Forensic Pharmacy and Forensic Pharmacist Past Paper

 FORENSIC PHARMACY (Past Papers)

• Forensic pharmacy is application of the sciences of drugs to legal issues. Forensic pharmacists engage in work related to litigation, the regulatory process, and the criminal justice system.
• Forensic pharmacy overlaps with many other forensic fields and Pharmacists hold a variety of positions with local, state, and federal governments.

FORENSIC PHARMACIST

• A forensic pharmacist can be a valuable resource in legal cases relating to malpractice, adverse drug reactions, drunk and drugged driving, health care fraud, poisoning, and numerous other types of civil and criminal cases.
• A forensic pharmacist's job responsibilities are slightly different than a forensic scientist's duties because a forensic pharmacist specifically applies the science of drugs to legal matters.
• Forensic pharmacists spend much of their time researching, testing and analyzing drug-related evidence for lawyers to use in litigation as part of the criminal justice system.

HISTORY OF PHARMACY EDUCATION IN PAKISTAN

• Pharmacy education was started in the province of Punjab of subcontinent in year 1944 within pharmacology department of King Edward Medical College (K.E.M.C), Lahore.
• Initially, K.E.M.C. offered a 3-year degree course along with a 2-year diploma tracked by 3 months of practical training in Pharmacy.
• Later on due to its wider prospects the department of Pharmacy was undertaken by the Punjab University, Lahore.
• In the year 1948 an independent Pharmacy department was established in Punjab University, Lahore in the present location, which is known as Allama Iqbal Campus.
• Initially at Punjab University, the education of Pharmacy was taught in various institutions in and out of the University. The Physiology and Pharmacology departments of King Edward Medical College helped the department of Pharmacy in teaching subjects of Physiology and Pharmacology, the subject of Pharmacognosy and Pharmaceutical chemistry were taught in the department of Botany, Government
• College, Lahore and in the department of Chemistry, University of the
• Punjab, Lahore respectively. Pharmaceutics, however, was taught at
• present premises of the Pharmacy department.
• In 1958 all the subjects were taught in the Department of Pharmacy. With the development of well-equipped research laboratories and additional facilities, the university started master and doctoral programs in Pharmacy in 1966 and 1974 respectively.
• The department was up-graded to the level of faculty in 1979 and 3- years bachelor’s course was transformed into 4-years degree program, another major milestone in the history of Pharmacy.
• Later on, in 2003, its status was further up-lifted to the level of College and it is known as University College of Pharmacy. Thereafter, 4-year of Bachelor of Pharmacy was changed to 5-years Doctor of Pharmacy degree.

HISTORY OF DRUG LEGISLATION IN PAKISTAN

INTRODUCTION

• Pakistan has legislation namely the Drug Act, 1976.

NEED OF LEGISLATION

• To ensure the availability of safe, effective, and quality products at reasonable prices.

KEY FEATURES OF LEGISLATION

• Before independence of Pakistan, pharmaceutical industry was regulated by the Drugs Act, 1940 in the sub-continent. This Act provided basic guidelines to manufacture, distribution, sale, import and export of drugs. In order to check the standard of the drugs, central drug laboratory was established whereas drug inspectors had been provided for implementation of the provision of this Act.
• In 1976, Drugs Act was promulgated in order to cope the scientific advancement and cover the shortcomings of the Drugs Act, 1940. Drug Act 1976 and rules made under this act are the measures to ensure manufacture, register, import/export and sale of drugs. It includes:

- The manufacture, import, export and sales of drugs without license is banned.
- Whereas the sale of the drugs in the streets is prohibited.

• Later on, following rules were made to strengthen the regulatory system in Pakistan:

The Drugs (Licensing, Registration & Advertising) Rules, 1976
The Drugs (Import & Export) Rules, 1976
The Drugs (Labeling & Packing) Rules, 1986

• Alternative Medicines (unani, ayurvedic, homeopathic, Chinese, biochemical etc.) & Health & OTC products (probiotics, disinfectants, food supplements, nutraceuticals, baby milk, medicated cosmetics etc.) were non-regulated till promulgation of “Alternative Medicines & Health Products (Enlistment) Rules, 2014”. Provincial governments are regulating pharma business w.r.t. distribution and sale by following rules:

Punjab Drug Rules, 2007
Sindh Drug Rules, 2010
KPK Drug Rules, 2017
Baluchistan Drug Rules, 2018

• Punjab drug rules 2007, key features include: 

Pharmacy and medical store

• Medical Store means premises where drugs are excluding the drugs specified in the Schedule G are stored, sold or offered for sale.
• Pharmacy means premises where drugs are stored, sold, compounded, dispensed or prepared on prescription or distributed in case of authorized agent of manufacture, or importer.

• The DRAP Act 2012
The DRAP Act, 2012 promulgated and established a well-defined regulatory authority to regulate licensing, registration, pricing, quality assurance, laboratory testing, controlled drugs, pharmacy services etc., aspects of pharmaceutical industry. The Authority comprises of Chief Executive Officer (CEO) and 13 Directors for smooth working of DRAP.
Functions include:
To provide effective coordination and enforcement of the Drug Act 1976.
To bring Harmony in Inter-Provincial Trade.
Commerce of Therapeutic goods.
• The Punjab Drugs (Amendment) Bill 2015
- A bill further to amend the Drug Act, 1976 
- Certain amendments in the Drug Act, 1976
 For the eradication of the menace of spurious drugs.
 For more effective enforcement of the law through stricter penalties and for ancillary matters.

NATIONAL HEALTH POLICY

Pakistan is committed to the goal of Health for all. To achieve this, the Government is taking all possible measures in the field of health services at large and drugs in particular.
• Formulation of the national drug policy thus forms an integral component of its national health policy, purpose of which is to ensure regular availability of essential drugs of acceptable efficacy, safety and quality at affordable prices to all irrespective of their socio-economic status or place of living.
• Towards achieving this goal, Pakistan has a drug legislation, a quality control system, and certain other elements of a drug policy in fragmented form, but to meet the challenges of the day, a more comprehensive drug policy is necessary.
• The National Drug Policy encompassing all aspects of drugs which has been formulated for the first time in Pakistan to serve as a future guide.

NATIONAL DRUG POLICY

OBJECTIVES

The specific objectives of the National Drug Policy are as under:

1. To develop and promote the concept of essential drugs and to ensure regular, uninterrupted and adequate availability of such drugs of acceptable quality and at reasonable prices
2. To inculcate in all related sectors and personnel the concept of rational use of drugs with a view to safeguarding public health from over-use, misuse or inappropriate use of drugs.
3. To encourage the availability and accessibility of drugs in all parts of the country with emphasis on those which are included in the National Essential Drugs List.
4. To attain self-sufficiency in formulation of finished drugs and to encourage production of pharmaceutical raw materials by way of basic manufacture of active ingredients.
5. To protect the public from hazards of substandard, counterfeit and unsafe drugs.
6. To develop adequately trained manpower in all fields related to drugs management.
7. To develop a research base particularly for operational and applied research with a view to achieving the above mentioned objectives.
8. To develop the pharmaceutical industry in Pakistan with a view to meeting the requirement of drugs within the country and with a view to promoting their exports to other countries.

NATIONAL ESSENTIAL DRUGS LIST (NEDL)

PREPARATION OF NEDL

• The Federal Government and each provincial government until 1993 had their on lists of drugs for purchases for the government institutions and thus there was lack of uniformity in these lists.
• The concept if these lists for various levels of Health Institutions was also not distinctly defined. There was, therefore, an urgent need to prepare a National list of Essential Drugs of Pakistan with graded lists for various levels to be implemented uniformly both at the Federal and Provincial levels.
• A National Essential Drugs List of Pakistan was thus prepared in 1994 in view of the health needs of the country with the help of specialists organizations in the field of medicines and pharmacy from all over the country. This has already been published and circulated widely throughout the country.

BULK PURCHASES FOR HEALTH INSTITUTIONS

 Future bulk purchases of drugs for all government and semi-government

health institutions shall be made in accordance with this list. The NEDL

has specified the health care levels at which each essential drug is to be

used.

 Effective and well organized operating systems shall be developed for

procurement and distribution of such drugs for the population. This shall

envisage quantification of the actual needs for drugs and effective

logistics for supply.

PROMOTION OF ESSENTIAL DRUGS CONCEPT (Past Papers)

 The Essential Drug Concept and the National Essential Drug List will be

promoted in the public and private sector. Policy will be geared to

increase share of essential drugs in local production and to make such

drugs available at affordable prices where-ever needed.

 Efforts will also be made to promote rationality in essential drug

prescribing and use. To encourage this, Drug Information Sheets in line

with those of WHO model providing concise, accurate and

comprehensive information shall be prepared and widely circulated.

 A comprehensive public information shall be launched to enhance

understanding and acceptance of the Essential Drugs Concept by the

patient and the health care personnel.

 In order to promote the concept of Essential Drugs, the doctors in the

public sector shall be persuaded to prescribe rationally cost-effective

drugs from the Essential Drugs List.

 In order to encourage such practices, unbiased information about drugs

shall be published and widely circulated to the Federal and Provincial

Health Institutions.

SYSTEM OF AUDIT AND ACCOUNTABILITY

 A system of audit and accountability shall also be introduced for

monitoring the prescribing practices.

 Procurement of drugs in the public sector shall also be subject to similar

audit and accountability.

REVIEW OF NEDL

 The National Essential Drugs List will be periodically reviewed and

revised every year and made more pragmatic by a committee that

includes competent specialists in clinical medicine, pharmacology and

pharmacy and from other related fields and published.

CRITERIA FOR SELECTION OF EDS

 For the selection of essential drugs and for establishing a national

program for the use of essential drugs, the guidelines and criteria

recommended by the WHO shall be followed.

AVAILABILITY OF EDS

 The availability of essential drugs which could be in short supply shall be

ensured through the establishment of hospital pharmacy for

manufacture of such drugs and also by providing incentives to the local

industry.

CONSTITUTION OF PTC

 All teaching divisional and district hospitals shall constitute “Pharmacy

and Therapeutic Committees” to monitor and promote rational use of

drugs in the hospitals.

GENERIC NAMES FOR EDS

 Only generic names will be used for drugs in the NEDL all public sector

drug lists, inventory sheets and tender documents.

PRESCRIPTION HANDLING AT RETAIL LEVEL AND RECORD KEEPING

HANDLING OF PRESCRIPTION

 The following procedures should be adopted by the pharmacist while

handling the prescription for compounding and dispensing:

1. RECEIVING

 The prescription should be received by the pharmacist. While

receiving a prescription, a pharmacist should not change his/her

facial expression.

2. READING AND CHECKING

 After receiving the prescription it should be screened behind the

counter. Prescription authenticity should be checked.

 The signature of the prescriber and the date of prescription should be

checked. The pharmacist should read all the lines and words of the

prescription. If there is any doubt, the pharmacist should consult with

the other pharmacist or the prescriber over telephone.

3. COLLECTING AND WEIGHING THE MATERIALS

 Before compounding a prescription all the materials should be

collected from the shelves or drawers. All the materials shall be kept

in the left hand side of the balance. After measuring each material

should be kept on the right hand side of the balance.

 After compounding of the prescription materials are replaced back to

the shelves.

 While compounding every container of material should be checked

thrice in the following manner:

When

collected from the shelves.

When

the materials are measured.

When

the containers are placed back to the shelves.

4. COMPOUNDING, PACKAGING AND LABELING

 Only one prescription should be compounded at a time.

Compounding should be done on a clean table. All equipment

required should be cleaned and dried.

 The preparation should be prepared according to the direction of the

prescriber or as per methods given in pharmacopoeia or formulary.

The compounded preparations should be filled in suitable containers.

At the end label the container.

RECORD KEEPING OF PRESCRIPTION

 It is recommended for pharmacists to keep the following records for a

minimum of 5 years:

A

record of the purchase and supply of an unlicensed medicine.

The specification of the unlicensed medicine agreed with the

supplier. This should be documented and kept on file in the

pharmacy.

Verification

of the specification of the unlicensed medicine, such

as a certificate of analysis or a certificate of conformity from the

manufacturer. This should be obtained on delivery and must

include the batch number and expiry details of the product kept

on file in the pharmacy.

Patient

details, such as name and address linked to the unlicensed

medicine should also be maintained to provide an adequate audit

trail.

The

source of the product i.e. manufacturer details. The batch

number and expiry date of the product. This will be listed on

certificate of analysis or a certificate of conformity.

If

the product is in response to a prescription, the records must

also include the patient’s details, prescription details and the date

of dispensing.

The

date the product was supplied – as this may differ from the

date of manufacture.

DRUG CONTROL ADMINISTRATION AT FEDERAL AND PROVISIONAL

LEVEL

 After the commencement of DRAP Act 2012, the Federal Government

shall establish an Authority to be known as the Drug Regulatory

Authority of Pakistan.

 The Authority shall be an individual body having common seal and shall

work for the purposes of this Act.

 The Authority shall be an autonomous body under the administrative

control of the Federal Government with its headquarters at Islamabad.

 The Authority may set up its sub-offices provincial capitals and such

other places, as it may consider necessary from time to time.

 The common seal of the authority shall be kept under custody of CEO.

REGISTRATION OF DRUGS

ESTABLISHMENT OF REGISTRATION BOARD

1. Section 7 of Drugs Act 1976 describes the rules and regulations for

registration of drugs. The Federal Government shall register drugs inaccordance

with prescribed conditions and procedure and for that

purpose a Registration Board was set up, consisting of persons with

appropriate qualifications.

2. The members of the Registration Board shall exercise powers of an

Inspectors.

3. Registration board shall establish committees, sub-committees. RB shall

conduct meeting in every month and Agenda shall be circulated to

members.

COMPOSTION OF REGISTRATION BOARD (Past Papers)

1. Director Registration Board (Chairman)

2. One Representative, each from Directorate of biological drugs, medical

devices and medicated cosmetics and QA and LT directorates.

3. Director DTL Punjab, Sindh, KPK and Balochistan.

4. Veterinary medicine expert at least 15 years’ experience.

5. Pharmacology expert with 15 years’ experience to be nominated by

Federal Government.

6. Hospital Pharmacy expert with at least 15 years of experience.

7. One Experts, each having at least 15 years of experience in fields of

biologicals, physician, drug manufacturing.

8. IPO representative.

9. Law expert not below BS-19 nominated by Law Division.

10. Additional director (Regular) is Secretary.

DRUG REGISTRATION (Past Papers)

1. The registration shall be granted and reviewed on the basis of

established criteria of acceptable safety, efficacy, in terms of significant

therapeutic value, quality and keeping in view real health needs of the

country and the public interest.

2. Fixed ratio combinations products will be registered only when the

dosage of each ingredient meets the requirements of a defined

population group and when the combination has proven advantage over

single compounds administered separately in therapeutic effect, safety

or compliance.

3. All irrational, unsafe and obsolete formulations and combinations shall

be de-registered. Regsitration Board can cancel or suspend the

regitration after giving show cause notice in case of discepency or

specify further conditions.

4. Application for registration given on prescribed forms:

Form

5 (local manufacture)

Form

5A (Imported drugs)

Form

5D (New molecules)

Form

5E (Patent drugs)

 The Common Technical Document (CTD) is a set of specifications for an

application dossier for the registration of medicines. New format of

dossiers for registration consists of five modules:

Module

I – Regional administrative information (Not part of CTD)

Module

II – Quality over all summary (Clinical and non-clinical

summary and overviews)

Module

III – Quality

Module

IV – Non-clinical study reports (safety)

Module

V – Clinical study reports (efficacy).

 Duration of registration certificate is 5 years unless suspended or

cancelled. Renewal is done for further 5 years. Application for renewal

shall be received within 60 days.

 Conditions of regsitration are:

Import,

export in accordance with approval.

Indications,

side effects, dosage and cautions etc be clearly

mentioned on labels.

Suffieient

supply in market.

No

shortage of the drug in market.

Can

not discontinue production.

PRICING OF DRUGS

DRUGS PRICING

1. Section 12 of Drugs Act 1976 describes the rules and regulations for

pricing of drugs. Federal Govenrment shall fix price and profit margins of

drugs.

2. Drug manufacurers, stockist, importers, exporters etc are bound to

disclose relevant information to Fedral Government.

3. Fedral Government by notification in official Gazatte can delegate its

powers to committee or any other authority.

PRICING POLICY (Past Papers)

 Pricing policy notified on 12-06-2018. The definitions in said policy are:

 CPI – Consumer price index.

 Drug Pricing Committee – means committee notified under section 10

of Drug Act 1976.

 IMS data – Information medical statics. An organization which provide

pharmaceutical market information globally.

 Quintiles IMS data – information of Pharmaceutical market in Pakistan

by IQVIA, An organization which provides pharmaceutical market

information globally.

 Landed cost – Import price + freight + custom duty + income tax paid at

import stage + insurance + bank charges + clearing charges + civil

aviation charges + other import levies (if any).

 Manufacturing cost – API cost + other raw material cost + packaging

material cost + wastage not exceeding 3% + QC cost + production cost

including labor + depreciation on plant and machinery + fuel + energy

cost + other cost as per standards.

 NCE/NBE – New chemical entity / New biological entity that has not been

registered in the same dosage form, strength and delivery system in

Pakistan.

 Originator brand – means branded drug containing a new chemical

entity through research and development.

BASIS OF PRICING

 Two categories of drugs:

1. Drugs and biologicals on National Essential Medicine list.

2. All other drugs.

 MRP of generic never exceeds originator brand except originator brand

is de-registered or manufacturer or importer confirm the non-availability

due to non-viability.

 No person including retailer, hospital, clinic, whole seller or distributor

sell any drug to any consumer at price exceeding the MRP printed on

pack. Loose quantities should be calculated on pro-rata basis.

 Stickers, overlapping or masking of price shall not be allowed to anyone.

In case of price reduction it can be permitted on request.

PRICE FIXATION OF NCE (Past Papers)

 Price fixation of originator brand of NCE shall be based on average price

of same brand, in same strength in India and Bangladesh.

 If originator brand of NCE has not been marketed in India or Bangladesh:

Than

check average price of basket countries namely, Indonesia,

Philippines, Lebanon, Sri Lanka and Malaysia.

If

not available in these countries than check average wholesale /

procurement price available in:

 UK monthly index of medical supplies or BNF.

 Australian pharmaceutical benefit scheme.

 New Zealand pharmaceutical management agency.

 If price is not available in above references than average price of