Ethics in products

Pharmacists
 Pharmacy concept
• Science and technique of knowing the substances
of therapeutic action, of obtaining them and
combining them to prepare medicines.

• It is the science and practice of the

preparation, conservation,
presentation and dispensing of
medicines; It is also the place where
medicinal products are prepared,
dispensed and sold.

• The pharmacist or pharmaceutical

chemist: is the professional with
comprehensive skills in health, drug
manufacturing, quality control, drug
development and research, is the
expert in drugs, and in the use of
drugs for therapeutic purposes in
humans. .
 HISTORY OF PHARMACY IN THE REPUBLIC
DOMINICAN AND ITS CURRENT SITUATION
• Pharmacy has simultaneous
origins in the third millennium
BC in: India, Mesopotamia,
Egypt and China. The first
efforts that can be considered
as antecedents of the
Dominican Pharmaceutical
Industry date back to the
1930s, when some companies
began the production and
marketing of some
pharmaceutical products.
• The first synthetic drug
launched was acetophenidine,
 in 1885, sold as Phenacetin and the second important
synthetic drug, marketed in 1897, was acetylsalicylic
acid, created by Dr. Félix Hoffman in the Bayer research
laboratories in the Dominican Republic.

• In 1953, under the Trujillo dictatorship, incentives were

given to the sector, career growth was encouraged at
the Autonomous University of Santo Domingo and the
Dominican Chemical Laboratory (LaboQuiDom) was
inaugurated.
 Latest Advances

• The essential medicines program (promese) was created in the 1980s by

President Salvador Jorge Blanco.
In the 90s, the Dominican pharmaceutical industry took an impressive leap
when national companies began to get involved in more advanced products,
with greater technology and managed to position themselves in the market
in a decisive way, with very important products that still remain today. very
successful (But Unfortunately Without Pharmacists Being At The Head).
 Universities that have served as a
contribution
to growth in the
pharmaceutical field
• UNPHU
This School of Pharmacy was created since the
founding of the University on April 21, 1966, to
UNPHU
offer programs to study higher education in
pharmacy, being the oldest belonging to a
private university.

• UASD
The career had its origin in 1882, the date on
which the first pharmacist in the country
graduated and it was in 1969 when it was
transferred to the Faculty of Medical Sciences.
 GOVERNMENT ORGANIZATIONS
RELATED TO THE SECTOR

• UCE
The Pharmacy Course at this university emerged in 1983
with the fundamental objective of training professionals in
the area of Pharmacy, who could respond to the needs of
the Eastern Region and the country in general.

• UTESA
The Pharmaco-Biochemistry Career was established in
1979 (UTESA was founded in 1974), corresponding to the
area of health sciences. UTESA being the first and only
institution in the Cibao region in charge of these
professionals.
• In June 2005, the official pharmaceutical policy document (PFN)
was published to improve the rational use of medicines.
Since 1991, the Drugs and Pharmacy Directorate of the MSP has
introduced significant changes to strengthen pharmaceutical
regulation actions and control of services.

• There are more than 150 licensed pharmaceutical manufacturers in

the Dominican Republic. Currently 5 multinational pharmaceutical
companies produce medicines locally. There are 90 manufacturers
with certificates of compliance with Good Manufacturing Practices
(GMP). And we have around 10,000 professionals in the country.
• The pharmaceutical industry in the Dominican Republic is one of
 the most economically profitable and growing markets in the
country. The sector registers more than 23,000 medications, 16% of
them are in the generic category.

• It contributes 3% to the Gross Domestic Product (GDP), close to

RD$62,865 million since 2010. 150 companies in the pharmacy area
operate in the country, 39 of them are Dominican. The
pharmaceutical industry generates nearly 10,000 jobs, that is, 3% of
the national industrial workforce and 0.3% of the country's
economically active population.
 HISTORY OF PHARMACEUTICAL ETHICS

• The need to include deontology in official pharmacy teachings as the most

effective way to create a moral sense in pharmaceutical professionals has been
constantly evidenced for years. It was essential that the ethical and deontological
principles that should govern the professional performance of the pharmacist in all
its aspects, are instilled in students in the Faculties of Pharmacy through teachings
of morals and ethics applied to the specific situations that can occur in
pharmaceutical practice and, which, sometimes, go beyond the content and
purpose of what is established in the Legislation that regulates the profession.

• In effect, the Pharmacy Degree Study Plans contained the Pharmaceutical

Legislation on a mandatory basis since 1884. Such original inclusion highlighted, on
the one hand, the importance and, on the other, the need for a certain legal
training for future pharmacists. In principle, Pharmaceutical Legislation was
assigned as a complement to the subject Practical Pharmacy, which would later be
called Galénic Pharmacy.
• Among these disciplines, Pharmaceutical Legislation was also included, but in this
new and modern orientation, it was already incorporated along with Deontology,
"Legislation and, where appropriate, Pharmaceutical Deontology" as expressed in
the Community Directive. Therefore, the origin of Pharmaceutical Deontology as
an academic discipline is found in the community guidelines of the Curricula,
although its inclusion, in principle, seems to imply an integrated treatment of both
realities, legal and ethical, in order to provide the appropriate approach to train
students. so that they are capable of assuming their social responsibilities.
•
• Deontological approaches forget that ethics, as a fundamental constituent of
human conduct, is the most radical determination of the person and the most
direct expression of his dignity, which projects the human being to his personal
fulfillment, and leads him to a progressive improvement of its activity without it
being reduced to a mere fulfillment, sometimes thoughtless, of obligations, with
respect to which its projective nature is not always appreciated - open to new
improvement initiatives -, to a progressive effort to achieve the professional
excellence.
• . The evolution of the pharmaceutical profession in our
century, the new social requirements and the change
that has also occurred in the world of Law - with clear
ethical implications - impose a certain change in the
orientation of teaching in this matter, which has
already been suggested some time ago by Valverde. It
should aim, in our opinion, to train students in the
subject in a way that is proportionate to their new
social responsibilities, for which it is currently
insufficient to provide them with general information,
no matter how exhaustive, about the regulations that
govern healthcare.
 ETHICS, MORALITY AND LAW AT THE
PLANE
PHARMACIST
• Ethical values
• Since classical Antiquity, three types of ethical values have been distinguished: a)
strictly moral ones, that is, those that found morality itself, those that refer to the
fulfillment of man's supreme mission in his own life, and that usually be included
under the name of honesty; b) those of justice, or rather, those that must serve as
a guide for the Law; and c) those of decorum or decency, relating to the external
aspect of interhuman relations, which are what establish the rules of social
treatment (courtesy, good manners, etc.).

• The Law is oriented towards values that are ethical in nature. But those ethical
values that must inspire the Law, in which it has to seek its justification, are not
the same ethical values that refer to morality itself. While morality provides the
plenary norm that encompasses all the ingredients of behavior and gravitates
towards the root of it, intending to lead man to the realization of his supreme
ends, Law proposes only the realization of a certain, secure, peaceful order. and
fair of human coexistence and cooperation.
• It happens that, even when the Law is also based on
ethical principles, however, its solutions to certain
situations may differ from what is ordered by morality
with respect to them. The eminent Jesuit Francisco
Suárez wondered if positive law should contain
everything ordered by the moral law. His answer is a
resounding no, since positive legal law, he says, differs
from moral law in terms of purpose, extension and
meaning. The Law is inspired not by the intrinsic
honesty of acts, such as morality, but by what the
common good requires directly or immediately.
• Thus, not everything permitted by law is
 morally good, not everything legally
permissible is honest. And, furthermore, not
everything honest can or should be governed
by the Law. However, the Law can and must
create favorable social situations so that men
are in better conditions to fulfill, by
themselves, their moral duties.
Ethics in Pharmaceutical Services

A profession is identified by the willingness of its individual practitioners to conform to

ethical and professional standards that exceed the minimum legal requirements.
Pharmacists are health professionals who help people maintain good health, and,
where appropriate, get and make the best use of their medicines. The role of the
pharmacist has changed significantly in the last twenty years. While the fundamental
ethical principles remain essentially the same. These principles, based on moral
obligations and values, are established to enable national pharmaceutical
organizations, through their Code of Ethics, to guide pharmacists in their relationships
with patients, with other health professionals, and with society in general.

Pharmacists seek to act with justice and equity in the allocation of the health
resources available to them.

In the practice of his profession

Beginning
1. The pharmacist's main responsibility is the well-being of the individual
2. The pharmacist demonstrates the same dedication to everyone.
3. The pharmacist respects the individual's right to freedom of choice of treatment.
4. The pharmacist respects and protects the individual's right to confidentiality.
5. The pharmacist cooperates with colleagues and other professionals and respects
their values and abilities.
6. The pharmacist acts with honesty and integrity in professional relationships.
7. The pharmacist serves the needs of the individual, the community and society.
8. The pharmacist maintains and develops professional knowledge and skills.
9. The pharmacist ensures continuity of care in the event of labor disputes, pharmacy
closure, or conflict of personal moral beliefs.
 Obligations

• The distribution and content of advertising for professional services. They should
be dignified and moderate, so as to give the public the impression that medicines
are not ordinary articles of commerce.

• Advertising
In the pharmaceutical field it covers all
forms
communication, newspapers, prints,
notices, signs, packaging material, labels,
public address systems, telephones and
radio and television advertisements or
other media such as computers, the Web,
etc.
• Advertising for professional services, in addition to meeting the
conditions mentioned above, must be real, dignified and moderate
and must not discredit the professional services of other
pharmacists or pharmaceutical establishments, nor claim
superiority, express or implied, in this regard.

• Entities that represent pharmacists are allowed to advertise in

accordance with the Code of Ethics to try to promote the
profession as a whole and in pursuit of general well-being.

• Advertising for professional services must not contain more than

the name, address, telephone number and opening hours of the
pharmacy or other pharmaceutical establishments.
 The information provided about professional services should be presented in a way that allows the
recipient to decide which services to use, without being subjected to pressure.

When advertising in the telephone directory and

other local directories, the highlighted letter is
accepted, as long as they are complete or partial
advertisements that do not conflict with other
regulations or with the obligations contained in the
Code of Ethics.

A pharmacist cannot mention his services or any

pharmaceutical establishment, medical or dental
offices or any other professional in the art of healing.

• The methods by which

medicinal products for
human use are
promoted to the public
 must reflect the responsibility of all health
agents, and the need to maintain trust.
• Any pharmacist who offers his services
directly or indirectly to the public must do so
in establishments that reflect his professional
character.
• A pharmacist must ensure that the external and internal appearance of
the Pharmacy Office and Hospital Pharmacy premises inspire confidence in
the nature of the health care they provide and that the establishment
meets the requirements of the Standards of Good Professional Practice.

• A pharmacist must establish and maintain safe systems of work to

eliminate, as far as possible, errors in any component of the
pharmaceutical service.
• The production of products that will be used for human consumption
must be in accordance with the principles of Good Manufacturing
Practices at all times of the process.
All components used in production must be subject to quality control, and a quality
examination must be carried out on the finished product, which must carry a lot number and
expiration date.

When dispensing, a high level of personal

cleanliness must be maintained. No staff may
smoke or prepare or consume food in any area
where medications are dispensed.

In the Hospital Pharmacy service, information

about a patient is an important basis for advice,
or for monitoring medication treatment.

Working conditions must be organized in such a

way as to protect the safety of the public and the
personnel working on the premises.
Example of a case in the pharmaceutical field
The reformist leader José Cruz Gómez managed to create an entire economic emporium based on
the indiscriminate marketing of hundreds of counterfeit medicines to the detriment of citizens. It
formed a total of 20 companies between 2003 and 2007, the majority being suppliers and
distributors of drugs.

With his companies, Cruz Gómez supplied medications

with up to three years of expiration to the Ministry of
Public Health and independent pharmacies. Among
these medicines are antihypertensives, analgesics,
antibiotics, vitamins and many others considered
sensitive, since a large percentage of the population
suffers from these diseases.

“Apart from the fact that you are deceiving the client,
when you apply an expired medication to a patient,
you would be causing such severe injuries to that
person's health that they can easily lead to death,”
condemned Jessenia Rodríguez, a pharmacist who has
been practicing for 20 years. .
 Criminal complicity

To counterfeit the medicines, José Cruz partnered with Felipe Jesús Santos,
owner of the Felipe printing press, located in the V Centenario. In this
business, new labels were made to
put on expired medications. This
operation allowed the drugs to go
“unnoticed” and for Cruz to offer
very competitive prices, since they
were damaged merchandise.
Halonate 250 milligrams, Mannitol
Jones 20%, Jonespen 0.4 and
Ferrofer Lifenetgy 100-5 milligrams
were just some of the medications
that were relabeled.
 Millionaire benefits
With his companies marketing adulterated medicines, the accused managed to win million-dollar
contracts with the Dominican State to supply drugs to the Essential Medicines Program
(Promese-Cal). Only in invoices analyzed between July 2013 and November of that same year by
the companies owned by Yomifar, SRL. Guifar, SRL, and Jones Farmacéutica, SRL, were benefited
from purchases of RD$53,111,784.06. These operations
show that among these three companies, the monthly
contracts for just some of Cruz's “businesses” were around
no more and no less than RD$10,622,356.81. The invoices
in favor of the aforementioned companies range from
RD$6,000 to RD$2.9 million. At least 11 of its 20 companies
were suppliers to the State.

Some of the invoices analyzed were made just days after

Cruz was arrested on November 22, 2013.

The authorities determined that of Cruz's total assets,

around RD$100 million, come from this type of illicit activity, which without contemplation
endangers the lives of thousands of vulnerable people due to their sufferings.
 benign agreement
The accused, whose judicial process has been ongoing for less than two years, reached an
agreement with the authorities that would free him from serving a sentence behind bars.

The agreement that favors Cruz Gómez contemplates the holding of an abbreviated trial in
which the accused would be released from prison and only prevented from carrying out
activities related to the health system for 10 years. In this sense, it is planned to cancel the
permit to operate for 15 of its companies, including Yomifar, SRL., Guifar,
SRL. And Jones Farmacéutica, SRL.

“With the weaknesses that we have in the country, especially with the
issue of monitoring, it is very difficult to guarantee that that person for a
certain time is not going to dedicate themselves to the same thing or that
they will not do it through third parties,” said the jurist. Trajano Vidal
Potentini.

Among the alleged motivations for the agreement are the alleged health
complications of Cruz Gómez, who suffers from chronic kidney failure and
diabetes. Health conditions similar to those suffered by other people that
were not taken into account by the guilty party when selling adulterated
medications.

It is also stipulated that the Ministry of Public Health will not pay RD$10.4 million that it
owed to the accused. Considering the contracts that the businessman obtained monthly,
this amount is insignificant, especially when it came to the sale of damaged medications.