116
Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first soothing application.

Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Embed Size (px)

Citation preview

Page 1: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Prehistoric Medication (30,000 BC)

Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first soothing application.

Page 2: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Ancient Babylonia (about 2600 B.C.)

Practitioners of healing of this era were priest, pharmacist and physician, all in one. Ancient Babylonian methods find counterpart in today's modern pharmaceutical, medical, and spiritual care of the sick.

Page 3: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Medicine in Ancient China (2000 BC)

Chinese Pharmacy, according to legend, stems from Shen Nung. He reputed to have tested many of them on himself, and to have written the first Pen T-Sao, or native herbal, recording 365 drugs.

Page 4: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Egyptian Medicine (1500 BC)

Though Egyptian medicine dates from about 2900 B.C., best known and most important pharmaceutical record is the "Papyrus Ebers" (1500 B.C.), a collection of 800 prescriptions, mentioning 700 drugs.

Page 5: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Greece Medicine ( About 300 BC)

• Most medicines were prepared from plants.

• Physicians took care of the pharmaceutical part of treatment and they were responsible for the drug being prepared properly and for the administration of the drug.

• Were groups of drug preparers and sellers which some physicians used.

Theophrastus the greatest early Greek philosophers and natural scientists, is called the "father of botany

Page 6: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Pharmacy in Greece: Hippocrates

• Father of Medicine• Developed the concept of

the “ four humors”.• Blood, phlegm, yellow bile

and black bile.• Believed that illness was a

result of an imbalance of the humors.

Page 7: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Pharmacy in Greece: Dioscorides

• Traveled with Roman soldiers and recorded his observations.

• Developed the first encyclopedia of drugs, Materia Medica– A systematic way of

describing the drugs, their effects and how they should be stored.

Page 8: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Monastic Pharmacy

During the Middle Ages remnants of the Western knowledge of Pharmacy and Medicine were preserved in the monasteries (fifth to twelfth centuries).

Page 9: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The First Apothecary Shops in Baghdad in 754

The Arabs separated the arts of apothecary and physician, establishing in Bagdad late in the eighth century the first privately owned drug stores.

Page 10: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Avicenna – The “Persian Galen”

Among the brilliant contributors to the sciences of Pharmacy and Medicine during the Arabian era was one genius who seems to stand for his time - the Persian, Ibn Sina (about 980-1037 A.D.),

Page 11: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Separation of Pharmacy and Medicine (17th Century)

In areas where Arabic culture interacted with the West the idea of separation of pharmacy and medicine was passed on.

Page 12: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The First Official Pharacopeia

The idea of a pharmacopoeia with official status, to be followed by all apothecaries, originated in Florence. The Nuovo Receptario, originally written in Italian, was published and became the legal standard for the city-state in 1498.

Page 13: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

American Pharmaceutical Association was founded in 1852

Page 14: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The Great Transformation

1902-1952

Page 15: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The Standardization of Pharmaceuticals Development of Chemotherapy

Page 16: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Pharmaceutical Research The Era of Antibiotics

Page 17: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The Continuing Evolution

1952-2002

Page 18: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Pharmaceutical Manufacturing Comes of Age

Page 19: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

An advertisement, c. 1885, promoting the medicinal use of a cocaine based product.

The marketing of medication has a long history

Page 20: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

At a Glance

• The Global Pharmaceutical market is worth US$300 billion a year

• A figure expected to rise to US$400 billion within three year

• Companies currently spend their one third of all sales revenue on marketing their product.

Page 21: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Pharmaceutical industry Spending on Promotion

Page 22: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

17.8

21

15.713.9

12.511

9

0

5

10

15

20

25

1996 1997 1998 1999 2000 2001 2002

Pro

mot

ion

al e

xpen

dit

ure

s ($

bil

lion

s)

Promotional spending on prescription drugs, l996-2002

Source: NIHCM, 2001

Page 23: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

DTC ads 12.5%$2.63billion

Samples 56.1%$11.78 billion

Detailing to doctors 25.3%$5.3 billion

Journal ads 2%$480 million

Hospital detailing 4.1%$861 million

Promotional spending on prescription drugs, 2002

Total spending: $21 billionSource: IMS Health

Page 24: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

2.5

1.85

1.321.07

0.791

0

0.5

1

1.5

2

2.5

3

1996 1997 1998 1999 2000

Pro

mot

iona

l exp

endi

ture

s ($

bill

ions

)Direct to consumer advertising on prescription drugs,l996-2000

Source: NIHCM, 2001

Page 25: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Direct to consumer advertising spending in the U.S., 2000

Source: NIHCM, 2001

125

146161

169

0

20

40

60

80

100

120

140

160

180

Pepsi Budweiser Vioxx GM Saturn

Spen

ding

($

mil

lion

s)

Page 26: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Comparison of median revenue dedicated to R&D, profits, and marketing/administration, Fortune 500 drug companies, 2000 (n=11)

Source: Public Citizen, 2001

12%17%

30%

0%

10%

20%

30%

40%

50%

60%

R&D as % of revenue Profits as % ofrevenue

Marketing &administration as %

of revenue

Page 27: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Main task of drug company employees, 2000

Distribution, Other

2%

Production,Quality Control

26%

R&D22%

Marketing39%

Administration11%

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

Page 28: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Drug company jobs in marketing and research, 1995-2000

55,348

87,810

49,409 48,527

0

20,000

40,000

60,000

80,000

100,000

1995 1996 1997 1998 1999 2000

Marketing

Research

Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar

# Jobs

Page 29: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

18.7%

11%

5%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%P

rofi

t a

s %

rev

enu

e

drug industry median profit as % revenueother industry median profit as % revenue

Profitability of drug industry, l993-2000

•Source: Public Citizen update of Stephen W. Schondelmeyer calculation, Competition and Pricing Issues in the Pharmaceutical Market, PRIME Institute, University of Minnesota based on data found in Fortune magazine, 1958 to 1999; Fortune magazine, April 2000, Fortune 500 (www.fortune.com).

2.8%

Page 30: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Fortune 500 drug company profitability compared to all other Fortune 500 companies, 2000

Source: Public Citizen, 2001

19% 18%

29%

15.8%

3.9%4.9%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Profits as %of revenues

Profits as %of assets

Profits as %of equity

Drug industrymedian

All Fortune 500industriesmedian

Page 31: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 32: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sources of increased drug expenditures, 2000-2001

Increased number of

RxsShift to more expensive

drugs

Increased cost of drugs

Source: NIHCM, 2002 Total increase: $22.5 billion

24%

39%

37%

Page 33: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

“Gifts are just a form of promotion or advertising, and advertising is a part of our society, like it or not.”

Page 34: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Gifts:

• Cost money (like other advertising).

• Influence behavior (like other advertising).

• Create obligation, need to reciprocate (unlike advertising). Conflict of interest

• Create sense of entitlement (unlike advertising).

• Erode professional values; demean profession (probably unlike advertising).

Page 35: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Conflict of interest

Set of conditions in which judgment concerning a primary interest tends to be unduly influenced by a secondary interest.

NEJM 1993;329:573-6

Page 36: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Conflict of interest?

“I have never been bought, I cannot be bought. I am an icon, and I have a reputation for honesty and integrity, and let the chips fall where they may.” “It is true that there are people in my situation who could not receive a million-dollar grant and stay objective. But I do.”

Page 37: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

“That stuff doesn’t influence me at all. I don’t even know what drug is on my pen. I just go for the food.”

--Fill in your name here?

Page 38: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Should doctors be held to different (higher) standards?

Page 39: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The physician-patient relationship is a fiduciary relationship.

Page 40: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Characteristics of a Fiduciary:

• Has specialized knowledge or expertise

• Holds the trust of others

• Held to high standards of conduct

• Avoids conflicts of interest

• Is accountable or obligated (ethically and legally)

Page 41: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Levels of Interactions:

• Clinicians– gifts– promotional information

• Researchers• Professional societies; medical journals• Continuing medical education (CME)

Page 42: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

At a Glance

• The 10 largest drugs companies control over one-third of this market

• Several with sales of more then US$10 billion a year. And profit margin of 30%

• Six are based in USA & other in Europe

Page 43: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

• Here, the pharmaceutical industry developed rapidly from the 1980s after the introduction of Drug (Control) Ordinance-1982.

• Due to recent development of this sector, the country is exporting medicines to global market including European countries and on the top of it, the industry has been supplying about 95 per cent of the domestic demand for medicines.

Page 44: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Over view of Last 5 Years Pharmacy Market in

BangladeshSI Number Year Taka in Crore Growth %

1 2009 5485 16.83

2 2010 6800 23.97

3 2011 8404 11.91

4 2012 9404 8.12

5 2013 10168 8.12

Ref. IMS 4th quarter report of 2009-2013

2009-13 Pharmacy Market Size is increased 85.38 %

Page 45: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

SI No NameBusiness Value

in Crore % Growth % Over Last Year

National 10168 100.00 8.12

1 SQUARE 1972 19.40 12.55

2 INCEPTA PHARMA 1018 10.02 11.84

3 BEXIMCO 8,96 8.82 8.04

4 OPSONIN PHARMA 5,30 5.21 4.77

5 RENATA 5,05 4.97 8.75

6 ESKAYEF 4,54 4.47 4.28

7 ARISTOPHARMA 4,38 4.31 11.37

8 A.C.I. 4,26 4.19 8.69

9 ACME 3,95 3.89 5.76

10 DRUG INTERNATIONAL 3,92 3.86 10.51

Last year top 10 Company of Bangladesh

Ref: IMS 4th quarter of 2013

Page 46: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

SI No Company Business Value in tk Crore

1 Beximco 1182 Novartis 1013 Square 864 Incepta 635 Techno Drug 46.16 Acme 24.9

7 Aristo Pharma 23.7

8 Renata 21.59 Eskafey 16.8

10 Globe Pharma 15.7

11 Biopharma 11.612 ACI 10.913 Popular 914 Opsonin 8.715 Jayson 7.6

Export Statistic 2013

Page 47: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 48: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 49: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 50: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

For out come of successful treatment

Doctor and pharmacist, illustration from Medicinarius (1505) by Hieronymus Brunschwig.

Page 51: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

World Medial Association International Code of Medical Ethics

DUTIES OF PHYSICIANS IN GENERALA PHYSICIAN SHALL

•always maintain the highest standards of professional conduct.

•not permit motives of profit to influence the free and independent exercise of professional judgment on behalf of patients.

•in all types of medical practice, be dedicated to providing competent medical service in full technical and moral independence, with compassion and respect for human dignity.

•deal honestly with patients and colleagues, and strive to expose those physicians deficient in character or competence, or who engage in fraud or deception.

Continue……

Page 52: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

• respect the rights of patients, of colleagues, and of other health professionals and shall safeguard patient confidences.

• act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.

• use great caution in divulging discoveries or new techniques or treatment through non-professional channels.

• certify only that which he has personally verified.

Continue……

Page 53: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

DUTIES OF PHYSICIANS TO THE SICKA PHYSICIAN SHALL

•always bear in mind the obligation of preserving human life.

•owe his patients complete loyalty and all the resources of his science. Whenever an examination or treatment is beyond the physician's capacity he should summon another physician who has the necessary ability.

•preserve absolute confidentiality on all he knows about his patient even after the patient has died.

•give emergency care as a humanitarian duty unless he is assured that others are willing and able to give such care.

Page 54: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

DUTIES OF PHYSICIANS TO EACH OTHER

•behave towards his colleagues as he would have them behave towards him.

•Shall not entice patients from his colleagues.

•observe the principles of the "Declaration of Geneva" approved by the World Medical Association

Page 55: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The following practices are deemed to be unethical conduct:

a) Self advertising by physicians, unless permitted by the laws of the country and the Code of Ethics of the National Medical Association.

b) Paying or receiving any fee or any other consideration solely to procure the referral of a patient or for prescribing or referring a patient to any source.

Page 56: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The following practices are deemed to be unethical conduct:

a) Self advertising by physicians, unless permitted by the laws of the country and the Code of Ethics of the National Medical Association.

b) Paying or receiving any fee or any other consideration solely to procure the referral of a patient or for prescribing or referring a patient to any source.

Page 57: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sources of In formations

Page 58: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sources of Information

1.Irish Medical Council2. Code on Interactions with Healthcare Professionals: The Pharmaceutical Research and Manufacturers of America (PhRMA)- 2009

3. Association of the British Pharmaceutical Industry (ABPI):

Page 59: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sources of Information continued

4. Organisation of Pharmaceuticals Producers of India (OPPI):OPPI Code of Pharmaceutical Practices- 2012

5.China Association of Enterprises with Foreign Investment

R&D-Based Pharmaceutical Association Committee code

6. A Cross-sectional Analysis of Pharmaceutical Marketing Codes and the WHO Ethical Criteria for Medicinal Drug Promotion September 2006 - February 2007

7. WHO Ethical Criteria for Medicinal Drug Promotion

Page 60: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

CODE OF PRACTICEfor the

PHARMACEUTICAL INDUSTRY

Second 2012 Edition

together with the

PRESCRIPTION MEDICINES

CODE OF PRACTICE AUTHORITY

Constitution and Procedure

ABPI

Page 61: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Iris Medical Council

Guide to Professional Conduct & Ethics for Medical Practitioners

Frequently asked question- relationship between doctors & industry

Edited & ApprovedNALA’s plan English Mark

October 2012

Page 62: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Is it right for doctors to accept drug samples from pharmaceutical sales representatives?

•Most general practitioners (GPs) say they only accept drug samples to use as emergency medication during night calls. If the samples are used only in this way, it would be acceptable for doctors to receive them.

•Doctors must store the samples in line with their marketing authorizations and must make sure that all relevant safety and quality measures are in place to maintain the safety, quality and effectiveness of the drugs.

Page 63: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

• A person shall not supply a free sample of a medicinal product to any person unless that person is qualified to prescribe such product, and in such case only where the following conditions are satisfied—

• The EFPIA Code is by far the most demanding international code on samples. It specifies that only a limited number of samples of a particular medicine may be provided, and this is only permitted in response to a written, signed and dated request from the health-care professional, qualified to prescribe the medicinal product [EFPIA 12.01 p10].

Page 64: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sample in OPPI code: India

Samples Permitted: In accordance with local laws and regulations, free samples of a pharmaceutical product

may be supplied to healthcare professionals or to persons duly authorised by them who are qualified to prescribe

such products in order to enhance patient care. Samples should not be resold or otherwise misused.

Page 65: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

such sample is provided on an exceptional basis only and for the purpose of acquiring experience in dealing with such a product;

the number of such samples of each product that may be supplied to any one recipient in any one year shall be limited and in any case shall not exceed six in number;

the supply of any such sample is made only in response to a written request, signed and dated, by the recipient;

the supplier of such samples maintains an adequate system of control and accountability;

each such sample is no larger than the smallest presentation of the product on the market;

each such sample is marked “free medical sample — not for sale” or words to the like effect; and

each such sample is accompanied by a copy of the summary of product characteristics for each such product.

Page 66: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Cash

Cash: Member Companies shall not provide to a medical

practitioner any cash or monetary grant for individual purpose in

individual capacity under any pretext

OPPI, ABPI IFPMA, PMCPA, EFPMA

Page 67: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Gifts

Page 68: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

WHO Review

•In the IFPMA2006 Code, the payment in cash (equivalents) is prohibited

• Contrary to the 2000 Code, in the 2006 Code all gifts for the personalbenefit of the health practitioner are prohibited [IFPMA 7.6.2 p13].

• ‘The provision of an inexpensive gift, not related to the practice of medicine, may be given on an infrequent basis to health-care professionals, in acknowledgment of significant national, cultural or religious holidays in some countries

Page 69: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Professional Guidelines

Page 70: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

American Medical AssociationCouncil on Ethical & Judicial Affairs

• “Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value.”

• “No gifts should be accepted if there are strings attached.”

JAMA 1991;261:501

Page 71: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

American College of PhysiciansGuidelines on Physician-Industry Relations

• The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged.

• The acceptance of even small gifts can affect clinical judgment and heighten the perception (as well as the reality) of a conflict of interest..

• The dictates of professionalism require the physician to decline any industry gift or service that might be perceived to bias their judgment, regardless of whether a bias actually materializes.

• Ideally, physicians should not accept any promotional gifts or amenities, whatever their value or utility, if they have the ability to cloud professional judgment and compromise patient care.

Annals of Internal Medicine 2002;136:396-402.

Page 72: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

American College of PhysiciansGuidelines on Physician-Industry Relations

Acceptable industry gifts:

• Inexpensive gifts for office use (pens and calendars).

• Low cost gifts of an educational or patient-care nature (such as textbooks). < 15 Euro/ 6 bp/ 100 USD

• Modest refreshment.

Annals of Internal Medicine 2002;136:396-402.

Page 73: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

PhRMA Code on interactions with healthcare professionals

• Items primarily for the benefit of patients may be offered to healthcare professionals if they are not of substantial value ($100 or less).

• Items of minimal value may be offered if they are primarily associated with a healthcare professional’s practice.

• Items intended for the personal benefit of healthcare professionals (CDs, tickets to a sporting event) should not be offered.

www.PhRMA.org, April 2002

Page 74: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 75: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

PhRMA Code FAQs

Question:

Under the Code, may golf balls and sports bags be provided if they bear a company or product name?

Answer:

No.

www.PhRMA.org, April 2002

Page 76: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

PhRMA Code FAQs

Question:

Under the Code, may healthcare professionals be provided with gasoline for their cars if they are provided with product information at the same time?

Answer:

No.

www.PhRMA.org, April 2002

Page 77: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

PhRMA Code FAQs

Question:

Under the Code, may items such as stethoscopes be offered to healthcare professionals?

Answer:

Yes

www.PhRMA.org, April 2002

Page 78: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

• It further says that“gifts for the personal benefit of healthcare professionals

(such as tickets to entertainment events) should not be offered or provided.”

Page 79: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Is it right for doctors to accept gifts and hospitality from pharmaceutical, medical devices or other commercial companies?

•Paragraph 59.9 of the Guide says that doctors should not accept gifts (including hospitality) from pharmaceutical, medical devices or other commercial companies.

•However, doctors can accept reasonable fees for any work they do as part of a contractual arrangement with a commercial company.

•Paragraph 59.9 also says that doctors should be aware that commercial companies may use even low-value promotional items to try and influence prescribing and treatment decisions.

Page 80: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Is it acceptable for doctors to attend promotional or sponsored educational meetings?

•A ‘promotional meeting’ is a meeting held by a pharmaceutical, medical devices or other commercial company to teach doctors about a particular new drug or device. In general, promotional meetings do not give objective educational information and doctors should not use them for continuing professional development (CPD) points unless the event has been approved by a professional body.

•The Guide also advises doctors not to rely solely on promotional literature from pharmaceutical companies for information about particular drugs and to seek independent, evidence-based sources of information on the benefits and risks before prescribing

Page 81: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Events

The WHO-ECPM:

1.The objective scientific content of a meeting should be paramount, hospitality

2. Entertainment be secondary to the main purpose of the event and kept to a modest level

3.Should not lead to any obligation to promote

any medicinal product.

Page 82: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

The Medical Council advises doctors not to accept direct hospitality from pharmaceutical, medical

devices or other commercial companies so that their professional judgment is not affected by the

hospitality.

Page 83: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Is it acceptable for a doctor to accept sponsorship from a pharmaceutical, medical devices or other commercial company?

The Medical Council accepts that payment of travel and accommodation expenses for doctors to attend meetings, either as participants or speakers, supports the aim of continuing professional development.

However, the Council says that these payments should go through unrestricted Education and Development Funds made available by the sponsoring company to the institution which is hosting the meeting or the conference organiser

Page 84: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sponsorship

“any such support must not be linked in any way with product

promotion. No commitment must be sought or given in relation to the prescribing, supply or use of the company’s products.”

Page 85: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sponsorship

“Where appropriate and depending on the time, location and length of the meeting, support to healthcare professionals may cover actual travel expenses, meals, refreshments, accommodation and registration fees.”

Page 86: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sponsorship

“It should be the programme that attracts delegates and not the associated venue or hospitality. Companies must not organise meetings to coincide with sporting, entertainment or other leisure events or activities. Venues that are renowned for their entertainment or leisure facilities or are extravagant must not be used.”

Page 87: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Sponsorship

Travel expenses may not be paid for spouses or other accompanying persons, unless they are healthcare professionals who qualify as participants in their own right;

Page 88: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

WHO Review

WHO-ECPM [IFPMA2006 7.5.3 p13] [EFPIA 9.07 p9]. More specifically, the restriction of hospitality to

meals, refreshments, accommodation, travel costs and registration fees is clear and relevant and therefore commendable for all codes on self-

regulation of drug promotion

The additional restriction of travel

costs to economy air travel, made by ABPI and MedA

Page 89: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Is it acceptable for a doctor to accept sponsorship for research from a pharmaceutical, medical devices or other commercial company?

Doctors have a responsibility to make sure their work is not influenced in any way as a result of sponsorship or any

other relationship with a pharmaceutical, medical devices or other commercial company.

Doctors should tell patients, employers and other institutions where they see or treat patients about the

relationship.

If the relationship involves medical research, the doctor must make sure that the relationship does not influence the

study, design or interpretation of any research data or affect the research or education in any way.

The doctor should also tell the relevant ethics committee about the relationship.

Page 90: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Are you aware of the guidelines and regulations which deal specifically with doctors’ interactions with pharmaceutical and medical device companies?

•The Medical Council’s Guide, the 2007 Regulations and the Code of Marketing Practice As a doctor, it is your duty and responsibility to be familiar with the latest guidelines and regulations in this area.

Page 91: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Is educational sponsorship or funding a good idea?•Paragraph 59.10 of the Guide says that, in general, educational sponsorship or funding from commercial companies should go through unrestricted Education and Development Funds. The funding should be managed without influence from the commercial company.

Page 92: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Are you using the right sources to keep up-to-date with developments in medication and device safety?

•The Guide says that you should not rely solely on promotional literature distributed by pharmaceutical companies for information about particular drugs or medical devices.

•Instead, you should seek independent evidence based sources of information on the benefits and risks of all medication and medical devices before prescribing.

Page 93: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Relevant Paragraph from the Guide

Paragraph 53.6 -

If you are paid directly or indirectly by pharmaceutical, medical device or other commercial companies or organizations to conduct medical research, you must make sure that such payment does not influence your study design or interpretation of research data.

Page 94: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Paragraph 53.7 –

If you are paid directly or indirectly by pharmaceutical, medical device or other commercial companies or organisations to conduct medical research, you must address any potential conflict of interest arising from such payment and make appropriate disclosure in any publication of research results.

Page 95: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Paragraph 59.8 –

You must keep up to date with developments in medication safety. You should not rely solely on promotional literature distributed by pharmaceutical companies for information about particular drugs. You should seek independent evidence based sources of information on the benefits and risks before prescribing.

Page 96: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Paragraph 59.9 –

You are advised not to accept gifts (including hospitality)from pharmaceutical, medical devices or other commercial enterprises. This does not preclude the payment of reasonable fees. You should be aware that even low value promotional materials are offered by commercial enterprises with the intention of influencing prescribing and treatment decisions.

Page 97: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Paragraph 59.10 – In general, educational funding from commercial enterprises to the healthcare sector should be channelled through unrestricted Education and Development Funds and be managed without influence from the commercial enterprise in question.

Page 98: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Paragraph 59.11 – If you receive financial support or other resources from pharmaceutical companies and/or related enterprises in connection with professional activities, including lectures, presentations and publications, development of clinical services or conducting research, you should address any potential conflicts of interest that arise. In these circumstances, your patients and any other relevant party should be informed about any potential professional relationship you have with these companies.

Page 99: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Relevant section from the 2007 regulation

• Section 21 (1) - A person shall not, in the course of promoting medicinal products to persons qualified to prescribe or supply such products, supply, offer or promise to such persons any gift, pecuniary advantage or benefit in kind, unless it is inexpensive and relevant to the practice of medicine or pharmacy.

• 21 (2) a person may offer hospitality at sales promotion events or at other events for purely professional and scientific purposes

Page 100: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

• In relation to educational, research or employment grants, donation or sponsorship of equipment, any such support must be made only in response to a written request and “must be paid directly to an institution rather than to an individual healthcare professional.”

• It is also made clear that “any such support must not be linked in any way with product promotion. No commitment must be sought or given in relation to the prescribing, supply or use of the company’s products.”

Page 101: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Pharmaceutical Research and Manufacturers of America

(PhRMA)

Code of Interaction with Health care Professionals 2009

Page 102: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

CME: Continuing medical education

Continuing medical education (CME), also known as independent medical

education (IME), helps physicians and other medical professionals to obtain

information and insights that can contribute to the improvement of patient

care, and therefore, financial support from companies is appropriate. PhRMA

Page 103: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Under the PhRMACode, what are examples of permissible items that

may be provided to educate healthcare professionals?

Items primarily designed for the education of patients or healthcare professionals, as long as such items are not of substantial value ($100 or less) and do not have a value to the healthcare professionals outside of their professional responsibilities. For example; medical text book, a subscription to a relevant scientific journal, or copies of relevant clinical treatment guidelines.

Page 104: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

A field sales representative of Company X provides pizza for the staff of a medical office during lunch time. Is this consistent PhRMA with the Code?

Providing an occasional meal would be consistent with the Code if the sales representative will provide an

informational presentation to the medical staff in conjunction with the meal of modest value, so long as the

location of the in-office presentation is conducive to scientific or educational communication. Merely dropping

off food for the office staff, however, would not be consistent with the Code.

Page 105: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 106: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first
Page 107: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

But What we are doing ?

Page 108: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Service to Qualified Doctors

1. Cash for products Prescription

2. Pleasure trip (family, friends, colleague) for prescription share

3. Cash or Sponsor for Personal program, such as wedding program, birthday, akhika, different cultural program etc.

4. Home decoration, chamber decoration

5. Hotel room service

6. Personal visiting card, Rx pad & prescription folder

7. Medial Equipment & Medical Books

8. Use survey companies provided prescription pad. ( which contain carbon paper)

9. Take share ( taka) from each prescription. Eg. Vitamin & food supplement product.

Page 109: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

10. Children tuition fee ( Domestic & overseas)

11. Fix deposit or Monthly DPS for self or family person12. Exclusive gift such as Home, flat, car etc13. Personal overseas tour cost ( plane fare, hotel cost etc)14. Different food item15. Dress & cloth in different occasions16. Extra & excess sample medicine17. Use MR or MPOs for personal work- Banking work, family work18. All type of insurance coverage of physician & his family members.

Page 110: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Service to Medical College & General Hospital

1. Sponsor to Medical Conference & Seminar

2. Sponsor to Cultural program & Picnic

3. Medial Equipment & Medical Book for indoor use

4. Doctors Refreshment room decoration ( Chair, water filter, TV etc)

5. Snacks, Lunch & Dinner

6. Personal gift to doctor nurse & nurse.

Page 111: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

To young Intern doctors

I. Give mobile recharge card, Internet modem & Recharge card

II. Free lunch, snacks, dinner.

III. Finance in different pleasure trip & program

IV. Medical book & Equipment

V. Extra Sample Medicine

VI. Exclusive gift

VII. Transport ticket

Page 112: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

At OT

• OT dress

• OT order sheet

• Injectable Sample

• OT instrument

• Hand sanitizer & OT wash materials

• Give sample, gift to OT boy

Page 113: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

DMF/LMAF

1. Special Discount (out of regular discount) 2. Cash for products Prescription3. Pleasure trip (family, friends, colleague) home & abroad4. Cash or Sponsor for Personal program, such as wedding

program, birthday, akhika, different cultural program etc.5. Home decoration, chamber decoration6. Medial Instrument7. Occasional gift

Some time they give below standard product due to high profit margin.

Page 114: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

To Chemist ShopA) There are two type of discount 1. General ( all chemist shop

will get is), 2. Special discount ( it is vary)

B) Printed promotional item gift

C) Special discount for selective product- such as Injectable antibiotic, Amino acid, Injectable vitamins

D) Pleasure trip

E) Sessional gift

Some time they change the brand that is prescribed by the doctor, due to biased

Page 115: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

Over view of Cash serviceS No Company Cash Service per month Av. Sales per month

1 A 2.5 crore 90 crore

2 B 5.5 crore 105 crore

3 C 3.75 crore 65 crore

4 D 72 Lac 26 crore

5 E 24 Lac 7.8 crore

6 F 7 Lac 2.5 crore

Avg. 440 crore taka cash are given for 10,000+ crore sale

For confidentiality company name are not shown

Page 116: Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first

A Case Study

In Dhaka there is a famous diagnostic center & Hospital, situated at dhanmondi, Its name’s first later is P.

There are Total 105 is practicing, among them1.About 80 person receive different service from different companies ( by force)2.About 20 person receive not by force( if companies willingly gift)3.There are 5 doctor they do not take any kind of thing.