Allergosan sopharma gsd 2012 2015

www.wjpr.net Vol 3, Issue 10, 2014.

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Petkova et al. World Journal of Pharmaceutical Research

MARKETING STRATEGIES FOR RETAINING THE MARKET SHARE

OF PHARMACEUTICAL PRODUCTS AFTER THE PATENT

PROTECTION

1Antoaneta Cvetkova,

2Valentina Petkova*,

3Anna Todorova,

2Milen Dimitrov

1Medical College, Medical University – Varna, Bulgaria.

2Faculty of Pharmacy, Medical University – Sofia, Bulgaria.

3Faculty of Pharmacy, Medical University – Varna, Bulgaria.

SUMMARY

After a patent expires, pharmaceutical companies face the risk of

losing market shares. Reclassifying a brand drug that is “prescription

only” as OTC (over-the-counter) drug is a company strategy for

retention of revenue and profit that come from the sales of this product.

The tendency for reclassification of medical products as OTC drugs

corresponds both to the already prevailing model of patient-centered

care in the health systems and to the greater autonomy of the individual

patient in health care. The decision to switch from Rx to OTC is a real

challenge.

KEYWORDS:- patent expires, reclassification, pharmaceutical companies face.

INTRODUCTION

According to Art.171 [1]

of the Law on the medicinal products in human medicine, the

medicinal products dispensed on the Bulgarian market shall be classified as medicinal

products dispensed with medical prescription and medicinal products dispensed without

medical prescription (over-the-counter drugs). [9]

In most countries, access to and supply of medicinal products are governed by a regulatory

framework which is based on the risk-benefit assessment of a particular drug. In the United

Kingdom, for instance, there are three categories of medicines: POM (prescription only

medicines) – drugs available to patients only when prescribed by a medical practitioner, P

(pharmacy supervised sale) – drugs sold only under the supervision of a pharmacist, and GSL

World Journal of Pharmaceutical Research SJIF Impact Factor 5.045

Volume 3, Issue 10, 01-07. Research Article ISSN 2277– 7105

Article Received on

07 October 2014,

Revised on 29 Oct 2014,

Accepted on 19 Nov 2014

*Correspondence for

Author

Dr.Valentina Petkova

Faculty of Pharmacy,

Medical University-

Sofia, Bulgaria.

,


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(general sales list) – drugs available even outside pharmacies. [1]

These three categories are in

dynamic equilibrium and jointly shape the pharmaceutical market. When a new medicinal

product is licensed for use in the UK for the first time, in accordance with the evidence of its

safety and efficacy provided in the preclinical period, it is classified as POM. Two years later,

this medicine can be reclassified as P, unless there are specific circumstances to retain its

POM status, which is the more normal practice. The reclassification of a medicine goes

through a stringent and precise process of evidence submission and consultations with the

MHRA (Medicines and Health care products Regulatory Agency).

In Europe, there are also clear requirements about the criteria defining when a medicine

retains its POM status (Directive 92/26/EEC). There are various options for reclassification

across European countries, regardless of the initiatives for achieving harmonization of

pharmaceutical regulations within a common framework. When the patent expires, generic

products enter the market almost immediately, causing drastic decline in market share and

sales slump. The switch from Rx status to OTC status can be a good strategy for sales

retention long after patent expiration. Switches are motivated mainly by three factors:

pharmaceutical firms' desire to extend the viability of brand names; attempts by healthcare

funders to contain costs; and the self-care movement. Making drugs available over the

counter affects a large number of stakeholders, including patients, pharmaceutical firms,

physicians, pharmacists, drug regulatory agencies, and private and public health funding

organizations. [3]

Over the counter licensing is linked to direct to consumer advertising. [2]

This gives much

more marketing possibilities for drug promotion, as switch to over the counter can become

indirect advertising directly to consumers. [4]

A successful Rx-to-OTC switch depends on

several factors including the intensity and timing of the OTC marketing campaign of the drug

itself. [5]

In practice however, it is unusual for companies to switch the drug status as long as the patent

is still valid. The decision for drug reclassification is dependent on healthcare policies across

countries and, in particular, on attitudes of medical professionals, evolution of scientific

knowledge, national reimbursement and pricing policies, brand rules and regulations. Drug

deregulation reduces public expenditures, because when a number of drugs switch from

prescription-only to OTC status, they attract new consumers who already do not need a

prescription from a medical practitioner. Since 2007, there have been common European


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standards guiding the reclassification to OTC status. There is also a draft guide developed by

the European Medicines Agency (EMA) on the packaging of OTC drugs, which includes

guidelines on pictorial symbols, web link, etc. supposed to help patients sort through the

information. The UK has the most “liberal” regime for switching to OTC status. Italy and

Hungary are also in the process of approving the sale of OTC drugs outside pharmacies. [6]

The aim of the European regulatory bodies is to introduce a centralized unified European

guidance on OTC drug status by 2015. (10) The number of medicines that have their status

switched to OTC will continue to grow worldwide, particularly the number of drugs for

treatment of chronic conditions. On a global scale, the most well-established procedures for

switching to OTC status are in the US, the UK, Germany, Spain and Mexico. [8]

Objectives: To examine the impact of drug reclassification on the sales volume across

pharmacies in the city of Varna.

Methodology: We surveyed four allergy products after their switch to OTC status and

examined the impact on their sales volumes. We used data provided by a retail pharmacy

chain of five pharmacies located in the city of Varna.

FINDINGS AND DISCUSSION

For the purpose of this research, we decided to trace the changes in sales volumes of four

different medical products: Allergosan tb. (Chloropyramine hydrochloride) 25 mg / 25

Tablets; Lorano tb. (Loratadine) 10 mg / 7 Tablets; Zyrtec tb. (Cetirizine dihydrochloride) 10

mg / 10 Tablets and Claritine tb. (Loratidine) 10 mg / 10 Tablets.

We selected these antihistamines for a couple of reasons. Allergosan is a typical antiallergic

agent manufactured by a Bulgarian company - Sopharma AD, it is familiar to patients across

a wide age range, and its price is low (BGN 3.06). Zyrtec tb. is a brand name drug

manufactured by UCB Pharma GmbH, Germany. In comparison with Allergosan, it is a more

recent product with less side effects, its dosing is more convenient, but its price is

considerably higher (BGN 13.53). Lorano tb. and Claritine tb. are drugs with different brand

names but with the same INN (both products have the same original molecule - loratadine).

Lorano tb. and Claritine tb. are non-sedating antihistamines with relatively lower prices as

compared to Zyrtec. Lorano tb. is manufactured by Salutas Pharma GmbH Otto-von-

Guericke-ALLee 1 and its price is BGN 11.60. Claritine tb. is manufactured by Schering-

Plough and its price is BGN 11.60.


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Table 1 displays unit sales data by year (the data corresponding to the year of reclassification

are in bold).

Table 1. Unit sales before and after deregulation.

Zyrtec Allergosan Lorano Claritine

2008 332 439 Not available 430

2009 480 652 276 627

2010 404 955 389 515

2011 662 1028 344 478

2012 417 1198 397 536

Data show that the sales of all surveyed products increased after the Rx-to-OTC switch.

Especially distinct is the sales trend of Allergosan tb. - the sales in 2012 increased 2.73-fold

in comparison to the sales in 2008 (the year preceding the status switch). The sales after the

switch to OTC status of the other surveyed drugs increased as well – a 1.26-fold increase for

Zyrtec tb, a 1.44-fold increase for Lorano tb, and a 1.25-increase for Claritine tb. The sales of

Allergosan for the period 2008-2012 surged at an average annual sales growth rate of 213.16

percent. Though Claritin tb. saw a downward sales trend from 2009 until 2011, its average

annual sales growth rate from 2008 through 2012 was 124.72 percent. For the same period,

Zyrtec tb. faced an unstable growth and an average annual sales growth rate of 14.88 percent.

For the period 2009-2012, Lorano tb. experienced an unstable growth and its average annual

sales growth rate was 135.78 percent.

The graphs below display the sales trends of each separate product.

Fig.1 Allergosan tb. Fig.2 Zyrtec tb.


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Fig.3. Claritine tb. Fig.4. Lorano tb.

The model of annual sales trends was developed with regression analysis techniques. As we

can see, the annual sales of Allergosan continued an upward trend throughout the entire

period, whereas Zyrtec tb. faced an unstable sales growth. As a result of deregulation, both

Allergosan and Zyrtec faced an increase in sales in the first year of Rx-to-OTC switch. And

while this uptrend continued throughout the entire period for Allergosan, Zyrtec faced an

increase in sales and sales fluctuations alike. It seems reasonable that the economic crisis and

the considerably higher price of Zyrtec have influenced consumers in their decision to choose

Allergosan rather than Zyrtec.

Fig.5 Sales volume in pharmacies before and after deregulation.


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As a result of deregulation, both Lorano sales and Claritine sales rose in the first year after

the Rx-to-OTC switch. In the years following the peak in 2009, both products experienced a

sales decline. Still, the levels of sales remained higher than 2008 (the last year the medicines

were dispensed on prescription). Throughout the entire period, both products faced a gradual

increase in sales, more pronounced for Lorano tb. The similar trends of both medicines

indicate the impact of market factors over the sales.

Fig.6 Sales volume in the pharmacies before and after deregulation.

CONCLUSIONS

Intensifying competitive pressure in the health care market and patients’ discontent with the

long waiting times for prescriptions create favourable conditions for a future broadening of

pharmacists’ authority to include pharmaceutical care activities. The trend to deregulation

from POM status and the fact that OTC drugs are available only in pharmacies should be

considered by the pharmacy profession as an opportunity for extending the range of effective

patient counselling and a way of maintaining market positions. The Rx-to-OTC switch

enhances the sales volume and has a positive impact on retailers.

The tendency of Rx-to-OTC switch is inextricably linked to another tendency – the transfer

of drug related costs from the government to the individual consumer. As far as low-priced

OTC drugs are concerned, this is not a major issue. However, some of the newly deregulated

drugs are quite expensive, which additionally restricts patient access and increases health

inequalities. There is a trend toward broadening the range of medicines with OTC status. The


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OTC market is becoming more competitive and profitable. The Rx-to-OTC switch is one of

the strategies for retention of revenue and profit resulting from product sales. [7]

According to FDA, pharmacists have not only more professional opportunities but also more

responsibilities within this new drug paradigm. [11]

REFERENCES

1. Bond C. The OTC Pharmaceutical Market - Policy and Practice. Pharmaceutical

Monitoring Journal, XII, 2011; 6(64): 5.

2. Bunney RG (2005) Switching prescription drugs to over the counter: Over the counter

licensing is linked to direct to consumer advertising, BMJ, 2005; 330: 906.

3. Cohen JP, Paquette C, Cairns CP (2005) Switching prescription drugs to over the counter,

BMJ 2005 330:39-41)

4. Duerden M and Walley T (2005) Direct to consumer marketing: Switch to over the

counter can become indirect advertising directly to consumers, BMJ, 2005; 330: 906)

5. RX-to-OTC Switching. Market Analysis, Data & Figures, Press Release, www.the-

infoshop.com/press/fe14207_en.shtml, Navigant Consulting, Inc., Accessed November

2014.

6. Major S, Vincze Z, Self-medication in Hungary, from the Perspective.

7. http://www.arbilis.com/periodicals.php?magid, Danchev N, Nikolova I, Petkova V,

Benbassat N, OTC medicines: Bulgarian and World Experience. Science Pharmacology

Journal, No. 1/2011.

8. http://ec.europa.eu/health/ph_overview/Documents/strategy_wp_en.pdf, WHITE PAPER

Together for Health: A Strategic Approach for the EU 2008-2013

9. http://lex.bg/laws/ldoc/2135549536

10. http://www.medicinenet.com/script/main/art.asp?articlekey=79398, Stoppler, M. Alli

(orlistat) Weight Loss Drug Available OTC,

11. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3411219/, Barlas, St. FDA Considers a

New Paradigm for Over-the-Counter Medications, P&T, May 2012; v 37(5).

Брой 6, юли 2014 г.26

Възможностите за лечение на алергииПредстави проф. Николай Данчев в рамките на презентация на Софарма

„Първата описана алергична реакция е преди 5500 години; първият фараон на Египет умира след ухапване на пчела.

Алергията „променя“ и римската история. Император Claudius е имал син Brittannicus, който страдал от алергична реакция към коне, до степен, че очите му отичали и се затваряли до пълна слепота. Това е причината, доведения син на Claudius, Nero, да стане император. Nero убива Britannicus и собствената си майка, ставайки причина за падението на Рим.

Крал Richard III (Крал на Англия през 15-ти век) е бил алергичен към ягоди”. Така накратко бе описана историята на алергиите от проф. д-р Николай Данчев, зам.-декан на ФФ към МУ-София, който изнесе лекция на тема „Лечение на алергия с продукти на Софарма”.

Алергията на практика представлява реакция на свръхчувствителност, вследствие производството на анти-тела - Имуноглобулин Е (IgE), локализирани в мастоцити-те в тъканите и базофилите в кръвта и масивно освобож-даване на хистамин. По данни на СЗО, алергиите засягат 30% от населението. Деца, чиито родители имат алергия, е по-вероятно да развият също такава. При един родител с алергия, рискът е 50%, а ако и двамата родители имат такава, той нараства до 70%.

Някои от най-честите алергени са прахът, храни като мля-ко, яйца, ядки, морски продукти, насекоми, полени, лекар-ства като пеницилини, цефалоспорини, АСЕ инхибитори, НСПВС, домашните любимци, латексът и др.

Антихистамините блокират ефектите на хистамина, кой-то е основната субстанция, образувана от организма при алергична реакция. Прилагането на антихистамини е най-честото лечение на алергиите, напомни проф. Данчев.

Той очерта какви са преимуществата на Алергозан® (хло-ропирамин хидрохлорид) таблетки при лечение на ринит, уртикария, атопичен дерматит и пр.

При ринит например, медикаментът ефективно намаля-ва отока и назалната секреция, повлиява възпалението и премахва зачервяването, премахва сърбежа и дразненето, спира интензивното отделяне на секрети в горните диха-телни пътища, потиска центъра на кихането и намалява ка-шлицата, възстановява назалната проходимост дори при 5-дневна терапия в редуциран наполовина дозов прием, редуцира необходимостта от назални деконгестанти, които обострят ринита при продължителна употреба.

За разлика от антихистамините втора генерация, Алер-гозан® (хлоропирамин) блокира не само H1-хистаминови-те рецептори, но и проявява конкурентен антагонизъм по отношение на мускариновите и серотонинови рецептори.

Блокирайки парасимпатикусовата регулация, свързана с обилното секретоотделяне, той води до ефективно потис-кане на симптомите на ринита – оток на лигавицата, назал-на конгестия, ринорея, кихане, сърбеж в носа.

Медикаментът оказва влияние върху рецепторите в про-дълговатия мозък и хипоталамуса и потиска центъра на кихането.

Лекарството е доста ефективно и при уртикария. Тя пред-ставлява хетерогенна група от заболявания, характеризира-ща се с бърза поява на уртики и/или ангиоедем. Кожните про-яви са резултат от действието на възпалителни медиатори (хистамин, серотонии др.), освободени от кожните мастоцити. Ангиоедемът се среща в около 40% от случаите с уртикария и се дължи на същите мeдиатори, освободени от мастоци-тите в подкожието и по-дълбоките слоеве на дермата. Фар-макокинетичния профил на Алергозан® (хлоропирамин) пре-възхожда, този на "новите" антихистамини, които подържат постоянни високи нива на плазмена концентрация - над 98%, слабо тъканно разпределение и имат продължителен пери-од на елиминиране от тялото. Алергозан® (хлоропирамин) има балансирано разпределение в тъканите - над 80%, ниска плазмена концентрация - под 10% и кратък период на пълно елиминиране, което обяснява липсата на кардиотоксичност и риск от лекарствени взаимодействвия.

За разлика от Второ поколение антихистамини, терапия-та с Алергозан® (хлоропирамин) осигурява ефективен кон-трол въху неприятните симптоми на най-често срещаните кожни алергични заболявания, като: атопичен дерматит, контактен дерматит, уртикария, хранителни и лекарствени алергии, инсектни дерматити и др.

В заключение може да се каже, че Алергозан® (хлоропира-мин) е с добре установена употреба, има мултимодален ме-ханизъм на действие (вкл. серотонин), седативен компонет, което е важно при стрес и тревога. Освен това е удобен, тъй като се предлага в различни лекарствени форми – таблетки, крем, унгвент. „Медикаментът фармакоикономически пре-възхожда другите антихистамини”, обобщи проф. Данчев.

Най-използваният антихистамин в България(1):a бърз и ефективен при остри алергични реакции(2)

a благодарение на комплексния си механизъм на действие, e ефективен при по-голяма част от симптомите на ринит, в сравнение с антихистамините втора генерация(2)

a по-голям брой одобрени индикации в сравнение с втора генерация антихистамини(3,4,5,6,7)

a дозови форми, съобразени с индивидуалните нужди на пациента

АЛЕРГОЗАН®

ПЪРВА ПОМОЩ ПЪРВА ПОМОЩ ПРИ ОСТРИ АЛЕРГИИ?ПРИ ОСТРИ АЛЕРГИИ?

Референции:1) Данни на IMS Bulgaria – Market of Antihistamines

2009-20132) Морозова С.В., Лусс Л.В. Супрастин: современные

аспекты применение. Available at: http://medi.ru/doc/a02404.htm

3) КХП Алергозан табл. – юни 2012 г.4) КХП Ериус табл. – октомври 2013 г.5) КХП Зиртек табл. – ноември 20136) КХП Ксизал табл. – март 20147) КХП Кларитин табл. – декември 2011

Пълна лекарствена информация е на разположение при поискване.Софарма АД, София 1220 , ул. „Илиенско шосе“ № 16,България, тел.: +359 2 8134200

Изпълнителна агенция по лекарствата, [email protected]ИАЛ-18886/07-05-2014 год.

z

Full Length Research Paper

THE ROLE OF THE PHARMACIST IN ACHIEVING THERAPEUTIC EFFICACY AND COST EFFECTIVENESS IN THE MANAGEMENT OF ALLERGIC RHINITIS

1Tsvetkova, A.,

2Todorova, A.,

1Tsvetkov, L.,

1,*Mihailova, S. and

3Dimitrov, M.

*,1

Assistant Pharmacist, Education and Research Center, Medical College of Varna, Medical University of Varna, Bulgaria 2Department of Pharmaceutical Sciences and Pharmaceutical Management, Faculty of Pharmacy, Medical University of

Varna, Bulgaria 3 Department of Drug Technology and Biopharmacy, Faculty of Pharmacy, Medical University, Sofia

*Corresponding Author

Received 29th March 2015; Accepted 30th April 2015

Abstract Introduction: The explosive growth in the number and variety of drugs has proven the pressing need for health professionals who can provide both physicians and patients with medical advice on the drugs available and on the potential adverse drug reactions (ADRs). Therefore, counseling and consultation have become a key component of pharmacist-provided patient care activities. Pharmaceutical care as a new direction in pharmacy practice has evolved over the years. Pharmaceutical care is focused on promoting patient-centered health care that should supplement rather than supplant the care provided by physicians and other health professionals. Pharmaceutical care has risen to the challenges of the increased prescription volume, the wide variety of new drugs, and the need for comprehensive drug-related information. (2) Objectives: To outline the role of the pharmacist in the responsible provision of therapeutically appropriate and cost-effective disease management Methods and materials: We examined the therapeutic algorithm in the management of allergic rhinitis in order to define the pharmacist’s role in providing both medical advice on a self-medication programme, and professional assessment of health conditions that require physician supervision to guarantee patient safety. Results: Pharmacists play a key role in providing professional advice on a self-medication programme for the treatment of intermittent and mild persistent allergic rhinitis. In these cases, appropriate management with OTC antihistamines can ensure good disease control and reduce healthcare spending for individuals and health insurance funds alike.

Keywords: ADR, Antihistamines, GPP (Good Pharmacy Practice), Pharmaceutical Care, Self-Medication.

Copyright © Tsvetkova et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. To cite this paper: Tsvetkova, A., Todorova, A., Tsvetkov, L., Mihailova, S. and Dimitrov, M. 2015. The Role of the Pharmacist in Achieving Therapeutic efficacy and cost Effectiveness in the Management of Allergic Rhinitis. International Journal of Information Research and Review. Vol. 2, Issue, 04, pp. 593-596

INTRODUCTION The NDP (National drug policy) is a component of the National health policy designed to meet patients’ needs, to provide patient access to safe and affordable medications, and to ensure good therapeutic outcome. The NDP is implemented by various institutions such as the Parliament health committee, the Ministry of Health, The national Health Insurance Fund, the Bulgarian drug agency, and the National Council on Prices and Reimbursement of Medicinal Products, (www.parliament.bg). Inefficiently incurred treatment costs may result from inadequate drug dispensing and inappropriate dosage regimen, unclear instructions in the patient information leaflet, and packing that fails to ensure drug quality. Pharmacists’ active participation can prevent the irrational use of drugs. Pharmacist-delivered patient counseling is the final checking process for ensuring the correct administration of drugs. Therefore, pharmacists should have the necessary skills

and competence that ensure an errorless dispensing process and adequate treatment control, (weruditabg.com/? pid=9&NewsID=130). Major health-related social issues, such as reducing the level of morbidity and mortality resulting from drug abuse, are within the scope of pharmaceutical care. Therefore, the duties and responsibilities of pharmacy practitioners should be clearly defined, (Petkova et al., 2007). To add value to society, each profession should meet specific needs. Through the application of pharmaceutical knowledge, including the use of medicines, pharmacists play a key role in the provision of healthcare services to the public. The concept of pharmaceutical care shifts the focus from the drug to the patient, without disregarding the value of pharmaceuticals. (Petkova et al., 2005 and Petkova et al., 2006). Although the pharmacotherapy prescribed by the physicians often includes both prescription drugs and OTC drugs, the responsibility for the treatment with OTC drugs is primarily borne by pharmacists. Thus, pharmaceutical care can be implemented to

ISSN: 2349-9141

Available online at http://www.ijirr.com

International Journal of Information Research and Review Vol. 2, Issue, 04, pp. 593-596, April, 2015

OPEN ACCESS JOURNAL

a full extent in the process of OTC drug treatment, (Petkova et al., 2005). The implementation of pharmaceutical care requires compliance with the guidelines on good pharmacy practice (GPP). GPP includes standards for pharmacists’ professional attitude towards patients, as well as standards for pharmacists’ professional self-assessment and self-monitoring, thus ensuring the high quality of pharmaceutical services. The compliance with GPP standards is supported and controlled by the Quality Committee of the Bulgarian Pharmaceutical Union (BPU) and by the Ethics and quality committees at the regional pharmaceutical associations of the BPU. The compliance with GPP standards benefits the pharmacists in performing their professional duties, but above all it benefits the society guaranteeing rational and safe drug use. Healthcare systems in Central and Eastern Europe face serious challenges in terms of patient access to healthcare services and medications:

The average GDP percapitain Central and Eastern Europe is 5 time slower than the average GDP in the EU member states

Personal health care expenditures per capita in Central and Eastern Europe are less than EUR 400, whereas they are as high as EUR 1600 in the rest of the EU member states. (9)

In the developed countries, the role of the pharmacist in the dispensing of drugs takes on greater importance. Pharmacists contribute to the safe and effective use of medications. They play a substantial role in the promotion of rational drug use by providing patients with drug information, by promoting the substitution of brand-name products with appropriate generic products, and by participating in drug use researches. (8) In collaboration with physicians and other healthcare providers, pharmacists take part in government programs for disease prevention and health promotion by optimizing and monitoring the prescribed drug therapies. The pharmacist is a reliable source of medical information and an intermediary between the physician and the patient in delivering adequate therapy. Various researches have proven that generics not only reduce the treatment costs but also prevent the potential spending growth. Furthermore, the increased use of generics improves the access to drug therapy. Generic substitution promoted by pharmacists creates high potential for cost savings. OTC drugs and prescription drugs that are excluded from the reimbursement lists do not affect the spending of public healthcare funds. This is a feasible control mechanism, provided that there are well established legislation rules and regulations. Rational drug policy is a prerequisite for good patient access to prescribed drug therapies that are reimbursed by public funds. The legislative and executive government institutions, professional organizations, patients, and the pharmaceutical industry have their relevant role in this process. Over the past 5 years, the use of generics in the Bulgarian pharmaceutical market has driven down the average daily cost of treatment by 23%, and the access to treatment has increased by 80% for seven therapeutic main groups (Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholesterol regulators and oral anti-diabetics), (http://www.bgpharma.bg/bg/za-lekari-i-farmacevti.html). Ulgarian patients need a modern and realistic government strategy for pharmaceutical care, which can identify their needs, promote the collaboration among health

professionals, and enhance the shared responsibility for safe and effective drug use. Pharmacists are an essential factor for the improvement of public health and a key component in the successful implementation of the national health strategy.

The national drug policy defines the following guidelines for improving public health:

Improving patient access to safe medications with high quality

Optimization and coherence of the registration and pricing regulations of drugs

Introducing an integrated information system for drug prescribing and dispensing

Improved control over the distribution Maintaining control over the distribution practice of

medicinal products Training of health professionals in rational drug use Raising the awareness of patients about the rational drug

use of medicines Provision of medicinal products and medical devices Introducing a methodology for the reimbursement of

medicinal products and medical devices to ensures better patient access

Introducing modern systems for medical information and control over the process of prescribing and dispensing of medicinal products and medical devices

Educational intervention in improving health professionals’ competence on rational drug use

Independent drug information services

There is an inextricable mutual linkage between the profession of pharmacy and the implementation of these guidelines.

RESULTS AND DISCUSSION

We will support our argument with the evidence-based pharmacy model for implementing a therapeutic algorithm in the management of allergic rhinitis. Responsible self-medication is “the practice where by individuals treat their conditions with medicines which are approved and available without prescription, and which are safe and effective when used as directed.” The community pharmacies are the most appropriate setting for advising and counselling on a self-medication programme. Community pharmacists are the health professionals most accessible to the public. They can offer professional medical information and counselling that meets patients’ needs for anappropriate self-medication plan and tailor-made healthcare services, (Petkova et al., 2005; Petkova et al., 2007). According to ARIA guidelines, the first-line treatment for all types of allergic rhinitis, regardless of the symptom severity, are the topical or oral non-sedating H1-receptor antagonists. Second generation oral antihistamines (Cetirizine, Levocetirizine, Loratadine, Desloratadine, Fexofenadine) are favoured in the management of all types of allergic rhinitis for two main reasons: firstly, they do not cause central nervous system side effects such as drowsiness and fatigue, and secondly, they have higher H1-receptor affinity. (Zyrtec et al., 2007) However, the OTC status of antihistamines underlies their indiscriminate administration without professional supervision. (Dykewicz et al., 1998) This focuses the attention on the role of the pharmacist as a source

594 Mihailova et al., The role of the pharmacist in achieving therapeutic efficacy and cost effectiveness in the management of allergic rhinitis

of counselling and advice on the management of intermittent and mild persistent rhinitis, where good disease control can be achieved and maintained. The pharmacist has to identify the type of allergic rhinitis and decide whether to recommend an appropriate treatment with OTC drugs, or to refer the patient to a physician in cases of poorly controlled severe persistent rhinitis. Figure 1 below shows the therapeutic algorithm of pharmaceutical care and the two potential alternatives for allergic rhinitis management – either a pharmacist-guided self-medication plan, or a consultation with a medical specialist when the condition necessitates it. Therapeutic algorithm in the management of allergic rhinitis

Once the allergic rhinitis has been identified as intermittent or mild persistent and the patient’s choice is self-medication, the therapeutic algorithm recommends pharmacist-provided counselling and advice on appropriate drug therapy at an affordable price. This alternative suggests the purchase of OTC drugs (antihistamines) as the final stage. The treatment cost includes only the OTC drug price set in accordance with retailers' price caps. There are no treatment costs incurred by sick leaves or hospitalization charges. Table 1 below includes several potential alternatives for generic substitution, which the pharmacist can recommend in accordance with patient’s condition and financial abilities. The four medicines are intended for the treatment of AR and have an OTC status.

Table1. Alternative choices for self-medication of AR with OTC antihistamines

Medication Patient expenditures, BGN per pack

Allergosantabl.( chloropyramine hydrochloride 25 mg)

3,06

Loranotabl.(loratidine) 4,63 Zirtectabl.(cetirizine dihydrochloride) 13,52 Claritin tabl.(loratidine) 11,60

The pharmacist can recommend alternatives for generic substitution, and the purchase decision depends on patient’s preferences and financial abilities. Patients’ out-of-pocket payments affect the decision making process, since OTC drugs are not reimbursed by public health funds and patients face additional access barriers. The concept of pharmaceutical care

shifts the focus from the drug to the patient, without disregarding the value of pharmaceuticals. (2) In the short run, the benefit for the patient is the low price of the drug. In the long run, however, the appropriate drug choice, the optimal dosage regimen and the reasonable drug price will generate substantial savings not only for the individuals, but for the health insurance funds as well. Thus, unnecessary medical consultations and hospitalizations, high rates of sickness absence, and poor quality of life can be successfully avoided. Pharmacists are able to assist, counsel and facilitate the correct choice of drugs, since they have a direct contact with patients and very often are the only health professionals that can monitor the treatment process. Many patients face financial constraints, others have below basic or basic health literacy skills, and others simply demonstrate their discontent with the provided health care services. Each separate case requires an adequate approach and proactive attitude to stimulate the demand in accordance with the concept of pharmaceutical care and professional conduct standards. When the recommended therapy fails to provide a good therapeutic outcome, the pharmacist should refer the patient to the GP or to a medical specialist. This is the decisive key role of the pharmacist as the health professional who can objectively assess patient’s condition and prescribe the optimal therapy, thus ensuring a good therapeutic outcome. The results from the collaboration among different health professionals strongly exceed the results of the separate efforts of physicians, pharmacists, other healthcare professionals, patients, legislators, and regulatory bodies.

Conclusion

Being at the end of the drug supply chain, pharmacists provide drug manufacturers and distributors with professional feedback on the quality, efficacy and safety of the drugs available in the pharmaceutical market. They provide counselling to patients who have chosenanappropriate self-medication plan on the basis of sufficient information and objective assessment of the specific symptoms. (7) Playing the role of the intermediary between physicians and patients, pharmacists face increasing expectations and are challenged to meet stringent professional requirements.

595 International Journal of Information Research and Review Vol. 2, Issue, 04, pp. 593-596, April, 2015

REFERENCES Dykewicz, M. S. and Fineman, S. 1998. Executive Summary of

Joint Task Force Practice Parameterson Diagnosis and Management of Rhinitis. Ann Allergy AsthmaImmunol, 81:463-468.

http://infobulgariahelp.blogspot.com/2013/01/2007-2013. National Health Strategy 2007-2013.

http://www.bgpharma.bg/bg/za-lekari-i-farmacevti.html Petkova V., A. Antonova, 2005. Communication - A Key

Component of Pharmaceutical Care,Pharma News, 34(2): 3-10.

Petkova V., Physicians, 2006. Pharmacists and Patients’ Compliance with Chronic Treatment in Bulgaria, Pharmacoepidemiology and Drug Safety, 15(8): 607-612.

Petkova, V., 2007. Pharmaceutical Care for Chronically Ill Patients and its Impact on Patient Quality of Life, Pharma news, 36(1): 3-11.

rfk-sz.org/files/Pravila.DAP.MZ.pdf. Guidelines oh Good Pharmacy Practice.

weruditabg.com/?pid=9&NewsID=130.Guidelines on Good Pharmacy Practice as a Guarantee for Rational and Safe Use of Medicinal Products.

www.bgpharma.bg/userfiles/.../StatiaConfRadisOk.doc. Drug Regulations Challenges in the EU Process of Membership.

www.parliament.bg. The rational drug use policy – a Guarantee for Improved Patient Access to Medications.

Zyrtec (cetirizine) packageinsert. FortWashington, PA: McNeil-PPC, Inc; 2007.

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596 Mihailova et al., The role of the pharmacist in achieving therapeutic efficacy and cost effectiveness in the management of allergic rhinitis

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