Alenezi, M.G.

AlJeraisy, M.

Alkelya, M.

Alsultan, M.M.

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PHP23 The characteristics of Pharmacy and Therapeutic Committees in Saudi Hospitals 

A74  VA L U E  I N  H E A LT H  1 8  ( 2 0 1 5 )  A 1 – A 3 0 7  
OBJECTIVES: The Pharmacy and Therapeutics Committee (P&TC) is a policy recom-
mending and enforcing body which oversees the adoption of effective formulary 
system within the health care organization, the aim of the study is to explore the 
characteristics of P& TC in tertiary and secondary hospitals in Riyadh city, Saudi 
Arabia. METHODS: A cross-sectional survey targeted hospital pharmacy mangers 
in Riyadh city in 2014. The survey gathered information about P&TC organizational, 
communicational and functional characteristics. RESULTS: Of 30 hospital pharma-
cies, 23 (76.6%) pharmacy managers responded, 21(70%) hospitals met the inclu-
sion criteria, 15 (71.4%) are governmental and 6 (28.6%) are private hospitals. Of 21 
hospitals, 20 (95.2%) have P&T Committee. 15 (71.4%) committees have all required 
written policies and procedures that govern the committee business. The aver-
age total number of the P&T committee members is 13.5 (SD= 5), and dominated 
by physicians, pharmacists, and nurses (6.9 (SD= 3.4), 2.7(SD= 1.2), and 1.4(SD= 0.8)) 
respectively. 89.5% of these committees are chaired by physicians and 100% of them 
are coordinated by the pharmacists. Only 9 (45%) of the committees distribute the 
meeting agenda to their members 6 days or more before the meeting date. The 
average number of meetings is 12 (SD= 6) meeting per year, drug availability, for-
mulary change updates, drug safety related issues were frequently discussed in 
each meeting of 11(55%) hospital P&T committees. Formulary non adherence is less 
frequently, and prescribing guidelines is the least frequent. The average number of 
drugs deleted or added to the formulary are 6.3(SD= 5.9), 19.2 (SD= 18.9) drug per 
year, respectively. CONCLUSIONS: Adopting P&T Committee in Saudi governmental 
hospitals is a common practice, however, it considered in early stage in private hos-
pitals and more likely to be contributed to the accreditation requirements, therefore, 
more study to be done to study the quality of the committees in private hospital to 
ensure the effectiveness of formulary system.
PHP24
PrinciPles of Policy framework in tHe PHarmaceutical wHolesale 
and retail system in lower income euroPean countries
Inotai A.1, Csanadi M.1, Hanko B.2, Kalo Z.3
1Syreon Research Institute, Budapest, Hungary, 2Semmelweis University Faculty of Pharmacy, 
Budapest, Hungary, 3EÃ¶tvÃ¶s LorÃ¡nd University, Faculty of Social Sciences, Budapest, Hungary
OBJECTIVES: To determine the influencing factors and main principles of regulatory 
and policy framework in the pharmaceutical wholesale and retail system to identify 
good practices for adaptation in Central Eastern European (CEE) countries. METHODS: 
A comprehensive literature review in the scientific and grey literature and a series of 
expert interviews were conducted to identify influencing factors in three major cat-
egories: general political, business economic and health policy principles. RESULTS: 
Regulatory and policy framework related to the pharmaceutical wholesale and retail 
system is influenced by multiple stakeholders with different interest. Health policy 
demands timely access to high quality medicines to maximise health gain for the 
population with respect to equity. Budget constraints necessitate public need for a 
sustainable and efficient pharmaceutical distribution channel. To overcome these 
constraints, pharmaceutical wholesalers and pharmacies have to improve operational 
efficiency by taking into account economies of scale/scope; or positive synergies of 
horizontal and vertical integration. According to general political objectives policy 
makers may choose from 1) regulated vs. liberalised system, 2) with monopolistic 
vs. competing wholesalers and community pharmacies 3) with national vs. interna-
tional, and 4) public vs. private ownership. Pharmacists may consider the provision 
of advanced health care services besides the traditional logistic activities to intensify 
professional influence on health policies. CONCLUSIONS: Evidence base of policy 
and regulatory framework related to pharmaceutical trade can be improved based 
on comprehensive review of scientific evidence on major principles to harmonise 
different objectives of stakeholders. However, publications with relevance to CEE and 
in general lower income countries are very limited.
PHP25
orPHan and ultra-orPHan tecHnologies in tHe new era of Payment 
reform: united states Payer PercePtions
Hogue S.1, Brogan A.P.2, Croft E.3
1RTI Health Solutions, Research Triangle Park, NC, USA, 2RTI-Health Solutions, Research Triangle 
Park, NC, USA, 3RTI-Health Solutions, Manchester, UK
OBJECTIVES: To understand United States (US) payer perceptions and challenges in 
the evaluation of emerging health technologies with orphan and ultra-orphan des-
ignations. METHODS: In-depth, qualitative, one-on-one interviews were conducted 
with US payer decision makers from the RTI Health Solutions US Commercial Payer 
Advisory Panel. RESULTS: In the US, patient access to orphan and ultra-orphan 
technologies is seldom denied due to the rarity of the diseases, unmet needs, and 
lack of alternative treatments. Payers identify the biggest challenges as lack of clini-
cal and comparative efficacy data and pressures from advocacy groups, patients, 
and prescribers to fund the ever-increasing numbers of orphan and ultra-orphan 
technologies, which are often very expensive and have limited clinical evidence. 
Payers estimated that spending for orphan and ultra-orphan technologies will 
increase significantly in the next 5 years, leading to concerns over future funding 
and budgets. Payers were interested in data that could have an impact on costs, cost 
offsets, resource utilization, readmissions, and real-world outcomes in their set-
tings and patient/member populations. Payers wanted to see better-defined patient 
populations and unmet needs accompanied by well-defined treatment courses (e.g., 
when to stop treatment). Benefits of new technologies may not be captured in 
traditional health economic analyses, thus increasing uncertainty. Bridging the 
clinical evidence with other robust data will be critical, because payers will be 
passing on more risk to patients and prescribers in an effort to manage budget 
constraints. CONCLUSIONS: Payers are seeking more value-based information to 
better inform decision making in the evaluation of new orphan and ultra-orphan 
technologies. The challenge to payers lies with the value of the new technology and 
who is judging that value. Rising costs of orphan and ultra-orphan technologies will 
have more impact on market access in the future; over time there will be increasing 
resistance to high prices.
objective of this study was to assess the characteristics of the reviews performed by 
the PMPRB in the period of 1998 to 2014. METHODS: Data for all reviews performed 
by the PMPRB in the period 1998 to 2014 were derived from the PMPRB webpage. 
Descriptive analysis, and trend analysis were conducted. RESULTS: PMPRB reviewed 
a total of 1457 formulations/strengths corresponding to 689 active ingredients and 
combinations in the study period. Seventy percent of PMPRB prices were within the 
guidelines and accepted. Two percent of the prices exceeded the guidelines but did 
not trigger the criteria for commencing an investigation; however, the patentee is 
expected to decrease the price. Three percent of the National Average Transaction 
Price exceeded the Maximum Average Potential Price, which triggered the inves-
tigation criteria and the drug was reported “Under Investigation”. Four percent of 
the drug prices investigated were not excessive. One and half percent of the drug 
prices were considered excessive, and by getting to this conclusion two percent 
of patentees submitted a Voluntary Compliance Undertaking (VCU). Finally one 
and half percent of patentees did not submit a VCU and PMPRB decided that a 
patented medicine was sold at an excessive price in any market in Canada, and the 
PMPRB issued a Notice of Hearing. Drug prices that were within guidelines ranged 
from92.6% (2001 to 2004) to 95.2% (2005 to 2009) respectively. However, it decreased 
to 69.8%in 2010-2014. CONCLUSIONS: The majority of the reviews performed by 
the PMPRB concluded that the prices were not excessive.
PHP21
cHanges of tHe Hungarian HealtH insurance PHarmaceutical 
Budget Between 2007-2013
Boncz I.1, Ágoston I.1, Csákvári T.2, Vajda R.1, Molics B.1, Oláh A.1, Danku N.1, Répásy B.1, 
Endrei D.1
1University of Pécs, Pécs, Hungary, 2University of Pécs, Zalaegerszeg, Hungary
OBJECTIVES: At the end of 2006, there was an important reform in the Hungarian 
pharmaceutical market, including serious changes in the health insurance reimburse-
ment of medicines. The aim of our study is to analyze the changes in the Hungarian 
health insurance pharmaceutical budget between 2007-2013. METHODS: Data were 
derived from the nationwide administrative dataset of the National Health Insurance 
Fund Administration (OEP), the only health care financing agency in Hungary. We 
analyzed the changes of the health insurance pharmaceutical budget between 2007-
2013. Results are given in Hungarian Forint (HUF) and US dollars (USD). The annual 
average currency exchange rates were applied according to the data of the Central 
Bank of Hungary. RESULTS: The Hungarian pharmaceutical budget was 323.6 (2007), 
325.7 (2008), 343.2 (2009), 357.2 (2010), 376.9 (2011), 315.1 (2012) and 280.0 (2013) billion 
HUF. The average annual exchange rate between Hungarian Forint and US dollar was 
183.83 (2007), 171.80 (2008), 202.26 (2009), 208.15 (2010), 200.94 (2011), 225.37 (2012) and 
223.70 (2013), which means that Hungarian Forint significantly weakened compared 
to USD. After the changes in currency exchange rate, the Hungarian pharmaceutical 
budget measured by US dollars was 1.76 (2007), 1.90 (2008), 1.70 (2009), 1.72 (2010), 
1.88 (2011), 1.40 (2012) and 1.25 (2013) billion USD. The decrease of pharma reimburse-
ment budget from 2011 to 2013 was more significant in USD dollar (33.3 %) than in 
Hungarian Forint (25.7 %) due to the weakened Hungarian currency. CONCLUSIONS: 
Due to the reform of the whole Hungarian pharmaceutical market, the Hungarian 
health insurance pharmaceutical budget significantly changed between 2007-2013. 
This change was more remarkable in USD as the Hungarian currency weakened 
compared USD during the world economic crisis.
PHP22
effect of tHe u.s.-Peru free trade agreement on Peruvian new drug 
Policies and tHe registration of PHarmaceutical Products
Araujo L.E., Montagne M.
MCPHS University, Boston, MA, USA
OBJECTIVES: One controversial issue surrounding the Free Trade Agreement (FTA) is 
patent protection and access to medicines. The FTA necessitated changes in Peruvian 
legislation to meet requirements of the treaty. This study evaluated the impact of the 
FTA on number of brand and generic pharmaceuticals registered before and after 
the agreement and implementation of the new legislation of 2009. METHODS: Data 
from 2005 to 2013 were extracted from the database provided by the Peruvian drug 
regulatory authority, DIGEMID. The frequency and proportion of brand and generic 
products registered for the first time at DIGEMID were determined using the vari-
able ‘authorization date of first registration’. Re-registered products were determined 
using the ‘authorization and expiration date’ of registration. Products awaiting regis-
tration were determined by the variable ‘status of application’. Chi-square was used to 
assess differences in proportions. RESULTS: A total of 30,201 pharmaceutical and 913 
biologics products with a unique registration number were evaluated. The proportion 
of new registrations was 74% (n= 1789) for brand and 26% (n= 621) for generic products 
in 2005; and 80% (n= 455) for brand and 20% (n= 114) for generic products in 2013 with 
a decrease of 1,841 (76%) products after legislation. The proportion of re-registrations 
was 66% (n= 714) for brand and 34% (n= 361) for generic products in 2005 with the same 
proportions in 2013 but different frequencies (58 brand and 30 generic) with a decrease 
of 987 (92%) products after legislation. There were statistically significant differences 
between brand and generic products before and after the legislation. The proportion 
of awaiting registrations was 3 times greater for brand than for generic products 
from 2009 to 2013. CONCLUSIONS: Registration of brand products was greater than 
generic products before and after the FTA and new legislation. The frequency of new 
registrations and re-registrations decreased after 2009 but increased for products 
awaiting registration.
PHP23
tHe cHaracteristics of PHarmacy and tHeraPeutic committees in 
saudi HosPitals
Alkelya M.1, Alenezi M.G.2, Alsultan M.M.2, AlJeraisy M.3
1King Abdullah International Medical Research Center (KAIMRC), Ryiadh, Saudi Arabia, 2King 
Saud University, Riyadh, Saudi Arabia, 3King Saud Bin Abdulaziz University for Health Sciences 
(KSAU-HS), Ryiadh, Saudi Arabia


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PHP23 The characteristics of Pharmacy and Therapeutic Committees in Saudi Hospitals

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