online pharmacy

 

Reseach Proposal 1
Table of Contents
1. Research Aim and Objectives………………………………………………………………………… 3
2. Research Contex…………………………………………………………………………………………… 4
3. Research Plan………………………………………………………………………………………………. 7
4. Ethical considerations…………………………………………………………………………………. 10
5. References…………………………………………………………………………………………………. 10

1. Research Aim and Objectives:
The present research study is intended to evaluate the quality of registered online pharmacies (OPs) that are operating in the UK. The study will make particular reference to the OPs’ observation of drug prescription regulations, the legality of these facilities, and adverse drug events, including drug misuse/abuse that may occur among local populations. OPs have become a common phenomenon in the UK, with as much as 22.1% of the population reporting that they had bought medicine through OPs.1 The most critical aspect of that statistic is that drug purchases included prescription-only analgesics such as opioids that are typically dispensed with proof of prescription by a registered medical practitioner. However, they are also readily available in OPs without a need for the prescriptions.2 In the UK, the law is unequivocal that prescription medicine can only be dispensed after documentation of medical practitioners’ approval.2

The aim of research is to investigate the degree to which that the Ops adhere to the national regulations and explore any potential safety issues that arise from using them from the perspectives of both users and pharmacists.
The objectives advanced for the present research study have been designed to summarise its anticipated methods and outcomes. They are considered measurable, focused and practical in directing the research.4,5 The four objectives include:
1. To determine the nature and conditions of drugs supplied nationally as well as other medical and pharmaceutical services offered by the UK OPs to the public.
2. To review the reported cases of adverse drug events by OPs.
3. To explore users’ experiences and perceptions regarding the service provided by the Ops.
4. To seek pharmacist perspectives on Ops and the regulations governing them.

2. Research Context:
Pharmacies are a common feature in the UK medical community; charged with observing legal requirements in dispensing drugs. Still, there are two types of pharmacies. The first type operates from a physically accessible address with their customers expected to access the premises and present their prescriptions to be filled. The second type operates from a virtual address with the customers expected to complete online prescription forms before the drugs are sent to them. Despite the distinction, the same legal conditions apply to both pharmacies. Firstly, they are expected to correctly distinguish between prescription-only medicines (POMs) and over-the-counter (OTC) medicines. Secondly, they are both expected to confirm the validity of the prescription before dispensing any drugs. Finally, they must be operated by licenced and registered pharmacists. Still, policing inadequacies have meant that online pharmacies are not well policed. In fact, they can function outside the dictates of the law.3 It is this state of affairs that presents a worrying condition for the medical community in the UK.

As earlier indicated, more than 22% of all UK residents report that they had made some of their drug purchases using OPs.1 Worryingly, however, controlled drugs such as prescription-only analgesics that include opioids (such as codeine, morphine, oxycodone, hydrocodone and so on) are also readily available from OPs, even without a prescription. Customers only need to have an internet connection and access to wireless cash for them to purchase such drugs. This contact is impersonal and could take the form of a telephone verification.2 In this respect, it becomes evident that the increasing popularity and pervasiveness of the internet has allowed the rapid diffusion of procuring prescription medicines without first consulting qualified medical practitioners or obtaining a valid doctor’s prescription. Apart from increasing public access to controlled prescription medicines, OPs offer an avenue for children and teenagers to gain unrestricted access to drugs.4 The US-based National Association of Boards of Pharmacy (NAPB) summarises the situation by stating that, of the more than 10,500 OP sites that they had reviewed by July of 2013, as many as 97% of them did not comply with acceptable pharmacy and drug dispensing standards.5 The General Pharmaceutical Council (GPhC – UKs equivallent of the NAPB) does not have similar figures but notes that policing is seriously lacking.6 For this reason, it is evident that there is an increasing customer base for OPs, even though their drug dispensing practices are often unregulated.

Although OPs may appear as a distinct entity from the mainstream pharmacies, they are guided by similar principles presented as laws and ethics. Firstly, they must be registered with the General Pharmaceutical Council (GPhC). Registered pharmacies have an internet pharmacy logo that distinguishes them from unregistered pharmacies.6 Despite the requirement that all pharmacies be registered with the GPhC, not all do so.6 Formal reports are made to the GPhC and Medicines and Healthcare products Regulatory Agency (MHRA) for criminal proceedings to be brought against the unregistered pharmacies.7 Besides that, the pharmacists can be deregistered.8

Despite its distinctive nature, OPs apply similar principles to those used by other pharmacies in dispensing medicine and filling prescriptions. They use the same legislative framework used in controlling access to medical products. The UK Medicines Act of 1968 stipulates that all medicines fall into either of three categories. Firstly, pre-packed general sale medicine – such as aspirin and ibuprofen – that are sold in any secure commercial premises such as a supermarket and general retail shop. Secondly, pharmacy only medicine that must be sold in a registered pharmacy and under the supervision of a registered pharmacists who determined the medicine quantities to be sold based on the patient dynamics such as age, weight, gender, sickness severity and so on. Finally, prescription medicine that must be dispensed by a registered pharmacy supervised by a registered pharmacists who confirms the prescription validity before medicine dispensation.9 All OP medicine dispensation activities are governed by the conditions laid out in the three categories.

Active regulation of OPs’ practices is dire – evidenced by the relevant legislations inability to effectively regulate OPs management6 – requiring immediate intervention if access to prescription medicine is to be managed successfully. The situation is especially problematic because certain drugs – especially controlled drugs – could have an adverse effect on an individual if their use is conducted without adequate medical supervision. In so doing, OPs provide an opportunity for individuals to gain access to prescription medicine that they end up misusing while unsupervised, bypassing the safeguards inherent in doctor-patient relationships.10,11 Thus, regulatory bodies must prepare prescription standards for OPs and monitor their operations to guarantee that they conform to the standards of other, bricks and mortar pharmacies.

Currently, OPs’ drug dispensing activities are undertaken in one of two ways. First, the customer is required to provide a valid prescription that is then verified by the signing physician before medicine is dispensed.11,12 Secondly, the customer is asked to complete an online questionnaire that details their medical history and profile, as well as their current medications. The information is then reviewed by a licensed medical practitioner who can then opt to recommend that a particular drug be dispensed or that the customer seek medical attention from an attending doctor or hospital facility.13,14 There is a third group of OPs, often described as ‘rogue OPs’. They are created for the purpose of ‘scamming’ buyers and circumventing dispensing regulations. Those that scam buyers will collect payment, but fail to deliver the expected drugs, or deliver fake drugs.15 For instance, aspirin or another substance may be repackaged as the ordered drug. The substitution can cause serious side effects, as the customer may be allergic to the fake substance supplied, or the withdrawal of the ordered medication may cause significant health problems. OPs that circumvent dispensing regulations will dispense controlled prescription drugs without regard to dispensing laws, thereby placing their customers at risk. In fact, their only condition for dispensing is that payment be made before the drug can be dispensed; any individual who has access to an internet connection and virtual money can make a drug purchase.13

It is apparent that OPs offer an avenue for the general public to access controlled prescription drugs. While the more conventional pharmacies, such as mainstreet pharmacies, have operated within the confines of drug-dispensing regulations, OPs have substantial leeway about their observation of the laws. Owing to the virtual nature of OPs, regulators will often find it difficult to police them.6 Accordingly, the lack of the rules and enforcement applicable to OPs – even those based in the UK – presents a danger to the public.15 For this reason, there is a need to review the situation and determine how OPs affect the wider drug dispensing industry, with the intention of recommending viable strategies to be applied to impose control.
3. Research Plan:

1. The research study will apply quantitative strategies that will make use of both primary and secondary data. It was on the understanding that collecting detailed and objective information that measures the subject of interest would provide a better understanding.16,17

2. A structured questionnaire has been determined as the best primary data acquisition tool for collecting the opinion of the selected respondents. The respondents will be drawn from individuals residing in the UK with the respondents first asked whether they had used OPs at any time. The inclusion criteria will be previous use of OPs for medicine purchase. The formulation of respondents will be designed to collect data on their demographic and medicine purchasing behaviours. The use of a standardised questionnaire with closed-ended questions identifies the research as having adopted a quantitative research design.13,18,19 The population of interest will be the pharmacists who work in the UK OPs which listed on the NHS website and customers who use OPs.

3. The collected primary data will be in a general form that does not highlight the key data trends.20 As such, it will be subjected to statistical software analysis that pools, translates and correlates the variables and presents the results in tables and charts.20

4. The respondents will be approached after the determination of the number of respondents required for the research study.21 In this case, the number will be finalised after scrutiny of the targeted research population, generalisability, and available time. Focusing on a single, specific population and traits that are peculiar will determine the sampling size/procedure. In this case, the only inclusion criteria will be UK residency, use of OPs and a willingness to participate in the research study. The participants will be recruited mainly through social media such as Facebook and Twitter as well as online health forums. The point of the broad inclusion criteria is to make the research more generalisable and applicable to a greater number of UK residents. 22,23 The data collection will be stopped once the target number of participants is reached.

5. As indicated earlier, secondary data will also be used in the research study. But before that, a comprehensive literature review will be conducted to determine the state of knowledge on the subject. The secondary data such as systematic reviews, case reports will be collected by extensive reviews of the available literature on the research topic. The searches will be conducted on peer review sites such as online databases and books. This extensive literature search will be carried out using a search strategy, inclusion and exclusion criteria. The most important and extensively applied search tool will be online medical research databases, particularly CINAHL Complete, Cochrane Library, Google Scholar, Medline, ProQuest Health and Medical Complete, PsycINFO, Scopus, ISI and PubMed databases that will be accessible as an extension of the university virtual library platform.

6. Inclusion criteria will include that article must be published in the English language. In addition, an OR Boolean operator will be used for the unrefined search strategy since the operator is capable of refining searches. The collected articles will then be subjected to the AND Boolean operator to refine the search. The following search terms will be used to direct the online searches: e-pharmacy/ies; online pharmacy/ies; Internet pharmacy/ies; cyberpharmacy/ies; cyberdrugs; drug/s online; online chemist; medicine/s online; patient safety; drug misuse; drug abuse; public health; medicine purchases; and buy. All online searches will be restricted to articles published after January 1990, since the first recorded OPs become operational around that time.

7. The present research study intends to evaluate the OPs that serve UK residents, with special reference to their observation of drug prescription regulations, legality, and adverse drug events on local populations. The information to be collected will include the respondents’ use of OPs, their demographic information and opinions regarding the different aspects of OPs use. A descriptive correlational research design has been considered to be the best tool to achieve that goal. The descriptive design will allow the researcher to record and evaluate the constructs and variables that are being scrutinised. The constructs and variables will be the respondents’ demographics and opinions regarding OPs.24 The variables – both dependent and independent –will not be altered even if new elements that may produce a change are presented. This is intended to ensure that the objectives do not change even as the research proceeds.24 In addition, correlation research will be applied since it centres on recognising the prospect that there is a relationship between the independent and dependent variables.25,26 In the present research study, the independent variables are population demographics and controlled prescription drugs misuse statistics. The dependent variable is the use of OPs for purchase of drugs.

With regards to the four previously identified objectives, they will be met by analysing both the primary and secondary data collected on OPs using the questionnaires and literature review. The specific approaches will include:

1. The first objective will be achieved by exploring the website and analysing the contents and characteristics of OPs operating in the UK then recording the top selling drugs and pharmaceutical services that they provide. The data will be managed using MS Excel and collected data will be presented by proportions and percentages.
2. The second objective is to review the cases of adverse drug events resultant from OPs services through conducting a comprehensive literature review and any reports published by NHS, GPhC and MHRA with concern of regulations and management of OPs.

3. The third objective will mainly be achieved by designing a questionnaire using SurveyMonkey for online users distributed by social media websites eg.Twitter,Facebook and online health forums to retrieve feedback from them regarding their opinions, attitudes, behaviours, beliefs, their demographic information and any health problems they faced during use them.
4. The fourth objective will be met via sending out an online questionnaire to the all registered Ops in the UK to pursue the pharmacists’ opinion on different aspects of regualtios, legislations, experiences and any other suggestions to improve the patient safety issues associated with using the Ops.

4. Ethical Considerations:
 The NHS and other required ethical approvals will be sought prior to conducting this research.
 Anonymity can be achieved by indicating in the study questionnaires that the name of the participant is an optional requirement.
 Issues of anonymity, confidentiality and privacy will be addressed through appropriate storage in a secured computer with limited access.
 No data can be collected without ethical approval from the university.
5. References:

1. The Global Drug Survey [Internet] [Cited 2014 Dec 6]. Available from: www.globaldrugsurvey.com.
2. Raine C, Webb D, Maxwell S. The availability of prescription-only analgesics purchased from the internet in the UK. British Journal of Clinical Pharmacology, 2009; 67(2): 250-254.
3. Applbe G, Wingfield J. Dale and Appelbe’s Pharmacy and Medicines Law. 10th ed. London: Pharmaceutical Press; 2013.
4. Office for National Statistics Website [Internet] [Cited 2014 Dec 6]. Available from: www.ons.gov.uk/ons/rel/rsi/retail-sales/index.html.
5. Gerasimchuck J. Clicking to Health? A look at online pharmacies, counterfeit medicine, and drug reimportation. [Internet] 2011 [Cited 2014 Dec 22]. Available from: http://dash.harvard.edu/bitstream/handle/1/8965620/Gerasimchuk%20FDAPaper.pdf?sequence=1.
6. National Association of Boards of Pharmacy.Buying Medicine Online [Internet] 2013 [Cited 2014 Dec 6]. Available from: http://www.nabp.net/programs/consumer-protection/buying-medicine-online.
7. General Pharmaceutical Council. Internet Pharmacy [Internet] 2015 [Cited 2015 Jan 24]. Available from: http://www.pharmacyregulation.org/registration/internet-pharmacy.
8. Medicines and Healthcare Products Regulatory Agency. Medicines and Healthcare Products Regulatory Agency [Internet] 2015 [Cited 2015 Jan 24]. Available from: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency.
9. General Pharmaceutical Council. Registration [Internet] 2015 [Cited 2015 Jan 24]. Available from: http://www.pharmacyregulation.org/registration.
10. Pharmaceutical Society of Northern Ireland. Professional Standard and Guidance for Pharmacist Prescribers [Internet] 2009 [Cited 2015 Jan 24]. Available from: http://www.psni.org.uk/documents/319/Standards+on+Pharmacy+Prescribing.pdf.
11. Kanich C, Weaver N, McCoy D, Halvorson T. Show Me the Money: Characterizing spam-advertised revenue University of California, San Diego [Internet] [Cited 2014 Dec 6]. Available from: http://cseweb.ucsd.edu/~savage/papers/UsenixSec11-SMTM.pdf.
12. General Pharmaceutical Council. Internet Pharmacy [Internet] 2013 [Cited 2014 Dec 6]. Available from: http://www.pharmacyregulation.org/registration/internet-pharmacy.
13. National Association of Boards of Pharmacy. Verified Internet Pharmacy Practice Sites [Internet] 2013 [Cited 2014 Dec 6]. Available from: http://vipps.nabp.net.
14. Patel J. The Regulation of Online Pharmacies: The need for a combined federal and state effort. [Internet] 2013 [Cited 2014 Dec 6]. Available from: http://web.law.columbia.edu/sites/default/files/microsites/career-services/The%20Regulation%20of%20Online%20Pharmacies.pdf.
15. Kayne S. Pharmacy Business Management. London: Pharmaceutical Press; 2005.
16. Oliver A. Internet pharmacies: regulation of a growing industry. Journal of Law, Medicine & Ethics. 2000; 28(1): 98-101.
17. Conner M, Armitage C. Extending the theory of planned behavior: A review and avenues for further research. Journal of Applied Social Psychology. 1998; 28: 1440-1452.
18. Creswell J. Research Design: Qualitative, quantitative, and mixed method approaches. Thousand Oaks, CA: SAGE; 2003.
19. Ader J, Mellenbergh J, Hand J. Advising on Research Methods: A consultant’s companion. Huizen: Johannes van Kessel Publishing Company; 2008.
20. Urdan C. Statistics in Plain English. Mahwah, NJ: Lawrence Erlbaum Association, Publishers; 2001.
21. Rossman A, Chance B. Investigating Statistical Concepts, Applications, and Methods. London: Duxbury Press; 2005.
22. Yin K. Case Study Research. Thousand Oaks, CA: SAGE; 1994.
23. Kumar R. Research Methodology – A Step-By-Step Guide for Beginners. Singapore: Pearson Education Publishers; 2005.
24. Hathaway R. Assumptions underlying quantitative and qualitative research: implications for institutional research. Research in Higher Education. 1995; 36(5): 535-562.
25. Neuman W. Social Research Methods: Qualitative and quantitative approaches. New Jersey: Allyn & Bacon Publishers; 2002.
26. Babbie E, Benaquisto L. Fundamentals of Social Research. Scarborough, ON: Nelson Thomson Learning; 2002.

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