International Journal of Pharmacology and Pharmaceutical Sciences 2016; Vol: 3, Issue: 6, 10-17.
.
Research Article
ISSN: 2394-613X
A REALISTIC CASE STUDY: “WHAT DO PHARMACISTS REALLY THINK OF
GENERIC MEDICINES AND BRAND NAME MEDICINES?”
1
Sachin S. Mali*1, Manali R. Huddar1, Prasad V. Patrekar1, Priyanka M. Shinde1
Department of pharmaceutics, Adarsh Institute of Pharmacy, Vita, 415 311, Maharashtra, India
*Corresponding Author
ABSTRACT
This realistic case study suggests that although in general pharmacists were positively inclined towards generic medication use,
they have some considerations that determine to what extent they will support generic medicine use. These are economic,
scientific, and policy related considerations that are likely to remain matters for discussion in the future among pharmacists and
their professional organizations. A realistic case report form (RCRF) is designed to collect the data in a case report. The aims of
this article were to identify and take views by using questioner method from registered pharmacists from the different rural and
urban side' and predict the important changes required to improve on the use of generic medicines.
Keywords: Generic medicines, Brand name Medicines, A realistic case report form (RCRF) etc.
INTRODUCTION
Generic medicines are those where the original patent has expired and which may now be produced by Manufacturers other than
the original innovator company. The term ‘generic drug’ or ‘generic medicine’ is commonly understood, as defined by the World
Health Organization (WHO), to mean a pharmaceutical product that is usually intended to be inter- Changeable with an innovator
product, is manufactured Without a license from the innovator company and is Marketed after the expiry date of the patent or
other exclusive rights. [1-3]
Concerns about medication costs and drug safety have increased attention to the role and Purity of generic drugs. Generic
drugs are frequently sold at prices far below their brand-name counterparts, and therefore can promote patient adherence to
essential medications and reduce health care spending. This can be particularly important for patients with limited income and
public insurance programs with constrained budgets. Many countries permit or mandate pharmacists to substitute a generic
version (if one is available) whenever a physician writes a prescription, a flexibility that is critical to encouraging appropriate use
of generic products. [3-8]
A realistic case report form (RCRF) is designed to collect the data in a case report. It represents a significant part of the
RCRF and can affect study success. Site personnel capture the subject’s data on the RCRF, which is collected during the visits to
the different medical shops/pharmacists. [9 -12]
CASE REPORT FORM TEMPLATE
Mali SS,.et.al..; Int. J. Pharmacol. Pharm. Sci. (2016) 3:6;10-17
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For reasons of confidentiality, the name and initials of the study participant should not appear on the RCRF.
A REALISTIC CASE REPORT RESULTS
Q.1 Does the people know about generics?
52.94% pharmacists said that people doesn't know about generics. The pharmacist actually mean to say that people know generics
only as the drugs which are cheaper as per price and they don't have any idea about any detail information about it. While the
remaining 47.06% pharmacist says people really knows the actual concept of generics.
Mali SS,.et.al..; Int. J. Pharmacol. Pharm. Sci. (2016) 3:6;10-17
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Q.2 Does the physician aware about generics?
As per our survey 76.50% of the pharmacists said yes that the physicians are aware about generics. The answer of the about
question differs by the localities where the survey is taken. 23.50% pharmacists said that doctors are not aware about generics as
there are very few prescriptions of generics prescribed by physicians.
Q.3 Which type of medicines sold highly in market?
90.19% of pharmacist said that branded drugs are sold highly in market as compared to that of generics. As the pharmacist said
people don't have exact information about generics, that’s why the average no. of drugs sold in market are branded. Most of the
people believe in brand name drugs than generics and hence people prefer to buy brand name drugs over generics. 9.81% of the
people says that generics are sold highly in market as the poor people afford generics over branded due to their lower cost.
Q.4 Does the generic drug manufacture by well known industry?
Only 8% of the pharmacists said no that the generic drugs doesn't manufacture in well known industries. As they said the generic
drugs manufacture after the expiry of the patent of brand name drugs and it may be manufactured by local industries also. But the
remaining 92% of the pharmacist said that generic drugs also manufacture by well known industries (e.g. cipla).
Mali SS,.et.al..; Int. J. Pharmacol. Pharm. Sci. (2016) 3:6;10-17
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Q.5 Which type of medicine is cheaper to the customer?
76.47% of pharmacist said that generics are cheaper than brand name drugs and the main reason behind this that generics have
very low price than the brand name drugs.23.53% of pharmacist said that brand name drugs are cheaper to use because in some
cases branded drugs are cheaper than that of the brand name drugs.
Q.6 Are you selling generics as per MRP printed on label?
37.25% of pharmacist doesn't sell the drugs as per MRP printed on label .As the rule for generics says that the retailer should
minimize the price of generic drug up to 5% lower than original price. According to them as the drugs are categorized into generic
the price of the drug must be lowered .While the 62.75% of the pharmacist sells the drug as per MRP printed on label. As the
customer is not able to differentiate the drug is either generic or branded ,pharmacist sells the drug as per printed price.
Q.7 Do you provide bill for generics?
92% of the pharmacists provide the bill for generics whether the price of the generics is lowered or not .If the price of the generic
medicine is given with concession they provide the bill b mentioning the discount given to the patient. While the remaining 8% of
the pharmacist don’t provide the bill.
Mali SS,.et.al..; Int. J. Pharmacol. Pharm. Sci. (2016) 3:6;10-17
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Q.8 Is there any difference between generics and brand name drugs as per MRP?
According to our survey 100% of the pharmacist said yes for the question mentioned above. As we conclude the entire pharmacist
said that most of the generics have low price than that of brand name medicines.
Q.9 Does the generics are easily available in market?
92.15%of the pharmacist said that yes the generics are easily available in market .While the remaining 7.85% pharmacist found
difficulty in availability of generics. They said generics are used rarely and hence sometimes certain drugs cannot get readily
available in market.
Q.10 Is there any form of NDDS/ADDS available in generics?
According to our survey, 64.70%of the pharmacist said no about the availability of the NDDS/ADDS form. They give an example
about the Insulin which is not available in generics. While 35.30% said yes that NDDS/ADDS forms in generics are available in
market.
Q.11 Does the generis gives more profit over the brand name drugs?
98% of the pharmacist said that generics gives more profit than brand name drugs. The margin given to the retailer for generics is
much more as compared to brand name drug that’s why generics gives more profit over generics. Only 2% of the pharmacists said
that it doesn’t give more profit than brand name drugs as the brand name drugs sold more than generics.
Q.12 Does the doctor prescribe generics?.
92.15% of the doctors doesn’t prescribe generics. According to them pharmacist don’t get profit for the generics also, some said
many of the doctors have doubt on the therapeutic effect of generics. 7.85% of the doctor prescribe the generics only for those
patient who cannot afford the brand name drugs.
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Q.13 What is the average no. of generics prescribed by doctors?
92.15% for 10-20 & 7.85% for >50
Q.14 Does the generics are the first choice of the doctors?
According to the pharmacists(100%) , generics are not the first choice of the doctors due to quality of generics and due to
therapeutic effect of generics.
Q.15 Does the generics are the first choice of pharmacists?
58.80% of the pharmacist give first choice to the generics. Because, generics give more profit to the pharmacists over brand name
drugs. Also, some pharmacist said many of poor people cannot afford the brand name drugs. While 41.18% of the pharmacist
gives first choice to the brand name drugs cause, they do not believe in therapeutic effect of the generics.
Q.16 Response given by pharmacists toward generics about;
1.Economy
:
2.Patient response
Excellent:43.13%
:
Excellent:3.9%
3.Physician
:
Excellent:7.8%
4.Promotion
:
Excellent5.88%:
Good:52.94%
Good:68.62%
Good:14.60%
Good: 25.49%
Poor:3.90%
Poor:27.45%
Poor:27.45%
Poor:68.62%
Q.17 Does the generics are safe to use?
84.31% of pharmacist said yes that generics are safe to use. While the remaining 15.69% of pharmacist have a doubt on the safety
of the generics due to have low therapeutic effect.
Q.18 Does the generic medicines have an excellent quality?
58.83% of pharmacist said yes that generics have an excellent quality as they still didn’t found any problem regarding to the
generics. And the remaining 41.47% said that generics don’t have good quality as much as of brand name drugs. According to
them cover or wrappers used for generics are not of standard qualities.
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Q.19 Does the generics have same strength as that of brand name drugs?
72.55% of the pharmacist said yes that generics also have same strength as that of brand names. Because, the composition of the
formulation is same and it should not affect the strength of the formulation. While, the 27.45% of the pharmacist said that the raw
materials used for the generics is not of standard quality and it may affect the strength of the formulation.
Q.20 As per your opinion, which type of medicine people should prefer, generis or brand name?
58.82% of the pharmacists support to brand name drugs due to their standard quality, strength, therapeutic effect and most
important that the prescription given to pharmacist is most of the for brand name drugs and hence, people should prefer brand
name drugs over the generics.
41.18% of the pharmacists support to the generics because it has very low price and people afford to buy generics over brand
name drugs and hence, people should prefer to buy generics.
LIMITATIONS
This case study was limited to only 51 Cases so there will be the need of further opinions from pharmacists of different states.
DISCUSSION
This study provides a comprehensive overview of the available evidence comparing use of brand-name and generic versions of
Medicines. We have 51 case studies from different pharmacists which gives idea about what is the exact position of generic and
brand name drug in market.
Case report form design is the initial step in translating the questionnaires standard into protocol and is paramount to a successful
RCRF. These standard guidelines will contribute in preparing a well-designed RCRF for data acquisition. These studies range
from qualitative assessment of perceptions in specific patient cohorts to general lay/consumer knowledge versus knowledge of
professionals. Many of these studies focus on the influence of relative cheapness on perceptions and use of generic medicines.
CONCLUSION
As per our realistic case study report brand name and generic drugs both are found to be superior in respect quality and therapeutic
effect. To minimize comparative price between brand name and generics; the charge given by the pharmacist should be fixed for
generic medicines. It may possible only when the manufacturer provide fixed price for it. The physician, pharmacist and patient
interaction may key to influencing patient approval towards generic medicines. The response given by pharmacists toward
generics about sales promotion is very poor.
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ACKNOWLEDGMENT
We would like to thank the registered pharmacists from nearby places for their support during case study.
REFERENCES
1.
World
Health
Organization
(WHO).
Generic
drugs.
Geneva:
WHO;
2015.
http://www.who.int/trade/glossary/story034/en/index.html. Accessed 21 June 2015.
2.
http://www.fda.gov/cder
3.
Nahm M, Shepherd J, Buzenberg A, Rostami R, Corcoran A, McCall J, et al. Design and implementation of an institutional
case report form library. Clin Trials 2011; 8:94-102.
4.
Dr. M. S. Latha. Basics of case report form designing in clinical research. Perspectives in Clinical Research. OctoberDecember. 5(4); 2014.
5.
Nabil Abdo Al-Gedadi et.al., Pharmacists' Views on Generic Medicines: A Review of the Literature. Pharmacists' Views on
Generic Medicines: A Review of the Literature. 8/3/2016.
6.
US
Food
and
Drug
Administration.
What
are
generic
drugs?
Available
at:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/default
.htm. Accessed October 19, 2010.
7.
Zarowitz BJ. Th e generic imperative. Geriatr Nurs. 2008;29: 223-226.
8.
Henderson JD, Esham RH. Generic substitution: issues for problematic drugs. South Med J. 2001;94:16-21.
9.
Meredith PA. Generic drugs. Th erapeutic equivalence. Drug Saf. 1996;15:233-242.
10. Crawford P, Feely M, Guberman A, et al. Are there potential problems with generic substitution of antiepileptic drugs? A
review of issues. Seizure. 2006;15:165-176.
11. Office of Generic Drugs, Center for Drug Evaluation and Research,U.S. Food and Drug Administration (FDA), Generic Dr
ugs: What you need to know. 2009.
12. Gilman JT, Alvarez LA, Duchowny M. Carbamazepine toxicity resulting from generic substitution. Neurology
1993;43:2696– 2697.
Mali SS,.et.al..; Int. J. Pharmacol. Pharm. Sci. (2016) 3:6;10-17
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