july/august 2013 doh launches nationwide ‘healthy...

July/August 2013

DOH launches nationwide ‘healthy lifestyle movement’

FDA advises against e-cigarette use

In Practice

Study evaluates role of pharmacists in family planning

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Healing through music endorsed

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Framework for quality pharmacy education

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News | Pharmacy Today | July/August 2013 2

Organizations warn against ghost pharmacists

By Lauren Laforteza

According to the FDA Advisory No. 2013-11, the Philippine Pharmacists Association (PPhA) and the Drug-

stores Association of the Philippines (DAP) informed the public last April 13, 2013 of existing drugstores operating without reg-istered pharmacists.

Seventy percent of pharmacies in the CA-MANAVA region were considered as “ghost pharmacies,” which then alarmed the local Food and Drug Administration, according to PPhA executive vice president Dr. Yolan-da Robles. Because of this, the FDA initiated to address the problem of existing “ghost pharmacies” and the lack of pharmacists to serve as mediators for public health goods delivery, not only in CAMANAVA but in the whole country as well.

As stated in the Pharmacy Law (Section 27 of RA 5921), the operation of drug outlets should be managed by licensed pharmacists who had undergone mandatory training as required by DOH AO No. 56 s. 1989 or the Re-vised Regulations for the Licensing of Drug Establishments and Outlets. These pharma-cists are obliged to have their PRC license cer-tificates displayed in their respective outlets.

The launching of DOH’s Botika ng Baran-gay last 2000 showed the scarcity of licensed pharmacists, amounting to only 20,000 as of October 2012. This project served as a means of making government-supplied medicines available and accessible to the masses. Along with DOH, FDA contributes its assistance in maintaining this kind of

health system. However, with the conspicu-ous lack of registered pharmacists, the FDA struggles to guarantee the accessibility of essential drugs to every barangay with the limit imposed by Section 27. In line with this, the association sought to reassess the rules and regulations incorporated in the Pharmacy Law.

Reports to the DOH secretary Dr. Enrique Ona by the FDA last October 2012 stated that some regulations inhibit the availabil-ity of drugs and other health products in some areas in the country. A disproportion of community working registered pharma-cists and FDA-licensed drug establishments was observed after the January 2012 meet-ing between the FDA and PRC, according to Ms. Marilyn Tiu, chairman of the Board of Pharmacy.

Last February 2012, the FDA and Dr. Vir-ginia Ala of the National Center for Phar-maceutical Access Management addressed the alignment of goals of both parties. To ensure the protection of the public’s wel-fare, the FDA will conduct conferences with stakeholders and legislators to help resolve this current issue.

To address this existing problem, the FDA encourages pharmacists, drug store owners, as well as customers to observe the existing Pharmacy Law. The FDA requests pharmacists to observe the Code of Ethics for Pharmacists and for drug outlet owners to follow the provisions stated in AO No. 56 s. 1989. Consumers are recommended to purchase their medicines and health prod-ucts in legitimate drug stores.


The Champions for Health Governance Awards is a pro-gram that recognizes outstanding local government units (LGUs) for excellent and efficient implementa-

tion of local health programs. The Ateneo School of Govern-ment, the Department of Health, the Department of the Inte-rior and Local Government, Kaya Natin! movement and MSD have chosen five local government units for their outstand-ing community and public health programs. The five winners were Valenzuela City; Carmona, Cavite; Tayabas, Quezon; Anilao, Iloilo; and San Pablo, Zamboanga del Sur.

Some of the measures implemented by the LGUs were a customized ambulance for cit-izens living in the mountains dubbed Sakyananni Nanay, barangay emergency midwives and pageants for pregnant women. Dr. Teodoro Herbosa, undersecretary of health, said these LGUs are the proof that decentralization of healthcare is an effective strategy to bring health care closer to the people.

Dr. Teodoro Herbosa during the awarding

Health initiative awards outstanding LGUs

DOH launches nationwide ‘healthy lifestyle movement’

The Department of Health formally launched nationwide ‘healthy life-style movement’ PilipinasGo4Health

on June 6, 2013, to control rates of non-communicable diseases (NCDs) that the department reports to be on the rise due to improper diet, insufficient exercise and ex-cessive drinking and smoking.

PilipinasGo4Health encourages Filipinos to commit to physical activity, proper nutri-tion and cessation or prevention of tobacco and alcohol consumption citing “abundant

scientific and social evidence” that hab-its like these comprise the “path to better

Health secreatry Dr. Enrique Ona and Dr. Eric Tayag discuss the impor-tance of healthy lifestyle.


Study evaluates role of pharmacistsin family planning

By Maria Katrina Florcruz, MD

Arecent study done in the US evalu-ated the roles of pharmacists in in-creasing access to contraception are

being evaluated. The University of Washing-ton-School of Pharmacy conducted a commu-

nity-based intervention study aimed to inves-tigate the implementation of a collaborative drug therapy protocol to screen and counsel women for safe and hormonal contraceptives prescribed by community pharmacists.

Family planning, as defined by the World Health Organization, is a program that allows

health,” articulated health secretary Dr. En-rique Ona.

The worldwide toll of cardiovascular dis-ease, respiratory disease, diabetes and can-cer is 36 million lives annually, established the DOH press release on launch day. It further specified that 10 Filipinos die every hour due to cigarette smoking-associated diseases such as lung cancer, emphysema and bronchial disorders.

Ona also called out to drinkers and would-be drinkers, describing the effect of alcohol as “complex,” possibly leading to impairments in judgment and risky behav-ior that could result in road accidents or violent acts.

The Global Adult Tobacco Survey (GATS) in 2007 showed that 57.8 percent of youths live with smokers and 67.9 percent are ex-posed to smokers outside their homes. The 2009 GATS found that 17.3 million Filipinos ages 15 years and older are tobacco smok-ers. The Food and Nutrition Research Insti-tute informed DOH that only seven out of 100 adult Filipinos get “vigorous exercise” at least three or four times a week.

Ona explained, “GATS data show that a number of smokers accessed tobacco when they were very [sic] young to make informed choices. By the time they are old enough, they find it very hard to quit and some may already suffer its consequences.” He cited “misinformation or lack of infor-mation, indifference and careless practices and habits” among Filipinos when it comes to their health.

“We believe that every Filipino has the right to a healthy family, community and country. As lead advocate for the nation-wide healthy lifestyle movement, we work hand-in-hand with different sectors to pro-vide options for healthy living and make it accessible to as many people as possible,” pledged the movement’s web page at www.go4health.ph.

The web page provides lifestyle sugges-tions for various age groups such as kids, youth and adults as well as roles or settings such as parenting, education, health care and the workplace. Web page visitors may also download documents containing information on tobacco, alcohol, diet and exercise.


planning methods. In the US study, researchers identified

women at risk of unintended pregnancy. In order to evaluate if the women can safely use contraceptives, the researchers obtained the women’s weight, blood pressure and medical and contraceptive use history. Contraceptives were then dispensed by the pharmacists according to protocol guidelines.

Results of this foreign study showed that community pharmacists can efficiently screen women for safe use of hormonal contraceptives. The subjects expressed their willingness to continue seeing pharmacist prescribers for contraceptives. However, the patients reported that they also intend to have a gynecologic exam within three-year intervals while taking the contraceptives.

In the local setting, accessibility to family planning information and services are provided by doctors, nurses, midwives and

trained healthcare workers. These sectors help couples of reproductive age plan their family according to medically acceptable methods. Women’s reproductive needs are also made available and accessible through reproductive health care services.

At present, there are various family planning methods available and several of these options require prescriptions. Examples of these birth control methods include oral contraceptive pills, injectibles, patch, barriers and intrauterine devices. These medically prescribed contraceptives require a visit to a healthcare provider and medical supervision during the course of use.

“The major challenge therefore is how to monitor the implementation of the program, making sure that the support of the public does not wane. We also need to guarantee the financial sustainability of the program in the years to come through a sustained budget support,” said Ona.


By James Salisi, MD

Bioequivalence studies for generic drug products benefit everyone ac-cording to Leslie Benet, PhD, profes-

sor of Bioengineering and Therapeutic Sci-ences, Schools of Pharmacy and Medicine, University of California San Francisco.

“Bioequivalenc studies save money for consumers, patient care organizations and governments. They can be used to change formulation components, manufacturing pro-cess, manufacturing site and other pre-ap-proval changes,” Benet said.

“We are concerned as pharmacists in thera-peutic equivalence. In the US, there is a law that says what this is. Therapeutic equivalence is considered when drug products have phar-maceutical equivalence and can be expected to have the same clinical effect and safety pro-file when administered to patients under the conditions specified in the labeling,” Benet explained.

The professor also added that the criteria for pharmaceutical equivalence include same active ingredient, route of transmission, iden-tical in strength or concentration and same dose form.

“The issue with generic equivalence is the huge financial impact that it can have on gov-ernment, patients, and of course the pharma-ceutical industry. So, there is a great tempta-tion to mislead,” Benet said.

The same dose form criterion is still being

used in the US while the rest of the world got rid of this. Benet explained that the pharma-ceutical industry is against getting rid of this criterion for various reasons, but the common one being that it is often used to slow down generic equivalence approvals.

This criterion has been used by Somerset Pharmaceuticals to block the manufacturing of generic selegiline tablet by arguing at that time that the tablet, which they pulled out of the market and whose patent had expired, was not available anymore and therefore not equivalent to the capsule that they replaced it with.

Benet considered the US FDA definition bad because of the ambiguities of the terms “absorbed” and “site of drug action.”

“We are not interested in absorption; we are interested in bioavailability. It says avail-able at the site of action and in order to do that we must know the site of action and we can’t do that,” Benet explained.

This definition of bioavailability is used to discredit generic products that only have bio-

Bioequivalence studies for generic drug products benefit everyone

The Philippine Pharmacists Association National Convention 2013, 25-27 April 2013, Philippine International Convention Center


equivalence studies. Pharmaceutical compa-nies mislead people by saying that bioequiva-lence studies in healthy volunteers are not the same with patients. They also insist that bio-availability studies be done on patients when there is no significant difference in the efficacy and safety of bioequivalent products between healthy volunteers and patients.

Benet urged pharmacists to be vigilant about the misinformation and muddling of ambiguous definitions that pharmaceutical companies are prone to disseminate to dis-credit generic products that use bioequiva-lence studies.

A standard bioequivalence study consists of a cross-over experimental design with a small number of healthy adults (usually 24 to 36) administered with single doses of test and reference products. Measures of area un-der the curve and the peak blood or plasma

concentration are examined by statistical pro-cedures.

Two products are considered bioequiva-lent when their rate and extent of absorption differ by -20 percent / +25 percent or less.

Because healthy volunteers are the least variable test subjects for drug therapy, they are chosen as test subjects or population for bioequivalence studies.

Furthermore, no drug products that have been shown to be bioequivalent in healthy volunteers have then been demonstrated not to be bioequivalent in patient populations.

Benet emphasized that no prospective study has ever found that a US FDA approved generic product does not show the same clinical efficacy and safety as the innovator product, even when special populations like elderly, women, and severely sick patients are studied.

By Gabriel Angelo Sembrano

Pharmacy is ‘business unusual.’ It is not plainly sell-sell-and-earn but sell-earn-and-care,” said Ms. Leonila

Ocampo, president of the Philippine Phar-macists Association, as she explained the na-ture of operating a pharmacy in brief.

According to Ocampo, pharmacy entre-preneurship is both a health profession and a retail business, providing opportunities to serve patients and earn money. Services are delivered professionally in the most cost-ef-

fective manner while earning profit for a sus-tainable operation.

“This demands a more careful understand-ing of the business model in the context of pa-tients’ expectations, government regulations and the organization’s desire to succeed,” said Ocampo.

A good sense of pharmacy entrepreneur-ship comes with a number of requirements, according to Ocampo who spoke from ex-perience. Unlike other business ventures, it is a field that requires proper education and the development of the right competencies.

Expert describes good pharmacy entrepreneur


A proper pharmacy degree would equip one with the right knowledge, skills and attitude in running the business. With proper funda-mentals, one may easily grasp the principles of pharmacy management and develop man-agement skills. She also stressed that knowing the legal requirements in pharmacy operation is paramount to avoid any violations.

Ocampo highlights the need to determine the kind of products and services a pharma-cist wishes to offer by identifying guidelines to decision-making. This is done by figur-ing out one’s goals, purpose and strategies. Through this, he or she will be able to learn how to set priorities and identify the right branding or unique selling proposition.

Ocampo also added that the service pro-gram to be offered should clearly spell out how patients’ safety is protected and how convenience is offered in the most cost-effec-tive manner. This could be achieved by under-standing that stresses in patients are brought about by three things: inconvenience in the acquisition of medications, the high cost of medications and side and adverse effects of medications.

A good pharmacy entrepreneur should also know the difference between cash flow and profit. According to Ocampo, the pharmacy

operator does not solely “own” the money in the cash register, but that the suppliers should also be considered.

Although the law indicates that a pharma-cist must stay in the pharmacy, Ocampo rec-ommended that a good entrepreneur must understand the importance of networking and relationship building especially with fel-low pharmacists. Through this, he or she will be able to learn from others’ experiences.

She also added that one should be ready to adapt to higher stress levels and workloads, and must be prepared to face team manage-ment issues and to value the essence of team-work. There should be an acceptance of the idea that in running this kind of enterprise, everyone needs each other.

“There is no place for lies because when you succeed [in lying] for the first time, the next instances will definitely get you into trouble,” said Ocampo as she reminded everyone about honesty. A good pharmacy entrepreneur should represent himself or herself honestly by doing more than what he says and always supporting case with actions.

Finally, she identifies a good entrepreneur as someone who knows when to exit. When things do not work out, the courage of calling it a day is key, said Ocampo.

Patient education improves complianceBy Maria Katrina Florcruz, MD

Patient education improves medica-tion knowledge and inhaler technique among adult asthmatics, according to

a study done at the University of the Philip-

pines-Manila, College of Pharmacy. In the re-search, high cost of medication and lack of fi-nancial resources were identified as the main causes of non-compliance to medication.

There is a high prevalence of asthma in the local urban areas, with 27 to 33 percent of chil-


dren and 17 to 22 percent of adults with defi-nite or probable asthma. Uncontrolled asthma is often attributed to poor compliance to treat-ment, leading to reduced health-related qual-ity of life and high burden of disease cost. The investigators of the descriptive, correlational study aimed to evaluate the effect of asthma patient education on medication knowledge and compliance with medication regimen.

A total of 10 male patients from the Asthma Comprehensive Care Unit of the Philippine General Hospital participated in the research. A pre-test questionnaire was used to obtain demographic profile and baseline knowledge on asthma medication and inhaler use. The subjects attended an asthma patient education lecture followed by a post-test evaluation.

Proper inhaler technique was demon-strated using a training video followed by a graded return demonstration. Follow-up was done after six weeks to verify compliance and knowledge on medication and inhaler use.

The subjects had an age range of 40 to 69 years old and all of them were unemployed. Majority of the participants were single and reached tertiary level of education. On the

average, they have been known asthmatics and are under salbutamol or budesonide/formoterol inhaler therapy for seven to nine years. However, it was found that compliance remained low due to the subjects’ limited fi-nancial resources and non-prioritization of health needs.

Only monthly income in relation to occu-pation had a significant effect on the pre-test scores of the patients. Although there was an increase in the post-test knowledge scores on medication and inhaler use, the research-ers noted that patient education may be more effective when personalized and given indi-vidually.

There was an initial 12 percent improve-ment in asthma inhaler technique after the video demonstration. However, there was a 2 percent decrease in scores after six weeks. The investigators suggested the need for regular patient follow-up in order to reinforce the proper use of the inhaler and help increase compliance with asthma medication.

Researchers recommended an increase in sample size and inclusion of newly diagnosed patients in future studies.

Self-assessment for students must be improvedBy Gabriel Angelo Sembrano

Self-assessment practices related to the communication and counseling perfor-mance of students need to be improved

in order for them to gain better patient medi-cation counseling skills, according to re-

searchers from the University of Sto. Tomas. The study primarily aimed to evaluate the

accuracy of pharmacy students’ self-assessed patient medication counseling skills. The study concluded that there was a slight agree-ment between the students’ self-assessed non-verbal communication skills and the in-


structors’ assessment of their performance, as reflected in a result of Kappa (ave) = 0.55 (95 percent CI; 0.352 > 0.05). Furthermore, the researchers also found out that there is a fair agreement between the students self-assessed verbal communication skills and of their in-structors’ based on a result of Kappa (ave) = 0.253 (95 percent CI; 0.174 > 0.05).

According to the researchers, slight and fair agreements for non-verbal and verbal communication skills respectively, imply that pharmacy students need to improve their self-assessment practices.

In the study, the researchers involved 30 fourth-year pharmacy students aged 18 to 21 years old, with 60 percent being females. These students were enrolled in a Pharma-ceutical Care 4 laboratory course at a compre-hensive university. Pharmacy cases were then assigned to each of the students, and counsel-ing sessions with pseudo-patients were vid-eotaped.

After viewing their own videos, research-ers asked the subjects to answer a validated self-assessment form concerning verbal and non-verbal communication skills.

The verbal communication skills assess-ment form contained 39 items, and each had to be rated as complete, partially complete and none. The non-verbal communication skills assessment form had seven items and con-tained the following choices: strongly agree,

agree, disagree and strongly disagree. Then, their instructors evaluated these using vali-dated evaluation forms. Using Cohen’s Kappa in SPSS version 17.0, inter-rater reliability was analyzed and the consistency between the self-assessed counseling skills of pharmacy students and instructors’ assessment of their performance was determined.

Effective medication counseling is an inte-gral part in the practice of pharmacy and is es-sential towards the improvement of the qual-ity of healthcare, according to the researchers. Developing valuable teaching and learning activities to improve communication and counseling skills in the curricula for pharma-cy education is also crucial. In a Pharmaceuti-cal Care 4 course, students are tasked to do extemporaneous compounding and counsel-ing of different prescriptions. Feedback tech-niques such as video recording are employed to aid students in their development of non-verbal and verbal communication skills.

Verbal communication skills consist of establishing caring relationship, gathering information, providing information, verify-ing patient’s understanding of medication, other significant activities and closure of pa-tient counseling sessions. On the other hand, non-verbal communication skills include eye contact, body movement, body posture, facial expression and tone and loudness of voice during counseling.

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Flavonoid extracted from red cabbage has antimicrobial activity

The Philippine Pharmacists Association National Convention 2013, 25-27 April 2013, Philippine International Convention Center

By James Salisi, MD

The flavonoid quercetin isolated from the red cabbage plant has antimi-crobial activity against Staphylococ-

cus aureus and Escherichia coli comparable to tetracycline, concluded a study by Mr. Rufo Calixto from University of Perpetual Help System, Laguna.

Red cabbage or Brassica oleracea Linn f. capi-tata var. rubra is locally known as “repollong pula” and is known to contain flavonoids, which are potent plant compounds that ex-hibit antioxidant, antimicrobial, anti-inflam-matory and anticarcinogenic activities. The investigator aimed to demonstrate the antimi-crobial property of red cabbage against three bacterial and two fungal isolates, determine its minimum inhibitory and bactericidal or fungicidal concentration, and compare the effectiveness of the red cabbage flavonoid against the standard bacterial and fungal antibiotic.

In the experiment conducted by Calixto, the flavonoid quercetin present at concen-tration of 211.13 µg/mL from extracts of the red cabbage exhibited antimicrobial activity at 52.8 µg/mL as both minimum inhibitory concentration (MIC) and minimum bacteri-cidal concentration (MBC) against E. coli. For Staphylococcus aureus, the MIC and MBC were 105.5 µg/mL.

There was no significant difference be-tween the antibacterial action of the isolated

quercetin and tetracycline as standard against S. aureus.

However, the isolated flavonoid did not ex-hibit antibacterial activity against Pseudomo-nas aeruginosa. The investigator attributed this to the intrinsic resistance to many different types of antibiotics that makes it difficult to eliminate. Additionally, the same amount of isolated quercetin did not exhibit antifungal activity against Candida albicans and Tricho-phyton mentagrophytes.

The study characterized, isolated and quantified the specific flavonoids in red cab-bage using Reversed Phase High Perfor-mance Liquid Chromatography (HPLC). Red cabbage collected from Benguet State Univer-sity farm in La Trinidad, Benguet was used. It was dried and powdered using a grinder. The semi-purified flavonoid residue was purplish in color and syrupy in consistency.


The flavonoids were extracted from the ground substance and confirmed by the chemical tests Bate-Smith and Metcalf meth-od and Wilstatter “Cyanidin” tests. Calixto used HPLC analysis of the flavonoid extract to identify the exact flavonoid in red cabbage. The chromatogram of the extract revealed that the flavonoid in red cabbage is quercetin.

Calixto quantified quercetin using the ab-solute calibration curve method, which es-tablishes linearity between two variables: the

concentration of target substance in standard solutions and peak area of the chromatogram. To test the antimicrobial activity of the isolat-ed quercetin, he used the paper disk diffusion assay which revealed that antibacterial activ-ity against S. aureus and E. coli was achieved at 211.13 µg/mL. The average zone of inhibi-tion was 25.2 mm.

The results of this study are promising as plant sources are increasingly being used for their antimicrobial property.

Fresh latex from local mango may treat warts

By Maria Katrina Florcruz, MD

A study showed the potential of fresh latex from the unripe fruit of Philip-pine carabao mango (Mangifera in-

dica L. Carabo variety) in removing human Verruca vulgaris or the common wart.

Researchers from Centro Escolar Universi-ty-College of Pharmacy found that compared with placebo and control group, common warts treated with fresh latex resolved in as early as one to two weeks.

Verruca vulgaris is a viral infection that causes cutaneous lesions with raised rough-ened surface. They usually grow on the hands and feet, but can occur anywhere on the body. The study aimed to investigate the effective-ness of the local mango latex in wart removal through its caustic and skin irritation prop-erty. This may serve as an inexpensive alter-native for the various treatment modalities of common warts.

Fresh latex was collected from unripe ca-rabao mango fruits and underwent physical tests for color, odor, appearance, miscibility and specific gravity. Results showed that the collected sample has milky color and consis-tency which turns to transparent liquid after a few days of storage. Phytochemical evalu-ation revealed the presence of protein, resin and terpenoids.

Primary skin irritation test of mango latex was done on the ears of animal models, which resulted in erythema and crusting of the skin surface. Interpretation grading of the mouse ear test procedure proved that the substance has sufficient irritant activity but not percep-tibly irritant to human skin.

The effect of continuous application of the fresh latex to Verruca was tested on 15 hu-man subjects that were randomly assigned into three groups: placebo, positive control (salicylic acid topical solution) and experi-mental.


Results showed that in the placebo group, one of the three subjects had further growth in the lesion size while the rest remained un-changed. In the positive control group, three subjects received salicylic acid topical solu-tion. At the end of the study, there was wart removal in one subject while the remain-ing two showed no observable changes. The researchers owed this to the fact that the study time period did not reach one month, which was the minimum amount of time needed for salicylic acid to take full effect.

In the experimental group, all nine subjects

showed complete resolution of the warts in one to two weeks.

Adverse effects observed during the treat-ment include blisters, itching, redness, burn-ing sensation and hyperpigmentation. These effects resolved within two weeks.

Further tests may be done to evaluate the oil and protein polysaccharide fraction of the fresh latex and to identify the active compo-nent of the substance. Researchers recom-mended further studies that can establish the stability and effective dose of fresh latex from Philippine carabao mangoes.

Feature | Pharmacy Today | July/August 2013 14

Framework for quality pharmacy education

By Ian Carlos Achero

Pharmacists’ roles have transitioned from product-oriented to a patient-oriented approach. With this change in

required competencies, the Philippine Phar-macists Association (PPhA) invited Mr. Mi-chael Rouse to discuss quality assurance (QA) in pharmacy education. Rouse is the director for International Services of the Accreditation Council for Pharmacy Education, the US na-tional agency for accreditation of continuing pharmacy education and degree courses. He is also the convener of the International Fo-rum for QA of Pharmacy Education.

The need for a global frameworkBecause the expanded roles of pharmacists

are not yet widely known, Rouse said this caused confusion and slowed the implementation of new practice models. Adding to the confusion, pharmacy education, practice and QA systems vary from country to country. To address the need for an international QA consensus, the forum was established within the International Pharmaceutical Federation (FIP). Global standards, as espoused by the World Federation for Medical Education, are inappropriate for pharmacy education, according to the FIP statement on QA of

Feature

pharmacy education. “It’s important that each country develop its

own philosophy and structure for education,” Rouse said.

Instead of global standards, a framework was developed by the forum. This is intended as a foundation that can be adopted and built upon to suit each country’s needs. Unlike global standards, the framework for pharmacy education does not advocate for any one model or QA system but instead describes different approaches to QA.

The Global Framework for QA of Pharmacy Education was developed by FIP, with validation and revisions added by international third parties. Citing the framework, Rouse said that different professions, including pharmacy, modify

Mr. Michael Rouse explains the need for a localized practice guidelines.


three main areas for advancement: practice, education and regulation. Changes in one area bring about changes in the other two areas. For example, changes in regulation may be required to change practice patterns, especially if practice is deeply held. It is also essential for gaps to remain small between these three areas. For example, if pharmacy educators implement a goal for pharmacy practice but practitioners and regulators do not support it, graduates may become disheartened if practice is markedly different from what they have learned.

Pillars and foundations of educationRouse designed an analogy comparing

quality pharmacy education with a building supported by pillars and foundations. The five pillars for quality are context, structure, process, outcomes and impact. These pillars stand on three foundations of education that include science, practice and ethics.

According to Rouse, context is the starting point for pharmacy education.

“What is the context in which our education is being delivered?” Asked Rouse.

Preferably, the school’s mission, vision and values should align with national and community needs, as well as the culture the school develops. Evolving technologies and trends in the local setting can be included in education.

Structure includes resources (eg, human, financial, technological), collaborative relationships and organizational structure in the college of pharmacy. Structures should be placed in context where education is being delivered, said Rouse. Structures can be likened to raw materials which can be manufactured to become a product. The third pillar, process, refers to management

plans, teaching methodologies and curricular development. These processes shape structures towards the attainment of goals.

“We are focusing more and more now on outcomes [of our practice],” noted Rouse. Examples of outcomes include the practice-readiness of graduates, quality and quantity of research produced, community service rendered and practice advancement. The impact of the previous four pillars can be manifested by changes in the community or entire nation, he said. These impacts include scientific innovations, graduates who become leaders and agents of change, and resolution of health care issues in the community.

Science, considered as the first foundation, guides the scholarly activity of a school, said Rouse. Appropriate qualifications of academic staff, scientific foundation of the curriculum and evidence-based curricular content are necessary for a science-based education, he explained. The second foundation, practice, requires involvement of preceptors to reinforce application of learning. Experiential learning with preceptors occurs during practice. The third foundation, ethics, guides pharmacists in decisions about appropriate patient care and rational medicine use.

The global frameworkAfter discussing the pillars and foundations

of education, Rouse then outlined the framework. It has four parts: the context of quality pharmacy education, the QA agency, policies and procedures, as well as quality criteria.

In addition to the needs of the community, stakeholders are a part of the context of QA. The government is a stakeholder because it has the duty to protect the interests and wellbeing of the public. Students are also stakeholders


as the primary recipients of quality education. According to the framework, universities and colleges as stakeholders can benefit from standardized, external evaluation. In the end, the general public benefits from the system pharmacists create and, therefore, are considered stakeholders as well.

Different models of QA are part of the context. In the traditional model of QA, government agencies are responsible for regulation of education. Another model assigns QA under the responsibility of the national pharmacy organization (eg, PPhA) or institutions to self-regulate.

The QA agency, the second part, needs to have a structure and purpose. Rouse emphasized the importance of legal and statutory status of the agency because it outlines its authority, accountability and autonomy to make decisions. It is also important who recognizes the agency (ie, government health department) and what influence it can exert. For example, if the QA agency can influence licensure and employment of pharmacists, necessary laws need to be approved.

The third part, policies and procedures, refers to procedures to evaluate colleges of pharmacy. For example, policies must list key components the QA agency will use to evaluate pharmacy schools. The prerequisites needed to approve a school also fall under the policies and procedures of the framework.

The core elements of QAThe quality criteria are the principles and

core elements for QA. Similar to the pillars mentioned earlier, the criteria are composed of three parts: outcomes, structure and process.

According to Rouse, educational outcomes

and competencies need to be measured to know the effectiveness of teaching. The school also needs to evaluate its curricular structure based on assessment of students and staff. Schools can adapt their required competencies from the seven roles of pharmacists acknowledged by the FIP and WHO. These seven roles exemplified by the “seven star pharmacist” are care giver, decision maker, communicator, leader, manager, life-long learner and teacher. Schools may describe competencies in terms of high-level objectives (eg, provision of patient care, health promotion, disease prevention) or more specific low-level competencies.

Physical facilities, financial resources and faculty are part of the structure of quality criteria, Rouse pointed out. The framework recommends having sufficient number of full-time faculty and staff. The physical facilities need to be safe, well-maintained and adequately equipped. Practice sites for students such as hospitals and pharmacies are recommended to promote experiential learning.

Processes in quality criteria are required to manage everyday operations of the school. For example, processes for enrolment management, academic policies and teaching methodology are needed to ensure proper operation for staff and students.

Rouse ended his lecture by saying that even with the different QA systems around the world, the framework did not discuss the merits of one system over another. This is because the principles and core elements in the framework can be applied with modification for each country. He also said countries should have their own national system of QA adapted to contemporary and emerging pharmacy practice.

In Practice | Pharmacy Today | July/August 2013 17

FDA advises against e-cigarette use

By Ian Carlos Achero

Citing research from the German Can-cer Research Center (DKFZ) Unit Cancer Prevention and the WHO

Collaborating Center for Tobacco Control, the Food and Drug Administration of the Philippines (FDA) announced that second-ary exposure to e-cigarettes may be harmful to health. According to Advisory No. 2013-15, the FDA said e-cigarettes released vola-tile substances such as propylene glycol, fla-vours and nicotine into indoor air. If several people use e-cigarettes at the same time in a room, air pollution can accumulate and re-sult in harmful second-hand exposure. E-cig-arettes are used predominantly because they are believed to be less harmful than regular cigarettes. Some also believe it can help them quit smoking.

Research from the two organizations showed that e-cigarettes cannot be rated safe. The devices emitted nicotine, tobacco-specific nitrosamines, benzo(a)-pyrene, silicate and various metals. Tobacco-specific nitrosamines are formed from nicotine and related tobacco alkaloids. These substances are carcinogenic both in humans and animals. Benzo(a)pyrene is found in coal tar and is also carcinogenic. Propylene glycol, the main ingredient used to produce vapor, may cause respiratory irritation and possibly increase the risk for

In Practice

asthma. The sizes of particles emitted were found

to be between 100 to 600 nanometers which is comparable to particle sizes found in smoke from regular cigarettes. Even though the levels of harmful ingredients were lower in e-cigarettes, the emissions still accumulated in room air.

The FDA also noted that four metals, namely sodium, iron, aluminium and nickel, have higher levels than those in regular cigarette smoke. Copper, magnesium, lead, chromium and manganese were also present in the same amount. Nickel and chromium are carcinogenic and lead is suspected to be carcinogenic, the FDA said.

The DKFZ reported various technical flaws. Device leakage may lead to excessive swallowing of nicotine or absorption in the


oral mucosa or through the skin. Depending on nicotine content, these flaws may provoke symptoms of intoxication.

The research found that some e-cigarettes may reduce cravings and withdrawal symptoms. However, researchers also found that even e-cigarettes without nicotine can

reduce the desire to smoke and withdrawal symptoms. The mere holding of the product, sucking at it and inhaling the aerosol can reduce withdrawal symptoms, the research said. The FDA urges local government units to be guided by the advisory in strengthening ordinances against smoking in public places.

PHAP pioneers a training program for health sectors

By Lauren Laforteza

The Pharmaceutical and Healthcare As-sociation of the Philippines (PHAP), in line with the organization’s advocacy

to promote universal healthcare, launched a pioneering training and development pro-gram, fostering commitment to patient inter-est and well-being.

Accredited by the Professional Regulation Commission, the Integrity and Proficiency Program for the Pharmaceutical Sector (IPPS) revolves around the national campaign of good governance and business ethics pro-moted by the government and private sec-tors, emphasizing on patient focus, as well as principles of integrity, transparency, indepen-dence and accountability.

In order to provide their intended health care, IPPS warrants patient-centered deci-sions. This includes ethical, appropriate and professional relations between pharmaceuti-cal companies, healthcare professionals, med-ical institutions and patient organizations. In order to serve the patient’s best interest, em-ployees interacting with the aforementioned

sectors are made competent by undergoing training and assessment. These training mod-ules are categorized as mandatory, recom-mended and optional.

Modules in the mandatory training encom-passes Philippine healthcare landscape, anti-corruption laws, the Mexico City Principles For Voluntary Codes of Business Ethics in the Pharmaceutical Sector and the 1993 PHAP Code of Ethics, which “sets the standards for the ethical marketing and promotion of prescription products directed to healthcare professionals as well as covers rules related to interaction with medical institutions and patient organizations”.

Recommended and optional modules on the other hand are more particular, training individuals in their specific roles. Included are basic pharmacology, physiology, basic anatomy, among others.

The IPPS aims to proactively ensure that member companies are aligned with the highest accepted standards of integrity in the context of best professional and ethical business practices.

The program would also equip mem-


ber companies with knowledge on ethical business practices provided by the Indus-try, PHAP and Government. In addition, it is expected that representatives will be

accredited professionally and will be able to establish a standard for developing professional growth in the health care industry.

FDA develops IT to improve services

The Philippine Food and Drug Admin-istration (FDA) has started work on the use of information and communi-

cations technology (ICT) to improve its ser-vices and regulatory functions.

According to Dr. Peter Glenn Chua during his presentation on the use of ICT in drug regulation at the Health Information System Forum in Mindanao held last May 2013, the FDA plans to implement several IT programs to monitor drug prices and pharmacy registration, mapping of accredited establishments, licensing, clinical trial database for medical devices and adverse events experienced by patients.

“The use of ICT in FDA is crucial. Part of the law is the creation of database for price monitoring. What the National Center for Pharmaceutical Access and Management (NCPAM) relies on the enforcement power of FDA,” Chua of FDA explained.

The FDA faces the challenge of lack of public access to the database of establishments and health products with valid authorizations.

“Pharmacies fail to send data to the FDA about their records on health products. This then forces the FDA to refuse to renew outlets’ authorization to sell drugs. Thus, consumers may be buying medicines from unauthorized pharmacies,” Chua said.

The mandate of FDA should be to close establishments without accreditation for drug provision. Records are important for customs, users and costumers. If the database has holes, it is unreliable and may lead to patchy monitoring and proliferation of unregulated drugs.

In order to address this problem, the FDA plans to map the establishment using Global Positioning System (GPS) technology. The consumers will be able to locate the authorized pharmacies in Google and other mobile device applications.

“We are working with Google for GPS tagging to ensure that these establishments exist in GPS coordinates. We are looking at the end of 2013 to create a digital map where [one] can locate a licensed pharmacy in a map,” Chua said.

Crowd sourcing information about average market price, preference and availability of certain drugs will also be done to enhance


monitoring.Licensing of retailers and pharmaceutical

businesses is another area that the FDA plans to improve with ICT. According to Chua, a single window will provide issuance of clearance for release of imported products. All imported products even those from “balik-bayan” boxes would be monitored.

As for licensing, the fee for licenses is being restructured and the processes of obtaining them are being streamlined. Currently, registration of new drugs cost PhP 350,000 with licenses valid for five years.

Another application of ICT is the clinical trials database relevant to medical devices.

This is to monitor health products with on-going trials in the country.

Protecting consumers from substandard drugs and drugs that have adverse effects is part of the mandate of FDA and in this regard they plan to enhance pharmacovigilance through an online reporting system for health professionals, post-marketing surveillance activities and results of laboratory test of patients experiencing adverse events due to a particular drug.

“We protect them at first glance and those reporting adverse events will be protected. Hopefully, we’ll report more comprehensive data next year,” Chua concluded.

21 Shorts | Pharmacy Today | July/August 2013

ShortsGSK addresses health issues for denture wearers

GlaxoSmithKline, the maker of Polident denture adhesive cream and powder, in cooperation with dental experts, recently held an event called A Healthy Life in Every Bite. The advocacy aims to highlight the ef-fects of improper use and care of dentures, which can ultimately lead to health issues among denture wearers.

According to dental experts, many denture users are not aware of the correct way of wearing it and the importance of having the proper fit. Experts remind denture users that unlike natural teeth, dentures are more porous and requires more cleaning. Regular toothbrush and toothpaste create abrasions on the dentures where stuck food sediments may harbor harmful bacteria.

Participants of the event were taught how to take advantage of the products that help clean their denture and keep them properly fit. Denture adhesive cream and powder can give denture-wearers up to 12 hours of hold and properly fitting dentures, giving them the ability to eat, speak and smile with confidence. Cleansing tablets are also available for clean-ing dentures without scratching, which helps preserve the life of dentures.


Unique eye imaging system acquired for newborns

The International Eye Institute of St. Luke’s Hospital Quezon City acquired the first RetCam3 imaging system for newborns in the Philippines. RetCam3 is a fully-integrated, wide-field digital imaging system used to capture images of the retina and anterior chamber of premature infants and children. It is excellent for the diagnosis and documentation of retinopathy of prematurity (ROP), the single leading cause of childhood blindness.

ROP affects the eyes of premature and underweight babies who received intensive neonatal care. It is caused by disorganized growth of retinal blood vessels. Dr. Jose Jimenez IV, ROP service head of St. Luke’s Hospital Quezon City said the new technology will “not only allow more accurate judgments of the eye condition of the babies but more so bring about better documentation and progress monitoring of ROP cases to save or recover eyesight.”

Healing through music endorsed The media launch of Himig ng Kalinga was held at Dusit Thani Hotel last July 3, 2013. Two speakers, Dr. Jocelyn Eusebio, a devel-opmental behavioral pediatrician, and Ms. Celeste Sanchez, the mother of Philippine Music Therapy graced the event. Television personality Suzi Abrera hosted the event. GlaxoSmithKline Philippines instituted the Himig ng Kalinga program supported by doctor-recommended paracetamol (Calpol) and in partnership with hospitals in Metro Manila and Luzon.

Volunteer mothers sang the lullaby Gagaling Ka Rin written by composer Jimmy Antiporda. According to Eusebio, when soothing music occupies the mind, it allows the patient to es-cape into his or her own world that facilitates relaxation for the patient. She said music en-ables the patient to focus on something pleasant which promotes healing.

From left: host Suzi Abrera, Dr. Jocelyn Eusebio, Ms. Celeste Sanchez and Ms. Rachelle Gamboa, Calpol product manager, GSK Philippines.


Hydrocortisone safer than dexamethasone in premature babies

Researchers at the Wilhelmina Children’s Hospital of the University Medical Center Utrecht, the Netherlands, found that hydrocortisone may be a better alternative to prevent damage to the immature lungs of premature babies.

According to Dr. Karina Kersbergen, medical researcher, and Dr. Manon Benders, neonatolo-gist, MRI scans showed that hydrocortisone have fewer adverse effects on brain develop-ment than dexamethasone. Corticosteroids are widely given to premature babies to promote surfactant production in immature lungs.

Aside from decreased brain size by 20 percent to 30 percent, infants treated with dexametha-sone have more development problems in later life. “We believe that our research could encourage the use of hydrocortisone instead of dexa-methasone in this vulnerable group of infants,” said Benders.

The difference between hydrocortisone and dexamethasone might be explained by differ-ences in receptor binding in the brain. Hydrocortisone is metabolized faster and can also be administered in smaller doses. This study was published in the Journal of Pediatrics.


Health groups push for intensive TAPS ban implementation

The Philippine College of Chest Physicians (PCCP) and The Framework Convention on To-bacco Alliance Philippines (FCAP) urged the government to intensify its implementation of banning of tobacco advertising, promotion and sponsorship (TAPS) in the country. It is esti-mated that 78 percent of youth aged 13 to 15 years have regular exposure to TAPS. One third of youth experimentation with tobacco is due to TAPS exposure.

According to PCCP Chair of Council on Tobacco or Health and Air Pollution Dr. Imelda Ma-teo, the Philippine government “should start thinking of making people not just productive but also healthy.”

FCAP Executive Director Dr. Maricar Limpin said that one out of 10 Filipino youth are still engaged in smoking. “Tobacco companies continue to entice young people to start smoking through aggressive ads and promotions,” said Limpin.

The ban of TAPS is included in Republic Act 9211, which is the Philippine government’s adherence to the Framework Convention on Tobacco Control (FCTC). “There are only a few number of local government units that have seriously implemented it despite numerous at-tempts to interfere from the tobacco industry,” said Limpin.

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Pharmacy Today is published 6 times a year by MIMS Philippines. Pharmacy Today is on controlled circulation publication to pharmacists in the Philippines. Editorial matter published herein has been prepared by professional editorial staff. Articles ending with MT Philippines have been adapted from Medical Tribune Philippines. Views expressed are not necessarily those of MIMS Philippines. Although great effort has been made in compiling and checking the information given in this publication to ensure that it is accurate, the authors, the publisher and their servants or agents shall not be responsible or in any way liable for the continued currency of the information or for any errors, omissions or inaccuracies in this publication whether arising from negligence or otherwise howsoever, or for any consequences arising therefrom. The inclusion or exclusion of any product does not mean that the publisher advocates or rejects its use either general-ly or in any particular field or fields. The information contained within should not be relied upon solely for final treatment decisions.

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Editorial Advisory Board

Leonila Ocampo, RPh, MS President, Philippine Pharmacists Association

Prof Yolanda Robles, RPh, PhD College of Pharmacy, University of the Philippines-Manila

Gloria de Chavez, RPh Drugstores Association of the Philippines

july/august 2013 doh launches nationwide ‘healthy...

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