The contents of the normative acts that regulate the presence of medicinal resources

Organization of pharmaceutical care conception of responsible selftreatment. Organization of non- prescription drugs sales

1. Criteria for categories of dispensing of medicines

   Medications are divided into two categories:

• prescription drugs

• medicines, dispensing without a prescription

   Prescription medications can be divided into separate groups according to the following classification:

    medicines for dispensing by single or reusable recipes

    medicines, dispensing with the special recipes

  Medicines are released by one-time or reusable recipes:

    if they can cause direct or indirect threat to the health of the consume, even when properly applied, but without medical supervision

    if they are used by many consumers incorrectly, which could be direct or indirect threat to the health of the consumer

    if they contain substances, actions and side effects of which require further study

    If the drug is intended for parenteral poreparat appointment

Medications, which released by special recipe account the following factors:

    the medicinal product is attributed to narcotic or psychotropic in accordance with the laws

    the incorrect application of medicinal may cause a significant risk (of abuse, addiction, or use of medication for illegal purposes)

    the medicinal product contains a substance which because of the novelty or pharmacological properties can be attributed to this group

    the medicinal product contains substances of the list 1 and 2 of Table IV ( Decision of CMU #770)

Medicines prescription and have a limited range of application, consider the following factors:

    the medicinal product in connection with its pharmacological properties or novelty or in the interests of health of the population intended for use only in hospital

    medicinal product used for the treatment of diseases, diagnosis of which can be installed in a hospital or institutions that have the necessary diagnostic equipment

    the medicinal product is intended for outpatient treatment, but its application can lead to serious side effects, resulting in the need that prescription was issued for specialists and treatment was carried out under medical supervision.

Medicines products are dispensed without prescription if they do not apply to prescription. They contain small quantities of narcotic drugs or psychotropic substances and precursors included in the respective tables of Resolutions # 770 and will not be extracted from the medicines easily accessible way in quantities that will abuse them.

   The list of drugs approved for use in Ukraine, dispensing without a prescription from pharmacies, chemist’s kiosks and chemist’s items described in order MH of Ukraine № 897.

2. Causes of the concept of self-treatment.

     Issue by drugs without a prescription is an integral part of retail pharmacies. In Ukraine, as well as around the world, experiencing growth in sales of OTC medicines, which has a number of reasons, including:

    Improve access to medicines

    Increase awareness of population

    Increasing responsibility for their health and the health of family members

    Attempts to healthy lifestyle.

 Over the counter drug – OTC-drug forms an important part of the pharmacy. This activity becomes even more pharmacies in connection with a significant focus of public policy in health on improving responsibility of the citizens for their health, which provides independent selection of drugs. It is necessary to know that such processes take place in most developed countries.

   OTC sales of medicines to the population is closely related to the self treatment, in which understanding disease prevention, treatment of not very difficult deseases, or lesions with drug dispensing without prescription.

   OTC drugs are often used to treat: headaches, high temperature, coughing, colds, stomach disorders, heart attacks, skin disease.

Self-treatment – the use of a consumer of medicinal preparations, which are in open sale for preventive of disorders with health and treatment of symptoms, which are recognized by consumers himself. In practice self treatment also includes a treatment of family members and friends, especially when it comes to children. In 1994 the European association of manufacturers of OTC drugs introduced the term “responsible self-treatment”.

Self-care understands those cases where is necessary to help on health by those or other drugs in the period of exacerbation of chronic disease and give first aid before the arrival of doctor.

Self-profilaxys of disease helps to take measures by population to reduce the risk of disease.

Information on box of OTC – drugs.

   Safe effective use of OTC medicinal preparations is possible only if patients receive a clear and available information about these medicines. Consumers should clearly know in which cases of the illness it may be treated without doctor.

    Instruction must contain in the form available to the consumer with the exhaustive list of information about medicinal drugs.

1.Information for identification of medicinal product:

    Name of medicinal product and its International title (or name of the active complex);

    complete qualitative and quantitative characterization of active complex;

    medicinal form and its composition, doses (one for each medicinal form);

    Pharmacotherapeutic group or character of pharmacologic actions in the term, which is clear for patient;

    address of the manufacturer’s and its name;

2. Pharmacotherapeutical information about the properties of the drug:

    indications;

    contraindications;

    •measure barrier in the application;

    interaction with other medicinal means;

    interaction with food, alcohol;

    any special warning.

All these data should:

    Draw attention to the distinctiveness of certain categories of consumers (children, pragnent, women who are breastfeeding, older age, drivers of vehicles);

    Reminded of the possible effects on speed of reactions in operation of vehicles or other engines of potential dangerous.

3. Information on how to use medicinal preparations should include:

    Information about the dosage, method and path of input, frequency of reception with appointment, if necessary, time of day when the medicines should be taken;

    Duration of treatment course when it should be limited;

    Actions in case of overdose.

4. Information about the term of use:

    Warning not to take medication after a specified period;

    Appointment for any special storage conditions.

Let say  that even in the provision of full information about drugs with instructions no warranty that the patients understood the text. Professional understanding of the text intended for patients with certain medical or pharmaceutical training.

Several patients adversely affect your option to explore in detail instructions from a medical application. All these reasons in case of growing popularity among the population concept self-treatment determine the necessity of vocational training of pharmacists as a strategic choice of experts from the use of OTC drugs. Separate category of patients need an increased attention, because of the risk of side effect it may be much higher than in other patients.

The original medicinal product – a product which is exclusive property of the company that develop it – Brand.

Generic drug (generic drug) the term of patent protection on the actions of the active substance is ended.

Pharmaceutical care – is a complex problem of interaction of pharmacist and patient during the total period of medicinal therapy. Pharmaceutical care understands the responsibility of pharmacist to the patient fop effectiveness and result of treatment.

To provide the pharmaceutical care to leave OTC drugs in pharmacy pharmacist must:

1. Correctly estimate the problem of patients:

    Obtain information that allows you to properly estimate the specific health problem with patients (when there are problems, symptoms, or taken other drugs).

    Decide whether the symptoms associated with serious health disorders

2. Ensure patient OTC medicines

    Pharmacist must maximize their professional knowledge and professional experience in case of choose of OTC medicines means (effectiveness, safety, quality and economic feasibility).

    In case of leaving OTC products provide patients with information about effect of the drug, method of use, duration of treatment, the possible actions of side effect.

3. To ensure patients follow-up:

    Pharmacists have to estimate effectiveness of the drug by patients

    Pharmacists have to recommend to the patients to consult with a doctor if symptoms do not disappear after a certain period

In accordance with the recommendations of GPP for each symptom that can be treated independently exists independently developed algorithm, which should be known to the pharmacist:

1. Set for the treatment of which symptom medicinal drug is supposed.

2. Explain on the basis of survey of patients, or is this a symptom of disease that requires an intervention of the doctor.

3. Identify pharmacological group of drugs to treat this symptom.

4. Choose among a group of medicinal preparations optimal preparation for this patient.

5. Provide the patient with adequate information about the selected drug.

After choosing OTC products Pharmaceutical care includes the following recommendations for patients and consultations:

1.    Choice of optimal form of the drug and ways of input

2.    Rules on the use of various medicinal forms

3.    Features of individual doses

4.    Features of the interaction with other medicinal drug

5.    Features of the interaction of drugs with food, alcohol and cigarettes

6.    Time, which is optimum for the reception of the medicinal product

7.    Possible undesirable effects on the functions of human organs and systems

8.     Specific storage conditions of drugs

To implement the above algorithm of realization of pharmaceutical care pharmacist should be able to:

    Initiate a dialog with patients to obtain data about disease

    Ask Key questions for elucidation of the patients

    Recognize specific symptoms of desease

    For a short time (3.4 asking questions)  take a decision about the possibility of self-treatment

    Convince the patient about the need to treat a limited term and doctor consultations if the treatment is not effective

    Persuade the patient to visit the doctor  in the case of  “threatening” symptoms

    Provide confidentiality of details of the status of the patients condition

    Know well OTC-drugs

    Know the chemical, pharmaceutical and pharmacological properties of OTC drugs

    Provide unbiased information about medicines and send it in available for patients form

    Help patients to provide responsible self-treatment

Today is an important place take such factors as the willingness of patients to doctor recommendations, prepossession of patient before treatment. This new phenomenon was named complience.

In prepossession of patients can affect:

    Age, education level

    Frequency of dosing

    Number of doses on days

    Medicinal form

    Time needed for results of treatment

    Limitations at taking of drug

    Side effects of treatment

    Completeness and Availability of information on drug

    Price of drug and cost of the course treatment

    Number of simultaneously used drugs

Any drug is potentially dangerous and can be prescribed to the patient in extremis.

Thalidomide, a tranquilizer weak, cause severe birth defects in 10 thousand babies. In West Germany without a prescription.
There are 220 medicinal substances that have adverse effects included in the drug. Diane-35.
In the U.S. medicines are sold in specialty stores by persons who do not have pharmaceutical education. Doctors themselves have to offer big profits for producers, realizing their products.
Medicine and Pharmacy ceased to be primitive and become increasingly industrial nature and become commercial.

4. Organization of OTC Department

Independent department of OTC organized in pharmacies of 1 group. In other pharmacies it is usually together with the department of prepared medicinal forms.

In the workplace of OTC department an important place is for registration information for visitors.

5.Organization of work of retail trade network

  Retail trade pharmacy network is organized for approaching medicinal assistance to the population. It includes pharmacy points of 1category, 2 category, pharmacy kiosks. “A typical rules about pharmacy kiosks ” approved by order of the Ministry of Health 49 in 1993. In accordance with this rules pharmacy points of 1 category are  organized by self-supporting pharmacies in hospitals. In cities where hospitals located in distance more than 0.5 km from the nearest self-supporting pharmacy, in other locations its are organized in case of absence of pharmacies according to Decision of CM 447 1997. The minimum area must be not less than 18m sq.m.. Premises for pharmaceutical points of 1 category are provided by hospitals and equipment –  by pharmacy. Pharmaceutical points of 1 category must have:

– Equipment and furniture: Pinwheel, refrigerator, safe for poisons, cabinets, table for receiving of prescriptions and leaving of drugs.

– Unit and devices – scales, engineering, distiller, water bath.

Production facilities, utensils – funnels, flasks, beaker, mortars and etc.

Economic facilities – rubber mat, scissors etc.

In cities pharmacy points of 1 category leave ready means on prescription – with the exception of narcotic drugs, psychotropic, and without prescription, realizes sanitary items, hygiene, care, takes recipes from people for the manufacture of drugs in pharmacy and leave them after making .

  Pharmacy points of 1 category make medicines by prescription, control their quality and leave it for patients in other towns, villages. Pharmacy points of 1 category is headed by chief. He is assigned by a chief of pharmacy.

   Pharmaceutical point of  2category is organized at health posts. They provide population with prescription medicinal means (except narcotics)  and non-prescription drugs, medicinal herbs, dressing materials, care objects.

  From the chemist’s point of 2 category can be leaved drugs which is prescribed by midwife of health posts and doctors for free or in preferential terms. According to the Law #360 free recipes at the end of the month is donated to the pharmacy to take payment from hospitals.

Equipment of pharmaceutical points of 2 category includes table for leaving of drugs, turntables for finished drugs, safe for toxic medicines. Realization of pharmaceutical products is performed by specialists with nursing education

   Pharmaceutical kiosk organize its work in accordance with the “typical rules of the pharmacy kiosk” (49 order). The area must be at least 18 square meters. Pharmacy kiosks realize to people ready medicinal means which are allowed to OTC leaving, care items,other goods. Pharmacy kiosks are located in crowd places – stations, post offices.

The contents of the normative acts that regulate the presence of medicinal resources in pharmacy network.

According to order of MOH of Ukraine 233 1997 “On approving the list of medicines means that are registered in Ukraine” approved:

1.list of medicinal preparations that are allowed for use in Ukraine, which are leaved with prescription from pharmacy and pharmacy points. This list includes 1735 drugs -1997 – domestic and foreign production. Information about medicinal products include:

 trade name

 internationally generic name

 medicinal form with appointment of number of doses in the package

2.List of medicinal preparations that are allowed for use in Ukraine, which are leaved without prescription from pharmacy points and kiosks. This list includes near 670 medicinal preparations.

2. Organization of the Department of finished medicinal preparations.Equipment. Rights and duties of department employees.   Department of finished medicinal means is organized to leave to the population ready means of industrial production and medicines, which are made in pharmacy.

Independent department finished medicinal preparations is presented in pharmacies of 1 group. In more pharmacies of lower groups they are leaved from recipe-production department 

Department of finished medicinal means includes material room of finished medicinal forms and workstations of pharmacist which is posted in reception hall of visitors for taking of receipts and leaving of drugs according to the receipts. In pharmacy of 1 group should be 2 material rooms of finished medicinal forms. Material rooms in accordance with the requirements of the order 44 are equipped with shelves and cabinets, premises for the storage of narcotic medicinal means – safes, security and fire facilities, refrigerators, purge ventilation. Material rooms are equipped with hygrometrs and thermometers to monitor the maintenance of necessary temperature and moisture.

Workstations of pharmacist, who is busy in taking of receipts and leaving drugs, is equipped with a desk, counter and cabinets for medicinal means.

Workstations of pharmacist of department of finished medicinal means is equipped with:

    list of surnames of doctors, phone numbers

    stamps – not a full-prescription, drugs released

    calculator

    reference literature

    orders

    accounting documentation

  Every day at the end of the day (changes) pharmacist fill into the appropriate gaps of the “Journal of the recipes” the number and sum (price) of finished medicinal means which are leaved to the population. As recipes for free and preferential medicinesa remain in pharmacy so number of drugs and amount (price) which are leaved according to this recipts is calculated by this receipts and included into the Journal of compounding-form AP -7.

   In the staff  of department of finished medicinal means are all individuals with higher pharmaceutical education: the head of department, deputy head of the department and pharmacists. 

Head of the department must:

    organize the work of department, provide sale of medicines to population

    control the presence of the necessary range of medicines at the department department and follow the rules of trade

    provide the storage of medicines in accordance with their properties

    maintain accounting inventory of material values, introduce into the practice modern methods of organization of medicines to the population

    organize work to improve the skills of workers of the department

    inform the head of pharmacy managers and medicinal-preventive institutions of all cases of violations of the writing retseptiof receipts

–  Deputy head of department in absence of the head of department take all duties of head of the department.

The department released:

    Medicines that are allowed to leave without prescription

    Medicinal thermometers, one-time syringes and syringes of multiple applications, different kit and others.

    -items of personal hygiene – tooth powder, toothpaste, toilet soap, beauty creams and  others.

    Dezinfectants which are allowed for sales to population – lizol, monohloramin, karbozol and others.

 

Department of OTC leave as i finished likasrkyh means department, consisting of department i kladovyh workstations pharmacist, rozpolozhenoho in the hall oobsluhovuvannya vidviduvachiv.V shtati department is the head of department-provizor or pharmacist, deputy head of department, pharmacists from secondary education, molodshi pharmacists (position zamischayetsya person zi secondary education, or one person in order perdbachynymy rules for admission to the pharmaceutical activities)

   Junior pharmacist conducts leaving of drugs according to the specific allocation of duties, approved by order of pharmacy.

  Pharmacist of Department of finished medicinal means must:

    receive recipes, control right of their writing and clearance. All cases of violation of writing of recipes immediately bring to a known direct head.

    follow the rules of storage of medicines in the material room

    conduct the leaving of drugs in accordance with the requirements of orders of MOH of Ukraine

    lead registration of absent and denied to the population drugs

    participate in composing of planning applications for medicines

    monitor compliance with the sanitary regime in the premises of the department

LIST

Of drugs (psychotropic) drugs that contain a small quantity of narcotic drugs or psychotropic substances and precursors, dispensing without prescription.

(Order of the Ministry of Health of Ukraine

14.05.2003 N 210)

Trading of name	Preparations	composition of active ingredients
Aktifed Ekspektorant	Solution for peroral application for 100 ml in the small bottles N 1	5 ml contains: Triprolidin – 1.25 mg of pseudoephedrine – 30.0 mg huayfenezyn – 100.0 mg
Aktifed	Solution for peroral application for 100 ml in the small bottles N 1	5 ml contains: Triprolidina – 1.25 mg of pseudoephedrine – 30.0 mg
Barboval	Solution for 25 ml in small bottles-droppers	100 ml contain: ethyl ether acid alpha-bromizovalerianic -1.8 g, Validolum – 8.01 g, phenobarbital – 1.7 g
Bronkhobryu	Syrup is for 125 ml in small bottles	1 ml of syrup contains:   sodium dyterbutylii –   naftalindysulfonatis-1.0 mg, ephedrine hydrochloride – 1.0 mg sodium kamfosulfonatis-1, 0mh
Bronkholitin	Syrup for 125 ml in the small bottles of N 1	125 ml syrup contains:   glaucini hidrobromidi – 0.125 g   ephedrine hydrochloride – 0.1 g   basil oil – 0.125 g
Bronkhosept	Syrup for 125 ml in the small bottles of N 1	125 ml syrup contains:   glaucini hidrobromidi – 0.125 g   ephedrine hydrochloride – 0.1,   basil oil- 0.125 g
Bronkhocin	Syrup for 125 ml in the small bottles of N 1	125 ml syrup contains:   glaucini hidrobromidi – 0.125 g   ephedrine hydrochloride – 0.1 g   basil oil – 0.125 g
Valokordin	Drops for 20 ml in the small bottles-droppers N 1	100 ml contain:   phenobarbital – 2.0 g, ethyl ester of alpha-bromizovalerianic acid – 2.0 g, oil mint – 0.14 g hop oil – 0.02 g
Valokordin	Drops for peroral application for 25 ml in small bottles	100 ml contains: alpha-ethyl ether bromizovalerianic acid – 2.0 g, phenobarbital – 2.0 g
Kaffetin	Pills of N 10	1 tablet contains: propifenazoni – 210.0 mg, paracetamoli – 250.0 mg, coffeini – 50.0 mg, codeine, 10, 0mg
Korvaldin	Solution is for 25 ml in small bottles-droppers	100 ml contain: alpha-ethyl ether bromizovalerianic acid – 2.0 g, phenobarbitali – 1.8 g   mint oil – 0.14 g   hop oil – 0.02 g
Korvalol	Solution is for 25 ml in small bottles-droppers	100 ml contain: alpha-ethyl ether of bromizovalerianic acid – 2.0 g, phenobarbitali – 1.826 g, oil mint – 0.142 g
Kofeks	Syrup for 60 ml in the small bottles of N 1	5 ml syrup contains: hlorfeniramini maleatis-4, 0 mg, codeini phosphatis – 10.0 mg
New figure  drops Dr. Theiss	Solution for internal application for 50 ml in small bottles	100 ml containing homoeopathic Divorced: brown algae D1 – 6 ml, gold metal D8 – 6 ml, phosphoric acid D3 – 6 ml, lilies D2 – 6 ml, pankreatyni D8 – 6 ml, trees Gvozdikova D6 – 6 ml, ephedrini D2 – 20 ml, rhamni D2 – 2 ml, birch D1 – 2 ml, onion sea D4 – 2 ml, Lycopodii clavati D 4 – 2ml kendyri hemp D4 -2 ml , celandine D2 – 2 ml, Hawthorn D1 – 2 ml tsymitsyfuhy D2 – 2 ml, sulfur D6 – 2 ml, milkweed D4 – 2ml
Nomigren	Pills, obducted,N10	1 tablet contains: propifenazoni – 200.0 mg, coffeini – 80.0 mg, kamilofini hydrochloridi – 25.0 mg, mekloksamini citratis – 20.0 mg, erhotamini tartratis – 0.75 mg
Penalgin-icn	Pills of N 12	1 tablet contains: Metamizoli Sodii – 300.0 mg, paracetamoli – 300.0 mg, coffeini – 50.0 mg and codeini phosphatis – 8.0 mg, phenobarbitali – 10.0 mg
Pentalgin-Á	Pills of N 10	1 tablet contains: Metamizoli Sodii – 0.3 g, paracetamoli-0.3 g, codeini – 0.01 grams, coffeini-sodii benzoatis – 0.05 g phenobarbitali – 0.01 g
Piralgin	Pills of N 10	1 tablet contains: Metamizoli Sodii – 0.3 g, 0.1 g of naproxeni, coffeine – 0.05 g, phenobarbitali – 0.01 g, codeini – 0.008 g
Sedalgin-neo (R)	Pills of N 10	1 tablet contains: paracetamoli – 300.0 mg, sodii Metamizoli – 150.0 mg, coffeini – 50.0 mg, phenobarbitali – 15.0 mg and codeini phosphatis – 10.0 mg
Solpadein	Pills of N 6, N 12	1 tablet contains: paracetamoli – 500.0 mg, coffeini – 30.0 mg, codeini – 8.0 mg
Solpadein	Capsules of N 2, N 12	1 tablet contains: paracetamoli – 500.0 mg, caffeine – 30.0 mg,codeine – 8.0 mg
Solpadein	Pills soluble N 2, N 12	1 tablet contains: paracetamoli – 500.0 mg, coffeini – 30.0 mg, codeine – 8.0 mg
Spazmoleks	Pills N 4	1 tablet contains: paracetamoli – 500.0 mg, ditsiklomini hydrochloridi, 10.0 mg, dekstropropoksyfeni hydrochloridi – 50.0 mg
Traifed (R)	Syrup for 100 ml in the small bottles N 1	10 ml syrup contains: tryptolidyni Hydrochloridi – 2.5 mg, pseudoephedrini hydrochloridi – 60.0 mg
Traifed (R) – expectorant	Syrup for 100 ml in the small bottles N 1	10 ml syrup contains: tryptolidyni Hydrochloridi – 2.5 mg, pseudoephedrini hydrochloridi – 60.0 mg, hvayfenezyni – 200.0 mg

 

2. Medicines that are allowed to release without medical prescription, dispensing with the pharmaceutical institutions of all forms of property not more than 2 packages

Compulsory minimum range of drugs

 For pharmacy

Order of MOH of Ukraine 25.11.2004 N 569

1. Adenozintriforic acid	55. Metronidazolum
2. Allocholum *	56. Tincture of hawthorn *
3. Althaea *	57. Tincture  of nettle doggy *
4. Combination of aluminium and magnesium *	58. Solution Natrii chloridi isotonicum *
5. Ambroksol	59. Nafazolin
6. To the ammonia solution *	60. Nicotine acid
7. Amiodaron	61. Nistatin
8. Ampicillin	62. Nitroglycerine *
9. Ascorbic acid	63. Nitroxolinum
10. Asparkam *	64. Nitrofural
11. Atenolol	65. Nifedipin
12. An acetophene and  its  combination	66. Omeprazol
13. Bellasthesinum *	67. Papaverin and its combination
14. Bendazolum	68. Paracetamolum
15. Benzilbenzoat	69. Perekis hydrogen *
16. Valeriana and its combination is with the lily of the valley, deadly, Mentholum *	70. Pertussinum *
17. Validol *	71. Pyracetamum
18. Verapamilum	72. Pyridoxin
19. Vicairum *	73. Platyphyllinum
20. Vicalinum *	74. Polivitamini *
21. Water is for injections	75. Prednizolon
22. Coal is activated *	76. Prokain
23. Heparinum	77. Propranolol
24. Hydrochlorthiazidum	78. Antihaemorrhoidal candles *
25. Glibenclamidum	79. Raunatin *
26. Glyukoza *	80. Regidron *
27. Hormonal contraceptive *	81. Solution of iodine *
28. Dekametoksin	82. Salbutamolum
29. Digoksin	83. Sena *
30. Diklofenak	84. Silibininum
31. Diamond green	85. Solizim
32. Doksiciklin	86. Sulfanilamidum
33. Drotaverinum	87. Thiaminum
34. Eleuterokok *	88. Tocopherolum *
35. Enalapril or his combination	89. Famotidin
36. Iron combination *	90. Folieva acid
37. Inozin	91. Ftalilsul’fatiazol
38. Inhalyptum *	92. Furazolidonum
39. To the calcium chloride	93. Furosemidum
40. Kaptopril	94. Cefazolin
41. Clotrimazolum	95. Cinnarizinum
42. Combination with   ethyl   ether  alpha-bromizovalerianic acids *	96. Cianokobalamin
43. Caffeine-benzoate of sodium	97. Cotton wool or wares is from cotton wool
44. Levamisole	98. Girchichniki
45. Lidocainum	99. Hot-water bottles
46. Liniment is balsam after Vishnevskim *	100. Sparadrap
47. Loperamid	101. A sparadrap is bactericidal
48. To magnesium sulfate	102. Bandaging material
49. Ointment is sulphuric simple *	103. Pipette
50. Mebgidrolin	104. Contraceptives
51. Menovasinum *	105. Devices/systems   are for ³íôóç³é
52. Metamizolum is sodium	106. Sprincivki
53. Metoclopramidum	107. Thermometers
54. Metoprolol	108. Syringes