Prospectus
Changing Pharmacists’ Perceptions of Generic Medicines Quality in Ghana: A Policy Decision
Changing Pharmacists’ Perceptions of Generic Medicines Quality in Ghana: An improvement to Medicines Access

PhD Public Policy and Administration: Health Policy

Prospectus: Changing Pharmacists’ Perceptions of Generic Medicines Quality in Ghana: A Policy Decision
Problem Statement
From the 2017 Government of Ghana annual budget of 12,998 million Ghana cedis (GH¢) allocated to the social sector, 4,226 million GH¢ (32.5%) was allocated to the health sector Ashiagbor, (2017). No funds were assigned specifically for the pharmaceutical sector for procurement of medicines. This resulted in inequalities and difficulty for pharmacists to obtain funds for the procurement of quality essential medicines. National acquisition of medicines is dependent on private pharmaceutical companies supplying directly on a “cash and carry basis” to hospitals and pharmacies accredited by the National Health Insurance Scheme or by donations from partners (GNDP, 2017). The undesirable effect of the Ghana National Health Insurance Scheme on access to medicines is influenced by the medicines pricing procedure and repayment plan (Mordi, Eghan, & Rankin, 2015, Ashigbie, Azameti, & Wirtz, 2016). The plan is detrimental to accessibility of medicines by all and it encourages co-payment of medicines. The problems effect the high cost of brand-name medicines representing 60% of Ghana’s total medicine purchases. The influence on affordable quality generic medicines for public health needs is also negative (GNDP, 2017). Some contributing factors to the problem include the high death rate due to preventable diseases such as malaria, tuberculosis, immunization against childhood diseases, and an increase in infectious diseases. The literature reviewed for this study indicated others have investigated the problem by looking at the best variable cost of generic medicines to brand-name medicines (Nordrum, 2015), the comparative effectiveness of quality generics to brand medicines to reduce the health burden, and the perception by health professionals regarding the quality and equivalence of generic and brand medicines (Dunne, & Dunne, 2015). None of the studies examined how the pharmacists in Ghana perceive the switching of brand-name to quality generic medicines to improve the availability of affordable medicines to the populace.
Purpose
The purpose of this phenomenological, qualitative research study is to explore the pharmacists’ perception on the choice of quality generic medicines to brand-name medicines in Ghana (Ravitch, & Carl, 2016) and the inadequacy of funds to improve the availability of medicines. Data will be collected through a content analysis of the existing medicines policies and interviews with different groupings of pharmacists. The results can assist pharmacists and the public to understand better that affordable quality generic medicines are worth using to treat diseases. A national generic medicines policy might also be drawn from the research (Ansari, 2018). The research will contribute to the literature by providing policy makers with data to consider when making decisions on the national drug policy to increase generic medicines usage.
Significance
The research is significant because it contributes to social change by creating insight into the Ghana National Drug Policies and the low availability of essential medicines in Ghana. It will also alleviate the pharmacists’ bias against the use of generic medicines, and it will encourage the government of Ghana to invest in the pharmaceutical sector to improve public health care. The positive change in pharmacists would build multiple benefits; the public trust and confidence in locally produced generic medicines and the local manufacturers’ motivation to produce in higher volumes (Hafner, Walkowiak, Lee, and Aboagye-Nyame, 2017). It would also encourage patronage of quality generic medicines by the government of Ghana to increase availability of essential medicines at affordable prices. For effective implementation a policy change to stress on the usage of quality generic medicines would improve the health status of the population. Gammie, Lu, & Babar (2015) also emphasize the re-design of the national drug policy to include a scientifically-proven quality generic medicine agenda to promote access to affordable and quality assured medicines (Gammie, Lu, & Babar 2015).
Background

Literature reviews provided information on inadequate available funds to strengthen the pharmaceutical sector, pharmacists’ perceptions of medicines quality and access to affordable quality generic medicines as well as the need for drug policy change.
1. The government of Ghana agenda for growth and job creation envisaged improving access to basic healthcare as critical to maintain a healthy Ghana. Given that out of the annual budget for the health sector 17% is from development partners, decreasing donor funding create bottlenecks to successful implementation of the health sector initiatives, posing problem for pharmaceutical sector development and procurement of medicines (Ashiagbor, 2017).
2. Alfadi (2018), introduced the “perspective, knowledge, and attitude of various stakeholders” with special emphasize on consumers vulnerability to substandard and falsified medicines and policy making (Alfadi, 2018). This play a serious negative impact quality of medicines and health care.
3. Dunne & Dunne (2015), posit revealed governments emphasis on the use of generic medicines with related financial reimbursements and the benefit of evidence-base results proving to the citizens the equivalence of generic medicines in comparison to brand-name medicines (Dunne & Dunne, 2015).
4. Ansari (2018), stand on the importance of quality socio-behavioral aspect of medicine use in pharmacy training curricula. For this reason pharmacists are to pay attention to respect patients’ socio-behavioral to promote safe and effective use of medicines (Ansari, 2018).
5. The high price of brand-name medicines relates to the cost of production. Meanwhile generic medicines offer approximate flexible costs of price at 80 to 85 percent below brand-name medicines, therefore creating resistance from medicines innovators to release patent molecules to produce generic medicines (Nordrum, 2015).
6. The opinion on the relationship between price and quality of medicines, in that the more expensive the better or “its inverse if it’s cheaper, it can’t be good”. Overcoming this challenge calls for innovative pharmaceutical policy that embrace generic medicine agenda to promote access to affordable and quality assured medicines (Kaplan & Wirtz, 2014).
7. Pricing procedures and repayment plan for Ghana National Health Insurance Scheme (NHIS) influences the pharmaceutical system and impact negatively on access to medicines (Mordi, Eghan, & Rankin, 2015).
8. Identification of the inadequate sources of essential medicines is equally attributed to gaps in the national legislation and policies in Ghana. Okpechi, Swanepoel & Venter (2015) indicated that a research conducted to find out why there are gaps in these instruments (Okpechi, Swanepoel & Venter, 2015).
9. Hafner, Walkowiak, Lee, & Aboagye-Nyame, (2017) posit that medicines are vital for improving public healthcare, it is therefore important to establish flexible systems for the different pharmaceutical sectors. However, diminutive effort is assign to the pharmaceutical sector as a relevant body that provides enormous support to strengthen the health system (Hafner, Walkowiak, Lee, & Aboagye-Nyame, 2017).
10. Access to medicines in countries is influenced by national policies, legislation and regulations, and that “drug types, marketing authorization, marketing exclusivity and incentives such as tax credits” are influencing factors (Gammie, Lu, & Babar, 2015).
. Theoretical Framework
The practice of specifying relationships between thoughts scientifically strengthens the recognition of errors and facilitates “lesson learning over time” (Weible, & Sabatier, 2018, p 3). The benefit of such approach allows for clearer application of “data collection and analytical methods” (p.3) with implied observations. From the collection of experiences and thoughts, Weible, et al, (2018), therefore defined theories as “arrange of approaches that specify the scope of inquiry, lay out assumptions, provide a shared vocabulary among members of a research team, and clearly define and relate concepts in the form of principles and testable hypotheses and propositions” (Weible, & Sabatier, 2018, p 3-4). The two theoretical frameworks identified to best suit the dissertation topic, the problem statement and the elaboration of the policy process in this research study are the innovation and diffusion models in policy by Berry and Berry and Advocacy Coalition framework by Paul Sabatier and Hank Jenkins-Smith (Weible, & Sabatier, 2018).
Berry & Berry (1990) clearly indicated that to understand policy making it is necessary to first explain the process by which government adopt new programs which are innovative and steadily adopted by the government in a measurable manner over time (Berry & Berry, 1990). The blend of innovation and diffusion models in new policy ideas is based on the principles of government adoption behaviors that simultaneously reflect the effects of “both internal determinants and policy diffusion under the political, economic and social characteristics to internal jurisdiction as well as the inherent adoption of intergovernmental policies by simple imitation” (Bauer, Pool, & Dexter, 1964).
Paul Sabatier and Hank Jenkins-Smith through the Advocacy Coalition framework identified characteristics that integrate structured groups to learn from each other either by information sharing or scientific proven data to influence government policy change over a period of time. Understanding the framework reveals governance and political structures of the society and how best to apply the theory to effect broader public opinions to bring about policy change. The concept “Advocacy Coalition” generates political awareness in groups of people to repetitively advocate for a change in political process or legislative renewal to solve a particular public issue (Weible, & Sabatier, 2018, p. 183-223). Coalition of resources and skills create greater force for comparative advantage during competition and as well creates a voice for the community.
Public health policies influence access to quality essential medicines for the health of the population. Policy is therefore a dynamic process that requires transformation from time to time to address the needs of the health situation of particular interest. The process involves multidisciplinary stakeholders making it more complicated. The choice of the theoretical frameworks innovation and policy diffusion model for policy change (Barry & Barry, 1990) is to impact on the policy innovation reforms of existing drug medicines policies to bring about social change to improve the health of the Ghanaian population. Taking particular interest in the diffusion of the new drug policy on quality generic medicines usage.
The existing Ghana National Drug Policies (2014 and 2017) do not strongly address the issue of generic medicines usage to solve price issues, as well as the procedures to ensure incremental high quantities of quality and safe generic medicines. It therefore calls for reformation of the policy through pharmacists’ consensus to create a new and innovative policy diffusing across the pharmaceutical industries, wholesalers, medicines regulators, procurement officers, policy and decision makers for better understanding and implementation of the policy change. The policy change can be effectively implemented to impact social change if efficient campaign strategies are established to create awareness of the population to erode the negative perception on the use of quality of generic medicines.
The two chosen theoretical frameworks would therefore explore why pharmacists’ perceive that quality generic medicines which are affordable to improve access to medicines for the Ghanaian population cannot be used to replace brand-name medicines. It is therefore the pharmacists’ responsibility to ensure the policy change and create awareness through “Advocacy Coalition” (Weible, & Sabatier, 2018) to bridge the gap by continually advocating for social change. Overcoming this barrier would also fulfill the Universal Health Coverage goal three (3) of the Sustainable Development Goals (SDGs) on availability and accessibility of health commodities for immunization coverage, mental health management, communicable and non-communicable diseases (Wirtz, et al, 2016).
Research Questions
The research questions for this study are important drive towards improving access to quality-assured generic medicines at affordable prices under the enable influence of the pharmacists’ altitudinal change and acceptance of quality generic medicines. The following research questions to be addressed in this study:
RQ1: What is the pharmacists’ role as the negotiating voice for the increase use of quality generic medicines to improve public health care?
RQ2: Why does pharmacists’ perceive that substituting quality generic medicines for innovator medicines is not right?
Nature of the Study
Due to the fact that medicines are crucial for improving health outcomes, an extensive body of work on access to and use of medicines has been researched but none addressed Pharmacist’s perception on the use of quality assured generic medicines in Ghana. This theoretical phenomenon being quiet new in Ghana, a qualitative research study would be applied to explore on how the Ghanaian pharmacists perception on the use of generic medicines do impact on access to medicines. Rudestam, & Newton, (2015, p. 99) clearly outlined the processes in research methodology to imply that the method chosen addresses the research questions, which should therefore align itself to the research statement, purpose, problem (Rudestam, & Newton 2015). In this research an initial secondary content analysis of the two existing Ghana Drug Policies (2004 and 2017) would be carried out. And a semi-structured interviews and or focus groups with 40 pharmacists, 10 each from medicines regulation, production, procurement and supply chain, and hospital pharmacists in Accra, Ghana would also be undertaken.
With the participants permission the interview would be recorded besides note and memo taking. Depending on the convenience for the interviewee the interview could be face-face, telephone or Skype. The face-face interviewing with the participants would provide the opportunity to observe participants “non-verbal emotions” (Wyse, 2014). Since the study involves human subjects ethical considerations are important (Walden University, Center for Research Quality. (n.d.-e). The interviewees would therefore fill informed consent form to ensure confidentiality of the process. The benefit is that the participants would feel protected and confident to provide information that would be reliable to ensure the validity of the research findings. To strengthen that component, a confidentiality agreement could be signed by the respondents (Walden University, Center for Research Quality n.d.b) as well. The research results would offer evidence-based information on the relevance of the usage of affordable quality generic medicines which would add value to improve healthcare for social change.
Possible Types and Sources of Data

1. Interview information would be coded, categorized and themes identified and expressed in numerical forms and analyze (Saldaña 2016, Wyse 2014).
2. A flexible interpretation of the qualitative data structured to address the real social health problem and the readiness to change their minds to accept the substitution of brand medicines for quality generic medicines to improve therapeutic outcomes.
3. Databases for literature research could be assessed from Walden Library databases, the Center for Scholarly Writing, the Doctoral Capstone Resources, Google Scholar, Research gate tool, and WHO websites.
4. PubMed proved more effective in identifying relevant publications which are specific locating relevant primary literature when comparing effective search databases for drug-related topics. PubMed offers optimal update frequency and includes online early articles and an optimal tool in biomedical electronic research. Reported that the keyword search with PubMed, although Scopus offers more coverage of journals and so is Google Scholar.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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