Drug Distribution is the process of making a product or drug available for use or consumption by a consumer or patients, using direct means, or using indirect means with intermediaries.

1. RESTRICTED DRUG
DISTRIBUTION SYSTEM
MUHAMMED RASHID P.P
1ST MPHARM
JSSCP, MYSURU

2. DRUG DISTRIBUTION SYSTEM
Drug Distribution is the process of making a
product or drug available for use or
consumption by a consumer or patients, using
direct means, or using indirect means with
intermediaries.
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3. RESTRICTED DRUGS
According to COMPREHENSIVE DRUG ABUSE
PREVENTION AND CONTROL ACT OF 1970
A drug or substance or immediate precursor,
included in schedule I,II,III,IV or V of part B of
public law 91-513.
It doesn’t include distilled spirit, wine, malt
beverages.
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4. 8/9/2017 4

5. EXAMPLES OF DRUGS
Schedule-I:
heroin.
lysergic acid diethylamide (LSD)
marijuana (cannabis), peyote, methaqualone.
3,4-methylenedioxymethamphetamine
Schedule II
hydromorphone (Dilaudid),
methadone (Dolophine),
meperidine (Demerol),
oxycodone (OxyContin, Percocet), and
fentanyl (Sublimaze, Duragesic).
morphine, opium, and codeine.
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6. Schedule III:
Products containing less than 15 mg of
hydrocodone per dosage unit (Vicodin)
products containing not more than 90 milligrams
of codeine per dosage unit (Tylenol with Codeine)
 buprenorphine (Suboxone).
Schedule IV:
Alprazolam, diazepam, clonazepam, midazolam,
lorazepam etc..
Schedule V:
cough preparations containing not more than 200
mg of codeine per 100 ml or per 100 grams
(Robitussin AC, Phenergan with Codeine)
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7. IMPORTANT LAWS
1. The Federal Harrison Narcotic Act- 1914
 To protect the health of American people
 To serve as a source of tax revenue to the
government.
2. Drug Abuse Control Amendments by FD&C
Act -1965.
 The combination of these two formed as a
basis for the control of majority of special
drugs within the hospital environment.
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8. 3. COMPREHENSIVE DRUG ABUSE PREVENTION
AND CONTROL ACT- 1970
Also known as Public law 91-513.
Also called as control substance act.
Purposes
 prevention of drug abuse and drug
dependence.
Provide the treatment and rehabilitation of
drug abusers and drug dependence persons.
Strengthens existing law enforcement
authority in the field of drug abuse.
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9. TERMINOLOGIES
CONTROLLED SUBSTANCE:
COUNTERFEIT SUBSTANCES: a controlled
substance whose container or label came
without authorization, the identification of a
producer other than actual producer.
DELIVER: the actual, constructive, or
attempted transfer of a controlled substance
DISPENSE: to deliver a controlled substance to
an ultimate user on a legally valid prescription
by a medical practitioner.
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10. DISTRIBUTOR: a person who so deliver a
controlled substance.
IMMEDIATE PRECURSOR: a substance which
The principal compound used or primarily
produced will use in the manufacture of a CS.
Immediate chemical intermediate used to
produce CS.
A substance which should be prevented,
curtail or limit to reduce the production of CS.
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11. NARCOTIC DRUGS:
• Any of the following produced directly,
indirectly by extract or chemical synthesis.
a) Opium, coca leaves and opiates.
b) A compound, salt, derivative or preparation
of opium, coca leaves or opiates.
c) Any form of products which is chemically
similar to the substance referred in A,B.
Excluding decocainized coca leaves or
extract without cocain
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12. Distribution pattern in hospital
RESPONSIBLITY:
 Administrative head of the hospital is
responsible for proper safeguarding and
handling.
 chief pharmacist - Purchase, storage,
accountability and proper dispensing.
 Head nurse – proper storage and use of the
nursing unit’s CS.
PREPARATION OF ORDERS:
 Typed or written in ink or indelible pencil and
signed.8/9/2017 12

13. ORDERING WARD STOCK FROM PHARMACY
Requisition with name, strength and form of CS
Sent to pharmacy along with empty container
Before issuing new order, the previous supply
must be fully accounted
Whenever a dose of drug is lost or wasted on
the wards, nurse in charge prepare a report to
cover the incident.8/9/2017 13

14. RMP ORDER FOR ADM.OF CS
Must be written in doctor’s order sheet of
patient’s chart.
Should be written in the hospital prescription
blank.
Should be signed by the RMP.
Then send to pharmacy
And pharmacist should review the
prescription.
SOS order must be encouraged except in
special circumstances
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15. INFORMATION MUST APPEAR IN
DIALY ADMINISTRATION CHART.
Date
Amount given
Patient’s full name
Patients hospital No.
Name of the doctor ordering
Signature of nurse administering
Number of tab. or ml administered
Filling out inventory column
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16. DOCTOR’S SIGN
Full name should be written
Sign must be by the doctor’s own hand
TELEPHONE ORDERS
Doctor  call to nurse  order CS write in order
sheet  doctor name & nurse’s initial 
administer only once  it should be signed by
RMP within 24 hours.
VERBAL ORDERS
Extreme emergency
No time to write
Nurse will write and RMP should sign within 24
hours
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17. DIRECT PRESCRIPTION TO PHARMACY
• Dispensed only on a prescription and it should
contain:
Patient’s full name
Address or hospital No
Date
Name and strength of drug prescribed
Quantity of drug to be prescribed
Frequency and route of administration
Name , sign and Reg. No of RMP
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18. SPECIALTY PHARMACIES
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19.  Specialty pharmacy refers to distribution channels
designed to handle specialty drugs.
Specialty drugs:
High cost:
 both in total and on a per-patient basis
 priced at more than $1,000 per 30-day supply
High complexity:
 complex medications, typically biology-based
 drugs derived from living cells
 But not always deemed to be specialty drugs
High touch:
 High-touch patient care management is usually required to
control side effects and ensure compliance
 Specialized handling and distribution are also necessary to
ensure appropriate medication administration
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20. Limited availability:
challenging for providers to manage
 necessity of having controlled environments
Rare and complex diseases:
 cancer, rheumatoid arthritis, haemophilia, H.I.V,
psoriasis, inflammatory bowel disease(IBD)
and Hepatitis C.
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21. Characteristics of Therapies Handled by Specialty
Pharmacy
 Use for treatment of chronic or rare diseases
 Annual cost exceeding $5000
 Administration by a route other than oral
 Product delivery to patients via mail or at home,
possibly requiring special handling (e.g., refrigeration)
 Administration outside a hospital setting (e.g.,
physician’s office, specialty clinic, or patient’s home)
 Management outside the traditional outpatient
prescription drug benefit
 Requirement for complex care, patient education, and
continuous monitoring.
Ex: biotechnological- gene based drug therapy
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22. 8/9/2017 22

23. Comparison b/w traditional & specialty pharmacies
VARIABLE TRADITIONAL PHARMACY SPECIALTY PHARMACY
Source of prescription
drug Outpatient, retail, or mail order
pharmacy
Mail order or specialty
pharmacy as dictated
by payer
Purchasing of products
Purchases drug products from
traditional wholesalers on volume,
cost-minus basis
Purchases drug products from
specialty suppliers on
cost-plus- markup basis
Role of group purchasing
organization
Negotiates contract pricing for
products and wholesaler
agreements
Few or no contract
relationships.
rebates usually apply unlikely
Pricing Contract price few to none at a
contract price
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24. RESTRICTED DDS
It is an entrepreneurial or business
approaches to working with
manufacturers, third-party payers, or
pharmaceutical distributors.
provide an avenue for manufacturers to
implement REMS (risk evaluation and
mitigation strategies) for medications that
require elements to ensure safe use.
It was developed to ensure that drugs with
very high risks are prescribed, dispensed, and
administered safely.
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25. Established by
• pharmaceutical manufacturers
• specialty pharmacies
• wholesale distributors
• Third party payers (most often)
• other specialty suppliers
• Who involved in distribution and administration
of drugs
with known serious risks
Unavailable in common market and practice
those that are not commercially
available and require sterile compounding
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26. REMS
• Established by Food and Drug Administration (FDA)
• Management of known or potential serious risks
from certain drugs.
• Although REMS vary based on the drug product, they
have a common framework and components.
• The number of drugs with REMS requirements is
increasing due to increasing commitment of
FDA to post marketing surveillance.
• RDDS may be a component of REMS, but not
mandatory.
• The scope of RDDS extends beyond fulfilment of
REMS requirements.8/9/2017 26

27. brown bagging
• Practice of taking specialty drugs from home
to o/p clinic or i/p for the administration of
that drug.
• Ensure proper administration of drug
• Can avoid the wastage of that drug
• Can reduce the cost by preventing errors
• but sometime, it is costly because they have
to pay extra money for that.
Pharmacy centric approach
Patient centric approach
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28. Domains of Concerns
Problems faced by patients
lack of sufficient education and knowledge
about the drug
Patient safety
lack of sufficient education and knowledge
about the operations of specialty pharmacies
or RDDS
Lack of knowledge about the use of portable
or implantable infusion devices.
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29. Problems faced by Health care providers
understanding and implementing the individual
requirements of each specialty pharmacy.
Investment of time by purchasing by pharmacy
and nursing staff.
Educating nurses and other health care providers
about requirements for obtaining and handling
the drug .
Lack of knowledge about the specialty drugs and
their administration aspects
Health care provider relationships and evidence-
based practice
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30. Problem with the facilities
Rules and regulations relating to product
integrity
Financial impact
Cost of treatment.
Lack of training programmes.
New techniques and experts requirement
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31. Future of RDDS/ SP
An integrated approach is needed for managing
the cost of RD.
Ensuring the safety of specialty drug products
Pharmacy partnerships with specialty pharmacies
home infusion networks for timely product
delivery
Utilization management to ensure appropriate
treatment initiation and adherence
coordination and standardization of electronic
billing
Comprehensive data capture and outcomes
analysis with online reporting capabilities
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32. IS IT USEFUL ?????
DISCUSSION TIME
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33. RESOURCES
 Bonnie e. KirschenBaum , Specialty pharmacies and other
restricted drug distribution systems: Financial and safety
considerations for patients and health-system pharmacists,
Am J Health-Syst Pharm—Vol 66 Dec 15, 2009 Suppl 7.
Henry N. Butler , REMS-Restricted Drug
Distribution Programs and the Antitrust
Economics of Refusals to Deal with Potential
General Competitors. Florida Law Review
Volume 67,Issue 3, Article 1,January 2016
Hospital pharmacy by WILLIAM E. HASSAN JR.
Page no: 323-343
http://medshadow.org/resource/drug-
classifications-schedule-ii-iii-iv-v/
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34. THANK YOU SO MUCH.......
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