ACT 857- Health Professions Regulatory Bodies Act, 2013

Question 1

What part of the act establishes the pharmacy council?

Answer 1

Part Four

Question 2

What sections of the act pertains to the pharmacy council?

Answer 2

Section 78 to 114

Question 3

What is the object of the council?

Answer 3

To secure in the public interest the highest standards in the practice of pharmacy in the country.

Question 4

What are the functions of the council?

Answer 4

• ensure accreditation for pharmacy programs in collaboraton with appropriate State agencies
• ensure that the education and training of pharmacists and any other pharmaceutical support staff are carried out at approved educational institutions for efficient pharmacy practice
• provide guidelines for the education, training, registration, licensing and the practice of all pharmaceutical support staff
• set standards for CPD for practitioners and pharmaceutical support staff
• register practitoners
• set and ensure standards for pharmacy practice and professional conduct
• exercise disciplinary power over pharmacists and any other pharmaceutical support staff,
• ensure the equitable and accessible distribution of pharmaceutical premises
• monitor and inspect pharmacy practices where pharmaceutical care is provided:
• develop a management and administrative structure and systems to provide an efficient mechanism to regulate pharmacy practice
• advise the Minister on pharmacy practice and related matters. and
• perform any other function that is ancillary to the object of the Council.

Question 5

Who ensures the proper and effective performance of the functions of the council?

Answer 5

The Governing body of the council

Question 6

What constitutes the governing body?

Answer 6

• a chairperson who is a registered pharmacist of not less than ten years standing a pharmacist,
• one rep of the Ministry of Health not below the rank of a Director,
• one rep of an accredited training institution that provides tertiary training for pharmacists nominated by the Minister,
• one registered pharmacist elected by registered pharmacists;
• one rep of the Attorney-General’s department not below the level of Principal State Attorney
• the Registrar
• three other persons who may not be health professionals one of whom is a woman nominated by the Minister,

The current board is the 7th session, inaugurated on 28th January 2022.

Question 7

Who appoints the Board?

Answer 7

The members of the Board shall be appointed by the President in accordance with article 70 of the Constitution.

Question 8

Which section talks about the registration?

Answer 8

Section 82 to 92

Question 9

Who do you apply to for registration?

Answer 9

The Registrar

Question 10

Who determines how registration is done and for how long it’s valid for?

Answer 10

The Board

Question 11

What are the qualifications for registration as a pharmacist?

Answer 11

A person shall not be registered to practice as a pharmacist unless that person
- holds a degree in pharmacy, or
- holds a qualification recognised by the Board that entitles that person to be registered as a pharmacist, and
- provides evidence of completion of an internship program undertaken in an accredited pharmacy institution after academic training in the country,
- has passed the professional qualifying examination
- Satisfies any other requirements of the part 4.

⛔Effective JANUARY 2022, the minimum registrable qualification NO LONGER includes the BPharm degree.

Question 12

How is a foreign trained person registered?

Answer 12

A foreign trained person may be registered as a practitioner where that person
- has satisfied the requirements in section 83,
- has a good working knowledge of the English language, and
- has proof of qualification and registration to practice in that person’s country of origin or where that person was trained.

- Has a working permit

Question 13

How many types of register are there?

Answer 13

THREE (3)

Question 14

What are the types of register?

Answer 14

• a) a permanent register for practitioners who intend to practice permanently in the country:
• b) a temporary register for practitioners who intend to practice for a period of not more than three months; and
• c) a provisional register for newly qualified and foreign trained practitioners who have passed the prescribed exams.

Question 15

Who keeps the register?

Answer 15

The Registrar shall keep the registers but
The form and nature of the register shall be determined the Board.

Question 16

How does permanent registration work?

Answer 16

(1) A person may apply to the Registrar for permanent registration after practicing with a provisional registration for a period dew-pined by the Board.

(2) A permanent registration is valid for the calendar year in which it was registered

(3) The registration shall be renewed by the practitioner before specified expiry date as determined by the Board

Question 17

How does temporary registration work?

Answer 17

(1) A temporary registration is valid for a period of not more than three months and is renewable yearly for another period of not more than three years

(2) A practitioner on a temporary register shall not practise pharmacy except in an approved hospital, premises or institution.

🔰 A practitioner who contravenes subsection 2 commits an offence and is liable on summary conviction to a fine of not less than 250 penalty units and not more than 2500 penalty units or to a term of imprisonment of not more than four years or to both.
[1 PENALTY UNIT 🟰 12 cedis]

Question 18

When is the list published?

Answer 18

The Registrar shall publish the list of registered practitioners yearly in the Gazette by the 31st of January.

Question 19

Under what circumstance will a person’s name be removed from the register?

Answer 19

A person
- who is dead
- who has been found guilty of professional misconduct by the DC; or
- who has not paid the prescribed fee

The name of a person may be restored to the register by the Registrar as directed by the Board

Question 20

When is a person’s registration suspended?

Answer 20

Where:
* an offence or allegation of misconduct in relation to the pharmacist or support staff is being investigated,
* a false declaration has been made in an application for registration by the practitioner;
* the pharmacist or pharmaceutical support staff has contravened a provision of this Part.

⛔ Registration shall not be suspended unless the Board has given the pharmacist or support staff at least thirty days’ notice of its intention to suspend the registration and has provided them an opportunity to make a representation to the Board⛔

Question 21

What may lead to cancellation of Registration?

Answer 21

Where the practitioner
* is convicted of an offense under this Part or the Regulations;
* has lost the qualification on the basis of which the registration was made
* is sentenced to a prison term for a criminal offense
* fails to comply with the penalty imposed by the Council after due process

✳️ Registration shall not be cancelled unless the Board has given the practitioner at least thirty days’ notice of its intention to cancel the registration.

Question 22

Licensing of corporate bodies

Answer 22

Section 93

(1) The Board may grant a license to a body corporate or a government institution if satisfied that
- a) the applicant is fit to carry on the business of mixing, compounding, preparing or supplying restricted medicines by retail, and
- b) the business of the applicant is carried on under the supervision of a superintendent pharmacist.

(2) The Board may revoke the license granted under subsection (1) where a condition specified in the license has not been complied with.

Question 23

What are the requirements for licensing an OTC medicine seller?

Answer 23

a) the applicant is fit to carry on the business of the retail supply of restricted medicines other than prescription only medicines or pharmacy only medicines, or

b) the area where the applicant proposes to carry on the business is deprived of a pharmaceutical service.

Question 24

When may the OTC license be revoked?

Answer 24

• The Board may revoke the license granted to an over the counter medicine seller if the OTC medicine seller is in default of a provision of this Part or if a condition specified in the license has ceased to exist.
• The Board may impose a penalty not exceeding 250 penalty units instead of revoking a license where an OTC medicine seller contravenes this section.

Question 25

How does License for wholesale supply of restricted medicines?

Answer 25

A person shall not carry on the business of the wholesale supply of restricted medicines unless that person has a license for the wholesale supply of restricted medicines. A promotional or marketing office where a person intends to engage in the wholesale pharmacy business shall be licensed and supervised by a registered pharmacist. The Board may revoke the license granted for wholesale pharmacy if the license holder has contravened a provision of this Part or a condition specified in the license has ceased to exist.

Question 26

What is a valid prescription?

Answer 26

A prescription is valid only if - it is **for the sale or supply of medicine** - is **in indelible writing, signed and dated** by a medical practitioner, dentist or veterinary surgeon, or approved prescriber - **states the name, qualification and address of the person signing it**, - **states the name and address of the person for whom the treatment is given** or the name of the person to whom the medicine is to be delivered if for veterinary purposes, - **indicates the total amount of the medicine to be supplied** and **the dose of the medicine to be taken** except in the case of an ointment, and - **has not previously been fully dispensed** ## Footnote A valid prescription signed by a) a dentist shall bear the words "for dental treatment only", or b) a veterinary surgeon shall bear the words "for animal treatment only".

Question 27

How are prescription and supply of medicines done?

Answer 27

A pharmacist or licensed pharmaceutical company shall not sell or supply POM except under a valid prescription issued by a medical practitioner, a dentist or a veterinary practitioner or any person authorised or approved by the Minister. A pharmacist or licensed pharmaceutical company may sell or supply POM to a person without a valid prescription if the supplier of the medicine reasonably believes that the person to whom the medicine is to be supplied is the proper person.

Question 28

Which persons may be allowed to mix, compound, prepare or supply a restricted medicine other than a pharmacist or a licensed pharmaceutical company?

Answer 28

* a **medical practitioner**, dentist or veterinary practitioner **to a patient in urgent need of treatment** * **other health practitioners** who may supply a **limited range of medicines determined by the Board** * A **nurse or midwife** may administer a medicine **in accordance with directions given by a medical practitioner** to an **out-patient attending a medical treatment centre or to an in-patient** * A **licensed OTCMS** supplying **medicine other than a POM or pharmacy restricted medicine** * A **pharmacy technician or student under the supervision of a pharmacist** * By a **student or a trainee** undergoing instructions at an **institution approved by the Board** * At **programs of the Council** aimed at enhancing **access to pharmaceutical services**

Question 29

How is the classification of medicines done?

Answer 29

The **Minister** shall **on the advice of the FDA and the Pharmacy Council** by executive instrument classify medicines and conditions for the supply and dispensing of medicines for the purpose of this Part.

Question 30

What are restricted medicines?

Answer 30

Restricted medicines are classified into 1) Class A drugs (Prescription Only Medicines) 2) Class B drugs (Pharmacist List medicines) 3) Over The Counter medicines

Question 31

What must one do before the sale of restricted medicines?

Answer 31

Before a person supplies a restricted medicine, that person shall record in the Restricted Medicines Record Book * the **name and quantity of the medicine** to be supplied, * the **name, address and signature or thumbprint of the person to whom it is supplied** * **the name and signature of the person who supplied the medicines** * the **date of supply**

Question 32

What conditions must one fulfill when supplying POM?

Answer 32

A person shall not sell or supply prescription medicine unless IT IS * **under a valid prescription** * the medicine is **in a container of the prescribed description**, and * the **container bears a label indicating the prescribed particulars of its contents**

Question 33

What actions are taken after supplying a restricted medicine under a valid prescription?

Answer 33

After the supply, the supplier of the medicine shall a) Write on the valid prescription in indelible writing, **the date** on which the medicine is supplied and the **name and address of the supplier**, and b) if the medicine is fully dispensed, **retain the valid prescription for two years** on the premises at which the medicine is dispensed. ⛔️These are not done when the transaction is electronic

Question 34

When may a pharmacist or pharmaceutical support staff give medical and dental advice?

Answer 34

* **as first aid where there is an accident** * as first aid treatment for **simple ailments** of common occurrence where it is **not reasonably practicable for the patient to consult a medical practitioner or dentist**

Question 35

When may an inspector enter a pharmacy premise?

Answer 35

An inspector may enter premises **at a reasonable time** * **to inspect the registration** of a pharmacist, pharmaceutical support staff or pharmaceutical company, * if that person has reasonable cause to believe that **an offence** ● **has been**, or ● **is about to be** or ● **is being** committed on the premises.

Question 36

What can an inspector do when he enters a premise?

Answer 36

a) He may require a person on the premises to furnish information in the person's possession concerning the activities carried on the premises and the people who carry out the activities, b) He may inspect the premises and articles found on the premises, or c) He may take away medicines found on the premises.

Question 37

If he takes away medicines, must he pay?

Answer 37

Yes, **except** * If he **reasonably suspects that the medicine is unfit for its purpose** due to deterioration, impurity or etc * if the medicine is found to be fit, **the inspector shall pay for the portion of the medicine that is not returned in good condition**; * if the inspector **anticipates that proceedings for an offence may be brought in respect of the medicine**

Question 38

When is the inspector required to tender payment for the medicines?

Answer 38

Where proceedings are not commenced **within six months** and the **goods have not been returned to the owner in good condition** yet.

Question 39

After taking the medicines, .......

Answer 39

**An inventory** of the medicines shall be **made and shall be signed by the pharmacist (or pharmaceutical support staff or the OTC medicine seller) and the inspector** A **copy** of the inventory shall then be **given to the pharmacist, pharmaceutical support staff or the OTC medicine seller**

Question 40

When can the inspector close a premises?

Answer 40

1. Where there are **grounds to believe that a health hazard may exist** on the premises. 2. Where the **premises is unlicensed**.

Question 41

How is the closure done?

Answer 41

The closure of the premises shall be made with the police BUT where this is not possible, the closure shall be reported to the police within 24 hours after the closure.

Question 42

Give 5 general offences?

Answer 42

A person who * is found to be **in possession of restricted drugs without lawful authority** * peddles restricted medicines as an **itinerant medicine supplier**, * supplies or **sells restricted medicines from unauthorised premises** * **makes a false declaration in an application for registration** * willfully **destroys or damages a register** * **supplies restricted medicines** _from a marketing office_ **without the supervision of a registered pharmacist**, * willfully and falsely **uses a name, title or addition implying a qualification to practise as a pharmacist** * **operates or permits any other person to open premises** to the public **under the description of pharmacy**, chemist, drug store or any other similar description **without a registered pharmacist** on the premises **to supervise the dispensing of medicine** * **without being registered** i. **practices or professes to practice as a pharmacist** ii. **falsely claims to be qualified to practise as a pharmacist** * obstructs a person authorised by the Board from exercising lawful authority

Question 43

What are the penalties for these offences?

Answer 43

* a fine of **not less than 250** penalty units and **not more than 5000** penalty units OR * a prison term of **not more than ten years** OR * both

Question 44

The Minister may, on the advice of the Board, by legislative instrument, make **Regulations to**;

Answer 44

* **prescribe the conditions for registration of pharmacists** and pharmaceutical support staff; * **prescribe practice standards for pharmacists** and pharmaceutical support staff; * **provide for the discipline of pharmacists** and pharmaceutical support staff; * **prescribe the fees to be paid** under this Part; * **prescribe conditions** including the type of premises **for the issue of general and limited licenses of the Council**; * **prescribe standards of pharmacy practice in public health institutions**; * **prescribe fees payable to a pharmacist in respect of professional services**, medicines and other articles supplied; * **prescribe the scope of practice** of the various categories of persons registered under this Part; * **prescribe the range of medicines for health practitioners**; * **provide for the supply of medicines**; * provide for any other matter necessary for the effective implementation of the provisions of this Part.

Question 45

How does the provisional register work?

Answer 45

* For **newly qualified and foreign trained practitioners who have passed the prescribed** * Period is determined by the board

Question 46

What are the requirements for retention in the register?

Answer 46

The Pharmacist must; * Be **duly registered under sections 83 (1) and 84** of the Health Professions Regulatory Bodies Act 2013, Act 857 Part 4. * Possess a **valid certificate of registration as pharmacist** in Ghana; * Have **not contravened section 91** (a) (b) (c) and (d) of the Health Professions Regulatory Bodies Act 2013, Act 857 Part 4. * Satisfy the **minimum CPD** requirements. * Pay the prescribed fee.