Marketing Strategies for Retaining Market Share of Pharmaceutical Products After Patent Expiry

www.wjpr.net Vol 3, Issue 10, 2014. 1
Petkova et al. World Journal of Pharmaceutical Research
MARKETING STRATEGIES FOR RETAINING THE MARKET SHARE
OF PHARMACEUTICAL PRODUCTS AFTER THE PATENT
PROTECTION
1
Antoaneta Cvetkova, 2
Valentina Petkova*, 3
Anna Todorova, 2
Milen Dimitrov
1
Medical College, Medical University – Varna, Bulgaria.
2
Faculty of Pharmacy, Medical University – Sofia, Bulgaria.
3
Faculty 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.
,

(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

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.

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.

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.

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

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 алергии
Представи 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 ПОМОЩПЪРВА ПОМОЩ
ПРИ ОСТРИ АЛЕРГИИ?ПРИ ОСТРИ АЛЕРГИИ?
Референции:
1) Данни на IMS Bulgaria – Market of Antihistamines
2009-2013
2) 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 2013
6) КХП Ксизал табл. – март 2014
7) 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, bda@bda.bg
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
1
Tsvetkova, A.,
2
Todorova, A.,
1
Tsvetkov, L.,
1,
*Mihailova, S. and
3
Dimitrov, M.
*,1
Assistant Pharmacist, Education and Research Center, Medical College of Varna, Medical University of Varna, Bulgaria
2
Department 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=9NewsID=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=9NewsID=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.
*******
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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