IPSF Phuture Issue 20

ISSN 2307-1338

2016

IPSF Phuture Issue 20

Latest Research in the World of Pharmacy and Pharmaceuticals

Introduction Dear IPSFers, Phuture is for the next generation pharmacists and pharmaceutical scientists who want to bring a positive change to the profession. Phuture 2016 has articles to update the readers on pharmacy student research, current trends, and a special focus on fighting counterfeit medicines.

We at IPSF constantly strive to improve our publications and are committed to be the forefront for pharmacy student research. The Pharmacy Education Committee has worked a great deal to deliver articles from across the globe.

We hope our readers find this issue educational and inspiring. It has been a great experience to serve as editor of this year’s publication and thanks are due to all our readers, contributors and IPSF team. Special thanks go to Whitley Yi and Dana Mohamed for their constant support. Enjoy reading this issue!

Viva La Pharmacie!

www.ipsf.org

Farooq Ali Khan Phuture Editor 2015-16

Whitley Yi IPSF Chairperson of Pharmacy Education 2015-16

• Design & Layout Mr. Ahmed Ali Awed

IPSF Chairperson of Media and Publications 2016-2017 publications@ipsf.org

Edited by Ms. Sara DiTursi

Editor-in-Chief 2015-2016

• Ms. Sheena Patel • Ms. Katarina Zunic • Mr. Odokonyero Kennedy • Mr. Cheah Chong Sheng • Ms. Christine Echtenkamp • Mr. Pedro Martins

Contents Half a century of the Portuguese National Vaccination Program ������������������������������������������������������������������� 1 Eduardo de Melo Corvacho

Online illegal pharmacies ���������������������������������������������������������������������������������������������������������������������������������� 3 Maria - Isabelle Pîslă

Inviting the public: Untapped potential in the fight against counterfeit medicines ����������������������������������� 5 Nathaniel Refalo

Abstracts from the poster competition at World Congress 2016 In situ forming implants as multi-purpose prevention technology formulations ������������������������ 9 Clement M. Haeck, Thakur Raghu Raj Singh, R. Karl Malcolm

Investigation of the potential memory-enhancing activity of Carissa edulis in an aluminium chloride induced Alzheimer’s disease BALB/c mouse model ����������������������������������������������������������������������� 10 Kevin Tatenda Tamirepi

Nano Particulate Drug Delivery Systems for Anti-Cancer Drugs �������������������������������������������������� 11 Ashma Nepal

Is Pharmacogenetics the new challenge for Pharmacists? ������������������������������������������������������������ 12 Ariana Victoria Gonzalez

Self-learning Herb Cabinet for Blind Children �������������������������������������������������������������������������������� 13 Albertus Ivan Brilian

Bisphosphonates and Oral Health Management in the Community �������������������������������������������� 14 Clement Haeck

Semaglutide - could it be the next blockbuster drug? ���������������������������������������������������������������������������������� 15 Farooq Ali Khan

Who Are We? ����������������������������������������������������������������������������������������������������������������������������������������������������� 16 Whitley Yi

Half a century of the Portuguese National Vaccination Program Eduardo de Melo Corvacho, Recent Graduate from Faculdade de FarmĂĄcia, Universidade de Lisboa

Vaccine against 2 months 4 months 6 months Age

12 months 18 months 5 - 6 years 10-13 years Every 10 years

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Birth

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Tuberculosis Hepatitis B Haemophilus influenzae b Difteria- tentanusconvulsive cough

The Portuguese NVP initially covered the poliomyelitis vaccine, but nowadays is a complex, yet much necessary program, as we can depict from table 1.2

Poliomyelitis Streptococcus pneumoniae Neisseria meningitidis C Measles- rubeola

The Portuguese National Vaccination Program (NVP) has celebrated half a century of existence, as it has been implemented since October 1965, and is classified by experts as a major advantage in the fight against morbidity and mortality, due to its organizational model and accession of both healthcare professionals and general population. The three most important characteristics of the NVP are its universal status, accessibility and gratuitousness.

Vaccines that integrate the NVP are chosen from the currently existent in the market by evaluating their adequacy to the diseases that threat public health and their cost-benefit ratio, and can be administered to any person residing in Portugal, free of charge and without the need of a prescription. Simple, easy, cheap and, as one might expect, effective.1,2

Table 1. The Portuguese National Vaccination Program. Adapted from reference 3.

Human papilloma virus

Health is as big a right as freedom, since an individual’s health condition influences his or hers overall freedom. Being ill imprisons you. It takes away your ability to perform certain activities, removes your willpower and, ultimately, may deprive you of your life. Vaccination is one of the greatest barriers to illness created by mankind that allows for the achievement of the so-called group immunity. In this article, I aim to show how Portugal has used this resource, having as final purpose the protection of its citizens’ health.

Although the Portuguese NVP consists only of a recommendation and is not actually mandatory, 94% to 99% of the vaccines present were administered on the recommended period during the past years, and group immunity is believed be achieved with these numbers of accession to the NVP. The human papilloma virus vaccine is an exception, with a rate of vaccination of 85%. However, this vaccine was only introduced to the NVP in 2008. Therefore, this rate can be considered has extremely positive. Portugal is now considered to be an example of how vaccination significantly reduces child mortality and leads to benefits in public health.

The overall vaccination rate is 97%, which translates in one of the best in Europe and in the world.2,3 ISSN 2307-1338

As other healthcare professionals, the pharmacist also plays a role in vaccination. In spite of not being possible to administer vaccines included in the NVP, the community pharmacist may administer every other vaccine that is not included in the NVP, such as the yearly flu vaccine or the ones required for travelling to regions of the globe that are endemic for certain diseases. This has been possible since late 2007. Pharmacies may provide this service to the population if they have the proper conditions: certified staff, adequate facilities, adequate means of disposing of the materials used and the capability of treating any anaphylactic reaction that may occur.3

Vaccination has ensured high quality of life for long now, and it is rewarding to see the Portuguese NVP as one of the best qualities of my country.

Portugal continues to further develop its NVP, to make sure it remains updated and able to respond to the population’s needs because, in the end, fighting for improved overall health is one of the noblest causes.

Ponce, R. Portugal não aderiu à moda antivacinação, mas as autoridades estão atentas.

Publico [Serial on the internet]. 2015 [cited 2015 September 04]. About 3 p. Available from: http:// www.publico.pt/sociedade/noticia/portugal-naoaderiu-a-moda-antivacinacao-mas-as-autoridadesestao-atentas-1685467?page=-1 Programa Nacional de Vacinação: História do PNV. Carmo Gomes, M. c2012 [cited 2015 September 5]. Available from: http://www.vacinas. com.pt/calendario-de-vacinacao/pnv/o-pnv-e-a-suahistoria Leça A., Silva A., Calé, E., Freitas G. et al. PNVAvaliação 2014. Boletim Vacinação, DGS. 2015 April.

Nº09.

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Nowadays, when considering vaccination, one might remember the anti-vaccination trend that hit several countries in the world. Fortunately, this hasn’t been an issue in Portugal, as the existence of a free NVP has proven to be of much help. Daycare centres and primary schools have developed a crucial role in this sense. Even though it is not mandatory, it is general practice of these establishments to require the applicant’s vaccination sheet. This not only allows for a better control of the group immunity in an early-stage but also reinforces the need for vaccination. Even international schools, those that receive students with many different nationalities, check every applicant’s vaccination status and compare it to the recommended status in Portugal.1

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Online illegal pharmacies Maria - Isabelle Pîslă Introduction The Internet is part of our lives because of its advantages: it is always available, it offers a vast range of information, it gives you the opportunity to contact people very easily and you can purchase almost everything you want using it. For example, is the medical products online which are becoming more and more accessible. In many countries, such as Germany, Netherlands, Portugal, UnitedKingdom, United-States, there are authorised online pharmacies, where you can buy medicines and medical products. These pharmacies require patient prescriptions and deliver medications from government licensed facilities. Nevertheless, there are a lot of illegal Internet websites which sell medicines, including Substandard/Spurious/FalselyLabelled/Falsified/Counterfeit (SSFFC) Medical Products without prescriptions. Unfortunately, these websites sell products with an unclear origin all over the world.

Law Enforcement, Customs and National Medicines Regulatory Authorities undertake a series of initiatives to disrupt and remove illegal websites supplying medical products. What can look like a highly professional website providing quality medical products on your computer screen can be supported by a very different back office which fails to comply with the most basic of International standards of storage and distribution.1 One of the main benefits of the online pharmacies is that people can use them even though they have a busy lifestyle or a bad health state. Staying in front of your computer is easier than going out of your house to search for the necessary medical drugs. In case of local pharmacies, this search can come to nothing as there can be no drugs available. Moreover, the patient could have a health state which doesn’t let him out of the house.

This is why, the online pharmacies have become so popular, nowadays.

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1 This image shows an illegal internet pharmacy website distribution centre3.

Risks

The counterfeit medicines contain ingredients of low quality or wrong ingredients. They may react with other medicines the patient is taking and this is why these drugs may not work or they can put in danger the patient’s health. Online illegal pharmacies not only put in danger the health state but also attack the customer’s privacy. When a person purchases on an illegal market his personal data or his payment card details may be misused. Also, some spam email advertising medicines has been found to contain hidden software which will compromise his computer and privacy.

Advice • • • • • • • • •

•

Even though a patient should have some questions after ordering a medicine without a prescription, he can be easily deceived.

Be careful! Here are some advices: Check if you have received exactly the medicine you ordered; Check if it is the correct dosage; The package should be in a good and a clean condition; Search for a patient information leaflet; Check the smell, look and feel of the drug; The security seals must be intact with no sign of tampering; The batch number and expiry date on the primary internal packaging must match the batch number and expiry date on the secondary (external) packaging; The package should have a Customs declaration or postal label declare the contents as medicines.

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Logo

To avoid these counterfeit medications, check if the pharmacy is legal. On the website is a logo that helps us check which pharmacies operate legally. The common logo for legally operating online pharmacies/ retailers in the EU Member States was introduced

by Directive 2011/62/EU (the Falsified Medicines Directive) as one of the measures to fight against falsified medicines.

On 24 June 2014, the European Commission adopted the new common logo through the Implementing Regulation 699/2014. Member States had one year from this date to ensure that the provisions on the common logo are applied. Therefore, as of the 1st of July 2015, all online pharmacies or retailers legally operating in the EU, should display the logo.

The logo works very easy. By simply clicking on the logo you will be redirected to the website of the national competent authority, where you find a list of all legally operating online pharmacies or retailers.

National websites are listed with the European Medicines Agency.

Statistics

Buying over the internet has become very popular in the Europe. A survey from 2015 shows that 11% of individuals aged 16 – 74 buy medicines over the internet. About 15% of the participants aged 55 – 74 purchase online drugs and almost 12% of the Europeans between 25 – 54 years old prefer online pharmacies. The youngest group (16 – 24 years represents less than 10% of the online buyers.3

All pharmaceutical companies are concerned, whether they are research companies or generic producers.

For too long we have underestimated the phenomenon of drug counterfeiting which, from small, marginal beginnings is now completely industrialised and global. According to official World Health Organization (WHO) figures in 2006, drug counterfeiting represented approximately 45 billion Euros in sales. This represents almost 10 percent of the world pharmaceutical market.4 Medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.5 Conclusion In conclusion, online pharmacies may be a real problem for patients. Online illegal pharmacies sell counterfeit drugs and can put people’s health at risk, but most patients aren’t aware of that. To protect yourself, you should know how to recognize a legal Internet pharmacy and how to buy medicines online safely. The online sale of counterfeit drugs is clearly a major global issue.

1

http://www.who.int/medicines/regulation/ssffc/med_ prod_internet/en/ 2 http://ec.europa.eu/health/human-use/eu-logo/index_ en.htm 3 http://ec.europa.eu/eurostat/statistics-explained/index. php/E-commerce_statistics_for_individuals 4 http://ec.europa.eu/internal_market/indprop/docs/ conf2008/wilfried_roge_en.pdf 5 http://www.who.int/en/ IPSF Phuture

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The national flag and the text are an integral part of the logo. The flag in the middle left side of the logo corresponds to the Member State where the pharmacy or retailer is registered or authorised. Only national flags of the EU Member States as well as those of Norway, Iceland and Lichtenstein are allowed.2

Inviting the public: Untapped potential in the fight against counterfeit medicines Nathaniel Refalo, B.Sc. (Hons) (Pharmaceutical Science) Graduate, University of Malta.

Corresponding email address: nref0002@um.edu.mt Abbreviations EMA: European Medicines Agency EU: European Union FDA: Food and Drug Administration WHO: World Health Organisation WHPA: World Health Professions Alliance WMA: World Medical Association

Introduction The death of hundreds of patients in Nigeria and Bangladesh, mostly children, has been linked to the consumption of paracetamol elixir contaminated with diethylene glycol.1-2 In these cases, a medicine which was supposed to help these people may have contributed to their death. These examples illustrate the global nature of counterfeit medication and the terrible consequences of its use.

Counterfeit medicines have previously been defined by the World Health Organisation (WHO) as “medicines which are deliberately and fraudulently mislabelled with respect to their identity and/or source”1. Given that this definition includes both medicines which infringe intellectual property rights and those medicines which have an incorrect composition or packaging, the proper terminology to be used to describe this problem is controversial.3 Many national legislations relating to counterfeit medication have used the WHO’s previous definition when referring to counterfeiting.4 The WHO now uses the term “Substandard, spurious, falsely labelled, falsified and counterfeit medicinal product”* when referring to such medication. This article will refer to the previous WHO definition when using the term ‘counterfeit medicines’.

Counterfeiting impacts all the stakeholders in the legitimate supply chain, including the public, industry and regulatory authorities. The

1

World Health Organisation; Definitions of SSFFC Medical Products, 2016 http://www.who.int/medicines/regulation/ssffc/definitions/en/ Accessed July 13, 2016.

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high profitability of the drug counterfeiting industry and the difficulties involved in detecting counterfeit medication have resulted in an increased prevalence of such medication in both developing and developed countries.5-6 It is estimated that up to 10% of drugs in developing countries and 1% of drugs in developed countries are counterfeit.5 There is an increasing tendency for counterfeiters to access developed markets, as evidenced by the greater number of counterfeit medicines seized at European Union (EU) borders. Both developed and developing countries are therefore at an increased risk of counterfeit medicines entering their markets.

The increased availability of counterfeit medicines has had negative effects on the public.

Counterfeit medicines may contain sub-therapeutic doses, or no active ingredient at all. Toxic ingredients may also be included in counterfeit preparations.

These characteristics have been linked to increased morbidity, mortality and the associated costs of medical care.3, 5 Adverse events caused by counterfeit medication may also distort the adverse event profile of the genuine drug. This would lead to increased restrictions on the use of the drug.7 Other economic impacts include revenue losses due to decreased sales of genuine medicines and time and money spent on detecting and seizing counterfeit medicines. Given that antimicrobials tend to be the most counterfeited medicines in developing countries, the administration of sub-therapeutic levels of active ingredient may possibly increase the risk of antimicrobial resistance development. This could seriously compromise the effectiveness of infectious disease control in such countries.8 Counterfeit medicines also compromise the public’s perception of medicine, the pharmaceutical industry and regulatory authorities. The increased proliferation of counterfeit medicines may lead the public to lose trust in genuine medicines. Efforts in the past may therefore have focused on a discreet ISSN 2307-1338

counterfeit medication.5. 9

The role of public awareness campaigns Trends in counterfeiting are region-dependent: Antimicrobials are the most counterfeited drugs in developing countries. However, the most counterfeited medicines in developed countries tend to be ‘lifestyle’ drugs. Developed countries are also noting a shift in counterfeiting towards more expensive therapies such as anticancer treatments.9 Differences such as these imply that public awareness campaigns have to be designed according to an individualised country basis.

Design of public awareness campaigns on counterfeit medicines should also incorporate the public’s perspectives and motivations. Past examples of such campaigns have shown that the public itself can suggest effective means to disseminate campaign messages, such as the use of radio announcements part of a media campaign.10 An effective campaign would also tap into patients’ motivations: People knowledgeable of the harmful effects of counterfeit medication have been reported to be three times more likely to be able to identify counterfeit medicines.8 Patients should also be encouraged to note and report any deviations of bought medicine from what it is expected. For example, the presence of the medicine as a dosage form which does not match the dosage form stated on the packaging should arouse suspicion.3, 9 Any successful campaign should also include local stakeholders such as healthcare professionals and other personnel which may be involved in primary care, such as patient medication vendors.5,11 Training these people would allow them to transmit the information onwards towards their patients. This would optimise the time and money required for the campaign.

Possible outcome measures Any public campaigns undertaken to increase awareness of drug counterfeiting require clearly defined outcome measures. These would allow campaign managers to evaluate the campaign’s performance. These measures would also be used for improvement when planning future campaigns.

Possibly the most direct outcome measure is the ability of the public to distinguish between genuine and counterfeit products, when confronted by both products. Ultimately, patients who are aware of the possibility of drug counterfeiting must be able to make this distinction. Mhando et al.8 used this measure in an investigation to assess awareness of antimalarial counterfeiting in Tanzania. Respondents were confronted with both genuine and counterfeit samples of antimalarial medication and asked to differentiate between the two. The respondents had to justify their decision. The investigators were thus able to identify which features of medicinal products are most easily noticed by the public in order to detect counterfeit medication.8 A broader measure of the effectiveness of such public awareness campaigns would be the prevalence of counterfeit medication among medication bought by the general public. This medication can be subjected to tests which would identify any counterfeits. Medicines which fail such tests are counterfeit. The proportion of medicinal products bought by the public which fail the test would give a measure of the quantity of counterfeit products bought. In this way, it might be possible to identify changes in consumer behaviour when exposed to the possibility of buying counterfeit products.12

Examples of public awareness campaigns and initiatives Public awareness campaigns should aim to encourage the adoption of a proactive approach by the public. Patients should be encouraged to only purchase medicines from the legitimate supply chain. Fraudulent internet pharmacies available to the EU public bypass the legitimate supply chain and may be supplying up to 62% of their medicines IPSF Phuture

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approach to detecting and seizing counterfeit medication. However, there is nowadays a shift in behaviour towards including patients in dealing with the problem of counterfeit medication. The public is now encouraged to be on the lookout for counterfeits. Alerts relating to the presence of counterfeit medication in a market would also be more effective if the public is already aware of the negative consequences of taking

as counterfeits.13 Initiatives to improve regulation of internet pharmacies increase the accessibility of medication while protecting patients from fraudulent internet pharmacies. The European Commission has adopted a common logo system for internet pharmacies which helps patients assess whether an internet pharmacy is regulated by a European member state.14 The internet is also an easily accessible means to impart information relating to counterfeit medicines to the public. Both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) have relevant sections in their websites on counterfeit medicines. The EMA’s website has a section on falsified medicines which clarifies the legal framework for such medicines in the EU.15 The FDA’s website contains various resources for both healthcare professionals and the general public in relation to counterfeit medicines. These include a Questions and Answers section with common questions likely to be asked by the public.16-17 The mass media therefore plays a significant role in disseminating campaign messages. Pharmacy posters have been used in an awareness campaign in both Mali and Mauritania in order to highlight the dangers of illegal street medicines. Schoolchildren were then asked to complete a questionnaire. This method assessed the visibility of the posters (seen by 61% of the schoolchildren) and any discussion they had with their parents regarding illegal medicines (by 61% of the schoolchildren).18 The World Health Professions Alliance (WHPA) has supported numerous media campaigns relating to counterfeit products, such as in Argentina, Ethiopia, Lesotho, the Philippines and Rwanda. These initiatives all support the role of pharmacists and other professionals in using mass media to empower the public to avoid using counterfeit medicines.19 There is however little information regarding the effectiveness of public awareness campaigns in changing consumer behaviour. Preliminary results do imply that there is a potential benefit which can be optimised. Abdoulaye et al.10 conducted a public awareness campaign in Benin which incorporated both television and radio announcements. The 7

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outcomes of the campaign were changes in consumer purchasing behaviour, which was compared before and after the campaign. A cross-sectional study was carried out and noted that 51.5% of the households buying medicine from street markets (which have a higher risk of selling counterfeit medicines) decreased this practice. Receiving campaign messages increased the probability of not obtaining medicines illegally by six times.10, 12

Conclusion Counterfeiting of medicinal products remains a global challenge requiring the involvement of the public in order to be overcome. While public awareness interventions may be costly, especially due to the lack of sufficient evidence for what approaches are most effective, what we stand to lose in terms of human health and wealth far outweighs such costs.

References 1.

Hanif M, Reaz Mobarak M, Ronan A, Rahman D, Donovan JJ, Bennish ML, Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic, BMJ, 1995; 311(88): 88-91. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2550149/ Accessed Jul 14, 2016.

2.

Okuonghae HO, Ighogboja IS, Lawson JO,

Nwana EJ, Diethylene glycol poisoning in Nigerian children [abstract], Ann Trop Paediatr, 1992; 12(3): 235-8. http://www.ncbi.nlm.nih.gov/pubmed/1280035 Accessed Jul 15, 2016.

3.

Cockburn R, Newton PN, Kyeremateng Agyarko E, Akunyili D, White NJ, The global threat of counterfeit drugs: Why industry and governments must communicate the dangers. PLoS Med, 2005; 2(4): e100. http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC1062889/ Accessed Jul 13, 2016.

4.

World Health Organisation; Definitions of SSFFC Medical Products, 2016 http://www.who.int/ medicines/regulation/ssffc/definitions/en/ Accessed 2016 Jul 13.

Feldschreiber P, Public health measures with 5. counterfeit medicines, Clin Med (Lond), 2009; 9(1): 63-4. http://www.clinmed.rcpjournal.org/content/9/1/63. long Accessed Jul 13, 2016.

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World Medical Association. Inc; Counterfeit Medical Products, 2016 http://www.wma.net/ en/20activities/30publichealth/50counterfeits/ Accessed 2016 Jul 13.

Mhando L, Jande MB, Liwa A, Mwita S, Marwa 8.

KJ, Public awareness and identification of counterfeit drugs in Tanzania: A view on antimalarial drugs, Advances in Public Health, 2016; 2016 (1): 8 pages. http://www.hindawi.com/journals/aph/2016/6254157/ Accessed Jul 15, 2016.

9.

Cordina M, Counterfeit medicines. The Journal of the Malta College of Pharmacy Practice, 2010; 1(16): 4-6. http://www.mcppnet.org/publications/issue16.pdf Accessed Jul 13, 2016.

10.

Abdoulaye L, Chastanier H, Azondekon A, Dansou A, Bruneton C, [Evaluation of public awareness campaigns on counterfeit medicines in Cotonou, Benin] [abstract]. Med Trop (Mars), 2006; 66(6): 6158.

French. http://www.ncbi.nlm.nih.gov/pubmed/17286035 Accessed Jul 13, 2016.

11.

Chan V, Lui I, Lun G, Nagji N. From Nigeria to Benin: Applying a vendor awareness initiative to combat the counterfeit drug trade. The Meducator, 2010; 1(17): 9-12. https://journals.mcmaster.ca/ meducator/article/view/758/725 Accessed Jul 13, 2016.

12.

El-Jardali F, Akl EA, Fadlallah R, Oliver S, Saleh N, El-Bawab L, et al., Interventions to combat or prevent drug counterfeiting: a systemic review. BMJ Open, 2015; 5(3): e006290. http://bmjopen.bmj.com/ content/5/3/e006290.full.pdf+html Accessed Jul 13, 2016.

14.

Directive 2011/62/EU of the European Parliament and of the council of 8th June 2011 amending Directive 2001/83/EC on the community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. http://ec.europa.eu/health/files/eudralex/vol-1/ dir_2011_62/dir_2011_62_en.pdf Accessed 2016 Jul 13.

15.

European Medicines Agency, Falsified medicines, 2016 http://www.ema.europa. eu/ema/index.jsp?curl=pages/special_ topics/general/general_content_000186. jsp&mid=WC0b01ac058002d4e8 Accessed 2016 Jul 13.

16.

Food and Drug Administration, Counterfeit drugs Questions and Answers, 2016 http://www.fda. gov/Drugs/DrugSafety/ucm169898.htm Accessed 2016 Jul 12.

17.

Food and Drug Administration, Counterfeit medicines – filled with empty promises 2016 http:// www.fda.gov/Drugs/ResourcesForYou/ucm079278. htm Accessed 2016 Jul 12.

18.

Cuchet-Chosseler M, Bocoum O, Camara M, Abad B, Yamani E, Ordre des Pharmaciens du Mali, [Results of a survey to evaluate the efficacy of a regional awareness campaign on counterfeit street medicines in Bamako, Mali and Nouakchott, Mauritania] [abstract], Med Trop (Mars), 2011; 71(2): 1526. French. http://www.ncbi.nlm.nih.gov/ pubmed/21695872 Accessed Jul 13, 2016.

Know more

6.

Gaudiano MC, Manna L, Rodomonte AL, Bartolomei M, Bertocchi P, Gallinella B, et al., A survey on illegal and counterfeit medicines for the treatment of erectile dysfunctions in Italy. J Sex Med, 2012; 9(8): 2130-7. http://www.ncbi.nlm.nih.gov/pubmed/22612848 Accessed Jul 13, 2016.

19.

World Health Professions Alliance; WHPA Counterfeit Medical Products Campaign, 2016 http:// www.whpa.org/counterfeit_campaign.htm Accessed July 13, 2016.

13.

European alliance for access to safe medicines. The counterfeiting superhighway, 2008 http://eaasm.eu/cache/downloads/ dqqt3sge9hwssgcgcos440g40/455_EAASM_ counterfeiting%20report_020608(1).pdf Accessed 2016 Jul 15.

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In situ forming implants as multi-purpose prevention technology formulations Clement M. Haeck1,2*, Thakur Raghu Raj Singh1, R. Karl Malcolm1 1 School of Pharmacy, Queen’s University Belfast, Belfast, United Kingdom 2School of Pharmacy, Lille 2 University of Health and Law, Lille, France * haeck.clement@gmail.com

Background

Results

There is growing interest in the development of multi-purpose prevention technology (MPT) products for women that combine contraceptive activity with prevention of human immunodeficiency virus (HIV) and/or other sexually transmitted infections. In situ implant-forming subcutaneous (SC) or intramuscular (IM) gels represent a practical formulation option for development of long-acting antiretroviral products for HIV prevention or treatment. It is important to evaluate gel syringeability to ensure their clinical usefulness.

The ISFI formulations made were syringed through three different needles to investigate the ease at which they could be expelled from these narrow bore needles. They were then compared to one another and to the control. An increase in the gauge number of the needle, i.e. a decrease in the needle outer diameter, resulted in an increase in the WoS and MF exerted on the syringe in order to expel the fixed volume of formulation. For each set of parameters, the greatest WoS and MF were recorded with the 27G needle, with 22G showing the lowest. WoS and MF increased with increasing polymer concentration and were higher with PLGA 75:25 compared to PLGA 50:50. More force was required to expel a higher volume of formulation and with an increasing rate of expulsion. Furthermore, it was not possible to syringe some highly concentrated formulations (at 30% w/w) using the smallest needles (25G and 27G) and at high speeds (2 and 5 mm/s).

Objectives In situ forming implant (ISFI) gels containing Poly(lactic-co-glycolic acid) (PLGA) in N-methyl2-pyrrolidone (NMP) were formulated and tested to determine ideal gel concentrations that will be suitable for SC or IM injection. Syringeability tests were conducted to select optimum gel formulations that can be easily expelled using standard syringes.

Care was taken to select clinically relevant rates of expulsion and suitable needle types. Thus, impact of polymer type, polymer concentration and expelled volume was investigated.

Methods ISFI formulations were prepared by dissolving the required amount of PLGA 50:50 or PLGA 75:25 in NMP to produce concentrations of 10, 20 and 30 % w/w, respectively. The formulations were left to stir for at least 24 hours, at room temperature, to ensure complete dissolution of the polymers in NMP. Work of syringeability (WoS) and maximum force (MF) of expulsion were investigated using needles of different diameter, i.e. 22G, 25G and 27G. Using a Texture Analyser, 0.1 or 0.5 mL of formulation was expelled from a 1 mL syringe at different rates (0.5, 2 and 5 mm/s). The resultant force-distance plot was used to determine the WoS and the MF to expel the formulations. Five replicate measurements were made in each case and the solvent NMP (without PLGA) was used as control.

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Discussion This study helped to define optimum ISFI formulations. After incorporating a combination of an antiretroviral and a contraceptive drug within these ISFI formulations, we aim to use them to develop injectable MPT products for simultaneous hormonal contraception and HIV prevention therapy.

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Investigation of the potential memory-enhancing activity of Carissa edulis in an aluminium chloride induced Alzheimer’s disease BALB/c mouse model K.T. Tamirepi, L.L. Gadaga, D. Tagwireyi , Drug and Toxicology Information Service (DaTIS), School of Pharmacy, College of Health Sciences, University of Zimbabwe, P.O. Box A 178, Avondale, Harare, Zimbabwe.

Correspondence: kevintamirepi@gmail.com

Background Alzheimer’s disease (AD) is the most predominant cause of dementia. It is a neurodegenerative disease characterized by a progressive loss of memory. Currently, there are no effective pharmacotherapeutic options for prevention and treatment of AD. However, antioxidants from some medicinal plants, have been found to attenuate the immune- inflammatory response that contributes to the neurodegenerative process. The root extract of the indigenous plant Carissa edulis (CE) has been reported to have significant antioxidant and antiinflammatory properties that may curb the oxidative stress mediated neurodegeneration.

Results The extract had the highest percentage free radical scavenging activity (% FRSA) compared to the standards.

Discussion and Conclusion The effects of the extract may be due to the presence of polyphenols such as flavonoids which have an antioxidant effect against the neurotoxic activity of AlCl3, thus protecting against memory loss. The major findings from this study is that the extract at a dose of 200mg/kg may improve learning and enhance long-term and working memory with comparable effects to that of donepezil.

Objective

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To investigate the in vivo effect of the crude extract of Carissa edulis on memory enhancement in aluminium chloride induced Alzheimer’s disease BALB/c mice.

Methodology Thirty-six BALB/c mice were divided into 6 groups and each group had 6 mice. For 28 days, the extract was administered in doses of 50, 100 and 200mg /kg to 3 groups simultaneously with AlCl3. The group that received Donepezil (3mg/kg) plus, AlCl3 was used as a positive control. The Morris water maze and Novel object recognition behavioural tests were carried out after 28 days to assess memory and learning.

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Nano Particulate Drug Delivery Systems for Anti-Cancer Drugs Ashma Nepal¹, Mandana Tajmal¹, Leila Esfandiari², Acharya and BM Reddy 1.College of Pharmacy, 2.Rajiv Gandhi University of Health Sciences, Bangalore, India.

Abstract: The present investigation is aimed at the fabrication and characterization of ionically crosslinked gefitinib-loaded chitosan nanoparticles using ionic gelation technique with sodium tripolyphosphate (TPP) as the cross-linking agent.

The formulated nanoparticles were characterized in terms of Fourier transform infrared spectroscopy (FTIR), Differential scanning calorimetry (DSC), particle size, drug entrapment efficiency (EE), zeta potential, and in-vitro release. Formulation factors (chitosan, TPP) were examined systematically for their effects on size of the nanoparticles. The average size of the nanoparticles was observed to be in the range of 159.03 ± 4.96 to 306.76 ± 10.07 nm with 58–68% encapsulation efficiency (EE) for optimized formulations the results indicate that systematic modulation of the surface charge and particle size of ionically cross linked nanoparticles can be readily achieved with the right control of critical processing parameters. Thus, a gefitinib chitosan nanoparticle shows a promising delivery alternative for cancer treatment.

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ISSN 2307-1338

Is Pharmacogenetics the new challenge for Pharmacists?

Gonzalez Ariana; Melito Graciela and Capani Francisco Institutional affiliation of each author: Maimónides University Presenting author’s contact information: congresos.fyb@maimonides.edu Background

Results

Using the genetic information of each patient can be the key when making a pharmacological plan or simply to adjust the first dose of a medication.

Pharmacogenetics, which studies the relationship between genetic variations and drugs, is a vital tool to improve and attain perfection individualized therapies.

The total of 189 surveys were processed. It included 128 females and 61 males. The results showed that 85% of the respondents had notions about what pharmacogenetics was and 91% showed a positive point of view of pharmacogenetics and its implementation in the healthcare system. In addition, 93% expressed the urgent need for its inclusion in the academic curriculum and as part of pharmaceutical specializations.

The objective of this work was to determine by an online survey if pharmacy students and pharmacists (with a maximum of 2 years after graduation) have knowledge about pharmacogenetics and the real dimension of its importance and application in the healthcare system.

Methods The research relied on an online survey that was distributed through email from January to March of 2016 for participants to complete. This survey targeted pharmacy students and pharmacists. It was available through MaimĂłnides University and other universities associated with IPSF. They were asked about their conceptions of pharmacogenetics, the active role of this discipline and how they consider this could help patients in regards to the correct use of medications

Discussion This data suggests the implementation of a plan of action, in order to insert this theme in the different subjects that compose our carrier. It will improve formation and will help settle new tools for the pharmacist and his frontiers in the working business.

Suggestion for last paragraph This data suggests the implementation of pharmacogenetics, which will provide new tools for pharmacists in their clinical practice.

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Objectives

Self-learning Herb Cabinet for Blind Children Albertus Ivan Brilian1, Raden Muhamad Hovi Nurakbar1, Yovita Mella Feliciana1, Dirga2, Angela Rosari Prameswari3 1 Bachelor Degree of Pharmacy, Faculty of Pharmacy, Sanata Dharma University, Yogyakarta, Indonesia 2Bachelor Degree of Electrical Engineering, Faculty of Science and Technology, Sanata Dharma University, Yogyakarta, Indonesia 3 Bachelor Degree of Psychology, Faculty of Psychology, Sanata Dharma University, Yogyakarta, Indonesia

albertus_ivan@hotmail.com Background

One of the roles of pharmacists is to serve society, including people with disabilities, such as the blind. Jamu, the Indonesian traditional medicine consisting of a herbal preparation, has the aim of promoting health and vitality and has been used among members of the community for centuries.

Objectives: The aims of the activity were improving blind children’s knowledge and ability to distinguish five herbs using a self-learning Herb Cabinet named “MEGATRON” and to prepare the jamu drink.

Methods: The “MEGATRON” is a microcontroller system cabinet with six lockers. Each locker contained one particular herb, ginger, galangal, turmeric, temulawak or black ginger. Each herb was stored in one of four shapes,rhizome, fresh simplicia, dried simplicia, or powder. Once the locker was opened, the cabinet generated a sound that contained information concerning each one of the herbs. While the blind children were listening to the information, they were able to sense and distinguish the texture, taste, odour, and shape of each herb.

The knowledge was measured with a pre-post test and further analysed with the paired samples t-test, whereas the ability to prepare the jamu drink was evaluated by means of direct observation.

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There were 14 blind children, 5 educators and 6 volunteers that participated in the activity. Results and Discussion: The herb related knowledge of blind children significantly increased at 4.43±1.2 to 6.07±1.8 (p<0.03). Furthermore, 7%, 14%, and 79% of blind children in the study were able to distinguish 3, 4, and 5 kinds of herbs, respectively. All blind children who participated were able to prepare the jamu drink. In the future, the knowledge and abilities learned during this activity are expected to be useful and improve the health of blind children who participated. The “MEGATRON” may be a useful tool for blind children in communities outside of this pilot activity.

Keywords The Blind, Herb Knowledge and Skill, Jamu, Selflearning Herb Cabinet

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Bisphosphonates and Oral Health Management in the Community Alice P. McCloskey1, Aidan J. Murphy2, Joanne T. Murphy2, Maria T. McGuinness,2 Clement Haeck1,3 1 School of Pharmacy, Queen’s University Belfast, Medical Biology Centre, 97 Lisburn Rd, Belfast, BT9 7BL, Northern Ireland, United Kingdom 2 M.T.McGuinness Pharmacy, 4 Main Street, Belleek, Co. Fermanagh, BT93 3FX, Northern Ireland, United Kingdom 3 School of Pharmacy, Lille 2 University of Health and Law, 3 rue du Professeur Laguesse, BP83, 59006 Lille, France. haeck.clement@gmail.com

Osteoporosis, often considered as a disease of females and the elderly, is managed using a variety of medications including oral bisphosphonates1. The UK Medicines and Healthcare Products Regulatory Agency guidelines require patients have a dental check prior to commencement of, and at regular intervals during bisphosphonate therapy, maintain good oral hygiene and report any oral symptoms2.

Anecdotal evidence from the dentist and doctor in our target area suggested that patients are not adhering to this advice. Osteonecrosis of the jaw is a rare adverse effect with symptoms of pain, swelling, and exposure of necrotic bone. Good oral health prevents osteonecrosis development3.

Objectives • Identify if patients on long-term oral bisphosphonates (at least 6 months of therapy) were advised to and visited a dentist for a dental check prior to commencing therapy • Investigate whether these patients maintain good oral health • Determine if patients have experienced adverse oral health whilst taking bisphosphonates • Based on the findings, develop an education poster relating to oral health management for this patient group

Methods Ethical approval was sought and granted through the Integrated Research Application System.

Anonymous paper-based questionnaires were conducted over 10-weeks at the point of dispensing (participation was voluntary). Questions included demographics, drug choice and duration of treatment, and oral health. Only patients receiving long-term oral bisphosphonates were targeted.

Results 70 patients completed the questionnaire: 70% were 66 years or older and 85% female.

Patients were prescribed alendronic acid, ibandronic acid or risedronate sodium. 2.8% were taking

bisphosphonates longer than the recommended 10 years. Only 20% of participants recalled being advised to attend the dentist prior to commencing bisphosphonates, of these 86% received a dental check. Oral health problems included dentures (14%) and teeth falling out (4%). Only one suspected case of osteonecrosis was identified, this proved to be a false positive.

Discussion Patients were largely non-adherent and unaware of oral health guidelines surrounding bisphosphonate use. A multidisciplinary approach is needed regarding patient education. Pharmacists are in an ideal position to reiterate advice at the point of dispensing. We developed a patient education poster for this patient group highlighting the importance of regular dental checks and identifying oral health symptoms. This is displayed in the doctor and dental practices and the pharmacy. This work has had a positive impact on our practice and patients, and has strengthened our relationship with the other healthcare professionals in our community.

References Bor, A., Matuz, M., Gyimesi, N., Biczók, Z., Soós, G., & Doró, P. (2015). Gender inequalities in the treatment of osteoporosis. Maturitas, 80(2), 162169.

1

MHRA Guidance, Bisphosphonates: use and safety, 18 December 2014. https://www.gov.uk/ government/publications/bisphosphonates-use-andsafety/bisphosphonates-use-and-safety (Accessed 15th Dec 2015) 2

Colella, G., Campisi, G., & Fusco, V. (2009).

American Association of Oral and Maxillofacial Surgeons position paper: Bisphosphonate-Related Osteonecrosis of the Jaws-2009 update: the need to refine the BRONJ definition. Journal of oral and maxillofacial surgery: official journal of the American Association of Oral and Maxillofacial Surgeons, 67(12), 2698-2699.

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Background

Semaglutide - could it be the next blockbuster drug?

Farooq Ali Khan, M.S. (Pharm.), National Institute of Pharmaceutical Education and Research Corresponding email address: communicatetofarooq@gmail.com A blockbuster drug is defined by Investopedia as “An extremely popular drug that generates annual sales of at least $1 billion for the company that creates it.” [1]. Drugs which have generated such huge amounts are the much known Lipitor (atorvastatin), and Zoloft (sertraline).

Type-2 diabetes management can be painful as it might involve multiple daily subcutaneous insulin injection. There have been advances made by companies to overcome this. Once-daily (Victoza® Novo Nordisk) and once-weekly (Bydureon® AstraZeneca) GLP-1(glucagon-like peptide) analogue (incretin based therapies) injections have been developed and the market for this class is growing. In 2013, the GLP-1 analogue market reached sales over $2.6 billion. Victoza® was the most prominent with its 2013 first half sales which were about $1 billion and gained it the blockbuster status. [2] Incretin based therapies enhance glucose dependent insulin secretion, decrease beta cell apoptosis and preserve the function of beta cells.

GLP-1 analogues mimic the action of natural incretin GLP-1, which is secreted from the L-cells in the ileum and colon. [3] Though incretin based therapies are improving they are limited to injectable preparations. Oral GLP1 analogues have not reached the market.

Semaglutide is a long acting GLP-1 analogue that is being developed for oral administration (NN9924, OG217SC) by Novo Nordisk. It is being developed in the form of oral tablet by using Emisphere’s Eligen® technology. Eligen® uses sodium N-[8-(2-hydroxybenzoyl) amino]caprylate (SNAC) which acts as an oral absorption enhancer[4].

Semaglutide successfully completed its fourth phase IIIa trial and is showing positive results in the following trials. The other GLP-1 analogue, liraglutide of Novo Nordisk which is currently leading the market had shown sustained and substantial 15

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glycemic control and also significant reduction of body weight [3]. Semaglutide is being developed to achieve improved blood glucose levels in people with type-2 diabetes with a low risk of hypoglycemia and also weight management. In recent trials, it has also been shown to reduce the risk of major adverse cardiovascular events in people with type-2 diabetes [5]. These results and its development for oral delivery show semaglutide could be a better version of the GLP1 analogues. If semaglutide successfully navigates through the FDA and reaches the market, could it be the next blockbuster or super blockbuster drug and the new leader of GLP-1 market?

1.

Investoedia.com [Internet] Investopedia.

Blockbuster Drug. 2016:2016. http://www.investopedia. com/terms/b/blockbuster-drug.asp.

Fiercepharma.com [Internet] Staton T. 2.

Victoza - Novo Nordisk. 2016:2015-2017. http://www. fiercepharma.com/special-report/victoza-novo-nordisk.

3.

Rossi MC, Nicolucci A. Liraglutide in type

2 diabetes: from pharmacological development to clinical practice. Acta Biomed. 2009;80(2):93101. http://www.ncbi.nlm.nih.gov/entrez/query. fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_ uids=19848045. ir.emisphere.com [Internet] Emisphere 4.

Highlights Eligen Licensee Novo Nordisk ’ s Entry Into Phase 3a Development of Oral Semaglutide , a Once Daily Oral GLP ­1. http://ir.emisphere.com/releasedetail. cfm?ReleaseID=928925.

5. novonordisk.com [Internet] Novo Nordisk.

Semaglutide significantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial. Press Release. 2016;(31):24-26. http://www. novonordisk.com/bin/getPDF.2007805.pdf.

ISSN 2307-1338

Who Are We?

A glimpse inside the debate over pharmacy identity from the 62nd IPSF World Congress Whitley Yi Chairperson of Pharmacy Education 2015-2016

The evolution of pharmacy is directly connected with the need to fill the growing healthcare gap and increase the healthcare workforce. However, pharmacy faces the inevitable struggle of being able to describe itself to those outside of the profession. This includes other healthcare professionals, and even perhaps pharmacists themselves. One of the central bifurcations of the discussion is the choice to centre it around a product or a service. As Dr. Dexter Tagwireyi pointed out in his presentation during the Educational Symposium, pharmacists are the medication experts, and wherever medications are discussed, pharmacists should be there. Dr. Catriona Bradley also further addressed the issue by looking at a study of how pharmacist identified themselves, which were not all positive. She concluded her presentation with a charge to the participants to be assertive in their roles and to critically think about how they describe themselves.

It is this discussion that IPSF has set out to dive into. In partnership with the Academic Pharmacy Section (AcPS) of the International Pharmaceutical Federation (FIP), Dean Ralph Altiere and the Pharmacy Education, conducted a workshop at the Educational Symposium on the primary professional identity of pharmacist.

Pharmacy students were asked to identify what they believe the primary professional identity of a pharmacist should be. Many of the responses were in relation to “medication expert” who provides information and optimizes medication use, as well as participates in drug development. However, before the primary identity of a pharmacist was discussed, students were asked their opinions on the pros and cons of having a universally recognized primary professional identity. Some of the most common

responses are summarized below:

Cons: • Hard to define a pharmacist’s role Can be limiting to the advancement of the • profession A universal identity limits growth in individuals • because the profession has been different views and visions

Pros: • Increased pride for the profession Help public and others to understand what a • pharmacist can do Others can know and appreciate the • pharmacist role Greater recognition and respect • Until the need or value of a primary identity is established, arriving at a universal definition of that identity seems less likely. Therefore, followup discussion should centre on the merits or disadvantages of a primary professional identity.

Should there be a primary professional identity for pharmacy? That is the question that must first be answered. From the results of this workshop, the main arguments for and against include limiting growth and diversity by defining a profession too narrowly versus enhancing pharmacy’s role by having universally consistent perceptions and expectations of a pharmacist.

Lastly, though of considerable importance, educational capacity must be addressed. If a primary professional identity is to be defined, there must be adequate educational capacity to prepare students in every country to meet the minimum standard competencies required of that professional identity, whether it includes direct patient care or drug development or drug procurement.

These are not easy questions, but ones that need to be addressed. Students, as the future of pharmacy, must think critically about these things and continue on the discussion started at the World Congress. The best way to influence the future is to take ownership in defining what it should look like and then take steps to make it a reality.

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This year, the 62nd IPSF World Congress took on a big task. Heading into a new era of pharmacy education, IPSF wanted to explore how pharmacy students define themselves, or more accurately, how they would ideally define themselves. This is no easy task. The world of pharmacy has seen more transformations in its job description than is easy to keep up with. To complicate things even further, the practice of pharmacy varies considerably by country, based on country-specific policy, health system infrastructure, perception, and educational capacity.

International Pharmaceutical Studentsâ&#x20AC;&#x2122; Federation Andries Bickerweg 5 2517 JP Den Haag The Netherlands Tel: +31 70 302 1992 Fax: +31 70 302 1999 Email: ipsf@ipsf.org Website: www.ipsf.org