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Essential Drugs Monitor No. 028-029 (2000)
(2000; 36 pages) [French] [Spanish] View the PDF document
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View the documentEditorial - Antimicrobial resistance: A global threat
View the documentNewsdesk
View the documentAntimicrobial resistance
View the documentLetters to the editor
View the documentNational drug policy
View the documentNewsdesk
View the documentAccess
View the documentDRUG INFORMATION
View the documentResearch
View the documentCourses & meetings
View the documentNetscan
View the documentPublished lately
View the documentTraditional medicine
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DRUG INFORMATION

Introducing Pakistan’s first Drug Helpline for professionals and patients

AYESHA AHMED*

* Ayesha Ahmed is the pharmacist in charge of the Helpline. For further information contact: The Network For Consumer Protection, 40-A, Ramzan Plaza, G-9 Markaz, Islamabad, Pakistan. Tel: + 92 51 2296802, fax: + 92 51 2291552, e-mail: helpline@best.net.pk

Providing independent drug information to health professionals and consumers through specially designated drug information centres is a relatively new concept in Pakistan. Although many countries automatically incorporate such centres in hospitals, in Pakistan they are rare.

Those that exist, such as at the Aga Khan Medical University Hospital and Jinnah Post-Graduate Hospital, Karachi, and Lahore’s Children’s Hospital, are only for use by health professionals. But recently The Network-Association for Rational Use of Medication in Pakistan has established a Drug Information Helpline, the first of its kind in the country. Catering to the needs of doctors and patients, it is not hospital based but is run from The Network’s office in Islamabad.

Meeting a need

As elsewhere, the available sources of drug information for Pakistan’s health professionals, apart from pharmaceutical companies, are the standard pharmacology textbooks, and local and international compendia. These are not only cumbersome but soon become outdated. Busy physicians have little time to go through these sources and may rely mostly on industry information about medicines.

Although patient information leaflets supplied by the manufacturer accompany each medicine, the Bulletin consumers’ sources of information about drugs Drug are mainly their prescriber and word of Network’s mouth. But prescribers The have little or no time to tell people about possible adverse/side-effects, precautions or drug interactions, as there are usually other patients waiting. They may also be unaware of some details if the drug company does not provide complete information.

Sales representative may minimise the importance of side-effects and precautions, for example. This creates a situation where there is insufficient information for the doctor and even less for the consumer. In the vast majority of cases people discuss their medicines with others showing similar symptoms, leading to abuse of medicines and the use of completely inappropriate drugs.

The Network’s efforts

Since it became involved in the health sector nine years ago, The Network, a not-for-profit organization, has been committed to protecting consumers from harmful effects of medicines caused by lack of knowledge and misinformation. Through its publications, especially the Drug Bulletin, The Network has been catering to the information needs of health professionals and consumers, but on an individual level there was no system to deal with specific requests. The Helpline has filled this gap. Started with initial support from WHO, it aims to give adequate, objective and up-to-date information on request.

A comprehensive service

A pharmacist, trained at the WHO Collaborating Centre for Drug Information, The National Poison Centre in Penang, Malaysia, runs the Helpline. Consumers and health professionals access the service by phone, fax, mail and e-mail. Working hours are quite short, 9am - 5pm Monday to Friday, mainly due to financial and staffing constraints.

The Helpline provides information on drug dosage, formulations, effects and adverse reactions, and probable drug interactions with food and with other allopathic medicines used together. The service does not offer any help with disease diagnosis or with prescribing medication to consumers, nor does it provide information on herbal or homeopathic medicines.

Requests from health professionals and consumers are dealt with in different ways. Consumers have to supply additional information about their prescribers and their prescriptions. Requests are documented on a standard form (see right) and scheduled on the basis of their urgency and the available resources - all are answered as quickly as possible. Different queries about the same drug by the same person are recorded as one. For example: if a request comes in for misoprostol and the doctor has asked for its availability, drug interactions, contraindications, precautions and side-effects, staff complete only one form and the various categories are marked on it.

Our resources

The Centre uses the latest version of MICROMEDEX, the standard updated database. It has the Drug Index and the poisoning information database, Poison Index. In addition, the Australian Prescriber, Prescrire International, Drug and Therapeutics Bulletin, Worst Pills Best

Pills, American Hospital Formulary Service, Physician’s Desk Reference, USP Drug Information, WHO Drug Information, British National Formulary and Ellenhorne’s Medical Toxicology are available. Information is also gathered from the electronic discussion groups Essential Drug (E-Drug) and International Network of Drug Information Centres (INDICES).

Much in demand

Although it is early to assess its contribution to rational drug use, the service is catering to the needs of eleven hospitals, both Government- and non Government-run. Analysis after 12 months in operation showed that 47% of users were health professionals including doctors, pharmacists and paramedic staff, and 53% consumers. The most frequently asked questions concern side-effects, availability and cost of medicines, followed by drug dosage regimen, drugs of choice, drug interactions and drug use during pregnancy. Approximately 95% of questions are answered by telephone, and the rest receive written replies.

Spreading the word

The Helpline has printed separate publicity brochures in English and Urdu and posters in the local Urdu language. Each hospital in Islamabad and Rawalpindi was contacted separately, with a letter and promotional materials sent to the Medical Superintendent or Executive Director. Doctors and other health staff received publicity materials at seminars about the service, which were held at all hospitals. The Drug Bulletin and our Urdu publication featured articles, as did the national daily English and Urdu newspapers when the Helpline was launched.

Ref No.
The Network’s Drug Information Helpline

 

Administrative Record:

Requestor (Name):

 

Date:

Profession (Please tick the right option):

 

Time:

Doctor

Pharmacist

Nurse

 

Status: New Follow up

Paramedic

Medical/Pharmacy students

 

Method of communication:

Public

     

Verbal

Written

           

Address of the requestor:
Tel:
Patient Information:

Age:

Diagnosis:

Sex:

Allergies:

Weight:

Medication being used:

Occupation:

 

Marital Status:

Laboratory values:

Additional Information:

 
           

Request:
Drug Information:

General product information

Drug interaction (unknown/drug/ laboratory/disease/food)

Pharmacokinetics/Pharmacology

Side effects/Adverse effects/ Contraindication

Therapy Evaluation/Drug of choice

Teratogenecity/Genetic effects

Dosage/Regimen recommendation

Poisoning/Toxicology

Pharmaceutical (formulation)

Pregnancy/Lactation/Infant risks

Others

Compatibility/Stability/Administration (rate/method)

           

Search Conducted (Source and utility, record specific data):

           
           

Findings/Evaluation:

           
           

Response:

         
           
           

Responder:

 

Method of response: Verbal, Written

Date:

 

Time:

 

Time spent:

 
           

Follow Up:

Additional Comment:

Effective
Required additional help
Unsatisfactory

Educational activities

The drug information Helpline has regular input in The Network’s Drug Bulletin and the Urdu publication Sarfeen Aur Sehat. As well as providing articles on specific drugs, the service also passes on the information it has on drug use trends, who is accessing the Helpline and the types of requests it is receiving.

Money matters

The service’s major constraint is lack of finance. Eventually, we want to create a national service, but for this we need more staff. At present answering queries and promoting our service are the major activities, and one person is sufficient to run the Centre. But we need to publicise our work in other cities; we need money to travel to them, and more staff to handle the increased number of queries. We want to open at least 12 hours a day or even become a round-the-clock service. Resources and equipment also need to be updated. At present we have older editions of the core titles and our subscription to MICROMEDEX, one of our major information sources, must be renewed in 2001. Moreover, we want to improve the service by using the Iowa Drug Information Service too.

Currently our dedicated phone-line is sufficient for people calling from within Islamabad and Rawalpindi. But it is inconvenient for people calling from outside the cities, mainly because it is expensive to call during the peak daytime hours. A separate toll free telephone line would solve this problem.

Proving our value

Since the Helpline started as a small pilot project in Islamabad in November 1999, it has proved popular with doctors and consumers. Now it is facilitating several hospitals, including major Government-run ones. We now believe that if information services are based within hospitals, doctors and patients could access them quicker. It could also boost the profile of hospital pharmacists and give them an opportunity to become a more integral part of the health team.

Independent and objective drug information is essential for achieving rational drug use. If it is to be effective, this information has to be tailored to the level and specific needs of the enquirer. But this is a complex process. By starting small, with what we had, we have shown that Helplines can be successful. We intend to form a network of such services, based within hospitals, and once we have shown our value nationally, we hope to attract the funding to ensure sustainability.


One of the posters produced by the Service as part of its publicity campaign

UK’s new bulletin fills patient information gap

For many years the UK’s Consumers’ Association has been providing professionals and consumers with impartial information about health. Now, as more patients want to be involved in the increasingly complex decisions regarding their health care, the Association is introducing a new information service. It will reinterpret the information it gives to doctors and pharmacists in its Drug and Therapeutics Bulletin in a new bulletin for health care consumers. The doctor- or pharmacist-supplied leaflet will be accurate, concise, easy to read and up-to-date.

The Association acted because although there is a plethora of health and medical information available, especially on the Internet, many patients do not have access to it or cannot find the right information when they need it. Also, it was felt that the quality of Internet information is mixed and can be heavily biased towards commercial sources. The Consumers Association decided there was still a dearth of high-quality, impartial information about drugs and medical treatments designed expressly for patients.

The new information bulletin will cover one topic per leaflet, for example, antibiotic resistance or weight loss. It will give background information for the newly diagnosed patient, and advice and recommendations that match the “parent” Drug and Therapeutics Bulletin. Pilot issues were tested with patients and health professionals. The Association hopes local health authorities will purchase the bulletin and make it available, free of charge, in doctors’ surgeries and community pharmacies. An electronic version should follow soon.

For further information contact: Philip Taylor, Consumer’s Association: Drug and Therapeutics Bulletin, 2 Marylebone Road, London NW1 4DF, UK. Tel: + 44 20 71 830 7608, fax: + 44 20 71 830 7664, e-mail: taylorp@which.co.uk

Transparency in US drug approval system - a lesson for others?

It is common practice for manufacturers to selectively make clinical trial results of new drugs available only as abstracts or in meeting presentations, rather than publishing full length journal articles. This creates a problem for those wanting complete information. However, it is the companies’ data, and the release of some results may have a negative impact on sales. But even when manufacturers do give a more complete report, the boundaries may be blurred between what is science - publication of peer reviewed journal articles - and what is basically drug promotion. An independent assessment of the drug becomes impossible.

A partial solution can be found in the transparency of the US drug approval process, at least for drugs approved there. The Freedom of Information Act gives public access to Food and Drug Administration (FDA) reviews of the clinical trials and other data submitted by manufacturers as part of a new drug application.

These reviews are referred to as approval packages and are available for many drugs approved since 1997 on the FDA’s web site at http://www.fda.gov/cder/foi/nda/index.htm Approval packages typically contain pharmacology/toxicology, biopharmaceutics and pharmacokinetics, and statistical reviews of the data submitted in a new drug application. The FDA Medical Officer also writes an overall assessment of a drug’s safety and efficacy, based on the reviews and the clinical trials submitted in the application.

Transcripts of FDA Advisory Committees are also valuable in that they can reveal members’ concerns about a drug’s safety and efficacy. Committee members are outside experts who make recommendations to the Agency about a drug’s approval that are not always followed. Meetings are conducted under the Federal Advisory Committee Act to ensure that the public has access to the workings of the government. Transcripts are found at http://www.fda.gov/foi/electrr.htm on the FDA’s web site, although not all drugs go before FDA Advisory Committees.

Copies of approval packages and Advisory Committee transcripts for drugs approved prior to 1997 can be obtained from the FDA through a request under the Freedom of Information Act. Access to these documents is not limited to US citizens and US non-profit organizations are granted a fee waiver when the requested information is shared with the public. Procedures for making a Freedom of Information Act request can be found at http://www.fda.gov/opacom/backgrounders/foiahand.html on the Agency’s web site.

Since January 2000, FDA reviews of new drugs are available on the FDA’s web site at least one day before Advisory Committee meetings. About 30% of the drugs approved by the FDA go before an Advisory Committee. Legal hearings have been taking place to decide if safety and efficacy data can be considered confidential commercial information that is exempt from public disclosure under the Freedom of Information Act until a drug is approved.

The selective publication of clinical trials by manufacturers can influence the perception of a new drug’s therapeutic value by only making available evidence that is most favorable to the drug. It now appears necessary to wait until a drug’s approval package is publicly available from the FDA before independent recommendations or formulary decisions can be made about new drugs. Controlled access to published clinical trial results by manufacturers and the lack of transparency in the drug approval process in other countries remain problems.

Source: E-Drug electronic discussion group message from Larry D. Sasich, Research Analyst, Public Citizen Health Research Group, 1600 20th Street, NW, Washington DC, 20009, USA. Fax: + 1 202-588-7796, e-mail: lsasich@citizen.org, Web Site: www.citizen.org/hrg

Going from strength to strength - Iran’s Drug and Poison Information Service

SHEKOUFEH NIKFAR, MOHAMMAD ABDOLLAHI, ABDOLMAJID CHERAGHALI*

* Dr Shekoufeh Nikfar, is Director of the Drug and Poison Information Centre, Tehran, Dr Mohammad Abdollahi, is Associate Professor of Pharmacology and Toxicology, Faculty of Pharmacy, Tehran University of Medical Sciences, and Scientific Consultant to the Drug and Poison Information Centre, Tehran, and Dr Abdolmajid Cheraghali is Associate Professor of Pharmacology and Toxicology, Faculty of Medicine, Baghiyatallah University of Medical Sciences, and Scientific Consultant to the Drug and Poison Information Centre, Tehran, Iran. For further information contact: Drug and Poison Information Centre, 2nd floor, Under-Secretary of Food and Drugs, Ministry of Health, Fakhr-E-Razi Street, Engheleb Avenue, Tehran-Iran.

Pharmacotherapy has become increasingly complex, as patients receive more and more drugs to manage their diseases. New prescription drugs are being introduced at a bewildering rate1,2,3, and people hear of them through the media, and increasingly through Internet. Patients request these drugs before their doctors have a chance to build their knowledge base on them. Advertising has also increased demand for non prescription and herbal drugs, nutritional therapies and even homeopathic remedies. Studies showed that drug- and poison-related problems existed in the Islamic Republic of Iran, as in many countries, and the lack of a drug information centre was evident. To go some way to meeting the needs of health professionals and consumers4, we opened the first Drug and Poison Information Centre in Tehran, in February 1997. Three and a half years of hard work later, what have we achieved?

The Centre has 10 staff, two doctors, two pharmacists and the rest are specialists in pharmacology and toxicology. Conveniently located in the city centre, we open from 8 a.m. to 8 p.m. Users can leave a message on the answer machine after working hours, or submit queries by post or e-mail. We answer requests by phone or in writing. Staff complete a standard request form, covering: name, address, occupation, education, patient history, the question, category of question, the answer and the references used. The staff member also records age, weight, sex, diagnosis, allergies and current medications, together with any other relevant details of the conversation. The request form is countersigned by the supervisor who reviews the responses. If we suspect that a caller has had an adverse reaction to medication, we report the incident to the National Adverse Drug Reaction Centre, with which we collaborate very closely.

We are rigorous about quality, and an internal committee at the Centre reviews response forms regularly, looking at the references used, and the clarity, accuracy and completeness of answers.

Table 1
Categories of enquiries at the Drug and Poison Information Centre from February 1997 to January 2000 (n=31931)

Enquiries

Number

Frequency (%)

Therapeutic use

5109

16

Poisoning

4470

14

Pregnancy and lactation

3832

12

Adverse effects

3512

11

Dosage

3193

10

Drug abuse

3098

9.7

Therapeutic comparative efficacy

2554

8

Interaction

2235

7

Substitution

1277

4

Precautions

958

3

Identification of foreign product

639

2

Contraindications

639

2

Metabolism

319

1

Pharmaceutical compatibility

96

0.3

Fast, efficient and increasingly popular

We analysed 31,931 enquiries to assess the type of users, questions asked and references used between February 1997 and January 2000. Most questions were answered verbally (85%), 3% were answered only in writing and 12% were answered verbally and followed up with a written response. Ninety percent of the questions took less than 15 minutes to answer, while 10% took more than 15 minutes, up to a maximum of two days. The number of enquiries rose from 6,500 in our first year to 16,898 between February 1999 and January 2000. The number and type of questions received by the Centre are given in Table 1. The majority concerned problems involving therapeutic use (indication and efficacy), poisoning, pregnancy and lactation, and adverse effects. Among poisoning cases most enquiries concerned drugs (70%), followed by other chemicals (20%) and herbals or natural toxins (10%).

Physicians (26%), pharmacists (25%) and patients or their relatives (25%) were the most frequent users, while nurses (8%), dentists (6%) and other health professionals (5%) use us to a lesser extent. Physicians mainly asked about drug dosage and therapeutic use, while specialists were interested in the comparative efficacy and toxicity of drugs, particularly new ones. Most pharmacists wanted to know about formulations, interactions, identification of foreign products and substitution. Nurses commonly asked us about pharmaco-kinetics, dosage and compatibility of intravenous drugs.

Table 2
Distribution of drug-related questions according to anatomical therapeutic chemical classification system from February 1997 to January 2000

Drug class

Number

Frequency(%)

Central nervous system

6386

20

Gastrointestinal system

4790

15

Systemic anti-infectives

4151

13

Systemic hormonal preparations

3832

12

Cardiovascular system

3831

12

Genitourinary system

3193

10

Dermatological system

1916

6

Respiratory system

1914

6

Antineoplastic/ immunosuppressive drugs

957

3

Blood and blood-forming organs

319

1

Various

642

2

Significantly 10% of the patients contacting the Centre said they did so because their doctor or pharmacist had failed to provide any information about the uses and effects of prescribed medications. Forty percent considered the information provided to be unclear or in some way inadequate, and 50% wanted a second opinion, to verify the accuracy of information provided by the physician or pharmacist.

Table 2 gives a breakdown of drug-related questions according to anatomical therapeutic classification. Questions about drugs acting on the central nervous system (mostly antidepressants and anticonvulsants) were the most common, followed by requests concerning gastrointestinal drugs (mostly acid lowering agents), systemic anti-infectives (mostly fluoroquinolones, cephalosporins and penicillins), systemic hormonal preparations (mostly sex and thyroid hormones, then antidiabetics), cardiovascular drugs (mostly β-adrenoceptor blockers and antihypertensives), drugs affecting the genitourinary system (mostly drugs for impotence and erectile dysfunctions),dermatological drugs (mostly drugs used for acne and alopecia), respiratory drugs (mostly antiasthmatic agents). There are also questions concerning drugs used for specific disease groups like hepatitis, cancer, immune disease, coagulation factors deficiency and thalacemia.

The references we use most are the DRUGDEX (used in 48.9% of queries), POISINDEX (16%), TOMES (8%) and EMERGINDEX (7%) databases. Among our textbooks Briggs’ Drugs in Pregnancy and Lactation is used most often. Other frequently used textbooks were Martindale’s The Extra Pharmacopoeia, followed by Kathzung’s Basic and Clinical Pharmacology, Merck Manual, Harrison’s Principles of Internal Medicine, American Hospital Formulary Service Drug Information Source and Ellenhorn’s Medical Toxicology. The bibliographic databases of IOWA Drug Information, Medline and useful Internet sites are also used regularly to search medical literature (Table 3).

Table 3
The most frequently used references at the Drug and Poison Information Centre from February 1997 to January 2000 (n=31931)

Reference name

Number

Frequency
(%)

DRUGDEX Micromedex international health care series

15615

48.9

POISINDEX Micromedex international health care series

5109

16

TOMES Micromedex international health care series

2554

8

EMERGINDEX Micromedex international health care series

2235

7

Briggs Drugs in pregnancy and lactation

1596

5

Martindale The extra pharmacopoeia

734

2.3

Kathzung Basic and clinical pharmacology

639

2

Merck manual

639

2

Harrison Principles of internal medicine

638

2

AHFS Drug information source

638

2

Ellenhorn Medical toxicology

447

1.4

MEDLINE

416

1.3

IOWA drug information services

319

1

Others

352

1.1

More than an enquiry service

Drug and poisoning information requests take up most time. But in our efforts to educate and promote rational use of drugs we do far more than wait for questions to come to us. As Table 4 shows the Centre participates in pharmacy and therapeutic committees; gives workshops, seminars and lectures as part of its training and education programme; produces information newsletters, pamphlets and review articles; conducts literature searches; provides mass media information to help increase rational use of drugs; and reports to the Adverse Drug Reaction Centre. As the Service’s popularity has grown so too has the variety of organizations we assist.

The Centre tries to ensure that the literature it produces meets the needs of users. So, when we do quality checks on our responses we also assess the need for education materials on particular topics. For example, we were receiving questions from young men about the effects of anabolic drugs that might be used for body building. We immediately increased our dissemination of information on this subject in seminars, the mass media and our newsletters.


Drug and Poison Information Centres

Drug and Poison Information Centre, Tehran

New drug and poison information centres are being set up throughout Iran

As our drug and poison information pamphlets are so popular, the Centre has created a subscription service, which includes over 20,000 health professionals. They regularly receive literature promoting rational drug use, often based on our most interesting queries.

We want as many Iranians as possible to have access to drug information, not only those living in the capital. So we have established new drug and poison information centres - more than 15 to date - all with access to a computer and references (see map). The Tehran Centre supports them by providing reference materials and funds.

After our first assessment of the Centre we are optimistic about its future. Questionnaires distributed to health professionals during seminars showed that they thought our service has an impact on prescribing practice, and in most cases users were satisfied with their consultation. The increased rate of enquiries and users are other positive indicators.

Now we want to build on success. The Centre is preparing more reference materials for health professionals and expanding its e-mailing of information on specific diseases to patients. We are doing more evaluation of Internet sources for patients. We are also considering having a computer-based system to assist in analysing information, and documenting the Centre’s activities and effectiveness.

Staff believe they could be even more effective if health professionals’ training and continuing education covered the role and use of drug information centres. We also want to see more training in applied toxicology, to reduce the large number of poisoning queries we receive.

Our work with the public is very important, particularly given our findings on the lack of information patients receive about their prescribed medicines, and people’s increased exposure to advertisements and media-provided information. Correct, unbiased and practical drug and poison information is one of the best ways to neutralise the effect of drug promotion and reduce drug-related adverse effects.

Table 4
Percentage of time spent on Drug and Poison Information Centre activities from February 1997 to January 2000

Activity

Frequency (%)

Providing drug and poisoning information

30

Producing newsletters and pamphlets

14

Providing seminars and giving lectures

10

Reporting to the Adverse Drug Reaction Centre

10

Preparing review articles

9

Providing workshops, training and education

8

Establishing new drug and poison information centres

7

Participating in pharmacy and therapeutic committees

5

Conducting literature searches

4

Providing mass media information

3

Our analysis of queries has shown that too little of this exists in Iran and underlines the Centre’s crucial role in the health care system and the community.

References

1. Johnson JA, Bootman JL. Drug-related morbidity and mortality. Arch Intern Med 1995;155:1949 - 1956.

2. Fontanarosa PB, Lundberg GD. Alternative medicine meets science. JAMA 1998; 20:1615 - 22.

3. Rodriguez C, Arnau JM, Vidal X, Laporte JR. Therapeutic consultation: a necessary adjunct to independent drug information. Br J Clin Pharmacol 1993;l 35:46 - 50.

4. Hemminki E, Herxheimer A. Should drug information be an integral part of health care? J R Coll Physicians Lond 1996; 30:104 - 6.

 

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