines production and supply
chains
• Mechanisms for large scale procurement needed
• Adequate measures in place to control for quality, safety, efficacy of medicines
being produced to meet the demand

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 Market responses
• Industry protects margins by cutting
costs:
– reduce quality of starting materials,
APIs, excipients, packaging
– Save costs on storage, distribution
(supply chain)
– Subcontract manufacturing under
pooled/auction procurements to
unqualified sources
• Regulatory authority ‘overlooks’ GMP
issues in favor of domestic markets in
response to political pressure
03/08/2024
• Risk to product quality:
– Poor quality FPPs, affecting
stability, not meeting
pharmacopeial standards
– Product degradation through supply
chain exposure (distribution and
storage
– Poor GMP compliance
• Inspectorate resources stretched, limited
regulatory enforcement results in weak
industry
15
 Market responses
• Industry protects margins by • Shortage of clinically-indicated
avoiding unprofitable products or medicines
markets
• Increased incentives to purchase
• Multi-nationals may avoid domestic from unregulated suppliers
markets with little profit (generics)
• Global trade drives profitability:
shifting products to different
markets leaves ‘vacuum’ of demand
• Distribution limitations: remote
areas (e.g. islands) have reduced
access due to cost-cutting measures
in supply chain investment
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 Market responses
• Industry and health service providers • Undermines confidence in public supply
promote profitable products system

– Promotion of ‘off book’ products • Drives health seeking behavior of

not covered under UHC patients, and prescribing/dispensing
behavior of health providers
– Maximizing profits by promoting
sales of innovators vs UHC-
covered generics (OOP)
– Taking advantage of customers’
perception: expensive = better
quality

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 Examples of SF medicines

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 SC products: global distribution
Falsified cough syrup
manufactured in India:

2012: 60 deaths in Pakistan

2013: 44 children hospitalized
in Paraguay

Delays in QC testing
contributed to continued
distribution and lack of
identification (levomethorphan
instead of dextromethorphan)
03/08/2024 19
Fake vaccine production in Indonesia discovered 2016
THE ROLE OF GOVERNMENT AND
PHARMACIST

21
A robust Quality Assurance system reduces supply chain risk

Obat SF
Prof.
Assoc.

Ministry
of Health
BPOM
MRA Policies,
Guidelines,
Infrastructure

Police &
Customs

Industry
Government’s regulation of Medical Supply Chain
• Central government role has specific role in establishing
NSPK (Norm, standard, guideline and criteria) in health
services including medicine
- Pharmacy Practices (PP 51/2009)
- GPP at health facilities (PMK 30/2014, PMK 72/2016)
- Standard of Government Pharmacy installation (draft)
- Guideline for procurement (PMK 63/2014)
- Medicine quality testing at Government Pharmacy installation (PMK 75/2016)
• National Medicine Policy 2016, ensuring
- The availability of essential medicine at all public sector health facilities
- Quality, safety and efficacy of marketed medicine
- Promoting rational use of medicine
BPOM’s regulation of Medical Supply Chain
– BPOM responsible for pre- and post-market quality assurance activities:
QC in ISO labs (33 provinsi + pusat)
– Registration/market authorization of medicines
– Regulatory enforcement actions/recalls/market authorization
cancellation/fines/etc
– GxP inspections of production facilities and clinical sites
– Collaboration with Kemenkes on public sector medicines production,
procurement, and distribution and dispensing
– Drafting and implementing official technical guidelines: GMP
Substandard antimicrobials and AMR

25
 Response to
pressure on
profits, and
potential effects
on medicine
quality

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 Actions by national medicine regulators mitigating market risk

Pisani E, Nistor AL, Hasnida A et al. Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative
research in China, Indonesia, Turkey and Romania [version 1]. Wellcome Open Res 2019, 4:70 (doi: 10.12688/wellcomeopenres.15236.1)
 Regulatory strengthening is not enough:

“We find that unless quality is explicitly included in pricing and procurement policies,
downward price pressures can actively incentivise the production of substandard
medicines and facilitate degradation. No country can hope to achieve sustainable, effective
UHC without quality-assured generic products, yet low-profit-margin generic products are
especially vulnerable to corner-cutting in response to price pressures.”

Pisani E, Nistor AL, Hasnida A et al. Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative
research in China, Indonesia, Turkey and Romania [version 1]. Wellcome Open Res 2019, 4:70 (doi: 10.12688/wellcomeopenres.15236.1) 28
What can pharmacists do?
- Roles within the health system under UHC

29
 Role of the Pharmacist in combatting Substandard and
Falsified Medical Products
– Pharmacists play a key role in protecting the public health through vigilance,
professionalism, reporting, patient communication and education
– Pharmacists are on the “front lines” protecting patients against substandard and
falsified medical products
– While the regulatory framework and laws exist, pharmacists must protect patients
by identifying poor quality medicines
– Pharmacists should implement FIP/WHO Good Pharmacy Practice/Good
Dispensing Practice, etc. to prevent SF products from entering their supply chain
https://www.fip.org/www/uploads/database_file.php?id=331&table_id=

03/08/2024 30
“
A system should exist that enables pharmacists to
report and to obtain feedback about adverse
events, medicine-related problems, medication
“
errors, misuse or medicine abuse, defects in
product quality or detection of counterfeit
products…

FIP/WHO GPP Guidelines

31
 Inspect
Meds for
Quality

Pre-
Pharmaco-
qualify
vigilance
vendors

Role of the Pharmacist in Pharmacis

t
combatting SF medical products
Practice Educate
GPP Patients

Report
suspicious
meds

03/08/2024 32
 Actions within purview of dispensing pharmacies
• Procurement:
– prequalify/verify vendors &
suppliers
– Confirm product sourcing with
distributors
– Work with regulatory authority to
monitor SF alerts, publications,
product recalls
• Education and outreach
– Work closely with your
professional association to continue
education and updates on SFs in
your market
– Provide patient education: avoid
internet-sourced products from
unvalidated vendors
– Monitor and report ADEs via
regulatory, PV center, others

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 Actions within purview of dispensing pharmacies
• Compounding: • Regulatory compliance
– Ensure full compliance with – Know and understand requirements
recognized standards for for Good Pharmacy Practices, Good
compounding pharmacies, e.g. USP Dispensing Practices, Good Storage
<797> and others to avoid creating and Distribution Practices
substandard/contaminated products – Ensure rational prescribing is
employed: avoid irrational use of
antibiotics which can lead to AMR

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 Actions within purview of industrial pharmacy
• Regulatory:
– Comply with local or international
GMPs
– Promote a culture of quality using
continuous improvement
– Ensure a robust and strong quality
control system within your QC
laboratories
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• Market and manufacturing
– Work with the procurement
agencies to advocate for quality
requirements in procurement
policies
– Ensure a strong supply chain
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Visual Inspection of Pharmaceutical Packaging
The drug’s strength
Trade Company (important-primary to
name logo prescriber)

The drug’s Dosage form

scientific Indicating
name The route of
administration
The number
of units per
container
Batch number
Storage Manufacturing
Condition data

The Expiry date -

manufacturer’s stability
full address
 Discoloration,
uniformity of tablets,
friability,
secondary packaging
examination
Reporting suspicious or suspected SF products

Unit Layanan Pengaduan Konsumen BPOM RI

021-4246726
021-4263333
021-32199000
Inspektorat.bpom@yahoo.com
ulpk@pom.go.id
ulpk_badanpom@yahoo.co.id

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Educating Patients:
Protecting public health through effective communications

Short public service announcement

Pharmacide Online:
the risk of buying medicines from the internet

Pharmacide Online

39
 Thank you

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