Forensic Exam Flashcards
(148 cards)
1
Q
what does the pharmacist registration act entail? (2007)
A
FIVE sections
1) singapore pharmacy council
2) pharmacist registration (full, conditional, temporary, specialist)
3) practice of pharmacy
4) specialist accreditation
5) disciplinary and health committee
more details on the ‘practice of pharmacy’ can be seen in the schedule.
2
Q
what does the pharmacist registration (practising cert) regulation 2008 entail?
A
SECTIONS
practising cert (2 years validity) - obtaining and renewal
CPE requirements
accredited and recognised CPE programmes
fees payable
3
Q
what are the CPE requirements and where to find them?
A
50 points for active pharmacists ( over 2 years) of which 15 must be from pharm care points.
20 points for inactive pharmacists (over2 years).
specialist pharmacist must obtain points related to their specialty.
found in the second schedule of the PRR 2008 regulations.
4
Q
what do part (e), (f),(g), and (h) of the PRA 2007 (schedule on practice of pharmacy) mean?
A
part (e) = managing medication therapy
- eg titrating medication according to monitoring parameters
part (f) = evaluating med use
- eg check compliance
part (g) = manufacturing/distributing medicinal products, oral dental gums and therapeutic products
- eg pharma companies ensure compliance to laws of manufacturing/distribution
part (h) = quality assurance of medicinal products, oral dental gums and therapeutic products
- eg GMP standards
5
Q
what is the purpose of the PRA?
A
legal avenue for SPC tor exercise powers to govern
provide opportunities for the profession to learn and improve
for public/patient to hold pharmacist accountable for their professional actions
6
Q
what is the composition of the SPC
A
11 MEMBERS
9 registered pharmacist appointed by the minister
1 chief pharmacist
1 head of dept of nus (or registered pharmacist designated by the head).
7
Q
important details for SPC?
A
found in PRA 2007
- president of SPC will be elected by the minister
- if absent, another council member will preside over the meeting
- 5 council members need to be present to form a quorum
- president/member presiding has the casting vote (if equality of votes)
8
Q
where to find the different registration of pharmacists in the PRA and their details
A
under sections 16-19 of PRA 2007
s16: fully registered
s17: conditionally registered
s18: register of specialists
s19: temporarily registered pharmacists
9
Q
conditions for full registration PRA 2007
A
NUS degree holder with 12 months training (9 months under registered pharmacists)
OR a pharmacy degree recognised by SPC
may be demoted to conditional registration if deemed fit by SPC
10
Q
conditions for conditional registration under PRA 2007
A
degree from outside of Singapore recognised by SPC
to pass an examination conducted by the council
+ 12 months training (3 months supervised by registered pharmacist)
+ selected for employment
must work under the supervision of fully reg pharmacist for a specified amount of time
can apply for full registration after period of supervision, and as deemed fit by the council.
11
Q
conditions for temporary registration under PRA 2007
A
temporary resident in singapore for teaching, research, post grad
with skills/knowledge (of intl standing) considered of special value to SG
but not entitled for registration
may require examination
registration for 2 years (and can be extended for further periods not exceeding 12 months).
12
Q
where to find details on specialists accreditation board and what is the composition?
A
6 registered pharmacists of which 1 chairperson will be appointed by the minister from the board
the chairperson and all members must be appointed for a term not exceeding 3 years but may be elgiible for reappointment/ removal from office by the minister.
13
Q
process for specialist certification with specialists accreditation board
A
must apply with the board
in which case if rejected, there is 30 days to appeal to minster of health (whose deicison is final).
14
Q
where to find information on disciplinary and health inquiries for pharmacists?
A
PRA 2007
part 6
15
Q
what is the flow of a complaint filed against a pharmacist ?
A
1) information given to council (will require statutory declaration unless by a public officer or member of council)
2) council refers information to a complaints panel
3) complaints panel is formed and inquiry is formed
(a) no formal inquiry
(b) formal inquiry required = inquiry held be either the disciplinary committee OR the health committee.
16
Q
composition of the disciplinary committee
A
3 registered pharmacists (with atleast 10 years standing) appointed by the council
OF WHICH
2 members are from the council
+
1 layperson
17
Q
composition of the disciplinary committee
A
3 members of the council THAT IS
appointed by the council
18
Q
difference between pharmaceutical care points and non pharm care points for CPE?
A
under PRR (practising certificates)
pharmaeutical care points include:
- direct patient care activities
vs
non pharm care points include:
- research, teaching in academia, manufacturing, sales of pharmaceuticals
19
Q
for an inactive pharmacist to qualify for renewal, what must he/she do
A
under PRR (practising certificates) 2008
pharmacist must apply for a declaration form to SPC (with their approval) to qualify for status.
20
Q
reasons for CPE
A
1) embrace continuing professional development as personal responsibility
2) keep up/engage with latest technology
3) learn and apply new knowledge and skills to expand roles and responsibilities
21
Q
what are the fees payable for license renewal and where to find them?
A
practicing certificate regulations, PRR 2008
500$ for specialists and active
200$ for inactive
for 2 years
22
Q
what are the criteria for CPE programmes allowed?
A
1) relevant to pharmacy.
2) from an accredited CPE provider.
3) list of books and journals as recommended by SPC.
4) CPE activity is verifiable by SPC.
can also include: programmes, lectures, talks, seminars and conferences
23
Q
what are the 4 main scope of the PRR (practising cert) 2008?
A
1) practising cert
2) CPE requirements
3) CPE (education and programmes)
4) Fees payable
24
Q
what are the three types of certificates
A
1) active
2) inactive
3) specialist
25
basis and fundamental outcomes derived from the code of ethics
1) respect for every person (including autonomy)
2) beneficence for all person in need
3) Justice for all
4) collaborative relationship with other healthcare professionals, patients, and caregivers
5) continuing education, development and training of pharmacists.
26
relationship between COE and PRA?
if prosecuted under civil or criminal law, will be liable to punishment from SPC (disciplinary proceedings) under the PRA
27
what constitutes professional incompetence as a pharmacist?
negligence in duty of care
attributed to
lack of knowledge/ skills, not up to date or incomplete review for appropriateness, efficacy, and safety of medication therapies prescribed.
28
what does the PRA (2007) control
1) registration
2) scope of practice
3) education (eg cpe)
4) training, accreditation, credentialing
5) disciplinary proceedings
6) fitness to practice
X 6
- which includes fraudulent registration, wrongful use/advertisement of titles/qualifications
- falsely submitting under CPE
29
PRR (2008) vs COE
PRR = ensures competency of pharmacists.
COE = ensures pharmacists practice professionally and ethically.
30
laws pertaining to governance of individual pharmacists VS public institution pharmacies?
individual pharmacists = PRR, PRA, COE
public institution pharmacies = Healthcare Services Act (HCSA)
31
what are EXAMPLES the torts in pharmacy practice
1) negligent (act of omission)
2) liability (liable for providing defective good/service)
3) intentional (intentionally flouting the law)
ALSO
practising unethically is a tort under COE , or flouting PRA or regulations
32
what are some examples, of TORTS under PRA 2007?
refer to part 4 of the PRA on 'practice of pharmacy'
33
professional incompetence VS professional negligence (difference?)
professional incompetence = display of a lack of knowledge, skill or judgment causing unfit to practice.
professional negligence = failure to perform duty of
34
the PRR is empowered by what section of the PRA?
74
35
policy maker vs product regulator (in health products regulation)
policy maker
- primary legislation for health product made with approval from the parliament and president.
product regulator
- HSA
- administer and enforces the legislation
- sets regulatory requirements, inspect & licenses dealers, and manages health products safety/quality/efficacy.
36
what does the 'sale of drugs act 1914' entail
'sale of drugs in a pure state', ie consumers are supplied with drugs that are of the QUANTITY and QUALITY requested/expected by them
= focus on the transaction (sale + supply) and possibility that the consumer may be defrauded by the seller
37
what does the 'poisons act 1938' entail
'regulate the importation, possession, manufacture, compounding, storage, transport, and sale..."
covers all types of medicinal poisons (FINISHED or RAW) including bulk active ingredients, vet products, complementary health products AND food products (adulterated with potent med substances)
38
what are the health products covered under the poisons act and where do we find them?
med devices, therapeutic products, and CTGT products as specified in the SCHEDULE of the poisons act that can be prepared from NATURAL/ARTIFICIAL sources.
except those covered under the group 1 and group 2 (first and second column) of the SECOND schedule found in the POISONS RULES
39
what substances are excluded from the MEDICINES act and where to find them?
therapeutic products
cosmetic products
medical devices
oral dental gums
under the 'medicines (cessation of application of act to XXX) order 20xx'
and under section 3 of the medicines act.
40
what does the 'medicines (advertisement and sale) act 1955' entail?
control on the element of advertising regardless of whether there is an actual sale.
41
what are the products covered under the medicines act?
1) chinese proprietary medicines
2) traditional medicines
3) homeopathic medicines
4) quasi medicinal products
5) topical antiseptics
6) medicated oil and balm
42
what are some future transitions for the health product act?
remaining products from the medicines act moved to the health products (complementary health product) category
products from the poisons act moved to the HPA (active ingredients) category
43
what products do the health products act cover, its definition, and where to find each point?
based on s2(1) = refers to anything in the FIRST schedule, which includes
1) oral dental gum
2) cosmetic products
3) therapeutic products
4) CTGT products
5) medical devices
used for a 'health related purpose' s2(1)
for use by HUMANS
can be active ingredients.
44
differences between primary and subsidiary legislation?
primary = basic framework
- enacted , amended, repealed by parliament (bills passed from parliament)
subsidiary = specify more technical details (more likely to change) and DOES NOT NEED parliamentary approval
45
what are the laws governing clinical research
1) human biomedical research act
2) health products (clinical trials) regulations
3) health products (clinical research materials) regulations
4) medicines (clinical trials) regulations
5) medicines (medicinal products as clinical research materials) regulations
46
what is the human biomedical research act? what does it exclude and where to find the sections
regulate and prohibit certain types of human biomedical research
schedule 2 excludes the act from clinical trials of health products and medicinal products
= class 1 ctgt and medical devices covered under this act
47
what health products are regulated under clincial trials act of both HPA and MA?
therapeutic products and class 2 CTGT products
medical devices not covered = covered under human biomedical research act
48
what are the roles and responsibilities of a sponsor in a clinical trial and where to find them
HPA (clinical trials) regulations
1) have a sponsor = r4
2) trial must be conducted under supervision of a principal investigator = r5
3) authorisation by BOTH hsa AND irb = r7
4) good clinical practice = r13/14
5) conducted at specified premises = r15
49
what clincial trials need only to be authorised vs notified (via health product (CT) reg)
and where to find
authorised = high risk
notify = low risk (already registered TP or class 2 CTGT , or product that poses minimal/no additional risk to safety).
50
what are the requirements for approval for clincial trials under the medicines act?
clinical trial certificate required
+
approval by IRB
both under regulation 7
51
what are the requirements for approval for clincial trials under the human biomedical research act?
regulatory approval not required
only at approved institutions
APPROVAL BY IRB !!
52
what are the exceptions for the CRM for registration and licensure and where to find them?
CRM regulations - r3
exempted from
manufacture, import, wholesale and registration of CRM under the HPA 2007.
HOWEVER MUST STILL NOTIFY HSA before import AND supply!! (r4, 7)
53
what regulations/ requirements still apply to CRM?
1) record keeping
2) product defect and adverse effect reporting
3) product recall notification
54
what important information for the supply/admin of CRM? and the relevant regulations
r11 and 12
- no supply unless named under part 1 of second schedule
- admin unless qualified or instructions of qualified
r13
must be properly labelled according to second schedule
55
what are the labelling requirements of all investigational products and auxiliary materials? (CRM)
r26 of CT regulations
= follow the second schedule of CT
based on r13(2) of CRM,
follow third schedule of CRM if do not fulfil
- must refer back to paragraph 5 of CT second schedule
56
additional labelling requirements for CTGT products ? (class 2)
UNDER second schedule
class ii ctgt products require
- labelling with words 'autologous use'
- list of excipients
- warning
- precautions on disposal
57
adverse event reporting for clinical trials what to do (which part of the regulations)
CT regulations r24
if life threatening or cause death
- report in 7 days
- follow up in 8 days (after first report)
if not
- report in 15 days
to HSA and IRB
ONLY REPORT IF SERIOUS (not serious = no need to report)
58
what kind of products require licensing and what are the requirements involved?
all high risk products require dealers license and compliance with GMP and GDP as requirements
low risk products (including cosmetic products ) do not require dealer license unless CPM
- however, will still require compliance to basic GMP and GDP
59
provisions for manufacturer and importer in the health products act? where to find?
r12 = need for manufacture license
r13 = need for import license
(part 6) r24-28 = license renewal, suspension... etc
(part 8) r39-45 = duties of licensee
- record keeping, reporting, recall
60
exceptions regarding manufacture of cosmetic products? where to find
refer to the third column of first schedule
- sections 12(1), (2) and (3), 13(1), (2) and (3), 14(1) and (2), 15 and 19(1)(b), and Parts 6 and 7 do not apply.
61
provisions for manufacturing and import in the medicines act? where to find?
s5 = import
s6 = manufacture
part 2 = info on license renewal, suspension... etc
62
what products are exempted from manufacturing and import licenses under the medicines act (and where to find them)
ALL TYPES EXCEPT CPM
refer to medicines (traditional medicine, homeopathic medicines and other substances) exemption order
63
where are the requirements for license approval found in the health product (therapeutic product) act?
and where to find
r4 = manufacture license
- maintain staff, equipment, storage etc
- correct identity + conform with strength/purity/quality standards
- comply with GMP
r5 = imports
- same as pt 1 and 3 above
64
where are the requirements for license approval found in the health product (CTGT product) act?
and where to find
r6 = manufacture
r9 = import
65
where are the requirements for license approval found in the health product (med device) act?
and where to find
r2a
- pt 1 and 3 same except pt 2 is about wrongly labelled
r2b
66
where to find license requirements regulated by the medicine act?
under the
'medicines (licensing, standard provisions and fees) regulations
under r3 and the relevant schedules
for cpm specifically r3(4) and r3(2)
67
exemptions from (import and manufacture) license under which regulations in the HPA?
r70 - minister can exempt any of the provisions
r12 and r13 - 'except in such cases as may be prescribed'
68
exemptions from (import and manufacture) license under which regulations in the MEDICINES ACT ?
s7 = compounding
s8 = herbal remedies
s9 = minister (on s5 6)
69
exemptions from manufacture/import license in HP (TP) regulations?
MANUFACTURE
r46 = not commercially available, for compassionate use, ordered by qualified practitioner (healthcare service licensee)
r48 = compounding (not commercially available) (licensed retail pharmacy)
r50 = unregistered, for compassionate use, attach diff label
r60a = emergency
IMPORT
r51 = compassionate
r52 = personal use (except psych)
r60a
70
exemptions from manufacture/import license in HP (CTGT) regulations?
MANUFACTURE
r4 = minimally manipulated
IMPORT
r7
r8 = to be imported for manufacture
r9 = compassionate use
71
exemptions from manufacture/import license in HP (med device) regulations?
MANUFACTURE
r3 = compassionate use, fitting/adjustment, lab blood banking, low risk (for charitable purposes; subject to HSA), class A/B custom made dental medical device (notification)
r4 = secondary assembly (comply with GMP)
r13 = emergency
IMPORT
r4 = personal use, radiation protection act, clincial research
r13
72
what governs 'wellness devices'
health product (exemption) order
p5
second schedule
73
exemptions from (import and manufacture) license under
medicines (traditional medicine, homeopathic medicines and other substances) exemption order
p5 = import solely for re export
p4 b and c = compassionate use
74
poisons act relevant info on licenses
s5
s10 (1)
75
which health product does not require a responsible person?
medical devices
76
what special requirements for provision of CTGT records
for manufacturer (r32)
- RECORD (for non traceable) = 1 year AFTER expiry, 5 years AFTER manufacture date
- RECORD (traceable) = 30 years AFTER expiry
for supply (r33)
- 30 years AFTER expiry
r34 - system of traceability
77
med devices vs tp records regulations (where and what)
TP
- manufacture (r31) = 1 year after expiry, or 5 years after manufacture
- supply (r32) = 2 years after supply
MD
- manufacture (r38) = for projected useful life OR 2 years after supply
- supply (r39) = SAME as ^
- complaints (r41) = 5 years after expiry of projected useful life
78
field safety corrective action for MD (which regulation provision)
r46
notify BEFORE carrying out field safety corrective action
79
which products are subjected to pre market product registration
high risk = yes
low risk = no
medicines act product all no (even though s5(1) says need
=
CPM not subject to pre market product registration
as per paragraph 2a of the medicines (...) exemption order
BUT will still need approval from HSA (via import and manufacture license)
as per r3 of medicines (licensing...) regulations
class 1 CTGT
- r15(1)(f) = exemption of class 1
- r16 = must notify HSA for supply
of HPA (CTGT)
class A med device
- r10b
BUT must still notify HSA
of HPA (MD)
cosmetic products
- HPA second schedule column 3 = exemption
- notify (r4 of cosmetic products ASEAN cosmetic directive)
80
do cosmetic products need product registration (and relevant regulation)
no need for registration as per first schedule column 3
however must still comply with -part 8 of HPA
and
require notification (r4 of cosmetic products ASEAN cosmetic directive)
81
where to find general info on product registration for health products
refer to s15 of HPA
part 7 of HPA on registration requirements and procedures
82
where to find registration requirements for health products specific to the product
(TP) HPA
- part 5 - r22 (benefit > risk)
(CTGT) HPA
- r29 (benefit > risk)
(MD) HPA
- r25 (benefit > risk)
83
what regulation related to changing HP eg. TP from POM to P only
what are the considerations
r 35
r36
of health products act
considerations
- does disease require diagnosis by med practitioner?
- does disease require medical supervision?
- are the c/I, ddi, precautions easily recognised?
84
where to find classifications of CTGT class and what do they entail
class 1 =
- minimal manipulation
- homologous use
- not combined/used with TP / MD
class 2
- everything else
under definitions section in r2
85
where to find classifications of med device class and what do they entail
r24 > third schedule part 1
class a = low risk
class b - d (moderate low > mod high > high risk)
86
where to find exemptions to supply(registration) of therapeutic products and the details included
HPA (TP) r58 - 60
r58
(a-d) - compounding
(f-h) - compassionate use
(i) - personal use
(j) - ship/aircraft
(k) - non clincial purpose eg research
(l) - for (re) export
60a - emergency
87
where to find exemptions to supply(registration) of CTGT products and the details included
r15 of CTGT HPA
(a-e) - compassionate use
(f) - class I products with notification to HSA
(g) - non clincial purpose
(h) - for (re) export
88
where to find exemptions to supply(registration) of med devices and the details included
(MD)HPA
division 2: r6-11
AND
r13c - emergency
89
what are the quality, safety, and efficacy requirements in product approval
QUALITY
- data for the drug product (composition, excipients, etc) and drug substance (manufacturing process, etc)
SAFETY
- PK, PD, toxicology
EFFICACY
PRODUCT LABEL
- e.g., pharmacological class, dosage form, ROA, etc
based on the international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH)
90
what are GENERAL registrations requirements for HEALTH products ?
1) risk < benefit
2) product is suitable for intended purpose based on safety, quality, efficacy data + risks associated with use
91
registration routes for therapeutic products?
FULL (no prior approval from any drug reg agency) = full quality, non clincial + clinical data = 270 days
ABRIDGED (approved by one drug reg agency) = full quality; abridged early phase clinical + non clinical data = 180 working days
VERIFICATION (approved by two drug reg agency) = reference agency assessment report = 60 working days
agencies : AUS, CAN, EU, UK, USA
92
registration routes for CTGT products?
FULL (no prior approval from any drug reg agency) = full quality, non clincial + clinical data = 270 days
ABRIDGED (approved by one drug reg agency) = full quality; abridged early phase clinical + non clinical data = 180 working days
93
registration routes for MED DEVICES ?
FULL (no prior approval from any drug reg agency) = full quality, non clincial + clinical data = 120-310 days
ABRIDGED (approved by one drug reg agency) = quality, pre clinical and clinical summary reports = 100-220 working days
IMMEDIATE for class B
(approved by 2 independent RA OR 1 RA and 3 years safe marketing history in singapore/the jurisdiction)
= verification of certificates and documents
= immediate upon successful submission
94
what do the safety etc requirements focus on for medicines act
mainly quality and safety
efficacy less important because limited to self care/ complementary medicine.
95
labelling requirements for CPM and where to find them
refer to
'medicines (labelling of Chinese proprietary medicines) regulations'
96
what requirements for approval of CPM?
indicated ONLY for uses that are documented in herbal monographs of well-established reference texts which are based on a long history of use
labelling based on 'medicines (labelling of Chinese proprietary medicines) regulations'
requisite quality data = basic manufacturing control and quality control data.
- EFFICACY DATA not required = non-clinical data + clinical data are not required.
97
further (therapeutic product) specific duties of registrants
and what provision
42 - changes concerning registered therapeutic product
43 - information on validity
44 - benefit-risk evaluation report
45 - risk-management plan
98
further (CTGT product) specific duties of registrants
and what provision
48 - changes concerning registered CTGT product
49 - information on validity
50 - benefit-risk evaluation report
51 - risk-management plan
99
when is approval required for changes concerning health products ?
examples where approval is required:
* technical changes that impact the safety and efficacy such as change in manufacturing process/site, new indication will require HSA approval.
examples where approval is NOT required;
* non technical or administrative changes that do not impact the quality or safety e.g., change in product batch numbering system, packaging NOT IN DIRECT CONTACT w drug, admin changes to the product label
100
what does 'compassionate use' refer to
and what are the requirements for import / supply of compassionate use
for use in SPECIFIC patients when the product is NOT COMMERCIALLY AVAILABLE
need to inform patient that the products are not evaluated or registered
need to notify HSA for import (with limits)
101
what does 'wholesale' mean?
supply to a person who obtains it for the purpose of supplying it again to some other person
supply by export (since no export license)
102
what regulations govern the wholesale supply of health products under HPA?
part 4 (s14-18) - supply of health products
specifically for s14 (1) = valid wholesaler license / carried in accordance to conditions of license
s14(2) = must be stored at authorised premise
part 6 - licenses
pary 8 - duties
103
what regulations govern the wholesale supply of health products under medicines act?
part 2 - licenses / certificates
part 3 - further provisions for dealing with medicinal products
part 4 - containers, packages... etc
104
specific information on the supply by wholesale of a therapeutic product (and relevant provision)?
r10 of TP HPA
specifies that wholesale of therapeutic products containing second schedule ingredients MUST have a SIGNED ORDER
stating name, address, trade/business/profession
+
name , qty of product
(SATISFIED that they will carry on the trade)
105
information on the supply by wholesale of CTGT products (and relevant provisions)?
CTGT HPA
r19 = requirement for wholesaler license
r20 = supply requirement for class 2 CTGT
- signed order required (name, address, trade/profession/business; name and qty of product)
106
requirements for the supply by wholesale of MED DEVICE (and relevant provisions)?
r4 - requirements for wholesalers license
(including ISO13485)
r13 - supply of 'professional use only' medical devices
r13b - supply of 'trained user only' medical devices
107
what are the duties of wholesalers for therapeutic products (and relevant provisions)?
specific duties
- r38
- r39 = responsible person
general
r32-35
108
what are the duties of wholesalers for CTGT products (and relevant provisions)?
specific duties
- r41
- r43 = responsible person
general
r33-37
109
what are the duties of wholesalers for MED DEVICES (and relevant provisions)?
specific duties
- r35
- r39 record
- r41 record of complaints
- r42-r45
- r46 field safety corrective action
110
what are the EXCEPTIONS of wholesalers for HEALTH products (and relevant provisions)?
TP: r47, r49, r53, r55 - 57
CTGT: r10-14
med devices: r5, r5a, r11b
note points on import to export and manufacturer to wholesaler
- both bound by GDP and GMP respectively.
111
what are the regulations for retail supply of therapeutic products (and the relevant provisions)?
r11 = POM supplied by retail
r12 = pOM administration
r13 = p only supplied by retail
r16 = records of supply
r17 - supply by dispensing
112
what constitutes a valid prescription?
r2(2) of TP HPA
date of prescription
name and address of the practitioner
name/identity and contact details of patient
name and qty of product
repeats (if relevant)
'for dental use only' (if relevant)
113
what are the records to be kept for retail sale of pharmacy only medicine?
r13(2) for supply of PHARMACY-ONLY therapeutic products
record of
- date of supply
- name, identity, contact details of person supplying
- name, strength, total amt of p-only medicine supplied
- dosage, frequency, purpose of treatment
to be made on the day and within 24 hours
kept for 2 years
made available for inspection by HSA.
same for r16(1) for PRESCRIBED therapeutic products
114
what exceptions are made for the supply of pOM medicines (by retail sale; and the relevant provisions)
r11 (d)
- person specified in FIRST COLUMN of THIRD SCHEDULE
eg owner/master of ship (with no dr on board), navy corpsman, need to comply with written laws on medical tx of employees, etc
and following the SECOND and THIRD COLUMNS of that schedule
115
where to find the labelling requirements for dispensing of THERAPEUTIC products (and the relevant information)
r17(1) - labelling
(2) - additional requirements for POM
116
what are the regulations for retail supply of CTGT products (and the relevant provisions)?
r21 - supply by retail sale
r22 - supply by admin
r23 - records of supply (30yrs)
r26 - supply by dispensing (includes labelling requirements)
117
where to find information on retail pharmacy regulations?
health products (licensing of retail pharmacies) regulations 2016
r5 - requirements for approval of pHARMACY LICENSE
118
what is the regulations governs for setting up e-pharmacy OR tele pharmacy services>?
refer to HP(licensing of retail pharmacies) regulations
r4 - telepharmacy services
- will require HSA approval, with fulfilment of requirements
e-pharmacy
- not defined in regulations
119
requirements for e pharmacy set up
1) need prior approval from HSA
2) service provided through secured online platform
- controls to ensure security, integrity, accuracy, and confidentiality of the system
3) prescriptions transmitted electronically through closed loop system
4) procedures for storage, packing, labelling, and secure delivery of products
5) suitably designed and well maintained premises.
119
veterinary medicine regulations
TP for use by humans but off-label for vet purposes are within the scope of “health products” and regulated under HPA. They are under the purview of the Ministry of National Development and the National Parks Board
Animals & Birds Act
- 53 = license to treat/vax/innoculate
- 54 = license for vet centres
- 55 = license to possess/inoculate vet biologics
types of vet products
- human use products used off label for vet
- animal use only products
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what constitutes unsafe products?
1) adulterated = containing any substance not declared as an active ingredient on its label
2) counterfeit = resemble or pass off as registered OR false information on manufacturer/origin
3) unwholesome
4) tampered = modified/interfered (intro/incorporation)
definitions found in s2(2) of HPA
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regulations on prohibitions of unsafe HEALTH products?
s12 under manufacture
s13 under imports
s16 = under supply
selected parts
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regulations on unsafe COSMETIC products
ASEAN COSMETIC directie
- refer to r6 on suitable contents
and third schedule for contents disallowed
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(provisions on) prohibitions of unsafe products in the medicines act?
sale supply of adulterated medicines = under MA s31
MA (prohibitions of sale, supply and importation) order
p3
p4
p5
(and relevant schedules)
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difference between prohibitions of unsafe products in HPA vs MA
HPA
- adulterated, counterfeit, unwholesome, tampered
- applies to manufacture, import, supply
- fine not exceeding 100,000 or imprisonment not exceeding 3 years, OR both
vs
MA
- adulterated, unwholesome, unsafe/harmful
- applies to sale and supply (and some import)
- fine not exceeding 50,000 or imprisonment not exceeding 2 years, OR both
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what are the exemptions of supply of unwholesome health products?
based on HP (exemptions) order
third schedule paragraph 3-6
CTGT product that are "out of specification" can be supplied and administered if appropriate risk assessments and relevant notifications (IRB) / informed consent
- out of specification can also mean lower than the viable cell count
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difference in definition of wholesale in HPA vs MA
HPA
- supply for export
- supply for purpose of supplying it again to some other person
MA
- selling to person who buys for purpose of selling/supplying in course of business
- sale by person that is NOT the MANUFACTURER
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difference between HPA and MA in terms of safety reporting
for MA, if exempt from license, they are not compelled to duties to safety reporting stated in the medicines (licensing, standard provisions and fees) regulations
= inform within 7 working days
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product category specific requirement for AE reporting:
TP
records - r33 (2 years)
reporting - r34 (immediate and within 15 days for SAE)
CTGT
records - r35 (2 years)
reporting - r36 (immediate and within 15 days for SAE)
med devices
reporting - r42 (48h / 10 days / 30 days)
cosmetic products
reporting - r11(2)
7 days + detailed report (within 8 days after)
15 days
CRM
48h / 15 days
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what constitutes serious adverse events (under which provision)
(TP) HPA r34 (3)
serious adverse reaction
(CTGT) HPA r36(3)
refer for the definition
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product category specific requirement for product defect reporting:
TP
records - r33 (2 years)
reporting - r34 (48h / 15 days)
CTGT
records - r35 (2 years)
reporting - r36 (48h / 15 days)
med devices
records (of complaints) - r41 (5 years after expiry of projected useful life)
reporting - r42 (48h / 10 days if already happened / 30 days)
cosmetic products
reporting - r11(2)
7 days + detailed report (within 8 days after)
15 days
CRM
48h / 15 days
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reporting for non serious AE regulated under what provisions
exempted from reporting
under HPA (exemptions) order
refer to schedule
- for TP, CTGT, med device
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types of product recall?
class I
= critical defect = may cause serious adverse health consequence (death or serious injury)
- issue dear purchaser letter within 1 day of recall commencement
- to be completed within 1 week
class II
= non critical defect = may cause TEMPORARY/MEDICALLY REVERSIBLE health consequence OR probability of serious health consequence is REMOTE
- issue dear purchaser letter within 3 days of recall commencement
- to be completed within 3 week
level of recall: consumer, retailer, wholesaler
Consumer = Direct-to-consumer supply, highest risk, must notify public via mass media if needed
Retail - Supplied to pharmacies, clinics, hospitals; moderate to high risk
Wholesale = Supplied to wholesalers/distributors; low risk or can be managed with checks by healthcare professionals
within 24 hours !!! as per specific regulations
+
report findings
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health product control on advertisements (specific to TP and CTGT)
health products (advertisement of specified health products) reg 2016
- second schedule indicates for TP and CTGT only.
- r4 = code of advertising
- r5 - r10
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EXEMPTIONS to health product control on advertisements (specific to TP and CTGT)
health products (advertisement of specified health products) reg 2016
exceptions in
r11-13
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health product control on advertisements (specific to med devices)
HP (med device) regulations
r19 - r22
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health product control on advertisements (specific to cosmetic)
HP (asean cosmetic directive) reg
r9
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what are the corrective measures for contravening advertisement controls (of health products)
refer to s23
or the corrective advertisement, info required:
1) expression of apology or regret
2) corrective statement about product
3) statement on breach
4) description of facts/infomration on where and when the contravening advertisement was placed.
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medicine product control on advertisements under what regulations
under
medicines (medical advertisements) regulations
includes exemptions
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what are the controls for psychotropic drugs under the HPA (TP)
r6 = import (need approval)
r8 = export of tp containing psychotropic substances (need approval + show evidence)
r52(1)(a) = import for personal use without license not applicable for psychotropic
psychotropic substances listed under FIRST schedule
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what are the controls for opioids drugs under the HPA (TP)
r9 = export of codeine cough prep
r14 = restriction on supply by retail sale of codeine cough prep
r52(1)(b) = import for personal use without license not applicable for codeine
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what are the controls for CD under the misuse of drugs reg
part 2 = exemptions from provision
part 3 = requirements to documentation/record keeping
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specific restrictions on imports of cough syrup for personal use (and where)
under HPA (TP)
R52(1)(b)
relevant to the SEVENTH schedule.
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classification of controlled drugs and the relevant provisions
misuse of drugs regulations
CD in 4 schedules
FIRST schedule: small qty or formulated in a way that there is low risk of abuse
SECOND schedule: high risk of abuse but use as medicines
THIRD schedule: same as second schedule but less risk of abuse
FORTH schedule: high potential for abuse and little therapeutic value
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what counts as a defect in a health product?
1) adulterated/tampered
2) counterfeit/unwholesome
3) inadequate quality OR unsafe OR inefficacious for intended purpose
4) fails to satisfy standards/requirements as may be prescribed
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