Transcript 09 Organization of the quality control system (2)

Department of Management and Economics of
Pharmacy
ORGANIZATION OF THE MEDICINE
QUALITY CONTROL SYSTEM IN
PHARMACY
Lecturer Assoc. prof. M.V. Leleka
Regulations
On the State Administration of Ukraine on Medicinal
Products(SAUMP)
1. The State Administration of Ukraine on Medicinal
Products (SAUMP) is a central executive authority
whose activities directed and coordinated by the
Cabinet of Ministers of Ukraine through the
Ukrainian Minister of Health.
The SAUMP is integrated into the system of
healthcare executive authorities and is established
to ensure implementation of the national policy in
the areas of quality control and safety of medicinal
products, including medicinal immunobiological
preparations (hereinafter - medicinal products),
medical equipment and medical devices that are out
in circulation and/or applied in health care, that are
approved for marketing in pharmacy institutions and
their structural subdivisions (hereinafter – medical
devices), as well as for the licensing of
pharmaceutical manufacturing, wholesale and retail
sale of medicines.
3. The mainSAUMP objectives are:
put forward proposals for the national policy-making
in the areas of quality control and safety of medicinal
products, medical devices and licensing of
manufacturing, wholesale and retail sale of
medicines;
implementation of the national policy in sphere of
the state quality control and safety of medicinal
products and medical devices;
licensing of activities in pharmaceutical
manufacturing, wholesale and retail sale of
medicinal products.
The Drug Situation In Nigeria
There is a large market for drugs in Nigeria. Out
of over 130 existing pharmaceutical manufacturers
only 60 are in active manufacturing. This is despite
the installed capacity of the industry to produce
between 50% and 75% of the nation’s drug needs.
Capacity utilization is below 30% and about 70% of
the drugs are thus imported. (Okoli, 2000).
Availability:
Drug availability in the public and private health
care delivery system in Nigeria is in a poor state.
Various reasons have been adduced for this trend
(Erhun, 1996). These include:
(i) Inadequate funding of hospital Pharmacies and
the “out of stock syndrome”
(ii) Involvement of unqualified persons in the
procurement and distribution of drugs
(iii) Inadequate storage facilities, transportation and
distribution.
The adoption of an essential drugs program
through the promulgation of Decree 43 of
1989 on Essential Drugs was a step taken to
ensure the availability of drugs. Ordinarily,
branded drug prescribing is still quite
common in many public health institutions,
contrary to specifications of the Essential
Drug Act (Govt. of Nigeria, 1990). This has
partially eroded the expected gains of the
essential drugs program.
In 1996 a health intervention program was put
in place under the Petroleum (Special) Trust Fund.
A drug revolving fund (DRF) was established
under the scheme that ran parallel to the existing
DRF in public health institutions. Under this
scheme, local manufacturers produced the drugs
directly on a contract basis. To a large extent this
intervention increased drug availability in the
public health institutions. The scheme was
however phased out in 1999 (Erhun, 2000)
National Agency for Food and
Drug administration and control
Decree No. 15 of 1993. This is
the decree establishing the
National Agency for Food and
Drug Administration and control
(NAFDAC). The Agency
performs the following
functions:
(a) Regulate and control the importation,
exportation, manufacture,
advertisement, distribution, sale, and
use of food, drugs, cosmetics, medical
devices, bottled water and chemicals,
(b)
Conduct appropriate tests and ensure
compliance with standard specifications
designated and approved by the council
for the effective control of the quality of
food, drugs, etc., as well as their raw
materials and production, including
processes in factories and other
establishments.
(c) Undertake appropriate investigations into the
production premises and raw materials for food,
drugs, etc. and establish relevant quality assurance
systems, including certification of the production sites
and regulated products.
(d) Undertake inspection of food, drugs etc.
(e) Compile standard specifications and regulations
and guidelines for the production, importation,
exportation, sale and distribution of food, drugs, etc.
(f) Undertake registration of food, drugs, etc. (g)
Establish and maintain relevant
laboratory or other institutions
in strategic areas of Nigeria as
may be necessary for the
performance of its functions.
The Federal task force on
counterfeit and fake drugs
established under the provisions
of the counterfeit and fake
drugs (miscellaneous provisions)
Act operates within NAFDAC.
In the pharmacy should be appointed at
least one authorized person with
appropriate authority and is responsible
for development, implementation and
operation of quality. An authorized
person must personally serve duties,
have higher pharmaceutical education
and work experience for specialty at
least two years.
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Authorized persons with application check
amount, price, total worth of commodity, and
conduct collation them with information of
invoice. The special attention is spared
verification of amount of acceptanced
commodity. Receiving control which consists in
checking of original appearance is conducted to
that end, to marking, packing, blocked of
commodity.
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One of elements of system of warranting of
medicines quality is intrachemist's quality
control.
Intracliemist's quality control is an industrial
activity which is directed on the
prevention (warning) of the poor-quality of
receipt and forged medicines from a
drugstore to the patient, and also the
prevention of wrong storage of medicines in
chemist's establishments and
pharmaceutical firms. It includes a complex
of warning. measures, carrying out of
obligatory and selective kinds of quality
control of; medicines prepared in a
drugstore.
If the chemist shop has the production function preparation of medicines; under individual recipes
and requirements, it should have properly
organized control system of quality.
First of all, it is necessary, that the full complex of
measures preventing occurrence poor-quality
medicines by manufacture was carried out,
namely:
• observance of rules and norms of a sanitary-andhygienic and epidemiological mode;
providing of serviceability and
accuracy of the equipment;
providing of rules and conditions of
storage medicines according to their
physical and chemical properties;
control of recipes and hospital
requirements which come in a
drugstore;
observance of manufacturing
techniques of medicines;
preparation of auxiliary materials,
utensils according to the requirements
showed to them.
Second, functions of the controlanalytical laboratories include realization
of the selective control of medicinal forms
of chemist's manufacture.
The drugstores has a post of the
pharmacist - analitic which should held all
kinds of intrachemist's quality control, and
even at absence of this post, the head is
obliged to provide quality control of
medicines in full according to documents.
Functions of the pharmacist - analytics:
Realization of all kinds of intrachemist's quality
control;
The control over observance of technology of
preparing of medicines, rules of storage in a
drugstore;
Consultation on questions of storage, technology of
preparation and quality control;
Conducting registration forms under the established
forms. To the intrachemist's control are exposed:
all medicines prepared in a drugstore;
intrachemist's preparations;
solutions - concentrates;
semifinished items;
water cleaned and sterile.
There are 6 kinds of the intrachemist's
control. They can be divided on:
obligatory - each preparation made in
conditions of a drugstore is exposed to
the control,
selective forms - are carried out
depending on different factors (age of
the* patient, the medicinal form, structure
of a preparation).
OBLIGATORY kinds of the control
The written control - consists in check of conformity of
records in the passport of written control prescription in the
recipe, correctness of the made calculations.
Organoleptical control - is carried out as check of
appearance of the medicinal 1 form, color, smell, uniformity,
absence of mechanical inclusions.
The control over realisation - provides conformity:
• packings of a medicine to the physical and chemical
properties
registrations of a preparation
• dosages of medicines of the list A and age of the patient
I
• numbers on the recipe and numbers on the label
• surnames of the patient on the receipt and on the medicine
The SELECTIVE forms of the control:
The polling (oral) control is carried out after
manufacturing by the pharmacist no more than
5 medicinal forms. The pharmacist who is
carrying out the control, calls 1 the first
component, and the assistant should call
components of the medicinal form and their
amounts.
The physical control - is carried out by
check of a weight or volume of the
medicinal form, quantity(amount) and
weight of separate components, and
also by means of quality control of
packing.
The subject to check:
• 3-5 units of packing or preparations in
each series of packing or preparation
• sterile medicinal forms
The chemical control includes the
definition of authenticity (the
qualitative analysis) and the
quantitative contents of the medicines
included in the medicinal form.
The chemical control is obligatory for the
following medicinal forms:
Solutions for injections;
Eye drops and the ointments containing
narcotic, strong, poisonous substances;
• Medicinal forms for newborns;
Solutions of an acid for internal application;
Concentrates, the semifinished items prepared
in a drugstore;
Stabilizers, the buffer solutions used for
manufacturing of injection solutions;
Series of intrachemist's medicines.
The qualitative chemical control is carried out for
the following forms:
Water cleared from each cylinder daily.
Medicines, concentrates, the semifinished
items acting in assistant their rooms of
storage.
Concentrates, the semifinished items coming
from a warehouse - in case of doubt.
Estimation ofqualitv of medicines
There are 2 terms of quality estimation of the
made medicines:
"Satisfactory"
"Unsatisfactory"
«It is unsatisfactory on conformity »:
absence of the attributed component;
presence of not registered component;
use of preparation - analogue without
corcesponding instructions (indications) of the
doctor in the recipe;
« It is unsatisfactory on physical
parameters »:
bad mixing or grinding of components;
impurity of a solution with mechanical inclusions;
excess of norms of a deviation of separate
dozes, lump (volume).
1. Groups, in the case of outpatient treatment which
medicines prescribed by doctors dispensed free of
charge :
1) persons who provide free of charge delivery of drugs
according to the Law of Ukraine "On Status of War Veterans
and Guarantees of their Social Security ";
2) persons who have special labor services to the country
under the Law of Ukraine "On Basic Principles of Social
Protection of Labor Veterans and Other Elderly Citizens in
Ukraine ";
3) persons who provide free of charge delivery of medicines
according to the Law of Ukraine "On the status and social
protection of citizens affected by the Chernobyl disaster ";
4) pensioners among farmers, workers, employees who
receive old-age , disability and survivors' benefits in minimal
amounts ( except for persons receiving pensions for children
survivors );
5) Children under three years of age;
6) disabled children under 16 years;
7) Children under 18 years who underwent
in 1988, chemical intoxication alopecia in
Chernivtsi ;
8) teenage girls and women with
contraindications pregnancy and women
who suffered from the Chernobyl disaster,
provided free contraceptives according to
the National Family Planning Program ,
approved by the Cabinet of Ministers of
Ukraine dated September 13, 1995 № 736.
2. Groups, in -patient treatment which medicines
prescribed by doctors dispensed with pay 50 percent of
their value :
1) disabled groups I and II as a result of employment injury,
occupational or general disease;
2) disabled since childhood I and II ;
3) Children aged three to six years;
4 ) persons rehabilitated in accordance with the Law of Ukraine
"On the rehabilitation of victims of political repression in Ukraine
", which became disabled as a result of repression or is retired ;
5) persons awarded with "Honorary donor Ukraine " and "
Honorary donor USSR" under the Law of Ukraine "On the
donation of blood and blood components ."
LIST
categories of disease, when outpatient treatment
which medicines are dispensed free of charge *
Cancer
Hematologic diseases
Diabetes (diabetes insipidus and )
rheumatism
Rheumatoid arthritis
Pemphigus
Acute systemic lupus
Systemic, chronic , severe skin disease
syphilis
leprosy
tuberculosis
Addison 's disease
Hepatotserebralna dystrophy
Phenylketonuria
Schizophrenia and epilepsy
Mental Illness ( disabled groups I and II , as well as patients who work
in the health production workshops neuropsychiatric and psychiatric
institutions)
Condition after heart valve replacement surgery
Acute intermittent porphyria
Cystic Fibrosis
Severe forms of brucellosis
dysentery
hypophyseal dwarfism
Condition after transplantation of organs and tissues
asthma
Spondylitis disease
Miosteniya
Myopathy
Cerebellar ataxia Marie
Parkinson's disease
Myocardial infarction ( first six months)
Cerebral Palsy
AIDS and HIV infection
Postoperative hypothyroidism, including cancer
thyroid
hypoparathyroidism
Congenital adrenal dysfunction
• Free supply of medicines for
the diseases listed categories
is made only if the outpatient
treatment of the underlying
disease , which provided
benefits to patients .
•
AIDS patients and HIV positive , regardless of the
underlying disease are
entitled to free supply of
medicines if they have any
other medical conditions.