Activities with pharmaceuticals
• research,
• preparation,
• manufacture,
• distribution,
• storage and keeping,
• supply and transportation,
• offering for the purpose of sale,
• dispensing,
• sale,
• use of pharmaceuticals in the provision of healthcare
services or veterinary care, or the disposal of
pharmaceuticals.
HANDLING
Goal
Right MP
Right Patient
Right Dose
Right Route
Right Time
R response, documentation, education..
Dispensing of medicinal products
• DIRECTIVE 2001/83/EC
• REGULATION (EC) No 726/2004
Dispensing of medicinal products
• Act 378/2007 Coll. on Pharmaceuticals
Assortment in CZE
Additional
assortment,
OTC medicinal
products
OTC with
restricted
dispensing
PrescriptionOnly
medicinal
products
Restricted
PrescriptionOnly
medicinal
products
Medicinal devices
Medical prescription
with blue strip
Selected medicinal
products
The most important questions –
in practical way
Each category :
• Where
• Who
• Whom
• How
Where?
• Pharmacies
• Public health protection authorities
• Nuclear medicine workplace
• Blood centres
• Immunology or microbiology workplace of a
healthcare service provider or a public health
protection facility
• Mail ordering
• Veterinarians
• Dispensaries of medical devices
• ….Physicians ?
• Vendors of selected medicinal products
Dispensing – who, where, what?
Medicinal products may be dispensed in
pharmacies by
• pharmacists;
• pharmaceutical assistants: OTC
Physicians
• may „dispense“ only if the patient's health
statute requires immediate medication use
and
it is not possible due to time or local conditions
to ensure supply of needed medicines on the
prescription.
Dispensing – who, where, what?
• Vendors of selected medicinal products
Only selected medicinal products
nuclear medicine workplace
• only radiopharmaceuticals prepared at this
workplace
employees of public health protection
authorities with professional qualification
• only immunological products intended for
vaccination
doctors, pharmacists or other healthcare
professionals of a blood centre and a blood
bank
• only blood derivatives and transfusion
products;
• immunology or microbiology workplace
• only human autogenic vaccines prepared at
this workplace.
Dispensing – who, where, what?
Medicinal products may be, furthermore, dispensed
by:
• veterinarians authorised to engage in
professional veterinary activities;
Only medicinal products intended for the treatment
of animals.
Dispensing of medicinal products
• quality of MP is not compromised
• MP before dispensing: handling complies with
the conditions established in the MA
Dispensing of medicinal products
• Not compromise the integrity of packaging of
MP with marketing authorisation
(with the exception:
preparation of medicinal products
dispensing for a healthcare care facility)
Dispensing of medicinal products
• Obligation:
– keep records for the period of 5 years;
(identification of the pharmaceutical form, quantity
of the active substance contained in a unit of
weight, volume or pharmaceutical form, type of
packaging, and pack size of the medicinal product)
• Obligation to provide to the SIDC data about
dispensed medicinal products - Rx medicinal
products. OTC with restriction…
Dispensing of medicinal products
• Obligation to co-operate:
– the replacement of a MP in which a quality defect
has been detected;
If a pharmacy dispenses medicinal products to
other pharmacies or inpatient healthcare
providers:
• specified „in the licence“ of such pharmacy
Obligation - right
• Inform the patient about alternative options
for the MP and may replace (consent of the
patient) identical
in terms of its efficacy and
safety, contains the same active substance with
the same route of administration and the same
pharmaceutical form.
Note: could be restricted by the prescriber
Obligation - right
MP may be dispensed also to a person other
than the one for whom it has been prescribed.
Obligation - right
• Doubts arise in respect of credibility of the
medical prescription,
• doubts as to whether the person to whom are
products dispensed, is able to guarantee proper
use of the MP
MAY NOT BE DISPENSED
Obligation - right
• Suspected abuse of the medicinal product
• The conditions for dispensing of medicinal
products with restriction haven‘t been fulfilled
MAY NOT BE DISPENSED
• --------------------
• Interactions
• (threat to the life or health of the worker)
Conscientious objection
refusal to fulfill a legal obligation due to a conflict with conscience
Refuse
But !!! - another worker will perform needed service / another health
care facility
Never - If there is a possibility of:
• a threat to the patient's life
• serious threat to patient‘s health - due the refuse
(Act No. 372/2011 Coll., on health services and the terms and
conditions for the providing of such services, as amended)
Additional obligations
• comply with the principles of
good pharmacy practice
OTC
• Pharmacist, pharmaceutical assistant
• Statut OTC - SIDC – marketing authorisation
• Switching Rx OTC; eventually. OTC Rx
Tools for dispensing
WWHAM:
• Who?
•What?
•How long?
•Action taken?
•Medication?
Tools for dispensing
ASMETHOD
• Age/appearance
• Self or someone else
• Medication
• Extra medicines
• Time persisting
• History
• Other symptoms
• Danger symptoms
Tools for dispensing
SIT DOWN SIR
• Site or location of a sign/symptom
• Intensity or severity
• Type or nature
• Duration
• Onset
• With (other symptoms)
• Annoyed or aggravated by….
• Spread or radiation
• Incidence or frequency
• Relieved by ….
Dispensing OTC - ethics
• Do not offer more expensive products
• Do not offer more products than the
corresponding to state of health / patient needs
• Do not prefer …. Supplier…
• Provide information to patient (self –service too!)
Medicinal products - Rx Only
MP shall be available only Rx:
• present a jeopardy either directly or indirectly
even when used correctly if taken without
medical supervision;
• frequently used incorrectly, and as a result can
present a direct or indirect jeopardy to human
health;
Medicinal products - Rx Only
• contain substances serious AR
• intended for parenteral administration
• contains a substance classified as narcotic or
psychotropic or a precursor in amounts not
allowing for being dispensed without medical
prescription
Medicinal products - Rx Only
• lead to addiction or be misused for illegal
purposes
• due to its novelty
Dispensing of Rx only
• Verification of formal correctness
Suspend dispensing - absence: paper form of Medical
prescription:
• signature of the prescribing physician / doctor
• identification of providers of health services, and can not
be completed and there is no risk of delay,
• Name and surname of the patient and can not be added
unless if the risk of delay (in danger of death or serious
health disorders appear)
• Patient ID-code and the insurance company and can not
add, name and surname of breeder, and may not be
complete.
Dispensing of Rx only
• Verification of formal correctness
– Including: prescribed amount of MP
Dispensing of Rx only
Verifying the correctness of the therapeutic
content:
• dosing and dosage form;
• interactions
Dispensing of Rx only
Informations
• necessary for the safe use of the product
• necessary for handling with the product
• inform the patient upon the actual amount of total
reimbursement covered by the public health insurance for
the dispensed packages for each item in the medical
prescription;
• …..patient counselling
Reimbursement vs Co-payment
Pharmacy retail
price of the
medicinal
product
Reimbursement Co-payment
„Eligible“ extra
payment
„Non- Eligible“
extra payment
Co-payment limit
Annual limit based on „Eligible“ co-payment
Regulatory fees - patient
• Canceled!!!!!
• Dispensing fee - insurance
Reimbursement from the public health
insurance
• List of medicinal products and foods for special medical
purposes with reimbursement from the public health
insurance
• Updates – every month
• SIDC
– Maximum reimbursement from health insurance
– Increased maximum reimbursement from health insurance
Dispensing of medicinal devices
• Verification of formal correctness
• Verifying the correctness of the therapeutic
content
• Informations
OTC with restricted dispensing
In this category if:
• causing jeopardy to human health which
might be prevented by setting:
– certain restrictions on such dispensing
– prior expert consultation with a pharmacist
OTC with restricted dispensing
Such MP may only be dispensed:
• to the person for whom it is intended,
The provider authorised for the dispensing obliged
to maintain records of its
dispensing.
OTC with restricted dispensing
• Details and further restrictions may be
established e.g.:
– determination of the age limit of the natural person who
requests the dispensing of such medicinal product,
– specification of the dose for individual administration
– restriction of the amount of the medicinal product to be
dispensed to a single patient over a specified period of
time.
OTC with restricted dispensing
Pseudoephedrine – MP containing 30 mg / tbl
• the total amount of pseudoephedrine for an
individual dispensing shall not exceed 900 mg
pseudoephedrine
And
• shell not exceed 900 mg in 7 days concurrently
Emergency contraception
• From 28.11.2011 – till Spring 2015:
OTC with resctriction
• NOW – OTC!!!
emergency contraception
• Note : Ellaone – directly OTC….
Restricted Prescription-Only medicinal
products
In this category:
• due to its pharmaceutical characteristics or novelty or in the interest of
public health protection, reserved for disease treatment which may only
be conducted in inpatient healthcare facilities;
• is used to treat diseases which must be diagnosed in an inpatient
healthcare facility or in healthcare facilities with adequate diagnostic
equipment even if the administration and follow‐up need not be carried
out in such facilities;
• is intended for out‐patients care but its use may produce very serious
adverse reactions or may represent significant risk of abuse requiring
special supervision is ensured during treatment.
Restricted Prescription-Only medicinal
products
• Only by specialists
• E-prescription
• Restrictions on the amount of a medicinal
product dispensed to a single patient over a
specified period of time can be set.
Restricted Prescription-Only medicinal
products
• „Medical Cannabis“:
– Limits:
• Age: 18
• Diagnosis
• Prescribed dose: 180 g / month
• MP with Misoprostol, mifepristone intended to:
– Abortion pill / or induction of the birth under special
condition
Restricted Prescription-Only medicinal
products
• Central repository for medicinal products with
restriction
• SIDC
Dispensing for health care facilities
• Not only original package
• Medical Orders
Dispensing - orders
• Not only for health care facilities
• OTC whose dispensing, according to the
marketing authorisation, is not restricted
• Food supplements,..
• Rx MP – only attached with prescription
Mail‐order dispensing
General principles:
Announce to SIDC
Publish information about:
• products on offer,
• prices and costs associated with the mail‐order
dispensing
• Link to SIDC
Mail‐order dispensing
Obligations:
• Ensure the origin and quality (packaging and
transport)
• OTC whose dispensing is not restricted
• Food supplements,…
Mail‐order dispensing
Obligations:
• ensure an information service
• collect and handover information on
suspected AR and quality defects of MP
Mail order – public risk:
• Counterfeit / falsified medicinal product