Department of Management and Economics of Pharmacy

ORGANIZATION OF THE MEDICINE QUALITY CONTROL SYSTEM IN

PHARMACY

Lecturer Assoc. prof. M.V. Leleka

RegulationsOn 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-and-hygienic 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 control-analytical 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 controlThe 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 medicinesThere 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 ."

LISTcategories of disease, when outpatient treatmentwhich medicines are dispensed free of charge *

CancerHematologic diseasesDiabetes (diabetes insipidus and )rheumatismRheumatoid arthritisPemphigusAcute systemic lupusSystemic, chronic , severe skin diseasesyphilisleprosytuberculosisAddison 's diseaseHepatotserebralna dystrophyPhenylketonuriaSchizophrenia and epilepsyMental 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 surgeryAcute intermittent porphyriaCystic FibrosisSevere forms of brucellosisdysenteryhypophyseal dwarfismCondition after transplantation of organs and tissuesasthmaSpondylitis diseaseMiosteniyaMyopathyCerebellar ataxia MarieParkinson's diseaseMyocardial infarction ( first six months)Cerebral PalsyAIDS and HIV infectionPostoperative hypothyroidism, including cancerthyroidhypoparathyroidismCongenital 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.