PANAMERICAN NETWORK ON DRUG REGULATORY HARMONIZATION

(P A N D R H)

CONSULTANCY ON STRATEGIES AGAINST

SSFFC MEDICAL PRODUCTS
GEORGETOWN, GUYANA

MAXIMILIANO DERECHO
ANMAT - ARGENTINA

WORKING GROUP ON COMBAT

FALSIFIED MEDICINES WG/CFM

November, 2014

I. CONSULTANCY SCOPE
The Health Authority of Guyana requested cooperation fromPan American Health
Organization(PAHO), which consisted on the contribution by an expert from the Working Group
on Combat to Falsified Medicines to the initiative of that country to work on the prevention and
combat of Substandard, Spurious, Falsely labelled, Falsified, Counterfeit (hereinafter SSFFC)
Medical Products.
For such purpose, a lecture was required at a conference focused on raising awareness on the
topic and the visit to the Government Analyst Food and Drug Department facilities and
establishments that take part in the countrywide supply chain, within the framework of a
consultancy process.
Improvement measures are expected to be recommended as a result from the survey
performed.
II. CONSULTANCY ACTIVITIES
The activities scheduled took place onNovember 26th and 27th, 2014. On November 26th, a
National Conference on SSFFC Medical Products was held jointly by the Ministry of Health and
PAHO.
On the second day, Health Authority facilities and establishments involved in the supply chain
in the country were visited.
1. Conference on SSFFC Medical Products
The Conference was opened by the Director of the Government Analyst Food and Drug
Department (GA-FDD), Mr. Marlan Cole. He gave a welcoming speech, introduced speakers
and participants, and made an introduction about the reality of the country as regards SSFFC
Medical Products.
Mr. Cole noted that, in less than a year, they have encountered a high amount of reported
incidents with regards the use of a suspected SSFFC drugs or medicines, and cosmetics
also.As a result, he explained that the GA-FDD has intensified their means of investigations
and have since recovered a lot of SSFFC products being sold in stores and pharmacies locally.
He added that PAHO has also rendered assistance to the GA-FDD in their effort to reduce the
quantity of SSFFC products being sold on the local markets.
Cole noted that apart from intensifying their investigations, they have been making efforts
to enhance the Food and Drug Act which governs the work of the GA-FDD.
He also disclosed that the GA-FDD would soon be developing a new state-of-the-art food
and drug lab which is critical for the consistent and continuous analysis of food and medical
drugs being sold locally.
In closing, Cole noted that they will continue to work towards developing and maintaining
the technical skills of their staff to ensure that the local markets are free of SSFFC products.

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS

After that, PAHO Country Representative, Dr. William Adu-Krow, stated that the marketing
of SSFFC drugs is a major issue across the globe, and use of them can prove to be fatal
because of their inability to cure patients. He said also that the use of SSFFC drugs can result
in resistance.
Citing the use of malaria medication in Guyana, he explained that some pharmacists are
reducing the portion of medicine to increase the number of sales, but this he warned can
result in the malaria parasite developing a resistance to the drugs used to treat the illness.He
added that SSFFC drugs can also result in inaccurate diagnosis and treatment, in addition to
unwarranted expense.
Dr. Adu-Krow noted also that there is need for more resources in Guyana to test for SSFFC
drugs and products. He pointed out the need for a strong political will to work on this topic
and offered world expertise through PAHO.
Next, ANMAT representative lectured on proven systems, procedures and structures against
SSFFC drugs in Argentina, with a focus on awareness-raising on this topic based on other
countriesexperiences.
Then, the Minister of Health took the floor and also highlighted the importance of the topic
and expressed the political will to move forward with the combat against SSFFC Medical
Products and suggested that a Working Group consisting of representatives from all the
areas involved should be established.
Later, the Vice President of the Guyana Pharmacist Association took the floor to point out
the significant role of pharmacists, as trained professionals, in identifying SSFFC Medical
Products. She briefed on the current situation from the Associations perspective and
stressed the following issues: quality of products, parallel importation, unlicensed premises
selling pharmaceutical products, improper labeling of pharmaceuticals,inadequate
surveillance by the relevant regulatory body, uncertainty of the Standard Operational
Procedures (SOP) for reporting questionable products.
Likewise, she expressed her concern as to whether the Health Authority number of staff is
appropriate, whether its staff is duly trained, and whether the laboratories used fulfill testing
requirements for this type of products. She made recommendations for improvements.
The Conference went on with a presentation by the representative of the Material
Management Unit, who spoke about the tasks performed there and the testing and control
performed on the products received. This unit consists of a large Warehouse where products
intended for public supply are received and dispatched for distribution.
After that, ANMAT representative lectured on the Legal Framework for SSFFC medical
products.
At the end of the meeting, a presentation about the procedures for product registration and
obtaining marketing authorization was given by the Senior Drug Inspector Ms Fabiola
Robertson, the person responsible for the area concerned, and Mr. Cole presented the
strategy of his Department for the procedures he is in charge of and which are of particular
importance for the identification and combat against SSFFC Medical Products.

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS

2. Visit to the Governement Analyst-Food and Drug Department (GA-FDD) laboratories

On November 27th 2014, a visit was paid to the National Regulatory Authority (GA-FDD)
facilities in the company of its staff who provided information on the processes performed
there.
The survey shows that there are two (2) local manufacturers in the country, which are, in
turn, also importers of foreign products. Said firms hold an annually-renewable license
applicable to a list of products they are authorized to manufacture/import. Likewise, there
are twenty-five (25) importers, which are also distributors and they are required to appoint a
pharmacistresponsible for the operation. Both manufacturers and importers are required to
test the products prior to releasing them to the market, but only manufacturers are required
to maintain retention samples.
Currently, not all medical products are registered but the GA-FDD is working aggressively to
make firms register their products. As to manufacturers, products are included in the list
related to their license. On the other hand, importers are granted a marketing authorization.
For product-approval purposes, firstly, the product dossier is assessed by inspectors and,
subsequently, a senior inspector reviews it; however, staff is not duly trained to evaluate all
the applications submitted.
A marketing authorization allows firms to import products as many times as they
want.Nevertheless, the import license application is to be filled in for every import. An
assessment is performed and an Approval Stamp is placed on it. Then the importer is
required to obtain an authorization from the Customs Office (Customs entry) and return to
the GA-FDD. At this stage, the GA-FDD may authorize the release of the product
(approximately in 70% of thecases); it may authorize the release to the Warehouse (5-10%),
which implies the GA-FDD will inspect the products at the warehouse; or it may decide that
products be held for an inspection (20-25%), that is to say, an inspection will be conducted
at the port of entry.
Likewise, special permits (annual) are granted to sell OTC products. Any person can sell these
products but this permit is required.
On the other hand, there are around one hundred (100) pharmacies in the country.
Pharmacies are regulated by the Pharmacy and Poisons Board (under the Ministry of Health)
and are inspected by both authorities. The GA-FDD focuses on products and the Pharmacy
and Poisons Board focuses on facilities and professional compliance.
GA-FDD has 4 inspectors for medical products and 4 inspectors for food products. In turn,
the Pharmacy and Poisons Board has 2 inspectors.
Likewise, the GA-FDD official laboratory was visited. It should be mentioned that the current
space used by the Laboratory is temporary and it was removed from its previous location for
developmental purposes, and efforts are being made for the construction of a New GA-FDD
laboratory beginning 2015.

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS

3. Visit to the Material Management Unit

Next, a visit was paid to the MMU, which consists of a large warehouse where the receipt of
medical products intended for public supply is centralized.
The building and hygienic conditions
of the place are very good. Medicines
are handled largely according to Good
Storage and Distribution Practices,
even though no rulings or specific
procedures
providing
for
requirements to be fulfilled seem to
exist. Minor non-compliances are
observed as regards Good Storage
Practices, such as the inadequate
stacking of some products and the
lack of temperature records of the temperature-measuring instruments used.
The MMU handles 1,700 line items, out of which 900 account for regular outflow operations.
It supplies approximately 75% of Guyana market and distributes medical products to 368
facilities countrywide for public freeof-charge supply.
It handles several million units
annually, out of which, 90% are
supplied by the New GPC Inc. (a local
manufacturer and distributor). Around
20% of units accounts for local
production. India is the origin country
of 90% of the products. The purchase
of products is opened up for biddings
by the Procurement Department. The
registration of products is not checked at the warehouse. For instance, at the reception bay
some products labeled as exclusively intended for other markets were found. Failures are
detected in the communication between the Health Authority and the MMU as to the
registration of the medicinal products the latter receives.
4. Visit to a pharmacy
Then, the largest pharmacy in the country was visited. It holds
the highest rate of dispensations in the city of Georgetown. A
large amount of products was observed as well as various
dispensing sectors according to the type of product. In general,
the activity was performed appropriately; nevertheless, Good
Storage Practice deficiencies were detected, such as the
existence of humidity in some parts of the warehouse and an
inadequate storage of some medicinal specialties. A large staff

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS

was working at the pharmacy and the pharmacist responsible for the operation was present.

5. Visit to an importer of medical products

One of the largest importers in the country was
visited. The facility was large and a large number of
products were there but building and hygienic
conditions were deplorable. The facility had serious
deficiencies in terms of Good Storage Practices. By the
way of example,
it
can
be
mentioned that
there were free
shelves but at the
same time there were products stacked on the floor
and aisles; a large number of medical products were
stacked in a deficient way, some of them in a halfcovered entrance exposed to weather conditions. No
protection was installed against insects and rodents;
cold-chain requiring products were also stored in a
deficient
manner.
No
temperature-recording
equipment was observed in the warehousing room or
refrigerators; loose primary packaging of medicinal
products was found as well as broken vials on the
shelves. Flooring and walls materials were not
appropriate; humidity and material shedding were
observed on the walls; different products stored all
together, etc. Photographs of the place conditions are
herein exhibited.
The conditions observed suggest that the
establishment should be closed-down and a much
better performance by importers as to Good Storage
and Distribution Practices should be sought.

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS

III. CONCLUSIONS AND RECOMMENDATIONS

As a consequence of the activities conducted, a positive result is observed, first, from the
existence of a strong political will to move forward towards strengthening the Health Authority
and the improving the prevention and combat against SSFFC medical products, as stated by the
Minister of Health. Also, the involvement of Mr. Marlan Cole, Director of the GA-FDD, should be
appraised as well as the existence of a strategy to improve procedures at the Department and
strengthen the capacities of its staff.
At the same time, as Guyana is a small country with few health establishments, improvement
possibilities in registration, licensing and control processes are envisaged as easier to be
implemented. Conversely, the Health Authority resources availability and training represent a
key factor to attain such objective.
Based on the observations made, the following recommendations are herewith provided:
1) To involve GA-FDD personnel in training activities and/or programs on product registration,
company licensing and Good Distribution Practices as those provided by international bodies
such as WHO /PAHO.
2) To form a cross-functional work team, made up of representatives from all stakeholders, in
order to implement an inter-jurisdictional joint strategy for combating SSFFC Medical
Products. In this regard, it is hereby informed that PAHO Group to Combat Falsified Medical
Products has created a Workshop on tools and proposal generation for preventing and
combating the falsification of medical products (a reference document is provided
herewith), which is available for the countries in the Region so requiring it. Among the
objectives of this activity is that of establishing a strategy and an inter-institutional work
matrix which involves all stakeholders. This workshop was given in various countries of the
region (Panama, Bolivia, English-speaking Caribbean and Costa Rica). It may also be useful to
contact Panamas Health Authority for a briefing on its experiences after taking the
workshop.
3) To take into consideration international technical documents written by WHO and/or PAHO
with the purpose of implementing a work strategy against SSFFC Medical Products. In this
regard, the following reference documents are provided herewith:GUIDELINES TO BE
CONSIDERED BY HEALTH AUTHORITIES IN SUSPECTED CASES OF COUNTERFEIT MEDICINES
of the WORKING GROUP TO COMBAT FALSIFIED MEDICINES (PAHO); ACTIONS, ACTIVITIES
AND BEHAVIOURS THAT RESULT IN SSFFC MEDICAL PRODUCTS and RECOMMENDATIONS
FOR HEALTH AUTHORITIES TO DETECT AND DEAL WITH ACTIONS, ACTIVITIES AND
BEHAVIOURS THAT RESULT IN SSFFC MEDICAL PRODUCTS, both by WHO MEMBER STATE
MECHANISM ON SSFFC MEDICAL PRODUCTS.4) To review and update the regulations applicable to the various processes involved.
According to the survey, the Food and Drugs Act dates back to 1971, reason why it should be
useful to revise norms and update them in agreement with the evolution experienced in the
field over the last years. With a particular focus on the situations observed, it is suggested
that updated standards be adopted on Good Distribution Practices applicable to all players
in the supply chain. This may be one of the topics to be addressed by an Inter-institutional
Working Group.

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS

5) To address improvement processes with a primary focus on the establishmentsthat operate

the largest volume of medical products. In this connection, the MMU is extremely important
as it clusters approximately 75% of medical products supplied in Guyana. Some procedural
deficiencies that can be easily corrected were observed. The correction of such deficiencies
impact the quality and safety of a significant number of products. It is recommended that a
quality assurance policy be implemented to ensure compliance with stringent and modern
Good Storage and Distribution Practices. To such purpose, it may be very useful to work
jointly with the GA-FDD towards the strengthening of staff capacities. Likewise, it is
recommended that product procurement processes be improved so as to gain control and
the assurance that the products acquired are,always and in every case, duly authorized by
the health authority, inescapably. At this point, it is also essential to use fluent and
permanent communication channels with the Health Authority.
6) In this connection, as one sole supplier provides for approximately 90% of the products
supplied to the MMU, it is convenient that controls be intensified and periodic inspections
be conducted by the Health Authority.
7) To complete the development and construction of a duly equipped official laboratory to
perform all the controls the Health Authority deems necessary.
8) To implement a unit-based traceability system for high-cost medical products.

CONSULTANCY ON STRATEGIES AGAINST SSFFC MEDICAL PRODUCTS